EP1772191A1 - Seperation device, receptacle and separation process - Google Patents

Abstract

A filter element (11, 42) for use in a two chamber separation device contains channels (46) between its faces (44, 45) which open only during application of pressure and after the separation operation resist flow of parent fluid into the filtrate liquid. The filter element may be made from plastics, cellulosic or ceramic material. The open channels typically have a diameter of 10-50 micron. Independent claims are included for: a separation device, which comprises a tubular container (5) preferably of plastics or glass construction, divided by a separation element (11, 42) into an upper chamber (47) for first receiving a sample, and a lower filtrate chamber (48).The separation element contains channels (46) between its faces (44, 45) which open only during application of pressure and after the separation operation resist flow of parent fluid into the lower chamber, and also the use of the separation device in a centrifuge, or the use of the device with a pressure differential across the element created by evacuating the atmosphere inside the container (10; 47, 48) prior to sealing with the cap (20,33,34).

Description

The invention relates to a separating device for insertion into an interior of a receptacle, a receiving device equipped therewith and a method for separating constituents of a substance, such as body fluid, tissue parts or tissue cultures, as described in claims 1, 28 and 52.

There are already known different methods and apparatus for treatment. In the process, substances, for example blood, are subdivided into a light and a heavy phase. The light phase in the blood is formed, for example, by the blood serum or blood plasma, while the heavy parts of the blood are formed by cellular components, such as blood cells.

The piston moving inside the blood sample tube under the influence of a centrifugal force, especially when centrifuging the sample, is usually designed to deform under centrifugal force and to allow light components to pass upwards towards the open end of the tube, which is usually at this time is closed with a closure device allows, whereas the movable piston on the heavy phase of the blood, so the blood cells, comes to rest and can not pass through them down towards the closed end of the tube. Thus, an accurate separation of the blood cells from the blood plasma and blood serum is achieved.

The blood serum is extremely important for the medicine, since these analyzes of the blood serum or blood plasma various essential ingredients, such as glucose, cholesterol, calcium, inorganic phosphorus, proteins, uric acid and others can be determined. These analytical data are directly related to the health of the person tested by taking the blood sample.

Such, equipped with a movable piston blood sampling tubes or methods using a movable piston are, for example, from US 3,508,653 A , of the US 4,294,707 A and the US 6,280,400 B1 known. It describes the US 6,280,400 B1 an elongated separating body, with an elastic upper part and an elongated lower part with an opening passing through this. The elastic top is with a press fit held on the inner wall of the receptacle, wherein during the centrifuging a passage of one of the media to be separated takes place either between the upper part and the inner wall or through a passage arranged in the upper slot. A perfect separation could not be prevented in all applications.

Another separating device for insertion into a receiving space of a receptacle of a receiving device is the US 5,266,199 A has become known, which has an elastic support body, a surrounding elastic ring having a separation in its peripheral region, as well as an insertable into a flow channel within the elastic support body for sealing ball. The elastic ring surrounding the elastic supporting body serves as a sealing device between the inner wall of the receiving container and the elastic supporting body in the separating position of the separating device. The flow channel arranged in the elastic support body, which extends between the end regions which are distanced from each other in the direction of a longitudinal axis, is closed in the separating position by the ball floating on the more dense components.

From the EP 0 753 741 A1 is a receiving device with a receptacle known which has two spaced apart in a longitudinal axis ends, of which at least one is formed with an opening. The inner dimension of the receptacle in the region of the first open end in the plane aligned perpendicular to the longitudinal axis is greater than the inner dimension in the region of the further end in the plane aligned parallel thereto in the same spatial direction. Furthermore, an annular component is used in the open end, which covers the open end side of the receptacle with a collar and a cylindrical wall portion projects into the interior of the receptacle at least partially. The annular component has, following the cylindrical wall part, a shoulder and, connected thereto, a cross-sectional widening on which the elastic sealing element of the separating device is supported in the starting position. In the center, the separator has a recess which is closed with a thin cover plate in the region of the upper end of the receptacle. The joining of the individual components, in particular the onset of the separating device, takes place in a vacuum chamber, since after insertion of the separating device without damaging it, access to the interior is no longer possible. In addition, a film is still glued on the collar-shaped projection of the annular member and a cap appropriate. The filling of the interior is carried out by means of a puncture of the thin cover plate of the separator, the thin film and possibly the cap. Through this filling process, the vacuum is reduced in the interior, which also air is sucked into the interior. Subsequently, there is the centrifuging process, in which the separating device emerges from the annular member in the direction of the closed end and further comes with its sealing element on the inner surface of the receptacle to the plant. The rate of descent in the mixture or the already separated components is determined by the contact pressure of the elastic sealing element on the inner surface. By choosing the density of the entire separation device with respect to the components of the mixture to be separated, they float at the interface between the two different density media. A passage of the lighter medium during the centrifuging process is possible between the inner surface of the receptacle and the elastic sealing element.

Another receiving device with a separator is from the EP 1 005 910 A2 has become known, which has a cylindrical-shaped receptacle with a nearly constant inner diameter. At the open end of the receptacle, a pierceable closure device is arranged, on which, even in the starting position, the separation device is arranged almost fitting. This separator is formed of a flexible recoverable material, wherein on the outer periphery of the separator, a sealing device is provided for sealing with the inner surface of the receptacle. In addition, a deformable element is still used in the interior, which is pressed during the application of the centrifugal force by the pressure exerted by the medium to the inner wall of the outer container and between the separator and the inserted deformed insert a flow channel is formed, which after removal of the Centrifugal force again assumes a sealing position with the arranged on the separator sealing elements, whereby the separated media remain separated from each other.

Another separating device or a receiving device with a separating device and a corresponding method is known from DE 195 13 453 A1 known, which has a eprouvettenartigen receptacle closed in an open Stirnendbereich with a closure device and in which a separating device for separating the different media of the mixture is used after separation. In order to prevent the subsequently coming into contact with a medium face of the separator is contaminated when filling the mixture into the interior of the container, the separator is provided in the central region with a through hole through which the mixture in the remaining interior of the receptacle can be introduced. During the subsequent separation process by centrifugation in a conventional manner with a radial centrifugal force (rcf) of 1,000 g to 5,000 g - g being gravity and 1 g a value of 9,81 m / s ² - this becomes a medium separated from the mixture transferred by the breakthrough in the separating device in the area located between the sealing device and the separating device and decreases in consequence in the direction of the closed end of the receptacle from. In order to prevent that after separation by the breakthrough, the other medium located between the closed end and the separating device can mix again with the medium separated therefrom, in one of the usual remaining amount of the other medium corresponding height is in the direction of the closed End cone-shaped widening end stop provided with the separator on the end stop, which penetrates through the aperture, runs up. As soon as the outer diameter of the end stop corresponds to the inner diameter of the opening, the separating device remains in this position and thereby the opening is closed with the stop and there can be no exchange or re-mixing of the two media. A disadvantage of this embodiment is that a special tube with an internal stop must be made and no safe function of the medium separation, due to the arranged in the separator breakthrough can be ensured. Furthermore, a permanent sealing seal between the two separate phases is not always possible.

Other recording devices for centrifuging mixtures to be separated from at least two different media, in which the receptacle is closed in both Stimendbereichen with a closure device are known from WO 96/05770 A1 known. Inside a separating device formed by a sealing disc is arranged, which is formed by a gel. During the centrifuging process, this gel piston migrates because of its specific gravity, which is higher than the specific gravity of the medium with the lower specific gravity and lower than the specific gravity the medium with higher specific gravity, due to the centrifugal forces acting on it between the two different, separate media. In this position positioned so that a separation of the one medium from the other medium of the mixture take place. The disadvantage here is that the storage time, due to the separation device made of gel, in many cases is not sufficient for the normal duration of use.

Other recording devices with separators for separating mixtures during centrifuging are known from US 5,478,074 US 3,931,018 A . US 3,779,383 A . US 3,849,072 A . US 3,862,042 A . US 3,882,021 A . US Pat. No. 3,887,464 . US 3,887,465 A . US 3,890,237 A . US 3,891,553A . US 3,894,950 A . US 3,894,951 A . US Pat. No. 3,897,337 . US 3,897,340 A . US 3,897 . 343 a . US 3,931,010 A . US 3,931,018 . US 5,632,895 A1 . US 5,860,937 A . US Pat. No. 6,406,671 B1 . US 6,516,953 B1 . EP 0 753 741 A1 . EP 1 006 360 A2 . EP 1 106 250 A2 . EP 1 106 251 A2 . EP 1 106 252 A2 . EP 1 106 253 A2 . DE 2 243 569 A known.

