Membrane module with inclined inflow

Abstract

The invention relates to a membrane module (1) for treating blood (B), comprising at least one treatment space (3), an exchange membrane (5) having a plurality of semi-permeable hollow fibers (7), each hollow fiber extending through the treatment space (3) in a fiber longitudinal direction (RF1, RF2), an encapsulation (21) in which a first fiber end (17) and a second fiber end of the hollow fibers (7) of the exchange membrane (5) are fixed, at least a first subset (37) of hollow fibers is arranged in the treatment space (3) such that the fiber longitudinal directions (RF1, RF2) thereof are inclined with respect to the main flow direction (RH). The invention also relates to a blood treatment system (200), to two methods (300, 400) for manufacturing the membrane module (1), to an assembly method and to a method (500) for the extracorporeal treatment of blood (B).

Description

[0001] This invention relates to a membrane module for processing blood, comprising at least one processing space having at least one blood inlet and at least one blood outlet connected to each other in the main flow direction through the processing space; an exchange membrane having a plurality of semi-permeable hollow fibers, each semi-permeable hollow fiber extending through the processing space in the fiber longitudinal direction and designed for a processing medium to flow longitudinally from a first fiber end to an opposing second fiber end; and a potting compound in which the first and second fiber ends of the hollow fibers of the exchange membrane are fixed, and at least partially define the processing space. Furthermore, this invention relates to methods of manufacturing the membrane module, blood processing systems, assembly methods, and methods of in vitro blood processing.

[0002] Filling fluids with gas and controlling the temperature of fluids in heat exchange membranes are well-known techniques for preparing fluids for subsequent processes or procedures. In medical technology, these principles are crucial for blood management. Providing oxygen to patients is essential, especially in cases of acute deterioration of respiratory function. In particularly severe cases, oxygenation of the patient's blood is necessary. In extracorporeal membrane oxygenation (ECMO), a large portion of the treated patient's blood is oxygenated extracorporeally through a suitable device. Removing large amounts of blood can place significant stress on the body and carries considerable risks. For example, large amounts of anticoagulants must be used to prevent thrombosis or blockage of the ECMO device due to thrombosis. Therefore, ECMO is typically used as a last resort in cases of particularly severe respiratory failure or during surgery. However, in other situations, such as carbon monoxide poisoning, ischemia treatment, or cancer treatment support, filling the patient's blood with oxygen may also be beneficial. Furthermore, the filling and / or removal of gas from fluids is often also necessary. For example, removing carbon dioxide from the blood of a patient receiving treatment.

[0003] However, there are virtually no suitable devices on the market to support the oxygenation of a patient's blood. As previously mentioned, conventional devices for extracorporeal membrane oxygenation (ECMO) are designed for high blood flow rates and are therefore unsuitable for supportive care of conscious patients. Due to the required high blood flow rates, known devices, particularly membrane modules for treating blood, pose significant health risks, especially thrombosis, when used at lower flow rates.

[0004] In view of this, the object of the present invention is to provide a membrane module that allows for improved blood handling, particularly for gentle patient handling and / or efficient blood handling, especially at relatively low blood flow rates.

[0005] The present invention addresses this problem in a first aspect by means of a membrane module according to claim 1. In particular, the present invention addresses this objective by means of 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 main flow direction through the processing space; an exchange membrane having a plurality of hollow fibers, each hollow fiber extending through the processing space in a longitudinal direction and designed to allow a processing medium to flow longitudinally from a first fiber end to an opposing second fiber end; a potting compound in which the first and second fiber ends of the hollow fibers of the exchange membrane are fixed together and at least partially define the processing space; wherein at least a first subset of the hollow fibers are arranged in the processing space such that their longitudinal direction is inclined relative to the main flow direction.

[0006] Preferably, some, and particularly preferably all, of the hollow fibers are semi-permeable. Therefore, the exchange membrane may comprise multiple semi-permeable hollow fibers. In variations, some or all of the hollow fibers may also be completely airtight, for example, when the hollow fibers are used for temperature treatment of blood. In other variations, some or all of the hollow fibers may be porous.

[0007] The fluid to be treated, particularly blood, flowing through the treatment space can be treated by a treatment medium flowing through the hollow fibers. Treatment may include temperature treatment, particularly heating and / or cooling, temperature rise, cooling and / or temperature stabilization, and / or mass exchange, particularly gas exchange. This gas exchange may be, in particular, oxygenation (oxygenation) and / or reduction of carbon dioxide content in the treated blood. The treatment space is preferably part of a membrane module in which the blood to be treated contacts the hollow fibers of the exchange membrane. It should be understood that the treatment space may also have a free cross-sectional flow region that allows blood to flow through. Thus, the hollow fibers of the exchange membrane are preferably spaced apart from each other, allowing blood to flow close to the hollow fibers through the resulting free cross-sectional flow region. Furthermore, the treatment space may include portions without hollow fibers or without fibers. However, preferably, the treatment space includes at least partially hollow fibers in each cross-section perpendicular to the main flow direction. There are also embodiments of the membrane module according to the invention in which hollow fibers are not provided. For example, a continuous membrane module and / or at least one flat membrane may be provided. In other variations of the invention described herein, the membrane may also be omitted. Then, for example, treatment can be carried out by a wall defining a treatment space, for which the wall may be formed at least by a membrane material sub-part. It should be understood that, within the scope of this disclosure, if the treated blood is given to a patient in a subsequent step that does not constitute part of this invention, the treatment does not necessarily have a direct or indirect therapeutic effect on the patient. Treatment may include any form of action on blood or other fluids to be treated.

[0008] Hollow fibers preferably extend through the processing space in a straight line. In this way, the hollow fibers can be tensioned, thereby minimizing fiber deformation caused by the fluid flowing through the processing space. Blood inlets and blood outlets are connected to each other in the main flow direction. The main flow direction preferably extends substantially straight, particularly preferably from the blood inlet to the blood outlet. Preferably, the main flow direction is defined along a straight line connecting the centroids of the blood inlet and the blood outlet. The blood inlet and blood outlet are preferably positioned opposite each other along the main flow direction. However, the main flow direction may also be specified to extend at least partially along a curve. The main flow direction may also be curved, and then preferably perpendicular to the free flow cross-section in each cross-section of the processing space. The blood inlet and blood outlet may be adjacent to each other, for example, on the same side of the housing, and the main flow direction may, for example, be substantially U-shaped. The main flow direction describes the flow of the medium to be processed, particularly blood, through the processing space when viewed globally. It should be understood that, for example, local turbulence or secondary flow occurring due to the flow around individual hollow fibers may still cause individual fluid particles of the medium to not follow the main flow direction. In a preferred embodiment of the invention, the main flow direction may also be defined by the average velocity or its vector in each cross-section of the processing space.

[0009] The hollow fibers of the exchange membrane are designed to have a treatment medium flowing longitudinally along their respective fibers. The fluid to be treated, particularly blood flowing through the treatment space, comes into contact with the hollow fibers in the treatment space and is thus treated. The treatment medium is preferably a fluid. For example, the treatment medium can be temperature-controlled water, preferably used for temperature control (heating and / or cooling) of the blood flowing through the treatment space. Preferably, the treatment medium is a gas or a mixture of gases. Such a gas or gas mixture is also called a purge gas. The purge gas is particularly preferably oxygen and / or an anesthetic gas, or includes oxygen and / or an anesthetic gas. In addition, or as a supplement, the purge gas may also 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 and / or reduce its carbon monoxide and / or carbon dioxide content. Preferably, the treatment medium enters the fiber at a first fiber end and exits at a second fiber end. However, the flow through the fibers can also be in the opposite direction.

[0010] Solid fibers can also be provided as an alternative to or supplement to hollow fibers. For example, heated fibers can be provided to process blood, with the heated fibers extending through the processing space.

[0011] The potting element preferably accommodates or holds the corresponding first and second fiber ends of the hollow fibers of the exchange membrane in place. For example, the potting element can be bonded with an adhesive to the fiber ends. Preferably, the potting element is impermeable to liquid and / or air. The potting element may also form one or more walls that at least partially define a treatment space. For example, the potting element may define a sidewall of the treatment space along which the blood to be treated preferably flows in the main flow direction. It should be understood that the potting element may have different potting portions, which may be formed continuously and / or at least partially separated from each other. For example, the potting element may include two potting portions, each forming a wall separate from the other wall. The potting element preferably comprises a potting material selected from silicone, polyurethane, polyolefin, polyethylene, epoxy resin, cyanoacrylate; or mixtures thereof.

[0012] The invention described herein may also include embodiments without potting, wherein the hollow fiber or other membrane element is fixed in another manner.

[0013] Furthermore, the invention described herein may also include embodiments in which the exchange membrane comprises at least one fiber pad having a plurality of fibers, particularly hollow fibers, connected by warp threads. In a particularly preferred embodiment, the main flow direction is substantially along the warp threads, preferably parallel to them. In this variant, the longitudinal direction of the fibers does not necessarily have to be at an angle to the main flow direction.

[0014] Preferably, a first subset of a plurality of semi-permeable hollow fibers is arranged in the processing space such that their longitudinal fiber direction is inclined relative to the main flow direction. The first subset of hollow fibers may further include all hollow fibers from the plurality of hollow fibers of the exchange membrane. Preferably, the hollow fibers of the first subset are substantially parallel or unidirectional to each other. Hollow fibers arranged inclined relative to the main flow direction are neither parallel nor perpendicular to the main flow direction. Hollow fibers inclined to the main flow direction (or their longitudinal direction) form an acute or obtuse angle with the main flow direction that is not equal to 90°. The angle of attack is the smaller of the angles formed between the main flow direction and the fiber longitudinal direction. The hollow fibers of the first subset (each in its longitudinal direction) form an angle of attack with the main flow direction, preferably greater than 0° and less than or equal to 90°, preferably greater than or equal to 5° and less than or equal to 90°, preferably greater than or equal to 10° and less than or equal to 90°, preferably greater than or equal to 15° and less than or equal to 90°, preferably greater than or equal to 15° and less than or equal to 85°, preferably greater than or equal to 15° and less than or equal to 80°, preferably greater than or equal to 12° and 75°, preferably greater than or equal to 15° and less than or equal to 75°, preferably greater than or equal to... The angle of attack is between 20° and less than or equal to 75°, preferably greater than or equal to 20° and less than or equal to 70°, preferably greater than or equal to 25° and less than or equal to 70°, preferably greater than or equal to 25° and less than or equal to 65°, preferably greater than or equal to 30° and less than or equal to 65°, preferably greater than or equal to 30° and less than or equal to 60°, preferably greater than or equal to 35° and less than or equal to 60°, preferably greater than or equal to 35° and less than or equal to 55°, preferably greater than or equal to 40° and less than or equal to 55°, preferably greater than or equal to 40° and less than or equal to 50°. When viewed from the flow direction, the angle of attack is the smaller of the angles between the main flow direction and the fiber longitudinal direction. The angle of attack is determined within the plane of the hollow fiber, which in this case is also called the fiber orientation plane. The hollow fibers of the first subset of the hollow fibers extend within or are parallel to this fiber orientation plane.

[0015] Preferably, the hollow fibers of the first subset can form a second angle of attack with the main flow direction, which is determined in a plane perpendicular to the fiber direction plane. The value of the second angle of attack is preferably in the range of greater than 0° and less than or equal to 90°, preferably greater than or equal to 5° and less than or equal to 90°, preferably greater than or equal to 10° and less than or equal to 90°, preferably greater than or equal to 15° and less than or equal to 90°, preferably greater than or equal to 15° and less than or equal to 85°, preferably greater than or equal to 15° and less than or equal to 80°, preferably greater than or equal to 12° and 75°, preferably greater than or equal to 15° and less than or equal to 75°, preferably greater than or equal to 20° and less than or equal to 75°, preferably greater than or equal to 90°. The angles are 20° to less than or equal to 70°, preferably greater than or equal to 25° to less than or equal to 70°, preferably greater than or equal to 25° to less than or equal to 65°, preferably greater than or equal to 30° to less than or equal to 65°, preferably greater than or equal to 30° to less than or equal to 60°, preferably greater than or equal to 35° to less than or equal to 60°, preferably greater than or equal to 35° to less than or equal to 55°, preferably greater than or equal to 40° to less than or equal to 55°, preferably greater than or equal to 40° to less than or equal to 50°, wherein edge values ​​should also be protected. The first subset of hollow fibers 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%, preferably at least 95%. The first subset of hollow fibers may also comprise all the hollow fibers of the exchange membrane.

[0016] When viewed in the reference frame 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 pad plane of the fiber pad of the exchange membrane. This flow can also be referred to as flow in the pad plane. The invention described herein may also include variations in which hollow fibers without a first subset of hollow fibers flow in at an angle. The aforementioned flow through the pad plane is also preferred for such variations, particularly for at least one subset of hollow fibers whose fibers are longitudinally arranged transversely to the main flow direction. In a preferred variation of the invention, the hollow fibers of the first subset of hollow fibers are arranged in the processing space such that their fibers are longitudinally parallel to and / or transverse to the main flow direction.

[0017] According to a further development of the first preferred embodiment, the processing space has a main cross-section that varies perpendicular to the main flow direction. Therefore, in this variant, the main cross-section of the processing space varies at least in cross-section when viewed along the main flow direction. For example, the first main cross-section may have a smaller area than a second main cross-section arranged downstream along the main flow direction. The main cross-section of the processing space preferably includes a free-flow cross-section and a fiber cross-section occupied by the hollow fibers of the exchange membrane through which the medium to be treated flows along the main flow direction. Therefore, considering the free-flow cross-section and the fiber area, the main cross-section is preferably the cross-sectional area of ​​the processing space. The flow rate of blood through the processing space is substantially determined by the free-flow cross-section. The main cross-section (or main cross-sectional area) is an important factor affecting the flow rate. For example, by increasing the main cross-section while keeping the absolute fiber cross-sectional area (or fiber cross-section) constant, the blood flow rate in the processing space can be reduced at a constant blood flow rate because the free-flow cross-sectional area can generally be increased. Therefore, changing the main cross-section can optimally regulate the flow rate in the processing space. For example, regulating the flow rate can reduce the thrombotic properties of the treated blood. Therefore, the anticoagulant dose required by the patient can be minimized. Furthermore, a variable principal cross-section can promote uniform flow. For example, it can reduce the occurrence of reflux zones and / or stagnant water zones, which can negatively impact thrombosis in the treated blood. Further development of this preferred feature is also preferred for the membrane module of the second aspect of the invention described below.

[0018] Preferably, the processing space is rotationally asymmetric. Specifically, the processing space can be rotationally asymmetric or non-rotationally symmetric relative to the longitudinal axis of the membrane module and / or the axis of the membrane module extending parallel to the main flow direction. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below. In the production of potting materials (also known as potting), potting materials, such as adhesives, are typically used. Due to the capillary action of the hollow fibers, this potting material can migrate along the hollow fibers, both internally and externally, before curing. This can impair the exchangeability of the hollow fibers. Therefore, during the potting process, forces are typically applied to the potting material to prevent this propagation. For example, the mold used for potting can be rotated on a centrifuge until the potting material cures. However, rotationally symmetric processing spaces can only be manufactured at high cost. The inventors have discovered that by providing a rotationally asymmetric processing space, the manufacture of membrane modules can be made considerably easier.

