EP1871530B1 - Wegwerfvorrichtung für die kontinuierliche trennung einer physiologischen flüssigkeit durch zentrifugation - Google Patents

Wegwerfvorrichtung für die kontinuierliche trennung einer physiologischen flüssigkeit durch zentrifugation Download PDF

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Publication number
EP1871530B1
EP1871530B1 EP06700529A EP06700529A EP1871530B1 EP 1871530 B1 EP1871530 B1 EP 1871530B1 EP 06700529 A EP06700529 A EP 06700529A EP 06700529 A EP06700529 A EP 06700529A EP 1871530 B1 EP1871530 B1 EP 1871530B1
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European Patent Office
Prior art keywords
chamber
outlet
tubular
inlet
axial
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Not-in-force
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EP06700529A
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English (en)
French (fr)
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EP1871530A1 (de
Inventor
Jean-Denis Rochat
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Individual
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B11/00—Feeding, charging, or discharging bowls
    • B04B11/08—Skimmers or scrapers for discharging ; Regulating thereof
    • B04B11/082—Skimmers for discharging liquid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/10—Centrifuges combined with other apparatus, e.g. electrostatic separators; Sets or systems of several centrifuges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B7/00—Elements of centrifuges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B9/00—Drives specially designed for centrifuges; Arrangement or disposition of transmission gearing; Suspending or balancing rotary bowls
    • B04B9/12—Suspending rotary bowls ; Bearings; Packings for bearings
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • B04B2005/0478—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation with filters in the separation chamber
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B7/00—Elements of centrifuges
    • B04B2007/005—Retaining arms for gripping the stationary part of a centrifuge bowl or hold the bowl itself