The invention has for its object to provide a separation devices, equipped with such a separation device receiving device and a method for separating, which allows a simple operation, a secure operation and a high degree of purity in the course of separation.

This object of the invention is solved by the features of claim 1. The resulting by the features of the characterizing part of claim 1 surprising advantage is that the arranged in the separating element channels are formed so that all components to be separated of the substance only when applying a compressive force or a pressure difference on the liquid column to be separated only when exposed of these forces can pass. The pressure forces can be built up by centrifugal or centrifugal forces or by pressure differences on both sides of the front ends. Upon removal of these compressive forces, the channels prevent any passage of the components to be separated, whereby after separation, as in the recovery of serum or plasma, a permanent separation of the physically separated components is maintained. As a result, a subsequent mixing is prevented and it is achieved a high degree of purity. This passage allows a simple design of the separating element in terms of construction and is also inexpensive to manufacture.

Also advantageous is a further embodiment according to claim 2, because thereby a secure passage of the heavy components, as is the case with blood, is made possible. At the same time, however, even a worn, lighter medium can in turn flow back through the separating device into the subspace provided for this purpose.

A further advantage is an embodiment according to claim 3, since such a premature passage of the components to be separated before the application of the necessary minimum pressure force is prevented secured.

By the formation according to claim 4, it is possible to achieve an even safer separation between the two components separated from each other.

According to another embodiment variant according to claim 5 or 6, a kind of valve effect is achieved in the region of the channels, wherein the opening and closing in dependence on the force acting on the separating element or the channels pressure force and thus also a high level of security for the user can be achieved.

Also advantageous is a development according to claim 7, since so easy to take into account for different applications and thus the size of the passing through components is easily defined.

In the embodiment according to claim 8, it is advantageous that, with the separation device already inserted, an evacuation of the entire inner space can take place before closing with the closure device.

Through the development according to claim 9 ensures that a secure seal in the region of the outer circumference can be achieved.

Due to the construction according to claim 10 or 11 can be carried out at constant dimensions of the separating element simply adapt to different inner dimensions of the receptacle.

Also advantageous is an embodiment according to claim 12, since thereby also in the field of Supporting body between this and the inner surface of the receptacle, a sufficient sealing effect can be achieved.

According to one embodiment, as described in claims 13 to 15, a unitary one-piece assembly can be created from a plurality of components, which is easy to handle and designed to be tunable in their functionality.

In this case, an embodiment according to claim 16 proves advantageous, because thereby an even higher security in the region of the connection point in terms of tightness and strength is achieved.

According to an advantageous embodiment according to claim 17 or 18, an additional support between the two components to be joined is created, thus creating a reliable support.

However, an embodiment according to claim 19 is also advantageous since this prevents unintentional retention of heavier components in the region of the separation space provided for the plasma or the serum.

According to claims 20 to 22, the separating element can be easily adapted to a wide variety of operating conditions, depending on the intended use. In addition, possible interactions between the materials of the separating element and the constituents of the substance to be separated can also be eliminated or taken into consideration.

In the embodiment according to claim 23, it is easy to take into account the interaction between the male separating element or the receiving container and, moreover, to adapt it to a wide variety of application conditions.

Also possible are embodiments according to claims 24 to 27, because this prevents the adhesion of constituents of the substance to be separated or the passage of the constituents of the substance through the channels during the application of the compressive force is facilitated or promoted. As a result, even higher degrees of purity are achieved for the components to be separated, in particular the serum or plasma.

However, the object of the invention is independently achieved by the features of claim 28. The advantages resulting from the combination of features of the characterizing part of this claim lie in the fact that the separating device is fixedly held relative to the receptacle even before the filling of the interior with the components to be separated in a predeterminable position. This fixed support additional sealing problems over previously known separation devices are avoided in which always the separation device in the course of Separiervorganges due to the force acting on the separator centrifugal force was relatively displaced relative to the receptacle in the direction of its longitudinal axis. In this case, a high level of operational reliability is achieved, since the predeterminable position can be determined exactly and thus a perfect separation result between the components of the substance to be separated can be achieved with certainty. Furthermore, precisely predeterminable subspaces are created in the interior of the receptacle by the fixed support, which each serve to receive the components to be separated. In addition, the construction of the entire separation device is much easier, since during the separation process no relative movement between the separator and the receptacle is more. Thus, a compact and reliable unit is created, which is simple and inexpensive to manufacture and also provides a high level of operational reliability during use or proper use.

Also advantageous is a further embodiment according to claim 29, characterized in that the receiving volume is provided, which is absolutely necessary to achieve a proper separation, without any mixing or residues in the lighter of the components to be separated, such as a serum or plasma.

A further advantage is an embodiment according to claim 30, characterized in that the separating device with respect to the receptacle in both directions of movement is held stationary and so a subsequent release or displacing is prevented secured.

Due to the embodiments according to claims 31 to 33, it is possible to take account of a wide variety of material combinations and conditions of use and still achieve a secure mounting of the separation device relative to the receptacle.

According to other embodiments according to claims 34 to 43, a simple to manufacture and to be assembled unit is created, which can be inserted into the interior of the receptacle. This makes it possible to use standard trained receptacle in which the partial length of the inner housing has to be adjusted depending on the filling volume to be accommodated, and so rapid consideration can be given to the most diverse conditions of use. Furthermore, by arranging or forming at least one flow channel between the inner surface of the receptacle and the outer surface of the inner housing facilitates the insertion of the inner housing in the receptacle and additionally prevents trapped air volume between these two components. At the same time, however, in the course of the evacuation process of the interior, the still existing residual air can be mitabgesaugt in these areas.

Also advantageous are developments according to claims 44 to 46, as this always between the components to be joined together a perfect weld joint both in terms of tightness and in terms of connection quality and thus the strength can be taken into account.

In the embodiment according to claim 47 or 48, it is advantageous that it is so easy to take into account a wide variety of application conditions and, with regard to the substances to be separated, an interaction between the materials used and the constituents of the substance can be avoided or prevented.

The development according to claim 49 ensures that thereby a material is used, which has neutral properties with respect to the components to be separated and beyond any combination with the plastic material is given.

Due to the design according to claim 50, the amount of the mixture to be taken up or the substance to be absorbed can be easily determined by the extent of the negative pressure in the interior of the receptacle and, in addition, the filling process can be accelerated or facilitated.

Also advantageous is an embodiment according to claim 51, since, depending on the type of coating, in particular of the chemicals used, an influence or pretreatment of the substance or its constituents is made possible in order to achieve perfect analysis results.

The object of the invention is, however, independently solved by a method for separating components of substances according to the features indicated in claim 52. The advantages resulting from the combination of features of this claim are that thereby the manufacture and manufacture of the receiving device and the separating device disposed therein is substantially simplified, as by the predetermined position and the fixed support during the separation process any relative movements between the separator and the receptacle be avoided. As a result, a receiving device is provided which is easy to operate during the filling process and then has a high degree of operational reliability during the centrifuging process, achieving a high degree of purity. Furthermore, it is advantageous that a passage of the individual components of the substance to be separated is made possible only when exceeding a predeterminable minimum force in both directions of passage and in all other operating conditions a secure seal between the two subspaces is created by the separator.

Furthermore, an approach according to the features specified in claim 53 is advantageous because the amount of the mixture to be accommodated in the receptacle can be easily determined by the extent of the predeterminable negative pressure.

A further advantageous procedure is described in claim 54, whereby a subsequent mixing in both directions of passage after the successful separation is reliably prevented.

Also advantageous is a variant of the method according to claim 55, characterized in that before the beginning of the separation process or when applying the pressure force premature passage is prevented and can be exposed as a result, the entire absorbed substance of the applied pressure force for the separation process.

Furthermore, a procedure according to the features specified in claim 56 or 57 is advantageous because thereby allow the channels in the form of a valve action in dependence on the pressure force acting on the substance, in particular the centrifugal force, a passage or prevent. As a result, a perfect separation result can be achieved with a high degree of purity.

