EP1688183A1 - Verfahren und Wegwerfartikel für die Trennung einer physiologischen Flüssigkeit in einer Zentrifuge - Google Patents

Verfahren und Wegwerfartikel für die Trennung einer physiologischen Flüssigkeit in einer Zentrifuge Download PDF

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Publication number
EP1688183A1
EP1688183A1 EP05405052A EP05405052A EP1688183A1 EP 1688183 A1 EP1688183 A1 EP 1688183A1 EP 05405052 A EP05405052 A EP 05405052A EP 05405052 A EP05405052 A EP 05405052A EP 1688183 A1 EP1688183 A1 EP 1688183A1
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EP
European Patent Office
Prior art keywords
tubular
liquid
enclosure
chamber
centrifugal
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Withdrawn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
EP05405052A
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English (en)
French (fr)
Inventor
Jean-Denis Rochat
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Individual
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Individual
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 Individual filed Critical Individual
Priority to EP05405052A priority Critical patent/EP1688183A1/de
Priority to JP2007553434A priority patent/JP2008528213A/ja
Priority to CA002596450A priority patent/CA2596450A1/fr
Priority to PCT/CH2006/000061 priority patent/WO2006081699A1/fr
Priority to EP06701051A priority patent/EP1846167A1/de
Priority to US11/815,419 priority patent/US20080128367A1/en
Priority to AU2006209864A priority patent/AU2006209864A1/en
Publication of EP1688183A1 publication Critical patent/EP1688183A1/de
Withdrawn legal-status Critical Current

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    • 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

