EP1965925A1 - Disposable device for centrifugation of blood - Google Patents

Disposable device for centrifugation of blood

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Publication number
EP1965925A1
EP1965925A1 EP06817753A EP06817753A EP1965925A1 EP 1965925 A1 EP1965925 A1 EP 1965925A1 EP 06817753 A EP06817753 A EP 06817753A EP 06817753 A EP06817753 A EP 06817753A EP 1965925 A1 EP1965925 A1 EP 1965925A1
Authority
EP
European Patent Office
Prior art keywords
chamber
centrifugation
blood
opening
gaseous fluid
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.)
Granted
Application number
EP06817753A
Other languages
German (de)
French (fr)
Other versions
EP1965925B1 (en
Inventor
Jean-Denis Rochat
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Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to EP06817753A priority Critical patent/EP1965925B1/en
Publication of EP1965925A1 publication Critical patent/EP1965925A1/en
Application granted granted Critical
Publication of EP1965925B1 publication Critical patent/EP1965925B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • B04B7/00—Elements of centrifuges

Definitions

  • the present invention relates to a disposable blood centrifugation device for separating or also washing constituents of the blood.
  • blood may be for example whole blood, blood already leucocyte filtered or blood bled from an operative field.
  • centrifugation The most commonly used principle for separating blood components, such as red blood cells, plasma, white blood cells and platelets, from blood directly from the donor, a collection bag, an operating field or a sample blood, is the centrifugation.
  • separators consisting of a centrifugation chamber rotated about a vertical axis by a motor that can rotate at high speed, generally between 100 ° and 50,000 rpm.
  • the blood is introduced continuously or discontinuously into the centrifugation chamber through a feed channel forming part of a fixed axial member of the centrifuge device.
  • each blood component is conducted separately to a outlet channel located in the fixed axial member of the device. Once extracted from the centrifuge chamber by these outlet channels, they can be collected in separate pockets or re-injected to the patient.
  • the main drawbacks of this device lie in the fact that it is of complex construction, that it involves the cumbersome rotation of a tube around the centrifugation chamber and that this tube is subjected to a significant tensile stress generated by the centrifugal force to which it is subjected.
  • the seal between the fixed and movable parts of the centrifugation device is achieved by means of a tubular seal.
  • One of the ends of this seal is fixed on a cylindrical portion of the fixed axial member, while the other end is introduced into an annular space of the neck of the centrifuge chamber while bearing against a convex surface of this collar.
  • the tubular seal undergoes a radial deformation which seals the centrifuge chamber.
  • the diameter of the neck of the centrifuge chamber against which rubs this seal is of small diameter, the fact remains that it results in a heating directly depending on the speed of rotation of the chamber. With this system, the maximum speed of rotation is limited because of this heating.
  • the use of chambers provided with a larger diameter neck would again remove any satisfaction in the use of this gasket to solve the problem of heating referred.
  • the purpose of the present invention aims to remedy at least in part the aforementioned drawbacks by suggesting a disposable blood centrifugation device which can allow, on the one hand to ensure the sterility of all the internal volumes of this device which are in contact with the blood, and secondly to eliminate any heating resulting from the rotation of this chamber around the static inlet / outlet member disposed on the axis of revolution of the chamber.
  • Another object of the present invention is to provide a centrifuge device which is also economical. Indeed, in the field of handling or blood processing, it is not uncommon that the material used is thrown after its first use. Although still functional from a functional point of view, such a centrifugation device will be intended for a single use for the reasons that are known and which aim to avoid any risk of blood contamination. It is therefore advantageous to provide a single-use device design that is as simple as possible while meeting the requirements of sterility and efficiency requirements.
  • the first advantage of this device lies in the fact that it suppresses any possible rise in temperature of the blood or its constituents. As a result, the quality of the latter is ensured since it is not altered.
  • the speed of rotation of the centrifugation chamber is no longer dependent on the means ensuring the sterility of the device relative to a non-sterile external medium.
  • the higher this speed the shorter the residence time of the blood in the chamber in order to obtain the separation of its constituents.
  • the treated blood flow can usefully be increased and the effectiveness of the device will also be improved.
  • Figure 1 is a schematic vertical sectional view of the device of the present invention shown in a so-called opening position.
  • FIG. 2 is a detailed view of a portion of the centrifugation chamber shown diagrammatically in FIG.
  • Figure 2a is a detail view of a variant of the illustration given in Figure 2.
  • Figure 3 is a view similar to that of Figure 1 illustrating the connection of a channel of the device of the present invention to an external machine.
  • Figure 4 is a schematic view, similar to that of Figure 2, showing a variant of the device of the present invention wherein the device is shown in a so-called closing position.
  • the disposable device of the present invention comprises a centrifuge chamber 10 having an axis of revolution 2, preferably vertical. This axis of revolution passes through an opening 11 formed in the upper part 3 of the centrifugation chamber. The latter is rotated about its axis of revolution by drive means 20, such as an electric motor whose rotation shaft 21 is secured to the lower portion 4 of the centrifuge chamber.
  • drive means 20 such as an electric motor whose rotation shaft 21 is secured to the lower portion 4 of the centrifuge chamber.
  • guide means 22 preferably arranged in its upper part 3 so as to engage with the latter.
  • These means may for example consist of three centering rollers, engaged with a tread 13 and arranged at 120 ° around the axis of revolution 2 of the chamber.
  • they can be mounted retractable, for example at the end of a pivoting arm or a telescopic arm.
  • the tread 13 will preferably be part of the neck 12 of the centrifugation chamber and will be formed of a perfectly circular outer surface and concentric with the axis of revolution 2.
  • at least one centering roller could advantageously be mounted on an elastic suspension. Such an arrangement could for example be achieved by arranging a roller at the end of an arm pivotally mounted under the action of a return spring so as to ensure the permanent contact of the roller against the tread 13.
  • the opening 11 of the centrifugation chamber 10 is traversed by at least one static member 30 for admission / evacuation of the blood and at least one of its constituents.
  • the static connotation given to this member 30 is simply to clarify that it is not rotated, unlike the centrifuge chamber.
  • the device of the present invention comprises a part movable in rotation, through the opening of which is engaged at least one non-movable part in rotation. These parts may be fixed or preferably movable, relative to each other, in translation along the axis of revolution 2 as will be seen later.
  • the static inlet / outlet member 30 is engaged in the centrifuge chamber 10 through its opening 11, so that a portion of this member is located inside the centrifugation chamber 10 while another portion is outside of it.
  • This organ comprises at least one supply channel 31 of the blood, for example from a pocket, not shown, for collecting a determined volume of blood.
  • it could also be possible to treat blood directly from a donor via flexible conduits connected to the end In the case of autotransfusion, it is possible to treat bleeding blood from an operating field.
  • the flow of blood is continuously or intermittently from the outside to the inside of the centrifuge chamber.
  • the static member also comprises at least one outlet channel 32 of a blood component.
  • the flow of this component is from the inside to the outside of the chamber, according to the arrow 32a.
  • a constituent will for example consist of a concentrate of red blood cells.
  • the outlet channel 33 is a third channel which is preferably arranged within the static organ 30 and which is used to extract a second component of the blood, such as, for example, the platelet-rich plasma.
  • the direction of flow of this second blood constituent is in accordance with the illustration given by the arrow 33a.
  • an additional channel may be added to introduce into the centrifugation chamber 10 a blood wash solution, such as saline, for example.
  • a blood wash solution such as saline, for example.
  • This solution will be mixed with the blood in the chamber 10, then, thanks to the centrifugal forces, separated from the red blood cells by taking with it the impurities contained in the collected blood before being extracted with the plasma by the outlet channel 33.