Finally, a further advantageous procedure is described in claim 58, whereby, depending on the applied chemical, an influence or an action on the filled substance or its components is possible, so the subsequent analysis operations are perfectly feasible.

The invention will be explained in more detail below with reference to the embodiments illustrated in the drawings.

Fig. 1

eine erfindungsgemäß ausgebildete Aufnahmeeinrichtung mit einer in der Ausgangsstellung angeordneten Trennvorrichtung sowie einer Verschlussvorrichtung und befülltem Innenraum, in Seitenansicht geschnitten und schematisch vereinfachter Darstellung;

Fig. 2

einen Teil einer weiteren Aufnahmeeinrichtung mit einer in der Ausgangsstellung angeordneten weiteren erfindungsgemäßen Trennvorrichtung, in Seitenansicht geschnitten und schematisch vereinfachter Darstellung;

Fig. 3

einen Teil einer anderen Aufnahmeeinrichtung mit einer in der Ausgangsstellung angeordneten Trennvorrichtung, in Seitenansicht geschnitten und schematisch vereinfachter Darstellung;

Fig. 4

eine mögliche Ausbildung einer Trennvorrichtung, in Seitenansicht geschnitten und schematisch vereinfachter Darstellung;

Fig. 5

einen Teil einer weiteren Aufnahmeeinrichtung mit einer in der Ausgangsstellung angeordneten Trennvorrichtung, in Seitenansicht geschnitten und schematisch vereinfachter Darstellung.

Show it:

Fig. 1

an inventively designed receiving device with a arranged in the starting position separating device and a closure device and filled interior, cut in side view and schematically simplified representation;

Fig. 2

a part of a further receiving device with a arranged in the starting position further inventive separation device, cut in side view and schematically simplified representation;

Fig. 3

a part of another receiving device with a arranged in the starting position separating device, cut in side view and schematically simplified representation;

Fig. 4

a possible embodiment of a separation device, cut in side view and schematically simplified representation;

Fig. 5

a part of a further receiving device with a arranged in the starting position separating device, cut in side view and schematically simplified representation.

By way of introduction, it should be noted that in the differently described embodiments, the same parts are provided with the same reference numerals or the same component names, wherein the disclosures contained in the entire description can be mutatis mutandis to the same parts with the same reference numerals or component names. Also, the location information chosen in the description, such as top, bottom, side, etc. related to the immediately described and illustrated figure and are to be transferred to the new situation mutatis mutandis when a change in position. Furthermore, individual features or combinations of features from the different exemplary embodiments shown and described can also represent independent, inventive or inventive solutions.

The embodiments show possible embodiments of the separation device or a receiving device, it being noted at this point that the invention is not limited to the specifically illustrated embodiments thereof, but also various combinations of the individual embodiments are mutually possible and this possibility of variation due to the teaching technical action by objective invention in the skill of working in this technical field expert. There are therefore also all possible embodiments, which are possible by combinations of individual details of the illustrated and described embodiment, the scope of protection.

All statements of value ranges in the present description should be understood to include any and all sub-ranges thereof, e.g. the indication 1 to 10 should be understood to include all sub-ranges, starting from the lower limit 1 and the upper limit 10, i. all subregions begin with a lower limit of 1 or greater and end at an upper limit of 10 or less, e.g. 1 to 1.7, or 3.2 to 8.1 or 5.5 to 10.

In Fig. 1 is a receiving device 1 for a mixture 2 or substances from at least two mutually different components or media 3, 4, such as body fluids, tissue parts or tissue cultures, shown, which is designed such that the present in the receiving device 1 mixture 2 is separable in at least two of its components. These components or media 3, 4 are in blood, for example, serum or plasma and cellular components (erythrocytes, leucocytes and platelets). The erythrocytes have a size of 7.5 x 2 microns and are seedless cells with a disc-shaped form. A reversible shape change is possible with these components.

The leucocytes include the granulocytes, monocytes and lymphocytes. The granulocytes have a segmented or rod-shaped cell nucleus. Neutrophils have a diameter between 9μm and 12μm, eosinophils have a diameter between 11μm and 14μm and basophils have a diameter between 14μm and 16μm. The monocytes have a kidney-shaped cell nucleus with a size between 15μm and 30μm. The lymphocytes, on the other hand, have a round nucleus with a diameter between 7μm and 9μm as well as 12μm. The platelets have a disk-shaped form with a size of 4μm x 0.6μm and are coreless.

This separation or separation of the mixture 2 into its constituents or media 3, 4 can be carried out physically, for example, by centrifugation in a conventional manner and starting from the rest position until reaching a radial centrifugal acceleration of 1000 g to 5000 g, preferably between 1800 g and 2,200 g, where g is the gravitational acceleration and the value of 1 g is 9.81 m / s ² . This makes it possible, for example, to separate the firmer phase from the liquid phase or to separate it according to the different density values, as will be described in more detail in the following figures for different embodiments.

The receiving device 1 consists of an approximately cylindrical receptacle 5 with two mutually distanced ends 6, 7, wherein in this embodiment, the end 6 is formed open and the end 7 is formed by an end wall 8 closed. The open end 6 here is closed with a closure device 9 shown in a simplified manner, if necessary, and can, for example, according to the EP 0 445 707 B1 , of the EP 0 419 490 B1 , of the US 5,275,299 A , of the US 5,495,958 A as well as the US 5,522,518 A to avoid repetition, reference is made to the disclosure for the formation of the cap, the sealing device, the housing, the coupling device between the cap and the sealing device and the cap and the receptacle 5 and the retaining ring and in the present application is accepted. In a space enclosed by the receptacle 5 interior 10, a separator 11 is used, which in the starting position and before filling the interior 10 with the components to be separated, inserted into the receptacle 5 and fixed in this position with respect to the receptacle 5 in a predeterminable distance 12 is supported starting from that open, provided for filling end 6 of the receptacle 5 toward the other end 7.

The procedure for the assembly or assembly of the individual components will be described in more detail below. This receptacle 5 with the closure device 9 may for example be designed or used as an evacuated blood sampling tube in various embodiments.

The receptacle 5 may, for example, bottle, vial, piston-shaped or the like. Formed and formed of a variety of materials, such as plastic and / or glass. Is selected for the receptacle 5 as the material plastic, this may be liquid-tight, in particular waterproof and optionally gas-tight and for example of polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polystyrene (PS), high-density polyethylene (PE -HD), acrylonitrile-butadiene-styrene copolymers (ABS) or the like or a combination thereof. Furthermore, the receptacle 5 has a container wall 13 with a preferably constant wall thickness, wherein the container wall 13, starting from the one end 6 with an inner dimension 14 in a perpendicular to a longitudinal axis 15 extending between the two ends 6, 7 aligned plane 16 can extend to a further, arranged in the region of the end 7 and parallel to the first plane 16 extending further level 17 with a preferably smaller dimension 18 thereto. The container wall 13 of the receptacle 5 has an inner surface 19 delimiting the inner space 10 or an inner surface facing the inner space 10 and an outer surface remote therefrom, which thus defines an outer circumference for the receptacle 5. Due to the inner surface 19 of the container wall 13 with the inner clear dimension 14, 18 is thus an inner cross section, which the most varied cross-sectional shapes, such as circular, elliptical, oval, polygonal, etc., may have. The shape of the outer cross section may also be circular, elliptical, oval, polygonal, etc., but it is also possible to make the shape of the outer cross section different from the shape of the inner cross section.

It is advantageous if the inner dimension 14 of the receptacle 5, starting from one end 6 to the distant from this further end 7 continuously minimally reducing to the inner dimension 18 is formed, for example, the receptacle 5, if this plastic material in a Injection molding process is made to be able to easily remove from the injection molding tool. Further, by this tapered taper between the two planes 16, 17, the extent of decrease of the inner dimension from the larger dimension 14 to the smaller dimension 18 is predetermined. The taper or the cone angle is, based on the opposite inner surfaces 19 of the receptacle 5, between 0.1 ° and 3.0 °, preferably between 0.6 ° and 0.8 °. Regardless, however, it is also possible to form the inner surface 19 and / or the outer surface of the receptacle 5 at least partially parallel or cylindrical with respect to the longitudinal axis 15. This may relate to that portion of the receptacle 5 into which the separating device 11 is inserted up to the predetermined position.

