Oblique flow membrane module

Abstract

The present invention relates to a membrane module (1) for processing blood (B), the membrane module (1) comprising at least one processing space (3), a replacement membrane (5) having a plurality of semipermeable hollow fibers (7), and potting (21) to which first fiber ends (17) and second fiber ends (19) of the hollow fibers (7) of the replacement membrane (5) are fixed and which at least partially define the processing space (3), wherein at least a first subset of hollow fibers (37) is arranged in the processing space (3) such that its longitudinal directions (RF1, RF2) are oblique to the main flow direction (RH). The present invention also relates to a blood processing system (200), two methods (300, 400) for manufacturing the membrane module (1), an assembly method, and a method (500) for extracorporeal processing of blood (B).

Description

Technical Field

[0001] The present invention relates to a membrane module for blood treatment, which comprises at least one blood inlet and at least one blood outlet, wherein the blood inlet and the blood outlet are connected to each other by a processing space along the main flow path direction, the exchange membrane has a plurality of semipermeable hollow fibers, each hollow fiber extends through the processing space in the longitudinal direction of the fiber, and is designed such that a processing medium flows from a first fiber end to an opposite second fiber end in the longitudinal direction of the fiber, the first fiber end and the second fiber end of the hollow fibers of the exchange membrane are fixed, and the exchange membrane is provided with potting that at least partially defines the processing space. Furthermore, the present invention relates to a method for manufacturing the membrane module, a blood treatment system, an assembling method, and an extracorporeal blood treatment method.

Background Art

[0002] Adding gas to a fluid and controlling the temperature of a fluid using a heat exchange membrane are well-known techniques for preparing a fluid for subsequent processes and procedures. In medical technology, these principles are very important in blood treatment. In particular, when respiratory function deteriorates sharply, supplying oxygen to a patient is essential. Especially in severe cases, it is necessary to oxygenate (concentrate) the patient's blood. In extracorporeal membrane oxygenation (ECMO), a considerable portion of the blood of the patient to be treated is drained extracorporeally through a device suitable for extracorporeal oxygen enrichment. Draining a large amount of blood extracorporeally places a great burden on the body and involves considerable risks. For example, to prevent thrombosis in the patient and blockage of the ECMO device due to thrombus formation, it is necessary to use a large amount of anticoagulants. Therefore, ECMO is generally used as a last resort, especially in cases of severe respiratory failure or during surgery. However, in other cases such as carbon monoxide poisoning, anemia treatment, and adjuvant cancer treatment, it may be beneficial to enrich the patient's blood with oxygen. Furthermore, it is often necessary to remove gas from body fluids or remove gas therefrom. For example, this is the case when removing carbon dioxide from the blood of a patient undergoing treatment.

[0003] However, there are very few devices on the market suitable for assisting the oxygenation of a patient's blood. As already mentioned, conventional extracorporeal membrane oxygenation (ECMO) devices are designed to handle high blood flow rates and are therefore not suitable for supportive therapy in conscious patients. Due to the high blood flow rate required, known blood processing devices, especially their membrane modules, pose a very high health risk, particularly with regard to thrombosis, when used at low flow rates. [Overview of the Initiative]

[0004] The object of the present invention is to provide a membrane module that improves blood processing, particularly processing that is less burdensome for the patient, and / or enables efficient blood processing even at relatively low blood flow rates.

[0005] The present invention solves this problem in a first aspect by using the membrane module described in claim 1. In particular, the present invention provides a membrane module for processing blood, the membrane module comprising at least one processing space having at least one blood inlet and at least one blood outlet connected to each other in the direction of the main flow path, and a replacement membrane having a plurality of hollow fibers, each extending through the processing space in the longitudinal direction of the fibers, and designed so that the processing medium flows from a first fiber end to a second fiber end on the opposite side in the longitudinal direction of the fibers, and comprising potting to which the first and second fiber ends of the hollow fibers of the replacement membrane are fixed and at least partially define the processing space, and at least a first subset of the hollow fibers is arranged in the processing space such that its longitudinal direction is oblique to the direction of the main flow path.

[0006] Preferably, some of the hollow fibers, and more preferably all of them, are semipermeable. Therefore, the exchange membrane can be composed of multiple semipermeable hollow fibers. In another embodiment, some or all of the hollow fibers may be completely airtight, for example, when intended for the temperature treatment of blood. In yet another embodiment, some or all of the hollow fibers may be porous.

[0007] The fluid to be processed, particularly blood, can be processed by a processing medium flowing through hollow fibers as it flows through the processing space. The processing may include temperature processing (particularly the addition and / or removal of heat), heating, cooling, and / or temperature stabilization, and / or mass transfer (particularly gas exchange). Such gas exchange is, in particular, oxygenation (concentration of oxygen) and / or reduction of carbon dioxide content of the blood to be processed. The processing space is preferably the portion of the membrane module through which the blood to be processed comes into contact with the hollow fibers of the exchange membrane. It is important to understand that the processing space may also contain a free cross-sectional area through which the blood can pass. Therefore, it is preferable that the hollow fibers of the exchange membrane be spaced apart from each other so that the blood flows near the hollow fibers through the formed free cross-sectional area. Furthermore, the processing space may include portions without hollow fibers or fiber-free portions. However, preferably, the processing space has portions containing at least hollow fibers in each cross-section perpendicular to the main flow direction. Embodiments of the membrane module according to the present invention also exist in which hollow fibers are not provided. For example, a continuous membrane module and / or at least one planar membrane may be provided. In other embodiments of the present invention, the membrane may be omitted. The processing may be carried out, for example, through a wall partitioning the processing space, which may be formed at least partially from a membrane material for this purpose. It should be understood that, within the scope of this disclosure, if the processed blood is administered to a patient at a later stage that does not constitute part of the present invention, the processing does not need to have a direct or indirect therapeutic effect on the patient. The processing may include any form of action on the blood or other bodily fluids to be processed.

[0008] The hollow fibers preferably extend linearly through the processing space. This allows tension to be applied to the hollow fibers, minimizing deformation of the fibers due to the fluid flowing through the processing space. The blood inlet and outlet are connected along the main flow direction. The main flow direction is preferably substantially linear, and particularly preferably from the blood inlet to the blood outlet. Preferably, the main flow direction is defined along a straight line connecting the centroid of the blood inlet and the centroid of the blood outlet. The blood inlet and outlet are preferably located on opposite sides of the main flow. However, the main flow may extend along a curve at least partially. The main flow direction may be curved, preferably perpendicular to the free flow section in each cross-section of the processing space. The blood inlet and outlet may be adjacent to each other, for example, on the same side of the housing, and the main flow direction may be, for example, substantially U-shaped. The main flow direction refers to the direction of flow of the medium to be processed, particularly blood, through the entire processing space. For example, it is important to understand that local turbulence and secondary flow caused by the flow around individual hollow fibers can cause individual fluid particles in the medium being treated to not follow the main flow direction. In a preferred embodiment of the present invention, the main flow direction may be defined by the average velocity or its vector at each cross-section of the processing space.

[0009] The hollow fibers of the exchange membrane are designed so that the processing medium flows along the longitudinal direction of each fiber. The liquid to be processed, particularly blood, comes into contact with the hollow fibers in the processing space as it flows through it and is processed. The processing medium is preferably a liquid. For example, the processing medium is temperature-controlled water, preferably used to control the temperature (heating and / or cooling) of the blood flowing through the processing space. Preferably, the processing medium is a gas or a mixture of gases. Such a gas or mixture of gases is also called a scavenging gas. The scavenging gas is oxygen and / or anesthetic gases, or preferably contains them. In addition or supplement, the scavenging gas may include ozone (O3), carbon dioxide (CO2), carbon monoxide (CO), nitric oxide (NO), nitrogen (N2), xenon (Xe), argon (Ar), isoflurane (C3H2ClF5O), and / or mixtures thereof. The oxygen flowing through the hollow fibers can be used to oxygenate the blood in the treatment space or to reduce the carbon dioxide and carbon monoxide content in the blood. Preferably, the treatment medium enters from one end of the fiber and exits from the other. However, the flow within the fiber can be in the opposite direction.

[0010] In addition to, or instead of, hollow fibers, solid fibers may be provided. For example, heat-treated fibers may be used for heat-treating blood, and these may extend throughout the entire treatment space.

[0011] Preferably, the potting holds or fixes in place the first and second fiber ends of the hollow fibers of the exchange membrane. The potting may be, for example, formed by bonding the fiber ends with an adhesive. Preferably, the potting is liquid-tight and / or airtight. The potting may form one or more walls that at least partially partition the processing space. For example, the potting may form side walls of the processing space through which the blood to be processed flows in the direction of the main flow path. It should be understood that the potting may be formed continuously or may consist of at least several potting sections that are separated from each other. For example, the potting may consist of two potting sections, each section forming a wall separated from the other wall. The potting preferably comprises a potting material selected from the group consisting of silicone, polyurethane, polyolefin, polyethylene, epoxy, cyanoacrylate, or mixtures thereof.

[0012] The inventions described herein may also include embodiments in which potting is not performed, and in which hollow fibers or other membrane elements are fixed in a different manner.

[0013] Furthermore, the present invention may also include embodiments in which the replacement membrane comprises at least one fiber mat in which a plurality of fibers, particularly hollow fibers, are connected by warp threads. In a particularly preferred embodiment, the main flow direction extends basically along the warp threads, preferably parallel to the warp threads. In such embodiments, the longitudinal direction of the fibers does not necessarily have to be at an angle with respect to the main flow direction.

[0014] Preferably, a first subset of a plurality of semipermeable hollow fibers is arranged in the processing space such that its fiber longitudinal direction is oblique to the main flow direction. The first hollow fiber subset may include all of the plurality of hollow fibers of the replacement membrane. Preferably, the first hollow fiber subset is substantially parallel to each other or unidirectional. Hollow fibers arranged oblique to the main flow direction are neither parallel nor perpendicular to the main flow direction. When hollow fibers (or their fiber longitudinal direction) run oblique to the main flow direction, the angle with the main flow direction is either acute or obtuse, other than 90°. The angle of attack is the smaller of the angles formed between the main flow direction and the fiber longitudinal direction. The first hollow fiber subset (each fiber in its longitudinal direction) forms an angle of attack with respect to the main flow direction that is preferably greater than 0° and 90° or less, preferably 5° to 90°, preferably 10° to 90°, preferably 15° to 90°, preferably 15° to 85°, preferably 15° to 80°, preferably 12° to 75°, preferably 15° to 75°, preferably 20° to 75°, preferably 20° to 70°, preferably 25° to 70°, preferably 25° to 65°, preferably 30° to 65°, preferably 30° to 60°, preferably 35° to 60°, preferably 35° to 55°, preferably 40° to 55°, and preferably 40° to 50°. When viewed from the direction of flow, the angle of attack is the smaller of the angles that can be formed between the main flow direction and the fiber longitudinal direction. The angle of attack is determined within the plane of the hollow fiber, which is also called the fiber direction plane. The first subset of hollow fibers extends within or parallel to this fiber direction plane.

[0015] Preferably, the first hollow fiber subset can form a second angle of attack with respect to the main flow direction, determined in a plane perpendicular to the fiber direction plane. The second angle of attack is preferably greater than 0° and less than or equal to 90°, preferably greater than 5° and less than 90°, preferably greater than 10° and less than 90°, preferably greater than 15° and less than 90°, preferably greater than 15° and less than 85°, preferably greater than 15° and less than 80°, preferably greater than 12° and less than 75°, preferably greater than 15° and less than 75°, preferably greater than 20° and less than 70°, preferably greater than 25° and less than 70°, preferably greater than 25° and less than 65°, preferably greater than 30° and less than 60°, preferably greater than 35° and less than 60°, preferably greater than 35° and less than 55°, preferably greater than 40° and less than 55°, preferably greater than 40° and less than 50°, thereby allowing for the requirement of limit values. The first hollow fiber subset preferably comprises at least 5%, preferably at least 10%, preferably at least 15%, preferably at least 20%, preferably at least 25%, preferably at least 30%, preferably at least 35%, preferably at least 40%, preferably at least 45%, preferably at least 50%, preferably at least 55%, preferably at least 60%, preferably at least 65%, particularly preferably 70%, preferably at least 75%, preferably at least 80%, preferably at least 85%, preferably at least 90%, and preferably at least 95% of the total hollow fibers of the exchange membrane. The first hollow fiber subset may comprise all of the hollow fibers of the exchange membrane.

[0016] Viewed in the coordinate system of the membrane module, the main flow direction may have directional components in all three spatial directions. Preferably, the main flow direction is oriented such that the largest directional component of the main flow direction is parallel to the mat surface of the fiber mat of the replacement membrane. Such a flow may also be called a flow within the mat surface. The invention described herein may also include modifications in which the first hollow fiber subset does not flow in obliquely. The flow through the mat surface described above is also preferred in such modifications. It is particularly preferred in the case of at least one subset of hollow fibers whose fiber longitudinal direction runs transverse to the main flow direction. In a preferred embodiment of the invention, the first hollow fiber subset is arranged in the processing space such that its fiber longitudinal direction is parallel and / or transverse to the main flow direction.

[0017] According to the first preferred embodiment, the main cross-section of the processing space changes in a direction perpendicular to the main flow direction. In this embodiment, the main cross-section of the processing space changes in at least several cross-sections when viewed along the main flow direction. For example, the area of ​​the first main cross-section may be smaller than that of the second main cross-section located downstream in the main flow direction. The main cross-section of the processing space preferably includes a free flow cross-section in which the medium to be processed flows in the main flow direction and a fiber cross-section occupied by the hollow fibers of the exchange membrane. Therefore, the main cross-section is preferably a cross-sectional area of ​​the processing space that takes into account both the free flow cross-section and the fiber cross-section. The flow velocity of blood passing through the processing space is basically determined by the free flow cross-sectional area. The main cross-section (or main cross-sectional area) is an important factor that affects the flow velocity. For example, by increasing the main cross-sectional area while keeping the absolute fiber cross-section (or fiber cross-sectional area) constant, the free flow cross-sectional area can usually be increased, thus reducing the blood flow velocity in the processing space at a constant blood flow rate. By changing the main cross-sectional area in this way, it becomes possible to optimally adjust the blood flow velocity in the processing space. For example, by adjusting the flow rate, the thrombus-forming capacity of the blood being processed can be reduced. As a result, the amount of anticoagulant that the patient needs to take can be minimized. Furthermore, the variable main cross-sectional area promotes uniform blood flow. For example, it can reduce the occurrence of backflow regions and dead water regions that could adversely affect the thrombus-forming capacity of the blood being processed. Such desirable further developments are also preferred in the membrane module according to the second aspect of the present invention, which will be described later.

[0018] Preferably, the processing space is rotationally asymmetric. In particular, the processing space may be rotationally asymmetric or non-rotationally symmetric with respect to the longitudinal axis of the membrane module and / or the axis parallel to the main flow direction of the membrane module. This preferred further development is also preferred in the membrane module according to the second aspect of the present invention, which will be described later. During the production of potting (also called potting), a potting material such as an adhesive is usually used. Due to the capillary action of the hollow fibers, this potting material may move inward and outward along the hollow fibers before it solidifies. This can impair the replaceability of the hollow fibers. Therefore, during molding, force is usually applied to the molding material to prevent this creep phenomenon. For example, the mold used for molding is rotated in a centrifuge and waited for the molding material to solidify. However, manufacturing a rotationally symmetric processing space is very costly. The inventors have found that by providing a rotationally asymmetric processing space, the production of membrane modules can be greatly simplified.

