DE102019115162A1 - Device for the exchange of substances and / or energy between two media and process for its production - Google Patents

Abstract

The invention relates to a device for material and / or energy exchange between a first exchange medium and at least one second exchange medium comprising a housing (1) which surrounds at least one chamber in which a package (3) of material and / or energy-permeable hollow fibers (3h) and which is divided into two chamber areas (1a, 11a / b) by the hollow fibers (3h), wherein the hollow fibers (3h) in a first chamber area (1a) of the at least one chamber can be flowed around by the first exchange medium and the hollow fibers (3h) in a second chamber region (11a / b) of the at least one chamber can be traversed by the at least one second exchange medium, the hollow fiber packet (3) having a packet axis (4), to which all hollow fibers (3h) of the hollow fiber packet ( 3) are oriented transversely, preferably vertically, the hollow fiber package (3) being penetrated with a potting compound at a radial distance from the package axis (4) over a full 360 degrees around the package axis (4) is, by means of which the hollow fibers (3h) of the hollow fiber package (3) are glued to one another, and the hollow fiber package (3) has on its outer circumference at least two circumferentially spaced apart and axially extending sealing elements (5), in particular those formed by the potting compound are, and the sealing elements (5) in a state compressed in the radial direction lie tightly against the inner wall of the housing (1) and the second chamber region (11a / b) of the at least one chamber through the sealing elements (5) in the circumferential direction in at least two Chamber subregions (11a, 11b) is divided.

Description

The invention relates to a device for the exchange of substances and / or energy between a first exchange medium, in particular blood, and at least one second exchange medium, in particular a gas, comprising a housing that surrounds at least one chamber in which a package of substance and / or energy-permeable hollow fibers and which is divided by the hollow fibers into two chamber areas, the hollow fibers in a first chamber area of the at least one chamber being able to flow around the first exchange medium and the hollow fibers in a second chamber area of the at least one chamber by the at least one second exchange medium are permeable. The invention also relates to a method for manufacturing such a device.

Devices of this type and methods for their production are basically known in the prior art. Such devices with material-permeable hollow fibers are used, for example, to lower the carbon dioxide partial pressure in the blood of a living being, in particular by increasing the oxygen partial pressure. Blood can thus serve as the first exchange medium and a gas as the second, which is also understood to mean a mixture of several gases, in particular which has a higher oxygen partial pressure than the blood to be treated. Devices of this type are used e.g. referred to as oxygenators.

Furthermore, such devices are known in which energy is transported between the media participating in the exchange by means of energy-permeable hollow fibers, in particular across the hollow fiber walls. Here the device serves e.g. as a heat exchanger for exchanging heat between the media.

In devices of the type mentioned, both only material-permeable and only energy-permeable hollow fibers, as well as combinations of both fiber types, can occur.

In the housing of the device, said first chamber area is in fluid connection with the outer surfaces of the material and / or energy-permeable hollow fibers, whereas said second chamber area is in connection with the inner volumes of the hollow fibers. The chamber of the device is thus effectively divided into the two chamber areas by the hollow fiber walls or membranes. The exchange of substances and / or energy between the exchange media can thus take place between the two chamber areas across the hollow fiber walls. In this way, the first exchange medium can flow into one chamber area, e.g. Blood and, in the second chamber area, a second exchange medium, e.g. the gas for oxygen enrichment and / or carbon dioxide depletion.

The hollow fibers are understood to be material-permeable to the extent that they are permeable to certain substances that are hollow-fiber-specific, but not to other substances. Such semipermeable hollow fibers can be used e.g. Carbon dioxide molecules and oxygen molecules through the walls of the hollow fiber in both directions, but blood components not. Such hollow fibers are understood to be energy-permeable, which allow an energy exchange, e.g. Allow heat exchange between the media on both sides of the hollow fiber walls, in particular where such energy-permeable hollow fibers are not material-permeable, but can also be.

The invention also relates to such energy- and / or substance-permeable devices as mentioned at the beginning, e.g. Heat exchangers and / or oxygenator devices, but is not limited to these.

In the prior art, such devices are manufactured specifically for the size of the living being to be treated. E.g. the devices for adult humans have larger housings and the hollow fiber packages a larger exchange surface than for children and especially newborns. The production and storage is accordingly complex and costly.

Furthermore, the prior art provides for the hollow fibers of the hollow fiber package to be glued to one another and, at the same time, also to the housing which receives the hollow fiber package, with a potting compound. This process is also called mocking. As a result, the hollow fibers of the hollow fiber package are materially connected to the housing by the adhesive bond. It is therefore not possible to remove a hollow fiber package from the housing without destroying it after such a device has been used, but this would be desirable for research applications.

It is therefore an object of the invention to provide a device of the type mentioned at the beginning, preferably for use as an oxygenator and / or heat exchanger, in which exchange surfaces of different sizes can be easily implemented in the hollow fiber package, preferably hollow fiber packages of different axial lengths in unchanged housing arrangements can be used. It is preferred to be able to subsequently remove a used hollow fiber package from a housing without destroying it, for example in order to be able to carry out research work on it. Furthermore, it is a task to provide a method of making such a device.

With regard to the device, this object is achieved in that the hollow fiber package has a package axis to which all hollow fibers of the hollow fiber package are oriented transversely, preferably perpendicularly, the hollow fiber package being radially spaced from the package axis over a full 360 degrees around the package axis with an, in particular hardened, Sealing compound is impregnated / penetrated, by means of which the hollow fibers of the hollow fiber package are glued to one another, in particular exclusively only to one another, and the hollow fiber package has on its outer circumference at least two circumferentially spaced apart and each axially extending sealing elements, in particular those through the sealing compound, preferably after them Hardening, are formed and the sealing elements lie tightly against the inner wall of the housing in a compressed state in the radial direction and the second chamber area is divided into at least two chamber subareas by the sealing elements in the circumferential direction is. These sealing elements preferably have an axial length which corresponds exactly or at least to the axial length of the hollow fiber packet viewed in the direction of the packet axis. In one possible embodiment, the axial ends of the sealing elements can thus each end in alignment with the axial end face of the hollow fiber packet or, according to an embodiment described below, protrude beyond it in the axial direction.