It should be noted at this point that the dimensions described are based on the distance between the opposing inner or outer surfaces of the components, the diameter, the circumference along an envelope or a Hüll line and the cross-section or the cross-sectional area in each case one of the perpendicular to the longitudinal axis 15 aligned planes 16, 17 and always the same spatial direction for the determination of the dimensions can relate.

As can further be seen from this illustration, the end 6 has an open end side, which can be closed by the closure device 9, which can be opened as required. For this purpose, the closure device 9 consists of a cap 20 enclosing the open end and a sealing device 21 held therein, such as a sealing plug 22 made of a pierceable, highly elastic and self-sealing material, such as pharmaceutical rubber, silicone rubber or bromobutyl rubber. This cap 20 is concentric arranged to the longitudinal axis 15 and formed by an annular or approximately tubular cap jacket 23. Between the cap 20 and the sealing device 21 are means for coupling, such as coupling parts 24 to 27 of a coupling device 28, consisting in the cap 20 from at least over the inner circumference partially arranged projections 29, 30, optionally a retaining ring 31, and in the sealing device 21st from an at least partially projecting over its outer periphery approach 32nd

The sealing device 21 is formed in the present embodiment by the sealing plug 22 and has a circumferential and approximately concentric with the longitudinal axis 15 arranged cylindrical sealing surface 33, which comes in its sealing position in the section of the end 6 on the inner surface of the receptacle 5 to the plant. As a result, in this section, the inner surface or the inner surface 19 of the receiving container 5 is to be formed in its surface quality as a sealing surface. Furthermore, the sealing device 21 has an approximately perpendicular to the longitudinal axis 15 aligned, further sealing surface 34, which closes or seals the interior 10 of the receptacle 5 at its open end opposite the outer environment in cooperation with the voltage applied to the inner surface 19 sealing surface 33. The arrangement of the extension 30 between the sealing surface 33 projecting shoulder 32 and the open end of the receptacle 5, a bonding or strong adhesion of the neck 32 can be avoided directly on the front page.

Furthermore, the sealing device 21 may preferably have on the side facing the retaining ring 31, a recess 35 which has approximately the same cross-sectional area as an opening 36 in the retaining ring 31, wherein this opening 36 is formed in its dimension such that an unhindered passage of a Cannula, not shown here and subsequent piercing through the sealing device 21 is possible.

The coupling part 26 forming the projection 32, which projects beyond the sealing surface 33 of the sealing device 21 at least in partial areas of the circumference flange is supported between the projections 29 and 30, which are arranged in two spaced apart in the direction of the longitudinal axis 15 and perpendicular to this aligned planes and, for example, as at least partially or annular circumferential projections or

Arretierfortsätze are formed. For secure mounting of the sealing device 21 in the cap 20, it is additionally possible to use the retaining ring 31 between the projection 32 and the extension 29. In this case, the retaining ring 31 has a larger outer diameter than an extending between the extensions 29 and 30 inner dimension in the direction perpendicular to the longitudinal axis 15. Likewise, the diameter of the opening 36 of the retaining ring 31 is smaller than a largest outer dimension of the projection 32 in a plane perpendicular to the longitudinal axis 15. However, this outer dimension of the sealing device 21 is dimensioned such that it is greater than the inner dimension 14 of the inner cross-section and thus of the inner space 10 at least twice the wall thickness of the receiving container 5 after the extension 30, the coupling part 25 forms, has an inner opening width which corresponds substantially to the inner dimension 14 of the receptacle 5 in its upper end 6, there is a very good support of the projection 32 in the cap 20 and a good seal between the interior 10 of the receptacle 5 and the receiving device 1 u atmosphere.

Above all, the tightness of the closure device 9 for the open end of the receiving device 1 is further improved if an outer diameter of the sealing device 21 in the region of its sealing surface 33 in the relaxed state outside of the receptacle 5 is greater than the inner dimension 14 of the receptacle 5 in the the sealing device 21 facing area.

Furthermore, in the relaxed, unassembled state, a longitudinal or vertical extent of the projection 32 of the sealing device 21 in the direction of the longitudinal axis 15 is greater than a distance of a groove-shaped depression between the two extensions 29, 30 and optionally minus a thickness of the retaining ring 31. Due to the previously described dimensional differences between the groove-shaped recess and the length dimensions of the projection 32 and the thickness of the retaining ring 31 in the direction of the longitudinal axis 15 there is a bias of the projection 32 between the two extensions 29, 30. This simultaneously causes a compression and bias of the sealing device 21 with respect to the cap 20 and optionally additionally causes a tight fit of the retaining ring 31 as well as a whopping conditioning of the two end faces of the projection 32 in the region of the two extensions 29, 30th

It is advantageous, furthermore, if the cap jacket 23 as a cylinder mantle sheath or

Truncated cone mantle is formed, whereby overreaching of the cap jacket 23 is ensured in the region of the upper end side of the receptacle 5.

Furthermore, it may prove to be advantageous if at least two guide extensions 37, 38 are arranged in the region of the open front side of the receptacle 5, which project beyond the outer circumference of the cylindrical receptacle 5. However, it is any other number of guide projections 37, 38 possible, which together with arranged on a receptacle 5 inner surface of the cap 20 and on the surface thereof in the direction of the longitudinal axis 15 projecting guide webs 39, 40 cooperate. The number and the e.g. uniform, angularly offset division of the guide webs 39, 40 over the circumference of the number of arranged on the receptacle 5 guide extensions 37, 38 dependent. These guide projections 37, 38 cooperate with the guide webs 39, 40 arranged on the inside of the cap jacket 23, which makes it possible, when the cap 20 is pushed in the direction of the longitudinal axis 15 of the receptacle 5, into the open end side thereof and corresponding rotation in the clockwise direction, the guide webs 39, 40 accumulate on the guide projections 37, 38, and that due to the combined rotational and longitudinal movement due to the leadership of the guide webs 39, 40 along the guide extensions 37, 38, the sealing device 21 with its sealing surface 33 in the interior 10th of the receptacle 5 can be inserted or inserted. Instead of the guide projections 37, 38 and guide webs 39, 40 but also cooperating sections of threads would be possible, which also allow a simple screwing or unscrewing the cap 20 and the entire closure device 9.

Furthermore, the pre-positioned in the interior 10 of the receptacle 5 separator 11 is shown here, which comprises at least one support body 41 and at least one separator 42 in this embodiment. A surface facing the receptacle 5 is optionally surmounted by a sealing device 43. This sealing device 43 may be formed, for example, by one or more sealing lips. It is advantageous if the material for the support body 41 is resiliently deformable deformable and is formed for example by a silicone rubber, pharmaceutical rubber, bromobutyl rubber, rubber, a gel or an elastomeric plastic. Regardless, however, a plastic can be selected which liquid-tight, in particular waterproof, and optionally can be gas-tight and for example from the group of polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polystyrene (PS), high-density polyethylene (PE-HD), acrylonitrile-butadiene-styrene copolymers (ABS) , Thermoplastic Elastomers (TPE), Thermoplastic Polyurethane (TPU), Ultra High Molecular Weight Polyethylene (PE-UHMW), Polycarbonate (PC), Polyamide (PA), Polyoxymethylene (POM) or other thermoplastics or a combination thereof become. Likewise, however, a wide variety of additives can also be added to the material for exact tuning of the predeterminable density.

The separating element 42 of the separating device 11 has in the direction of the longitudinal axis 15 mutually distanced front ends 44, 45, in which case the first end face 44 is the open end of the receptacle 5 is facing. Furthermore, it is also shown schematically simplified in the region of the separating element 42, that in this, a plurality of extending between the two front ends 44, 45 channels 46 are arranged.

As already described above, the separating device 11 has already been used or spent in the starting position of the receiving device 1 in a predetermined position relative to the receptacle 5, before a filling of the interior 10 has taken place. This predetermined position or position is selected in the use of the receiving device 1 as a blood sampling tube such that the heavier or cellular components in that portion of the interior 10 find space in terms of volume, which formed between the separator 11 and the end wall 7 closed by the end wall 8 is. In whole blood, the cellular components form a volume fraction ranging from 40% to 50%, mostly 45%. As a result of the insertion into the predetermined position already carried out prior to the filling, the separating device 11 divides the inner space 10 into sub-chambers 47, 48 arranged on both sides thereof. In all the exemplary embodiments described, the sub-chamber 47 is always between the open end 6 and the separating device 11 and the further Subspace 48 between the separator 11 and the other closed end 7 is arranged. Thus, a receiving volume of formed between the separator 11 and the other end 7 of the receptacle 5 subspace 48 is chosen so that this is at least equal, but preferably slightly larger than that recorded volume of the heavier component, ie the cellular components of the substance.