[0019] In a preferred embodiment, the processing space has essentially an elliptical cylindrical shape. This preferred further development is also preferred in the membrane module according to a second aspect of the present invention, which will be described later. The elliptical cylinder has an elliptical base and extends vertically. The elliptical base region includes a minor axis and a major axis. Preferably, the main flow direction extends substantially along the principal axis of the elliptical base shape of the elliptical cylinder. Preferably, the main flow direction does not extend in the height direction of the elliptical cylinder. The main flow direction may extend along the minor axis. Depending on the deformation, the elliptical base area may change in the height direction, in which case the processing space does not necessarily have to be an elliptical cylinder. It should be understood that the shape of the processing space may deviate partially from the shape of an elliptical cylinder, but still essentially maintain the shape of an elliptical cylinder. In particular, the processing space may deviate from the shape of an elliptical cylinder near the blood inlet and / or blood outlet, while the rest of the processing space basically has the shape of an elliptical cylinder. For example, the blood inlet is located at one end of the elliptical base shape, and the blood outlet is preferably located at the opposite end.

[0020] Preferably, the processing space is basically cylindrical. This preferred shape is also preferred in the membrane module according to the second aspect of the present invention, which will be described later. The cylindrical shape has a closed bottom surface displaced along a straight line in the height direction. The bottom surface may be circular, but does not have to be circular. Preferably, the bottom surface of the cylinder is basically defined by two arcs. It is a sub-region of a circular area enclosed by the arcs and chords, and is different from a sector defined by an arc and two circular radii. Preferably, the chord of at least one arc does not pass through the center of the bottom circle of that arc. Preferably, the chords of the arcs defining the bottom area of ​​the processing space are congruent. However, for example, the circular segments may be spaced apart from each other, in which case the bottom area of ​​the cylinder preferably also includes the area portion located between the circular segments. The circular segments are preferably mirror-symmetric to each other. The main flow direction is preferably perpendicular to the height direction of the cylinder. The bottom area of ​​the cylinder may be defined such that the arcs enclose a polygon, particularly a rectangle. The shape of the processing space may deviate locally from the cylindrical shape, particularly at the blood inlet and / or blood outlet.

[0021] The design of the processing space described above, particularly its rotationally asymmetric shape, a shape essentially resembling an elliptical cylinder, a shape essentially resembling a general cylinder, and / or a main cross-sectional shape that changes along the main flow direction, is preferred regardless of the presence of a membrane, the arrangement of fibers, and / or the alignment of the fiber longitudinal direction with the main flow direction. The invention described herein may also include, as another embodiment, an embodiment in which there are no fibers but the processing space is rotationally asymmetric. Furthermore, the invention described herein may include an embodiment in which a first subset of a plurality of hollow fibers is arranged in the processing space such that its fiber longitudinal direction is lateral to the main flow direction (fiber transverse flow direction), and the processing space has a main cross-section perpendicular to the main flow direction, and the main cross-section changes along the main flow direction. Accordingly, the orientation of the fibers in the processing space, or the orientation of the fibers with respect to the main flow direction, and the shape of the processing space should each be independently adjustable.

[0022] Preferably, the potting has a first potting section and a second potting section, the first potting section preferably forming a first side wall of the processing space, and the second potting section preferably forming a second side wall of the processing space opposite to the first side wall. In particular, the first side wall and / or the second side wall are preferably concave in shape. When viewed from the processing space toward the side wall or a plurality of side walls, these side walls are concave. This makes the processing space convex, preferably creating a bulge. This preferred shape is further developed in the membrane module according to a second aspect of the present invention, which is described below, and also includes a first potting section and a second potting section.

[0023] In some embodiments, the membrane module has a cover that encloses the processing space, and particularly preferably this cover is partially or at least transparent. Preferably, the cover is substantially flat. The partially or at least transparent cover allows visibility into the interior of the membrane module. This allows for easy visual monitoring of the condition of the replacement membrane. For example, thrombi that may clog the processing space can be easily detected. The cover preferably partitions the processing space at least partially. The membrane module may comprise multiple covers. For example, the processing space may be partitioned by side walls formed by potting and a cover that extends substantially laterally to the side walls. The cover may connect to and / or extend between potting sections or side walls formed by potting sections. Preferably, the cover has one or more reinforcing elements. If overpressure occurs inside the membrane module during operation, the membrane module may expand or bulge outward. Reinforcing elements may be provided to prevent this bulging. During normal use of the membrane module, it is preferable that the cover is flat. In addition to, or instead of, the reinforcing elements, the cover may be concave. Furthermore, in the membrane module according to the second aspect of the present invention, which will be described later, it is preferable to provide a predetermined cover for the processing space.

[0024] Preferably, the potting has a third potting section forming a third sidewall of the processing space, the third potting section preferably positioned substantially laterally with respect to the first and / or second sidewalls of the processing space. The third potting section does not need to hold the fiber ends. Preferably, the third sidewall has substantially the same shape as the first and / or second sidewalls, except for its orientation relative to the processing space. For example, the third sidewall has a concave shape, and particularly preferably, its concave recess is identical (depth, spread perpendicular to the depth) to the recess of the first and / or second sidewalls. Furthermore, the potting preferably has a fourth potting section forming a fourth sidewall of the processing space. Preferably, the fourth sidewall is located opposite the third sidewall. The fourth sidewall may be designed in a similar manner to the first, second, and / or third sidewalls. Particularly preferred are four side walls that define the processing space. The side walls may be designed symmetrically. However, all side walls may also be designed to be essentially the same shape, differing only in their orientation relative to the processing space. Particularly preferred are four side walls that define a processing space that is essentially the shape of an American football (excluding the main seams of the football) or a rugby ball, and the processing space may deviate from the football shape, especially at the tip. In other variations, each side wall may have its own unique shape. Regardless of the presence or absence of a membrane, the type of membrane, or how the hollow fibers of the membrane are arranged relative to the main flow direction, the processing space shapes described above are preferred. For example, a processing space with four concave side walls is preferred in both membrane modules where the fiber longitudinal direction is arranged laterally and / or parallel to the main flow direction, and in membrane modules where the fiber longitudinal direction is arranged obliquely to the main flow direction. This type is also preferred in modules without a membrane penetrating the processing space. The first, second, third, and / or fourth side walls are preferably curved in only one direction. This preferred further development, which includes a third potting section, is also preferred in the membrane module according to a second aspect of the present invention, which is described below.

[0025] Preferably, the packing density of the hollow fibers varies along the direction of the main flow path. The packing density is defined as the ratio of the fiber cross-sectional area to the main cross-sectional area in each cross-section of the processing space perpendicular to the direction of the main flow path, where the fiber cross-sectional area is the dividend and the main cross-sectional area is the divisor. Since the fiber cross-sectional area is calculated based on the outer diameter of the fiber, the free inner diameter of the fiber is also added to the fiber cross-sectional area. The packing density of the hollow fibers affects the flow velocity of the medium being processed in the processing space. By varying the packing density, the flow velocity in the processing space can be adjusted, reducing or preventing backflow regions, flow turbulence, and / or abrupt changes in flow velocity. This reduces the risk of coagulation and allows for gentler processing of blood. Reducing the amount of anticoagulant used makes it possible to treat patients more gently and extend the service life of the membrane module. This preferred development is also preferred in the membrane module according to the second aspect of the present invention, which will be described later.

[0026] In a preferred further development, the packing density increases along the direction of the main flow path from the blood inlet toward the central section of the processing space and / or decreases toward the blood outlet toward the central section. This increase and / or decrease is preferably continuous but can occur abruptly. For example, the packing density can be abruptly increased by locally supplying additional fibers, additional fiber bundles, and / or additional fiber mats (per main section). This preferred further development is equally preferred for the membrane module according to a second aspect of the present invention, which will be described later.

[0027] Preferably, the membrane module comprises at least a second hollow fiber subset among the plurality of hollow fibers. Preferably, the second hollow fiber subset of the plurality of hollow fibers of the exchange membrane has an orientation different from that of the first hollow fiber subset. The use of hollow fibers in different orientations can improve the treatment effect within the membrane module. For example, it is possible to more uniformly increase the oxygen concentration in blood flowing through the treatment space. In addition, the manufacture of the membrane module is also facilitated. As described above, the use of fibers with different orientations can prevent the fibers from slipping against each other during lamination. The first hollow fiber subset and the second hollow fiber subset having different orientations have different fiber longitudinal directions respectively. It should be understood that among the plurality of hollow fibers, different hollow fibers, particularly different hollow fiber subsets, may allow different treatment media to flow therethrough. This preferable further development using the second hollow fiber subset is also preferable for the membrane module according to the second aspect of the present invention described later.

[0028] In a preferred embodiment, only the first hollow fiber subset is located in the inlet region of the processing space adjacent to the blood inlet, and / or only the second hollow fiber subset is located in the outlet region upstream of the blood outlet. These regions are also called winglets. The outlet region is located upstream of the blood outlet and in the direction of the main flow path. When viewed along the direction of the main flow path, the inlet region is preferably the processing space region between the blood inlet and a first cross section perpendicular to the direction of the main flow path, where the fibers of the first subset of hollow fibers and the fibers of the second subset of hollow fibers overlap. When viewed along the direction of the main flow path, the outlet region is preferably the processing space region between the last cross section perpendicular to the direction of the main flow path (where the fibers of the first subset of hollow fibers and the fibers of the second subset of hollow fibers overlap) and the blood outlet. The inlet region extends to a region of preferably 50% or less, preferably 40% or less, preferably 30% or less, and preferably 20% or less of the total length of the processing space measured along the direction of the main flow path. The outlet region preferably extends to an area of ​​50% or less, preferably 40% or less, preferably 30% or less, and preferably 20% or less of the total length. By providing only one subset of hollow fibers in the outlet region and / or inlet region, the medium to be processed flows uniformly within the processing space. For example, the blood flow entering the processing space does not immediately contact all of the hollow fibers of the exchange membrane, but only the first subset. In this way, the rate of blood flow can be adjusted in stages, thereby reducing the risk of coagulation. In particular, by combining this with a structure in which the main cross-sectional area of ​​the processing space changes in the direction of the main flow path, extremely uniform blood flow can be achieved. This preferred further development is also preferred in the membrane module according to the second aspect of the present invention, which will be described later. In such modifications, the inlet section and / or outlet section preferably correspond to sub-sections.

[0029] Preferably, at the inlet of the processing space adjacent to the blood inlet, the hollow fibers of the first subset of hollow fibers protrude at least partially beyond the hollow fibers of the second subset of hollow fibers, and / or the hollow fibers of the second subset of hollow fibers protrude at least partially beyond the hollow fibers of the first subset of hollow fibers. Alternatively, or in addition, at the outlet section of the processing space upstream of the blood outlet, the hollow fibers of the first subset of hollow fibers at least partially cover the hollow fibers of the second subset of hollow fibers, and / or the hollow fibers of the second subset of hollow fibers at least partially cover the hollow fibers of the first subset of hollow fibers. The first hollow fiber subset may protrude above the second hollow fiber subset. In particular, it may protrude in the direction of the main flow path and / or laterally to the direction of the main flow path and / or obliquely to the direction of the main flow path, and vice versa. For example, in a first subsection adjacent to the first side wall of the inlet section, the first hollow fiber subset protrudes more than the second hollow fiber subset, while in a second subsection adjacent to the second side wall on the opposite side of the inlet section, the second hollow fiber subset protrudes more than the first hollow fiber subset. It should be understood that the shape of the side walls is not essential in the embodiments described herein. When viewed along the main flow direction, the inlet section is preferably part of the processing space between the blood inlet and a first cross section perpendicular to the main flow direction, where the maximum fiber density is first reached. The fiber density is always determined over the entire main cross section perpendicular to the main flow direction. Thus, the inlet cross section extends, for example, from the blood inlet to a first cross section where the hollow fibers of the membrane completely overlap. The outlet cross section is defined similarly to the inlet cross section, but defined from an upstream, i.e., reverse, viewpoint in the main flow direction. Thus, the outlet section is defined as the cross section between the last cross section where the fiber density is maximum and the blood outlet. This favorable further development is also applicable to the membrane module according to a second aspect of the present invention, which will be described later.

[0030] The inlet section preferably extends over a range of not more than 100%, preferably not more than 50%, preferably not more than 40%, preferably not more than 30%, preferably not more than 20%, preferably not more than 10%, more preferably not more than 5% of the total length of the processing space measured along the main flow direction. The outlet section preferably extends over a range of not more than 100%, preferably not more than 50%, preferably not more than 40%, preferably not more than 30%, preferably not more than 20%, preferably not more than 10%, more preferably not more than 5% of the total length of the processing space measured along the main flow direction. This preferred further development is also preferable for the membrane module according to the second aspect of the present invention described later.

[0031] According to a preferred embodiment, the fiber longitudinal direction of the hollow fibers of the first subset of hollow fibers forms an intersection angle with the fiber longitudinal direction of the hollow fibers of the second subset of hollow fibers in a range of more than 0° and less than 180°. Said intersection angle is preferably the angle between the hollow fibers of the first and second subsets of hollow fibers that opens toward the blood inlet. The first hollow fiber subset and the second hollow fiber subset preferably do not run parallel. However, the first hollow fiber subset and the second hollow fiber subset may differ only in the flow direction. For example, a first fiber end of the first hollow fiber subset may be adjacent to a second fiber end of the second hollow fiber subset, as a result of which the first and second partial amounts of hollow fibers can flow in opposite directions by the processing medium. This is preferable regardless of the presence or absence of an intersection angle. Preferably, the main flow direction bisects the intersection angle. This preferred further development is similarly preferable for the membrane module according to the second aspect of the present invention described later.

[0032] Preferably, the first and second hollow fiber subsets overlap in at least part to form a free rhombus, with the main component in the main flow direction preferably extending along the shorter semi-axis of the rhombus. However, the main flow direction may extend along the longer semi-axis of the rhombus. When viewed from the transverse direction, preferably the height direction, relative to the longitudinal direction of the fibers, the intersecting hollow fibers form a rhombic pattern. There is free space between the hollow fibers, which we will refer to here as a free rhombus. The medium to be processed, particularly blood, can flow through this free space. Due to the overlapping of the hollow fibers, transverse flow through the rhombic sections is also possible. The rhombic sections are preferably arranged so as to flow substantially parallel to the surface direction. Preferably, the rhombic sections are arranged in the processing space such that the main flow direction is substantially along the short axis of these rhombic sections. The first and second partial hollow fibers may overlap to form a free parallelogram or oblique rhombus. These rhombuses are preferably not square, i.e., they have two semi-axes of different lengths. This preferred development is also preferred in the membrane module according to the second aspect of the present invention, which will be described later.

[0033] In a preferred embodiment, the replacement membrane comprises a fiber mat, preferably made of unidirectional hollow fibers, which are preferably stacked in a height direction perpendicular to the main flow direction. Preferably, spacers may be provided between two or more fiber mats, and particularly preferably between all fiber mats. The use of fiber mats facilitates the manufacture of the membrane module. Furthermore, using a fiber mat of unidirectional hollow fibers allows for particularly uniform elongation of the hollow fibers. The fiber mat has a mat-like surface. The length of the fiber mat is determined by the number of adjacent fibers. The width of the fiber mat is considered along the longitudinal direction of the fibers. Thus, the width of the fiber mat corresponds to the fiber length of the unidirectional fibers. However, in the case of a mat with fibers arranged diagonally, the width of the fiber mat may be shorter than the length of the individual fibers. Preferably, the surface area of ​​the fiber mat changes in the height direction. In particular, it is preferable that the surface area of ​​the mat decreases from the center outward of the stacked fiber mats. The area of ​​the mat may decrease in both directions from the center in the stacking direction, or in only one direction. The cover of the processing space may be shell-shaped, in which case the smaller fiber mat can, particularly preferably, extend into the concave recess of the cover. Preferably, a fiber mat consisting of a first hollow fiber subset and a fiber mat consisting of a second hollow fiber subset are alternately stacked in a height direction perpendicular to the main flow path direction. This preferred arrangement is also preferred in the membrane module according to the second aspect of the present invention, which will be described later.

[0034] Preferably, the processing space is designed to accommodate pressurized blood, particularly blood with an absolute pressure of 3 bar or less. An absolute pressure of 3 bar corresponds to a pressure level approximately 2 bar above atmospheric pressure (approximately 1 bar). When the pressure level in the processing space exceeds atmospheric pressure, the blood processing efficiency is significantly improved. For example, it is possible to increase the oxygen concentration of the blood while keeping the volume of the processing space and membrane surface area the same. However, to prevent damage and leakage, the hollow fibers, potting material (filler), or cover of the processing space used must be adjusted to accommodate the pressure increase. This preferred further development is also preferred in the membrane module according to the second aspect of the present invention, which will be described later.