[0019] In a preferred variant, the processing space is substantially cylindrical in shape. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below. The elliptical cylinder has an elliptical base and extends in the vertical direction. The elliptical base region includes a short main axis and a long main axis. Preferably, the main flow direction extends substantially along the main axis of the elliptical base shape of the elliptical cylinder. Preferably, the main flow direction does not extend along the height direction of the elliptical cylinder. The main flow direction may also extend along the short main axis. In a variant, the elliptical base region may vary in the height direction, in which case the processing space no longer needs to be described as an elliptical cylinder. It should be understood that the shape of the processing space may also deviate from the shape of an elliptical cylinder in cross-section, and still substantially have the form of an elliptical cylinder. In particular, in the regions of the blood inlet and / or blood outlet, the processing space may deviate from the shape of an elliptical cylinder, while the remaining processing space substantially has the shape of an elliptical cylinder. For example, the blood inlet may be located at one apex of the elliptical base shape, while the blood outlet is preferably located at the opposite apex.

[0020] Preferably, the processing space has a generally cylindrical shape. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below. The generally cylindrical body has a closed base surface that moves linearly in the height direction. The base surface can be circular, but is not necessarily circular. Preferably, the base surface of the generally cylindrical body is defined by two arc segments. An arc segment is part of a circular region defined by an arc and an arc chord, distinct from an arc segment defined by an arc and the radii of two arcs. Preferably, the arc chord of at least one arc segment does not pass through the center of the base circle of that arc segment. Preferably, the chords of the arc segments defining the base region of the processing space are congruent. However, it can also be specified, for example, that the arc segments are spaced apart from each other, in which case the base region of the generally cylindrical body preferably also includes a region located between the arc segments. The arc segments are preferably mirror-symmetric to each other. The main flow direction is preferably transverse to the height direction of the generally cylindrical body. The base region of the generally cylindrical body can also be defined such that the arc segments are adjacent to polygons, particularly rectangles. It should be understood that the shape of the processing space may also deviate from the shape of a general cylinder in some local areas (especially at the blood inlet and / or blood outlet).

[0021] The above-described design of the processing space, particularly its rotationally asymmetric shape, its substantially elliptical cylindrical shape, its substantially cylindrical shape, and / or its variable main cross-section in the main flow direction, is also preferred, regardless of the presence of the membrane, the fiber configuration, and / or the alignment of the fiber longitudinal direction with the main flow direction. In variations, the invention described herein may also include embodiments without fibers but whose processing space is rotationally asymmetric. Furthermore, the invention described herein may include embodiments in which a first subset of a plurality of hollow fibers are arranged in the processing space such that their fiber longitudinal direction is transversely aligned with the main flow direction (transverse fiber flow), wherein the processing space has a main cross-section perpendicular to the main flow direction. Therefore, the orientation of the fibers in the processing space, or their orientation relative to the main flow direction, and the shape of the processing space should be independently adjustable.

[0022] Preferably, the filling component has a first filling portion and a second filling portion, wherein the first filling portion preferably forms a first sidewall of the processing space, and wherein the second filling section preferably forms a second sidewall of the processing space opposite to the first sidewall. Particularly preferred is that the first and / or second sidewalls have a concave shape. These are concave when viewed from the processing space toward the sidewalls. This results in a convex shape of the processing space, which preferably has a protrusion. This preferred further development of having a first filling portion and a second filling portion is also applicable to the membrane module according to the second aspect of the invention described below.

[0023] In one variation, the membrane module preferably has a cover for the treatment space, wherein the cover is particularly preferably at least partially transparent. Preferably, the cover is substantially flat. A cover that is at least partially transparent allows observation of the membrane module. This makes it easy to visually monitor the condition of the exchange membrane. For example, a thrombus that may obstruct the treatment space can be easily detected. The cover preferably at least partially defines the treatment space. The membrane module may also have several covers. For example, the treatment space may be defined by sidewalls formed by a potting member and a cover that extends substantially transversely to the sidewalls. The cover may connect to and / or extend between the sidewalls formed by the potting member or potting portion. Preferably, the cover has one or more reinforcements. Overpressure present in the membrane module during operation can cause the membrane module to expand or bulge outward. Reinforcements can be provided to prevent such expansion. Preferably, the cover is flat during normal use of the membrane module. As an alternative to or supplement to the reinforcements, the cover may be concave. For the membrane module according to the second aspect of the invention described below, a designated cover for the treatment space is also preferred.

[0024] Preferably, the potting compound has a third potting portion forming a third sidewall of the processing space, which is preferably oriented substantially transversely to the first and / or second sidewalls of the processing space. The third potting portion does not require fixing the fiber ends. Preferably, the third sidewall has a substantially the same shape as the first and / or second sidewalls, except for its orientation toward the processing space. For example, the third sidewall may also have a concave shape, whereby the concave indentation is particularly preferably the same as such indentations on the first and / or second sidewalls (depth, extension transverse to the depth). Furthermore, the potting compound preferably has a fourth potting portion forming a fourth sidewall of the processing space. Preferably, the fourth sidewall is opposite to the third sidewall. The fourth sidewall may be designed similarly to the first, second, and / or third sidewalls. Particularly preferably, the four sidewalls define the processing space. The sidewalls may be designed symmetrically in pairs. However, all sidewalls may also have substantially the same shape and differ only in their orientation relative to the processing space. Particularly preferred is that the four sidewalls define a processing space that is substantially shaped like an American football (without the main seam) or a rugby ball, whereby the processing space can deviate from the shape of a football, particularly at the tip. In other variations, all sidewalls may have their own independent shapes. The shape of the aforementioned processing space is preferred regardless of the presence of a membrane, the type of membrane provided, or how the hollow fibers of the membrane are oriented relative to the main flow direction. For example, a processing space with four concave sidewalls is preferred for membrane modules in which the fibers are arranged longitudinally transversely and / or parallel to the main flow direction and for membrane modules in which the fibers are longitudinally inclined to the main flow direction. For modules of membranes that do not pass through the processing space, a mold is also preferred. Preferably, the first, second, third, and / or fourth sidewalls are curved in only one direction. This preferred further development of having a third filling portion is also preferred for membrane modules according to the second aspect of the invention described below.

[0025] Preferably, the packing density of the hollow fibers varies in the main flow direction. In each cross-section of the processing space, the packing density transverse to the main flow direction is defined as the ratio of the fiber cross-sectional area to the main cross-sectional area, where the fiber cross-sectional area forms the divisor and the main cross-sectional area forms the divisor. The fiber cross-sectional area is considered based on the fiber's outer diameter; therefore, any free internal cross-sectional area of ​​the fiber is included in the fiber cross-sectional area. The packing density of the hollow fibers affects the flow rate of the medium to be processed in the processing space. Variable packing density allows for adjustment of the flow rate in the processing space, thereby reducing or preventing backflow area, flow turbulence, and / or rapid changes in flow rate. This can reduce the risk of coagulation and allow for gentler blood treatment. It can reduce the use of anticoagulants, thereby providing gentler overall treatment to patients and / or extending the lifespan of the membrane module. Further development of this preferred method is also preferred for the membrane module of the second aspect of the invention described below.

[0026] According to a preferred further development, the packing density increases along the main flow direction from the blood inlet to the center of the processing space and / or decreases from the center to the blood outlet. The increase and / or decrease preferably occur continuously, but can also occur abruptly. For example, the packing density can be abruptly increased by locally providing additional fibers, additional fiber bundles, and / or additional fiber pads (per main cross-section). Similarly, this preferred further development is also preferred for use in membrane modules according to the second aspect of the invention described below.

[0027] Preferably, the membrane module comprises at least a second subset of hollow fibers from a plurality of hollow fibers. Preferably, the hollow fibers in the second subset of the plurality of hollow fibers of the exchange membrane have a different orientation than the hollow fibers in the first subset. Providing hollow fibers with different orientations can improve the processability of the membrane module. For example, blood flowing through the processing space can be oxygenated more uniformly. It also facilitates the manufacture of the membrane module. Therefore, providing fibers with different orientations can prevent fibers from slipping into each other when stacked. The hollow fibers in the first subset and the hollow fibers in the second subset have different orientations and different longitudinal fiber directions. It should be understood that different hollow fibers in the plurality of hollow fibers, particularly different subsets of hollow fibers, can also be passed through different processing media. Further development of this preferred configuration with hollow fibers in the second subset is also preferred for the membrane module of the second aspect of the invention described below.

[0028] In a preferred embodiment, hollow fibers from only the first subset of hollow fibers are arranged in the inlet region of the processing space adjacent to the blood inlet, and / or hollow fibers from only the second subset of hollow fibers are arranged in the outlet region upstream of the blood outlet. These regions may also be referred to as winglets. The outlet region is located upstream of the blood outlet in the main flow direction. When viewed along the main flow direction, the inlet region is preferably the region of the processing space between the blood inlet and a first cross-section perpendicular to the main flow direction, wherein the fibers of the first subset of hollow fibers overlap with the fibers of the second subset of hollow fibers. When viewed along the main flow direction, the outlet region is preferably the region between the last cross-section of the processing space transverse to the main flow direction and the blood outlet, in which the hollow fibers of the first subset and the second subset overlap. The inlet region preferably extends over an area of ​​50% or less, preferably 40% or less, preferably 30% or less, preferably 20% or less of the total length of the processing space measured along the main flow direction. The outlet region preferably extends over an area of ​​50% or less, preferably 40% or less, preferably 30% or less, preferably 20% or less of the total length. Providing only a subset of hollow fibers in the outlet and / or inlet regions allows the medium to be treated to flow uniformly within the treatment space. For example, blood entering the treatment space will not immediately encounter all the hollow fibers of the exchange membrane, but only the first subset. Therefore, the blood flow rate can be gradually regulated, thereby reducing the risk of coagulation. In particular, combined with a variable main cross-section of the treatment space in the main flow direction, particularly uniform flow can be achieved. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below. In this variant, the inlet and / or outlet portions preferably correspond to secondary portions.

[0029] Preferably, in the inlet portion of the processing space adjacent to the blood inlet, the hollow fibers of the first subset of hollow fibers at least partially protrude over the hollow fibers of the second subset, and / or the hollow fibers of the second subset of hollow fibers at least partially extend over the hollow fibers of the first subset. Alternatively or additionally, in the outlet portion of the processing space upstream of the blood outlet, the hollow fibers of the first subset of hollow fibers at least partially extend over the hollow fibers of the second subset, and / or the hollow fibers of the second subset of hollow fibers at least partially extend over the hollow fibers of the first subset. The hollow fibers of the first subset of hollow fibers may protrude over the hollow fibers of the second subset, particularly in the main flow direction and / or transverse to the main flow direction and / or inclined to the main flow direction, and vice versa. For example, in the first sub-portion of the inlet portion adjacent to the first sidewall, the hollow fibers of the first subset may protrude beyond the hollow fibers of the second subset, while in the second sub-portion of the inlet portion adjacent to the opposite second sidewall, the hollow fibers of the second subset of hollow fibers protrude beyond the hollow fibers of the first subset. It should be understood that the shape of the sidewalls is not necessary for the embodiments described herein. When viewed along the main flow direction, the inlet portion is preferably part of the processing space between the blood inlet and a first cross-section transverse 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 transverse to the main flow direction. Thus, the inlet portion extends, for example, from the blood inlet to the first cross-section where the hollow fibers of the membrane completely overlap. The outlet portion is defined similarly to the inlet portion, but in the opposite viewing direction upstream of the main flow direction. Thus, the outlet portion is defined as the portion between the last cross-section where the maximum fiber density exists and the blood outlet. Similarly, this preferred further development is also preferred for membrane modules according to the second aspect of the invention described below.

[0030] The inlet portion preferably extends within a range of 100% or less, preferably 50% or less, preferably 40% or less, preferably 30% or less, preferably 20% or less, preferably 10% or less, preferably 5% or less of the total length of the processing space measured along the main flow direction. The outlet portion preferably extends within a range of 100% or less, preferably 50% or less, preferably 40% or less, preferably 30% or less, preferably 20% or less, preferably 10% or less, preferably 5% or less of the total length of the processing space measured along the main flow direction. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below.

[0031] According to a preferred embodiment, the longitudinal direction of the hollow fibers of the first subset forms an angle with the longitudinal direction of the hollow fibers of the second subset within a range of greater than 0° to less than 180°. The angle is preferably the angle between the hollow fibers of the first and second subsets of hollow fibers facing the blood inlet opening. The hollow fibers of the first subset and the hollow fibers of the second subset preferably do not extend parallel to each other. However, it can also be specified that the hollow fibers of the first subset and the hollow fibers of the second subset differ only in the flow direction. For example, the first fiber end of the hollow fibers of the first subset may be adjacent to the second fiber end of the hollow fibers of the second subset, such that the hollow fibers of the first and second subsets of hollow fibers are processed by the medium flowing in opposite directions. This is also preferred regardless of the presence or absence of an angle. Preferably, the main flow direction bisects the angle. Similarly, this preferred further development is also preferred for membrane modules according to the second aspect of the invention described below.

[0032] Preferably, the hollow fibers in the first subset and the hollow fibers in the second subset at least partially overlap, forming a free rhombus, wherein the main component in the main flow direction preferably extends along the short semi-axis of the rhombus. However, the main flow direction may also extend along the long semi-axis of the rhombus. When viewed transversely to the longitudinal direction of the fibers, preferably in the height direction, the intersecting hollow fibers form a rhombus pattern. There is a free space between the hollow fibers, referred to herein as a free rhombus. The medium to be processed, particularly blood, can flow through this free space. Transverse flow through the rhombus is also possible due to the overlap of the hollow fibers. The rhombus preferably flows substantially parallel to the surface direction. Preferably, the rhombuses are arranged in the processing space in such a way that the main flow direction extends substantially along the short semi-axis of these rhombuses. The hollow fibers of the first and second subsets of hollow fibers may also overlap in such a way that they define a free parallelogram or an oblique rhombus. The rhombuses are preferably not squares, i.e., they have two semi-axiss of different lengths. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below.