As already described in the introduction, the so-called starting position is to be understood such that the separation device 11 inserted before closing the receptacle 5 with the closure device 9 in the receptacle 5 and fixed in this position with respect to the receptacle 5 in the predeterminable distance 12, starting from open end 6 and whose end face is supported. This fixed support prevents further movement of the separating device 11 in the direction of the longitudinal axis 15 in the direction of the further, here closed end 7. After inserting the separator 11 and before closing the receptacle 5 with the closure device 9 is preferably the entire interior 10th lowered to one, with respect to the external ambient pressure, low pressure, ie evacuated. As a result, the receiving device 1 can be used for the blood sample to be carried out in a known manner.

Arranged in the separating element 42 and shown in simplified form channels 46 are formed such that they allow a passage of the components to be separated of the substance exclusively during the application of a compressive force on the substance - in a working position designated here. The application of the pressure force can be done either by generating an overpressure directly on the liquid column and / or by generating a negative pressure in the region on the side facing away from the separator 11 side. These differently structured pressure forces thus represent a pressure difference with respect to the part spaces 47, 48 formed on both sides of the separating device 11. For example, if blood is introduced in known manner into the first subspace 47 between the separating device 11 and the closing device 9, the pressure prevailing in this subspace 47 builds Vacuum relative to the ambient pressure and possibly the other subspace 48 from. Is an immediate pressure equalization between the two sides of the separator 11 formed sub-chambers 47, 48 not so quickly possible, the prevailing pressure difference can already cause a subset of the substance through the separator 42 and their channels 46 passes through it is also possible to apply this compressive force by a centrifuging operation to be carried out in a known manner, in which the force application, starting from the open end 6, takes place in the direction of the closed end 7 - and thus on the separating device 11. Over the period of application of the pressure force is the separating element 42, in particular their channels 46 in a so-called working position in which the passage of the components to be separated of the substance is possible. After separation of the substance in its components and removal of the compressive force, the channels 46 prevent passage for the components to be separated. In this case, this operating state of the receiving device 1, in particular of the separating element 42, referred to as a release position. In this disconnected position, the channels can prevent passage in both directions of passage.

The one or more channels 46 may each have a flow cross section during the period of the action of the pressure force, in particular during the separation process, which corresponds in size to at least the largest size of the components to be separated in its dimension. This ensures that the cellular components can pass through the separating element 42, in particular its channels 46, over this period of time. In order to prevent a passage of constituents of the substance during the filling process or before the beginning of the separation process, the channels 46 of the separating element 42 are formed so that they prevent or prevent passage in the starting position for the components to be separated.

If, for example, an elastically deformable material is used for the separating element 42, it is advantageous if the channels 46 are closed in the separating position. But it would also be possible that the channels 46 are formed automatically openable during the period of the action of the pressure force, wherein the channels 46 can close automatically after the removal of the pressure force again. The channels 46 preferably have an inner dimension with a lower limit of 10 μm, preferably 15 μm, in particular 20 μm and an upper limit of 25 μm, preferably 30 μm, in particular 50 μm. The internal dimension is understood here to mean a passage opening, wherein the values indicated are the dimensions in the direction perpendicular to the direction of flow.

In order to allow evacuation of the interior 10 in the prepositioned inserted position of the separating device 11, the channels 46 allow at least in the starting position a passage of air. This air passage may also be possible during the working position and / or separation position.

In the embodiment shown here, the separating element 42 is at least partially, but preferably completely enclosed by the supporting body 41 at its circumferential region which can be turned over to the receiving container 5. In this case, the support body 41 by means of a Injection molding process, such as a two - component injection molding, are integrally formed on the separator 42. This in turn can be created a fixed and dense connection.

However, it would also be possible, as will be described below, to find the only way with the arrangement of the separating element 42 to form the separating device 11 and apply it directly to the inner surface 19 of the receiving container 5.

For better sealing of the support body 41 relative to the inner surface 19 of the receptacle 5, this has the previously briefly described sealing device 43. The sealing device 43 projects beyond the supporting body 41 at its circumference which can be turned towards the receptacle 5 onto the side facing away from the longitudinal axis 15 and is preferably formed by at least one continuous sealing lip.

Furthermore, it is advantageous if the separating element 42 is fixedly connected to the support body 41. Thus, the partition 42 may be connected to the support body 41 via a press fit, a bond, a welding, such as an ultrasonic, laser welding. If the separating element 42 is connected to the supporting body 41 by means of an ultrasonic welding, it is advantageous to provide a so-called energy directing device at least in some areas of the parts to be interconnected - separating element 42 and / or supporting body 41. This energy directors may be formed as a circumferential projection, which is usually flange-shaped and tapering in the direction of the other component formed in cross-section, so as to ensure an energy concentration for the connection process.

Furthermore, it can be seen from this illustration that the separating element 42 in the region of its front end 44, which is the space provided for filling interior 10 - here the subspace 47 - facing, aligned planar to the support body 41 or even from the support body 41 toward the Filling provided interior 10 and subspace 47 is surmounted. This ensures that no dead spaces are created in which cellular components remain in the subspace 47, between the separating device 11 and the closure device 9 after the separation process has taken place.

The separating element 42 may be formed from the most diverse materials, in particular an elastic material, a ceramic, sintered or pressed material. For example, the material from the group of polyolefins, such as: polyethylene (PE) or polypropylene (PP), polyamides (PA), polystyrene (PS), polyethersulfanes, polyesters, thermoplastic elastomers (TPE, TPU), glass fibers, cellulose or Compounds thereof, such as: cellulose mixed esters, Zellloseacetate, cellulose nitrates, other natural fiber, such as: cotton fiber, or combinations thereof may be selected. For ceramic materials, the channels 46 are formed over interconnecting pores. Furthermore, the separating element 42 may also be referred to as a filter or filter element.

The support body 41, however, may from the group of materials of silicone rubber, pharmaceutical rubber, bromobutyl rubber, rubber, a gel or an elastomeric plastic, polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polystyrene (PS), polycarbonate (PC) , thermoplastic elastomers (TPE, TPU), high-density polyethylene (PE-HD), acrylonitrile-butadiene-styrene copolymers (ABS), thermosets, crystal clear polystyrene or a combination thereof.

Furthermore, it is possible to provide the support body 41 and / or also the separating element 42 at least in regions with a coating. The coating used can be a chemical substance, in particular from the group of silicones, silicone oil, or by nanotechnology, in particular by nanoparticles. By this coating, adhesion of the cellular components, such as blood cells, difficult or completely prevented and a hydrophobic and / or hydrophilic behavior can be effected. However, this coating can also be introduced into at least one of the channels 46 so as to be able to determine the blocking or flow behavior for the substance or its constituents by influencing or changing the surface properties or surface tensions.

The fixed support of the separating device 11 relative to the receptacle 5, in particular between these components, via a press fit, a positive stop, a snap-in connection, a bond, a welding, such as an ultrasonic, laser welding done. The form-fitting stop on the receptacle 5 can be formed, for example, by protrusions 49 arranged distributed over the circumference at least in regions, on which the separating device 11, in particular the supporting body 41, towards the closed end 7 is supported. The projections 49 form the reference point for determining the distance 12 in the embodiment shown here.

FIG. 2 shows a further and, if appropriate, separate embodiment of the receiving device 1, in which, for the sake of simplicity, only the receiving container 5 without the closure device 9 is shown. Furthermore, the same component designations or reference numerals, as in the preceding Fig. 1, are used for the same components. To avoid unnecessary repetition, reference is made to the detailed description in FIG.

In this embodiment shown here, the positive stop on or in the receptacle 5 is formed by a cross-sectional constriction of the interior 10, which is formed projecting stepwise in the direction of the longitudinal axis 15. Furthermore, it is shown here that the surface 19 of the receptacle 5, starting from the open end 6 to the positive stop, is cylindrical and so over the longitudinal extent in the direction of the longitudinal axis 15 between the open end portion 6 and the positive stop the same inner Has dimension or the same inner cross-section.