[0035] In a preferred embodiment, the free flow cross-sectional area of ​​the processing space along the main flow direction between the blood inlet and blood outlet varies within a range of up to 30%, preferably up to 25%, preferably up to 20%, preferably up to 15%, preferably up to 10%, and preferably up to 5% of the maximum free flow cross-sectional area. By limiting the variation in the free flow cross-sectional area, the variation in the flow velocity of the medium being processed in the processing space can also be limited. This reduces the risk of blood coagulation flowing through the processing space. Furthermore, the stress on the hollow fibers can also be reduced. This preferred development is also preferred in the membrane module according to the second embodiment of the present invention, which will be described later.

[0036] The variation in the processing space is preferably in the range of 5% to 200%, preferably 5% to 150%, preferably 5% to 125%, preferably 5% to 100%, preferably 5% to 90%, preferably 10% to 90%, preferably 15% to 90%, preferably 20% to 90%, preferably 20% to 85%, preferably 25% to 85%, preferably 30% to 85%, preferably 30% to 80%, preferably 35% to 80%, preferably 40% to 80%, preferably 40% to 75%, preferably 45% to 75%, preferably 45% to 70%, preferably 50% to 70%, and particularly preferably 55% to 65%. This variation is defined by the maximum distance between two opposing side walls of the processing space, the distance between the same side walls at the blood inflow section, and the length measured along the main flow direction of the processing space. The maximum distance between opposite side walls and the distance between side walls at the blood inlet are determined in the same direction as the processing space, preferably perpendicular to the height direction and / or the main flow direction of the processing space. This change is the quotient, where the length of the processing space is the divisor and the difference between the maximum distance and the distance at the blood inlet is the dividend. Therefore, this change can be calculated using the following formula:

[0037] Variation = (Maximum distance - Distance at blood inflow) / Length of processing space

[0038] The membrane module is preferably of a coreless design. The core is the solid wall of the membrane module, forming the inner boundary of the processing space, and is typically a structure through which fluid flows from multiple sides. In particular, wound membrane modules are manufactured by winding hollow fibers or a hollow fiber mat around a core (which may be a hollow structure). The coreless design simplifies manufacturing and reduces the number of parts in the membrane module. Furthermore, the flow rate within the membrane module can be improved. This leads to cost reduction and improved reliability of the membrane module. For example, in a coreless design, the number of components that come into contact with the blood flowing through the processing space can be reduced compared to a design with a core, thereby reducing the risk of thrombus formation. Such preferred developments using coreless membrane modules are also preferred in the second aspect of the present invention, which will be described later.

[0039] In a preferred embodiment, the membrane module is a direct flow module, and the blood inlet is located opposite the blood outlet along the main axis of the membrane module, particularly the longitudinal axis. Therefore, it is preferable that the flow of the medium to be processed does not change direction significantly as it passes through the processing space. It should be understood that in a direct flow module, the blood inlet and blood outlet do not necessarily have to be exactly on opposite sides. Rather, the blood inlet and blood outlet may be offset laterally with respect to the main axis. However, a direct flow module is preferable in which the blood inlet and blood outlet are located on at least different sides, particularly opposite sides. This preferred structure is also preferred in the membrane module according to a second embodiment of the present invention, which will be described later.

[0040] Preferably, the membrane module has a second processing space connected to a first processing space by a fiber-free connecting section, and the hollow fibers in the first processing space are preferably different from the hollow fibers in the second processing space. For example, preferably, the hollow fibers in the first processing space may consist of a first fiber mat, and the hollow fibers in the second processing space may consist of a second fiber mat different from the first fiber mat. A particular fiber mat is preferably located in either the first or second processing space, but not in both. Preferably, the membrane module may have two or more processing spaces connected to each other by fiber-free fluid line sections. Fiber-free fluid line sections or connecting sections are particularly suitable for distinguishing different processing spaces. Alternatively, or in addition, separate processing spaces may be formed from separate fiber bundles and / or fiber mats consisting of hollow fibers of the exchange membrane, or each may have its own exchange membrane. This preferred further development is also preferred in the membrane module according to a second aspect of the present invention, which will be described later.

[0041] Preferably, the replacement membrane has a main section and at least one sub-section, where the main packing density of hollow fibers in the main section is constant, and the sub-packing density of hollow fibers in the sub-section differs from the main packing density in at least some sections.

[0042] In a second embodiment, the present invention solves the object described in the introduction by a membrane module for blood processing, the membrane module comprising at least one processing space having at least one blood inlet and at least one blood outlet connected to each other in the direction of the main flow path via a processing space, and a replacement membrane having a plurality of hollow fibers, each hollow fiber extending through the processing space in the longitudinal direction of the fiber, and configured to allow a processing medium to flow in the longitudinal direction of the fiber from a first fiber end to a second fiber end on the opposite side, the first and second fiber ends of the hollow fibers of the replacement membrane being fixed in a potting, at least partially defining the processing space, the replacement membrane having a main section and at least one sub-section, the main packing density of the hollow fibers in the main section being constant, and the sub-packing density of the hollow fibers in the sub-section being different from the main packing density in at least one part. The sub-packing density of the hollow fibers in the sub-section may be constant or may vary. Preferably, the sub-section has a plurality of regions having different sub-packing densities, at least one of which is different from the main packing density.

[0043] The primary and secondary packing densities are expressed as the ratio of the volume occupied by the fibers within the exchange membrane to the total volume of the membrane in that region. In the case of hollow fibers, the fiber volume consists of the sum of the volume occupied by the cavity inside the fiber and the volume occupied by the fiber wall. Preferably, when determining the packing density, only fibers that completely penetrate the volume unit in question are considered. The packing density is preferably measured in the central region of the primary or secondary section, i.e., the region located in the center of each end region. Preferably, the packing density is measured at 1 cm². 3 The volume unit can be used. This packing density is an indicator of how densely the fibers are packed within the module.

[0044] In a preferred first embodiment, the sub-sections are located within the inlet section of the processing space adjacent to the blood inlet, and / or within the outlet section of the processing space upstream of the blood outlet. For example, the first sub-section is connected to the inlet section, and the second sub-section is located upstream of the outlet section.

[0045] Preferably, a subsection has at least two subsections. Preferably, the subsections are located on both sides of the main axis of the membrane module extending from the blood inlet to the blood outlet. The main axis may preferably be defined as described above with respect to a first aspect of the present invention. Preferably, the main axis is the central axis of the processing space and may pass through the centroid of the processing space. The main axis is preferably substantially linear. Each subsection of a subsection may have the same subfill density or may have different subfill densities. In this disclosure, subsections are also referred to as winglets. Subsections may overlap. However, preferably, subsections do not overlap each other. In a preferred embodiment, the subsections are symmetrical with respect to the main axis.

[0046] Preferably, the subsection extends in a direction away from the main axis. As the distance from the main axis increases, the area and / or volume of the processing space in the line of sight increases for the subsection extending in a direction away from the main axis. The line of sight is perpendicular to the main axis. The line of sight may also be perpendicular to the height of the processing space, which may be the same as the stacking direction of the fiber mat of the membrane module.

[0047] In preferred embodiments of the membrane module, the subsections are pyramidal and / or prism-shaped. However, the surfaces of the subsections away from the principal axis may be uneven, for example, if the sidewalls of the processing space defined by potting are convex or concave. The pyramidal and / or prism-shaped subsections can enhance the effect of uniformly distributing the medium to be processed, particularly blood, throughout the principal section.

[0048] Preferably, the main section has the shape of a cuboid or a polyhedron with eight or more sides. In particular, the polyhedron main section has four or six rectangular interface faces. Preferably, at least two interface faces of the polyhedron main section are convex. Of the sides of a main section that is essentially cuboid, one or more faces may be concave or convex. In other preferred embodiments, the main section has the shape of a cylinder, polyhedron, cuboid, and / or annular cylinder. Preferably, at least one face of the sides of the main section, particularly preferably two opposing faces, are convex and / or concave.

[0049] Preferably, the plurality of hollow fibers include a first subset of hollow fibers having at least a first hollow fiber and a second subset of hollow fibers having a second hollow fiber. Preferably, at least the first hollow fibers of the first subset of hollow fibers are arranged in the processing space such that their fiber longitudinal direction is oblique to the main flow direction. For definitions, details, and advantages of a replacement membrane having at least a first subset of hollow fibers whose fiber longitudinal direction is oblique to the main flow direction, see in particular the advantages, description, and preferred embodiments of the membrane module according to a first aspect of the present invention.

[0050] Preferably, the first hollow fibers of the first subset of hollow fibers have a smaller fiber diameter than the second hollow fibers of the second subset of hollow fibers. By providing hollow fiber subsets consisting of fibers with different fiber diameters, the mixing of the medium to be processed in the processing space becomes particularly good, and the flow through the processing space, especially through the exchange membrane, can become particularly uniform.

[0051] In a preferred further development of the membrane module, a first hollow fiber subset is formed from at least one fiber mat having a first fiber spacing between them, and a second hollow fiber subset is formed from at least one second fiber mat having a second fiber spacing between them, wherein the first fiber spacing is preferably smaller or larger than the second fiber spacing. By varying the fiber spacing, the flow in the processing space, particularly within the replacement membrane, can be made extremely uniform. It should be understood that the replacement membrane of the membrane module (according to the first or second embodiment) does not necessarily have to be composed of fiber mats. Preferably, the replacement membrane may consist of a single fiber, individual fibers, or fiber mats, one and / or more single fibers, and / or combinations of individual fibers.

[0052] Preferably, the first fiber type of the first hollow fiber is different from the second fiber type of the second hollow fiber. Examples of fiber types include semipermeable hollow fibers, porous hollow fibers, airtight hollow fibers, liquid-tight hollow fibers, and / or fluid-impermeable hollow fibers. The first hollow fiber is preferably semipermeable, and the second hollow fiber is preferably fluid-impermeable. Alternatively, the first hollow fiber is preferably liquid-tight, and the second hollow fiber is preferably semipermeable. In particular, the hollow fibers of the sub-section may be liquid-tight. This allows for temperature control of the processing medium, especially blood, in the sub-section.

[0053] Preferably, the blood inlet is provided with an inlet connector for connecting the membrane module to at least one blood supply line. Preferably, the blood outlet is provided with an outlet connector for connecting the membrane module to a blood discharge line. Preferably, the inlet connector is a first tube connector and / or the outlet connector is a second tube connector. Preferably, the inlet connector is basically tubular, and in particular has a circular flow channel cross-section. Alternatively, or in addition, the outlet connector is also basically tubular, and in particular may be circular tubular.

[0054] In a preferred further development, the inlet axis of the inlet connector and the outlet axis of the outlet connector are positioned at an angle to each other, preferably perpendicular to each other. The axes positioned at an angle to each other intersect at an angle other than 0° or 180° and are not parallel. However, the inlet axis of the inlet connector and the outlet axis of the outlet connector may be inclined. In another embodiment, the inlet axis of the inlet connector and the outlet axis of the outlet connector are positioned parallel to each other (preferably coincidental). If the inlet axis and / or outlet axis are curved, the tangents to the respective inlet axis or outlet axis are considered in the cross-section of the inlet or outlet connector closest to the replacement membrane.

[0055] Preferably, the blood inlet comprises a distribution section connected at least indirectly to the inlet connector. The distribution section is preferably designed to distribute the blood received at the inlet connector to the exchange membrane. In particular, the distribution section has or comprises an enlarged cross-sectional area.

[0056] Preferably, the distribution section is designed to be arrow-shaped along the direction of the main flow path in at least one plane. The arrow shape extends along the direction of the main flow path. A distribution section that is arrow-shaped in one plane will also be arrow-shaped in its projection onto that plane. The first plane is preferably perpendicular to the height direction of the processing space. The distribution section may be arrow-shaped in its projection onto a second plane perpendicular to the first plane. However, the distribution section is preferably designed such that the tip of the arrow-shaped distribution section is a straight line. This is the case, for example, when the distribution section is arrow-shaped only in its projection onto the first plane, and rectangular or semicircular in its projection onto a second plane perpendicular to the first plane.

[0057] Preferably, the arrow-shaped distribution section has at least a first wing portion and a second wing portion. The wing portions are preferably substantially rectangular in shape. Preferably, the wing portions are connected to each other by connecting lines. Preferably, the connecting lines form the arrowhead of the arrow-shaped distribution section. The wing angle between the first wing portion and the second wing portion in the arrow-shaped distribution section is preferably substantially the same as the inlet edge angle between the inlet edges of the sub-sections. The inlet edge is the edge of the sub-section located furthest upstream in the direction of the main flow path.

[0058] In a preferred embodiment, the distribution section is cup-shaped in at least one plane along the direction of the main flow path. In such an embodiment, the plane may be formed in the same manner as described above for arrow-shaped distribution sections. The cup shape flares out from the stem, at least in that plane. The stem of the cup-shaped distribution section preferably faces the inlet connector.

[0059] Preferably, the distribution section is wedge-shaped in at least one plane in the direction of the main flow path. The wedge shape preferably expands continuously. In such embodiments, the plane may be formed similarly to the above embodiments relating to the arrow-shaped distribution section. The tip of the wedge-shaped distribution section is preferably curved away from the inlet connector.

[0060] Preferably, the membrane module comprises an inlet membrane at least partially located in the distribution section. The inlet membrane may completely or partially fill the distribution section. Alternatively, the inlet membrane may be at least partially located in the main section, sub-section, and / or inlet section. The inlet membrane is composed of a plurality of fibers. The fibers of the inlet membrane may, but do not necessarily, be hollow fibers. Each fiber of the inlet membrane extends in the longitudinal direction of the inlet fiber, penetrating the distribution section. The longitudinal direction of the inlet fiber may differ from at least one longitudinal direction of the hollow fibers of the exchange membrane. Preferably, the longitudinal direction of the inlet fiber is perpendicular to the direction of the main flow path. Preferably, the inlet membrane is a heat exchange membrane. The heat exchange membrane is provided for temperature control of the processing medium, in particular blood. Thus, the heat exchange membrane may be designed, for example, to heat or cool blood flowing through the processing space. The fibers of the heat exchange membrane are, in particular, hollow fibers that do not allow fluid to pass through.

[0061] Preferably, the fibrous material of the inlet membrane is different from the fibrous material of the replacement membrane. However, the fibers of the inlet membrane are preferably plastic fibers or metal fibers.

[0062] In a preferred embodiment of the membrane module, the main flow direction in the inlet section forms an angle, specifically a perpendicular angle, with respect to the main flow direction on the membrane side of the distribution section facing the exchange membrane. The membrane side of the distribution section is the side of the distribution section located furthest downstream in the main flow direction. Thus, the main flow direction can be curved between the inlet section and the membrane side of the distribution section. This can improve the distribution of the medium to be processed, particularly blood, to the exchange membrane, or equalize the flow of the medium to be processed. Alternatively, or in addition, the main flow direction in the inlet connector may be perpendicular to the main flow direction in the transition between the blood inlet and the main section and / or sub-section.

[0063] Preferably, the blood outlet includes a collection section at least indirectly upstream of the outlet connector, or upstream of the outlet connector. The collection section is preferably designed to collect the medium discharged (or processed) from the exchange membrane and transfer it to the outlet connector.

[0064] Preferably, the membrane module includes an outlet membrane located at least partially in the collection section. The outlet membrane may completely or partially fill the collection section. Alternatively, or in addition, the outlet membrane may be located at least partially in the main section, sub-section, and / or the outlet section. The outlet membrane is composed of multiple fibers. The fibers of the outlet membrane may be, but do not necessarily have to be, hollow fibers. Each fiber of the outlet membrane extends through the collection section in the longitudinal direction of the outlet fiber. The longitudinal direction of the outlet fiber may be different from the longitudinal direction of at least one of the hollow fibers of the exchange membrane. Preferably, the longitudinal direction of the outlet fiber is perpendicular to the direction of the main flow path. Preferably, the outlet membrane is a heat exchange membrane. The heat exchange membrane is provided for temperature control of the processing medium, in particular blood. Thus, the heat exchange membrane may be designed, for example, to heat or cool blood flowing through the processing space. The fibers of the heat exchange membrane are, in particular, hollow fibers that do not allow fluid to pass through.