  • the ends of the outlet channels 32, 33 are intended to be connected to flexible bags, not shown, for collecting the blood components.
  • these outputs are respectively connected to a re-injection means of the washed component to the patient and to a bag containing washing waste.
  • the connections between these bags and the channels of the centrifuge device are hermetic and performed under the required sterility conditions.
  • these connections are made in advance, following the manufacture of the centrifugation device, so that this assembly can be packaged in a preferably hermetic and sterile packaging for marketing.
  • such a package may also be porous to allow subsequent sterilization with steam or gas, before use of the device.
  • the static member 30 further comprises at least one inlet channel 34 of a gaseous fluid under pressure opening inside the centrifugation chamber, preferably in the upper part 3 thereof.
  • This fluid may be pre-sterilized air from a source allowing at least to deliver this gas under a specific pressure, preferably at an adjustable flow rate.
  • the gaseous fluid enters the inlet channel 34, in accordance with the direction of flow indicated by the arrow 34a, before emerging at the mouth 35 of this channel in the centrifugation chamber, preferably slightly below the neck 12 of the centrifuge chamber. it.
  • the static admission / discharge member 30 comprises a plurality of collectors 37 for capturing the constituents. blood. These collectors extend radially until they reach the different zones of stratification 3a, 3b of these constituents. By these capture channels, these can be extracted simultaneously or successively from the centrifugation chamber via the outlet channels 32, 33 of the static member 30.
  • the zone 3a corresponds to the one where red blood cells of higher density are found than the plasma which will be located in zone 3b, closer to the axis of revolution 2 than the previous one. This distribution occurs naturally under the effect of the centrifugal force applied to the blood spilled in the centrifuge chamber.
  • the collectors 37 for capturing red blood cells have been represented. Similar collectors will also be used to capture plasma or wash waste. Because these collectors are located below the previous ones, they do not appear in the illustrations of the figures attached to this description.
  • a gap 38 is formed in the opening 11 of the chamber, between the latter and the static member 30 of admission / evacuation.
  • This gap is intended to constitute an escape route for the gaseous fluid introduced under pressure into the centrifuge chamber. From the inlet channel 34, this gaseous fluid arrives in the chamber through the mouth 35. It fills the space available in this chamber by putting it under pressure. The pressure results from the pressure loss created by the flow through the gap 38. The latter will therefore be dimensioned so as to generate a measurable and sufficient overpressure in the centrifuge chamber. Thanks to this calibrated gap, the gaseous fluid escapes from this chamber in a controlled manner in a continuous flow in accordance with the direction given by the arrow 34b.
  • the main function performed by this gas flow is to repel any infiltration of germs thus protecting the centrifuge chamber and its contents from any contamination via gas escape through the gap 38.
  • This function acts as a barrier against the infiltration of microorganisms into the device.
  • no rise in temperature of the blood or its constituents will be observed. This is due to the fact that there is no longer any contact between the static member 30 and the spinning chamber 10 rotatable.
  • the arrangement of this gap makes it possible to guarantee the absence of any wear between the rotating part and the non-rotating part of the device of the present invention. According to the preferred embodiment, it will be ensured that the opening 11 and the static member 30 are, around the neck 12, circular and concentric with the axis of revolution 2 so that the distribution of the gas flow through gap 38 can be as homogeneous as possible.
  • the inlet channel 34 may be provided with at least one filter 39, for single use, sterilization of the gaseous fluid as clearly visible in FIG. 1.
  • the arrangement of such a filter may have as its object to guarantee the sterility of the gaseous fluid so as not to contaminate the blood or its constituents.
  • such a filter can also serve as a sterile barrier preventing any microorganism from entering the inlet channel 34 when no other means closes the latter upstream.
  • it also makes it possible to guarantee the flawless state of the fluid filtration means because it is part of the single-use disposable device of the present invention.
  • the fluid used may be either a sterile gas or a gas pre-filtered at the source, or a gas that is intended to be purified by one or more filters 39 arranged in the upstream portion of the inlet channel 34
  • filters 39 any conventional device which allows the resulting fluid to destroy, inactivate, trap or reduce the microorganisms it contains at a level of sterility in accordance with the standards imposed in the field of transfusions and other blood manipulations.
  • the device is provided with a hermetic sealing means 40 of the gap 38.
  • a hermetic sealing means 40 may consist of a shoulder 41 and / or a bearing 42 , of conical rounded or cylindrical shape, which can fit into the opening 11 of the centrifugation chamber or around the neck 12, more precisely fit tightly against this neck, for example in the gap 38 by translation of the one or the other of the mobile and non-mobile parts in rotation of the device.
  • the hermetic closure of this means against the opening in the neck of the centrifugation chamber could if necessary be improved by the arrangement of an O-ring, not shown, integral with either the static member 30 or the collar 12 of the centrifuge chamber.
  • the centrifugation chamber 10 and / or the static admission / discharge member 30 can slide along the axis of revolution 2, between a closed position of the gap 38 and an open position thereof, and secondly hold in this open position by means of a means for automatically opening the gap 38.
  • a means of opening the gap 38 may be constituted by the pressure exerted by the gaseous fluid on the closure means 40, more particularly on the shoulder 41.
  • the overpressure within the chamber will allow to expel sufficiently, or the chamber 10 downwards in the case where the static member 30 is held fixed along the axis of revolution 2, or the static member 30 upwards in the opposite case where it is the centrifugation chamber which is kept fixed along its axis of revolution.
  • the opening means may be constituted by a conical portion 60 adjacent to the tread 13.
  • This variant is given in Figure 2a which shows in detail an illustration of the collar 12 in FIG. the guide means 22 are already engaged with the tread 13.
  • the conical portion 60 preferably a conical trunk portion, located just below the tread 13 is noted.
  • the operation of this opening means according to the second embodiment is as follows.
  • the automatic opening of the gap 38 is obtained by a slight sliding down of the centrifugation chamber 10 along its axis of revolution 2. This sliding is obtained automatically when the guide means 22 come into contact with the room in a room first time in contact with the opening means consisting of the conical portion 60. Indeed, the support and clamping of the guide means 22 against this conical portion will push the latter down until the means of guidance are engaged with the tread 13, as shown in Figure 2a. By this slight displacement of the sliding chamber downwards, the gap 38 will be released, the lower part 4 of the chamber will be able to engage the shaft 21 of the drive means 20, and the device will be soon ready to operate.
  • the opening means 40 also allows the gap 38 to be maintained in its open position, thus avoiding its inadvertent closing during the time necessary for using the device.
  • the filter 39, the closure means 40 and the possible sliding of one or the other of the two main parts 30, 10 of the device between two relatively close positions it is possible to condition and then sterilize, in the closed position , the device of the present invention in its packaging and to ensure the sterility of this device until its use.
  • the inlet channel 34 can be connected to a common, and therefore not shown, control or pressure regulation member within this channel.
  • this member could be supplemented or replaced by a control member or regulating the flow of the gaseous fluid.
  • control means make it possible to ensure the proper functioning of the centrifugation chamber by detecting for example a possible uncontrolled leak or an abnormal throttling, or even a total obstruction or blockage of the opening 11.
  • the overpressure within the centrifuge chamber can typically be of the order of 0.1 to 100 millibars for the main function of the gaseous fluid can be filled correctly.
  • the inlet channel 34 of the gaseous fluid terminates upstream by a protective membrane 45 which at least partially closes this channel.
  • this membrane Made of a flexible and elastic material, this membrane can be in two possible configurations.