Definitions

  • the present invention relates to a disposable device for the continuous separation by centrifugation of a physiological liquid, in particular blood, comprising a fixed axial input and output element around the axis of which a plastic centrifuge chamber. is rotatably mounted, an inlet channel for the centrifugal blood passing longitudinally through said axial inlet and outlet element and the dispensing opening of which is located near the bottom of said centrifuge chamber, an outlet passage for at least one separate component, the inlet opening of which is close to the end of said enclosure opposite said bottom and in a zone of concentration of at least one of the separated constituents having the lowest specific mass for the continuously withdrawing, this passage passing through a longitudinal portion of said fixed axial input and output element, a rotary joint between said element fixed axial and said centrifuge chamber.
  • the known cups or separation bowls of this type are intended for semi-continuous separation, which consists in progressively evacuating the plasma separated from the red blood cells and storing the red blood cells.
  • the reason why the red blood cells are not removed from the separation chamber as they separate, as the plasma is due to the fact that the tangential force applied to them is relatively high and the deceleration that it would suffer during the abrupt passage in a fixed evacuation conduit would cause a high rate of hemolysis.
  • the flexible tube rotating on itself at the speed - ⁇ is subjected to a tensile stress generated by the centrifugal force, to a bending stress due to the rotation on itself of the portion of the tube forming the open loop at the speed - ⁇ , and a heating generated by the work of the viscous forces in the material due to the aforementioned bending.
  • the temperature should not be> 40 ° C.
  • the rotational speed of the centrifuge bowl is limited, so that the diameter of this bowl can not be too small or it could affect the quality of the separation.
  • the drive mechanism of the bowl and the flexible tube is relatively complex and expensive.
  • centrifugal separators comprising a conical rigid conical centrifuge bowl, the supply and discharge of the separated components of which is carried out by fixed conduits engaged in an upper axial opening of the bowl. Given the bell shape of these enclosures, it is not possible to form a flow of the liquid to be separated. Indeed, the heaviest phase, the red blood cells remains in the larger diameter part of the truncated cone.
  • the red blood cells are removed by a conduit whose admission is located approximately halfway up the enclosure through a complex network of internal baffles.
  • the plasma is removed thanks to this same complex network of baffles, by a conduit whose admission is located towards the top of the enclosure.
  • the red blood cells are extracted by suction through a conduit whose admission is adjacent to the bottom of the enclosure.
  • the object of the present invention is to overcome, at least in part, the aforementioned drawbacks.
  • the present invention relates to a disposable device for the continuous separation by centrifugation of a physiological liquid, in particular blood according to claim 1.
  • the main advantage of this disposable device is its low volume and the fact of allowing a continuous separation with fixed supply and discharge ducts.
  • the small volume makes it possible to reduce the cost of the disposable device and consequently also the volume of the centrifugal separator.
  • a small volume centrifuge chamber makes it possible to reduce the time during which the liquid to be separated is subjected to separation forces, and thus to reduce the rate of hemolysis and platelet activation.
  • the tubular centrifugal receptacle has a cylindrical tightening at its upper end to engage with guide rollers and in which a rotating seal is housed between the fixed axial element and the receptacle to ensure the sterility of the liquid. centrifugation course.
  • the small diameter of the cylindrical tightening makes it possible to reduce the tolerance of this diameter by reducing the amount of shrinkage of the plastic, the importance of which is proportional to the size of the piece.
  • the fact that the rotary joint also works on a part of small diameter reduces the heating.
  • the precision of the guidance of the centrifugation device makes it possible to use the seal only for sealing and not for compensate for the decentering defects of the rotating centrifuge chamber relative to the fixed axial input and output element. Therefore, the preload to which the seal must be subjected can be reduced to a minimum, that is to say that it is only a function of the only conditions necessary for sealing and therefore no longer constitutes an hybrid, which also reduces heating.
  • the housing of the centrifugal separator for using the device according to the present invention and schematically illustrated by the figure 1 comprises two elongated centrifugal chambers 1, 2 of tubular form.
  • the first centrifugal tubular chamber 1 comprises a supply duct 3 which is connected to a fixed axial input and output element 4 of the centrifuge chamber 1.
  • This supply duct 3 is connected to a pumping device 5 which comprises two pumps 6 and 7 phase shifted by 180 ° one by to the other to ensure a continuous flow of a physiological fluid, especially blood.
  • An air detector 10 is arranged along the supply duct 3.
  • outlet ducts 8, 9 are connected to the fixed axial element 4, to allow the continuous output of two components of different densities of the physiological fluid.
  • the outlet duct 8 is intended for the outlet of the RBC concentrated red blood cells and the duct 9 for the outlet of the platelet rich PRP plasma.
  • This outlet duct 9 comprises a valve 11 and divides into two branches 9a, 9b.
  • the branch 9a is used to recover the platelet concentrate and is controlled by a valve 12.
  • the valves 11 and 12 operate in exclusive OR logic either to pass the PRP from the chamber 1 to the chamber 2, or to empty the platelet concentrate from enclosure 2 to exit 9a.
  • the branch 9b serves to drive the PRP to a pumping device 13 comprising two pumps 14 and 15 phase-shifted by 180 ° and serving to ensure the continuous supply of the second centrifugal tubular chamber 2 by a supply duct 16 connected to a fixed axial element 17 of the second centrifugal tubular enclosure 2.
  • An outlet conduit 24 for the platelet-poor plasma PPP is also connected to the fixed axial element 17.
  • the figure 2 represents the driving and guiding mode of the centrifugal tubular enclosure 1.
  • the set of driving and guiding elements of the centrifugal tubular enclosure is located on the same support 18 connected to the casing of the centrifugal separator by an anti-vibration suspension 19 of silentbloc type.
  • the support 18 has a vertical wall whose lower end terminates in a horizontal support arm 18a to which is attached a drive motor 20.
  • the drive shaft 20a of this motor 20 has a polygonal shape, such as a Torx ® profile, complementary to an axial recess formed in a small tubular element la which projects under the bottom of the tubular centrifugal chamber 1.
  • the coupling between the drive shaft of the motor 20 and the tubular element la must be realized with a very high precision, to ensure extremely precise guidance of this end of the tubular centrifuge chamber 1.
  • the upper end of the tubular centrifuge chamber 1 comprises a cylindrical axial guide member 1b of diameter substantially smaller than that of the tubular centrifuge chamber 1, which protrudes on its upper face.