[0033] In a preferred embodiment, the exchange membrane has a fiber pad preferably composed of unidirectional hollow fibers, wherein the fiber pads are preferably stacked on top of each other in a height direction transverse to the main flow direction. Preferably, spacers may also be provided between two or more fiber pads, particularly preferably between all fiber pads. The use of fiber pads facilitates the manufacture of the membrane module. Furthermore, the use of unidirectional hollow fibers in the fiber pads allows for a particularly uniform extension of the hollow fibers. The fiber pad has a pad surface. The length of the fiber pad is determined by the number of fibers adjacent to each other. The width of the fiber pad is defined along the longitudinal direction of the fibers. Therefore, the width of the fiber pad can correspond to the fiber length of the unidirectional fibers. However, in the case of fiber pads running at an angle, the width of the fiber pad may also be less than the length of a single fiber. Preferably, the pad surface of the fiber pad varies in the height direction. In particular, preferably, the pad surface decreases outward in the stacking direction from the center of the stacked fiber pads. The pad area can decrease from the center of the stacking direction in two directions, or it can decrease in only one direction. The cover of the processing space can be shell-shaped, and the fiber pads, which become smaller therefrom, can particularly preferably extend into the concave recesses of the cover. Preferably, fiber mats made of hollow fibers from the first subset and fiber mats made of hollow fibers from the second subset are stacked alternately in a height direction preferably transverse to the main flow direction. Further development of this preferred configuration is also preferred for the membrane module of the second aspect of the invention described below.

[0034] Preferably, the processing space is designed to accommodate blood under pressure, particularly blood with an absolute pressure of 3 bar or lower. An absolute pressure of 3 bar approximately corresponds to a pressure level exceeding atmospheric pressure (about 1 bar) by 2 bar. Pressure levels above atmospheric pressure in the processing space can significantly improve blood processing. For example, using the same volume of processing space and / or the same membrane area can improve blood oxygenation. However, the hollow fiber and / or potting material used and / or the cover of the processing space must be adapted to the increased pressure level to prevent damage and / or leakage. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below.

[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 the blood outlet varies by a maximum of 30%, preferably 25%, preferably 20%, preferably 15%, preferably 10%, and preferably 5% of the maximum free-flow cross-sectional area. By limiting the variation in the free-flow cross-sectional area, the flow rate variation of the medium to be processed in the processing space can also be limited. This can reduce the risk of blood coagulation as it flows through the processing space. Furthermore, stress on the hollow fibers can be reduced. Further development of this preferred embodiment is also preferred for the membrane module of the second aspect of the invention described below.

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

[0037] Change = (Maximum distance - Distance to blood inlet) / Length of processing space.

[0038] The membrane module is preferably designed to be coreless. The core is a solid wall of the membrane module that forms the inner boundary of the processing space and typically flows along several sides. In particular, wound membrane modules are manufactured by winding hollow fibers or hollow fiber pads around a core, which can also be hollow. The coreless design facilitates manufacturing and / or reduces the number of components in the membrane module. Furthermore, it can improve flow through the membrane module. This can reduce costs and / or increase the reliability of the membrane module. For example, compared to variants with a core, the coreless design can reduce the number of components in contact with blood flowing through the processing space, thereby reducing the risk of clotting. Further development of this preferred coreless membrane module is also preferred for the second aspect of the invention described below.

[0039] In a preferred variant, the membrane module is a direct-flow module, wherein the blood inlet is opposite the blood outlet along the main axis, particularly the longitudinal axis, of the membrane module. The flow of the medium to be treated preferably does not undergo any significant change in direction as it flows through the treatment space. It should be understood that in a direct-flow module, the blood inlet does not necessarily have to be completely opposite to the blood outlet. Instead, the blood inlet and blood outlet can also be arranged laterally offset from each other along the main axis. However, the direct-flow module preferably has a blood inlet and a blood outlet, which are arranged at least on different sides of the direct-flow module, particularly opposite sides. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below.

[0040] Preferably, the membrane module has a second processing space connected to the first processing space via a fiberless connecting portion, wherein 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 comprise a first number of fiber pads, and the hollow fibers in the second processing space may comprise a second number of fiber pads different from the first number. Then, preferably, specific fiber pads are arranged only in the first or second processing space, rather than in both. Preferably, the membrane module may also have two or more processing spaces connected to each other via fiberless fluid conduit portions. Fiberless fluid conduit portions or connecting portions are particularly suitable for distinguishing different processing spaces. Alternatively or additionally, separate processing spaces may be provided, formed by individual fiber bundles and / or fiber pads of the hollow fibers of the exchange membrane, or each processing space may have its own exchange membrane. Further development of this preference is also preferred for the membrane module of the second aspect of the invention described below.

[0041] Preferably, the exchange membrane has a main portion and at least one secondary portion, wherein the main packing density of the hollow fibers in the main portion is constant, and wherein the secondary packing density of the hollow fibers in the secondary portion differs from the main packing density at least in some portions.

[0042] In a second aspect, the present invention addresses the aforementioned objective through 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 interconnected with each other in the main flow direction through the processing space; an exchange membrane having a plurality of hollow fibers, each hollow fiber extending through the processing space in the fiber longitudinal direction and adapted to allow flow of a processing medium in the fiber longitudinal direction from a first fiber end to an opposing second fiber end; and a potting member, wherein the first and second fiber ends of the hollow fibers of the exchange membrane are fixed in the potting member and at least partially define the processing space; wherein the exchange membrane has a primary portion and at least one secondary portion, wherein the primary packing density of the hollow fibers in the primary portion is constant, and wherein the secondary packing density of the hollow fibers in the secondary portion differs from the primary packing density at least in some portions. The secondary packing density of the hollow fibers in the secondary portion may be constant or variable. Preferably, the secondary portion has several regions with different secondary packing densities, at least one of which differs from the primary packing density.

[0043] The primary and secondary packing densities describe the relationship between the volume occupied by the fibers within the exchange membrane and the total volume of the membrane in that region, respectively. In the case of hollow fibers, the fiber volume includes the fiber lumen plus the fiber wall volume. Preferably, when determining the packing density, only fibers that fully extend through the considered volume unit are considered. The packing density is preferably determined in the central region of the primary or secondary portion, located at the center between the various edge regions. Preferably, 1 cm can be considered. 3 The fill density is determined by the volume unit. This fill density indicates the degree to which the fibers are packed into the module.

[0044] In a first preferred embodiment, the secondary portion is arranged in the inlet portion adjacent to the blood inlet and / or the outlet portion upstream of the blood outlet in the processing space. For example, the primary portion may be connected to the inlet portion, and the secondary portion may be located upstream of the outlet portion.

[0045] Preferably, the secondary portion has at least two sub-sections. Preferably, the sub-sections are arranged on opposite sides of the main axis of the membrane module, which extends from the blood inlet to the blood outlet. The main axis can preferably be defined as explained above with reference to the first aspect of the invention. Preferably, the main axis is the central axis of the processing space, which may specifically pass through the center of gravity of the processing space. The main axis is preferably substantially straight. The sub-sections of the secondary portion can have the same or different secondary filler densities. In the context of this disclosure, the secondary portion is also referred to as a winglet. The sub-sections may overlap. However, preferably, these sub-sections do not overlap each other. In a preferred variant, the sub-sections are symmetrical with respect to the main axis.

[0046] Preferably, the sub-section extends away from the main axis. With increasing distance from the main axis, the sub-section extending from the main axis occupies a larger processing space area and / or volume in the observation direction. The observation direction is transverse to the main axis. The observation direction can be transverse to the height of the processing space, which can be the same as the stacking direction of the fiber pads of the membrane module.

[0047] In a preferred embodiment of the membrane module, the sub-sections are pyramidal and / or prismatic. However, the side of the sub-section facing away from the main axis may also be an uneven surface, for example, if the sidewalls of the processing space defined by the potting compound are convex or concave. The pyramidal and / or prismatic design of the sub-sections can improve the uniform distribution of the medium to be processed (especially blood) on the main section.

[0048] Preferably, the main portion is substantially cuboid or polyhedral in shape, having eight or more lateral faces. In particular, the polyhedral main portion has four or six rectangular boundary surfaces. Preferably, at least two boundary surfaces of the polyhedral main portion are convex. One or more side surfaces of the substantially cuboid main portion may also be concave or convex. In other preferred variations, the main portion is substantially cylindrical, polyhedral, cuboid, and / or toroidal cylinder in shape. Preferably, at least one side surface of the main portion, particularly preferably two opposing side surfaces, is convex and / or concave.

[0049] Preferably, the plurality of hollow fibers comprises at least a first subset of hollow fibers having first hollow fibers and a second subset of hollow fibers having second hollow fibers. Preferably, the first hollow fibers in the at least first subset of hollow fibers are arranged in the processing space such that their fiber longitudinal direction is inclined relative to the main flow direction. For the definition, details, and advantages of an exchange membrane having at least a first subset of hollow fibers with its fiber longitudinal direction inclined relative to the main flow direction, reference is made in particular to the advantages, explanations, and preferred embodiments of the membrane module according to the first aspect of the invention.

[0050] Preferably, the first hollow fiber in the first subset has a smaller fiber diameter than the second hollow fiber in the second subset. Providing a subset of hollow fibers with different fiber diameters can result in good mixing and / or particularly uniform flow of the medium to be treated through the treatment space, especially the exchange membrane.

[0051] In a preferred further development of the membrane module, the first subset of hollow fibers is formed by at least one fiber pad, with a first fiber spacing between the first fibers, and the second subset of hollow fibers is formed by at least one second fiber pad, with a second fiber spacing between the second fibers, wherein the first fiber spacing is preferably less than or greater than the second fiber spacing. Different fiber spacings also result in particularly uniform flow through the processing space, especially the exchange membrane. It should be understood that the exchange membrane of the membrane module (according to the first or second aspect) need not be composed of fiber pads. Preferably, the exchange membrane can also be composed of a single fiber, a single fiber or a fiber pad, one and / or a combination of multiple single fibers and / or single fibers.

[0052] Preferably, the first fiber type of the first hollow fiber is different from the second fiber type of the second hollow fiber. Fiber types particularly include semi-permeable hollow fibers, porous hollow fibers, air-impermeable hollow fibers, liquid-tight hollow fibers, and / or fluid-tight hollow fibers. The first hollow fiber is preferably a semi-permeable hollow fiber, and the second hollow fiber is preferably a fluid-tight hollow fiber. Alternatively, the first hollow fiber is preferably a fluid-tight hollow fiber, and the second hollow fiber is preferably a semi-permeable hollow fiber. In particular, the hollow fibers in the secondary portion can be fluid-tight hollow fibers. This allows the medium to be processed, particularly blood, to be temperature-controlled in the secondary portion.

[0053] Preferably, the blood inlet has an inlet connector for connecting the membrane module to at least one blood supply line. Preferably, the blood outlet has an outlet connector for connecting the membrane module to a blood drainage line. Preferably, the inlet connector can be a first tube connector and / or the outlet connector can be a second tube connector. Preferably, the inlet connector is substantially tubular, particularly having a circular flow cross-section. Alternatively or additionally, the outlet connector can also be substantially tubular, particularly circular tubular.

[0054] In a preferred further development, the inlet central axis of the inlet connector and the outlet central axis of the outlet connector are arranged at an angle to each other, preferably perpendicular to each other. The angle between the angled axes is not equal to 0° or 180°, nor are they parallel. However, it is also possible to specify that the inlet central axis of the inlet connector and the outlet central axis of the outlet connector are staggered. In an alternative embodiment, the inlet central axis of the inlet connector and the outlet central axis of the outlet connector are parallel to each other, preferably coincident. If the inlet central axis and / or the outlet central axis are curved, the corresponding tangent to the inlet central axis or the outlet central axis is considered in the cross-section of the inlet connector or the outlet connector closest to the exchange membrane.

[0055] Preferably, the blood inlet has a dispenser portion that is at least indirectly connected to the inlet connector. The dispenser portion is preferably designed to dispense blood received at the inlet connector onto the exchange membrane. In particular, the dispenser portion is or includes a cross-sectional expansion.

[0056] Preferably, the dispenser portion is designed to be arrow-shaped along the main flow direction in at least one plane. The arrow shape extends along the main flow direction. The dispenser portion that is arrow-shaped in one plane is arrow-shaped at least at its projection in that plane. The first plane is preferably perpendicular to the height direction of the processing space. The dispenser portion may also be arrow-shaped, projected into a second plane perpendicular to the first plane. However, preferably, the dispenser portion is designed such that the arrowhead of the arrow-shaped dispenser portion is a line. This is the case, for example, if the dispenser portion is arrow-shaped only in its projection into the first plane, but rectangular or semi-circular in its projection into the second plane perpendicular to the first plane.

[0057] Preferably, the arrow-shaped dispenser portion has at least a first wing and a second wing. The wing is preferably substantially cuboid in shape. Preferably, the wing is connected to each other by a connecting line. The connecting line preferably forms the arrowhead of the arrow-shaped dispenser portion. The wing angle between the first and second wing of the arrow-shaped dispenser portion is preferably substantially the same as the inlet edge angle between the inlet edges of the sub-parts of the secondary portion. The inlet edge is the edge of the sub-part located at the upstream end of the main flow direction.

[0058] In a preferred embodiment, the dispenser portion is cup-shaped in at least one plane along the main flow direction. In these embodiments, this plane can be formed similarly to the description of the arrow-shaped dispenser portion above. The cup shape expands from the stem at least in the plane. The stem of the cup-shaped dispenser portion preferably faces the inlet connector.

[0059] Preferably, the dispenser portion is wedge-shaped in at least one plane in the main flow direction. The wedge shape is preferably continuously expanding. In these embodiments, the plane can be formed similarly to the embodiment of the arrow-shaped dispenser portion described above. The wedge tip of the wedge-shaped dispenser portion is preferably located away from the inlet connector.

[0060] Preferably, the membrane module has an inlet membrane at least partially disposed in the dispenser section. The inlet membrane may completely or only partially fill the dispenser section. Alternatively or additionally, the inlet membrane may also be at least partially disposed in the main section, secondary section, and / or inlet section. The inlet membrane comprises a plurality of fibers. The fibers of the inlet membrane may be hollow fibers, but are not required to be. Each fiber of the inlet membrane extends through the dispenser section along the inlet fiber longitudinal direction. The longitudinal direction of the inlet fiber may differ from the longitudinal direction of at least one fiber of the hollow fibers of the exchange membrane. Preferably, the longitudinal direction of the inlet fiber is perpendicular to the main flow direction. Preferably, the inlet membrane is a heat exchange membrane. A heat exchange membrane is provided for the temperature control of the treatment medium, particularly blood. Therefore, the heat exchange membrane can be designed, for example, to heat or cool blood flowing through the treatment space. The fibers of the heat exchange membrane are, in particular, impermeable hollow fibers.

[0061] Preferably, the fiber material of the inlet membrane is different from that of the exchange membrane. In any case, 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 of the inlet portion is angled, particularly perpendicular, to the main flow direction of the distributor portion facing the membrane side of the exchange membrane. The membrane side of the distributor portion is the downstream side of the distributor portion in the main flow direction. Therefore, the main flow direction can bend between the inlet portion and the membrane side of the distributor portion. This can improve the distribution of the medium to be treated (especially blood) on the exchange membrane and / or homogenize the flow of the medium to be treated. Alternatively or additionally, the main flow direction at the inlet connector can be perpendicular to the main flow direction at the transition between the blood inlet and the main and / or secondary portions.