  • the protective membrane 45 hermetically closes the inlet channel 34 in order to guarantee the sterility of the entire device when it is not yet connected to the source of gaseous fluid for which it is intended.
  • the protective membrane 45 and the closure device 40 make it possible to ensure the non-contamination of the device of the present invention as soon as it is removed from its sterile packaging, not shown, and until it is is connected to the source of gaseous fluid via the inlet channel 34.
  • this protective membrane can be pierced as is referred to in FIG.
  • this protective membrane may, if necessary, also be applied to a lining 46 integral with the upstream end portion of the inlet channel 34.
  • the device of the present invention can be connected to a machine 50 for treating blood fluids.
  • the wall of the machine will then comprise, for example, a tubular tip 51 for perforating the protective membrane 45. After perforation of this membrane, the insertion of this circular tip through the membrane will cause a natural deformation thereof until 'to present an elastic lip 47. This lip will surround the tubular tip and come to be plated by acting as joint sealing. Usefully, such a seal will prevent the gaseous fluid from escaping out of the liner 46.
  • This same machine is equipped with the means necessary to produce or connect to a source of gaseous fluid under pressure, preferably sterile or pre-sterilized.
  • this membrane According to the second possible configuration of this membrane, it is expected that it is provided with a circular opening of diameter smaller than that of the tubular nozzle 51, and that it therefore only partially closes the inlet channel 34
  • sealing of the lining 46 will only be performed after insertion of the tubular endpiece through the circular opening formed beforehand within this membrane, thanks to the elastic lip 47 that constitutes the part peripheral of the circular opening.
  • this lip will be automatically pressed against the tubular end because of the diameter of the latter which is greater than that of the circular opening previously formed in the membrane.
  • this membrane is then above all to ensure the seal between the tubular nozzle 51 and the device during its operation. It makes it possible to prevent the gaseous fluid injected into the channel 34a from escaping from the device before being passed through the centrifugation chamber 10.
  • the tubular end piece 51 on the one hand allows the piercing of the membrane 45 or the widening of its existing circular opening, and on the other hand acts as a channel for supplying the gaseous fluid within the admission channel 34.
  • FIG 4 it shows schematically an enlargement of the central portion of a variant of the device of the present invention. More precisely, this figure shows a detail of a second mode embodiment of the neck 12 of the centrifuge chamber, in which is engaged the static member 30 of admission / evacuation. The latter is illustrated in an initial position, called the closed position, which corresponds for example to the position in which the device is located when it leaves its packaging packaging.
  • the leakage path of the gaseous fluid out of the centrifugation chamber is via a gap 38 with sinuous shapes.
  • the labyrinth shape given to this gap is defined by the arrangement of baffles 36 which occupy at least part of the space of this interstice.
  • baffles may be integral with either the static member 30 or the neck 12 of the centrifugation chamber, or still partly of the static member 30 and partly of this chamber as shown in Figure 4.
  • the arrangement of these baffles makes it possible, for the same gas flow rate, to increase the pressure drop within the exhaust path constituted by the gap 38.
  • the overpressure in the centrifugation chamber will be all the more important.
  • the arrangement of such baffles improves the sealing of the disposable device, particularly where the static member 30 passes through the neck 12 of the centrifuge chamber.
  • the shape that the gap 38 takes can be more or less complex depending on the number, the position and the shape of the baffles 36.
  • the parts of this device are intended to be made by injection of a plastic material into a mold.
  • the dimensions of the centrifugation chamber are of the order of 20 to 200 mm in length for a diameter of between 10 and 100 mm approximately.
  • the parts that constitute this device are mainly cylindrical in shape which facilitates their injection. The realization of such a device by the This injection method is therefore perfectly suited to this type of implementation because of its small size, its single-use nature and the imperatives of obtaining limited manufacturing costs.
  • the subject of the present invention could also be used for blood analysis purposes from samples or else to perform other blood manipulations such as the washing of red blood cells, for the purpose of autotransfusion in particular, or deglycerolization of frozen red blood cells.

Abstract

The device has a static admission/evacuation unit (30) comprising a pressurized gaseous fluid inlet channel emerging into a centrifugation chamber (10). An interstice is arranged in an opening (11) between the chamber and the static unit for evacuating a fluid out of the chamber. The chamber and/or the static unit slide along a revolution axis (2) between an interstice closing position and an interstice opening position.

Description

DISPOSITIF JETABLE DE CENTRIFUGATION SANGUINE DISPOSABLE DEVICE FOR BLOOD CENTRIFUGATION
La présente invention a pour objet un dispositif jetable de centrifugation sanguine pour séparer ou également laver des constituants du sang. Un tel sang pouvant être par exemple du sang complet, du sang déjà déleucocyté par filtration ou encore du sang saigné provenant d'un champ opératoire.The present invention relates to a disposable blood centrifugation device for separating or also washing constituents of the blood. Such blood may be for example whole blood, blood already leucocyte filtered or blood bled from an operative field.
Le principe le plus communément utilisé pour séparer les constituants sanguins, tels que globules rouges, plasma, globules blancs et plaquettes, à partir de sang provenant directement du donneur, d'une poche de collection, d'un champ opératoire ou d'un échantillon sanguin, est la centrifugation. Pour ce faire, on utilise des séparateurs constitués d'une chambre de centrifugation mise en rotation autour d'un axe vertical par un moteur pouvant tourner à haute vitesse, généralement entre l'00O et 50*000 t/min.. Le sang est introduit de manière continue ou discontinue dans la chambre de centrifugation par le biais d'un canal d'amenée faisant partie d'un organe axial fixe du dispositif de centrifugation.The most commonly used principle for separating blood components, such as red blood cells, plasma, white blood cells and platelets, from blood directly from the donor, a collection bag, an operating field or a sample blood, is the centrifugation. To do this, separators are used consisting of a centrifugation chamber rotated about a vertical axis by a motor that can rotate at high speed, generally between 100 ° and 50,000 rpm. The blood is introduced continuously or discontinuously into the centrifugation chamber through a feed channel forming part of a fixed axial member of the centrifuge device.
Sous l'effet de la force centrifuge, les différents constituants sanguins se séparent en raison de leurs densités inégales. Cette séparation s'effectue naturellement dans un ordre prédéfini de sorte que le constituant sanguin de plus grande densité, à savoir les globules rouges, se positionne toujours à la plus grande distance possible de l'axe de révolution, alors que le constituant de plus faible densité se situera toujours plus proche de cet axe que tous les autres constituants. De par cette séparation en couches distinctes, ces constituants peuvent être extraits séparément par des collecteurs s ' étendant respectivement jusque dans les zones de stratification. Par ce moyen, chaque constituant sanguin est conduit séparément vers un canal de sortie situé dans l'organe axial fixe du dispositif. Une fois extraits de la chambre de centrifugation par ces canaux de sortie, ils peuvent être collectés dans des poches distinctes ou ré-injectés au patient.Under the effect of centrifugal force, the different blood components separate due to their unequal densities. This separation occurs naturally in a predefined order so that the blood component of higher density, namely the red blood cells, always positions itself as far as possible from the axis of revolution, while the weaker constituent density will always be closer to this axis than all other constituents. Because of this separation into distinct layers, these constituents can be extracted separately by collectors extending respectively into the lamination zones. By this means, each blood component is conducted separately to a outlet channel located in the fixed axial member of the device. Once extracted from the centrifuge chamber by these outlet channels, they can be collected in separate pockets or re-injected to the patient.