An arrangement of the hollow fibers transversely to the package axis is preferably understood to mean that the directions of the hollow fiber longitudinal extensions cross the direction of the package axis, that is, the two directions assume at least an angle different from 0 or 180 degrees to one another. The hollow fibers are preferably oriented perpendicular to the package axis.

In the following, an axial direction is understood as the direction of the package axis or parallel thereto, in particular the package axis being assumed to be preferably located centrally in the package. A radial direction is a direction that points towards the package axis or starting away from it, in particular perpendicular to the package axis.

The fact that the hollow fiber packet is penetrated by the potting compound at a radial distance results in an area in the hollow fiber packet that is free of potting compound directly adjacent to the packet axis and surrounding it, in particular an inner area, which thus represents a space in the hollow fiber packet in which the hollow fibers in the chamber of the Device exposed. This area represents the first chamber area of the at least one chamber or is at least fluidically connected to it. The radial distance between the casting compound and the package axis does not have to be the same for all angular positions around the package axis. E.g. The space free of potting compound can be angular, in particular rectangular, or partially circular or parabolic in cross section perpendicular to the package axis. In the axial direction, the cross section can preferably be the same for all axis positions. The cross-section can also change with the axial position, e.g. change from one axial end of the package towards the other, e.g. reduce. The radial distance between the potting compound and the package axis, on the other hand, can also be the same for all angular positions around the package axis, in particular also for all axial positions in the package. In this case, the space in the hollow fiber package free of potting compound is a cylindrical space with a circular area as the base area, which is surrounded on the outside in the radial direction by potting compound.

In general, the space free of casting compound can thus e.g. be a cylindrical space with any cylinder base or a cone section-shaped space with any cone base. The respective base areas are preferably circular or angular. The package axis is preferably an axis that lies in this space free of potting compound in the hollow fiber packet, more preferably lies centrally in the space free of potting compound.

The potting compound, which surrounds the free area in the hollow fiber package over a full 360 degrees around the package axis and cohesively connects the hollow fibers to one another, is preferably not materially bonded according to the invention to the inner walls of the housing in which the hollow fiber package is arranged.

In contrast to the previous state of the art, the sealing between the hollow fibers and the housing of the device does not take place via a material connection of the potting compound to the inner wall of the housing, but rather because the sealing elements, which extend axially, i.e. parallel to the package axis, attach to the outer circumference of the hollow fiber package in the compressed state the housing inner wall, thus being pressed against the housing inner wall with a force due to the compression and thereby preferably sealing. There is thus a force fit and / or form fit between a respective sealing element and the housing wall, whereby the tightness is achieved.

The sealing elements are preferably formed by the potting compound, in particular after a potting compound that is liquid during potting has hardened, which compound also surrounds the hollow fiber package around the free area. If this is not the case, the sealing elements can also be used separately Elements to be integrated into the potting compound in a materially bonded manner.

The material of the sealing elements, preferably the potting compound, is preferably one which - especially in the set, hardened state - has a Shore A hardness of 1 to 100, e.g. an elastomer, preferably that sets by polymerization or vulcanization, for example a silicone or latex.

The advantage of the invention is that the hollow fiber packet is not firmly bonded to the inner wall of the housing of the device, but is pressed against it in a sealing manner, in particular tightly separating the chamber areas from one another, by the radial forces, so that such a hollow fiber packet is non-destructive after use from the device can be taken.

Even if a later removal is not intended, the invention has the advantage that the hollow fiber package can be manufactured and stored separately from the housing of the device. In this way, different hollow fiber packages with different axial lengths in the direction of the package axis or with different sized free inner areas can be produced in order to be able to provide exchangeable areas of different sizes, which for example all have the same external cross section and can therefore all be used in housings with the same internal cross section . In this way, custom-made production for the respective application can be carried out using standardized housing components.

The at least two sealing elements subdivide the second chamber region into at least two chamber subregions which are spaced apart in the circumferential direction, ie around the package axis, and in particular have different angular extensions around the package axis.

For e.g. exactly two sealing elements, these can preferably be spaced apart by 180 degrees, that is to say they can be arranged opposite one another on the hollow fiber package. The chamber subareas are connected through the hollow fibers of the hollow fiber packet and form an inlet area and an outlet area for the in this case a second exchange medium which flows through the hollow fibers.

The chamber subareas that are formed between adjacent sealing elements can be connected, for example, by hollow fibers in different laying directions.

The invention can preferably provide that the hollow fiber package comprises several flat layers of hollow fibers which are stacked on top of one another in the direction of the package axis. The stacking can take place without a gap, but preferably also with a distance between the layers in the direction of the package axis, e.g. realized by a flat spacer element between adjacent layers.

A respective position can e.g. be formed by a mat of hollow fibers, preferably in which the hollow fibers are connected by warp threads. Within a layer the directions of the hollow fibers are preferably always the same, i.e. the hollow fibers are parallel. Furthermore, within a layer, the hollow fibers are all designed with the same cross section, preferably with identical material and / or energy permeability. A layer can also be formed by a folded area of a mat.

The layers in the hollow fiber package can all have the same orientation of the hollow fibers, for example.

