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WO2018197592A1 - Corps de séparation - Google Patents

Corps de séparation Download PDF

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Publication number
WO2018197592A1
WO2018197592A1 PCT/EP2018/060655 EP2018060655W WO2018197592A1 WO 2018197592 A1 WO2018197592 A1 WO 2018197592A1 EP 2018060655 W EP2018060655 W EP 2018060655W WO 2018197592 A1 WO2018197592 A1 WO 2018197592A1
Authority
WO
WIPO (PCT)
Prior art keywords
separating
ballast
float
density
tubular container
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.)
Ceased
Application number
PCT/EP2018/060655
Other languages
German (de)
English (en)
Inventor
Mark WEINSTOCK
Christian Wegener
Ulrich KARRENBERG
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.)
Sarstedt AG and Co KG
Original Assignee
Sarstedt AG and Co KG
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 Sarstedt AG and Co KG filed Critical Sarstedt AG and Co KG
Publication of WO2018197592A1 publication Critical patent/WO2018197592A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021Test tubes specially adapted for centrifugation purposes
    • B01L3/50215Test tubes specially adapted for centrifugation purposes using a float to separate phases
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/491Blood by separating the blood components
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02Adapting objects or devices to another
    • B01L2200/025Align devices or objects to ensure defined positions relative to each other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/16Surface properties and coatings