Un tel dispositif est décrit plus en détail dans la demande de brevet EP 05405037. Lorsqu'il est destiné à être utilisé en milieux non stériles, telles que dans des centres de transfusion sanguine ou en milieu hospitalier, il est impératif de pouvoir garantir la stérilité de l'ensemble des volumes par lesquels transiteront le sang et ses constituants. Afin de remplir cette exigence, les sets de séparation sont conditionnés dans un emballage stérile et sont conçus de manière à définir un espace clos, hermétique à toute entrée de gaz ou de fluide autre que le sang. A cet effet, les différentes poches de collection des produits sanguins sont généralement pré-connectées au set de séparation.Such a device is described in more detail in patent application EP 05405037. When it is intended to be used in non-sterile media, such as in blood transfusion centers or in hospitals, it is imperative to be able to guarantee sterility. of all the volumes through which the blood and its constituents will transit. In order to fulfill this requirement, the separation sets are packaged in a sterile package and are designed to define an enclosed space, sealed to any gas or fluid inlet other than the blood. For this purpose, the different collection pockets of the blood products are generally pre-connected to the separation set.
La stérilité de cet ensemble ne serait pas complète si aucun moyen n'était prévu pour assurer la non-contamination possible de la chambre de centrifugation à l'endroit de la jonction des parties fixe et mobile, à savoir entre l'organe axial d'admission/évacuation et la chambre de centrifugation. Ce moyen doit répondre à deux critères principaux qui sont, d'une part de garantir la stérilité du dispositif de centrifugation, et d'autre part de permettre des vitesses de rotation élevées de la chambre de centrifugation en minimisant l' échauffement entre les parties fixe et mobile du dispositif. Ce dernier critère vise à prévenir tout échauffement du sang par conduction au sein de ce dispositif. En effet, il convient impérativement de maintenir le sang à une température inférieure à 400C afin d'éviter que ses constituants ne se dégradent.The sterility of this assembly would not be complete if no means were provided to ensure the possible non-contamination of the centrifuge chamber at the junction of the fixed and movable parts, namely between the axial member of admission / evacuation and the centrifuge chamber. This means must meet two main criteria which are, on the one hand to guarantee the sterility of the centrifugation device, and on the other hand to allow high rotational speeds of the centrifugation chamber by minimizing the heating between the fixed parts. and mobile device. This last criterion aims to prevent any heating of the blood by conduction within this device. Indeed, it is imperative to maintain the blood at a temperature below 40 0 C to prevent its constituents from degrading.
Pour tenter de satisfaire à ces critères, on a eu recours à différents systèmes, parmi lesquels on citera le dispositif décrit dans le document US 3,586,413, et connu de l'homme du métier sous la désignation de "lasso". Ce système consiste en l'agencement d'un tube souple dont une extrémité est solidaire du centre de la chambre de centrifugation et l'autre extrémité est solidaire d'une partie fixe du dispositif. Les deux extrémités de ce tube lui donnent une forme de demi-boucle mise en rotation autour de la chambre de centrifugation suivant une vitesse égale à la moitié de celle de la chambre. Ce système permet de créer une connexion entre le tube et la chambre de centrifugation sans frottement et sans autre échauffement que celui provenant des efforts de flexion et de torsion du tube souple en raison de sa rotation sur lui-même. Les principaux inconvénients de ce dispositif résident dans les faits qu'il soit de construction complexe, qu'il implique la rotation encombrante d'un tube autour de la chambre de centrifugation et que ce tube est soumis à une contrainte de traction importante engendrée par la force centrifuge auquel il est soumis .In attempting to meet these criteria, various systems have been used, including the device described in US 3,586,413, and known to those skilled in the art under the designation "lasso". This system consists of the arrangement of a flexible tube whose one end is integral with the center of the centrifugation chamber and the other end is secured to a fixed part of the device. The two ends of this tube give it a half-loop shape rotated around the centrifugation chamber at a speed equal to half that of the chamber. This system makes it possible to create a connection between the tube and the centrifugal chamber without friction and without any other heating than that resulting from the bending and twisting forces of the flexible tube because of its rotation on itself. The main drawbacks of this device lie in the fact that it is of complex construction, that it involves the cumbersome rotation of a tube around the centrifugation chamber and that this tube is subjected to a significant tensile stress generated by the centrifugal force to which it is subjected.
Le document US.5,045,048 décrit un autre dispositif, de fabrication nettement plus simple que le précédent, dans lequel la jonction entre les conduits fixes d'admission/évacuation et la chambre mobile en rotation est réalisée par une paire de pièces ayant entre elles un coefficient de frottement très faible. La première pièce fait partie du set fixe et, dans le but de garantir l'étanchéité de la connexion, se trouve en appui contre la seconde pièce qui est solidaire de la chambre de centrifugation. Ce couple de pièces peut être réalisé au moyen d'un V-ring en polymère, tournant sur une rondelle métallique, ou être constitué d'un anneau en céramique s ' appuyant sur un anneau en graphite. Si ce système présente les avantages d'un faible coût de réalisation et d'une simplicité dans son utilisation, en revanche il présente l'inconvénient de limiter la vitesse maximale de rotation de la chambre à cause de 1 ' échauffement induit dans les pièces en frottement.The document US Pat. No. 5,045,048 describes another device, much simpler to manufacture than the previous one, in which the junction between the fixed inlet / outlet ducts and the rotatable chamber is formed by a pair of parts having a coefficient between them. very low friction. The first piece is part of the fixed set and, in order to ensure the sealing of the connection, is in abutment against the second piece which is secured to the centrifuge chamber. This pair of parts can be achieved by means of a V-ring made of polymer, rotating on a metal washer, or consist of a ceramic ring based on a graphite ring. Although this system has the advantages of a low cost of implementation and simplicity in its use, it has the disadvantage of limiting the maximum speed of rotation of the chamber because of the heating induced in the friction parts.
Afin de réduire cet échauffement on a également pensé à adjoindre une pluralité d'ailettes de ventilation, disposées à proximité de la surface de frottement des deux pièces en frottement. L'agencement au sein d'un dispositif de centrifugation d'un tel joint ventilé contribue en effet à améliorer la dissipation de la chaleur émanant de ces pièces sans toutefois donner pleine satisfaction. Un tel dispositif est décrit plus en détail dans le document EP 619 '145.To reduce this heating it has also been thought to add a plurality of ventilation vanes, disposed near the friction surface of the two parts in friction. The arrangement within a centrifuge device of such a ventilated joint contributes to improving the dissipation of heat emanating from these parts without giving full satisfaction. Such a device is described in more detail in EP 619 '145.
Dans la demande de brevet EP 05 '405 '037, l'étanchéité entre les parties fixe et mobile du dispositif de centrifugation est réalisée au moyen d'un joint tubulaire. L'une des extrémités de ce joint se trouve fixée sur une portion cylindrique de l'organe axiale fixe, alors que l'autre extrémité est introduite dans un espace annulaire du col de la chambre de centrifugation tout en prenant appui contre une surface convexe de ce col. En raison de cet appui, le joint tubulaire subit une déformation radiale qui assure l'étanchéité de la chambre de centrifugation. Bien que le diamètre du col de la chambre de centrifugation contre lequel frotte ce joint soit de petit diamètre, il n'en demeure pas moins qu'il en résulte un échauffement directement fonction de la vitesse de rotation de la chambre. Avec ce système, la vitesse maximale de rotation est limitée en raison de cet échauffement. En outre, l'utilisation de chambres pourvues d'un col de plus grand diamètre supprimerait à nouveau toute satisfaction dans l'utilisation de ce joint tubulaire pour résoudre le problème d" échauffement évoqué.In the patent application EP 05 '405' 037, the seal between the fixed and movable parts of the centrifugation device is achieved by means of a tubular seal. One of the ends of this seal is fixed on a cylindrical portion of the fixed axial member, while the other end is introduced into an annular space of the neck of the centrifuge chamber while bearing against a convex surface of this collar. Because of this support, the tubular seal undergoes a radial deformation which seals the centrifuge chamber. Although the diameter of the neck of the centrifuge chamber against which rubs this seal is of small diameter, the fact remains that it results in a heating directly depending on the speed of rotation of the chamber. With this system, the maximum speed of rotation is limited because of this heating. In addition, the use of chambers provided with a larger diameter neck would again remove any satisfaction in the use of this gasket to solve the problem of heating referred.