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

[0064] Preferably, the membrane module has an outlet membrane at least partially arranged in the collection section. The outlet membrane may completely or only partially fill the collection section. Alternatively or additionally, the outlet membrane may also be at least partially arranged in the main section, secondary section, and / or outlet section. The outlet membrane comprises a plurality of fibers. The fibers of the outlet membrane may be hollow fibers, but are not required to be. Each fiber of the outlet membrane extends through the collection section along the outlet fiber longitudinal direction. The longitudinal direction of the outlet fiber may differ from the longitudinal direction of at least one fiber of the hollow fibers of the exchange membrane. Preferably, the longitudinal direction of the outlet fiber is perpendicular to the main flow direction. Preferably, the outlet membrane is a heat exchange membrane. A heat exchange membrane is provided for temperature control of the treatment medium, particularly blood. Therefore, the heat exchange membrane can be designed, for example, to heat or cool blood flowing through the treatment space. The fibers of the heat exchange membrane are, in particular, impermeable hollow fibers.

[0065] Preferably, the fiber material of the outlet membrane is different from that of the exchange membrane. In any case, the fibers of the outlet membrane are preferably plastic fibers or metal fibers.

[0066] In variations where the membrane module includes an inlet membrane and an outlet membrane, the inlet and outlet membranes can also be combined membranes. Preferably, the fibers of the outlet membrane and the fibers of the inlet membrane share a common media connector. For example, the fibers of the outlet and inlet membranes can be supplied with hot water through the shared media connector to heat blood flowing through the treatment space.

[0067] The collecting section is preferably wedge-shaped, funnel-shaped, and / or inverted arrow-shaped in at least one plane in the main flow direction. An inverted arrow shape refers to an arrowhead shape indicating the direction of flow. The above descriptions of wedge-shaped, funnel-shaped, and / or arrow-shaped designs for the distributor section also apply similarly to the collecting section.

[0068] Preferably, the hollow fibers of one fiber type (semi-permeable, fluid-permeable, airtight, fluid-sealing) in the main portion are at least partially different from the hollow fibers of one fiber type in the secondary portion. Preferably, the secondary portion is arranged upstream of the main portion. Particularly in these cases, and especially in cases where the secondary portion is arranged downstream or sideways of the main portion, the hollow fibers in the secondary portion are preferably fluid-impermeable, while the hollow fibers in the main portion are semi-permeable fibers. For example, a heating and / or cooling processing medium (such as water) can be passed through the fluid-impermeable fibers in the secondary portion to regulate the temperature of the medium to be processed.

[0069] In a third aspect, the invention achieves the aforementioned objective by means of a blood processing system, which preferably includes at least one pump for generating blood flow, preferably includes a controller for controlling the pump, and preferably also includes a membrane module, which is preferably designed according to the first aspect and / or the second aspect of the invention. The control system may also preferably be a regulating system. Preferably, the pump can be connected to the human circulatory system via a first tubing portion and to the processing space of the membrane module via a second tubing portion. In variations, the pump may be designed to act on the tubing portion connecting the processing space to the human circulatory system to pump blood. This tubing may also be only part of the connection between the processing space and the circulatory system and / or may be formed by multiple elements. The system is preferably designed to allow blood to flow through the processing space, and the blood preferably has a pressure level higher than the ambient atmospheric pressure. It should be understood that the connection between the first tubing portion and the circulatory system need not be direct. It may also be specified that the first tubing portion is connected to the circulatory system via a cannula. The cannula is preferably a so-called single-lumen or so-called multi-lumen, particularly a double-lumen cannula. The system is particularly preferably equipped with a second pump, whereby the processing space is preferably arranged in the direction of blood flow between the first and second pumps. The first pump can then be designed to increase the pressure within the treatment space, particularly improving blood handling. Conversely, the second pump can be designed to reduce the blood pressure downstream of the treatment space to a level suitable for returning blood to the patient. The first pump can also be designed to set a predetermined volumetric flow rate. The second pump is then preferably designed to set the pressure within the treatment space. The first and / or second pumps are preferably peristaltic pumps, particularly roller pumps and / or rotary pumps.

[0070] In a fourth aspect, the present invention achieves the object described at the beginning by means of a method for manufacturing a membrane module for extracorporeal blood processing, particularly a membrane module according to the first aspect and / or the second aspect of the present invention, preferably comprising the following steps: inserting a fiber pad of hollow fibers, particularly a fiber pad of unidirectional hollow fibers, into a mold; performing primary filling of the first fiber end of the hollow fibers with a filling material to form a first sidewall of the processing space of the membrane module, wherein during the primary filling process, the mold preferably rotates at least intermittently about a first rotation axis; and / or performing secondary filling of the second fiber end of the hollow fibers, preferably opposite to the first fiber end in the longitudinal direction of the fibers, to form a second sidewall preferably opposite to the first sidewall, wherein during the secondary filling, the mold preferably rotates at least intermittently about a second rotation axis, which is preferably different from the first rotation axis, wherein the first and second rotation axes are preferably parallel, and / or wherein preferably the first and / or second rotation axes do not intersect with the fiber pad, and / or wherein preferably the first and / or the first rotation axis does not extend through the center of gravity of the fiber pad. Preferably, the method further includes connecting the first and second sidewalls via at least one cover plate to form a processing space. Furthermore, after primary and / or secondary potting, the fibers can be opened, for example, preferably by cutting off sealed fiber ends and / or portions of sealed fiber ends. It can also be specified that at least one hollow fiber of the fiber pad is formed from a single, meandering fiber, which can 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 pad. The rotation axes are defined in the mold's frame of reference. Therefore, rotation of the mold (in the global frame of reference) also results in rotation of the mold's frame of reference. From a global perspective (or in the global frame of reference), the first rotation axis and the second rotation axis, which are distinct from it, can also coincide, for example, when the mold rotates about its own axis (especially 180°) after rotating about the first rotation axis and before rotating about the second rotation axis. In particular, the mold can also be or include a housing of the membrane module, or include part of such a housing. The mold does not necessarily enclose the fiber pad on all sides. The mold may also be or include retainers or clamps for fibers and / or fiber ends.

[0071] A fiber pad made of hollow fibers is inserted into a mold, preferably by placing a predetermined number of fiber pads made of hollow fibers into the mold, or by inserting fiber pads made of hollow fibers into the mold until a predetermined height is reached. In alternative variations, hollow fibers may be inserted into the mold instead of fiber pads made of hollow fibers. Furthermore, in variations, both fiber pads made of hollow fibers and individual hollow fibers or bundles of hollow fibers may be inserted into the mold.

[0072] In a first preferred embodiment of the above method, when rotating about a first rotation axis and / or about a second rotation axis, the side of the smallest rectangle surrounding the mold perpendicular to the rotation axis is aligned at an angle with the direction of rotation. The direction of rotation is the circumferential direction. When viewed along the first and / or second rotation axes, the smallest rectangle is the smallest imaginary rectangle that can be placed around the mold and completely surround it. In the case of a rectangle, the smallest rectangle corresponds to the basic rectangle. Alternatively or additionally, the longitudinal axis of the membrane module, particularly the longitudinal axis of the processing space formed by the membrane module, can form an angle with the circumferential direction around the first or second rotation axis during primary and / or secondary potting, preferably greater than 0° and less than 90°. This allows the creation of a processing space that widens or narrows along the longitudinal axis. Preferably, during primary and / or secondary potting, the angle formed between the main flow direction of the processing space formed in the membrane module and the circumferential direction is preferably greater than 0° and less than 90°. However, during primary and / or secondary potting, the main flow direction is preferably parallel to the circumferential direction.

[0073] In a fifth aspect, the present invention achieves the aforementioned objective through a method for manufacturing a membrane module for in vitro blood processing, particularly a membrane module according to the first and / or second aspects of the invention, comprising the steps of: inserting a fiber pad of hollow fibers, particularly unidirectional hollow fibers, into a mold; preferably, filling the opposite ends of the hollow fibers to form at least one sidewall of the processing space of the membrane module, wherein during the filling process, the mold rotates at least temporarily about a main rotation axis, and the filled part is an incomplete circular filled part. The main rotation axis preferably extends at the center of the mold. An incomplete circular filled part refers to a filled part with a sidewall formed that is at least partially open in the circumferential direction. On the other hand, in a complete circular filled part, a rotationally symmetrical profile is formed. Preferably, the amount of filling material supplied during filling is limited. Thus, in an incomplete circular filled part, only sufficient filling material is provided to prevent the formed sidewall from closing in the circumferential direction. However, circumferential closure can also be prevented, for example, by providing a flow barrier. Preferably, during the potting process, only sufficient potting material is supplied to form at least two sidewalls, which are preferably partially separated from each other at least circumferentially. In a preferred further development, the main rotation axis extends at least partially along the longitudinal direction of the hollow fibers. However, the rotation axis may also be perpendicular to the fiber longitudinal direction. Preferably, the rotation axis extends along the main flow direction of the processing space of the membrane module to be formed.

[0074] In the method according to the fifth aspect of the invention, inserting the hollow fiber pads into the mold is preferably done by inserting a predetermined number of hollow fiber pads into the mold, or by inserting the hollow fiber pads into the mold until a predetermined height is reached. In alternative variations, hollow fibers may be inserted into the mold instead of hollow fiber pads. Furthermore, in variations, both hollow fiber pads 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 or fifth aspect of the invention, the fiber pads are inserted crosswise into the mold. Therefore, the fibers are preferably inserted into the mold in such a manner that the longitudinal directions of the corresponding fibers of the hollow fibers of adjacent fiber pads are not parallel.

[0076] In the method according to the fourth and / or fifth aspects of the invention, the insertion of the fiber pads is preferably performed prior to the pre-assembly of the fiber pads. During the pre-assembly process, it is preferable to join two or more fiber pads of the same or different orientations together to form a pad stack. The joining can be performed by melting, pressing, and / or gluing. Particularly preferred is that at least two fiber pads are cross-stacked during the pre-assembly process. In process variations that include pre-assembly, the insertion of the fiber pads is or includes the insertion of a pre-assembled pad stack.

[0077] The method according to the fourth and / or fifth aspects of the present invention can also be configured for the simultaneous production of multiple membrane modules.

[0078] According to a sixth aspect, the present invention solves the above-mentioned problems by means of an assembly method comprising the steps of: providing a console comprising at least one pump, a diaphragm module holder, and preferably a control unit; providing a disposable treatment module comprising a membrane module, particularly a membrane module according to the first aspect and / or the second aspect of the present invention; inserting the membrane module into the diaphragm module holder; and functionally connecting the disposable treatment module to the pump to deliver fluid, particularly blood, through the membrane module. The functional connection ensures that the pump can deliver fluid through the membrane module. For example, a tube of the disposable treatment module may be inserted into the effective portion of a tubular pump, the tube being fluidly connected to the membrane module. The disposable treatment module is preferably re-provided for each patient to be treated and discarded after use, while the console can be used for repeated treatment. The disposable treatment module may also include a working portion of the pump. In this case, the console may also have only one pump driver.

[0079] In a seventh aspect, the present invention achieves the aforementioned objective through a method for extracorporeal blood treatment, comprising the steps of: providing a blood flow; supplying the blood flow to a treatment space of a membrane module, particularly a membrane module according to the first and / or second aspects of the present invention, wherein the blood flow preferably has a pressure level higher than atmospheric pressure, the blood flow along the longitudinal direction of the respective fibers flows with a treatment medium (particularly oxygen) through hollow fibers penetrating the treatment space, preferably semi-permeable hollow fibers, wherein the blood flow flows through the treatment space along the main flow direction and contacts the hollow fibers penetrating the treatment space to treat the blood flow, particularly by filling it with oxygen; wherein at least a first subset of the semi-permeable hollow fibers are arranged in the treatment space such that their longitudinal direction is inclined relative to the main flow direction. Preferably, providing the blood flow includes providing a blood flow from a blood reserve. This method is preferably not intended for direct use in the human body. This method can also be used during dialysis as an adjunct, since drawing blood from the patient is itself part of dialysis.

[0080] It should be understood that the membrane module according to the first aspect of the invention, the membrane module according to the second aspect of the invention, the system according to the third aspect of the invention, the manufacturing method according to the fourth and fifth aspects of the invention, the assembly method according to the sixth aspect of the invention, and the method for in vitro treatment of blood according to the seventh aspect of the invention may have the same and similar sub-aspects, particularly those described in the dependent claims relating to the membrane module according to the first aspect of the invention and / or the dependent claims relating to the membrane module according to the second aspect of the invention. Therefore, reference is made to the above description of the membrane module according to the first aspect of the invention and / or the second aspect of the invention for the system, manufacturing method, assembly method, and method for in vitro treatment of blood. In particular, the membrane module according to the second aspect of the invention may also preferably have the features described above with respect to the membrane module according to the first aspect of the invention. Similarly, the membrane module according to the first aspect of the invention may also have the features described above with respect to the membrane module according to the second aspect of the invention. The secondary portions described with respect to the second aspect of the invention may preferably be or include the inlet and / or outlet portions described with respect to the first aspect of the invention. Similarly, the inlet and / or outlet portions may include secondary portions.

[0081] Embodiments of the invention are described below with reference to the accompanying drawings. These drawings are not necessarily drawn to scale, but are presented schematically and / or with slight modifications for ease of illustration. For supplements to the teachings directly apparent from the drawings, please refer to the relevant prior art. It should be noted that many modifications and changes can be made to the details of the molds and embodiments without departing from the overall concept of the invention. The features of the invention disclosed in the specification, drawings, and claims may be essential for further development of the invention, either individually or in any combination. Furthermore, all combinations of at least two features disclosed in the specification, drawings, and / or claims fall within the scope of the invention. The overall concept of the invention is not limited to the exact form or details of the preferred embodiments shown and described below, nor is it limited to the subject matter restricted compared to the subject matter claimed in the claims. Values ​​within the specified measurement range, as specified limits, should also be disclosed as limits and should be freely applied and claimed. For simplicity, the same reference numerals are used below for the same or similar parts or parts having the same or similar functions.