Definitions

  • the present invention relates to a method for the centrifugal separation of a physiological liquid and to a disposable device for the centrifugal separation of this physiological liquid, in particular blood, comprising a circular centrifuge chamber rotatably mounted about its axis. of revolution, an inlet channel for the centrifugal blood whose distribution opening is located near the bottom of said centrifuge chamber, an outlet passage for at least one of the separated constituents of said liquid having the highest density. low, whose collection opening is located near the end of said chamber opposite said bottom, said liquid forming a substantially axial tubular flow against the circular side wall of said enclosure between said distribution and collection openings, which is finds in a concentration zone of said separate constituent to remove it continuously.
  • leukocytes Given the viscosity of RBCs, their proportion and the small difference in the respective densities of leukocytes and RBCs, leukocytes have great difficulty in returning to the surface of the RBC layer during the separation of RBC components. blood by centrifugation, since leukocytes remain most often trapped under the red blood cell layer.
  • the object of the present invention is to remedy, at least partially, these disadvantages.
  • the subject of the present invention is firstly a centrifugal separation method for a determined volume of a physiological liquid, especially blood, according to claim 1. It also relates to a disposable device for the centrifugal separation of a physiological fluid, especially blood according to claim 3.
  • the method and the device according to the present invention provide an important simplification of the operations for separating physiological liquids, in particular blood, by making it possible to carry out the deleucocytation of the separated components during the liquid centrifugation separation operation.
  • the supply and outlet ducts of the components separated from the device according to the invention are fixed and the two main components RBC and PRP leave the device continuously.
  • the inner face of the side wall of the centrifuge chamber comprises an annular segment flaring in the direction of the axial flow of said liquid to cause a local acceleration of this flow and a corresponding reduction in the thickness of the the layer of said liquid.
  • This zone of acceleration of the flow is intended to allow leukocytes with a density slightly lower than that of red blood cells, but of a substantially larger size to be released from the mass of red blood cells. so that after the separation zone, when the flow velocity decreases and the liquid layer increases, the leucocytes are found at the interface between the red blood cells and the PRP.
  • this acceleration zone also makes it possible to eject the platelets from the red blood cells during concentration, thereby increasing the platelet yield of the PRP.
  • the housing of the centrifugal separator intended to use the device according to the present invention and illustrated schematically in FIG. 1 comprises two elongate centrifugation enclosures 1, 2 of tubular form.
  • the first centrifugal tubular chamber 1, which is the subject of the present invention, 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 ° relative to each 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 tubular centrifuge chamber 2 by a supply duct 16 connected to a fixed axial element 17 of the second centrifugal tubular chamber 2.
  • An outlet duct 24 for the platelet poor plasma PPP is also connected to the fixed axial element 17.
  • FIG. 2 represents the driving and guiding mode of the substantially tubular centrifugation enclosure 1.
  • the assembly of the driving and guiding elements of the centrifugal tubular enclosure is located on the same support 18 connected to the housing 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 element tubular 1a must be made with 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 with three centering rollers 21.
  • One of these rollers 21 is integral with an arm 22, one end of which is pivotally mounted on an upper horizontal part of the support 18.
  • This arm 22 is subjected to the force of a spring (not shown) or any other suitable means, intended to impart to it a torque tending to rotate it clockwise, so that it resiliently bears against the cylindrical surface of the cylindrical axial guide member 1b.
  • tubular centrifuge chamber can be put in place and removed from the support 18 by pivoting the arm 22 in 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 too much prestressing 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 uncoupling between the drive shaft 20a of the engine 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 a curved part to the outside, intended to transmit to these elastic branches forces to separate them from one another, during the lateral introduction of the fixed axial element 4 input and output between them.
  • the tubular centrifuge chamber 1 has a diameter of between 10 and 50 mm, preferably 30 mm, and is driven at a rotation speed of between 5,000 and 100,000 rpm, so that the tangential velocity at which the liquid is subjected does not exceed preferably 26 m / s.
  • the axial length of the centrifugal tubular chamber 1 is advantageously between 40 and 200 mm, preferably 90 mm.
  • Such parameters make it possible to ensure a liquid flow rate of between 20 and 400 ml / min (especially for dialysis), preferably 100 ml / min, corresponding to a residence time of the liquid of 0.5 to 60 seconds, preferably 5 seconds in the tubular enclosure.
  • the tubular enclosure 1 is made from two parts, the tubular enclosure itself and a closure element 1f, both of which terminate in respective annular assembly flanges 1c, 1d welded to each other.
  • the internal space of the tubular portion 1e is delimited by the substantially cylindrical wall of this chamber.
  • its cylindrical side wall Near the bottom of the tubular enclosure 1e, its cylindrical side wall has a conical segment 1g ( Figure 3) whose role will be explained later.
  • the axial fixed input and output element 4 enters this tubular enclosure 1 through an axial opening formed in the center of the cylindrical axial guide element 1b.
  • the tightness between this axial opening integral with the centrifuge chamber 1 and the fixed axial element 4 is achieved by a tubular joint 25, a segment of which is fixed on a cylindrical portion of this axial fixed element 4 inlet and outlet , while another segment is introduced into an annular space 26 of the cylindrical axial guide element 1b and bears on a convex surface of the tubular wall 27 separating the axial opening through the cylindrical axial guide element 1b of the annular space 26.