However, the invention can also provide that the hollow fiber package has different layers of hollow fibers with at least two different laying directions of the hollow fibers, i.e. So that different layers have different laying directions of the hollow fibers, the direction of all hollow fibers in the same layer being the same. Layers with different laying directions can e.g. be stacked alternately in the hollow fiber package. It can be provided that with different laying directions the layers are laid so that with a number of N different laying directions the hollow fibers of the layers are oriented at an angle of 180 degrees / N to one another.

Two chamber subareas of the second chamber can be connected by the hollow fibers, in particular the hollow fibers of the layers, of at least one specific laying direction, in particular with these chamber subareas forming the inlet and outlet areas of a second exchange medium.

The hollow fiber package preferably has a number of 2 × N sealing elements, where N is an integer greater than or equal to 1. This then results in 2xN chamber subareas which are arranged in the circumferential direction around the package axis. The 2xN chamber subareas are preferably divided into N pairs of chamber subareas, the chamber subareas of a pair being connected by the hollow fibers, preferably by those of one of several laying directions. With N different laying directions of the layers of hollow fibers, up to N different pairing of chamber sections can be generated. For example, N different second exchange media can be used by the Hollow fiber packet are guided when hollow fibers of different laying directions also lead different exchange media.

In the housing of the device, each chamber sub-area which is formed between two sealing elements preferably has its own connection leading through the housing wall, through which a second exchange medium can be introduced into the chamber sub-area or removed from it.

The hollow fibers of different layers can also have different material and / or energy permeability. Layers with exclusively material-permeable hollow fibers and layers with exclusively energy-permeable hollow fibers can be arranged in a hollow fiber package, preferably with the energy-permeable hollow fibers having no material permeability for the exchange media under consideration. Material- and energy-permeable hollow fibers can also be mixed within a layer.

If more than one hollow fiber package of the type according to the invention is used in a device according to the invention, it can be provided that a first hollow fiber package has hollow fibers with a first material permeability and another hollow fiber package has hollow fibers with a different (second) material permeability or only with one energy permeability , in particular the hollow fiber packets with the same first exchange medium but different second exchange media can be used. If a hollow fiber package has only energy-permeable hollow fibers but no material-permeable hollow fibers, the information given in this application for a package with material-permeable hollow fibers also applies in the same way to a package with energy-permeable hollow fibers and vice versa. A hollow fiber package with energy-permeable hollow fibers, in particular exclusively only with energy-permeable hollow fibers, which is used together with a hollow fiber package with material-permeable hollow fibers in a device of the invention, can preferably be connected upstream of the hollow-fiber package with the material-permeable hollow fibers in the flow direction of the first exchange medium, in particular blood.

• • Die Bildung eines Paketes von stoff- und/oder energiepermeablen Hohlfasern durch Anordnen einer Vielzahl von stoff- und/oder energiepermeablen Hohlfasern, insbesondere eines Stapels mehrerer Lagen aus Matten von stoff- und/oder energiepermeablen Hohlfasern in dem Hohlraum eines Formnestes, wobei die Längsrichtung der Hohlfasern quer, bevorzugt senkrecht zu einer im Hohlraum des Formnestes liegenden Paketachse angeordnet ist, die parallel ist zu einer Rotationsachse, um die das Formnest rotierbar ist;
• • Rotieren des Formnestes um die Rotationsachse. Diese Rotationsachse kann z.B. durch den Hohlraum des Formnestes laufen, insbesondere mit der Paketachse identisch sein. In diesen Fall rotiert das Formnest um sich selbst. Es bildet sich ein von Vergussmasse freier Innenbereich, bevorzugt mit kreiszylindrischer Form, um die Rotationsachse / Paketachse aus. Die Rotationsachse kann auch außerhalb vom Hohlraum des Formnestes liegen. So wird durch die Zentrifugalkräfte die flüssige Vergussmasse radial nach außen in Richtung einer Formnestwandung gedrängt und das nachfolgend benannte Befüllen wird für mehrere Drehwinkel-Positionen des Formnestes um die Paketachse wiederholt. Bevorzugt bildet sich so eine mehreckige Form des von Vergussmasse freien Raumes um die Paketachse aus.
• • Befüllen des Hohlraumes während der Rotation mit einer flüssigen erhärtbaren Vergussmasse an wenigstens einer Position radial beabstandet zur Paketachse und Durchtränkung eines zur Paketachse radial beabstandeten Bereiches des Hohlfaserpaketes mit der flüssigen Vergussmasse, wobei ein die Paketachse unmittelbar umgebender Bereich des Hohlfaserpaketes von der Vergussmasse durch die Zentrifugalkräfte freigehalten wird;
• • Erzeugen von wenigstens zwei in Umfangsrichtung zueinander beabstandeten und jeweils axial erstreckten Dichtelementen am äußeren Umfang des Hohlfaserpaktes durch Befüllen korrespondierend ausgeformter Hohlraumbereiche des Formnestes, die das Hohlfaserpaket radial und/oder axial außen umgeben mit Vergussmasse, bevorzugt derselben Vergußmasse, oder durch Einlegen von separaten Dichtelementen in korrespondierend angeordnete Formnestbereiche, wobei die Dichtelemente durch die Vergussmasse an das Hohlfaserpaket stoffschlüssig angebunden werden;
• • Entnehmen des gebildeten Hohlfaserpaketes aus dem Formnest, insbesondere nach Erhärtung der Vergussmasse;
• • Einsetzen des gebildeten Hohlfaserpaketes in ein rohrförmiges Gehäuse, bevorzugt mit einem zylindrischen Innenquerschnitt, zwischen zwei Deckelelementen, wobei die Dichtelemente in radialer Richtung komprimiert an der Innenwandung des Gehäuses anliegen bzw. an diese angelegt werden.