Definitions

  • the invention relates to a separating body for separating a first from a second phase of a liquid in a tubular container.
  • separators are meant to separate blood serum as the first phase of blood cake as the second phase in blood as a fluid within a blood collection tube.
  • blood collection tubes with separating bodies are basically known.
  • the separating bodies In the delivery state of the blood collection tubes, the separating bodies are fixed in a starting position.
  • blood flows or flows through the separator; In any case, in the initial position, the separator does not provide a seal for the blood within the blood collection tube.
  • the blood collection tube is centrifuged with the blood therein. The heavier blood cake then settles due to centrifugation in the near-bottom volume region of the blood collection tube, while the lighter blood serum floats on the blood cake.
  • the separator Under the action of the centrifugal force, the separator separates from its original position and moves to a sealing position. Because the density of the entire separating body is in a range of values between the density of the blood serum and the density of the blood cake, the separating body automatically positions itself exactly at the phase boundary between blood serum and blood cake. This position is also called sealing position, because the separating body in this position sition with its sealing edge circumferentially sealing against the inside of the tubular sample tube and thus cleanly separates the blood serum from the blood cake. The separating body maintains this sealing position even after the end of the centrifuging, so that the blood serum and the blood cake are separately available for a laboratory examination.
  • the separating bodies described therein each have a floating body made of elastic material with a peripheral circumferential sealing edge in plan view, wherein the sealing edge is formed for sealing engagement on the inside of a tubular sample container in a sealing position.
  • a ballast body is attached at the bottom of the float.
  • the density of the ballast body is in each case greater than the density of the floating body and the density of the entire separating body lies in a range of values between the density of the first phase and the density of the second phase of the liquid.
  • the invention has the object of developing a known separating body for separating a first of a second phase of a liquid in a tubular container and a corresponding known container to the effect that a release of the separating body from a starting position in the container is controlled only at a predetermined force ,
  • the separating body is characterized in that the ballast body at its end facing away from the floating body has a predetermined static friction coefficient on its surface or that the ballast body has at its end remote from the float at least one adhesive element having on its surface the predetermined static friction coefficient.
  • the predetermined static friction coefficient is dimensioned such that the Release body only under the action of a force, in particular a centrifugal force from a starting position in the delivery condition triggers when the force is greater than a predetermined force threshold.
  • the separating body In the delivery state or in its initial position, the separating body is releasably clamped in the tubular container. He then sits across the container. In this case, the ballast body presses with its end facing away from the float against the inside of the tubular container. In other words, the separating body is supported in this initial position as described against the tubular container. Under the action of a force, in particular the centrifugal force, the separating body is to be released from its starting position and migrate into the sealing position described above.
  • this release from the starting position should only take place when the force on the separating body is greater than the predetermined force threshold; in particular, the release from the starting position should not take place at the wrong time, for example, not when the tubular container with the separating body therein experiences a shock during transport in the starting position.
  • the present invention provides that a predetermined stiction between the ballast body and the inside of the tubular container is adjusted.
  • a predetermined static friction coefficient can be realized on the surface of the ballast body facing away from the floating body; ie the surface of the ballast body is then formed there with the appropriate static friction coefficient.
  • the ballast body at its end facing away from the float also have at least one adhesive element with the predetermined static friction coefficient. Ie. in this case then has the surface of the adhesive element, the predetermined static friction coefficient.
  • the predetermined coefficient of static friction is matched to the coefficient of friction of the inside of the tubular container, against which the ballast body or the adhesive element rests in the starting position. Only the interaction of the coefficient of static friction on the ballast body or the adhesive element and the (adhesive) friction coefficient on the inside of the container defines the force required to release the separating body from the starting position.
  • the density of the second phase of the liquid is greater than the density of the first phase of the liquid.
  • the density of the entire separator 100 is in a range of values between the density of the first phase and the density of the second phase of the liquid. Therefore, the separating body always positions itself in the sealing position on the phase boundary between the two phases.
  • the separator is described below in a normal position.
  • the ballast body In this normal position, the ballast body is arranged below the float.
  • the center of gravity of the float, the center of gravity of the ballast body and the center of gravity of the entire separation body are all on a vertical line.
  • the sealing position corresponds to the normal position with vertical tubular container.
  • the adhesive element is then advantageously manufactured in terms of production technology. inexpensive and easy to implement.
  • Float for example, can be easily realized by small channels are provided in an injection mold for the separator on the outside or inside the ballast body, which connect the float with the adhesive element.
  • the material of the floating body is then injected through the channels into the cavities for the adhesive elements.
  • the material of the float remains in the region of the channels of the injection mold on the outside or inside the ballast body in the form of webs obtained, which connect the float body with the adhesive element in one piece.
  • the bars are only optional.
  • the float and the adhesive elements can also be formed independently of each other as individual elements, but this is technically more complex.
  • the floating body may be disc-shaped, while the ballast body is in the form of a plurality of fingers, which extend from the underside of the disc-shaped floating body - distributed at the edge - away.
  • This design of the ballast body in the form of fingers ensures that the separator does not seal the tubular container in its initial position in the delivery condition for the liquid, but that the separator can be flowed around by the liquid flowing into the container, so that the liquid in the below Separator located volume of the tubular container can flow.
  • the float can also be designed in the shape of a ball or pot.
  • the ballast body may be made of a material which is less elastic than the material of the float or the material of Membrane. This is true because the said sealing edge is typically attached to the float and not to the ballast body.
  • the sealing edge under the action of centrifugal force on the float - and thus on the sealing edge - is elastically deformable. Under the action of the force, the separating body, in particular the floating body, is narrowed, so that the sealing edge no longer abuts in a circumferentially sealing manner against the inside of the container. This makes it possible to flow around the separating body with the liquid inside the tubular container. Because the sealing edge is typically not attached to the ballast body, this elasticity is not required by the ballast body; this can therefore be less elastic.