[0065] Preferably, the fibrous material of the exit membrane is different from the fibrous material of the replacement membrane. However, the fibers of the exit membrane are preferably plastic fibers or metal fibers.

[0066] When a membrane module comprises an inlet membrane and an outlet membrane, the inlet membrane and the outlet membrane may be an integrated membrane. Preferably, the fibers of the outlet membrane and the fibers of the inlet membrane have a common medium connector. For example, by supplying hot water to the fibers of the outlet membrane and the inlet membrane via a common medium connector, the blood flowing through the processing space can be heated.

[0067] The collection section is preferably wedge-shaped, funnel-shaped, and / or inverted arrow-shaped in at least one plane in the direction of the main flow path. An inverted arrow-shaped shape is an arrow shape in which the flow points in the direction of the arrowhead. The above description of the wedge-shaped, funnel-shaped, and / or arrow-shaped design of the distribution section applies equally to the collection section.

[0068] Preferably, one type of fiber (semipermeable, permeable, airtight, or permeable) among the multiple hollow fibers in the main section is at least partially different from one type of fiber among the multiple hollow fibers in the sub-section. Preferably, the sub-section is located upstream of the main section. In particular, not only in this case, but also in the case of a sub-section located downstream of or to the side of the main section, the hollow fibers in the sub-section are preferably fluid-impermeable, and the hollow fibers in the main section are semipermeable. For example, the temperature of the medium to be treated can be adjusted by flowing a heated and / or cooled treatment medium (e.g., water) through the liquid-tight fibers of the sub-section.

[0069] In a third embodiment, the present invention solves the object described at the beginning by a blood processing system. This system preferably comprises at least one pump for generating a blood flow, preferably a control device for controlling the pump, and preferably a membrane module designed according to the first and / or second embodiments of the present invention. The control system preferably also functions as a regulating system. Preferably, the pump is connected to the human blood circulatory system via a first tubing section and to the processing space of the membrane module via a second tubing section. In another embodiment, the pump may be designed to act on a tubing section connecting the processing space and the human blood circulatory system to pump blood. This tubing may be just one part of the connection section between the processing space and the blood circulatory system, or it may consist of multiple elements. Preferably, the system is designed so that blood at a pressure higher than ambient atmospheric pressure flows through the processing space. The connection between the first tubing section and the blood circulation does not necessarily have to be direct. The first tubing section may be connected to the blood circulation via a cannula. The cannula is preferably single-chamber or multi-chamber, and especially double-chamber cannulas. This system particularly includes a second pump, and the processing space is preferably arranged along the direction of blood flow between the first and second pumps. The first pump may be designed to increase the pressure in the processing space, particularly to enhance the blood processing efficiency. The second pump, on the other hand, may be designed to reduce the blood pressure downstream of the processing space to a pressure level suitable for returning the blood to the patient. The first pump may also be designed to set a predetermined flow rate. The second pump is preferably designed to set the pressure in the processing space. The first pump and / or the second pump are preferably peristaltic pumps, particularly roller pumps and / or rotary pumps.

[0070] In a fourth embodiment, the present invention solves the object described at the beginning by a method for manufacturing a membrane module for extracorporeal processing of blood, particularly by a method for manufacturing a membrane module according to the first and / or second embodiment of the present invention. The method preferably includes the steps of: inserting a fiber mat consisting of hollow fibers, particularly unidirectional hollow fibers, into a mold; primary sealing the first fiber ends of the hollow fibers with a sealing material to form a first side wall of the processing space of the membrane module, wherein during the primary sealing, the mold is rotated at least intermittently about a first axis of rotation; and secondary potting the second fiber ends of the hollow fibers facing the first fiber ends in the longitudinal direction of the fibers to form a second side wall facing the first side wall, wherein during the secondary potting, the mold is rotated at least temporarily about a second axis of rotation different from the first axis of rotation, wherein the first and second axes of rotation are preferably parallel, and further / or, the first and / or second axes of rotation do not intersect the fiber mat, and / or, preferably, the first and / or second axes of rotation do not pass through the center of gravity of the fiber mat. Preferably, this method further includes the step of connecting the first and second side walls with at least one cover to form a processing space. Furthermore, after primary and / or secondary potting, the fibers may be released, for example, preferably by cutting the sealed fiber ends and / or sealed fiber ends. Also, the hollow fibers of at least one fiber mat may be formed by a single meandering fiber, which may be separated into individual hollow fibers before or after primary and / or secondary potting. Preferably, the first and / or second rotation axes extend transversely to the longitudinal direction of the fibers in the fiber mat. The rotation axes are defined in the mold coordinate system. Therefore, the rotation of the mold (rotation in the global coordinate system) also causes a rotation of the mold coordinate system. In a global perspective (or global coordinate system), the first rotation axis and a different second rotation axis may coincide.For example, the mold may rotate around its own axis (especially a 180° rotation) after rotating around a first axis of rotation and before rotating around a second axis of rotation. In particular, the mold may be the housing of the membrane module, or may be part of such a housing. The mold does not need to surround the fiber mat on all four sides. The mold may be a holder or clamp for holding the fibers and / or fiber ends.

[0071] Methods for inserting hollow fiber mats into a mold include inserting a predetermined number of hollow fiber mats into the mold, or inserting hollow fiber mats into the mold until a predetermined height is reached. Alternatively, instead of inserting hollow fiber mats into the mold, hollow fibers may be inserted. Furthermore, as another method, both hollow fiber mats and individual hollow fibers or bundles of hollow fibers may be inserted into the mold.

[0072] In a preferred first embodiment of the above method, the sides of the smallest rectangle surrounding the mold are aligned at an angle with respect to the direction of rotation when rotating about a first axis of rotation and / or a second axis of rotation, in a direction perpendicular to the axis of rotation. The direction of rotation is the circumferential direction. The smallest rectangle is the smallest imaginary rectangle that can be positioned around the mold and completely enclose the mold when viewed along the first axis of rotation and / or the second axis of rotation. In the case of a rectangle, the smallest rectangle corresponds to the shape of the basic rectangle. Alternatively, or in addition, the longitudinal axis of the film module (in particular, which may be the longitudinal axis of the processing space formed by the film module) may form an angle with respect to the circumferential direction of the first or second axis of rotation during primary potting and / or secondary potting. This angle is preferably greater than 0° and less than 90°. This may form a processing space that expands or contracts along the longitudinal direction. Preferably, the direction of the main flow path in the processing space formed within the membrane module during primary potting and / or secondary potting is at an angle with respect to the circumferential direction, preferably greater than 0° and less than 90°. However, it is preferable that the direction of the main flow path during primary potting and / or secondary potting is parallel to the circumferential direction.

[0073] In a fifth embodiment, the present invention solves the object set forth in the introduction by a method for manufacturing a membrane module for extracorporeal processing of blood, particularly by a membrane module according to the first and / or second embodiments of the present invention. The method includes the steps of inserting a fiber mat consisting of hollow fibers, particularly unidirectional hollow fibers, into a mold, and potting both ends of the hollow fibers to form side walls of the processing space of the membrane module, wherein during the potting the mold rotates at least temporarily around a main rotation axis, and the potting is incomplete circular potting. The main rotation axis preferably passes through the center of the mold. Incomplete circular potting is potting in which at least a portion of the circumferential direction of the side walls is open. In contrast, complete circular potting forms a rotationally symmetrical contour. Preferably, the amount of potting material supplied during potting is limited. Thus, in incomplete circular potting, only enough potting material is supplied to prevent the formed side walls from closing circumferentially. However, circumferential closure can also be prevented, for example, by providing flow barriers. Preferably, during potting, only enough potting material is supplied to form at least two sidewalls, and these sidewalls are preferably at least partially separated from each other in the circumferential direction. In a preferred further development, the main rotation axis extends at least partially along the fiber longitudinal direction of the hollow fiber. However, the main rotation axis may be perpendicular to the fiber longitudinal direction. Preferably, the main rotation axis extends along the direction of the main flow path in the processing space of the membrane module being formed.

[0074] In a fifth aspect of the present invention, the method for inserting a hollow fiber mat into a mold is preferably performed by inserting a predetermined number of hollow fiber mats into the mold, or by inserting hollow fiber mats into the mold until a predetermined height is reached. In another embodiment, instead of inserting a hollow fiber mat into the mold, hollow fibers may be inserted into the mold. Furthermore, in yet another embodiment, both a hollow fiber mat and individual hollow fibers or bundles of hollow fibers may be inserted into the mold.

[0075] In a particularly preferred further development of the method according to the fourth aspect of the present invention, or the method according to the fifth aspect, the fiber mat is inserted laterally into the mold. Therefore, it is preferable that the fibers are inserted into the mold so that the longitudinal directions of the hollow fibers of adjacent fiber mats are not parallel to each other.

[0076] In a method according to a fourth and / or fifth aspect of the present invention, the fiber mats are preferably pre-assembled prior to insertion. During pre-assembly, preferably two or more fiber mats of the same or different orientations are joined to form a mat laminate. Joining can be carried out by melting, pressing, and / or bonding. Particularly preferred is that at least two fiber mats are laminated in a crisscross pattern during pre-assembly. In a step including pre-assembly, the insertion of the fiber mats includes or is the insertion of the pre-assembled mat laminate.

[0077] A method according to a fourth and / or fifth aspect of the present invention may also be provided for the simultaneous manufacture of multiple membrane modules.

[0078] According to a sixth aspect, the present invention solves the aforementioned problems by an assembly method comprising the following steps: providing a console comprising at least one pump, a diaphragm module holder, and preferably a control unit; providing a disposable processing module comprising a membrane module, in particular a membrane module according to a first and / or second aspect of the present invention; inserting the membrane module into the diaphragm module holder; and functionally connecting the disposable processing module to the pump to transport a fluid, in particular blood, through the membrane module. The functional connection enables the pump to transport the fluid through the membrane module. For example, the tubing of the disposable processing module, connected to the membrane module in a manner that transports fluid, can be inserted into the effective part of the tube pump. The disposable processing module is preferably provided anew for each patient being treated and discarded after use, while the console may be designed for repeated processing. The disposable processing module may comprise a pump operating section. In this case, the console may comprise only one pump drive unit.

[0079] In a seventh embodiment, the present invention provides an extracorporeal treatment method for blood, which solves the object set forth in the introduction by a method comprising supplying a blood flow, supplying a blood flow to a processing space of a membrane module, particularly according to a first embodiment and / or a second embodiment of the present invention, comprising the steps of supplying a blood flow pressure, preferably exceeding atmospheric pressure, to the processing space of a membrane module, and flowing a processing medium, particularly oxygen, through hollow fibers extending through the processing space, along the respective longitudinal directions of the hollow fibers, wherein the blood flow flows through the processing space along the direction of the main flow path, and in contact with the hollow fibers penetrating the processing space, to treat the blood and particularly enrich it with oxygen, wherein at least a first subset of a plurality of semipermeable hollow fibers is arranged in the processing space such that the longitudinal direction of the fibers is oblique to the direction of the main flow path (RH). Preferably, the blood supply includes a blood supply from a blood reservoir. The method is preferably not intended for use on the human body. This method can also be used during dialysis, in which case it is performed only as an auxiliary measure, and blood removal from the patient is performed as part of the dialysis process.

[0080] The membrane module according to the first aspect of the present invention, the membrane module according to the second aspect of the present invention, the system according to the third aspect of the present invention, the manufacturing methods according to the fourth and fifth aspects of the present invention, and the assembly method according to the sixth aspect of the present invention and the extracorporeal processing method of blood according to the seventh aspect of the present invention may have the same and similar sub-aspects as those described in particular the dependent claims relating to the membrane module according to the first aspect of the present invention and / or the dependent claims relating to the membrane module according to the second aspect of the present invention. The systems, manufacturing methods, assembly methods, and extracorporeal processing methods of blood refer entirely to the above-described descriptions of the membrane module according to the first aspect of the present invention. In particular, the membrane module according to the second aspect of the present invention preferably further has the features described above with respect to the membrane module according to the first aspect of the present invention. Similarly, the membrane module according to the first aspect of the present invention may also have the features described above with respect to the membrane module according to the second aspect of the present invention. The sub-sections described in relation to the second aspect of the present invention may preferably be the inlet section and / or outlet section described in relation to the first aspect of the present invention. Similarly, the inlet section and / or outlet section may comprise sub-sections.

[0081] Embodiments of the present invention will be described below with reference to the drawings. The drawings are not necessarily to scale and are schematic or slightly distorted for the sake of clarity. For additional teachings that can be easily understood from the drawings, refer to the relevant prior art. It should be noted that various modifications and changes can be made to the molds and details of the embodiments without departing from the basic concept of the present invention. The features of the present invention disclosed in the specification, drawings and claims may be essential to further development of the invention, individually or in any combination. Furthermore, at least two combinations of the features disclosed in the specification, drawings and claims are included within the scope of the present invention. The general spirit of the present invention is not limited to the exact forms or details of the preferred embodiments shown and described below, nor is it limited to the subjects that are limited compared to those described in the claims. Where a measurement range is specified, values ​​within the specified limits are also disclosed as limits and may be freely applied and defined. For simplification, the same reference numerals are used below for identical or similar parts, or parts having identical or similar functions. [Brief explanation of the drawing]

[0082] Further advantages, features, and details of the present invention will become apparent from the following description and drawings of preferred embodiments.

[0083] [Figure 1] This shows a blood processing system. [Figure 2] A perspective view of a membrane module for blood processing according to the first embodiment is shown. [Figure 3] A top view of the membrane module according to the first embodiment is shown. [Figure 4] A top view of a second embodiment of the membrane module, similar to Figure 3, is shown. [Figure 5a] A top view of a further preferred embodiment of the membrane module, similar to Figure 3, is shown. [Figure 5b] A top view of a further preferred embodiment of the membrane module, similar to Figure 3, is shown. [Figure 5c] A top view of a further preferred embodiment of the membrane module, similar to Figure 3, is shown. [Figure 5d] A top view of a further preferred embodiment of the membrane module, similar to Figure 3, is shown. [Figure 6] This shows a top view of a membrane module equipped with multiple processing spaces. [Figure 7] This shows manufacturing equipment that may be used in the process of manufacturing membrane modules. [Figure 8] A schematic diagram showing a first modified example of the method for manufacturing a membrane module is shown. [Figure 9] This representation is similar to Figure 7, showing that the molds used in this method are oriented in different ways within the manufacturing equipment. [Figure 10] A side view of the manufacturing equipment is shown. [Figure 11] A schematic flowchart of the method for processing blood outside the body is shown. [Figure 12a] This shows one of two diagrams of a membrane module with fibers flowing laterally. [Figure 12b] This shows one of two diagrams of a membrane module with fibers flowing laterally. [Figure 13a] This shows one of three figures representing a fifth embodiment of the membrane module. [Figure 13b] This shows one of three figures representing a fifth embodiment of the membrane module. [Figure 13c] This shows one of three figures representing a fifth embodiment of the membrane module. [Figure 15] A sixth embodiment of the membrane module is shown. [Figure 16a] This document presents an alternative design proposal for the blood inlet distribution section of the membrane module. [Figure 16b] This document presents an alternative design proposal for the blood inlet distribution section of the membrane module. [Figure 17] This shows a top view of a champagne glass-shaped membrane module. [Modes for carrying out the invention]

[0084] Figure 1 shows an extracorporeal processing system 200 for blood B. In the illustrated embodiment, the system 200 is connected to the patient P's blood circulatory system via a cannula 202. The patient P's blood B is supplied to the inlet tube 204 of the system 200 via the cannula 202. The inlet tube 204 is part of a disposable processing module 206 of the system 200. In addition to the inlet tube 204, the disposable processing module 206 also includes a membrane module 1 and a discharge tube 208. The structure of the membrane module 1 will be described in detail later. In Figure 1, the discharge tube 208 extends outside the system 200. When using a single-lumen cannula 202, the discharge tube 208 can be connected to another cannula (not shown in Figure 1), which is used to return the blood B to the patient P's bloodstream. When using a double-lumen type, the discharge tube 208 can be connected to cannula 202.