Le but de la présente invention vise à remédier au moins en partie aux inconvénients précités en suggérant un dispositif jetable de centrifugation sanguine qui puisse permettre, d'une part d'assurer la stérilité de l'ensemble des volumes intérieurs de ce dispositif qui sont en contact avec le sang, et d'autre part de supprimer tout échauffement résultant de la rotation de cette chambre autour de l'organe statique d'admission/évacuation disposé sur l'axe de révolution de la chambre.The purpose of the present invention aims to remedy at least in part the aforementioned drawbacks by suggesting a disposable blood centrifugation device which can allow, on the one hand to ensure the sterility of all the internal volumes of this device which are in contact with the blood, and secondly to eliminate any heating resulting from the rotation of this chamber around the static inlet / outlet member disposed on the axis of revolution of the chamber.
Un autre but de la présente invention vise à réaliser un dispositif de centrifugation qui soit également économique. En effet, dans le domaine des manutentions ou transformations sanguines, il n'est pas rare que le matériel employé soit jeté après sa première utilisation. Bien qu'étant encore parfaitement opérationnel d'un point de vue fonctionnel, un tel dispositif de centrifugation ne sera destiné qu'à un usage unique pour les raisons que l'on connaît et qui visent à éviter tout risque de contamination du sang. Il est donc avantageux de prévoir une conception des dispositifs à usage unique qui soit la plus simple possible tout en répondant aux critères d'exigence en matière de stérilité et d'efficacité.Another object of the present invention is to provide a centrifuge device which is also economical. Indeed, in the field of handling or blood processing, it is not uncommon that the material used is thrown after its first use. Although still functional from a functional point of view, such a centrifugation device will be intended for a single use for the reasons that are known and which aim to avoid any risk of blood contamination. It is therefore advantageous to provide a single-use device design that is as simple as possible while meeting the requirements of sterility and efficiency requirements.
Le premier avantage de ce dispositif réside dans le fait qu'il supprime toute élévation possible de température du sang ou de ses constituants. De ce fait, la qualité de ces derniers est assurée puisqu'elle n'est pas altérée. En outre et grâce à l'objet de la présente invention, la vitesse de rotation de la chambre de centrifugation n'est plus tributaire du moyen assurant la stérilité du dispositif par rapport à un milieu extérieur non stérile. Avantageusement, plus cette vitesse est élevée, plus court sera le temps de séjour du sang dans la chambre en vue obtenir la séparation de ses constituants. De ce fait, le débit de sang traité pourra utilement en être augmenté et l'efficacité du dispositif s'en trouvera aussi améliorée.The first advantage of this device lies in the fact that it suppresses any possible rise in temperature of the blood or its constituents. As a result, the quality of the latter is ensured since it is not altered. In addition and thanks to the object of the present invention, the speed of rotation of the centrifugation chamber is no longer dependent on the means ensuring the sterility of the device relative to a non-sterile external medium. Advantageously, the higher this speed, the shorter the residence time of the blood in the chamber in order to obtain the separation of its constituents. As a result, the treated blood flow can usefully be increased and the effectiveness of the device will also be improved.
D'autres avantages apparaîtront à la lumière de la description qui va suivre, se référant à un mode de réalisation préféré de l'objet de la présente invention, pris à titre nullement limitatif et illustré par les figures annexées dans lesquelles: La figure 1 est une vue schématique en coupe partielle verticale du dispositif de la présente invention représenté dans une position dite d'ouverture.Other advantages will become apparent in the light of the description which follows, referring to a preferred embodiment of the subject of the present invention, taken in a nonlimiting manner and illustrated by the appended figures in which: Figure 1 is a schematic vertical sectional view of the device of the present invention shown in a so-called opening position.
La figure 2 est une vue de détail d'une partie de la chambre de centrifugation schématisée à la figure 1.FIG. 2 is a detailed view of a portion of the centrifugation chamber shown diagrammatically in FIG.
La figure 2a est une vue de détail d'une variante de l'illustration donnée à la figure 2.Figure 2a is a detail view of a variant of the illustration given in Figure 2.
La figure 3 est une vue semblable à celle de la figure 1 illustrant le raccordement d'un canal du dispositif de la présente invention à une machine externe.Figure 3 is a view similar to that of Figure 1 illustrating the connection of a channel of the device of the present invention to an external machine.
La figure 4 est une vue schématique, semblable à celle de la figure 2, montrant une variante du dispositif de la présente invention dans laquelle ce dispositif est représenté dans une position dite de fermeture.Figure 4 is a schematic view, similar to that of Figure 2, showing a variant of the device of the present invention wherein the device is shown in a so-called closing position.
En référence à la figure 1, le dispositif jetable de la présente invention comprend une chambre de centrifugation 10 présentant un axe de révolution 2, de préférence vertical. Cet axe de révolution traverse une ouverture 11 ménagée dans la partie supérieure 3 de la chambre de centrifugation. Cette dernière est mise en rotation autour de son axe de révolution par des moyens d'entraînement 20, tel qu'un moteur électrique dont l'arbre de rotation 21 est rendu solidaire de la partie inférieure 4 de la chambre de centrifugation .Referring to Figure 1, the disposable device of the present invention comprises a centrifuge chamber 10 having an axis of revolution 2, preferably vertical. This axis of revolution passes through an opening 11 formed in the upper part 3 of the centrifugation chamber. The latter is rotated about its axis of revolution by drive means 20, such as an electric motor whose rotation shaft 21 is secured to the lower portion 4 of the centrifuge chamber.
Le positionnement, le guidage et le maintien de cette chambre en rotation sont assurés par des moyens de guidage 22 agencés de préférence dans sa partie supérieure 3 de façon à venir en prise avec cette dernière. Ces moyens peuvent par exemple être constitués de trois galets de centrage, en prise avec une bande de roulement 13 et disposés à 120° autour de l'axe de révolution 2 de la chambre. Avantageusement, ils peuvent être montés rétractables, par exemple au bout d'un bras pivotant ou d'un bras télescopique . Comme illustré dans les figures, la bande de roulement 13 fera de préférence partie du col 12 de la chambre de centrifugation et sera formée d'une surface extérieure parfaitement circulaire et concentrique à l'axe de révolution 2. Afin de tenir compte d'un éventuel faux- rond de la chambre de centrifugation, au moins un galet de centrage pourrait avantageusement être monté sur une suspension élastique. Un tel agencement pourrait par exemple être réalisé en disposant un galet en l'extrémité d'un bras monté pivotant sous l'action d'un ressort de rappel de façon à garantir le contact permanent du galet contre la bande de roulement 13.The positioning, guidance and maintenance of this rotating chamber are provided by guide means 22 preferably arranged in its upper part 3 so as to engage with the latter. These means may for example consist of three centering rollers, engaged with a tread 13 and arranged at 120 ° around the axis of revolution 2 of the chamber. Advantageously, they can be mounted retractable, for example at the end of a pivoting arm or a telescopic arm. As illustrated in the figures, the tread 13 will preferably be part of the neck 12 of the centrifugation chamber and will be formed of a perfectly circular outer surface and concentric with the axis of revolution 2. In order to take account of a eventual roundness of the centrifugation chamber, at least one centering roller could advantageously be mounted on an elastic suspension. Such an arrangement could for example be achieved by arranging a roller at the end of an arm pivotally mounted under the action of a return spring so as to ensure the permanent contact of the roller against the tread 13.