The object is also achieved by a method in which the following steps are included for producing a device for the exchange of substances and / or energy between a first exchange medium, in particular blood, and at least one second exchange medium, in particular a gas:

• • The formation of a package of material and / or energy permeable hollow fibers by arranging a large number of material and / or energy permeable hollow fibers, in particular a stack of several layers of mats of material and / or energy permeable hollow fibers in the cavity of a mold cavity, with the longitudinal direction the hollow fibers are arranged transversely, preferably perpendicularly, to a package axis lying in the cavity of the mold cavity, which axis is parallel to an axis of rotation about which the mold cavity can be rotated;
• • Rotating the mold cavity around the axis of rotation. This axis of rotation can run through the cavity of the mold cavity, for example, and can in particular be identical to the axis of the package. In this case, the mold cavity rotates around itself. An inner region free of casting compound, preferably with a circular cylindrical shape, is formed around the axis of rotation / package axis. The axis of rotation can also lie outside of the cavity of the mold cavity. The centrifugal forces force the liquid casting compound radially outwards in the direction of a mold cavity wall and the filling mentioned below is repeated for several rotational angle positions of the mold cavity around the package axis. In this way, a polygonal shape of the space free of casting compound is preferably formed around the package axis.
• • Filling the cavity during the rotation with a liquid hardenable potting compound at at least one position radially spaced from the package axis and impregnating a region of the hollow fiber packet radially spaced from the packet axis with the liquid potting compound, whereby an area of the hollow fiber packet immediately surrounding the packet axis is removed from the potting compound by the centrifugal forces is kept free;
• Generation of at least two circumferentially spaced and axially extending sealing elements on the outer circumference of the hollow fiber package by filling correspondingly shaped cavity areas of the mold cavity that surround the hollow fiber package radially and / or axially on the outside with potting compound, preferably the same potting compound, or by inserting separate sealing elements in correspondingly arranged mold cavity areas, the sealing elements being firmly bonded to the hollow fiber package by the potting compound;
• • Removing the hollow fiber package formed from the mold cavity, in particular after the potting compound has hardened;
• Insertion of the hollow fiber package formed into a tubular housing, preferably with a cylindrical inner cross section, between two cover elements, the sealing elements being compressed in the radial direction against the inner wall of the housing or being applied thereto.

The invention can provide that the hollow fiber packet has an oversize, preferably radial oversize, with regard to the arrangement of its sealing elements relative to the internal cross-section of the housing, in particular the distance between opposing sealing elements is greater than the distance between the surface areas of the housing contacted by the sealing elements, and due to the insertion is radially compressed into the housing at least in the area of its sealing elements.

A manufacture of the hollow fiber package in which the sealing elements are arranged in excess relative to the housing can be carried out using the method described above, the hollow fiber package with radially compressed sealing elements being pushed axially into the housing. E.g. For this purpose, the hollow fiber package can be passed through a funnel which, as the feed progresses, causes the radial compression.

In a preferred embodiment, the invention can provide that the housing has a tubular housing wall, the axis of which is parallel to the package axis, in particular wherein the axis of the tubular housing wall and package axis are collinear, with the at least one hollow fiber package being arranged between two cover elements that are used for the first Exchange medium are permeable and limit the chamber in the axial direction. The tubular housing wall preferably delimits an interior space that is cylindrical. The tubular housing can also be cylindrical on the outside or have a conical section shape, e.g. in order to offer a draft angle during injection molding.

The cover elements can e.g. have a channel through which the first exchange medium can be guided, which opens into the inner area of the hollow fiber package free of potting compound.

The cylinder base area of the free inner cross section of the tubular housing wall does not have to be circular, but this is preferred. The base can e.g. also be angular. In the case of a cylindrical housing wall, the inner cross-section is preferably constant over the axial extent, in particular apart from supply and discharge connections for the chamber subregions in the wall.

The tubular housing can also have an inner cross-section that tapers in the axial direction, in particular it can be designed as a conical section, which preferably brings about its radial compression when a hollow fiber packet is axially inserted.

The invention can particularly preferably provide that the radial compression of the sealing elements is generated by an axial application of force, in particular by an axial compression of the hollow fiber package after it has been inserted into the housing. For this purpose, it can be provided that the hollow fiber package is or is compressed between the mentioned cover elements in the axial direction.

This is preferably made possible by the invention in that at least one of the cover elements is displaceable in the interior of the tubular housing wall. Another one of the cover elements can in principle be displaceably but fixed locally on the housing, e.g. by a stop element. Such a stop element can e.g. be formed by a cover which is placed axially from the outside onto the end face of the tubular housing wall.

Due to the axial displaceability of at least one of the cover elements, on the one hand the axial length of the chamber in the housing can be variably adapted to the length of the hollow fiber package and on the other hand the force can be transmitted to the hollow fiber package by applying force to the movable cover element. As a result, the hollow fiber packet is axially compressed, which aims to increase the cross-section, which is prevented by the rigid housing wall. Therefore, the hollow fiber packet or at least its sealing elements is compressed radially as a result.

A further development of the invention can provide that in the housing, in particular in the space surrounded by its tubular housing wall, at least two chambers are arranged axially one behind the other. Each two axially spaced chambers are separated by an axially displaceable cover element, in particular which is permeable to the first exchange medium. A hollow fiber package is arranged in each of the chambers. In one possible embodiment, at least one of the hollow fiber packages in the device can have material-permeable hollow fibers. At least one other package can e.g. only have energy-permeable hollow fibers or hollow fibers of a different material permeability. In such a design, the entirety of all hollow fiber packages is enclosed between cover elements, at least one of which is axially displaceable.