[0085] In addition to the disposable processing module 206, the system also includes a console 210, which comprises a first pump 212, a second pump 214, and a control unit 216 within a housing 218. The console 210 also includes a diaphragm module holder 220 that holds the membrane module 1 of the disposable processing module 206. Dividing the system 200 into the disposable processing module 206 and the console 210, as in the embodiments shown herein, makes the system 200 particularly easy to handle and allows for economical use. The disposable processing module 206 can be replaced after each processing or per patient P, while the console 210 can be used multiple times. There is no need to clean the membrane module 1, minimizing hygienic risks.

[0086] The first pump 212 and the second pump 214 are designed to guide blood B through the disposable processing module 206, specifically through the processing space 3 of the membrane module 1. In the illustrated embodiment, the system 200 is designed to transport blood B through the membrane module 1 at a pressure level p1 higher than atmospheric pressure.

[0087] Here, the first pump 212 increases the pressure of blood B to approximately 3 bar. A second pump 214, located downstream of the membrane module 1, reduces the pressure of blood B to a pressure level suitable for patient P. In this embodiment, pumps 212 and 214 are designed as peristaltic pumps. The first pump 212 acts on the inlet tube 204, and the second pump 214 acts on the discharge tube 208. For example, the first pump 212 and / or the second pump 214 may be roller pumps or peristaltic pumps that change the cross-sectional area of ​​the inlet tube 204 to transport blood B.

[0088] As the pressure level of the blood B increases, the processing of the blood within the membrane module 1 is improved. In the embodiment shown in Figure 1, the blood B in the membrane module 1 is concentrated with oxygen O2 and processed in this manner. For this purpose, the membrane module 1 comprises an exchange membrane 5 having a plurality of semipermeable hollow fibers 7 that penetrate a processing space 3 through which the patient P's blood B flows. Thus, the blood B comes into contact with the hollow fibers 7 of the exchange membrane 5 within the processing space 3. Since oxygen O2 passes through the hollow fibers 7, gas exchange with the blood B in the processing space 3 occurs through the semipermeable membrane walls of the hollow fibers 7. The oxygen O2 diffuses into the blood B through the semipermeable hollow fibers 7, and carbon dioxide CO2 and / or carbon monoxide CO in the patient's blood enter the gas flow within the hollow fibers 7 from the blood B. Here, the oxygen O2 forms the processing medium M. In other embodiments, another gas, a mixture of gases, and / or a liquid may be used as the processing medium. For example, the temperature of the patient P's blood B can be adjusted by flowing cold or warm water through the hollow fibers 7.

[0089] The embodiment of the extracorporeal blood processing system 200 shown in Figure 1 includes a processing medium supply unit 222 connected to an oxygen source (not shown). Oxygen O2 is supplied to the hollow fibers 7 of the exchange membrane 5 via the processing medium supply unit 222. The oxygen O2 flows through the hollow fibers 7 and is discharged downstream of the system 200 by a processing medium discharge unit 224. To adjust the flow rate of the processing medium M, the console 210 is provided with an actuator 226, which is designed here as a throttle valve 228. Preferably, the actuator 226 is located downstream of the membrane module 1 and is configured, for example, to increase the gas pressure in the hollow fibers 7 of the membrane module 1. In the illustrated embodiment, the throttle valve 228 is controlled by a control system 216 of the system 200. For example, the throttle valve 228 may be an electronically controllable solenoid valve. In addition to the throttle valve 228, the control system 216 also controls two pumps 212, 214 of the console 210. Preferably, the control system 216 also includes a control system that performs pressure control and / or volumetric flow rate control. In this case, the system 200 may preferably be provided with at least one sensor, particularly a pressure sensor.

[0090] Figure 2 shows a preferred first embodiment of the membrane module 1. In this embodiment, the membrane module 1 includes a first tube connector 9 connected to an inlet tube 204 (not shown in Figure 2) of a disposable processing module 206. A second tube connector 11 is connected to a discharge tube 208 (also not shown in Figure 2). The processing space 3 of the membrane module 1 extends from a blood inlet 13 to a blood outlet 15. The hollow fibers 7 of the replacement membrane 5 extend through the processing space 3 along the longitudinal direction RF of each fiber. During operation, blood B flows into the processing space 3 of the membrane module 1 via the first tube connector 9 and the blood inlet 13. The blood B flows through the processing space 3 along the main flow direction RH and is discharged from the blood outlet 15. The blood B is returned to the patient P via the second tube connector 11 and the discharge tube 208. The blood B flowing through the processing space 3 is processed in contact with the hollow fibers 7.

[0091] The main flow direction RH extends linearly from the blood inlet 13 to the blood outlet 15. In the illustrated embodiment, the blood inlet 13 is located opposite the blood outlet 15 along the main axis A of the membrane module 3, where the main axis A coincides with the main flow direction RH. A membrane module 3 in which the blood inlet 13 and the blood outlet 15 are located opposite each other in the main flow direction RH is referred to here as a direct flow module. The advantage of this design is that the blood B flows particularly uniformly within the processing space, allowing for very gentle processing. Strong flow deflections that can cause turbulence or dead water regions in the blood flow are avoided.

[0092] Figure 2 shows just one example of the numerous hollow fibers 7 that make up the replacement membrane 5. Each hollow fiber 7 extends along the fiber longitudinal directions RF1 and RF2 from a first fiber end 17 to a second fiber end 19. The fiber ends 17 and 19 are each held within a potting 21. The potting 21 defines a first side wall 23 and a second side wall 25 of the processing space 3 opposite the first side wall 23. The potting 21 is impermeable to liquid and prevents blood B from flowing into the medium inlet 27 and / or medium outlet 29 of the membrane module 1. To supply the processing medium M, the medium inlet 27 is connected to a processing medium supply unit 222. The medium outlet 29 of the membrane module 1 is connected to a processing medium discharge unit 224 to remove the processing medium M used for processing from the membrane module 1.

[0093] As shown in Figure 2, the potting 21 does not need to form the entire side walls 23, 25 of the processing space 3. In the illustrated embodiment, the blood inlet 13 and blood outlet 15 are formed from separate elements that can be manufactured, for example, by injection molding. However, the potting 21 may be configured to define the blood inlet 13 and / or blood outlet 15.

[0094] In the illustrated embodiment, the processing space 3 is basically cylindrical, and the height H of the cylinder, or the height direction H of the processing space 3, is approximately perpendicular to the main flow direction RH. The base area of ​​this cylinder is defined by two arcs (congruent chords) that are tangent to each other in plane. However, at both ends, namely the blood inlet 13 and the blood outlet 15, the shape of the processing space deviates from the overall cylindrical shape. In the height direction H, the side walls 23, 25 of the processing space 3 are not curved. In the illustrated embodiment, the processing space 3 is surrounded by covers 31 on the sides of the membrane module 1 that face each other in the height direction H. Note that in Figure 2, only the lower cover 31 is shown for clarity. Here, the cover 31 is basically flat. However, in other embodiments, one or both of the covers 31 may be designed in a shell shape. In the illustrated embodiment, the cover 31 forms the lid of the cylinder. However, in other embodiments, the cover 31 may be a flat portion of the processing space 3, which does not necessarily have to be flat. The cover 31 connects or closes the two side walls 23, 25 to form the processing space 3. The illustrated design of the processing space 3 can be realized using potting 21, which is relatively easy to manufacture. Furthermore, at least one of the covers 31 may be transparent. This allows the processing space 3 to be observed from the outside. Thus, thrombi formed within the processing space 3 can be particularly easily detected, and the extracorporeal processing procedure 500 of blood B performed using the system 200 can be particularly easily monitored.

[0095] The processing space 3 has a variable main cross-section QH along the main flow direction RH. The main cross-section QH of the processing space 3 is shown as viewed from a direction perpendicular to the main flow direction RH (see also Figure 3). In the illustrated embodiment, the first side wall 23 and the second side wall 25 are symmetric with respect to the main axis A, but in other variations of the membrane module 1 they may be asymmetric. In the embodiment shown in Figure 2, the first side wall 23 and the second side wall 25 are concave. As a result, the side walls 23 and 25 form bulges within the processing space 3, and the processing space 3 has a basic convex shape when viewed along the height direction H.

[0096] The variable main cross-section QH is shown in particular by the top view shown in Figure 3. The line of sight in this top view is the height direction H relative to the membrane module 1. Therefore, the height direction H is perpendicular to the image plane of Figure 3. For simplification, only the hollow fibers 7 of the replacement membrane 5 and the side walls 23, 25 formed by the potting 21 are shown in Figure 3. Fiber length and fiber ends are also shown in simplification. For example, the fibers preferably do not terminate within the processing space 3. The rest of the membrane module 1, particularly the remaining material of the potting 21, is not shown in Figure 3. The top view in Figure 3 again shows the basic elliptical shape of the processing space 3. In Figure 3, the main flow direction RH extends horizontally from the blood inlet 13 at the left end of the image to the blood outlet 15 at the right end of the image.

[0097] In the illustrated embodiment, preferably, the main cross-sectional area QH of the processing space 3 increases continuously from the blood inlet 13 toward the central cross-sectional area QM when viewed in the direction of the main flow path RH. From the central cross-sectional area QM located at the center of the processing space 3, the main cross-sectional area of ​​the processing space 3 decreases continuously toward the blood outlet 15. Figure 3 shows, as an example, the first main cross-section QH1, the central cross-section QM located along the direction of the main flow path RH at the center of the blood inlet 13 and the blood outlet 15, and the second main cross-section QH2. Since the side walls 23 and 25 of the processing space 3 are at a constant distance from each other in the height direction H, the width of the cross-sections shown here directly corresponds to their respective cross-sectional areas. The central cross-section QM has the largest cross-sectional area because the side walls 23 and 25 of the processing space 3 are furthest apart from each other in the direction perpendicular to the direction of the main flow path RH. In the illustrated embodiment, it is preferable that the processing space 3 is symmetrical with respect to the plane of the central cross-section QM. The first main cross-section QH1 is located further from the central cross-section QM than the second main cross-section QH2 in the main flow direction RH, and therefore its cross-sectional area is smaller than that of the second main cross-section QH2. The cross-sectional area of ​​the processing space occupied by the hollow fibers 7 should be understood as being part of the main cross-sectional area QH. Therefore, in the illustrated embodiment, the area of ​​the main cross-section QH is determined only by the distance between the first side wall 23 and the second side wall 25 and the height of the processing space 3 in the height direction H. In this description, the terms "cross-section" and "cross-sectional area" may be used as synonyms in some cases.

[0098] However, when blood B actually flows through the processing space 3 of the membrane module 1, it is partially blocked by the hollow fibers 7 of the replacement membrane 5 that penetrate the processing space 3. Therefore, the free cross-sectional area of ​​the processing space 3 perpendicular to the main flow direction RH is equal to or less than the main cross-sectional area QH at the location under consideration.

[0099] In the illustrated embodiment, since the packing density of the hollow fibers 3 is constant, the free cross-sectional area of ​​the processing space 3 is approximately proportional to the main cross-sectional area QH. Preferably, the replacement membrane 5 comprises two or more fiber mats 33 stacked on top of each other in the height direction H. In the illustrated embodiment, the fiber mat 33 is composed of a plurality of unidirectional hollow fibers 7. The unidirectional hollow fibers 7 of the fiber mat are prevented from slipping by warp threads 35.

[0100] In the illustrated embodiment, it is preferable that multiple fiber mats 33 are stacked alternately in different orientations to form a diamond pattern when viewed from the height direction H. Of the hollow fibers 7 of the replacement membrane 5, a subset of the first hollow fibers 37 consists only of hollow fibers 7 that are parallel to each other. A subset of the second hollow fibers 39 includes further hollow fibers 7 of the replacement membrane 5 having a different orientation from the hollow fibers 7 of the first subset 37. In a particularly simple and preferred embodiment, in order to achieve the diamond pattern shown in Figure 3, otherwise identical fiber mats 33 may be stacked alternately in different orientations. Preferably, fiber mats 33 having a first subset 7 of hollow fibers 37 and fiber mats 33 having a second subset 7 of hollow fibers 39 are stacked alternately. In Figure 3, the hollow fibers 7 of the first subset, hollow fibers 37, extend from the upper left to the lower right, and the hollow fibers 7 of the second subset, hollow fibers 39, extend from the lower left to the upper right. The hollow fiber subsets 37 and 39, oriented in different directions from each other, can be realized without using the fiber mat 33. Furthermore, each individual fiber mat 33 may already have hollow fibers 7 oriented in different directions.

[0101] In the illustrated embodiment, the fiber longitudinal direction RF1 of the hollow fiber 7 of the first subset hollow fiber 37 and the fiber longitudinal direction RF2 of the hollow fiber 7 of the second subset hollow fiber 39 are both oblique to the main flow direction RH.

[0102] Therefore, in Figure 3, the fluid acts on each hollow fiber 7 at an angle of attack of approximately 70°. Here, the angle of attack is the smaller of the angles between the main flow direction RH and the fiber longitudinal direction RF.

[0103] The treatment of blood B is improved as the blood B passing through the treatment space 3 flows at least partially obliquely through the hollow fibers 7 of the first subset, hollow fibers 37, and the second subset, hollow fibers 39. Compared to hollow fibers 7 extending laterally with respect to the main flow direction RH passing through the treatment space 3, hollow fibers 7 extending obliquely with respect to the main flow direction RH passing through the treatment space 3 have a larger contact area with blood B. This improves the exchange of molecules and / or energy between the hollow fibers 7 or the treatment medium M flowing within the hollow fibers 7 and blood B. In contrast to hollow fibers 7 running parallel to the main flow direction RH, hollow fibers 7 running at an angle simplifies the design considerably because the blood inlet 13 and blood outlet 15 can be freed from the hollow fibers 7. Furthermore, hollow fibers 7 positioned at an angle to the main flow direction RH may improve the mixing of blood B and improve the treatment results compared to hollow fibers 7 positioned parallel to it.

[0104] The hollow fibers 7 of the adjacent fiber mat 33 enclose a free rhombus when viewed in the height direction H. In the illustrated embodiment, these free rhombuses 41 are asymmetrical. The short semi-axis of the rhombuses 41 extends approximately parallel to the main flow direction RH. The long axis of the rhombuses 41 is perpendicular to the height direction H and the main flow direction RH. In the height direction H, the rhombuses 41 may be offset from each other or not congruent.

[0105] In the illustrated embodiment, the hollow fibers 7 of the first subset of hollow fibers 37 and the hollow fibers 7 of the second subset of hollow fibers 39 intersect at an intersection angle α when viewed from the height direction H. As shown in Figure 3, the intersection angle α is defined between the two intersecting hollow fibers 7 and opens toward the blood inlet 13. In the illustrated embodiment, only the hollow fibers 7 of the first subset of hollow fibers 37 and the hollow fibers 7 of the second subset of hollow fibers 39 are shown. However, in other preferred embodiments, the membrane module 1 may further partially have hollow fibers that are identical or different in orientation to one another. For example, only the first subset of hollow fibers 7 of hollow fibers 37 is oriented obliquely with respect to the main flow direction RH, and the second subset of hollow fibers 7 is oriented transversely with respect to the main flow direction RH. The orientation of the hollow fibers 7 is determined by their longitudinal fiber direction RF.