  • This seal serves to preserve the sterility of the liquid contained in the centrifuge chamber.
  • the portion of the tubular seal 25 which bears on the tubular wall 27 undergoes a slight radial deformation to ensure sealing.
  • the diameter on which the tubular seal 25 rubs is small and is preferably ⁇ 10 mm, so that the heating is limited to acceptable values. It can also be seen from the aforementioned possible dimensions given for the tubular centrifuge chamber 1, that the axial distance between the centering and upper guide means 21 and lower 20a of this chamber 1 is greater than five times the diameter of the cylindrical axial guide member 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 known 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 rotational speed of the centrifugal tubular enclosure 1.
  • 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 collection 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 diameters of these four discs 28 to 31 are preferably substantially identical.
  • the circular collection openings formed between the discs 28, 29, respectively 30, 31 are separated from each other by a tubular barrier 32, shown separately in FIG. 5. It comprises a tubular wall 32a concentric and parallel to the side wall of the centrifuge chamber 1e. As can be seen in particular in FIG. 4, the radial spacing between this tubular wall 32a and the side wall of the tubular enclosure 1e, as well as the thickness of this tubular wall 32a are chosen so that this tubular wall 32a is entirely in the thickness formed by the L1 phase of the centrifugally separated liquid having the highest density, corresponding to RBC.
  • the end of this tubular wall 32a farthest from the bottom of the centrifuge chamber 1 has an annular portion 32b closes in the direction of the axial fixed portion 4, in the space between the discs 29 and 30.
  • This annular portion 32b has an inner annular flange 32c extending towards the bottom of the centrifuge chamber 1.
  • the diameter of this annular flange 32c is chosen to be in the thickness formed by the L2 phase of the separated liquid by centrifugation having the lowest density corresponding to the PRP.
  • the leucocytes which are in the vicinity of the interface of the phases L1, L2 of the centrifugally separated liquid have only one possibility, that of being deposited at the bottom of the annular storage space provided between the wall tubular 32a of the dam 32 and the inner annular flange 32c.
  • These leucocytes L3 accumulate by progressively pushing the RBC towards the open end of the dam 32.
  • the volume of the annular space thus formed between the tubular wall 32a and the annular rim 32c is chosen to contain at least the volume of leukocytes contained in a determined volume of blood to be centrifuged, for example 450 ml, which is the usual capacity of blood taken from a donor, this volume obviously being slightly variable from one individual to another.
  • the cylindrical portion formed by the annular rim 32c is located opposite the circular collection opening formed between the discs 30 and 31, thus isolating this opening of the liquid phases other than the L2 phase. intended to be sucked by this circular collection opening. This avoids the risk of re-mixing that could cause the swirls generated by this suction.
  • the two collection openings formed respectively between the discs 28, 29 and 30, 31 must be separated to allow them to have substantially the same diameters.
  • the diameter of the inner edge of the portion 32f extending radially towards the center of said tubular enclosure 1 must be smaller than those of the discs 28 to 31.
  • the fixing of the dam 32 is obtained by pinching an annular portion 32d between the assembly flanges 1c, 1d.
  • This annular portion 32d is connected to the tubular dam itself by arms 32e ( Figure 5) which form between them openings for the passage of RBC to the circular collection opening formed between the discs 28 and 29.
  • the diameter of the side wall of the closure member 1f of the tubular enclosure 1 is smaller than that of the side wall of the tubular enclosure proper 1e, because the tubular barrier 32 is entirely housed in the 1e part of this chamber 1. Thus reduces the volume of RBC immobilized in the centrifuge chamber 1.
  • the role of the conical portion 1g (FIG. 3) of the tubular enclosure 1 is to locally reduce the thickness of the liquid flow to be centrifuged by accelerating its flow rate. Thanks to this frustoconical zone 1g where the thickness of the liquid layer is very small, its thickness being close to the size of the leucocytes which often have difficulty emerging from the layer of red blood cells because of their density very close of their size substantially larger than that of red blood cells and viscosity of these, no longer have to go through a relatively large thickness of red blood cells, so that when the thickness of the liquid layer increases once the liquid in the cylindrical tubular zone, under the effect of the centrifugal force which exerts itself on the axial tubular flow of liquid, the leucocytes remain at the interface which forms between the RBCs and the PRP.
  • This conical portion 1g also has the effect of ejecting the platelets of the red blood cells during concentration, which increases the platelet yield of the PRP.
  • FIG. 6 illustrates a variant of the bottom shape of the tubular centrifugal enclosure 1.
  • the bottom of this enclosure 1 ' is connected to the conical portion 1'g by a rounded annular surface 1'h.
  • the role of this surface 1'h is to reduce the transition between the radial flow of the liquid and its axial flow, so as to reduce the risk of hemolysis.
  • the rounded surface 1'h could have a sufficiently large radius to allow to replace the conical surface 1g since this rounded surface 1'h would achieve the same goal, namely the acceleration of flow and the localized thinning of the thickness of the layer.
  • the thinning of the layer of liquid flow intended to prevent the leukocytes to be trapped under the RBC layer requires a sufficiently precise guidance of the centrifuge chamber, as allowed by the design of the embodiments of the enclosure described above and its variant. Indeed, if the accuracy of this axial guidance of the chamber was less than the thickness of the thinned liquid layer to a thickness close to the size of the leucocytes, the decentration of the centrifuge chamber would then not allow obtain a continuous thinned annular or tubular liquid flow layer.