L'ouverture 11 de la chambre de centrifugation 10 est traversée par au moins un organe statique 30 d'admission/évacuation du sang et d'un de ses constituants au moins. La connotation statique donnée à cet organe 30 vise simplement à préciser qu'il n'est pas entraîné en rotation, contrairement à la chambre de centrifugation. Ainsi on comprendra que le dispositif de la présente invention comprend une partie mobile en rotation, par l'ouverture de laquelle se trouve engagée au moins une partie non mobile en rotation. Ces parties peuvent être fixes ou de préférence mobiles, l'une par rapport à l'autre, en translation le long de l'axe de révolution 2 comme on le verra plus après .The opening 11 of the centrifugation chamber 10 is traversed by at least one static member 30 for admission / evacuation of the blood and at least one of its constituents. The static connotation given to this member 30 is simply to clarify that it is not rotated, unlike the centrifuge chamber. Thus, it will be understood that the device of the present invention comprises a part movable in rotation, through the opening of which is engaged at least one non-movable part in rotation. These parts may be fixed or preferably movable, relative to each other, in translation along the axis of revolution 2 as will be seen later.
L'organe statique 30 d'admission/évacuation se trouve engagé dans la chambre de centrifugation 10 par son ouverture 11, de sorte qu'une portion de cet organe est située à l'intérieur de la chambre de centrifugation 10 alors qu'une autre portion est à l'extérieur de celle-ci. Cet organe comprend au moins un canal d'amenée 31 du sang issu par exemple d'une poche, non illustrée, de collection d'un volume de sang déterminé. En variante, il pourrait être également possible de traiter du sang directement d'un donneur via des conduits souples branchés à l'extrémité extérieure de ce canal ou encore, dans le cas de 1' autotransfusion, de traiter du sang saigné provenant d'un champ opératoire. Conformément au sens donné par la flèche 31a, l'écoulement du sang se fait en continu, ou par intermittence, de l'extérieur vers l'intérieur de la chambre de centrifugation. L'organe statique comprend également au moins un canal 32 de sortie d'un constituant du sang. L'écoulement de ce constituant s'effectue de l'intérieur vers l'extérieur de la chambre, conformément à la flèche 32a. Un tel constituant sera par exemple formé d'un concentré de globules rouges. Le canal de sortie 33 est un troisième canal qui est de préférence agencé au sein de l'organe statique 30 et qui est utilisé pour extraire un second constituant du sang, tel que par exemple le plasma riche en plaquettes. Le sens d'écoulement de ce second constituant sanguin est conforme à l'illustration donnée par la flèche 33a.The static inlet / outlet member 30 is engaged in the centrifuge chamber 10 through its opening 11, so that a portion of this member is located inside the centrifugation chamber 10 while another portion is outside of it. This organ comprises at least one supply channel 31 of the blood, for example from a pocket, not shown, for collecting a determined volume of blood. Alternatively, it could also be possible to treat blood directly from a donor via flexible conduits connected to the end In the case of autotransfusion, it is possible to treat bleeding blood from an operating field. In accordance with the direction given by the arrow 31a, the flow of blood is continuously or intermittently from the outside to the inside of the centrifuge chamber. The static member also comprises at least one outlet channel 32 of a blood component. The flow of this component is from the inside to the outside of the chamber, according to the arrow 32a. Such a constituent will for example consist of a concentrate of red blood cells. The outlet channel 33 is a third channel which is preferably arranged within the static organ 30 and which is used to extract a second component of the blood, such as, for example, the platelet-rich plasma. The direction of flow of this second blood constituent is in accordance with the illustration given by the arrow 33a.
Dans le cas de l' autotransfusion, un canal supplémentaire, non représenté sur la figure 1, peut être ajouté pour introduire dans la chambre de centrifugation 10 une solution de lavage du sang, telle qu'une solution saline par exemple. Cette solution sera mélangée au sang dans la chambre 10, puis, grâce aux forces centrifuges, séparée des globules rouges en emportant avec elle les impuretés contenues dans le sang collecté avant d' être extraite avec le plasma par le canal de sortie 33.In the case of autotransfusion, an additional channel, not shown in Figure 1, may be added to introduce into the centrifugation chamber 10 a blood wash solution, such as saline, for example. This solution will be mixed with the blood in the chamber 10, then, thanks to the centrifugal forces, separated from the red blood cells by taking with it the impurities contained in the collected blood before being extracted with the plasma by the outlet channel 33.
Les extrémités des canaux de sortie 32, 33 sont destinées à être reliées à des poches souples, non illustrées, de collection des constituants sanguins. Dans le cas de l' autotransfusion, ces sorties sont respectivement connectées à un moyen de ré-injection du constituant lavé au patient et à une poche contenant des déchets de lavage. Il va sans dire que les connexions entre ces poches et les canaux du dispositif de centrifugation, sont hermétiques et réalisées dans les conditions de stérilité requises. En général, ces connexions sont effectuées par avance, à la suite de la fabrication du dispositif de centrifugation, de façon à ce que cet ensemble puisse être conditionné dans un emballage de préférence hermétique et stérile en vue de sa commercialisation. Néanmoins, un tel emballage peut aussi être poreux en vue de permettre une stérilisation ultérieure à la vapeur ou au gaz, avant l'usage du dispositif.The ends of the outlet channels 32, 33 are intended to be connected to flexible bags, not shown, for collecting the blood components. In the case of autotransfusion, these outputs are respectively connected to a re-injection means of the washed component to the patient and to a bag containing washing waste. It goes without saying that the connections between these bags and the channels of the centrifuge device, are hermetic and performed under the required sterility conditions. In Generally, these connections are made in advance, following the manufacture of the centrifugation device, so that this assembly can be packaged in a preferably hermetic and sterile packaging for marketing. However, such a package may also be porous to allow subsequent sterilization with steam or gas, before use of the device.
Selon la présente invention, l'organe statique 30 comprend encore au moins un canal d'admission 34 d'un fluide gazeux sous pression débouchant à l'intérieur de la chambre de centrifugation, de préférence dans la partie supérieure 3 de celle-ci. Ce fluide peut être de l'air pré-stérilisé, issu d'une source permettant au moins de délivrer ce gaz sous une pression déterminée, avantageusement suivant un débit réglable. Le fluide gazeux pénètre dans le canal d'admission 34, conformément au sens d'écoulement indiqué par la flèche 34a, avant de ressortir à l'embouchure 35 de ce canal dans la chambre de centrifugation, de préférence peu en dessous du col 12 de celle-ci.According to the present invention, the static member 30 further comprises at least one inlet channel 34 of a gaseous fluid under pressure opening inside the centrifugation chamber, preferably in the upper part 3 thereof. This fluid may be pre-sterilized air from a source allowing at least to deliver this gas under a specific pressure, preferably at an adjustable flow rate. The gaseous fluid enters the inlet channel 34, in accordance with the direction of flow indicated by the arrow 34a, before emerging at the mouth 35 of this channel in the centrifugation chamber, preferably slightly below the neck 12 of the centrifuge chamber. it.