In a preferred construction - regardless of the number of chambers - the housing has a compression element with which an axial compression pressure can be exerted on the at least one displaceable cover element. This compression element can be supported on one side on the housing and on the other side on the cover element. For example, the compression element can be designed as a compression spring or a screw, in particular a hollow screw. Both types of compression element have the advantage of being hollow on the inside so that the first medium can be passed through the compression element, for example through a hose or a pipeline through the compression element to the channel in the cover element.

A preferred embodiment provides that on at least one of the axial end faces of the hollow fiber package, preferably on both, at least one sealing lip completely surrounding the package axis over 360 degrees, preferably several radially spaced sealing lips, each completely surrounding the package axis over 360 degrees, which rests against a cover element. Several sealing lips can be connected in the radial direction by sealing webs.

A further development can provide that a respective axially extending sealing element of the hollow fiber packet protrudes in the axial direction over at least one of the axial end faces of the hollow fiber packet, preferably over both. Furthermore, at least one of the cover elements, preferably both, which axially enclose a hollow fiber packet, at a circumferential position corresponding to a sealing element of the hollow fiber packet, in its axial end face facing the hollow fiber packet, has a recess which extends in the axial direction to a sealing ring which is in a Groove is arranged in the peripheral surface of the cover element and the sealing element of the hollow fiber packet contacts the sealing ring of the cover element.

In this way, it is particularly advantageous to prevent a second exchange medium from leaking through the groove in the circumferential direction of the cover element between two chamber subregions.

In the manufacture of the hollow fiber package, the invention furthermore preferably provides that the hollow fiber package removed from the mold cavity is trimmed on its outer circumference in areas between adjacent sealing elements before being inserted into the housing, in particular by making cuts in the axial direction. E.g. be achieved that the hollow fiber ends occupied by potting compound are cut free, but also that the cross section of the hollow fiber package is designed so that it is free of contact with the housing wall on the outer circumference except for the areas in which the sealing elements are arranged. This ensures good axial compressibility, which then leads to transverse expansion in the radial direction and compression of the sealing elements.

To form the hollow fiber package, several hollow fiber mats can be positioned in a stable position in several layers one above the other in the cavity of the mold cavity, e.g. in that they are pressed axially between mold cavity walls and / or in that they are placed on guide rods which penetrate the cavity of the mold cavity and whose position corresponds to holes punched in the mats. It can be provided that holes are located in areas of the hollow fiber package which are later removed by trimming cuts.

Preferably, the invention provides that in the production with the mentioned method with molded structures in the axial wall areas of the mold cavity on at least one of the axial end faces of the hollow fiber package, preferably on both, at least one sealing lip completely surrounding the package axis over 360 degrees, preferably several radially spaced apart , sealing lips that completely surround the package axis over 360 degrees and / or an area of a sealing element that extends in the axial direction over at least one of the axial end faces of the hollow fiber package is formed from the potting compound. The sealing elements and sealing lips described for the construction of the wood fiber package can thus be created directly when the package is potted. They are preferably formed by a respective corresponding negative structure in the mold cavity walls.

The invention can also provide that, in the production process, a flat spacer element is inserted between two adjacent layers of hollow fiber mats, which has at least one recess in the area of the hollow fiber package that remains free of potting compound. The hollow fibers of the hollow fiber package thus remain free of contact with one another in the area free of potting compound. Endothelialization or another coating of the hollow fibers can thus be built up on the fibers without any gaps. Furthermore, it can be ruled out that the endothelialization or other coating is destroyed by a fiber movement.

• Die 1 zeigt eine Ausführung einer Vorrichtung der Erfindung mit einem Gehäuse, das eine rohrförmige Gehäusewandung 1, bevorzugt mit kreiszylindrischem Innenquerschnitt aufweist. Das Gehäuse insgesamt ist durch die Gehäusewandung 1 und die stirnseitigen Deckel 8, 10 ausgebildet. In dieser Gehäusewandung 1 sind zwei Deckelemente 2a und 2b des Gehäuses angeordnet, zwischen denen ein Hohlfaserpaket 3 gemäß der Erfindung liegt. Das Hohlfaserpaket 3 liegt somit in einer zwischen den Deckelelementen 2a, 2b und dem rohrförmigen Gehäuse 1 gebildeten Kammer. Ein innerer Bereich 3a des Hohlfaserpaketes 3, insbesondere der direkt um die Paketachse 4 angeordnet ist, ist frei von Vergussmasse. Der radial um den Innenbereich 3a liegende Bereich 3b des Hohlfaserpaketes ist mit erhärteter Vergussmasse getränkt/durchsetzt. Der Volumenbereich, der im von Vergussmasse freien Innenbereich 3a außen um die Hohlfasern angeordnet ist, ist Teil eines ersten Kammerbereichs 1a im Gehäuse 1, der in axialer Richtung von den Deckelelementen 2a, 2b begrenzt ist und durch die Hohlfaserwandungen von einem zweiten Kammerbereich getrennt ist. Dieser zweite Kammerbereich ist durch das Volumen radial außen um das Hohlfaserpaket herum und das Inneren der Hohlfasern gegeben.