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  • External Artificial Organs (AREA)
EP05405052A 2005-02-03 2005-02-03 Verfahren und Wegwerfartikel für die Trennung einer physiologischen Flüssigkeit in einer Zentrifuge Withdrawn EP1688183A1 (de)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP05405052A EP1688183A1 (de) 2005-02-03 2005-02-03 Verfahren und Wegwerfartikel für die Trennung einer physiologischen Flüssigkeit in einer Zentrifuge
JP2007553434A JP2008528213A (ja) 2005-02-03 2006-02-01 遠心分離による血液の分離のための方法および使い捨て装置
CA002596450A CA2596450A1 (fr) 2005-02-03 2006-02-01 Procede et dispositif jetable pour la separation par centrifugation de sang
PCT/CH2006/000061 WO2006081699A1 (fr) 2005-02-03 2006-02-01 Procede et dispositif jetable pour la separation par centrifugation de sang
EP06701051A EP1846167A1 (de) 2005-02-03 2006-02-01 Verfahren und einweg-vorrichtung zur zentrifugalen trennung einer physiologischen flüssigkeit
US11/815,419 US20080128367A1 (en) 2005-02-03 2006-02-01 Method and Disposable Device For Blood Centrifugal Separation
AU2006209864A AU2006209864A1 (en) 2005-02-03 2006-02-01 Method and disposable device for blood centrifugal separation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP05405052A EP1688183A1 (de) 2005-02-03 2005-02-03 Verfahren und Wegwerfartikel für die Trennung einer physiologischen Flüssigkeit in einer Zentrifuge