[0106] Figure 4 shows a top view of a second embodiment of the membrane module 1, where, as in Figure 3, only the side walls 23, 25 and the multiple hollow fibers 7 of the replacement membrane 5 are again shown. Figure 3 shows two fiber mats 33 stacked on top of each other, where the fiber mat 33 having the hollow fibers 7 of the first hollow fiber subset 37 is positioned in the height direction H on top of the fiber mat 33 having the hollow fibers 7 of the second hollow fiber subset 39. To illustrate the different fiber mats 33, here the hollow fibers 7 of the first hollow fiber subset 37 cover the hollow fibers 7 of the second hollow fiber subset 39. Therefore, the free rhombuses 41 are not shown in Figure 4.

[0107] In contrast to the first embodiment shown in Figure 3, in the second embodiment, most of the processing space 3 is not completely filled with hollow fibers 7. In the first embodiment, this is done solely to keep the blood inlet 13 and blood outlet 15 free of hollow fibers 7. Here, the inlet section 43 adjacent to the downstream side of the blood inlet 13 and the outlet section 45 upstream of the blood outlet 15 are partially free of hollow fibers 7 in the main flow direction RH. This results in a change in the packing density of hollow fibers 7, at least in the cross section along the main flow direction RH. Looking at the entire main cross section QH perpendicular to the main flow direction RH, the packing density is expressed as the ratio of the cross-sectional area of ​​the fibers to the area of ​​the main cross section QH. A high packing density indicates that a relatively large number of hollow fibers 7 are scattered within the main cross section QH, while a low packing density indicates that there are few hollow fibers 7.

[0108] In the second embodiment, the packing density of the hollow fibers 7, which varies in the main flow direction RH, is achieved by the hollow fibers 7 of the first hollow fiber subset 37 partially protruding above the hollow fibers 7 of the second hollow fiber subset 39, and further, by the hollow fibers 7 of the second hollow fiber subset 39 partially protruding above the hollow fibers 7 of the first hollow fiber subset 37. In Figure 4, the fiber mat 33 having the first hollow fiber subset 7 of the hollow fibers 37 protrudes into the first sub-section of the inlet section 43 located above the main axis A, while the second hollow fiber subset 7 of the hollow fibers 39 protrudes into the second sub-section of the inlet section 43 (below the main axis A). Compared to the central cross-section QM, the processing space 3 of these protrusions contains only half the number of hollow fibers 7. Thus, by using a simple fiber mat 33 with unidirectional hollow fibers 7, a packing density that varies in the main flow direction RH can be achieved. Furthermore, it is particularly advantageous that the packing density changes laterally with respect to the main flow direction. This reduces flow resistance near the side walls 23 and 25, allowing blood B to be distributed more uniformly within the processing space 3 and even to the edge regions.

[0109] Figures 5a to 5d are top views similar to those in Figures 3 and 4, showing other examples of the membrane module 1. In Figure 5a, the second hollow fiber subset 7 of the hollow fiber 39 is positioned perpendicular to the main flow direction RH, rather than at an angle to the main flow direction RH. In Figure 5b, the processing space 3 is perpendicular to the main flow direction RH and is not symmetrical with respect to the central plane E that bisects the processing space 3. In this fourth embodiment, the processing space 3 expands into a tulip or champagne glass shape, and the area of ​​the blood outlet 15 is significantly larger than the area of ​​the blood inlet 13. However, the processing space 3 can be funnel-shaped. Figure 5C also shows the hollow fibers 7 of a third hollow fiber subset, which are positioned almost perpendicular to the main flow direction RH. Figure 5c also shows that the hollow fibers 7 of hollow fiber subsets 37 and 39 have different fiber spacings. For example, the hollow fibers 7 of the first fiber mat 33 have a first fiber spacing, while the hollow fibers 7 of the second fiber mat 33 have a different fiber spacing in the transverse direction with respect to the fiber longitudinal direction. Preferably, the hollow fibers 7 of multiple fiber mats 33, and especially preferably all of the hollow fibers 7 of all fiber mats 33, have the same fiber spacing. In Figure 5d, the processing space 3 has a discontinuous cross-section and therefore expands abruptly or discontinuously in the main flow direction RH. In other embodiments, the fiber spacing between adjacent hollow fibers 7 of the fiber mat 33 may also vary. For example, preferably, the fiber spacing between adjacent hollow fibers 7 in the central region of the fiber mat 33 is either smaller or larger than the fiber spacing at the blood inlet 13 and / or blood outlet 15.

[0110] Figure 6 shows a membrane module 1 having multiple processing spaces 3, 47. Each of the processing spaces 3, 47 is substantially identical to the processing space 3 of the first embodiment. A membrane module 1 having two or more processing spaces 3, 47 is also preferred. Herein, the additionally provided second processing space 47 is connected to the first processing space 3 by a fiber-free fluid line section 49 (also called a fiber-free connecting section 49). The fluid line section 49 does not contain hollow fibers 7 and may be formed, for example, of tubes. However, adjacent processing spaces 3, 47 may be separated, for example, by a partition plate, in which case the processing spaces 3, 47 may be connected, in particular by a window provided in the partition plate. The hollow fibers 7 may extend through both processing spaces 3, 47. However, preferably, each processing space 3, 47 has its own exchange membrane 5 with a plurality of hollow fibers 7 independent of each other. For example, gas exchange can occur in the first processing space 3, and in the second processing space 47, blood B can be heated by hot water that has passed through the hollow fibers 7 of this processing space 47. Similarly, for example, oxygen O2 can be concentrated in blood B in the first processing space 3, and carbon dioxide CO2 can be mainly removed from blood B in the second processing space 47. In the embodiment shown in Figure 6, the main flow path direction RH is vertically upward in the first processing space 3 and vertically downward in the second processing space 47.

[0111] Figure 7 schematically shows a device 250 for manufacturing a membrane module 1. This manufacturing device 250 basically comprises a centrifugal separator 252 including a turntable 254. The turntable 254 can be rotated around a main rotation axis AD by a drive device (not shown). The turntable 254 is provided with a holder (not shown) for mounting a mold 256 for manufacturing the membrane module 1. The mold 256 preferably forms a housing that accommodates the completed membrane module 1. The device 250 also includes a material supply unit 258, but only a schematic diagram is shown here. The material supply unit 258 is responsible for supplying potting material 260 to the mold 256.

[0112] The procedure of the first method 300 for manufacturing the film module 1 according to the present invention is shown in Figure 8 and will be described below illustratively with reference to the device 250 shown in Figure 7. In addition to blocks 302, 304, and 306 showing the process steps, Figure 8 also shows a scaled view of the device 250.

[0113] In the first step 302 of process 300, the fiber mat 33 of hollow fibers 7 is inserted into the mold 256. As described above with reference to Figure 3, in this embodiment, the fiber mat 33 of unidirectional hollow fibers 7 of the first hollow fiber subset 37 and the fiber mat 33 of unidirectional hollow fibers 7 of the second hollow fiber subset 39 are alternately stacked in the height direction H (the direction perpendicular to the image plane in Figure 7).

[0114] In the second step 304 of process 300, after closing the mold 256, the first fiber end of each hollow fiber 7 placed inside the mold 256 is potted with potting material 260. However, in a variation, potting may be performed with the mold open. Here, the potting of the first fiber ends is referred to as primary potting 304. During primary potting 304, the mold 256 rotates at least temporarily around a first rotation axis AR1 to prevent the potting material 260, which is still fluid in the initial state, from flowing along the longitudinal direction RF of the hollow fiber 7 by capillary action. This first rotation axis AR1 is defined by its relative position to the mold 256, or its position in the mold's coordinate system. From an overall perspective, the first rotation axis AR1 and the main rotation axis AD are identical. With respect to the mold 256 containing the hollow fibers 7, the first rotation axis AR1 is located off-center and, in the illustrated case, is located outside the mold 256. The rotation of the mold 256 on the turntable 254 causes centrifugal force to act on the potting material 260, and this centrifugal force resists the flow of the potting material 260 along the longitudinal direction RF of the fibers. Preferably, the potting material 260 is supplied to the mold 256 during rotation and solidifies there. The potting material 260 may be, for example, an adhesive. In this embodiment, the mold 256 is rotated until the potting material 260 has almost solidified and no longer flows along the hollow fibers 7 by capillary action. However, it should be understood that it is not necessary to rotate until the potting material 260 has completely solidified. During the primary potting 304, the potting material 260 forms the first side wall 23 of the processing space 3 on the radially outward side of the mold 256.

[0115] Next, in the embodiment of method 300 described here, the mold 256 is rotated 180° and reattached to the turntable 254. In the coordinate system of the mold 256, this also changes the position of the main rotation axis AD. Subsequently, in secondary potting 306, which is substantially the same as primary potting 304, a second side wall 25 of the processing space 3 is formed, thereby potting the second fiber end face of each hollow fiber 7 opposite to the first fiber end face. In this process, the mold 256 is rotated again around the main rotation axis AD, thereby forming a second rotation axis AR2 which is different from the first rotation axis AR1. In the coordinate system of the mold 256, the second rotation axis AR2 of secondary potting 306 is different from the first rotation axis AR1 used in primary potting 304. This is because the mold 256 rotates between primary potting 304 and secondary potting 258. In the coordinate system of mold 256, the first rotation axis AR1 and the second rotation axis AR2 are located on different sides of mold 256.

[0116] After primary potting 304 and / or secondary potting 306, the closed fiber ends 17, 19 of the hollow fiber 7 are preferably opened, and particularly preferably opened by cutting or separating the closed ends.

[0117] The first potting section 24 of potting 21 forms the first side wall 23, and the second potting section 26 of potting 21 forms the second side wall 25. It is also possible and preferable to pot the fiber ends multiple times, but the primary potting section 304 and secondary potting section 306 referred to herein relate to potting different fiber ends. Multiple pottings of the first fiber end are referred to as the first primary potting 304 and the second primary potting 304, respectively. The terms primary potting 304 and secondary potting 306 are used here to clarify that the processes are performed in a chronological order and do not indicate priority. Therefore, secondary potting 306 may be performed before primary potting 304. In secondary potting 306, the mold 256 is rotated around the main rotation axis AD of the device 250.

[0118] The rotating axes AR1 and AR2, located outside the mold 256, cause a gentle concave curvature in the side walls 23, 25 of the processing space 3 formed by the solidified potting material 260. The shape of the side walls 23, 25 is basically determined by the distance between the mold 256 and the main rotating axis AD, and the alignment of the mold 256 on the turntable 254. In the illustrated embodiment, the longitudinal side surface 262 of the mold 256 is oriented substantially parallel to the circumferential direction RU of the rotational motion in both the primary potting 304 and the secondary potting 306. This results in a symmetrical shape for the processing space 3. In this embodiment, the processing space 3 is symmetrical with respect to both the longitudinal axis or the main flow direction RH and the central plane E perpendicular to the main flow direction RH. Preferably, the main flow direction RH of the processing space 3 being manufactured may be oriented with respect to the circumferential direction RU of the rotational motion in the primary potting 304 and / or secondary potting 306.

[0119] However, in other embodiments, the orientation of the mold 256 and the orientation of the main flow direction RH can be different. Figure 9 shows, as an example, a mold 256 in which the long side 262 of the mold 256 is oriented outward at an angle with respect to the circumferential direction RU, and the main flow direction RH of the processing space 3 being manufactured is oriented at an angle with respect to the circumferential direction RU. Figure 5b shows a processing space 3 in which the processing space 3 is reduced in the main flow direction RH (in the case of reverse flow, the main cross-sectional area QH of the processing space 3 expands accordingly) when the primary potting 304 and secondary potting 306 are arranged at an angle with respect to the circumferential direction RU with respect to the main flow direction RH.

[0120] Figure 10 shows a second modification of Method 400 for manufacturing a membrane module 1. Method 400 can be used in particular to create a processing space 3 having the shape of a processing space 3, preferably at least partially an elongated ellipsoid, elliptic cylinder, cylinder, or general cylindrical shape, with its base area defined at least partially by a circular arc. In contrast to the first embodiment of Method 300, the mold 256 containing the hollow fibers 7 is mounted vertically on a turntable 254. The fiber longitudinal direction RF of the hollow fibers 7 placed within the mold 256 extends at least partially along the rotating spindle AD. However, the rotating spindle AD may preferably be perpendicular to the fiber longitudinal direction RF of the hollow fibers 7. In the illustrated embodiment, the main flow direction RH of the processing space 3 to be created coincides with the rotating spindle AD. In the second embodiment of Method 400, all side walls of the processing space 3 can be manufactured in a single potting step 402. Once a sufficient amount of potting material 260 is supplied, the processing space 3 becomes essentially an elongated ellipsoid, or cylindrical, with its base area defined at least partially by a circular arc. On the other hand, if the supply of potting material 260 is limited, the side walls 23 and 25 of the processing space 3 will not be closed or separated in the circumferential direction. In this case, the potting 402 will be an incomplete circular potting. In the illustrated preferred embodiment, the potting material 260 is supplied to two opposing sides of the mold 256 by the material supply unit 258. When the mold 258 is rotated around the main rotation axis AD, the potting material 260 is partially distributed in the circumferential direction, forming two substantially symmetrical side walls 23 and 25 of the processing space 3 during solidification. The amount of potting material 260 is selected so that the side walls 23 and 25 are separated from each other. Preferably, the potting material 260 is introduced into the mold 256 by centrifugal force. Alternatively, or in addition to that, the potting material 260 may be introduced into the mold 256 under pressure.

[0121] In either method 300 or 400, the processing space 3 may be closed by placing one or more covers 31 after or before potting 304, 306, or 402.

[0122] Figure 11 schematically illustrates the procedure of a preferred method 500 for extracorporeal processing of blood B. In the first step of this processing method 500, a blood flow is supplied (supply 502 in Figure 11). The blood flow may be supplied, for example, by supplying blood B from a blood reservoir. In the second step 504, the blood flow is supplied to the processing space 3 of a membrane module 1. This membrane module 1 may be, for example, a membrane module 1 according to any of the embodiments described above. The blood B passes through the processing space 3 of the membrane module 1. In the embodiment of method 500 shown herein, the blood B has a pressure level of atmospheric pressure or higher when supplied to the processing space 3. Simultaneously with the supply of blood B 504, a processing medium M (in this case oxygen O2) flows along the longitudinal direction RF of the fibers through the hollow fibers 7 passing through the processing space 3 (flow 506 in Figure 11). The blood B flows through the processing space 3 along the main flow direction RH from the blood inlet 13 toward the blood outlet 15 and comes into contact with the hollow fibers 7 in the processing space 3. In this process, blood B is processed, the process described herein being the concentration of oxygen O2 in blood B and the reduction of carbon monoxide CO and / or carbon dioxide CO2 in blood B. Of the hollow fibers 7 that penetrate the processing space, at least a first subset of hollow fibers 37 have a fiber longitudinal direction RF oblique to the main flow direction RH of blood B in the processing space 3. This allows the contact between blood B and hollow fibers 7 to be optimized in terms of gas exchange, energy exchange, and / or coagulation risk. After passing through 506, the blood is supplied to 508 in a usable form, in particular as a blood reserve. Alternatively, after passing through 506, blood B may be supplied to patient P 510.

[0123] Figures 12a and 12b show a modified example of the membrane module 1 according to the present invention in which there is no oblique flow to the hollow fibers 7. In Figure 12a, the first side wall 23 of the processing space 3 formed by the first potting section 24 and the second side wall 25 of the processing space 3 formed by the second potting section 26 are not shown. A third side wall 51 extending laterally to the first side wall 23 and the second side wall 25 is shown transparently. The replacement membrane 5 of the illustrated embodiment comprises a fiber mat 33 laminated in the main flow direction RH. Here, the fiber mat 33 of the hollow fibers 7 of the first subset hollow fibers 37 and the fiber mat 33 of the hollow fibers 7 of the second subset hollow fibers 39 are laminated alternately. The first fiber longitudinal direction RF1 of the hollow fibers 7 of the first subset hollow fibers 37 and the second fiber longitudinal direction RF2 of the hollow fibers 7 of the second subset hollow fibers 39 extend laterally with respect to the main flow direction RH. Therefore, in the embodiment shown in Figure 12, the fluid flows through the hollow fiber 7 in a lateral direction, rather than diagonally.