The form-fitting stop formed here as a step forms a cross-sectional or diameter difference between the two subspaces 47, 48. This difference in diameter may for example be between 0.5 mm and 1.5 mm. In the area of the positive stop, only the separating element 42 for forming the separating device 11 without the supporting body 41 is shown. For better sealing in the outer edge region towards the inner surface 19 of the receptacle 5, at least one separating element 42 projecting, preferably continuously formed, sealing device may be arranged on the separating element 42 at its peripheral portion facing the receptacle 5, as already for the support body 41 and its sealing device 43rd has been described. Even with this sole arrangement of the separating element 42, this is again before the filling of the interior 10 with the components to be separated, inserted into the receptacle 5 and fixed in this position with respect to the receptacle 5 in the predeterminable distance 12, starting from the intended for filling , open end 6 of the receptacle 5 held toward the other end 7. It would also be the same Here, in turn, the fixed support with respect to the receptacle 5 via a press fit, the positive stop, a snap-in connection, a bond, a weld, such as an ultrasonic, laser welding possible. But it would also be at least partially constriction in the form of a bead or the like. Possible. By arranged in the separating element 42 channels 46, the previously described in Fig. 1 mode of action can be achieved.

The receptacle 5 may also be formed in this embodiment in the region of its outer surface is cylindrical with respect to the longitudinal axis 5, but also a conical taper between 0.1 ° and 3.0 °, preferably between 0.6 ° and 0.8 ° can be chosen. However, this conical taper described above can also be selected in the region of the inner surface 19 in the region of the partial space 47 and / or partial space 48.

FIG. 3 shows a further possible and optionally independent embodiment of the receiving device 1, again using the same reference numerals or component designations for the same parts as in the preceding FIGS. 1 and 2. In order to avoid unnecessary repetition, reference is made to the detailed description in the preceding Figs. 1 and 2 or reference.

For simplicity, here also only the receptacle 5 is shown with its spaced apart in the direction of the longitudinal axis 15 ends 6, 7, wherein the inner surface 19 may be tapered conically from the open end 6 in the direction of the closed end 7 formed to a small extent. The positive stop is formed here by an inserted into the interior 10 of the receptacle 5 inner housing 50, which is also closed in that, the closed end 7 of the receptacle 5 facing area with its own end wall. This inner housing 50 is inserted, starting from the open end 6 towards the closed end 7, wherein this rests almost free from play on the inner surface 19 of the receptacle 5 or is inserted. It is also advantageous if the inner housing 50 is held stationary in the receptacle 5 relative to this. In this case, the fixed support between the inner housing 50 and the receptacle 5 via a press fit, a bond, a welding, such as an ultrasonic, laser welding done. In order to achieve a rich investment, an outer surface 51 of the inner housing 50 at a major part of the inner surface 19 of the Receptacle 5 abut. This serves to make the gap formed between the inner housing 50 and the receptacle 5 as small as possible.

In order to facilitate the insertion movement of the inner housing 50 into the receptacle 5, means for forming at least one flow channel 52 may be provided between the outer surface 51 of the inner housing 50 and the inner surface 19 of the receptacle 5. This flow channel 52 preferably extends from the closed end 7 over a predominant part of the entire longitudinal extent up to the end face of the inner housing. These means can be achieved, for example, by deliberate minimal out-of-roundness or deviations thereof in the area of the outer surface 51 and / or inner surface 19. Likewise, corresponding recesses and / or elevations may also be formed in at least one of the two surfaces mentioned, namely the outer surface 51 or the inner surface 19. However, it would also be a surface structuring in the form of a plurality of elevations and depressions in the region of the inner surface 19 and / or outer surface 51 possible, which also form at least one continuous flow channel 52 so as during the insertion movement of the inner housing 50 between this and the receptacle 5 the The amount of air contained between these two components to escape and not to include the air in between. This can lead to impairment during storage up to an unwanted release of the interference fit in the event of temperature fluctuations. Regardless of this, it would also be possible for the inner housing 50 to bear sealingly on the inner surface 19 of the receiving container 5 in the region of its open front side 53. Furthermore, however, the mutually facing surfaces, namely the inner surface 19 and the outer surface 51 may be formed opposite to each other. As a result, an exact contact with each other is achieved both in the conical taper and the cylindrical design and the space formed between the facing surfaces of free space kept relatively low.

Regardless, it would still be possible to connect the separator 11 to the inner housing 50 fixed. If the separating device 11, as shown in the embodiment described here, formed only by the separating element 42, the fixed connection can also be made between these two components. If, in addition, a supporting body 41 is used, this can be connected to the inner housing 50 and thus carried out a common insertion into the inner space 10.

If an ultrasonic welding is provided as a fixed connection, in turn, at least in some areas, an energy-directing device can again be provided on at least one of the parts to be interconnected - receiving container 5 and / or supporting body 41 and / or separating element 42 - which is not shown here in detail. If the inner housing 5 is to be connected to the receptacle 5 via an ultrasonic welding, an energy directing device can also be provided on at least one of these two components to be interconnected. The same applies to the connection between the inner housing 50 with the support body 41 and / or the separating element 42nd

The inner housing 50 can be made of a plastic and / or of glass, wherein the plastic can be selected from the same group of materials, as has already been described above for the receptacle 5.

To achieve perfect examination or analysis results, at least partial surfaces of the inner surface 19 of the receptacle 5 and / or of the inner container 50 may be provided with a coating, not shown here, in order to use the receptacle 1 as a blood sampling tube, the introduced into the interior 10 whole blood and / or to prepare or influence the separate constituents of the substances for the investigations to be carried out subsequently. This coating is formed by a chemical, with the type and amount of the chemical on the filling volume and further analysis is tuned. Thus, the coating may e.g. be formed by lithium heparin or by a coagulation activator. The coagulation activator may in turn contain microscopic particles of silica and initiate blood clotting. The fibrinogen is converted into fibrin. This gives a serum sample. Lithium heparin counteracts blood clotting. This additive is an anticoagulant which blocks the coagulation cascade by activating antithrombins and thus prevents the coagulation of the blood sample. This gives a whole blood / plasma sample, instead of blood cake and serum.

FIG. 4 shows a possible embodiment of the separating device 11 which is possibly independent of itself for a receiving device 1, again using the same component designations or reference numerals for the same parts as in the preceding FIGS. 1 to 3. To avoid unnecessary repetition, the detailed Description in the preceding Figs. 1 to 3 referred or taken.

The separating device 11 shown here comprises the supporting body 41 as well as the separating element 42 shown partially in the region of the longitudinal axis 15. For peripheral sealing of the separating element 42 inserted into the supporting body 41, the supporting body 41 has at least one, but preferably several, in the direction of the longitudinal axis 15 from each other distanced sealing lugs 54. For relative positional fixation of the separating element 42, a shoulder 55 protruding in the direction of the longitudinal axis 15 is arranged on the supporting body 41 on the side facing the closed end 7. At this, the separating element 42 seen in the direction of the longitudinal axis 15 is prevented from further movement toward the closed end 7.

To seal the separating device 11, the support body 41 in the region of its outer circumference at the open end 6 side facing the sealing device 43 in the form of a circumferential sealing lip. This sealing lip is designed so that it additionally comes into contact with the form-fitting stop in the region of the inner surface 19 of the receiving container 5, which is shown in the left-hand area of FIG. 4. As a result, an axial fixation in the direction of the longitudinal axis 15 relative to the receptacle 5 is achieved. In addition to the above-described positional fixing of the separating device 11 with respect to the receiving container 5, this can also be seen in the direction of the longitudinal axis 15 in the direction of the open end 15 beyond. This could be done for example by a not-shown here, groove-shaped depression in the region of the inner surface 19, in which the sealing device 43 is used to fix the position. But it would also be correspondingly cooperating locking lugs or recesses conceivable.

In addition, it would also be possible that the separating element 42 - as shown in the upper right part of FIG. 4 - connected via at least one arranged on the support body 41 and the separating element 42 on the side facing away from the support member 41 side snap hook 56 to the support body 41 is, in particular, held. By the additional, sloping in the direction of the separating element 42 formed surface a kind of guide element is achieved, with which the components to be separated of the substance towards the separating element 42 during the application of the compressive force, in particular the centrifugal force, passed or spent.

Irrespective of this, however, the separating element 42 could also be inserted into a groove-shaped recess (not illustrated here) in the supporting body 41. As a result, an axial position fixation is achieved in both directions of movement.