  • Figures a separator according to the invention with disk-shaped 1a and 1b floating body according to a first variant; the separating body of Figure 1 in a tubular container; the disc-shaped separating body according to a second variant;
  • FIG. 4 shows the separating body according to FIG. 3 in the tubular container
  • FIG. 6 shows the separating body according to FIG. 5 within the tubular container
  • FIG. 8 shows the separating body according to FIG. 7 inside the tubular container
  • Figures show a cup-shaped separating body according to the invention.
  • Figure 10 shows the separator of Figure 9 within the tubular container.
  • FIG. 1 shows the separating body 100 according to the invention in a perspective view (FIG. 1 a) and in a cross-sectional view (FIG. 1 b).
  • the separating body 100 consists of a floating body 1 10 and a ballast body 120.
  • the floating body 110 is disc-shaped with a thickening 113 in its center and with a peripheral sealing edge 1 12 is formed.
  • the ballast body 20 is formed in the form of a plurality of fingers 124, which extend away from the underside of the disc-shaped floating body 1 10. The fingers 124 are arranged distributed on the edge of the ballast body.
  • Float facing away from the fingers each have adhesive elements 122 which have on their surface a predetermined static friction coefficient. As described above, this ensures that the separating body remains in its initial position or state of delivery within the tubular container until it experiences a force which is greater than a predetermined threshold force value.
  • the adhesive element 122 is formed in the embodiment shown in Figure 1 of the same material as the float 110 and even integrally therewith. This can be seen in FIG. 1 from the fact that the material of the
  • Float on the outside of the ballast body 120 is formed in the form of webs 126, which connect the float in one piece with the adhesive member 122.
  • FIG. 2 shows the separating body 100 according to the invention in the tubular container 200, for example a blood sampling tube.
  • the separating body 100 can be seen, on the one hand, in its starting position 210, in which it is located when the tubular container 200 is delivered. In this initial position, the separating body is supported by said adhesive elements 122 on the inside of the tubular container. Only under the action of the centrifugal force, the separating body 100 is released from its initial position 210 and moves to the sealing position 220. In this case, it rotates by 90 °. Only when the separating body 100 is no longer under the action of centrifugal force, he deforms back to its original state. Its sealing edge 1 12 is then in the sealing position 220 in the circumferential direction R everywhere sealing against the inside of the tubular container 200 and separated in this way the two phases of the liquid or the blood effectively from each other.
  • FIG. 3 shows the separating body 100 according to the invention in an alternative embodiment.
  • FIG. 3a shows it in a perspective view
  • FIG. 3b shows it in a side view.
  • the float 1 10 is basically disc-shaped, but it is spherically deformed. Therefore, the circumferential edge 1 12 viewed from the side is wavy with troughs 1 18 and Wel- lenbergen 1 17 trained.
  • 18 ballast bodies 120 in the form of fingers 124 project downward, in each case in the region of the wave troughs.
  • each of these fingers has at its end facing away from the float 110, the said adhesive element 122 on.
  • buoyancy bodies 1 13 In the area of the wave crests 1 17 material accumulations are formed on the top of the disc-shaped float; These act as additional buoyancy bodies 1 13.
  • This special arrangement of buoyancy bodies and ballast bodies causes under the action of a force, in particular the centrifugal force, that the floating body 1 10 deforms even more spherical.
  • FIG. 4 shows the separating body according to FIG. 3 inside the tubular container 200.
  • the separating body When delivered, the separating body is in its starting position 210. It then rests on the one hand with the adhesive elements 122 and on the other with the free ends of the buoyant bodies 13 on the inside of the tubular body Container 200 off.
  • the free ends of the buoyancy bodies 1 13 are therefore preferably rounded according to the inner radius of the tubular container 200.
  • the separating body 100 can be flowed around by blood flowing into the tubular container, so that the blood can also reach deeper volume regions of the tubular container.
  • FIG. 2 which applies analogously to FIG. 4 in this respect.
  • FIGS. 5a) and 5b) show the separating body 100 according to the invention in a spherical configuration. It consists of the elastic float 1 10 with the circular in plan view sealing edge 112. This is not precluded that the sealing edge 112 is formed wavy in the side view of Figure 1.
  • a ballast body 120 is attached.
  • the adhesive elements 22 can be seen.
  • the adhesive elements are here exemplified by webs 126 integral with the
  • the floating body 1 10 is locally narrowed. In the region of the constriction 1 14 it is designed as a membrane 1 16.
  • the membrane is undulating with straight wave crests and troughs.
  • the membrane 1 16 could also be formed of elastic material.
  • the formation of the membrane in wave form and / or of elastic material is required to allow a spring action of the membrane.
  • the spring effect contributes to the fact that in the sealing position, a sufficiently large pressure of the sealing edge is exerted on the inside of the container in order to effectively differentiate the two phases of the liquid against each other.
  • the floating body 110 has a local flattening 119 "or bead on its upper side remote from the ballast body 120. In the region of the flattening, the floating body does not lie sealingly against the inside of the container in the starting position and thus allows the separating body to flow around therewith the liquid flowing in the container.
  • FIG. 6 shows the separating body according to FIG. 5 inside the tubular container 200. On delivery, the separating body is in its starting position 210.
  • the separating body 100 can be flowed around in particular in the region of the flattened portions 19 "and the ballast body of blood flowing into the tubular container because the outer contour of the separating body 100 there-seen from the inlet 230 of the tubular container-is of the pure circular shape The blood can thus also flow into deeper volume regions of the tubular container.
  • FIG. 7 shows the spherical separating body 100 in a further embodiment.
  • Figures 7a and 7b show him in different side views.
  • Figures 7c and 7d show him in different sectional views of different depths.
  • the embodiment of FIG. 7 differs substantially only in the shape of the membrane 1 16 and in the design of the surface of the float of the embodiment of FIG. 5.
  • an adhesive element 122 can be seen on the underside of the ballast body 120 ,
  • FIG. 8 shows the separating body according to FIG. 7 in the interior of the tubular container 200. On delivery, it is supported on the inside of the tubular container 200 on the one hand with the adhesive elements 122 and on the other hand with the elevation 1 19 '.
  • the separating body 100 can be flowed around in particular in the region of the elevation 1 19 'and the ballast body of blood flowing into the tubular container, because the outer contour of the separating body 100 there - seen from the inlet 230 of the tubular container - of the pure circular shape differs.
  • the blood can thus also flow into deeper volume areas of the tubular container.
  • FIG. 9 shows the separating body 100 in a cup-shaped design.
  • Figures 9a and 9b show him in different side views.
  • Figures 9c and 9d show him in different sectional views of different depths.
  • this separation body differs essentially only in the circumferential sealing edge 1 12 of the separator of FIG. 7.
  • the sealing edge 1 12 is not wavy here, but just horizontally extending.
  • an adhesive element 122 can be seen on the underside of the ballast body 120.
  • FIG. 10 shows the separating body according to FIG. 9 in the interior of the tubular container 200. Otherwise, the description of FIG. 8 for FIG. 10 applies analogously. LIST OF REFERENCE NUMBERS