[0124] The fourth side wall 53 of the processing space 3 has a similar shape to the third side wall 51 and is positioned mirror-symmetrically on the opposite side. Here, the third side wall 51 and the fourth side wall 53 are designed separately for the potting 21. However, other embodiments are also possible in which the potting 21 has a third potting and a fourth potting that form the third side wall 51 and the fourth side wall 53. The third side wall 51 and the fourth side wall 53 are wedge-shaped. One end of the wedge extends toward the center of the processing space 3. In a membrane module 1 having laterally flowing hollow fibers 7, wedge-shaped side walls 51, 53 are generally preferred, but are particularly advantageous. The wedge-shaped side walls 51 and 53 allow the fourth side wall 53 and the third side wall 51 to fill the X-shaped empty spaces where the hollow fibers 7, formed by stacking hollow fibers 7 in different directions, are scattered, thus enabling particularly efficient use of the fiber mat 33.

[0125] Figure 12b also shows the first sidewall 23 and second sidewall 25 formed by potting 21. The dashed line 55 indicates the concave shape of the sidewalls 23 and 25. For simplification, fiber ends 17 and 19 are not shown in Figure 12b. In the embodiment of Figure 12, the processing space 3 also has a main cross-section QH that changes along the main flow direction RH. As shown in Figure 12b, the first sidewall 23 and second sidewall 25 define the processing space 3, which has a shape similar to an American football in plan. However, the third sidewall 51 and fourth sidewall 53 may also have a shape similar to the first sidewall 23 and second sidewall 25. In such a case, the processing space 3 is substantially American football shaped.

[0126] It should be understood that the shape of the processing space 3 described with reference to Figure 12 is also preferable in the deformation of the membrane module 1 according to the present invention, even when the longitudinal fiber direction RF of at least one hollow fiber subset 37, 39 is oblique to the main flow direction RH. Such a processing space 3 is also preferable in deformations that do not have hollow fibers 7 or replacement membrane 5.

[0127] Figures 13a to 13c show a fifth embodiment of the membrane module 1 according to the present invention, where Figure 13a is a perspective view of the membrane module 1, Figure 13b is a top view of the membrane module 1 (along the height H of the membrane module 1), and Figure 13c is a side view of the membrane module 1. Figure 13a exemplifies the hollow fibers 7, consisting of a first subset of hollow fibers 37 and a second subset of hollow fibers 39, arranged on one side of the membrane module 1. Although the fibers are shown on only one side in Figure 13, it should be understood that the hollow fibers 7 can be arranged along the entire height of the membrane module 1. Although Figure 13 shows only the processing space 3, it should be understood that, of course, there are walls that divide it, which are formed, for example, at least in part by potting 21. The hollow fibers 7 are not shown in Figure 13c.

[0128] In the membrane module 1 according to the fifth embodiment, the first hollow fiber subset 7 of the hollow fiber 37 is arranged in the processing space 3 such that its fiber longitudinal direction RF1 is oblique to the main flow direction RH (parallel to the main axis A in this case). However, the fiber longitudinal directions RF1, RF2 of the first subset hollow fiber 37 and / or the second subset hollow fiber 39 may be parallel or transverse to the main flow direction RH.

[0129] The replacement membrane 5, located within the processing space 3, comprises a main section 57 and two sub-sections 59. The first sub-section 59a is located upstream of the main section 57 with respect to the main flow direction RH. The second sub-section 59b is located downstream of the main section 57 with respect to the main flow direction RH. In the main section 57, the main packing density of the hollow fibers 7, which indicates the number of hollow fibers 7 per unit volume of the main section 57, is approximately constant, although there may be minor manufacturing variations. The hollow fibers 7 are composed of sub-packing densities in the sub-sections 59. The sub-packing density 7 of the sub-sections 59 is lower than the main packing density of the main section 57 and is therefore different from the main packing density. The sub-packing density 7 may vary or remain constant within the sub-sections 59a and 59b. Furthermore, the sub-packing densities 7a and 7b of the sub-sections 59a and 59b may be different from each other or the same. In the embodiments shown in Figures 13a to 13c, the fiber spacing between the hollow fibers 7 of the first subset hollow fibers 37 and the second subset hollow fibers 39 is constant, and therefore the subpacking density of the membrane module 1 is also constant. However, it is important to understand that a constant subpacking density can be achieved by other means. In the illustrated embodiments, the hollow fibers 7 of the first subset hollow fibers 37 and the second subset hollow fibers 39 protrude above the hollow fibers 7 of the other subset hollow fibers 37 and 39 in the subsection 59, thereby achieving a subpacking density lower than the main packing density of the main section 57. However, there are other ways to change the packing density. For example, hollow fibers 7 oriented laterally with respect to the main flow direction RH can be arranged in the subsection 59, and hollow fibers 7 oriented laterally with respect to the main flow direction RH can also be arranged in the main section, but with a smaller fiber spacing.

[0130] The subsection 59 contributes to homogenizing the flow of blood B, as indicated by the arrows in Figure 13b. In particular, the first subsection 59a, located upstream of the main section 57, contributes to evenly distributing the incoming blood B to the main section 57. For this reason, it is particularly advantageous for the subsection 59a to have two subsections 61 that extend away from the main axis A, as shown in Figures 13a and 13b. However, it should be understood that subsections 61 that do not extend are also advantageous and may be preferable in some cases.

[0131] The first sub-section 59a is located within the inlet section 43 of the processing space 3, adjacent to the blood inlet 13 of the membrane module 1. The second sub-section 59b is located within the outlet section 45, which is situated upstream of (or further upstream of) the blood outlet 15.

[0132] As specifically shown in Figure 13b, the subsections 61 are designed to be symmetrical with respect to each other, and this symmetry may or may not apply to the longitudinal fiber directions RF1, RF2 of the hollow fibers 7 located inside. Here, both subsections 61 extend away from the main axis A. In this case, the spread of the subsections 61 along the main axis A (width from left to right in Figure 13b) increases as the distance from the main axis A (upward or downward in Figure 13b) increases.

[0133] Figure 13c shows that in the embodiment under consideration, the height of the subsection 61 is constant. Therefore, in the fifth embodiment, the subsection 61 is substantially prismatic or extends prismatically from the main axis A. On the other hand, the main section 57 has a substantially polygonal base area and a constant height H. Therefore, the main section 57 can preferably be a polyhedron. In this case, the base of the main section 57 is substantially hexagonal, and the two opposing side walls of the main section 5 are convex.

[0134] In a fifth embodiment of the membrane module 1, the blood inlet 13 includes an inlet connector 63. The inlet connector 63 is designed to connect the membrane module 1 to a blood supply line. Here, the inlet connector 63 is cylindrical and has an inlet central axis A that coincides with the main axis A. The blood outlet 15 includes an outlet connector 67 for connecting the membrane module 1 to a blood outlet line. In the illustrated embodiment, the outlet connector is also cylindrical. The outlet connector 67 has an outlet central axis AA that coincides with the main axis A. In the embodiment shown in Figure 13b, the outlet central axis AA and the inlet central axis AE are parallel. However, the inlet connector 63 and / or the outlet connector 65 may not be cylindrical, but may be conical in particular. Particularly preferred is that the cross-section of the inlet connector 63 is at least partially tapered or widened in the direction of flow (the direction from the inlet connector 63 toward the replacement membrane 5). Alternatively, or in addition, the cross-section of the outlet connector 65 is at least partially tapered or widened in the direction of flow (the direction in which the flow exits the membrane module 1 through the outlet connector 65).

[0135] In Figure 13c, the blood inlet 13 and blood outlet 15, or the inlet connector 63 and outlet connector 65, are located in the center of the processing space 3 in the height direction. In a fifth embodiment, the inlet connector 63 and outlet connector 65 are also located in the center of the processing space 3 in the lateral direction perpendicular to the main flow path direction RH (see Figure 13b). However, preferably, the inlet connector 63 may be offset perpendicularly and / or laterally with respect to the central axis of the processing space 3. Alternatively, or in addition, the outlet connector 65 may also be offset perpendicularly and / or laterally with respect to the central axis of the processing space 3.

[0136] The distribution section 65 of the blood inlet 13 is connected to the inlet connector 63 in the main flow direction RH. Therefore, the distribution section 65 is located downstream of the inlet connector 63. The distribution section 65 is provided to distribute the blood B flowing into the blood inlet 13 onto the exchange membrane 5. In this embodiment, the distribution section 65 has an arrow shape in the image plane of Figure 13b. Therefore, the plane in which the distribution section 65 has an arrow shape is perpendicular to the height direction and parallel to the inlet central axis AE of the blood inlet 13 or the main flow direction RH. The side view in Figure 13c shows that the arrow shape of the distribution section 65 is evenly distributed across the entire height H of the membrane module 1.

[0137] Figure 14 shows details of the blood inlet 13. In this preferred embodiment, the arrow-shaped distribution section 65 comprises a first wing portion 69 and a second wing portion 71. The wing portions 69 and 71 are basically rectangular parallelepipeds and extend laterally (perpendicular to the main axis A) and rearward (upstream) from the arrowhead portion 73 (here linear) of the distribution section 65.

[0138] A collection section 75 is provided upstream of the outlet connector 67 of the blood outlet, in the direction RH of the main flow path (see Figure 13b). The collection section 75 is approximately funnel-shaped in the image plane of Figure 13b. The collection section 75 is also funnel-shaped in a plane perpendicular to the image plane of Figure 13b (see Figure 13c). The collection section 75 collects blood B flowing from the exchange membrane 5 in the direction of the main flow path and supplies it to the outlet connector 67. The funnel shape of the collection section 75 prevents backflow and reduces the risk of thrombus formation.

[0139] Figure 15 shows a sixth embodiment of the membrane module 1, which is essentially different from the membrane module 1 according to the fifth embodiment in the relative arrangement of the inlet connector 63. Here, the inlet central axis AE is positioned substantially perpendicular to the main axis A through the processing space 3. The arrangement of the blood outlet 15 and the outlet central axis AA is essentially the same as in the fifth embodiment described above. In other embodiments, the inlet central axis AE and the outlet central axis AA, and therefore the respective blood flows B in the blood inlet 13 and blood outlet 15, may also be inclined relative to each other.

[0140] In the sixth embodiment, a connector segment 66 is provided that connects the inlet connector 63 to the distribution section 65. The connector segment 66 may be directly connected to the distribution section 65. In the sixth embodiment, the distribution section 65 is basically arrow-shaped, similar to the fifth embodiment. However, with the change in the arrangement of the inlet connector 63, blood B is supplied from the upper side laterally relative to the height of the exchange membrane 5. Blood B flows from the inlet connector 63 laterally into the arrow-shaped distribution section 65. The distribution section 65 is formed here only by wing portions 69 and 71. However, for example, the distribution section 65 may be the same as the distribution section shown in Figures 13a to 13c, and the connector segment 66 may be assumed to be an elbow connecting the vertical inlet connector 63 and the distribution section 65. Furthermore, the arrow-shaped distribution section 65 is not constant in the height direction (perpendicular to the direction of the arrow, i.e., from top to bottom in Figure 15). In the embodiment, it is preferable that the distribution section 65 is tapered away from the inlet connector 63. However, in the case of lateral flow to the distribution section 65, the height of the distribution section 65 may be constant.

[0141] Figures 16a and 16b schematically illustrate other preferred embodiments of the blood inlet 13. In Figure 16a, the distribution section 65 is basically wedge-shaped in the image plane. The distribution section 65 may also be wedge-shaped in a direction perpendicular to this plane. However, the wedge-shaped distribution section may extend continuously over the entire height H of the membrane module 1, or it may have a different shape. The inlet connector 63 may be positioned parallel to the outlet connector, as shown in Figures 13a-13c, or it may flow into the distribution section 65 from the side, particularly from above, as shown in Figure 15. However, in Figure 16b, the distribution section 65 is cup-shaped. The stem 77 of the cup-shaped distribution section 65 faces the inlet connector 63. From the stem 77, the distribution section 65 extends along the main axis A and / or the main flow direction RH. The cup shape may exist on multiple planes, or in projections onto multiple planes, or on a single plane.

[0142] Figure 17, much like Figure 5b, shows that the cross-sections of the processing space 3 at the blood inlet 13 and blood outlet 15 do not need to be identical. For example, preferably, the processing space 3 may have the shape of a champagne glass or a tulip when projected onto at least one plane. Such a processing space has at least two opposing convex side walls 23, 25. The side walls 23, 25 are configured such that the processing space 3 narrows or widens along the main flow direction RH (towards the blood outlet 15). Preferably, the processing space 3 tapers along the main flow direction RH. The acceleration of blood flow through the processing space 3 that can be achieved in this way suppresses the formation of a "dead water zone" with very low flow velocity and prevents blood coagulation. In all the embodiments described above, the design of the processing space 3 is preferable. Note that the blood inlet 13 and blood outlet 15 in Figure 17 are for illustrative purposes only. [Explanation of Symbols]

[0143] 1. Membrane module 3 Processing space 5 Exchange membrane 7 Hollow Fibers 9. First tube connector 11. Second tube connector 13. Blood inlet 15 Blood outlet 17 First fiber end 19 Second fiber end 21 Potting 23 First side wall 24 First potting 25 Second side wall 26. Second potting 27 Media inlet 29 Media outlet 31 Cover 33 Fiber Mat 35 warp threads 37. First Hollow Fiber Subset 39. Second hollow fiber subset 41 Free rhombus 43 Entrance Section 45 Exit Section 47. Second Processing Space 49 Fluid line section 51 Third side wall 53. Fourth side wall 55 Dashed line 57 Main Sections 59 Subsection 61 Subsection of subsection 63 Inlet Connector 65 Distribution Section 66 Connector Segments 67 Outlet Connector 69 First wing section 71 Second wing section 73 Arrows 75 Collection Section 77 Stem 200 Blood Processing Systems 202 Cannula 204 Inlet tube 206 Disposable Processing Modules 208 Discharge tube 210 Console 212 First pump 214 Second pump 216 Control device 218 Housing 220 Diaphragm Module Holder 222 Processing medium supply unit 224 Processing medium discharge section 226 Actuator 228 Throttle valve 250 Manufacturing Devices 252 Centrifugal separator 254 Turntable 256 molds 258 Material supply department 260 potting material 262 Long side of the mold 300 Method for manufacturing a membrane module (first step) 302 Insertion of fiber mat 304 Primary potting 306 Secondary potting 400 Method for manufacturing membrane modules (second step) 402 Potting 500 Methods for extracorporeal processing of blood 502 Blood flow supply 504 Supply of blood flow to the processing space 506 Flow through hollow fibers 508, 510 Blood supply A spindle AA outlet center axis AD Main Rotation Axis AE inlet center axis B blood CO (carbon monoxide) CO2 (carbon dioxide) E center plane H: Height, height direction M Processing medium O2 (Oxygen) P patient QH, QH1, QH2 main cross section QM center section RF, RF1, RF2 Fiber optic direction RH Mainstream Road Direction RU circumferential direction α Cross-sectional angle

Claims

1. At least one blood inlet (13) and at least one blood outlet (15) are connected to each other by a processing space (3) in the direction of the main flow path (RH), A replacement membrane (5) having a plurality of hollow fibers (7), wherein each hollow fiber (7) extends through the processing space (3) in the longitudinal direction of the fiber (RF1, RF2), and the replacement membrane (5) is configured such that the processing medium (M) flows in the longitudinal direction of the fiber (RF1, RF2) from the first fiber end (17) to the opposite second fiber end (19), The first fiber end (17) and the second fiber end (19) of the hollow fibers (7) of the replacement membrane (5) are fixed, and the potting (21) defines at least partially the processing space (3), A membrane module (1) for processing blood (B) is provided, The membrane module (1) is characterized in that at least a first set of hollow fibers (37) among the plurality of hollow fibers (7) are arranged in the processing space (3) such that their longitudinal directions (RF1, RF2) are oblique to the main flow path direction (RH).