The receptacle 5 and / or the inner housing 50 may be formed of a liquid-tight, in particular waterproof and optionally gas-tight plastic. This plastic is from the group of polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polystyrene (PS), high-density polyethylene (PE-HD), acrylonitrile-butadiene-styrene copolymers (ABS), thermoplastic Elastomers (TPE), Thermoplastic Polyurethane (TPU), Ultra High Molecular Weight Polyethylene (PE-UHMW), Polycarbonate (PC), Polyamide (PA) Polyoxymethylene (POM), Silicone Rubber, Pharmaceutical Rubber, Bromobutyl Rubber, Rubber, Gel a combination chosen.

As a direction of passage in all the embodiments described above is always selected from top to bottom, ie from the open end 6 here to the closed end 7 of the receptacle fifth

FIG. 5 shows a further possible and optionally separate embodiment of the receiving device 1, again using the same reference numerals or component designations for the same parts as in the preceding FIGS. 1 to 4. To avoid unnecessary repetition, reference is made to the detailed description in the preceding Figs. 1 to 4 or reference.

In this embodiment shown here, the simplicity here again only the receptacle 5 is shown with its spaced apart in the direction of the longitudinal axis 15 ends 6, 7, wherein the inner surface 19 tapering conically to a small extent from the open end 6 in the direction of the closed end. 7 , as well as cylindrical or partially cylindrical may be formed. The fixed support of the separating device 11 relative to the receptacle 5 takes place here in that in the interior 10 of the receptacle 5, a further inner housing 57, starting from the open end 6, is used. This further inner housing 57 in turn is fixed fixed relative to the receptacle 5 in its position. This can be done, for example, by facing in the region of the open end 6 of the receptacle 5 Area on an end face 58 a, an outer surface 59 superior latching element 60 projects into a recess 61 in the region of the inner surface 19 of the receptacle 5 and so forms a latching connection. With appropriate design of the one or more locking elements 60 and the one or more recesses 61, a circumferentially tight connection between the further inner housing 57 and the receptacle 5 can be created.

The inner housing 57 shown here is approximately tubular and extends over a partial length of the receptacle 5. At a further, averted from the end face 58 front end 62 of the further inner housing 57, the separator 11 is fixedly connected to the further inner housing 57. This fixed connection can in turn be made by the possibilities already described above. If a welding or gluing is selected, a sealing connection is created in this transition region between the separating device 11 and the further inner housing 57.

In this embodiment shown here, the separating device 11 in turn comprises the support body 51, and the separating element 42. Here, the support body 51 is connected to the front end 62 of the further inner housing 57. Thus, both the separating device 11 and the further inner housing 57 is fixedly held or fixed relative to the receptacle 5 in its position.

It is advantageous if the further inner housing 57 is inserted into the receptacle 5 almost free of play or the outer surface 59 bears against a predominant part of the inner surface 19 of the receptacle 5.

For better sealing of the subspace 48, between the separating device 11 and the closed end 7 of the receptacle 5, it is advantageous if the sealing device 43 is provided on the separating device 11, in particular the supporting body 41 and / or the separating element 42 in the region of the outer circumference. This prevents the substance or the constituent constituents from entering into the intermediate space between the further inner housing 57 and the receptacle 5 and thus can lead to a falsification of the analysis results.

For the sake of order, it should be pointed out that for a better understanding of the Constitution recording device these or their components were partially displayed off-scale and / or enlarged and / or reduced.

The problem underlying the independent inventive solutions can be taken from the description.

Above all, the individual in Figs. 1; 2; 3; 4; 5 embodiments form the subject of independent solutions according to the invention. The relevant objects and solutions according to the invention can be found in the detailed descriptions of these figures.

REFERENCE NUMBERS

1

recording device

2

mixture

3

medium

4

medium

5

receptacle

6

The End

7

The End

8th

bulkhead

9

closure device

10

inner space

11

separating device

12

distance

13

container wall

14

dimension

15

longitudinal axis

16

level

17

level

18

dimension

19

palm

20

cap

21

sealing device

22

sealing plug

23

cap casing

24

coupling part

25

coupling part

26

coupling part

27

coupling part

28

coupling device

29

extension

30

extension

31

retaining ring

32

approach

33

sealing surface

34

sealing surface

35

deepening

36

opening

37

Guide extension

38

Guide extension

39

guide web

40

guide web

41

supporting body

42

separating element

43

sealing device

44

front end

45

front end

46

channel

47

subspace

48

subspace

49

head Start

50

inner housing

51

outer surface

52

flow channel

53

front

54

sealing nose

55

shoulder

56

snap hooks

57

inner housing

58

front

59

outer surface

60

locking element

61

recess

62

front end

Claims (58)