  • the cylindrical face of this element 1b is intended to engage three centering rollers 21 that can be seen in particular on the figure 3 .
  • One of these rollers 21 is integral with an arm 22, one end of which is pivotally mounted on an upper horizontal part 18b of the support 18.
  • This arm 22 is subjected to the force of a spring (not shown) or any other suitable means, intended to communicate to him a couple tending to rotate it clockwise if one refers to the figure 3 so that it resiliently bears against the cylindrical surface of the cylindrical axial guide member 1b, so that the tubular centrifuge chamber can be put in place and removed from the support 18 by pivoting the arm 22 into the opposite direction to that of the hands of the watch.
  • a device for locking the angular position of the arm 22 corresponding to that in which its roller 21 bears against the cylindrical surface of the cylindrical axial guide member 1b is provided, to avoid having a too strong preload of the spring associated with the arm 22.
  • the span between the cylindrical axial guide element 1b and the upper end of the tubular enclosure 1 serves, in cooperation with the centering rollers 21, axial abutment, preventing disengagement between the drive shaft of the motor 20 and the axial recess of the tubular element 1a protruding under the bottom of the tubular enclosure 1.
  • An elastic element for centering and fixing 23 of the fixed axial input and output element 4 of the tubular centrifugation enclosure is integral with the upper horizontal portion 18b of the support 18.
  • This element 23 comprises two symmetrical elastic branches, of semicircular shapes and which each end with an outwardly curved portion, intended to transmit to these elastic branches forces to separate them from one another, during the lateral introduction of the element axial fixed 4 input and output between them.
  • the centrifugal tubular enclosures will have a diameter of between 10 and 40 mm, preferably 22 mm, and will be driven at a speed of rotation of between 5,000 and 100,000 rpm, so that the tangential speed at which the liquid is submitted does not exceed 26 m / s.
  • the axial length of the tubular centrifugation chamber is advantageously between 40 and 200 mm, preferably 80 mm. Such parameters make it possible to ensure a liquid flow rate of between 20 and 400 ml / min (especially for dialysis), preferably 60 ml / min, corresponding to a residence time of the liquid of 5 to 60 seconds, preferably 15 to 60 seconds. s in the tubular enclosure.
  • the tubular chamber 1 is made from two parts which terminate in respective annular flanges 1c, 1d welded to each other.
  • the internal space of the enclosure is delimited by the substantially cylindrical wall of this enclosure.
  • the axial fixed input and output element 4 enters this tubular enclosure 1 through an axial opening formed through the cylindrical axial guide element 1b.
  • the diameter on which the tubular seal 25 rubs is small and is preferably ⁇ 10 mm, in so that the heating is limited to acceptable values. It can be seen from the aforementioned possible dimensions given for the centrifugal tubular enclosure, that the axial distance between the upper and lower centering and guiding means of this enclosure is greater than five times the diameter of the cylindrical element. axial guide 1b. Given the accuracy with which the tubular enclosure 1 is guided and the accuracy that can reach the relative positioning of the fixed axial input and output element 4, the seal has practically no need to compensate for a lack of concentricity. of the tubular enclosure 1 in rotation, as is the case of the aforementioned devices of the state of the art working in semi-continuous flow. This also contributes to reducing the heating of the rotating tubular joint 25 and thus makes it possible to increase the speed of rotation of the centrifugal tubular enclosure.
  • the fixed axial inlet and outlet element 4 comprises a tubular part 3a which extends the supply duct 3 connected to this axial fixed element 4 to the bottom of the centrifugal tubular enclosure 1 to bring the blood or other physiological fluid to be separated.
  • the outlet ducts 8 and 9 connected to the fixed axial inlet and outlet element 4 each comprise an axial segment 8a, respectively 9a which penetrates into the tubular enclosure and opens into the part of the fixed axial element 4d. inlet and outlet which is in the vicinity of the upper end of the tubular centrifuge chamber 1.
  • the inlet end of each of these outlet ducts 8a, 9a is formed by a circular slot. Each of these slots is formed between two disks 28, 29, respectively 30, 31, integral with the fixed axial element 4 input and output.
  • the radial distance between the edges of the discs 28, 29 and the side wall of the chamber 1 is less than the radial distance between the edges of the discs 30, 31 and the same side wall.
  • the diameter of the portion of the tubular centrifuge chamber 1 located in the exit zone of the PRP and the RBC where the discs 28 to 31 are located is slightly larger than that of the remainder of this tubular enclosure. 1, so as to increase the respective thicknesses of the PRP and RBC layers to facilitate their separate exits.
  • a dead space is provided between the adjacent disks 29 and 30. Its role is to trap leukocytes, whose density is between that of RBCs and platelets, but whose size is much greater than that of RBCs and platelets.
  • the disc 30 has a filter 30a to allow the leukocytes to be separated from the plasma and to trap in the dead space between the discs 29 and 30 only the leucocytes.
  • the second embodiment of the tubular centrifuge chamber illustrated by the figure 5 differs from that of the figure 4 essentially by the presence of a dam 32.
  • This has an annular shape, comprising a cylindrical portion 32a located opposite the circular inlet opening of the PRP formed between the discs 30 and 31.
  • the diameter of this cylindrical portion 32a is chosen to be in the space between the edges of the disks 28, 29 of the side wall of the chamber 1 substantially corresponding to the diameter of the interface between the layers formed by the RBC and the PRP.
  • the two ends of this cylindrical portion 32a end with flat rings, 32b, 32c.
  • the plane ring 32b extends outside the cylindrical portion 32a, while the flat ring 32c extends within this cylindrical portion 32a.
  • the outer plane ring 32b is housed in a clearance of the annular flange 1d and is clamped between the two annular flanges 1c and 1d. This outer plane ring 32b is still traversed by a plurality of openings 32d to allow the passage of the RBCs.
  • This dam 32 has three roles to play. One is to create a physical barrier between the circular inlet opening of the PRP located between the discs 30 and 31 and the RBCs, so as to prevent the swirls generated by the suction at the opening of the opening. admission is likely to re-mix RBCs and PRP. A second role is to collect the RBCs on the same diameter as the plasma, which reduces hemolysis because the edges of the disks 30, 31 forming the outlet of RBC dipping less deeply in the RBC layer since all the discs 28 to 31 are of the same diameter. Finally, the third role is to at least partially retain the leucocytes inside the cylindrical portion 32a of the dam 32.
  • this tubular centrifuge chamber 1 is substantially similar to the first embodiment which has just been described.
  • a leucocyte filter similar to the filter 29a of the figure 4 may also be provided to trap leukocytes between discs 29 and 30.