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Ecology (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Centrifugal Separators (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un corps de séparation (100) destiné à séparer une première phase d'une deuxième phase d'un liquide dans un récipient tubulaire. Le corps de séparation comporte un corps flottant (110) réalisé dans un matériau élastique et présentant un bord d'étanchéité périphérique (112), et au moins un corps de lestage (120) fixé sur la face inférieure du corps flottant (110). La densité du corps de lestage (120) est supérieure à la densité du corps flottant (110) et la densité de l'ensemble du corps flottant (100) se situe dans une plage de valeurs entre la densité de la première phase et la densité de la deuxième phase du liquide. L'invention vise à garantir qu'un détachement du corps de séparation à partir d'une position de départ dans le récipient n'ait lieu que de manière contrôlée sous l'effet d'une force prédéterminée. A cet effet, le corps de lestage (120) présente selon l'invention, à son extrémité opposée au corps flottant (110), un coefficient de frottement statique prédéfini sur sa surface ou comporte au moins un élément adhésif (122) qui présente sur sa surface le coefficient de frottement statique prédéfini.
PCT/EP2018/060655 2017-04-26 2018-04-26 Corps de séparation Ceased WO2018197592A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017108941.1A DE102017108941A1 (de) 2017-04-26 2017-04-26 Trennkörper
DE102017108941.1 2017-04-26