Embodiments of the invention are explained using the figures:

• The 1 shows an embodiment of a device of the invention with a housing which has a tubular housing wall 1 , preferably with a circular cylindrical inner cross-section. The housing as a whole is through the housing wall 1 and the front cover 8th , 10 educated. In this case wall 1 are two deck elements 2a and 2 B of the housing arranged between which a hollow fiber package 3 according to the invention. The hollow fiber package 3 is therefore in one between the Cover elements 2a , 2 B and the tubular housing 1 formed chamber. An inner area 3a of the hollow fiber package 3 , especially the one directly around the package axis 4th is arranged is free of potting compound. The radial around the inside 3a lying area 3b of the hollow fiber package is soaked / interspersed with hardened casting compound. The volume area in the inner area free of potting compound 3a is arranged outside around the hollow fibers, is part of a first chamber region 1a in the housing 1 , which in the axial direction of the cover elements 2a , 2 B is limited and is separated by the hollow fiber walls from a second chamber area. This second chamber area is given by the volume radially on the outside around the hollow fiber package and the interior of the hollow fibers.

The hardened potting compound itself is on the outer circumference of the hollow fiber package 3 at two opposite positions here in section 5 In one piece, which is formed with a radial force on the inner wall of the housing wall 1 are pressed and seal only thereby, so without material connection to the wall.

The sealing elements 5 are in the axial direction on both sides over the axial end faces of the hollow fiber package 3 protruding and lie in recesses 6a in cover elements 2a , 2 B inside the housing wall 1 are movable. Through the recesses 6a get the sealing elements 5 with their axial ends in contact with a respective sealing ring 2d in a groove in the peripheral surface of the respective cover element 2a , 2 B .

Through the inlets and outlets 6b , a first medium can pass through a channel in the respective cover element 2a , 2 B through the free interior 3a of the hollow fiber package. This forms a first chamber area 1a the device in which the exchange medium, for example blood, is guided around the hollow fibers.

Through the banjo bolt 7th that are threaded in a stationary cover 8th of the housing is supported and stored, a compression force can act on the sliding cover 2a be exercised by the hollow fiber package 3 is axially compressed. This results in a transverse expansion, i.e. in the radial direction. Because the sealing elements 5 inside on the immovable housing wall 1 are applied, they are thereby radially compressed. This causes a radial pressure force with which the sealing elements 5 without material bond and thus releasable again on the housing wall 1 be pressed.

The device can thus be seen after use by loosening the hollow screw 7th be taken apart again. The hollow fiber package 3 can be removed non-destructively. It can also be clearly seen that between the cover elements 2a , 2 B Hollow fiber packages with different axial lengths can be used. The device can thus be adapted well to the different exchange surfaces required by choosing different hollow fiber packages, which can all be used in the same housing. A housing can also be reused, for example after sterilization in an autoclave.

2 shows an alternative embodiment that differs from 1 differs in that the compression element is a compression spring element, for example at least one plate spring or a helical spring 9 is used between the stationary cover element 8th and the sliding cover element 2a is supported. By the pen 9 the compression force is applied.

3 shows a further development of the 1 , but also with the execution of 2 Can be combined in the axial direction in the preferably cylindrical interior of the tubular housing wall 1 two hollow fiber packages 3 lying one behind the other. Each of the hollow fiber packages 3 is of cover elements, namely 2a , 2c or. 2c , 2 B surrounded, which are permeable to the first exchange medium.
All lid elements 2a , 2 B , 2c are basically movable in the housing wall, but the one below 2 B fixed by the lower stationary cover 10 which forms an axial stop. The compression force of the banjo bolt 7th is through the two upper cover elements 2a , 2c on both hollow fiber packages 3 exerted, compresses both axially and thereby expands them radially, which their sealing elements 5 radially to the housing wall 1 pressed and seals there.

The two hollow fiber packages 3 can for example have different properties in terms of material permeability and / or energy permeability or one package is material permeable and the other is only energy permeable but not material permeable.

The 4th , 5 and 6th show in cross section perpendicular to the axial direction of the cylindrical housing wall 1 or the package axis 4th possible designs of the device. In the 4th and 6th are the tubular housing walls 1 in the free, preferably cylindrical inner cross-section with a circular base, in the 5 executed with a square base.

The hollow fiber packages 3 can see an interior area free of casting compound 3a have, which can also be circular or angular in cross section. In any case, the hollow fiber package is radially outside around the free inner area 3a arranged area 3b interspersed with hardened potting compound, which bonds the hollow fibers.

The axially extending sealing elements become through the hardened casting compound itself 5 formed, which according to the embodiments shown can be arranged in different numbers on the outer circumference of the hollow fiber packet and radially inward against the housing wall 1 are pressed.

Depending on the design, the second chamber area is divided into at least two chamber subareas 11a and 11b divided, or into several chamber sections 11a to 11h . Each chamber sub-area can have an inlet or outlet through the housing wall 1 have, for guiding a second exchange medium that through the inner volumes of the hollow fibers of the hollow fiber package 3 to be led.

In all versions, including those not shown here, the hollow fibers of the hollow fiber package open into the peripheral wall of the hollow fiber package between two sealing elements 5 .

All 4th to 6th show that the hollow fiber package can be trimmed outside by cuts in the axial direction so that the package except in the area of the sealing elements 5 to the housing wall 1 is plant-free. The cut surfaces produced can, for example, form planar surfaces or surfaces that are concave or convex to the inner wall of the housing.

Both 4th to 6th it can also be seen that on the axial end face of the hollow fiber package 3 , which is shown here in plan view, sealing lips 12th are arranged, which cover the area interspersed with casting compound and which extend in the circumferential direction over a full 360 degrees and which are arranged radially inside one another. About these sealing lips 12th are the cover elements 2a , 2 B axially sealed on the hollow fiber package. The sealing lips 12th are like the sealing elements 5 formed by the hardened potting compound and molded by corresponding negative structures in a mold cavity.

The 7th and 8th show a cavity for producing a hollow fiber package 3 .