Separating device (11) for insertion into an interior (10) of a receptacle (5) of a receiving device (1) for separating components of substances such as body fluids, tissue parts or tissue cultures, wherein the separating device (11) at least one separating element (42) in the direction of a longitudinal axis (15) spaced apart from each other end faces (44, 45) and in the separating element (42) a plurality between the two front ends (44, 45) ersteckende channels (46) are arranged, characterized in that in the separating element (42 ) arranged channels (46) are designed such that they allow in a working position a passage of the components to be separated of the substance only during the application of a compressive force on the substance and that the channels (46) in a release position a passage for the components to be separated prevention. Separating device (11) according to claim 1, characterized in that the channels (46) during the period of action of the pressure force, in particular during the separation process, each have a flow area corresponding in size to at least the largest size of the components to be separated. Separating device (11) according to claim 1 or 2, characterized in that the channels (46) of the separating element (42) prevent in the initial position a passage for the components to be separated. Separating device (11) according to one of the preceding claims, characterized in that the channels (46) of the separating element (42) is closed in the separating position. Separating device (11) according to one of the preceding claims, characterized in that the channels (46) are designed to be automatically openable during the period of the action of the pressure force. Separating device (11) according to one of the preceding claims, characterized in that the channels (46) are formed automatically closing after the removal of the pressure force. Separating device (11) according to one of the preceding claims, characterized in that the channels (46) has an inner dimension with a lower limit of 10 μm, preferably 15 μm, in particular 20 μm and an upper limit of 25 μm, preferably 30 μm, in particular 50 have μm. Separating device (11) according to one of the preceding claims, characterized in that the channels (46) allow passage of air, at least in the starting position. Separating device (11) according to any one of the preceding claims, characterized in that on the separating element (42) at its the receiving container (5) zuwendbaren circumferential region at least one separating element (42) superior, preferably continuous trained, sealing device is arranged. Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) is at least partially surrounded by a supporting body (41). Separating device (11) according to claim 10, characterized in that the separating element (42) at its the receiving container (5) zuwendbaren peripheral region is completely enclosed by the support body (41). Separating device (11) according to one of the preceding claims, characterized in that on the support body (41) at its the receiving container (5) zuwendbaren peripheral region at least one of the support body (41) superior sealing device (43), in particular a preferably continuously formed sealing lip, is arranged , Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) is fixedly connected to the supporting body (41). Separating device (11) according to claim 13, characterized in that the separating element (42) with the supporting body (41) via a press fit, a bond, a welding, such as ultrasonic, laser welding, is connected. Separating device (11) according to claim 13 or 14, characterized in that the supporting body (41) is injection-molded onto the separating element (42). Separating device (11) according to one of the preceding claims, characterized in that at least one of the parts to be interconnected (separating element (42) and supporting body (41)) at least partially an energy directing device for the ultrasonic welding is arranged. Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) arranged on at least one of the support body (41) and the separating element (42) on the side facing away from the support body (41) side snap hook (56) with the Supporting body (41) is connected. Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) is inserted into a groove-shaped recess formed in the supporting body (41). Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) in that area which is facing the filling provided for the interior space (10), arranged planar to the support body (41) or from the support body (41) out in Direction to the intended for filling interior (10) is surmounted. Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) is formed from an elastic material. Separating device (11) according to claim 20, characterized in that the material from the group of polyolefins, such as: polyethylene (PE) or polypropylene (PP), polyamides (PA), polystyrene (PS), polyethersulfanes, polyesters, thermoplastic elastomers ( TPE, TPU), glass fibers, cellulose or compounds thereof, such as: cellulose mixed esters, cellulose acetates, cellulose nitrates, other natural fibers, such as: cotton fiber, or combinations thereof. Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) is formed from a ceramic material. Separating device (11) according to one of the preceding claims, characterized in that the supporting body (41) from the group of materials of silicone rubber, pharmaceutical rubber, bromobutyl rubber, rubber, a gel or an elastomeric plastic, polyethylene terephthalate (PET), polypropylene (PP), Polyethylene (PE), polystyrene (PS), polycarbonate (PC), thermoplastic elastomers (TPE, TPU), high-density polyethylene (PE-HD), acrylonitrile-butadiene-styrene copolymers (ABS), thermosets, crystal clear polystyrene resp a combination thereof. Separating device (11) according to one of the preceding claims, characterized in that the supporting body (41) is provided at least partially with a coating. Separating device (11) according to one of the preceding claims, characterized in that the separating element (42) is provided at least in regions with a coating. Separating device (11) according to one of the preceding claims, characterized in that the channels (46) of the separating element (42) are at least partially provided with a coating. Separating device (11) according to one of claims 24 to 26, characterized in that the coating is formed by a chemical substance, in particular from the group of silicones, silicone oil, or by nanotechnology, in particular by nanoparticles. Receiving device (1) for components to be separated of substances, such as body fluids, tissue parts or tissue cultures, with a receptacle (5) which defines an interior (10) with an inner surface (19), and two in the direction of a longitudinal axis (15) from each other distanced ends (6, 7), of which at least one is formed with an opening, with at least one openable closure device (9) for the open end (6) of the receptacle (5) and with a separating device (11) inserted into the inner space (10), characterized in that the separating device (11) is designed according to one of claims 1 to 27 and Separator (11) before filling the interior (10) with the components to be separated, inserted into the receptacle (5) and fixed in this position with respect to the receptacle (5) at a predetermined distance (12) starting from that open, for filling provided end (6) of the receptacle (5) toward the further end (7) is supported and the separating device (11) the interior (10) in both sides thereof arranged subspaces (47, 48) divided. Receiving device (1) according to claim 28, characterized in that the distance (12) is selected so that a receiving volume of between the separating device (11) and the other end of the receptacle (5) formed part space (48) at least equal to or slightly larger that is the volume of the heavier component of the substance to be absorbed. Receiving device (1) according to claim 28 or 29, characterized in that the fixed support in the direction of the longitudinal axis (15) seen in the direction of the open end (6). Receiving device (1) according to one of claims 28 to 30, characterized in that the fixed support of the separating device (11) with respect to the receptacle (5) via a press fit, a positive stop, a bond, a welding, such as ultrasound, laser Welding done. Receiving device (1) according to claim 31, characterized in that the positive stop on the receptacle (5) by at least partially distributed over the circumference arranged projections (49) is formed. Receiving device (1) according to claim 31, characterized in that the positive stop on the receptacle (5) by a cross-sectional constriction of the interior (10) is formed. Receiving device (1) according to one of claims 31 to 33, characterized in that the positive-locking stop is inserted into the interior (10) of the receiving container (5) in the region away from the open end (6) of the receiving container (5). 50) is formed. Receiving device (1) according to any one of claims 28 to 33, characterized in that the fixed support of the separating device (11) with respect to the receptacle (5) via a from the open end (6) towards the further end (7) extending Another inner housing (57) takes place and the separating device (11) in the region of the further end (7) facing the front end (62) is connected. Receiving device (1) according to claim 34 or 35, characterized in that the inner housing (50, 57) is inserted into the receptacle (5) with almost no play. Receiving device (1) according to one of claims 34 to 36, characterized in that the inner housing (50, 57) is held stationary in the receptacle (5). Receiving device (1) according to claim 37, characterized in that the fixed holder between the inner housing (50, 57) and the receptacle (5) via a press fit, a snap-in connection, a bond, a welding, such as ultrasonic, laser welding, he follows. Receiving device (1) according to one of claims 34 to 38, characterized in that an outer surface (51, 59) of the inner housing (50, 57) abuts a predominant part of an inner surface (19) of the receptacle (5). Receiving device (1) according to one of claims 34 to 39, characterized in that between the outer surface (51, 59) of the inner housing (50, 57) and the inner surface (19) of the receiving container (9) means for forming at least one flow channel (52 ) are provided. Receiving device (1) according to one of claims 34 to 40, characterized in that the inner housing (50, 57) in the region of its open end face (53, 58) sealing on the inner surface (19) of the receptacle (5). Receiving device (1) according to any one of claims 34 to 41, characterized in that the mutually facing surfaces (51, 59; 19) of the inner housing (50, 57) and the receptacle (5) are formed opposite to each other. Receiving device (1) according to one of claims 28 to 42, characterized in that the separating device (11) with the inner housing (50, 57) is fixedly connected. Receiving device (1) according to one of claims 28 to 43, characterized in that at least one of the parts to be interconnected (receptacle (5), supporting body (41), separating element (42)) at least partially disposed an energy director for the ultrasonic welding is. Receiving device (1) according to one of claims 28 to 44, characterized in that at least one of the parts to be interconnected (receptacle (5), inner housing (50, 57)) at least partially an energy directing device for the ultrasonic welding is arranged. Receiving device (1) according to one of claims 28 to 45, characterized in that at least one of the parts to be interconnected (inner housing (50, 57), supporting body (41), separating element (42)) at least partially an energy directing device for the ultrasonic Weld is arranged. Receiving device (1) according to one of claims 28 to 46, characterized in that the receptacle (5) and / or the inner housing (50, 57) is formed from a plastic. Receiving device (1) according to claim 47, characterized in that the plastic from the group of group of polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polystyrene (PS), high-density polyethylene (PE-HD) , Acrylonitrile Butadiene Styrene Copolymers (ABS), Thermoplastic Elastomers (TPE), Thermoplastic Polyurethane (TPU), Ultra High Molecular Weight Polyethylene (PE-UHMW), Polycarbonate (PC), Polyamide (PA) Polyoxymethylene (POM), Receiving device (1) according to one of claims 28 to 48, characterized in that the receptacle (5) and / or the inner housing (50, 57) is formed from glass. Receiving device (1) according to one of claims 28 to 49, characterized in that the inner space (10) of the receiving container (5) is lowered to a lower pressure relative to the ambient pressure. Receiving device (1) according to one of claims 28 to 50, characterized in that at least partial surfaces of the inner surface (19) of the receptacle (5) and / or the inner container (50, 57) are provided with a coating. Method for separating components to be separated from substances, such as body fluids, tissue parts or tissue cultures, in which an isolation device (11) with a separating element (42) is inserted into an interior (10) of a receptacle (5) of a receptacle (1) and into a predeterminable distance (12) starting from that open, provided for filling end (6) of the receptacle (5) and is held stationary in this position relative to the receptacle (5), whereby on both sides of the separation device (11) spaced apart spaces ( 47, 48) are formed for the components to be separated, then the receiving container (5) is closed, then the substance at least in the subspace (47) between the separator (11) and the open, provided for filling end (6) of the Receptacle (5) introduced and subsequently introduced the substance with an acting on this and in the direction of the separating device (11) towards acting pressure force, in particular a centrifugal force, is acted upon, when a predeterminable minimum force is exceeded, the components to be separated of the substance through the channels (46) of the separating element (22) are moved through and at the same time during the action the centrifugal force the substance is divided into the components to be separated and at least the heavier constituents are brought into the subspace (48) between the separating device (11) and the further end (7) of the receiving container (5) and, after removal of the centrifugal force in the separating position of the separating device (11), the passage through the channels (46 ) is prevented in the separating element (42) for the components to be separated. A method according to claim 52, characterized in that before closing the receptacle (5), the entire inner space (10) is lowered to a lower pressure relative to the outer ambient pressure. A method according to claim 52 or 53, characterized in that the passage of the constituents of the substance through the channels (46) of the separating element (11) is prevented in the separation position in both directions of passage. Method according to one of claims 52 to 54, characterized in that the passage of the substance through the channels (46) of the separating element (42) is prevented in a release position. Method according to one of claims 52 to 55, characterized in that the channels (46) are automatically opened during the period of action of the pressure force. Method according to one of claims 52 to 56, characterized in that the channels (46) are automatically closed after the removal of the pressure force. Method according to one of claims 52 to 57, characterized in that at least partial surfaces of the inner surface (19) of the receptacle (5) and / or the inner container (50) are provided with a coating.

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