[0082] Other advantages, features, and details of the invention will become apparent from the following description and accompanying drawings of preferred embodiments, which illustrate:

[0083] Figure 1 Blood processing system;

[0084] Figure 2 An isometric view of a membrane module for processing blood according to the first embodiment;

[0085] Figure 3 A top view of the membrane module according to the first embodiment;

[0086] Figure 4 The second embodiment of the membrane module is similar to Figure 3 Top view;

[0087] Figures 5a-5d Further preferred embodiments of the membrane module are similar to Figure 3 Top view;

[0088] Figure 6 Top view of a membrane module with multiple processing spaces;

[0089] Figure 7 Manufacturing equipment that can be used in the membrane module manufacturing process;

[0090] Figure 8 A schematic diagram of a first variant of a method for manufacturing membrane modules;

[0091] Figure 9 Similar to Figure 7The view in which the mold used in this method has different orientations in the manufacturing equipment;

[0092] Figure 10 Side view of the manufacturing equipment;

[0093] Figure 11 A schematic flowchart of a blood in vitro processing method;

[0094] Figure 12a , 12b Two views of a membrane module with transverse flow fibers;

[0095] Figures 13a-13c Three views of the fifth implementation scheme for the membrane module;

[0096] Figure 14 Detailed view of the blood inlet of the membrane module according to the fifth embodiment;

[0097] Figure 15 The sixth implementation scheme for the membrane module;

[0098] Figure 16a , 16b An alternative design for the blood inlet dispenser section of the membrane module; and

[0099] Figure 17 A top view of the champagne glass-shaped membrane module.

[0100] Figure 1 A system 200 for the extracorporeal processing of blood B is shown. In the illustrated embodiment, system 200 is connected to the blood circulation of patient P via a cannula 202. Blood B from patient P can be supplied via cannula 202 to inlet tube 204 of system 200. Inlet tube 204 is part of disposable processing module 206 of system 200. In addition to inlet tube 204, disposable processing module 206 also includes membrane module 1 and drainage tube 208. The structure of membrane module 1 will be described in detail later. Figure 1 In the middle, the drainage tube 208 leads out of the system 200. When using the single-lumen cannula 202, the drainage tube 208 can be connected to another cannula ( Figure 1 (Not shown in the image), this cannula is used to return blood B to the bloodstream of patient P. When using the dual-lumen variant, drainage tube 208 can be reconnected to cannula 202.

[0101] In addition to the disposable treatment module 206, the system includes a console 210, which in turn has a first pump 212, a second pump 214, and a control unit 216 arranged in a housing 218. The console 210 also includes a diaphragm module holder 220 in which the membrane module 1 of the disposable treatment module 206 is held. As shown in the embodiment illustrated herein, dividing the system 200 into the disposable treatment module 206 and the console 210 allows for particularly easy handling and particularly economical use of the system 200. The disposable treatment module 206 can be replaced after each treatment or for each patient P, while the console 210 can be used multiple times. Cleaning of the membrane module 1 is not required, and hygiene risks are minimized.

[0102] The first pump 212 and the second pump 214 are designed to guide blood B through the disposable processing module 206, specifically the processing space 3 of the membrane module 1. In the illustrated embodiment, the system 200 is designed to deliver blood B through the membrane module 1 at a pressure level p1 above atmospheric pressure. Here, the first pump 212 is used to increase the pressure of blood B to approximately 3 bar. The second pump 214, located downstream of the membrane module 1, reduces the pressure of blood B back to a pressure level suitable for the 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 drainage tube 208. For example, the first pump 212 and / or the second pump 214 could be a roller pump or a peristaltic pump that alters the cross-section of the inlet tube 204 to deliver blood B.

[0103] An increase in the pressure level of blood B allows for improved blood processing in membrane module 1. Figure 1 In the illustrated embodiment, blood B located in membrane module 1 is aerated with oxygen O2 and treated in this manner. For this purpose, membrane module 1 has an exchange membrane 5 having a plurality of semi-permeable hollow fibers 7 extending through a treatment space 3 through which blood B of patient P flows. Thus, blood B comes into contact with the hollow fibers 7 of the exchange membrane 5 in the treatment space 3. Oxygen O2 flows through the hollow fibers 7, thereby exchanging gases with blood B in the treatment space 3 through the semi-permeable walls of the hollow fibers 7. Oxygen O2 diffuses into blood B through the semi-permeable 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 blood B. Oxygen O2 here forms the treatment medium M. In other variations, the treatment medium may also be another gas, gas mixture, and / or liquid. For example, cold or warm water may flow through the hollow fibers 7 to regulate the temperature of blood B of patient P.

[0104] Figure 1The illustrated embodiment of system 200 for in vitro processing of blood B has a processing medium supply source 222, which is connected here to an oxygen source (not shown). Oxygen O2 is fed into the hollow fiber 7 of the exchange membrane 5 through the processing medium supply source 222. The oxygen O2 flows through the hollow fiber 7 and is discharged downstream of system 200 through processing medium outlet 224. To regulate the flow rate of the processing medium M, console 210 has an actuator 226, which is designed here as a throttle valve 228. Preferably, actuator 226 may also be arranged downstream of membrane module 1, for example, to increase the gas pressure in the hollow fiber 7 of membrane module 1. In the illustrated embodiment, throttle valve 228 is controlled by control system 216 of system 200. For example, throttle valve 228 may be an electronically controllable solenoid valve. In addition to throttle valve 228, control system 216 also controls two pumps 212, 214 of console 210. Preferably, the control system 216 further includes a control system, particularly pressure control and / or volumetric flow control, in which case at least one sensor, particularly a pressure sensor, may be preferably provided in the system 200.

[0105] Figure 2 A first preferred embodiment of the membrane module 1 is shown. In this embodiment, the membrane module 1 includes a first tube connector 9, which is connected to the inlet tube 204 of the disposable treatment module 206. Figure 2 (Not shown in the image). The second tube connector 11 is connected to the drainage tube 208 ( Figure 2 (Not shown in the diagram). The processing space 3 of the membrane module 1 extends from the blood inlet 13 to the blood outlet 15. The hollow fibers 7 of the exchange membrane 5 extend through the processing space 3 along their respective fiber longitudinal directions RF. During operation, blood B enters the processing space 3 of the membrane module 1 through the first tube connector 9 and the blood inlet 13. Then, blood B flows through the processing space 3 in the main flow direction RH and exits at the blood outlet 15. Blood B is returned to the patient P via the second tube connector 11 and the drainage tube 208. Blood B flowing through the processing space 3 comes into contact with and is processed by the hollow fibers 7.

[0106] The main flow direction RH extends in a straight line from blood inlet 13 to blood outlet 15. In the illustrated embodiment, blood inlet 13 is opposite to blood outlet 15 along the main axis A of membrane module 3. Here, main axis A is aligned with the main flow direction RH. This membrane module 3, having blood inlet 13 and blood outlet 15 opposite to each other in the main flow direction RH, is referred to herein as a direct-flow module. The advantage of this design is that blood B flows particularly uniformly through the processing space, and therefore can be processed particularly gently. Strong flow deflections that could lead to turbulence in blood flow and stagnant water areas are avoided.

[0107] Figure 2Only a few examples of the numerous hollow fibers 7 of the exchange membrane 5 are shown. The hollow fibers 7 extend longitudinally from a first fiber end 17 to a second fiber end 19 along fiber longitudinal directions RF1, RF2. Fiber ends 17, 19 are held in a potting compound 21. The potting compound 21 defines a first sidewall 23 and a second sidewall 25 opposite to the first sidewall 23 of the processing space 3. The potting compound 21 is fluid-impermeable and prevents blood B from flowing to the media inlet 27 and / or media outlet 29 of the membrane module 1. For supplying the processing media M, the media inlet 27 is connected to a processing media supply 222. The media outlet 29 of the membrane module 1 is connected to a processing media discharge port 224 to remove the processing media M already used for processing from the membrane module 1.

[0108] like Figure 2 As shown, the potting compound 21 does not necessarily form the entire sidewalls 23, 25 of the processing space 3. In the illustrated embodiment, the blood inlet 13 and the blood outlet 15 are formed by separate elements, which can be manufactured, for example, by injection molding. However, it may also be specified that the potting compound 21 also defines the blood inlet 13 and / or the blood outlet 15.

[0109] In the illustrated embodiment, the processing space 3 is substantially cylindrical in shape, whereby the height H of the cylinder, or the height direction H of the processing space 3, is substantially transverse to the main flow direction RH. The base region of the general cylinder is defined by two circular segments (congruent circular arc chords) abutting each other on their flat sides. However, at the ends, i.e., from the blood inlet 13 and the blood outlet 15, the shape of the processing space deviates from the general cylindrical shape. In the height direction H, the sidewalls 23, 25 of the processing space 3 are not curved. On the opposite sides of the membrane module 1 in the height direction H, in the illustrated embodiment, the processing space 3 is defined by a cover plate 31 on each side, for clarity. Figure 2 Only the lower cover plate 31 is shown. Here, the cover plate 31 is substantially flat. However, in other variations, one or both cover plates 31 may be designed as shells. In the illustrated embodiment, the cover plate 31 defines a cylindrical cover. However, in other variations, the cover plate 31 may also be a flat area of ​​the processing space 3, and it need not be flat. The cover plate 31 connects or closes the two sidewalls 23, 25 to define the processing space 3. Therefore, the design of the processing space 3 shown can be achieved with relatively simple manufacturing of the potting compound 21. Furthermore, at least one of the cover plates 31 may be transparent. This allows the processing space 3 to be observed from the outside. Therefore, thrombi formed in the processing space 3 can be detected particularly easily, and the in vitro processing 500 of blood B using system 200 can be monitored particularly easily.

[0110] Along the main flow direction RH, the treatment space 3 has a variable main cross-section QH. The main cross-section QH of the treatment space 3 is viewed transversely to the main flow direction RH (see also...). Figure 3 In the illustrated embodiment, the first sidewall 23 and the second sidewall 25 are symmetrical with respect to the main axis A, but in other variations of the membrane module 1, they may also be asymmetrical with respect to each other. Figure 2 In the illustrated embodiment, the first sidewall 23 and the second sidewall 25 are concave. Therefore, the sidewalls 23 and 25 form protrusions in the processing space 3, and the processing space 3 has a protruding basic shape when viewed along the height direction H.

[0111] Figure 3 The top view shown specifically illustrates the variable master cross-section QH. The viewing direction of this top view is along the height direction H on membrane module 1. Therefore, the height direction H is perpendicular to... Figure 3 The image plane in the image. For simplicity, Figure 3 Only the hollow fibers 7 of the exchange membrane 5 and the sidewalls 23, 25 formed by the potting compound 21 are shown. Fiber lengths and fiber ends are also shown in a simplified form. For example, the fibers preferably do not terminate in the processing space 3. The remainder of the membrane module 1, particularly the remaining material of the potting compound 21, is not shown. Figure 3 As shown in the image. According to... Figure 3 The top view again shows the basic elliptical shape of processing space 3. The main flow direction RH is... Figure 3 The blood inlet 13 extends horizontally from the left edge of the image to the right edge of the image, where the blood outlet 15 is located.

[0112] In the illustrated embodiment, preferably, when viewed along the main flow direction RH, the main cross-section QH of the processing space 3 increases from the blood inlet 13 toward the central cross-section QM. This increase is continuous. Starting from the central cross-section QM located at the center of the processing space 3, the main cross-section of the processing space 3 then continuously decreases toward the blood outlet 15. Figure 3A first main cross-section QH1, a central cross-section QM, and a second main cross-section QH2 are shown as examples. The central cross-section QM is located at the center of the main flow direction RH between the blood inlet 13 and the blood outlet 15. Since the sidewalls 23 and 25 of the processing space 3 have a constant distance from each other in the height direction H, the widths of the cross-sections shown here directly correspond to their respective cross-sectional areas. The central cross-section QM has the largest cross-sectional area because the sidewalls 23 and 25 of the processing space 3 are most far apart from each other in the direction perpendicular to the main flow direction RH. In the illustrated embodiment, the processing space 3 is preferably symmetrical to the plane of the central cross-section QM. The first main cross-section QH1 is farther from the central cross-section QM in the main flow direction RH than the second main cross-section QH2, and therefore its cross-sectional area is smaller than that of the second main cross-section QH2. It should be understood that the cross-sectional area of ​​the processing space occupied by the hollow fiber 7 is a portion of the main cross-section QH. Therefore, in the illustrated embodiment, the area of ​​the main cross-section QH is determined solely by the distance between the first sidewall 23 and the second sidewall 25 and the height of the processing space 3 in the height direction H. It should also be understood that, in some cases, the terms cross section and cross-sectional area may be used synonymously in this specification.

[0113] However, in the actual flow through the processing space 3 of membrane module 1, the flowing blood B is partially blocked by the hollow fibers 7 of the exchange membrane 5, which extend through the processing space 3. Therefore, the free cross-sectional area of ​​the processing space 3 transverse to the main flow direction RH is at most equal to or less than the corresponding area of ​​the main cross-sectional area QH at the location under consideration.

[0114] In the illustrated embodiment, the filling density of the hollow fibers 3 is constant, so the free cross-sectional area of ​​the processing space 3 is substantially proportional to the main cross-sectional area QH. Preferably, the exchange membrane 5 comprises two or more fiber pads 33 stacked on top of each other in the height direction H. In the illustrated embodiment, the fiber pads 33 comprise a plurality of unidirectional hollow fibers 7. The unidirectional hollow fibers 7 of the fiber pads are secured by warp threads 35 to prevent slippage.

[0115] In the illustrated embodiment, preferably, several fiber pads 33 are stacked together in alternating directions, preferably forming a diamond pattern when viewed in the height direction H. The first subset 37 of the hollow fibers 7 of the exchange membrane 5 comprises only hollow fibers 7 parallel to each other. The second subset 39 of the hollow fibers comprises other hollow fibers 7 of the exchange membrane 5, which have a different orientation than the hollow fibers 7 of the first subset 37. In a particularly simple and preferred embodiment, each fiber pad 33 comprises only hollow fibers 7 from one hollow fiber subset 37 or 39. To achieve... Figure 3The diamond pattern shown allows identical fiber pads 33 to be stacked together in alternating directions. Preferably, fiber pads 33 with a first subset 37 of hollow fibers 7 and fiber pads 33 with a second subset 39 of hollow fibers 7 are stacked alternately. Figure 3 In the first subset 37 of hollow fibers, the hollow fibers 7 extend from the upper left corner to the lower right corner, while in the second subset 39 of hollow fibers, the hollow fibers 7 extend from the lower left corner to the upper left corner. It is also possible to achieve hollow fiber subsets 37 and 39 with different orientations relative to each other without using fiber pads 33. Furthermore, a single fiber pad 33 may already contain hollow fibers 7 with different orientations.

[0116] In the illustrated embodiment, the longitudinal fiber RF1 of the hollow fiber 7 in the first subset 37 and the longitudinal fiber RF2 of the hollow fiber 7 in the second subset 39 are both inclined relative to the main flow direction RH. Therefore, in Figure 3 In the process, the hollow fibers 7 all flow at an angle of attack of approximately 70°, where the angle of attack is the smaller of the closed angle between the main flow direction RH and the fiber longitudinal direction RF.