The mold cavity 20a forms the negative form of the hollow fiber package to be formed 3 , in which layered mats of hollow fibers connected with warp threads are inserted. Between a lid 21st and an axially movable floor 22nd the stack is clamped and removed from the peripheral wall 23 surround. Due to the axial mobility of the floor 22nd Different hollow fiber package thicknesses can be processed. The floor 22nd is through a variable-length ring 22b positioned.

The hollow fiber mats are here on pins 24 threaded and held in position. For this, the pin positions correspond to the hole positions in the mats that were punched beforehand.

The 8th , which shows the same mold cavity in a different cutting direction, makes it clear that through a casting compound distributor 25th a liquid or at least pasty casting compound via channels 26th is guided into the radially outer area of the stacked hollow fiber mats. This takes place when the mold cavity rotates around the axis of rotation 27 that is preferred to the package axis 4th corresponds. Due to the centrifugal forces, the casting compound that has not yet hardened is driven radially outwards and fills the mold cavity from the outside inwards, leaving the inner area free 3a of the hollow fibers. In the the negative form of the sealing elements 5 forming cavity areas 28 are therefore directly the sealing elements 5 formed from the potting compound. Likewise show the lid 21st and the floor 22nd Negative forms 29 the sealing lips 12th on, which are thus formed in the same way by the casting compound on the hollow fiber packet on their axial end faces by molding from the negative mold.

The 9 and 10 clearly shows the formation of a stack of material and / or energy-permeable hollow fiber mats 3c that are in the 9 all the same direction of the hollow fibers 3h have and in the 10 have intersecting directions in adjacent layers. Both figures make it clear that the hollow fiber mats 3c through flat spacer elements 3d between every two mats 3c are kept at a distance so that the hollow fibers 3h adjacent layers cannot touch. The area that remains free when potting compound 3a lies here in the spacers 3d in the area of the recess 3e . The edge of the recess 3e is completely in the potted area after potting. This is the diameter of the recess 3e chosen to be larger than the diameter of the area left free 3a . The recesses 3f that radially around the area 3e are arranged, are later in the potted area 3b and serve to better distribute the potting compound during potting. The holes 3g can serve here the pens 24 record.

After the potting and curing of the elastomer potting compound, the hollow fiber package with the cast-on sealing lips is made 12th and the sealing elements 5 taken from the mold cavity, if necessary trimmed and stored for later use or in the housing wall 1 inserted and in it between the cover element 6th compressed to form a device according to the invention.

Claims (21)