Bien que n'étant pas nécessaire à la compréhension de l'objet de la présente invention, on mentionnera qu'au dessous de cette embouchure 35, l'organe statique 30 d'admission/évacuation comprend une pluralité de collecteurs 37 de captation des constituants sanguins. Ces collecteurs s'étendent radialement jusqu'à atteindre les différentes zones de stratification 3a, 3b de ces constituants. Par ces voies de captation, ces derniers pourront être extraits simultanément ou successivement de la chambre de centrifugation via les canaux de sortie 32, 33 de l'organe statique 30. Selon l'illustration donnée aux figures 1 et 3, la zone 3a correspond à celle où se trouvent amassés les globules rouges de densité plus élevée que le plasma qui se situera dans la zone 3b, plus proche de l'axe de révolution 2 que la précédente. Cette répartition se fait naturellement sous l'effet de la force centrifuge appliquée au sang déversé dans la chambre de centrifugation. Dans ces figures, seules les collecteurs 37 de captation des globules rouges ont été représentés. Des collecteurs semblables serviront également à capter le plasma ou les déchets de lavage. Du fait que ces collecteurs sont situés en dessous des précédents, ils ne figurent pas dans les illustrations des figures jointes à la présente description.Although not necessary to understand the object of the present invention, it will be mentioned that below this mouth 35, the static admission / discharge member 30 comprises a plurality of collectors 37 for capturing the constituents. blood. These collectors extend radially until they reach the different zones of stratification 3a, 3b of these constituents. By these capture channels, these can be extracted simultaneously or successively from the centrifugation chamber via the outlet channels 32, 33 of the static member 30. According to the illustration given in Figures 1 and 3, the zone 3a corresponds to the one where red blood cells of higher density are found than the plasma which will be located in zone 3b, closer to the axis of revolution 2 than the previous one. This distribution occurs naturally under the effect of the centrifugal force applied to the blood spilled in the centrifuge chamber. In these figures, only the collectors 37 for capturing red blood cells have been represented. Similar collectors will also be used to capture plasma or wash waste. Because these collectors are located below the previous ones, they do not appear in the illustrations of the figures attached to this description.
En référence à la figure 2, celle-ci représente schématiquement un agrandissement de la partie centrale du dispositif de la présente invention. Plus précisément, cette figure montre un détail d'un mode de réalisation du col 12 de la chambre de centrifugation dans lequel est engagé l'organe statique 30 d'admission/évacuation. Le dispositif est illustré ici dans une position d'ouverture qui correspond à la position dans laquelle il se trouve lorsqu'il est en fonction.With reference to FIG. 2, this schematically represents an enlargement of the central part of the device of the present invention. More specifically, this figure shows a detail of an embodiment of the neck 12 of the centrifuge chamber in which is engaged the static member 30 of admission / evacuation. The device is illustrated here in an open position which corresponds to the position in which it is when it is in operation.
Comme bien visible sur cette figure, on remarque qu'un interstice 38 est ménagé dans l'ouverture 11 de la chambre, entre cette dernière et l'organe statique 30 d'admission/évacuation. Cet interstice a pour but de constituer une voie d'échappement pour le fluide gazeux introduit sous pression dans la chambre de centrifugation. Du canal d'admission 34, ce fluide gazeux arrive dans la chambre par l'embouchure 35. Il remplit l'espace à disposition dans cette chambre en la mettant sous pression. La pression résulte de la perte de charge créée par le débit traversant l'interstice 38. Ce dernier sera donc dimensionné de manière à générer une surpression mesurable et suffisante dans la chambre de centrifugation. Grâce à cet interstice calibré, le fluide gazeux s'échappe de cette chambre de façon contrôlée en un flux continu conformément à la direction donnée par la flèche 34b.As clearly visible in this figure, it is noted that a gap 38 is formed in the opening 11 of the chamber, between the latter and the static member 30 of admission / evacuation. This gap is intended to constitute an escape route for the gaseous fluid introduced under pressure into the centrifuge chamber. From the inlet channel 34, this gaseous fluid arrives in the chamber through the mouth 35. It fills the space available in this chamber by putting it under pressure. The pressure results from the pressure loss created by the flow through the gap 38. The latter will therefore be dimensioned so as to generate a measurable and sufficient overpressure in the centrifuge chamber. Thanks to this calibrated gap, the gaseous fluid escapes from this chamber in a controlled manner in a continuous flow in accordance with the direction given by the arrow 34b.
La principale fonction remplie par ce flux gazeux vise à repousser toute infiltration de germes en protégeant ainsi la chambre de centrifugation et son contenu de toute contamination via l'échappement du gaz par l'interstice 38. Cette fonction fait office de barrière contre l'infiltration de micro-organismes dans le dispositif. Avantageusement, aucune élévation de température du sang ou de ses constituants ne sera constatée. Ceci provient du fait qu'il n'y a plus aucun contact entre l'organe statique 30 et la chambre de centrifugation 10 mobile en rotation. Avantageusement encore, l'agencement de cet interstice permet de garantir l'absence de toute usure entre la partie tournante et la partie non tournante du dispositif de la présente invention. Selon le mode de réalisation préféré, on veillera à ce que l'ouverture 11 et l'organe statique 30 soient, aux abords du col 12, circulaires et concentriques à l'axe de révolution 2 de façon à ce que la répartition du flux gazeux par l'interstice 38 puisse être la plus homogène possible .The main function performed by this gas flow is to repel any infiltration of germs thus protecting the centrifuge chamber and its contents from any contamination via gas escape through the gap 38. This function acts as a barrier against the infiltration of microorganisms into the device. Advantageously, no rise in temperature of the blood or its constituents will be observed. This is due to the fact that there is no longer any contact between the static member 30 and the spinning chamber 10 rotatable. Advantageously, the arrangement of this gap makes it possible to guarantee the absence of any wear between the rotating part and the non-rotating part of the device of the present invention. According to the preferred embodiment, it will be ensured that the opening 11 and the static member 30 are, around the neck 12, circular and concentric with the axis of revolution 2 so that the distribution of the gas flow through gap 38 can be as homogeneous as possible.
Si nécessaire, le canal d'admission 34 peut être pourvu d'au moins un filtre 39, à usage unique, de stérilisation du fluide gazeux comme bien visible sur la figure 1. L'agencement d'un tel filtre, peut avoir comme but de garantir la stérilité du fluide gazeux de façon à ne contaminer ni le sang, ni ses constituants. Utilement, un tel filtre peut également servir de barrière stérile empêchant tout micro-organisme de pénétrer dans le canal d'admission 34 lorsque qu'aucun autre moyen ne ferme ce dernier en amont. Avantageusement, il permet encore de garantir l'état irréprochable du moyen de filtration du fluide du fait il fait partie du dispositif jetable à usage unique de la présente invention. Le fluide utilisé peut quant à lui être soit un gaz stérile, soit un gaz pré-filtré à la source, ou encore un gaz qui est destiné à être purifié par un ou plusieurs filtres 39 agencés dans la partie amont du canal d'admission 34. A noter encore qu'on entend par filtre, tout dispositif conventionnel qui permet au fluide qui en ressort de détruire, d' inactiver, de piéger ou de réduire les micro-organismes qu'il contient à un niveau de stérilité conforme aux normes imposées dans le domaine des transfusions et autres manipulations sanguines.If necessary, the inlet channel 34 may be provided with at least one filter 39, for single use, sterilization of the gaseous fluid as clearly visible in FIG. 1. The arrangement of such a filter may have as its object to guarantee the sterility of the gaseous fluid so as not to contaminate the blood or its constituents. Usefully, such a filter can also serve as a sterile barrier preventing any microorganism from entering the inlet channel 34 when no other means closes the latter upstream. Advantageously, it also makes it possible to guarantee the flawless state of the fluid filtration means because it is part of the single-use disposable device of the present invention. The fluid used may be either a sterile gas or a gas pre-filtered at the source, or a gas that is intended to be purified by one or more filters 39 arranged in the upstream portion of the inlet channel 34 It should also be noted that by filter means any conventional device which allows the resulting fluid to destroy, inactivate, trap or reduce the microorganisms it contains at a level of sterility in accordance with the standards imposed in the field of transfusions and other blood manipulations.