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  • Centrifugal Separators (AREA)
  • External Artificial Organs (AREA)
  • Sampling And Sample Adjustment (AREA)

Claims (6)

  1. Einmalvorrichtung zum kontinuierlichen Trennen einer Körperflüssigkeit, insbesondere Blut, durch Zentrifugieren mit einem festen axialen Einlass- und Auslasselement (4), um dessen Achse ein Zentrifugierbehälter (1) aus einem Kunststoffmaterial drehbar angebracht ist, mit einem Einlasskanal (3) für das zu zentrifugierende Blut, der sich in Längsrichtung durch das axiale Einlass- und Auslasselement (4) erstreckt und dessen Verteileröffnung in der Nähe des Bodens des Zentrifugierbehälters (1) angeordnet ist, mit einer Auslasspassage (9) für wenigstens einen getrennten Bestandteil, deren Eintrittsöffnung in der Nähe des dem Boden gegenüberliegenden Endes des Behälters (1) und in einem Konzentrationsbereich von wenigstens einem der getrennten Bestandteile mit der geringsten spezifischen Masse angeordnet ist, um diesen kontinuierlich zu entfernen, wobei diese Passage (9) sich durch einen sich in Längsrichtung erstreckenden Teil des festen axialen Einlass- und Auslasselements (4) erstreckt, sowie mit einer Drehverbindung (25) zwischen dem festen axialen Element (4) und dem Zentrifugierbehälter (1), dadurch gekennzeichnet, dass der Zentrifugierbehälter (1) von länglicher röhrenartiger Gestalt ist, dessen Wand eine Fließ- und Trennfläche für die zu trennende Flüssigkeit bildet, wobei das feste axiale Einlass- und Auslasselement (4) eine zweite Auslasspassage (8) für wenigstens einen zweiten der getrennten Bestandteile aufweist, deren Eintrittsöffnung in der Nähe des dem Boden gegenüberliegenden Endes des Behälters (1) und in einer Fließzone angeordnet ist, in der der zweite getrennte Bestandteil mit der größten spezifischen Masse sich konzentriert, um diesen kontinuierlich zu entfernen.
  2. Vorrichtung nach Anspruch 1, bei der das seinem Boden gegenüberliegende Ende des röhrenartigen Zentrifugierbehälters (1) eine zylindrische Verengung (1 b) aufweist, durch die sich das feste axiale Element (4) erstreckt und in dem die Drehverbindung (25) angeordnet ist.
  3. Vorrichtung nach Anspruch 2, bei der die Außenfläche der zylindrischen Verengung (1 b) dazu eingerichtet ist, mit ersten Führungsmitteln (21) des Behälters (1) in Eingriff zu kommen, wobei der Boden des röhrenartigen Zentrifugierbehälters Mittel (1a) aufweist, um mit zweiten Führungs-, Stütz- und Antriebsmitteln des Behälters (1) in Eingriff zu kommen.
  4. Vorrichtung nach Anspruch 1, bei der zwischen den Eintrittsöffnungen der ersten und zweiten Auslasspassagen (8, 9) eine Leukozytenfalle (32) eingerichtet ist und bei der ein Filterelement (32a) die Falle (32) mit der Auslasspassage (9) verbindet, deren Eintrittsöffnung in der Nähe des seinem Boden gegenüberliegenden Endes des Behälters und in einer radialen Entfernung von der Seitenwand des Behälters angeordnet ist, die dem Konzentrationsbereich von wenigstens einem der getrennten Bestandteile mit der geringsten spezifischen Masse entspricht.
  5. Vorrichtung nach einem der vorangehenden Ansprüche, bei der die feste Auslassleitung (9), deren Eintrittsöffnung in dem Konzentrationsbereich von wenigstens einem der getrennten Bestandteile mit der geringsten spezifischen Masse angeordnet ist, mit einem zweiten Zentrifugierbehälter (2) verbunden ist.
  6. Vorrichtung nach Anspruch 1, bei der die Eintrittsöffnungen der Auslasspassagen (8, 9) zwei runde Öffnungen mit gleichem Durchmesser sind, wobei eine ringförmige Sperre (32) gegenüber der runden Eintrittsöffnung der Phase der Flüssigkeit mit der geringsten Dichte angeordnet ist, wobei der Durchmesser der Sperre (32), die in dem die runde Eintrittsöffnung der ersten Passage (9) von der Seitenwand des Behälters (1) trennenden Raum angeordnet ist, im Wesentlichen dem Durchmesser der Schnittstelle zwischen den durch die RBC und das PRP gebildeten Schichten entspricht.
EP06700529A 2005-01-25 2006-01-23 Wegwerfvorrichtung für die kontinuierliche trennung einer physiologischen flüssigkeit durch zentrifugation Not-in-force EP1871530B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06700529A EP1871530B1 (de) 2005-01-25 2006-01-23 Wegwerfvorrichtung für die kontinuierliche trennung einer physiologischen flüssigkeit durch zentrifugation