Publications (1)

Publication Number Publication Date
EP1688183A1 true EP1688183A1 (de) 2006-08-09

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EP05405052A Withdrawn EP1688183A1 (de) 2005-02-03 2005-02-03 Verfahren und Wegwerfartikel für die Trennung einer physiologischen Flüssigkeit in einer Zentrifuge
EP06701051A Withdrawn EP1846167A1 (de) 2005-02-03 2006-02-01 Verfahren und einweg-vorrichtung zur zentrifugalen trennung einer physiologischen flüssigkeit

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EP06701051A Withdrawn EP1846167A1 (de) 2005-02-03 2006-02-01 Verfahren und einweg-vorrichtung zur zentrifugalen trennung einer physiologischen flüssigkeit

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US (1) US20080128367A1 (de)
EP (2) EP1688183A1 (de)
JP (1) JP2008528213A (de)
AU (1) AU2006209864A1 (de)
CA (1) CA2596450A1 (de)
WO (1) WO2006081699A1 (de)

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CN103582530A (zh) * 2010-11-19 2014-02-12 肯希纳什公司 离心机
US20210205734A1 (en) * 2019-06-06 2021-07-08 Pneumatic Scale Corporation Centrifuge System for Separating Cells in Suspension

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EP1683579A1 (de) * 2005-01-25 2006-07-26 Jean-Denis Rochat Einweggerät zur kontinuierlichen Trennung einer physiologischen Flüssigkeit mittels Zentrifugieren
WO2006086201A2 (en) 2005-02-07 2006-08-17 Hanuman Llc Platelet rich plasma concentrate apparatus and method
EP2666493B1 (de) 2005-02-07 2020-09-23 Hanuman LLC Vorrichtung für blutplättchenreiches Plasmakonzentrat
US7866485B2 (en) 2005-02-07 2011-01-11 Hanuman, Llc Apparatus and method for preparing platelet rich plasma and concentrates thereof
EP1911520A1 (de) * 2006-10-10 2008-04-16 Jean-Denis Rochat Wegwerfset zur Bluttrennung oder zum Waschen von Blutkomponenten
JP4548675B2 (ja) * 2007-05-28 2010-09-22 紘一郎 迫田 改良型レーサムボウル及び使用方法
US8337711B2 (en) 2008-02-29 2012-12-25 Biomet Biologics, Llc System and process for separating a material
US10040077B1 (en) * 2015-05-19 2018-08-07 Pneumatic Scale Corporation Centrifuge system including a control circuit that controls positive back pressure within the centrifuge core
US8012077B2 (en) 2008-05-23 2011-09-06 Biomet Biologics, Llc Blood separating device
US8187475B2 (en) 2009-03-06 2012-05-29 Biomet Biologics, Llc Method and apparatus for producing autologous thrombin
JP5631410B2 (ja) * 2009-12-11 2014-11-26 テルモ ビーシーティー、インコーポレーテッド シールド付きの抽出ポート及び光学的制御を有する血液分離システム
US8556794B2 (en) 2010-11-19 2013-10-15 Kensey Nash Corporation Centrifuge
US8317672B2 (en) 2010-11-19 2012-11-27 Kensey Nash Corporation Centrifuge method and apparatus
US8870733B2 (en) 2010-11-19 2014-10-28 Kensey Nash Corporation Centrifuge
US8394006B2 (en) 2010-11-19 2013-03-12 Kensey Nash Corporation Centrifuge
US9308314B2 (en) 2011-04-08 2016-04-12 Sorin Group Italia S.R.L. Disposable device for centrifugal blood separation
US11878312B2 (en) * 2011-11-21 2024-01-23 Pneumatic Scale Corporation Centrifuge system for separating cells in suspension
US11065629B2 (en) * 2011-11-21 2021-07-20 Pneumatic Scale Corporation Centrifuge system for separating cells in suspension
EP2814616A4 (de) * 2012-02-15 2015-08-12 Microaire Surgical Instr Llc Vorrichtung zur zentrifugation und verfahren dafür
CN102941163B (zh) * 2012-10-12 2014-06-11 天津大学 连续化海冰离心脱盐系统装置及方法
KR102502975B1 (ko) 2014-01-31 2023-02-23 디에스엠 아이피 어셋츠 비.브이. 지방 조직 원심 분리기 및 그 사용 방법
US10039876B2 (en) 2014-04-30 2018-08-07 Sorin Group Italia S.R.L. System for removing undesirable elements from blood using a first wash step and a second wash step
US9713810B2 (en) 2015-03-30 2017-07-25 Biomet Biologics, Llc Cell washing plunger using centrifugal force
US9757721B2 (en) 2015-05-11 2017-09-12 Biomet Biologics, Llc Cell washing plunger using centrifugal force
BR112020025083A2 (pt) * 2018-06-08 2021-03-23 Pneumatic Scale Corporation sistema de centrífuga para separar células em suspensão

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EP0257755A1 (de) * 1986-07-22 1988-03-02 Haemonetics Corporation Zentrifugengehäuse oder Rotor für Plasmapherese
EP0664159A1 (de) * 1994-01-21 1995-07-26 Haemonetics Corporation Zentrifugenbecker für Blutbehandlung mit mehreren Sammelstellen
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Publication number Priority date Publication date Assignee Title
CN103582530A (zh) * 2010-11-19 2014-02-12 肯希纳什公司 离心机
US20210205734A1 (en) * 2019-06-06 2021-07-08 Pneumatic Scale Corporation Centrifuge System for Separating Cells in Suspension
US11957998B2 (en) * 2019-06-06 2024-04-16 Pneumatic Scale Corporation Centrifuge system for separating cells in suspension

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AU2006209864A1 (en) 2006-08-10
US20080128367A1 (en) 2008-06-05
EP1846167A1 (de) 2007-10-24
JP2008528213A (ja) 2008-07-31
AU2006209864A2 (en) 2006-08-10
CA2596450A1 (fr) 2006-08-10
WO2006081699A1 (fr) 2006-08-10

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