EP1772191A1 - Dispsitif por séparation, dispositif pour réception et procédure pour séparation - Google Patents

Dispsitif por séparation, dispositif pour réception et procédure pour séparation Download PDF

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Publication number
EP1772191A1
EP1772191A1 EP06020356A EP06020356A EP1772191A1 EP 1772191 A1 EP1772191 A1 EP 1772191A1 EP 06020356 A EP06020356 A EP 06020356A EP 06020356 A EP06020356 A EP 06020356A EP 1772191 A1 EP1772191 A1 EP 1772191A1
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EP
European Patent Office
Prior art keywords
receptacle
separating
separating device
separating element
channels
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06020356A
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German (de)
English (en)
Inventor
Franz Ing. Konrad
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Greiner Bio One GmbH Austria
Original Assignee
Greiner Bio One GmbH Austria
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Greiner Bio One GmbH Austria filed Critical Greiner Bio One GmbH Austria
Publication of EP1772191A1 publication Critical patent/EP1772191A1/fr
Withdrawn legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021—Test tubes specially adapted for centrifugation purposes
    • B01L3/50215—Test tubes specially adapted for centrifugation purposes using a float to separate phases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/12—Specific details about manufacturing devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0409—Moving fluids with specific forces or mechanical means specific forces centrifugal forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof

Definitions

  • 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.
  • substances for example blood
  • substances 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 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.
  • a centrifugal force especially when centrifuging the sample
  • the piston moving inside the blood sample tube under the influence of a centrifugal force 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.
  • 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.
  • 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.
  • 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.
  • the separator has a recess which is closed with a thin cover plate in the region of the upper end of the receptacle.
  • 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.
  • 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.
  • 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 Stirnend Scheme with a closure device and in which a separating device for separating the different media of the mixture is used after separation.
  • the separator 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an additional support between the two components to be joined is created, thus creating a reliable support.
  • 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.
  • the separating element can be easily adapted to a wide variety of operating conditions, depending on the intended use.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the still existing residual air can be mitabgesaugt in these areas.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 9 ⁇ m and 12 ⁇ m
  • eosinophils have a diameter between 11 ⁇ m and 14 ⁇ m
  • basophils have a diameter between 14 ⁇ m and 16 ⁇ m.
  • the monocytes have a kidney-shaped cell nucleus with a size between 15 ⁇ m and 30 ⁇ m.
  • the lymphocytes on the other hand, have a round nucleus with a diameter between 7 ⁇ m and 9 ⁇ m as well as 12 ⁇ m.
  • the platelets have a disk-shaped form with a size of 4 ⁇ m x 0.6 ⁇ m 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.
  • a separator 11 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.
  • 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.
  • PET polyethylene terephthalate
  • PP polypropylene
  • PE polyethylene
  • PS polystyrene
  • PE -HD high-density polyethylene
  • ABS acrylonitrile-butadiene-styrene copolymers
  • 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.
  • an inner cross section 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.
  • 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.
  • 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 °.
  • 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.
  • 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.
  • the end 6 has an open end side, which can be closed by the closure device 9, which can be opened as required.
  • 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.
  • a coupling device 28 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.
  • 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.
  • 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.
  • 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
  • Arretierfortaries are formed.
  • the retaining ring 31 between the projection 32 and the extension 29.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • PET polyethylene terephthalate
  • PP polypropylene
  • PE polyethylene
  • PS polystyrene
  • PE-HD high-density polyethylene
  • ABS acrylonitrile-butadiene-styrene copolymers
  • TPE Thermoplastic Elastomers
  • 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.
  • 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.
  • the cellular components form a volume fraction ranging from 40% to 50%, mostly 45%.
  • the separating device 11 divides the inner space 10 into sub-chambers 47, 48 arranged on both sides thereof.
  • 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.
  • 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.
  • 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.
  • the receiving device 1 can be used for the blood sample to be carried out in a known manner.
  • 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.
  • 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.
  • 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.
  • 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 ⁇ m, preferably 15 ⁇ m, in particular 20 ⁇ m and an upper limit of 25 ⁇ m, preferably 30 ⁇ m, in particular 50 ⁇ m.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the separating element 42 is fixedly connected to the support body 41.
  • 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.
  • a welding such as an ultrasonic, laser welding.
  • 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.
  • 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.
  • 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.
  • the channels 46 are formed over interconnecting pores.
  • the separating element 42 may also be referred to as a filter or filter element.
  • the support body 41 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.
  • silicone rubber polyethylene terephthalate
  • PP polypropylene
  • PE polyethylene
  • PS polystyrene
  • PC polycarbonate
  • TPE thermoplastic elastomers
  • PE-HD high-density polyethylene
  • ABS acrylonitrile-butadiene-styrene copolymers
  • thermosets crystal clear polystyrene or a combination thereof.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • the separating element 42 for forming the separating device 11 without the supporting body 41 is shown in the area of the positive stop.
  • 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.
  • 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.
  • reference is made to the detailed description in the preceding Figs. 1 and 2 or reference.
  • 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.
  • a welding such as an ultrasonic, laser welding done.
  • 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.
  • 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.
  • the separator 11 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an axial fixation in the direction of the longitudinal axis 15 relative to the receptacle 5 is achieved.
  • 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.
  • 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.
  • 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.
  • 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.
  • PET polyethylene terephthalate
  • PP polypropylene
  • PE polyethylene
  • PS polystyrene
  • PE-HD high-density polyethylene
  • ABS acrylonitrile-butadiene-st
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the separating device 11 in turn comprises the support body 51, and the separating element 42.
  • the support body 51 is connected to the front end 62 of the further inner housing 57.
  • both the separating device 11 and the further inner housing 57 is fixedly held or fixed relative to the receptacle 5 in its position.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • External Artificial Organs (AREA)
  • Centrifugal Separators (AREA)
EP06020356A 2005-10-04 2006-09-28 Dispsitif por séparation, dispositif pour réception et procédure pour séparation Withdrawn EP1772191A1 (fr)