[0117] When blood B flows through processing space 3, the at least partially inclined flow of blood B through hollow fibers 7, including the first subset 37 and the second subset 39, improves the processing of blood B. Hollow fibers 7 flowing through processing space 3 at an angle to the main flow direction RH have a larger contact area with blood B compared to hollow fibers 7 flowing transversely to the main flow direction RH. This allows for better exchange of molecules and / or energy between the hollow fibers 7, or the processing medium M flowing within them, and the blood B. Because blood inlet 13 and blood outlet 15 can remain free of hollow fibers 7, the angled extension of hollow fibers 7 allows for a considerably simpler design compared to hollow fibers 7 extending parallel to the main flow direction RH. Furthermore, hollow fibers 7 oriented at an angle to the main flow direction RH improve the mixing of blood B compared to parallel hollow fibers 7, which improves the processing outcome.

[0118] When viewed from the height direction H, the hollow fibers 7 of adjacent fiber pads 33 surround each other to form free rhombuses. In the illustrated embodiment, these free rhombuses 41 are asymmetrical. The short semi-axis of the rhombuses 41 extends substantially parallel to the mainstream direction RH. The long semi-axis of the rhombuses 41 is transverse to both the height direction H and the mainstream direction RH. In the height direction H, the rhombuses 41 may also be offset from each other or not coincident.

[0119] In the illustrated embodiment, when viewed from the height direction H, the hollow fibers 7 of the first subset 37 and the hollow fibers 7 of the second subset 39 intersect at an angle α. Figure 3As shown, the intersection angle α is defined between the two intersecting hollow fibers and opens toward the blood inlet 13. In the illustrated embodiment, only the hollow fibers 7 of the first subset 37 and the hollow fibers 7 of the second subset 39 are shown. However, in other preferred variations, the membrane module 1 may also have more partial hollow fibers whose orientation relative to each other may be the same or different. For example, only the hollow fibers 7 of the first subset 37 may be tilted toward the main flow direction RH, while the hollow fibers 7 of the second subset 39 may be oriented transversely to the main flow direction RH. The orientation of the hollow fibers 7 is determined by their fiber longitudinal direction RF.

[0120] Figure 4 A top view of a second embodiment of membrane module 1 is shown, wherein, with Figure 3 Similarly, only the sidewalls 23, 25 of the exchange membrane 5 and the plurality of hollow fibers 7 are shown again. Figure 3 Two fiber pads 33 are shown stacked together, wherein a fiber pad 33 having a first subset 37 of hollow fibers 7 is arranged in the height direction H above a fiber pad 33 having a second subset 39 of hollow fibers 7. To illustrate the different fiber pads 33, the hollow fibers 7 of the first subset 37 are shown here covering the hollow fibers 7 of the second subset 39. Therefore, Figure 4 The free rhombus 41 is not shown in the figure.

[0121] and Figure 3 Compared to the first embodiment shown, in the second embodiment, a large portion of the processing space 3 is not completely filled with hollow fibers 7. In the first embodiment, this is only intended to keep the blood inlet 13 and blood outlet 15 free of hollow fibers 7. Along the main flow direction RH, the inlet portion 43 downstream of the blood inlet 13 and the outlet portion 45 upstream of the blood outlet 15 are partially free of hollow fibers 7. This alters the filling density of the hollow fibers 7 at least in the portions along the main flow direction RH. When observing the entire main cross-section QH transverse to the main flow direction RH, the filling density is a measure of the ratio of the fiber cross-sectional area to the corresponding area of ​​the main cross-sectional area QH. A high filling density generally indicates a relatively large number of hollow fibers 7 scattered across the main cross-section QH, while a low filling density indicates very few hollow fibers 7.

[0122] In the second embodiment, the filling density of the hollow fibers 7 varying in the main flow direction RH is achieved by the following manner: the hollow fibers 7 of the first subset 37 protrude above the hollow fibers 7 of the second subset 39, and the hollow fibers 7 of the second subset 39 protrude above the hollow fibers 7 of the first subset 37. Figure 4In the inlet portion 43, a fiber pad 33 of hollow fibers 7, comprising a first subset 37 of hollow fibers, protrudes in a first sub-section of the inlet portion 43, located above the main axis A, while a second subset 39 of hollow fibers 7 protrudes in a second sub-section of the inlet portion 43 (below the main axis A). Compared to the central cross-section QM, only half of the hollow fibers 7 are distributed in the processing space 3 within these protruding regions. Therefore, by using a simple fiber pad 33 with unidirectional hollow fibers 7, a filling density varying in the main flow direction RH can be achieved. Furthermore, a filling density varying transversely to the main flow direction may be particularly advantageous. This allows for lower flow resistance near the sidewalls 23, 25, resulting in better distribution of blood B within the processing space 3, even to the edge regions.

[0123] Figures 5a to 5d With similar Figure 3 and Figure 4 The top view shows a further example of membrane module 1. Figure 5a In the hollow fiber subset 39, the hollow fibers 7 are not arranged at an angle to the main flow direction RH, but are arranged laterally. Figure 5b In this fourth embodiment, the processing space 3 is asymmetrical with respect to the central plane E, which is transverse to the main flow direction RH and divides the processing space 3 in two. In this fourth embodiment, the processing space 3 widens in a tulip or champagne glass shape, making the area of ​​the blood outlet 15 significantly larger than the area of ​​the blood inlet 13. However, the processing space 3 can also be funnel-shaped. Figure 5c Hollow fiber 7 of the third hollow fiber subset is also shown, which is substantially transverse to the main flow direction RH. Figure 5c It is also shown that the hollow fibers 7 of the hollow fiber subsets 37, 39 can have different fiber spacings. For example, the hollow fibers 7 of the first fiber pad 33 can have a first fiber spacing, while the hollow fibers 7 of the second fiber pad 33 can have different fiber spacings transverse to the fiber longitudinal direction. Preferably, the hollow fibers 7 of several fiber pads 33, and particularly preferably all fiber pads 33, have the same fiber spacing. Figure 5d In this process, the processing space 3 has a cross-sectional jump, thus expanding abruptly or discontinuously in the main flow direction RH. In other variations, the fiber spacing between adjacent hollow fibers 7 of the fiber pad 33 may also vary. For example, preferably, the fiber spacing between adjacent hollow fibers 7 of the fiber pad 33 in the central region may be less than or greater than the fiber spacing at the blood inlet 13 and / or blood outlet 15.

[0124] Figure 6A membrane module 1 with multiple processing spaces 3, 47 is shown. The processing spaces 3, 47 are substantially the same as the processing space 3 of the first embodiment. It is also preferred that the membrane module 1 has two or more processing spaces 3, 47. The additional second processing space 47 is connected to the first processing space 3 via a fiberless fluid line portion 49 (also called a fiberless connection portion 49). The fluid line portion 49 has no hollow fibers 7 distributed and can be formed, for example, by a tube. However, adjacent processing spaces 3, 47 can also be separated, for example, by a partition, in which case the processing spaces 3, 47 can be connected specifically by a window in the partition. Hollow fibers 7 can extend through both processing spaces 3, 47. However, preferably, each processing space 3, 47 has its own exchange membrane 5, which has multiple hollow fibers 7 independent of each other. For example, gas exchange can take place in the first processing space 3, while the second processing space 47 is used to heat the blood B with hot water flowing through the hollow fibers 7 of that processing space 47. Similarly, for example, blood B can be oxygenated (O2) in the first processing space 3, while in the second processing space 47, carbon dioxide (CO2) is primarily removed from blood B. Figure 6 In the embodiment shown, the main flow direction RH is vertically upward in the first processing space 3 and vertically downward in the second processing space 47.

[0125] Figure 7 An apparatus 250 for manufacturing membrane module 1 is schematically shown. This manufacturing apparatus 250 mainly includes a centrifuge apparatus 252, which includes a turntable 254. The turntable 254 can be rotated about a main rotation axis AD by a drive (not shown). A retainer (not shown in detail) is provided on the turntable 254 to which a mold 256 for manufacturing membrane module 1 can be attached. The mold 256 preferably forms a housing for the finished membrane module 1. The apparatus 250 also includes a material feeding device 258, shown only schematically here. The material feeding device 258 is used to supply potting material 260 to the mold 256.

[0126] The sequence of the first method 300 for manufacturing the membrane module 1 according to the invention is as follows: Figure 8 As shown, the following will refer to Figure 7 The apparatus 250 shown is explained by way of example. Figure 8 In addition to boxes 302, 304, and 306 showing the process steps, a simplified representation of device 250 is also shown.

[0127] In the first step 302 of process 300, the fiber pad 33 of the hollow fiber 7 is inserted into the mold 256. (Refer to the above text.) Figure 3In this embodiment, the fiber pads 33 of unidirectional hollow fibers 7 in the first subset 37 and the fiber pads 33 of unidirectional hollow fibers 7 in the second subset 39 are alternately stacked in the height direction H (in... Figure 7 (Perpendicular to the image plane).

[0128] After the mold 256 is closed, in the second step 304 of method 300, the first fiber end of each hollow fiber 7 arranged in the mold 256 is filled with filling material 260. However, in a variant, filling can also be performed with the mold open. The filling of the first fiber ends is referred to herein as primary filling 304. To prevent the initially still flowable filling material 260 from flowing along the longitudinal direction RF of the hollow fiber 7 due to capillary action, the mold 256 is rotated at least temporarily about a first axis of rotation AR1 during primary filling 304. This first axis of rotation AR1 is defined by its relative position to the mold 256 or in the mold's frame of reference. From a global perspective, the first axis of rotation AR1 and the main axis of rotation AD are identical. Referring to the mold 256 containing the hollow fibers 7, in the illustrated case, the first axis of rotation AR1 is arranged in an off-center position, even outside the mold 256. The rotation of the mold 256 on the turntable 254 causes centrifugal force to act on the potting material 260, which impedes the flow of the potting material 260 along the longitudinal direction of the fiber RF. The potting material 260 is preferably supplied into the mold 256 during rotation and cured there. The potting material 260 can be, for example, an adhesive. In this embodiment, the mold 256 is rotated until the potting material 260 is substantially cured and can no longer flow along the hollow fiber 7 due to capillary action. However, it should be understood that rotation is not necessary until the potting material 260 is fully cured. During primary potting 304, the potting material 260 forms a first sidewall 23 of the processing space 3 on the radially outer side of the mold 256.

[0129] Subsequently, in an embodiment of method 300 described herein, mold 256 is rotated 180° and remounted on turntable 254. This also changes the position of the primary rotation axis AD when viewed from the frame of reference of mold 256. In the subsequent secondary encapsulation 306, which is substantially similar to primary encapsulation 304, a second sidewall 25 is formed in the processing space 3, thereby encapsulating the second fiber ends of the hollow fibers 7 opposite to their respective first fiber ends. During this process, mold 256 again rotates about the primary rotation axis AD, thus forming a second rotation axis AR2 different from the first rotation axis AR1. When viewed from the frame of reference of mold 256, the second rotation axis AR2 of secondary encapsulation 306 differs from the first rotation axis AR1 used in primary encapsulation 304. This is due to the rotation of mold 256 between primary encapsulation 304 and secondary encapsulation 258. When viewed from the frame of reference of mold 256, the first rotation axis AR1 and the second rotation axis AR2 are located on different sides of mold 256.

[0130] After primary filling 304 and / or secondary filling 306, the closed fiber ends 17, 19 of the hollow fiber 7 are preferably opened, particularly preferably by cutting or separating the closed ends.

[0131] The first filling portion 24 of the filling member 21 forms the first sidewall 23, and the second filling portion 26 of the filling member 21 forms the second sidewall 25. Although multiple fillings of the fiber ends are conceivable and preferred, the primary filling 304 and secondary filling 306 here refer to the filling of different fiber ends. The multiple fillings of the first fiber end will then be referred to as the first primary filling 304 and the second primary filling 304, as appropriate. The terms primary filling 304 and secondary filling 306 are used here to clarify the steps that occur sequentially in time, but do not imply any priority order. Thus, secondary filling 306 may also be performed before primary filling 304. In secondary filling 306, the mold 256 also rotates about the main rotation axis AD of the device 250.

[0132] Rotation axes AR1 and AR2, located outside the mold 256, cause gentle concave bends in the sidewalls 23, 25 of the processing space 3 formed by the cured potting material 260. The shape of the sidewalls 23, 25 is substantially determined by the distance between the mold 256 and the main rotation axis AD, and by the alignment of the mold 256 on the turntable 254. In the illustrated embodiment, the longitudinal edge 262 of the mold 256 is substantially parallel to the circumferential direction RU of the rotational motion during primary potting 304 and secondary potting 306. This results in a symmetrical shape of the processing space 3. In this variant, the processing space 3 is symmetrical both with respect to the longitudinal axis or main flow direction RH and with its central plane E, which is transverse to the main flow direction RH. Preferably, during primary potting 304 and / or secondary potting 306, the main flow direction of the processing space 3 to be produced corresponds to the circumferential direction RU of the rotational motion.

[0133] However, in other variations, different orientations or the main flow direction RH of mold 256 can also be selected. For example, Figure 9 The mold 256 is shown to be flipped outward, with the long side 262 of the mold 256 at an angle to the circumferential direction RU, and the main flow direction RH of the processing space 3 to be produced at an angle to the circumferential direction RU. Figure 5b It is shown that when the primary potting 304 and the secondary potting 306 are at an angle to the circumferential direction RU relative to the main flow direction RH, the resulting processing space 3 decreases in the main flow direction LH (when flowing against the current, the main cross-section QH of the processing space 3 expands accordingly).

[0134] Figure 10 A second variation of method 400 for manufacturing membrane module 1 is shown. Method 400 can be specifically used to produce processing space 3, which preferably has at least partially the shape of an elongated ellipsoid of revolution, an elliptical cylinder, a cylinder, or a general cylinder, its base region being at least partially defined by arcuate segments. In contrast to the first embodiment of method 300, a mold 256 provided with hollow fibers 7 is vertically mounted on a turntable 254. The longitudinal direction RF of the hollow fibers 7 arranged in the mold 256 extends at least partially along the main axis of rotation AD. However, the main axis of rotation AD may also preferably be perpendicular to the hollow fibers 7. In the variation shown, the main flow direction RH of the processing space 3 to be produced coincides with the main axis of rotation AD. In the second variation of method 400, all sidewalls of the processing space 3 can be produced in a single potting step 402. When a sufficient amount of potting material 260 is supplied, the processing space 3 has essentially the shape of an elongated ellipsoid of revolution or a general cylinder, its base region being at least partially defined by arcuate segments. On the other hand, if only a limited amount of potting material 260 is supplied, sidewalls 23, 25 of the processing space 3 that are not closed or separated in the circumferential direction can be produced. Then, the potting 402 is an incomplete circular potting. In the preferred variant shown, the potting material 260 is supplied to the mold 256 on two opposite sides via a material feeding device 258. Rotation of the mold 258 about the main rotation axis AD causes the potting material 260 to be partially distributed circumferentially, thereby forming two substantially symmetrical sidewalls 23, 25 of the processing space 3 upon curing. The amount of potting material 260 is selected such that the sidewalls 23, 25 are separated from each other. Preferably, the potting material 260 is introduced into the mold 256 by centrifugal force. Alternatively or additionally, the potting material 260 may also be introduced into the mold 256 under pressure.