Publications (1)

Publication Number Publication Date
WO2018197592A1 true WO2018197592A1 (fr) 2018-11-01

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Family Applications (1)

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PCT/EP2018/060655 Ceased WO2018197592A1 (fr) 2017-04-26 2018-04-26 Corps de séparation

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DE (1) DE102017108941A1 (fr)
WO (1) WO2018197592A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11478787B2 (en) 2018-07-09 2022-10-25 Hanuman Pelican, Inc. Apparatus and methods for separating blood components
US11534534B2 (en) 2018-07-09 2022-12-27 Hanuman Pelican, Inc. Apparatus and methods for processing blood
US11559613B2 (en) 2019-02-06 2023-01-24 Hanuman Pelican, Inc. Apparatus and methods for concentrating platelet-rich plasma
JP2023509274A (ja) * 2019-10-31 2023-03-08 エクリプス メッドコープ,エルエルシー 試料の成分を分離するためのシステム、方法および装置
US11654428B2 (en) 2019-01-21 2023-05-23 Vias Partners, Llc Methods, systems and apparatus for separating components of a biological sample

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269927A (en) * 1991-05-29 1993-12-14 Sherwood Medical Company Separation device for use in blood collection tubes
US5632905A (en) * 1995-08-07 1997-05-27 Haynes; John L. Method and apparatus for separating formed and unformed components
JPH1183847A (ja) * 1997-09-05 1999-03-26 I D S:Kk 血清分取補助具およびこの補助具を用いた血清分取装置ならびに検体からの血清分取方法
WO2010132783A1 (fr) 2009-05-15 2010-11-18 Becton, Dickinson And Company Dispositif de separation de phases par densite
EP3020482A1 (fr) * 2014-11-13 2016-05-18 Becton Dickinson and Company Séparateur mécanique pour un fluide biologique

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269927A (en) * 1991-05-29 1993-12-14 Sherwood Medical Company Separation device for use in blood collection tubes
US5632905A (en) * 1995-08-07 1997-05-27 Haynes; John L. Method and apparatus for separating formed and unformed components
JPH1183847A (ja) * 1997-09-05 1999-03-26 I D S:Kk 血清分取補助具およびこの補助具を用いた血清分取装置ならびに検体からの血清分取方法
WO2010132783A1 (fr) 2009-05-15 2010-11-18 Becton, Dickinson And Company Dispositif de separation de phases par densite
US20100288694A1 (en) * 2009-05-15 2010-11-18 Becton, Dickinson And Company Density Phase Separation Device
EP3020482A1 (fr) * 2014-11-13 2016-05-18 Becton Dickinson and Company Séparateur mécanique pour un fluide biologique

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12017211B2 (en) 2018-07-09 2024-06-25 Hanuman Pelican, Inc. Apparatus and methods for separating blood components
US11534534B2 (en) 2018-07-09 2022-12-27 Hanuman Pelican, Inc. Apparatus and methods for processing blood
US11534533B2 (en) 2018-07-09 2022-12-27 Hanuman Pelican, Inc. Apparatus and methods for processing blood
US11541388B2 (en) 2018-07-09 2023-01-03 Hanuman Pelican, Inc. Apparatus and methods for separating blood components
US12453968B2 (en) 2018-07-09 2025-10-28 New Orleans Apparatus and methods for separating blood components
US11478787B2 (en) 2018-07-09 2022-10-25 Hanuman Pelican, Inc. Apparatus and methods for separating blood components
US11654428B2 (en) 2019-01-21 2023-05-23 Vias Partners, Llc Methods, systems and apparatus for separating components of a biological sample
US12440835B2 (en) 2019-01-21 2025-10-14 Vias Partners, Llc Methods, systems and apparatus for separating components of a biological sample
US11559613B2 (en) 2019-02-06 2023-01-24 Hanuman Pelican, Inc. Apparatus and methods for concentrating platelet-rich plasma
US12097311B2 (en) 2019-02-06 2024-09-24 Hanuman Pelican, Inc. Apparatus and methods for concentrating platelet-rich plasma
US11672892B2 (en) 2019-02-06 2023-06-13 Hanuman Pelican, Inc. Apparatus and methods for concentrating platelet-rich plasma
US12007382B2 (en) 2019-10-31 2024-06-11 Crown Laboratories, Inc. Systems, methods and apparatus for separating components of a sample
JP7561189B2 (ja) 2019-10-31 2024-10-03 エクリプス メッドコープ,エルエルシー 試料の成分を分離するためのシステム、方法および装置
JP2023509274A (ja) * 2019-10-31 2023-03-08 エクリプス メッドコープ,エルエルシー 試料の成分を分離するためのシステム、方法および装置

Also Published As

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