Device for the exchange of substances and / or energy between a first exchange medium, in particular blood, and at least one second exchange medium, in particular a gas, comprising a housing (1) which surrounds at least one chamber in which a packet (3) of material and / or energy-permeable hollow fibers (3h) is arranged and which is divided by the hollow fibers (3h) into two chamber areas (1a, 11a / b), the hollow fibers (3h) in a first chamber area (1a) of the at least one chamber of the first exchange medium can flow around and the hollow fibers (3h) in a second chamber region (11a / b) of the at least one chamber can flow through the at least one second exchange medium, characterized in that a. the hollow fiber package (3) has a package axis (4) to which all hollow fibers (3h) of the hollow fiber package (3) are oriented transversely, preferably perpendicularly, the hollow fiber package (3) being radially spaced from the package axis (4) over a full 360 degrees around the A potting compound is penetrated around the package axis (4), by means of which the hollow fibers (3h) of the hollow fiber package (3) are glued to one another, and the hollow fiber package (3) on its outer circumference has at least two sealing elements (5 ), in particular which are formed by the potting compound, and b. the sealing elements (5) in a state compressed in the radial direction bear tightly against the inner wall, in particular the radially outer inner wall of the housing (1) and c. the second chamber area (11a / b) of the at least one chamber is divided into at least two chamber subareas (11a, 11b) in the circumferential direction by the sealing elements (5). Device according to Claim 1 , characterized in that the hollow fiber package (3) comprises several flat layers of hollow fibers (3h) which are stacked one on top of the other in the direction of the package axis (4), in particular at a distance from one another in the direction of the package axis (4). Device according to Claim 2 , characterized in that the hollow fiber package (3) has different layers (3c) of hollow fibers (3h) with at least two different laying directions of the hollow fibers (3h). Device according to one of the preceding claims, characterized in that two chamber subareas (11a, 11b) of the second chamber area (11a / b) of the at least one chamber are connected by the hollow fibers (3h) of at least one specific laying direction, in particular these chamber subareas (11a, 11 b) form the inlet and outlet areas of a second exchange medium. Device according to one of the preceding claims, characterized in that the hollow fiber package (3) is oversized with regard to the arrangement of its sealing elements (5) relative to the inner cross section of the housing (1), in particular the distance between opposing sealing elements (5) is greater than the distance the surface areas of the housing (1) contacted by the sealing elements (5) and is radially compressed by being inserted into the housing (1) at least in the area of its sealing elements (5). Device according to one of the preceding claims, characterized in that the housing (1) has a tubular housing wall (1), the tube axis of which lies parallel to the package axis (4) of the at least one hollow fiber package (3), in particular the tube axis and package axis (4) being collinear The at least one hollow fiber package (3), in particular each hollow fiber package (3), is arranged between two cover elements (2a, 2c; 2c, 2b) which are permeable to the first exchange medium, in particular which the at least one chamber in the axial direction limit. Device according to Claim 6 , characterized in that the at least one hollow fiber package (3) between the cover elements (2a, 2b) is compressed in the axial direction. Device according to Claim 6 or 7th , characterized in that at least one of the cover elements (2a, 2b) is displaceable in the interior of the tubular housing wall (1). Device according to one of the previous ones Claims 6 to 8th , characterized in that in the housing (1), in particular in the space surrounded by its tubular housing wall (1), at least two axially one behind the other chambers are arranged, which are separated by an axially displaceable cover element (2c), one in each of the chambers Hollow fiber package (3) is arranged, in particular at least one of which has material-permeable hollow fibers (3h). Device according to Claim 8 or 9 , characterized in that the housing (1) comprises a compression element (7,9) with which a compression pressure can be exerted on the displaceable cover element (2a), in particular wherein the compression element (7,9) is a compression spring (8) or a screw (7), in particular a hollow screw (7) through which the first medium can be passed. Device according to one of the preceding claims, characterized in that on at least one of the axial end faces of the at least one hollow fiber package (3), preferably on both, at least one sealing lip (12) completely surrounding the package axis (4) over 360 degrees, preferably several radially spaced sealing lips (12) each completely surrounding the package axis over 360 degrees ) are arranged, which rests on a cover element (2a, 2b, 2c). Device according to one of the preceding claims, characterized in that a respective axially extending sealing element (5) of the at least one hollow fiber package (5) protrudes in the axial direction over at least one of the axial end faces of the hollow fiber package (3), preferably over both. Device according to Claim 12 , characterized in that at least one of the cover elements (2a, 2b, 2c), which axially enclose a hollow fiber packet (3), at a circumferential position corresponding to a sealing element (5) of the hollow fiber packet (3) in its axial position relative to the hollow fiber packet (3) facing end face has a recess (6a) which extends in the axial direction to a sealing ring (7) which is arranged in a groove in the circumferential surface of the cover element (2a, 2b, 2c) and the sealing element (5) of the hollow fiber package (3 ) the sealing ring (7) of the cover element (2a, 2b, 2c) contacted. A method for producing a device for the exchange of substances and / or energy between a first exchange medium, in particular blood, and at least one second exchange medium, in particular a gas, comprising the following steps: a. Formation of a package of material- and / or energy-permeable hollow fibers (3h) by arranging a large number of material- and / or energy-permeable hollow fibers (3h), in particular a stack of several layers of material- and / or energy-permeable hollow fibers (3h) in the cavity ( 20a) of a mold cavity (20), the longitudinal direction of the hollow fibers (3h) being arranged transversely, preferably perpendicularly, to a package axis (4) lying in the cavity (20a) of the mold cavity (20), which is parallel to an axis of rotation (27), around which the mold cavity (20) can be rotated, b. Rotating the mold cavity (20) about the axis of rotation (27), in particular which is identical to the package axis (4), c. Filling the cavity (20a) during the rotation with a potting compound at at least one position radially spaced from the packet axis (4) and impregnating a region of the hollow fiber packet (3) radially spaced apart from the packet axis (4) with the potting compound, whereby a the immediately surrounding area of the hollow fiber package (3) is kept free of the casting compound by centrifugal forces, d. Generation of at least two axially spaced sealing elements (5) on the outer circumference of the hollow fiber package (3) by filling correspondingly shaped cavity areas (28) of the mold cavity (20) which the hollow fiber package (3) radially and / or axially on the outside surrounded with potting compound, preferably the same potting compound, or by inserting separate sealing elements (5) into correspondingly arranged cavity areas (28), the sealing elements (5) being firmly bonded to the hollow fiber package (3) by the potting compound e. Removing the hollow fiber package (3) formed from the mold cavity (20), in particular after the potting compound has hardened f. Insertion of the hollow fiber package (3) formed into a tubular housing (1), in particular with a cylindrical inner cross-section, between two cover elements (2a, 2b), the sealing elements (5) being compressed in the radial direction against the inner wall of the housing (1) . Procedure according to Claim 14 , characterized in that the radial compression of the sealing elements (5) is generated by manufacturing the hollow fiber package (3) in which the sealing elements (5) are arranged in excess relative to the housing (1) and the hollow fiber package (1) is radially compressed Sealing elements (5) is pushed axially into the housing (1). Procedure according to Claim 14 , characterized in that the radial compression of the sealing elements (5) is generated by an axial application of force, in particular axial compression of the hollow fiber package (3) after its insertion into the housing (1). Procedure according to one of the previous ones Claims 14 to 16 , characterized in that the hollow fiber package (3) removed from the mold cavity (20) is trimmed on its outer circumference in areas between adjacent sealing elements (5) before being inserted into the housing (1), in particular by making cuts in the axial direction. Procedure according to one of the previous ones Claims 14 to 17th , characterized in that to form the hollow fiber package (3) several hollow fiber mats (3c) in several layers one above the other in the cavity (20a) of the mold cavity (20) are positioned in a stable position, in particular placed on guide rods (24) whose position is included in the mats (3c) corresponds to existing, in particular punched holes (3g), in particular which are in regions of the hollow fiber package (3) that are removed by trimming cuts. Procedure according to one of the previous ones Claims 14 to 18th , characterized in that with mold structures (28, 29) in the axial wall areas of the mold cavity (20a) from the Potting compound on at least one of the axial end faces of the hollow fiber package (3), preferably on both, at least one sealing lip (12) completely surrounding the package axis over 360 degrees, preferably several radially spaced sealing lips (12) each completely surrounding the package axis over 360 degrees and / or a sealing element (5) extending in the axial direction is formed, in particular which protrudes beyond at least one of the axial end faces of the hollow fiber packet (3). Procedure according to one of the previous ones Claims 14 to 19th , characterized in that a flat spacer element (3d) is inserted between two adjacent layers of hollow fiber mats (3c) which has at least one recess (3e) in the area of the hollow fiber package (3) which remains free of potting compound. Procedure according to Claim 20 , characterized in that the adjacent layers of hollow fiber mats (3c) have hollow fibers (3h) with a coating, in particular with an endothelialization, in particular on the outer surfaces of the hollow fibers (3h) in contact with blood.

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