[0135] In both methods 300 and 400, the processing space 3 can be pre-closed after potting 304, 306, 402 or by arranging one or more covers 31.

[0136] Figure 11The sequence of a preferred method 500 for the in vitro processing of blood B is schematically illustrated. In the first step of this processing method 500, a blood flow is provided ( Figure 11 (Ref. 502). For example, the blood flow can be supplied from a blood reserve, supplying blood B. In the second step 504, the blood flow is introduced into the processing space 3 of the membrane module 1, which can be, for example, a membrane module 1 according to one of the above embodiments. Then, blood B flows through the processing space 3 of the membrane module 1. In the variant of method 500 shown here, when the blood B of the blood flow is supplied to the processing space 3 at 504, its pressure level is higher than atmospheric pressure. Simultaneously with the supply of blood B at 504, the hollow fiber 7 passing through the processing space 3 is traversed by a processing medium M along its longitudinal direction RF, in this case, the processing medium M is oxygen O2 ( Figure 11 The flow of blood B is 506. Blood B flows from blood inlet 13 to blood outlet 15 along the main flow direction RH and comes into contact with hollow fibers 7 in the processing space 3. During this process, blood B is treated, wherein in this case, the treatment is to oxygenate blood B with oxygen O2 and reduce carbon monoxide CO and / or carbon dioxide CO2 in blood B. Hollow fibers 7, extending through at least a first subset 37 of hollow fibers through the processing space, have a fiber longitudinal direction RF inclined with respect 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 flowing through 506, blood can be provided in a usable form 508, particularly in a blood reserve. Alternatively, after flowing through 506, blood B can also be supplied 510 to patient P.

[0137] Figure 12a and Figure 12b A variant of the membrane module 1 according to the invention is shown, wherein there is no oblique flow to the hollow fiber 7. Figure 12a In the figure, the first sidewall 23 and the second sidewall 25 of the processing space 3 are not shown. The first sidewall 23 is formed by a first potting portion 24, and the second sidewall 25 is formed by a second potting portion 26. A third sidewall 51 extending transversely to the first sidewall 23 and the second sidewall 25 is shown transparently. The exchange membrane 5 of the embodiment shown here includes fiber pads 33 stacked along the main flow direction RH. Here, the fiber pads 33 of hollow fibers 7 of the first subset 37 and the fiber pads 33 of hollow fibers 7 of the second subset 39 are stacked alternately. The first longitudinal direction RF1 of the hollow fibers 7 of the first subset 37 and the second longitudinal direction RF2 of the hollow fibers 7 of the second subset 39 are transverse to the main flow direction RH. Therefore, in the embodiment shown in FIG. 12, the hollow fibers 7 do not flow at an angle, but rather flow transversely.

[0138] The fourth sidewall 53 of the processing space 3 has a shape similar to the third sidewall 51 and is mirror-symmetrical to the third sidewall 51. Here, the third sidewall 51 and the fourth sidewall 53 are designed separately for the potting member 21. However, other variations are also possible, in which the potting member 21 has third and fourth potting portions to form the third sidewall 51 and / or the fourth sidewall 53. The third sidewall 51 and the fourth sidewall 53 are wedge-shaped. One tip of the wedge extends toward the center of the processing space 3. The wedge shape of the sidewalls 51, 53 is particularly advantageous for the membrane module 1 with transversely flowing hollow fibers 7, although wedge-shaped sidewalls 51 and 53 are generally preferred. The wedge-shaped sidewalls 51, 53 allow for particularly efficient use of the fiber pad 33, because the third sidewall 51 of the fourth sidewall 53 can fill the X-shaped free space formed by stacking hollow fibers 7 of different orientations.

[0139] Figure 12b The first sidewall 23 and the second sidewall 25 formed by the potting compound 21 are also shown. Dashed lines 55 indicate the concave shape of the sidewalls 23 and 25. For simplicity, Figure 12b Fiber ends 17 and 19 are not shown. In the embodiment according to Figure 12, the processing space 3 also has a main cross-section QH that varies in the main flow direction RH. Figure 12b In the view shown, the first sidewall 23 and the second sidewall 25 define a processing space 3, the shape of which resembles an American football in a plane. However, it is also possible to specify that the third sidewall 51 and the fourth sidewall 53 have shapes similar to the first sidewall 23 and the second sidewall 25. In this variation, the processing space 3 is essentially shaped like an American football.

[0140] It should be understood that the shape of the processing space 3 described with reference to FIG. 12 is also applicable to variants of the membrane module 1 according to the invention, wherein the longitudinal direction RF of at least one subset of hollow fibers 37, 39 is inclined relative to the main flow direction RH. Such a processing space 3 is also preferred for variants without hollow fibers 7 or without exchange membrane 5.

[0141] Figures 13a to 13c A fifth embodiment of the membrane module 1 according to the present invention is shown, wherein... Figure 13a This is an isometric view of membrane module 1. Figure 13b This is a top view of membrane module 1 (along height H of membrane module 1). Figure 13c This is a side view of membrane module 1. For ease of explanation, Figure 13aFigure 13 shows hollow fibers 7 of a first subset 37 and a second subset 39 of hollow fibers on one surface of membrane module 1. Although only fibers on one surface are shown in Figure 13, it should be understood that hollow fibers 7 can be arranged across the entire height of membrane module 1. Figure 13 shows only the processing space 3, but it should be understood that sidewalls are provided to define it, for example, said sidewalls are at least partially formed by potting compound 21. Figure 13c Hollow fiber 7 is not shown in the image.

[0142] In the membrane module 1 according to the fifth embodiment, the hollow fibers 7 of the first subset 37 of hollow fibers are also arranged in the processing space 3 in such a way that their fiber longitudinal direction RF1 is inclined relative to the main flow direction RH, which is parallel to the main axis A. However, it may also be specified that the fiber longitudinal directions RFI, RF2 of the first subset of hollow fibers 37 and / or the second subset of hollow fibers 39 are parallel to or transverse to the main flow direction RH.

[0143] The exchange membrane 5 arranged in the processing space 3 includes a main section 57 and two secondary sections 59. The first secondary section 59a is arranged upstream of the main section 57 relative to the main flow direction RH. The second secondary section 59b is arranged downstream of the main section 57 relative to the main flow direction RH. In the main section 57, the primary packing density of the hollow fibers 7 (representing the number of hollow fibers 7 per unit volume of the main section 57) is substantially constant, although minor fluctuations related to manufacturing may occur. The hollow fibers 7 are arranged in the secondary sections 59 with a secondary packing density. The secondary packing density 7 of the secondary sections 59 is lower than the primary packing density in the main section 57, and therefore differs from the primary packing density. The secondary packing density 7 can vary or remain constant within the secondary sections 59a and 59b. Furthermore, the secondary packing densities 7a and 7b of the sub-sections 59a and 59b can be different from or the same as each other. Figures 13a-13c In the illustrated embodiment, the fiber spacing of the hollow fibers 7 in the first subset 37 and the second subset 39 of hollow fibers is constant, and therefore the secondary packing density of the membrane module 1 is also constant. However, it should be understood that a constant secondary packing density can also be achieved in other ways. In the illustrated embodiment, since the hollow fiber 7 sub-parts of the first subset 37 and the second subset 39 of hollow fibers protrude, i.e., in the secondary portion 59, protruding above the hollow fibers 7 of the other subset 37, 39 of hollow fibers, the secondary packing density is lower than the primary packing density of the primary portion 57. However, different packing densities can also be achieved in other ways. For example, hollow fibers 7 oriented transversely to the main flow direction RH can be arranged in the secondary portion 59, while hollow fibers 7 oriented transversely to the main flow direction RH are also arranged in the primary cross-section, but with a smaller fiber spacing between them.

[0144] Secondary component 59 helps to even out the flow of blood B, such as Figure 13b As indicated by the arrows in the diagram. Specifically, the primary portion 59a, located upstream of the main portion 57, can help to evenly distribute the incoming blood B to the main portion 57. For this purpose, if the secondary portion 59a has two sub-portions 61 that are widened away from the main axis A, such as... Figure 13a and Figure 13b As shown, this is particularly advantageous. However, it should be understood that a non-widened sub-part 61 may also be advantageous, and is preferred.

[0145] The first part 59a is arranged in the inlet part 43 of the processing space 3, adjacent to the blood inlet 13 of the membrane module 1. The second part 59b is arranged in the outlet part 45 located upstream (or upstream of) the blood outlet 15.

[0146] like Figure 13b As shown, the sub-parts 61 are designed symmetrically to each other; therefore, this symmetry may or may not apply to the longitudinal directions RF1, RF2 of the hollow fibers 7 arranged therein. Here, both sub-parts 61 extend away from the main axis A. In this example, the extension of sub-parts 61 along the main axis A (in...) Figure 13b The width (from left to right) increases with increasing distance from the principal axis A (in... Figure 13b (Middle, up or down).

[0147] Figure 13c As shown, in the considered embodiment, the extension of sub-part 61 in the height direction is constant. Therefore, in the fifth embodiment, sub-part 61 is substantially prismatic, or extends prismatically from the principal axis A. On the other hand, the main part 57 has a base area of ​​a basic polygon and a constant height H. Therefore, the main part 57 can preferably be a polyhedron. In this case, the base region of the main part 57 is substantially hexagonal, and the two opposite sidewalls of the main part 57 are convex.

[0148] In a fifth embodiment of membrane module 1, blood inlet 13 includes inlet connector 63. Inlet connector 63 is designed to connect membrane module 1 to a blood supply line. Here, inlet connector 63 is cylindrical and includes an inlet central axis AE that coincides with main axis A. Blood outlet 15 has an outlet connector 67 configured to connect membrane module 1 to a blood outlet line. In the illustrated embodiment, the outlet connector is also cylindrical. Outlet connector 67 includes an outlet central axis AA that coincides with main axis A. Figure 13bIn the illustrated embodiment, the outlet central axis AA and the inlet central axis AE are therefore parallel. However, the inlet connector 63 and / or the outlet connector 65 may also be non-cylindrical, particularly conical. Particularly preferred is that the cross-section of the inlet connector 63 in the flow direction (through the inlet connector 63 towards the exchange membrane 5) may at least partially taper and / or widen. Alternatively or additionally, the cross-section of the outlet connector 65 in the flow direction (through the outlet connector 65 or exiting the membrane module 1) may at least partially taper and / or widen.

[0149] exist Figure 13c In the process space 3, the blood inlet 13 and blood outlet 15, or the inlet connector 63 and outlet connector 65, are centrally arranged in the height direction. In the fifth embodiment, the inlet connector 63 and outlet connector 65 are also centrally arranged laterally in the process space 3, transverse to the main flow direction RH (see [link to embodiment]). Figure 13b However, preferably, the inlet connector 63 may also be arranged off-center or offset in the vertical and / or lateral directions relative to the central axis of the processing space 3. Alternatively or additionally, the outlet connector 65 may also be arranged off-center or offset in the vertical and / or lateral directions relative to the central axis of the processing space 3.

[0150] The dispenser portion 65 of the blood inlet 13 is connected to the inlet connector 63 in the main flow direction RH. Therefore, the dispenser portion 65 is arranged downstream of the inlet connector 63. The dispenser portion 65 is configured to dispense blood B flowing into the blood inlet 13 onto the exchange membrane 5. In this embodiment, the dispenser portion 65 is located downstream of the inlet connector 63. Figure 13b In the image plane, it appears as an arrow. Therefore, the dispenser section 65 is an arrow-shaped plane perpendicular to the height direction and parallel to the inlet central axis AE or the main flow direction RH in the blood inlet 13. According to... Figure 13c The side view shows that the arrow shape of the dispenser section 65 extends uniformly along the height H of the membrane module 1.

[0151] Figure 14 The blood inlet 13 is shown in detail. In this preferred embodiment, the arrow-shaped dispenser portion 65 includes a first wing 69 and a second wing 71. The wings 69 and 71 are substantially cuboid in shape and extend from the arrow 73 of the dispenser portion 65 to the sides (transverse to the main axis A) and rear or upstream, and the dispenser portion 65 is linear here.

[0152] Collection section 75 is located upstream of the main flow direction RH of the blood outlet outlet connector 67 (see...) Figure 13b (Collection section 75) Figure 13b The image plane is essentially funnel-shaped. The collection section 75 is perpendicular to... Figure 13bThe image plane is also funnel-shaped within its plane (see...). Figure 13c The collection section 75 is used to collect blood B flowing out of the exchange membrane 5 along the main flow direction and deliver it to the outlet connector 67. The funnel shape of the collection section 75 can prevent backflow, thereby reducing the risk of thrombosis.

[0153] Figure 15 A sixth embodiment of membrane module 1 is shown, which differs substantially from the membrane module 1 of the fifth embodiment in the relative arrangement of the inlet connector 63. Here, the inlet central axis AE is arranged substantially perpendicular to the main axis A passing through the processing space 3. The arrangement of the blood outlet 15 and the outlet central axis AA is substantially the same as in the previous fifth embodiment. In other variations, the inlet central axis AE and the outlet central axis AA, and therefore the corresponding blood flows B at the blood inlet 13 and the blood outlet 15, may also be inclined relative to each other.

[0154] In the sixth embodiment, a connector segment 66 is provided that connects the inlet connector 63 to the dispenser portion 65. The connector segment 66 may also be assigned to the dispenser portion 65. In the sixth embodiment, the dispenser portion 65 is substantially arrow-shaped, similar to the fifth embodiment. However, according to the modified arrangement of the inlet connector 63, blood B is supplied to it from an upper side transverse to the height of the exchange membrane 5. Blood B flows laterally from the inlet connector 63 into the arrow-shaped dispenser portion 65, which here is formed only by wings 69, 71. However, it is also conceivable, for example, that the dispenser portion 65 is connected to... Figures 13a to 13c The distributor section shown is identical; connector section 66 is an elbow that connects the vertical inlet connector 63 to the distributor section 65. Furthermore, the arrow-shaped distributor section 65 is located in the height direction (perpendicular to the arrow direction, or in...). Figure 15 The height of the dispenser portion 65 (from top to bottom) is not constant. In this embodiment, the dispenser portion 65 preferably tapers gradually from the inlet connector 63. However, it is also possible to specify that the dispenser portion 65 is constant in the height direction when there is lateral flow towards it.

[0155] Figure 16a and Figure 16b A further preferred embodiment of the blood inlet 13 is schematically illustrated. Figure 16a In the image plane, the dispenser portion 65 is substantially wedge-shaped. Laterally to this first plane, the dispenser portion 65 may also be wedge-shaped. However, alternatively, the wedge-shaped dispenser portion may also extend constantly at the height H of the membrane module 1, or may have a different shape. The inlet connector 63 may be aligned parallel to the outlet connector, as... Figures 13a to 13c As shown, or it can flow from the side, especially from above, onto the dispenser section 65, as... Figure 15 As shown. However, in Figure 16b In this design, the dispenser portion 65 is cup-shaped. The stem 77 of the cup-shaped dispenser portion 65 faces the inlet connector 63. Starting from the stem 77, the dispenser portion 65 widens along the main axis A and / or along the main flow direction RH. The cup shape can exist in several planes, in projections of multiple planes, or only in one plane.