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05405038A EP1683579A1 (de) 2005-01-25 2005-01-25 Einweggerät zur kontinuierlichen Trennung einer physiologischen Flüssigkeit mittels Zentrifugieren
PCT/CH2006/000049 WO2006079238A1 (fr) 2005-01-25 2006-01-23 Dispositif jetable pour la separation en continu par centrifugation d'un liquide physiologique
EP06700529A EP1871530B1 (de) 2005-01-25 2006-01-23 Wegwerfvorrichtung für die kontinuierliche trennung einer physiologischen flüssigkeit durch zentrifugation

Publications (2)

Publication Number Publication Date
EP1871530A1 EP1871530A1 (de) 2008-01-02
EP1871530B1 true EP1871530B1 (de) 2010-09-08

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Family Applications (2)

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EP05405038A Withdrawn EP1683579A1 (de) 2005-01-25 2005-01-25 Einweggerät zur kontinuierlichen Trennung einer physiologischen Flüssigkeit mittels Zentrifugieren
EP06700529A Not-in-force EP1871530B1 (de) 2005-01-25 2006-01-23 Wegwerfvorrichtung für die kontinuierliche trennung einer physiologischen flüssigkeit durch zentrifugation

Family Applications Before (1)

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EP05405038A Withdrawn EP1683579A1 (de) 2005-01-25 2005-01-25 Einweggerät zur kontinuierlichen Trennung einer physiologischen Flüssigkeit mittels Zentrifugieren

Country Status (8)

Country Link
US (2) US8070664B2 (de)
EP (2) EP1683579A1 (de)
JP (1) JP2008528066A (de)
AT (1) ATE480333T1 (de)
AU (1) AU2006208525A1 (de)
CA (1) CA2592275A1 (de)
DE (1) DE602006016762D1 (de)
WO (1) WO2006079238A1 (de)

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AU2006208525A1 (en) 2006-08-03
CA2592275A1 (fr) 2006-08-03
AU2006208525A2 (en) 2006-08-03
US20120077663A1 (en) 2012-03-29
US8070664B2 (en) 2011-12-06
EP1871530A1 (de) 2008-01-02
EP1683579A1 (de) 2006-07-26
JP2008528066A (ja) 2008-07-31
ATE480333T1 (de) 2010-09-15
US8348823B2 (en) 2013-01-08
DE602006016762D1 (de) 2010-10-21
WO2006079238A1 (fr) 2006-08-03

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