2. The membrane module (1) according to claim 1, wherein the processing space (3) has main cross-sections (QH, QH1, QH2) that are perpendicular to the main flow direction (RH) and change within the main flow direction (RH).

3. The membrane module (1) according to claim 1 or 2, wherein the processing space (3) is rotationally asymmetric.

4. The film module (1) according to any one of claims 1 to 3, wherein the potting (21) comprises a first potting section (24) and a second potting section (26), the first potting section (24) forming a first side wall (23) of the processing space (3), and the second potting section (26) forming a second side wall (25) of the processing space (3) opposite to the first side wall (23), and the first side wall (23) and / or the second side wall (25) have a concave shape.

5. The membrane module (1) according to claim 4, further comprising at least one cover (31) of the processing space (3), wherein the cover (31) is at least partially transparent in at least a portion of it, and the cover (31) is preferably substantially planar.

6. The membrane module (1) according to any one of claims 1 to 5, wherein the packing density of the hollow fibers (7) changes along the main flow direction (RH), preferably increasing along the main flow direction (RH) from the blood inlet (13) toward the central section of the processing space (3) and / or decreasing toward the blood outlet (15) from the central section.

7. The membrane module (1) according to any one of claims 1 to 6, wherein the hollow fibers (7) of the second hollow fiber subset (39) of the plurality of hollow fibers (7) of the replacement membrane (5) have a different orientation from the hollow fibers (7) of the first hollow fiber subset (37).

8. The membrane module (1) according to claim 7, wherein only the hollow fibers (7) of the first hollow fiber subset (37) are arranged in the inlet region of the processing space (3) adjacent to the blood inlet (13), or only the hollow fibers (7) of the second hollow fiber subset (39) are arranged in the outlet region upstream of the blood outlet (15).

9. In the inlet section (43) of the processing space (3) adjacent to the blood inlet (13), the hollow fibers (7) of the first subset hollow fibers (37) protrude at least partially beyond the hollow fibers (7) of the second subset hollow fibers (39), and / or the hollow fibers (7) of the second subset hollow fibers (39) protrude at least partially beyond the hollow fibers (7) of the first subset hollow fibers (37), and / or The membrane module (1) according to claim 7, wherein in the outlet section (45) of the processing space (3) located upstream of the blood outlet (15), the hollow fibers (7) of the first subset hollow fibers (37) protrude at least partially beyond the hollow fibers (7) of the second subset hollow fibers (39), and / or the hollow fibers (7) of the second subset hollow fibers (39) protrude at least partially beyond the hollow fibers (7) of the first subset hollow fibers (37).

10. The membrane module (1) according to any one of claims 7 to 9, wherein the longitudinal fiber directions (RF1, RF2) of the hollow fibers (7) of the first subset hollow fiber (37) and the longitudinal fiber directions (RF1, RF2) of the hollow fibers (7) of the second subset hollow fiber (39) form an intersection angle (α) in the range greater than 0° and less than 180°, and preferably the main flow path direction (RH) bisects the intersection angle (α).

11. The membrane module (1) according to any one of claims 1 to 10, wherein the replacement membrane (5) includes a fiber mat (33) of unidirectional hollow fibers (7), the fiber mats (33) are stacked on top of each other in a height direction (H) perpendicular to the main flow direction (RH), and the surface of the fiber mats (33) preferably changes in the height direction (H), and particularly decreases outward.

12. The membrane module (1) according to any one of claims 1 to 11, wherein the processing space (3) is configured to receive pressurized blood (B), in particular blood (B) with an absolute pressure (Pa) of 3 bar or less.

13. The membrane module (1) according to any one of claims 1 to 12, wherein the membrane module (1) is designed to be coreless.

14. The membrane module (1) is a direct-pass type module, and the blood inlet (13) faces the blood outlet (15) along the main axis (A) of the membrane module (1), particularly the longitudinal axis, according to any one of claims 1 to 13.

15. The membrane module (1) according to any one of claims 1 to 14, wherein the membrane module (1) has a second processing space (47) connected to a first processing space (3), and the hollow fibers (7) in the first processing space (3) are preferably different from the hollow fibers (7) in the second processing space (3).

16. The membrane module (1) according to any one of claims 1 to 15, wherein the replacement membrane (5) has a main section (57) and at least one sub-section (59), the main packing density of the hollow fibers (7) in the main section (57) is constant, and the sub-packing density of the hollow fibers (7) in the sub-section (59) is different from the main packing density in at least some sections.

17. At least one blood inlet (13) and at least one blood outlet (15) are connected to each other by a processing space (3) in the direction of the main flow path (RH), A replacement membrane (5) having a plurality of hollow fibers (7), wherein each hollow fiber (7) extends through the processing space (3) in the longitudinal direction of the fiber (RF1, RF2), and the replacement membrane (5) is configured such that the processing medium (M) flows in the longitudinal direction of the fiber (RF1, RF2) from the first fiber end (17) to the opposite second fiber end (19), The first fiber end (17) and the second fiber end (19) of the hollow fibers (7) of the replacement membrane (5) are fixed, and the potting (21) defines at least partially the processing space (3), A membrane module (1) for processing blood (B) is provided, The replacement membrane (5) comprises a main section (57) and at least one sub-section (59), wherein the main packing density of the hollow fibers (7) in the main section (57) is constant, and the sub-packing density of the hollow fibers (7) in the sub-section (59) differs from the main packing density in at least one portion, characterized in that the membrane module (1).

18. The membrane module (1) according to claim 17, wherein the subsection (59) is located in the inlet section (43) of the processing space (3) adjacent to the blood inlet (13) and / or in the outlet section (45) of the processing space (3) upstream of the blood outlet (15).

19. The membrane module (1) according to claim 17 or 18, wherein the subsection (59) comprises at least two subsections (61) located on both sides of the main axis (A) of the membrane module (1) extending from the blood inlet (13) to the blood outlet (15).

20. The membrane module (1) according to claim 19, wherein the subsection (61) is symmetrical with respect to the principal axis (A).

21. The membrane module (1) according to claim 19 or 20, wherein the subsection (61) extends away from the main axis (A).

22. The membrane module (1) according to claim 21, wherein the subsection (61) unfolds in a pyramidal and / or prism shape.

23. The membrane module (1) according to any one of claims 16 to 22, wherein the main section (57) basically has the shape of a cylinder, annular cylinder, polyhedron, and / or cuboid, and at least one side of the main section, particularly preferably two opposing sides, is convex and / or concave.

24. The membrane module (1) according to any one of claims 16 to 23, wherein the plurality of hollow fibers (7) comprises a first hollow fiber subset (37) having at least a first hollow fiber and a second hollow fiber subset (39) having a second hollow fiber.

25. The membrane module (1) according to claim 24, wherein at least the first hollow fiber subset (37) is arranged in the processing space (3) such that its fiber longitudinal directions (RF1, RF2) are oblique to the main flow path direction (RH).

26. The membrane module (1) according to claim 24 or 25, wherein the first hollow fiber of the first subset hollow fiber (37) has a smaller fiber diameter than the second hollow fiber of the second subset hollow fiber (39).

27. The membrane module (1) according to any one of claims 24 to 26, wherein the first hollow fiber subset (37) is formed from at least one fiber mat, and the first fibers thereto have a first fiber spacing from each other, and the second hollow fiber subset (39) is formed from at least one second fiber mat, and the second fibers thereto have a second fiber spacing from each other, and the first fiber spacing is preferably smaller or larger than the second fiber spacing.

28. The membrane module (1) according to any one of claims 24 to 27, wherein the first fiber type of the first fiber is different from the second fiber type of the second hollow fiber, the first fiber is preferably a semipermeable hollow fiber and the second fiber is preferably a fluid-impermeable fiber, or the first fiber is preferably a fluid-impermeable fiber and the second fiber is preferably a semipermeable hollow fiber.

29. The membrane module (1) according to any one of claims 16 to 28, wherein the blood inlet (13) has an inlet connector (63) for connecting the membrane module to at least one blood supply line, and the blood outlet (15) has an outlet connector (67) for connecting the membrane module (1) to a blood discharge line.

30. The membrane module (1) according to claim 29, wherein the inlet central axis (AE) of the inlet connector (63) and the outlet central axis (AA) of the outlet connector (67) are at an angle to each other, and preferably are arranged perpendicular to each other.

31. The membrane module (1) according to claim 29, wherein the inlet central axis (AE) of the inlet connector (63) and the outlet central axis (AA) of the outlet connector (67) are arranged parallel to each other, preferably coincidentally.

32. The membrane module (1) according to any one of claims 29 to 31, wherein the blood inlet (13) comprises a distribution section (65) at least indirectly connected to the inlet connector (63) for distributing the blood received at the inlet connector (63) to the exchange membrane (5).

33. The membrane module (1) according to claim 32, wherein the distribution section (65) has an arrow shape in at least one plane in the direction of the main flow path (RH).

34. The membrane module (1) according to claim 33, wherein the arrow-shaped distribution section (65) has at least a first wing portion (69) and a second wing portion (71), the wing portions being basically rectangular parallelepipeds, the first wing portion (69) and the second wing portion (71) being preferably connected to each other by a connecting line, the connecting line preferably forming the arrowhead (73) of the arrow-shaped distribution section (65).

35. The membrane module (1) according to claim 32, wherein the distribution section (65) is cup-shaped in at least one plane in the main flow direction (RH), and the stem (77) of the cup-shaped distribution section (65) faces the inlet connector (63).

36. The membrane module (1) according to claim 32, wherein the distribution section (65) is wedge-shaped in at least one plane in the main flow direction (RH), and the wedge-shaped tip of the wedge-shaped distribution section (65) is oriented away from the inlet connector (63).

37. The membrane module (1) comprises an inlet membrane at least partially disposed within the distribution section (65), the inlet membrane including a plurality of fibers extending in the longitudinal direction of the inlet fibers through the distribution section (65), The longitudinal direction of the inlet fiber is preferably perpendicular to the main flow path direction (RH), and further / or, The membrane module (1) according to any one of claims 32 to 36, wherein the inlet membrane is preferably a heat exchange membrane.

38. The main flow direction (RH) in the inlet section (63) is at an angle to the main flow direction on the membrane side of the distribution section (65) facing the exchange membrane (5), and is perpendicular, and / or The membrane module (1) according to any one of claims 32 to 27, wherein the main flow direction (RH) in the inlet connector (63) is perpendicular to the main flow direction (RH) in the transition between the blood inlet (13) and the main section (57) and / or the sub-section (59).

39. The membrane module (1) according to any one of claims 29 to 37, wherein the blood outlet (15) has a collection section (75) located at least indirectly upstream of the outlet connector (67).

40. The membrane module (1) comprises an exit membrane at least partially located within the collection section (75), the exit membrane comprising a plurality of fibers, each extending through the collection section (75) in the longitudinal direction of the exit fibers, The longitudinal direction of the outlet fiber is preferably perpendicular to the main flow path direction (RH), and / or, The membrane module (1) according to claim 39, wherein the outlet membrane is preferably a heat exchange membrane.

41. The membrane module (1) according to claim 39 or 40, wherein the collection section (75) is wedge-shaped, funnel-shaped, and / or inverted arrow-shaped in at least one plane along the main flow direction (RH).

42. The membrane module (1) according to any one of claims 16 to 41, wherein the fiber types of the plurality of hollow fibers (7) in the main section (57) are at least partially different from the fiber types of the plurality of hollow fibers (7) in the sub-section (59).

43. At least one pump (212, 214) for generating blood (B) flow, A controller (216) for controlling the pumps (212, 214), A membrane module (1) according to any one of claims 1 to 42 or 48, A system (200) for processing blood (B), comprising: The pumps (212, 214) are connected to the patient's (P) blood circuit via a first tubular section and to the processing space (3) of the membrane module (1) via a second tubular section. The system (200) is a system (200) for processing blood (B), preferably one that allows blood (B) at a pressure level higher than ambient atmospheric pressure to pass through the processing space (3).

44. A membrane module (1) for extracorporeal processing of blood (B), particularly a method for manufacturing the membrane module (1) according to any one of claims 1 to 42 or 48, - A step of inserting a fiber mat (33) made of hollow fibers (7), particularly unidirectional hollow fibers (7), into a mold (256), - A step of primary sealing (304) the first fiber end of the hollow fiber (7) with a sealing material (260) to form the first side wall (23) of the processing space (3) of the membrane module (1), wherein during the primary sealing (304), the mold (256) is rotated at least intermittently around the first rotation axis (AR1), - A step of forming a second side wall (25) facing the first side wall (23) by secondary potting (306) the second fiber end of the hollow fiber (7) facing the first fiber end in the longitudinal direction of the fiber (RF1, RF2), wherein during the secondary potting (306), the mold (256) is rotated at least temporarily around a second rotation axis (AR2) different from the first rotation axis (AR2), Includes, A method for manufacturing a membrane module (1), wherein the first axis of rotation (AR1) and the second axis of rotation (AR2) are preferably parallel, and further / or the first axis of rotation (AR1) and / or the second axis of rotation (AR2) do not intersect with the fiber mat (33).

45. A membrane module (1) for extracorporeal processing of blood (B), particularly a method for manufacturing the membrane module (1) according to any one of claims 1 to 42 or 48 (400), - A step of inserting a fiber mat (33) made of hollow fibers (7), particularly unidirectional hollow fibers (7), into a mold (256), - A step of potting (402) both ends of the hollow fiber (7) to form the side walls (23, 25) of the processing space (3) of the membrane module (1), wherein during the potting (402), the mold (256) rotates at least temporarily around the main rotation axis (AD), Includes, A method for manufacturing a membrane module (1), wherein the potting (402) is an incomplete circular potting.

46. - A step of providing a console (210) comprising at least one pump (212, 214), a controller (216), and a diaphragm module holder (220), - A step of providing a disposable processing module (206) comprising a membrane module (1) according to any one of claims 1 to 42 or 48, - The step of inserting the membrane module (1) into the diaphragm module holder (220), - The disposable processing module (206) is functionally connected to the pumps (212, 214), and a fluid, particularly blood (B), is transported through the membrane module (1). An assembly method comprising the above.

47. - A step of supplying blood flow (502), - A step of supplying the blood flow to the processing space (3) of the membrane module (1), wherein the membrane module (1) is the membrane module (1) described in any one of claims 1 to 42 or 48, and the pressure of the blood flow (B) is preferably greater than atmospheric pressure, and the step of supplying the blood flow (B) to the processing space (3) of the membrane module (1), - Hollow fibers (7) extending through the processing space (3) are processed along their respective longitudinal directions (RF1, RF2) using a processing medium (M), particularly oxygen (O ２ The steps to play ) and Includes, The blood flow flows through the processing space (3) along the main flow direction (RH), comes into contact with the hollow fibers (7) that penetrate the processing space (3), and processes the blood (B), particularly oxygen (O). ２ In a method (500) for extracorporeal processing of blood (B) to enrich it, A method for extracorporeal processing of blood (B) (500), characterized in that at least a first subset (37) of a plurality of semipermeable hollow fibers (7) is arranged in the processing space (3) such that its fiber longitudinal directions (RF1, RF2) are oblique to the main flow path direction (RH).

48. At least one blood inlet (13) and at least one blood outlet (15) are connected to each other via a processing space (3) in the direction of the main flow path (RH), A replacement membrane (5) having a plurality of hollow fibers (7), wherein each hollow fiber (7) extends through a processing space (3) in the longitudinal direction of the fiber (RF1, RF2), and the processing medium (M) is configured to flow in the longitudinal direction of the fiber (RF1, RF2) from the first fiber end (17) to the opposite second fiber end (19), The first fiber end (17) and the second fiber end (19) of the hollow fibers (7) of the replacement membrane (5) are fixed, and the potting (21) defines at least partially the processing space (3), A membrane module (1) for processing blood (B) is provided, The processing space (3) has main cross-sections (QH, QH1, QH2) that change perpendicular to the main flow path direction (RH), and the processing space (3) preferably has a substantially American football shape in at least one plane, in a membrane module (1) for processing blood (B).

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