[0156] Figure 17 Display, with Figure 5b In a similar manner, the cross-sections of the processing spaces 3 at the blood inlet 13 and the blood outlet 15 need not be identical. For example, preferably, the projection of the processing space 3 onto at least one plane can substantially have the shape of a champagne glass or a tulip. Such a processing space has at least two opposing convex sidewalls 23, 25. The sidewalls 23, 25 are arranged such that the processing space 3 gradually tapers or widens in the main flow direction RH (towards the blood outlet 15). Preferably, the processing space 3 gradually tapers along the main flow direction RH. The accelerated blood flow through the processing space 3 achieved in this way counteracts the formation of a very low-velocity "dead zone," thereby preventing blood clotting. The design of the processing space 3 is preferred for all the embodiments described above. It should be understood that... Figure 17 The blood inlet 13 and blood outlet 15 are for illustrative purposes only. Reference List 1 Membrane Module 3 Processing space 5. Exchange membrane 7 Hollow Fiber 9 First tube connector 11 Second tube connector 13 blood entrance 15 Blood outlet 17 First fiber end 19 Second fiber end 21. Potting components 23 First sidewall 24 First Filling Section 25 Second sidewall 26 Second filling section 27. Medium Inlet 29. Medium outlet 31 Cover plate 33 Fiber Pads 35 meridian 37 Hollow Fiber First Subset 39 Hollow Fiber Second Subset 41 Free Rhombus 43. Entrance Section 45 Export Portion 47 Second Processing Space 49. Fluid Piping Section 51 Third sidewall 53 Fourth sidewall 55 Dashed line 57 Main Parts 59 Secondary Parts 61 Sub-parts of the secondary part 63 Inlet Connector 65 Distributor Section 66 Connector Section 67 Export Connector 69 First Wing 71 Second Wing 73 arrows 75 Collection Section 77. Stem 200 Blood Processing System 202 casing 204 Inlet Pipe 206 One-time processing module 208 Drainage Tube 210 Console 212 First Pump 214 Second Pump 216 Controller 218 Housing 220 Diaphragm Module Retainer 222 Processing Media Supply 224 Treatment Media Discharge 226 Actuator 228 Throttling Valve 250 manufacturing unit 252 Centrifuge Unit 254 turntable 256 mold 258 Material Feeding 260 potting material 262 The long side of the mold 300 The first method for manufacturing membrane modules 302 Inserted fiber pad 304 primary filling 306 Secondary Encapsulation 400 A second method for manufacturing membrane modules 402 potting compound 500 Extracorporeal treatment methods for blood 502 provides blood flow 504. Supply blood flow to the processing space. 506 flows through hollow fiber 508 Blood Supply 510 Blood Supply A spindle AA Exit Center Axis AD main rotating axis AE entrance center axis B Blood CO and carbon monoxide CO2 (carbon dioxide) E Central Plane H (height, height direction) M processing medium O2 (Oxygen) Patient P Main cross sections QH, QH1, QH2 QM center cross section RF, RF1, RF2 fiber longitudinal direction RH main flow direction RU Zhou Xiang α Cross angle

Claims

1. A membrane module (1) for processing blood (B), comprising: At least one processing space (3) having at least one blood inlet (13) and at least one blood outlet (15) connected to each other in the main flow direction (RH) through the processing space (3). An exchange membrane (5) having multiple hollow fibers (7), each hollow fiber extending through a processing space (3) along the fiber longitudinal direction (RF1, RF2) and configured to flow from the first fiber end (17) to the opposite second fiber end (19) via a processing medium (M) along the fiber longitudinal direction (RF1, RF2). A potting compound (21) in which the first fiber end (17) and the second fiber end (19) of the hollow fiber (7) of the exchange membrane (5) are fixed in the potting compound (21) and at least partially define the processing space (3). Its features At least a first subset (37) of the plurality of hollow fibers (7) is arranged in the processing space (3) such that its fiber longitudinal direction (RF1, RF2) is inclined relative to the main flow direction (RH).

2. The membrane module (1) according to claim 1, wherein, The processing space (3) has a main cross section (QH, QH1, QH2) perpendicular to 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 membrane module (1) according to any one of claims 1 to 3, wherein, The potting component (21) has a first potting portion (24) and a second potting portion (26), wherein the first potting portion (24) forms a first sidewall (23) of the processing space (3), and the second potting portion (26) forms a second sidewall (25) of the processing space (3) opposite to the first sidewall (23), wherein the first sidewall (23) and / or the second sidewall (25) are concave.

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

6. The membrane module (1) according to any one of claims 1 to 5, wherein, The filling density of the hollow fiber (7) varies along the main flow direction (RH), wherein the filling density preferably increases along the main flow direction (RH) from the blood inlet (13) toward the central portion of the processing space (3) and / or decreases from the central portion toward the blood outlet (15).

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

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

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

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

11. The membrane module (1) according to any one of claims 1 to 10, wherein the exchange membrane (5) comprises a fiber pad (33) of unidirectional hollow fibers (7), wherein, The fiber mats (33) are stacked on top of each other in the height direction (H) transverse to the main flow direction (RH), wherein the mat surface of the fiber mats (33) preferably varies in the height direction (H), particularly decreasing towards the outside.

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), particularly blood (B) with an absolute pressure (Pa) of 3 bar or lower.

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) according to any one of claims 1 to 13, wherein, The membrane module (1) is a direct flow module, wherein the blood inlet (13) is along the main axis (A) of the membrane module (1), particularly the longitudinal axis, opposite to the blood outlet (15).

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 the first processing space (3), wherein the hollow fiber (7) in the first processing space (3) is preferably different from the hollow fiber (7) in the second processing space (3).

16. The membrane module (1) according to any one of claims 1 to 15, wherein, The exchange membrane (5) has a main portion (57) and at least one secondary portion (59), wherein the main filling density of the hollow fibers (7) in the main portion (57) is constant, and wherein the secondary filling density of the hollow fibers (7) in the secondary portion (59) is different from the main filling density at least in some portions.

17. A membrane module (1) for processing blood (B), comprising: At least one processing space (3) having at least one blood inlet (13) and at least one blood outlet (15) connected to each other in the main flow direction (RH) through the processing space (3). An exchange membrane (5) having multiple hollow fibers (7), each hollow fiber extending through the processing space (2) along the fiber longitudinal direction (RF1, RF2) and configured to flow from the first fiber end (17) to the opposite second fiber end (19) by the processing medium (M) along the fiber longitudinal direction (RF1, RF2). A potting compound (21) wherein the first fiber end (17) and the second fiber end (19) of the hollow fiber (7) of the exchange membrane (5) are fixed in the potting compound (21) and at least partially define the processing space (3). Its features The exchange membrane (5) includes a main portion (57) and at least one secondary portion (59), wherein the main filling density of the hollow fibers (7) in the main portion (57) is constant, and wherein the secondary filling density of the hollow fibers (7) in the secondary portion (59) differs from the main filling density at least in some portions.

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

19. The membrane module (1) according to claim 17 or 18, wherein, The secondary portion (59) includes at least two sub-parts (61) arranged on opposite 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 sub-part (61) is symmetrical with respect to the main axis (A).

21. The membrane module (1) according to claim 19 or 20, wherein, The sub-part (61) expands away from the main axis (A).

22. The membrane module (1) according to claim 21, wherein the sub-part (61) expands in a pyramidal and / or prismatic shape.

23. The membrane module (1) according to any one of claims 16 to 22, wherein, The main part (57) is substantially cylindrical, annular cylindrical, polyhedral and / or cuboid in shape, wherein at least one side surface of the main part, particularly preferably two opposite side surfaces, 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 at least a first subset (37) of hollow fibers having a first hollow fiber and a second subset (39) of hollow fibers having a second hollow fiber.

25. The membrane module (1) according to claim 24, wherein, At least a first subset (37) of hollow fibers are arranged in the processing space (3) such that their fiber longitudinal direction (RF1, RF2) is inclined relative to the main flow direction (RH).

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

27. The membrane module (1) according to any one of claims 24 to 26, wherein the first subset (37) of hollow fibers is formed by at least one fiber pad, the first fibers of the at least one fiber pad having a first fiber spacing relative to each other, and wherein the second subset (39) of hollow fibers is formed by at least one second fiber pad, the second fibers of the at least one second fiber pad having a second fiber spacing relative to each other, wherein the first fiber spacing is preferably less than or greater 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, wherein the first fiber is preferably a semi-permeable hollow fiber and the second fiber is preferably an impermeable fluid fiber, or wherein the first fiber is preferably an impermeable fluid fiber and the third fiber is preferably a semi-permeable 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, wherein 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 center axis (AE) of the inlet connector (63) and the outlet center axis (AA) of the outlet connector (67) are arranged at an angle to each other, preferably perpendicular to each other.

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

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

33. The membrane module (1) according to claim 32, wherein, The distributor portion (65) is arrow-shaped in at least one plane in the main flow direction (RH).

34. The membrane module (1) according to claim 33, wherein the arrow-shaped dispenser portion (65) has at least a first wing (69) and a second wing (71), wherein, The wings are substantially cuboid, wherein the wings (69, 71) are preferably connected to each other at a connecting line, and wherein the connecting line preferably forms the arrow (73) of the arrow-shaped distributor portion (75).

35. The membrane module (1) according to claim 32, wherein, The dispenser portion (65) is cup-shaped in at least one plane in the main flow direction (RH), wherein the stem (77) of the cup-shaped dispenser portion (75) faces the inlet connector (63).

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

37. The membrane module (1) according to any one of claims 32 to 36, wherein, The membrane module (1) includes an inlet membrane at least partially disposed in the dispenser portion (65), wherein the inlet membrane includes a plurality of fibers, each fiber extending through the dispenser portion (65) in the longitudinal direction of the inlet fiber. The longitudinal direction of the inlet fiber is preferably perpendicular to the main flow direction (RH) and / or The preferred inlet membrane is a heat exchange membrane.

38. The membrane module (1) according to any one of claims 32 to 37, wherein, On the membrane side of the dispenser portion (65) facing the exchange membrane (5), the main flow direction (RH) at the inlet portion (63) is angled to the main flow direction, in particular perpendicular to the main flow direction (RH), and / or wherein the main flow direction at the inlet connector (63) is perpendicular to the main flow direction (RH) located at the transition between the blood inlet (13) and the main portion (57) and / or the secondary portion (59).

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

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

41. The membrane module (1) according to claim 39 or 40, wherein the collection portion (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 type of the hollow fibers (7) of the plurality of hollow fibers (7) in the main part (57) is at least partially different from the fiber type of the hollow fibers (7) of the plurality of hollow fibers (7) in the secondary part (59).

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

44. A method (300) for manufacturing a membrane module (1) for in vitro treatment of blood (B), particularly the membrane module (1) according to any one of claims 1 to 42 or 48, comprising the following steps: - Insert the fiber pad (33) of the hollow fiber (7) into the mold (256), wherein the hollow fiber (7) is in particular a unidirectional hollow fiber (7); - The first fiber end of the hollow fiber (7) is primary potted (304) with potting material (260) to form the first sidewall (23) of the processing space (3) of the membrane module (1), wherein during the primary potting process, the mold (256) rotates at least intermittently about the first rotation axis (AR1); - Secondary filling (306) is performed on the second fiber end of the hollow fiber (7) opposite to the first fiber end in the longitudinal direction of the fiber (RF1, RF2) to form a second sidewall (25) opposite to the first sidewall (23), wherein during the secondary filling (306), the mold (256) rotates at least temporarily about a second rotation axis (AR2) different from the first rotation axis (AR2); The first rotating axis (AR1) and the second rotating axis (AR2) are preferably parallel, and / or preferably, the first rotating axis (AR1) and / or the second rotating axis (AR2) do not intersect with the fiber pad (33).

45. A method (400) for manufacturing a membrane module (1) for in vitro treatment of blood (B), particularly the membrane module (1) according to any one of claims 1 to 42 or 48, comprising the following steps: - Insert the fiber pad (33) of the hollow fiber (7) into the mold (256), wherein the hollow fiber (7) is in particular a unidirectional hollow fiber (7); - The opposite ends of the hollow fiber (7) are potted (402) to form the sidewalls (23, 25) of the processing space (3) of the membrane module (1), wherein during the potting process, the mold (256) rotates at least temporarily about the main rotation axis (AD). The potting (402) is an incomplete circular potting.

46. ​​An assembly method, comprising the following steps: - Provides a control console (210) which includes at least one pump (212, 214), a controller (216) and a diaphragm module holder (220). - Provides a disposable processing module (206) comprising a membrane module (1) according to any one of claims 1 to 42 or 48; - Insert the membrane module (1) into the membrane module holder (220); as well as - The disposable processing module (206) is functionally connected to the pump (212, 214) to deliver fluid, particularly blood (B), through the membrane module (1).

47. A method (500) for the in vitro processing of blood (B), comprising the following steps: - Provides (502) blood flow; - Blood flow is supplied to the processing space (3) of the membrane module (1), particularly the membrane module (1) according to any one of claims 1 to 42 or 48, wherein the blood (B) of the blood flow preferably has a pressure level higher than atmospheric pressure. - The processing medium (M), especially oxygen (O2), flows along the corresponding fiber longitudinal direction (RF1, RF2) of the fiber (7) through the hollow fiber (7) that penetrates the processing space (3). The blood flow passes through the processing space (3) along the main flow direction (RH) and comes into contact with the hollow fiber (7) extending through the processing space (3) to process the blood (B) of the blood flow, particularly by oxygenating the blood with oxygen (O2). The feature is that at least a first subset (37) of the plurality of semi-permeable hollow fibers (7) is arranged in the processing space (3) such that their fiber longitudinal direction (RF1, RF2) is inclined relative to the main flow direction (RH).

48. A membrane module (1) for processing blood (B), comprising: At least one processing space (3) having at least one blood inlet (13) and at least one blood outlet (15) connected to each other in the main flow direction (RH) through the processing space (3). An exchange membrane (5) having multiple hollow fibers (7), each hollow fiber extending through a processing space (3) along the fiber longitudinal direction (RF1, RF2) and configured to flow from the first fiber end (17) to the opposite second fiber end (19) via a processing medium (M) along the fiber longitudinal direction (RF1, RF2). A potting compound (21) in which the first fiber end (17) and the second fiber end (19) of the hollow fiber (7) of the exchange membrane (5) are fixed in the potting compound (21) and at least partially define the processing space (3). The processing space (3) is characterized in that it has a main cross section (QH, QH1, QH2) that varies in the main flow direction perpendicular to the main flow direction (RH), wherein the processing space (3) preferably has a substantially American football shape on at least one plane.

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