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US9364828B2 (en) 2009-05-15 2016-06-14 Becton, Dickinson And Company Density phase separation device
US9919307B2 (en) 2009-05-15 2018-03-20 Becton, Dickinson And Company Density phase separation device
US9919308B2 (en) 2009-05-15 2018-03-20 Becton, Dickinson And Company Density phase separation device
US11351535B2 (en) 2009-05-15 2022-06-07 Becton, Dickinson And Company Density phase separation device
US8794452B2 (en) 2009-05-15 2014-08-05 Becton, Dickinson And Company Density phase separation device
US10343157B2 (en) 2009-05-15 2019-07-09 Becton, Dickinson And Company Density phase separation device
US10807088B2 (en) 2009-05-15 2020-10-20 Becton, Dickinson And Company Density phase separation device
US9802189B2 (en) 2009-05-15 2017-10-31 Becton, Dickinson And Company Density phase separation device
US10413898B2 (en) 2009-05-15 2019-09-17 Becton, Dickinson And Company Density phase separation device
US10456782B2 (en) 2009-05-15 2019-10-29 Becton, Dickinson And Company Density phase separation device
US11786895B2 (en) 2009-05-15 2023-10-17 Becton, Dickinson And Company Density phase separation device
EP2517791A1 (fr) * 2011-04-18 2012-10-31 Vibod GmbH Tube d'échantillon doté d'un bouchon amélioré
WO2013053620A1 (fr) * 2011-10-13 2013-04-18 Vibod Gmbh Tube à échantillon comportant un couvercle amélioré
US9694359B2 (en) 2014-11-13 2017-07-04 Becton, Dickinson And Company Mechanical separator for a biological fluid
EP3359961B1 (fr) * 2015-10-09 2020-08-05 Scheiter, Oliver Procédé pour la séparation de phase d'un mélange liquide et pour la séparation consécutive d'un surnageant liquide et séparateur de phase pour le procédé

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