Suivant une autre caractéristique de l'invention, il est prévu que le dispositif soit pourvu d'un moyen de fermeture hermétique 40 de l'interstice 38. Un tel moyen de fermeture peut être constitué par un épaulement 41 et/ou par une portée 42, de forme conique arrondie ou cylindrique, pouvant s'emboîter dans l'ouverture 11 de la chambre de centrifugation ou autour du col 12, plus précisément s'insérer avec serrage contre ce col, par exemple dans l'interstice 38 par translation de l'une ou l'autre des parties mobiles et non-mobiles en rotation du dispositif. La fermeture hermétique de ce moyen contre 1 ' ouverture ménagée dans le col de la chambre de centrifugation pourrait si nécessaire être améliorée par l'agencement d'un joint torique, non représenté, solidaire soit de l'organe statique 30, soit du col 12 de la chambre de centrifugation.According to another characteristic of the invention, provision is made for the device to be provided with a hermetic sealing means 40 of the gap 38. Such a closure means may consist of a shoulder 41 and / or a bearing 42 , of conical rounded or cylindrical shape, which can fit into the opening 11 of the centrifugation chamber or around the neck 12, more precisely fit tightly against this neck, for example in the gap 38 by translation of the one or the other of the mobile and non-mobile parts in rotation of the device. The hermetic closure of this means against the opening in the neck of the centrifugation chamber could if necessary be improved by the arrangement of an O-ring, not shown, integral with either the static member 30 or the collar 12 of the centrifuge chamber.
Associé à cette caractéristique, il est également prévu que la chambre de centrifugation 10 ou/et l'organe statique 30 d'admission/évacuation puisse d'une part coulisser le long de l'axe de révolution 2, entre une position de fermeture de l'interstice 38 et une position d'ouverture de ce dernier, et d'autre part se maintenir en cette position d'ouverture par le biais d'un moyen d'ouverture automatique de l'interstice 38. Selon un premier mode d'exécution, un tel moyen d'ouverture de l'interstice 38 pourra être constitué par la pression exercée par le fluide gazeux sur le moyen de fermeture 40, plus particulièrement sur 1' épaulement 41. Lorsque le dispositif se trouve dans sa configuration initiale fermée par emboîtement de l'organe statique 30 dans le col 12 de la chambre de centrifugation, ce moyen d'ouverture va permettre d'obtenir automatiquement le dégagement de l'interstice 38 lors de l'admission du fluide gazeux au sein de la chambre de centrifugation. En effet, la surpression au sein de la chambre va permettre d'expulser suffisamment, soit la chambre 10 vers le bas dans le cas où l'organe statique 30 est maintenu fixe le long de l'axe de révolution 2, soit l'organe statique 30 vers le haut dans le cas inverse où c'est la chambre de centrifugation qui est maintenue fixe le long de son axe de révolution.Associated with this feature, it is also provided that the centrifugation chamber 10 and / or the static admission / discharge member 30 can slide along the axis of revolution 2, between a closed position of the gap 38 and an open position thereof, and secondly hold in this open position by means of a means for automatically opening the gap 38. According to a first mode of execution, such a means of opening the gap 38 may be constituted by the pressure exerted by the gaseous fluid on the closure means 40, more particularly on the shoulder 41. When the device is in its initial configuration closed by interlocking the static member 30 in the neck 12 of the centrifugation chamber, this opening means will make it possible to automatically obtain the clearance of the gap 38 during the admission of the gaseous fluid into the centrifugation chamber . Indeed, the overpressure within the chamber will allow to expel sufficiently, or the chamber 10 downwards in the case where the static member 30 is held fixed along the axis of revolution 2, or the static member 30 upwards in the opposite case where it is the centrifugation chamber which is kept fixed along its axis of revolution.
Selon un second mode d'exécution possible du moyen d'ouverture, ce dernier pourra être constitué par une portion conique 60 adjacente à la bande de roulement 13. Cette variante est donnée à la figure 2a qui présente en détail une illustration du col 12 dans laquelle les moyens de guidage 22 sont déjà en prise avec la bande de roulement 13. Dans cette illustration, on remarque la présence de la portion conique 60, de préférence une portion de tronc conique, située juste en dessous de la bande de roulement 13. Le fonctionnement de ce moyen d'ouverture selon le deuxième mode d'exécution est le suivant.According to a second possible embodiment of the opening means, the latter may be constituted by a conical portion 60 adjacent to the tread 13. This variant is given in Figure 2a which shows in detail an illustration of the collar 12 in FIG. the guide means 22 are already engaged with the tread 13. In this illustration, the presence of the conical portion 60, preferably a conical trunk portion, located just below the tread 13 is noted. The operation of this opening means according to the second embodiment is as follows.
Lorsque que l'on positionne la chambre de centrifugation entre les moyens de guidage 22, l'interstice 38 est initialement maintenu fermé et les moyens de guidage 22 se trouvent en position rétractée de façon à faciliter l'insertion de la chambre entre ces derniers. Cette configuration est illustrée à la figure 4 en référence à une autre variante. Dans cette configuration initiale, la chambre est soutenue temporairement par l'organe statique 30, lequel se trouve encore emboîté dans la chambre de centrifugation et maintenu en cette position par le moyen de fermeture 40. De ce fait, la chambre de centrifugation est tenue en une position légèrement rehaussée par rapport aux moyens de guidage 22, comme représenté dans la figure 4.When positioning the centrifugation chamber between the guide means 22, the gap 38 is initially kept closed and the guide means 22 are in the retracted position to facilitate the insertion of the chamber between them. This configuration is illustrated in Figure 4 with reference to another variant. In this initial configuration, the chamber is temporarily supported by the static member 30, which is still fitted into the centrifugation chamber and held in this position by the closure means 40. As a result, the centrifugation chamber is held in position. a slightly raised position relative to the guide means 22, as shown in FIG. 4.
L'ouverture automatique de l'interstice 38 s'obtient par un léger coulissement vers le bas de la chambre de centrifugation 10 le long de son axe de révolution 2. Ce coulissement est obtenu automatiquement lorsque les moyens de guidage 22 viennent en prise avec la chambre, dans un premier temps en contact avec le moyen d'ouverture constitué de la portion conique 60. En effet, l'appui et le serrage des moyens de guidage 22 contre cette portion conique va pousser cette dernière vers le bas jusqu'à ce que les moyens de guidage soient en prise avec la bande de roulement 13, comme illustré sur la figure 2a. Par ce léger déplacement de la chambre en coulissement vers le bas, l'interstice 38 va être libéré, la partie inférieure 4 de la chambre va pouvoir venir en prise avec l'arbre 21 des moyens d'entraînement 20, et le dispositif sera bientôt prêt à fonctionner.The automatic opening of the gap 38 is obtained by a slight sliding down of the centrifugation chamber 10 along its axis of revolution 2. This sliding is obtained automatically when the guide means 22 come into contact with the room in a room first time in contact with the opening means consisting of the conical portion 60. Indeed, the support and clamping of the guide means 22 against this conical portion will push the latter down until the means of guidance are engaged with the tread 13, as shown in Figure 2a. By this slight displacement of the sliding chamber downwards, the gap 38 will be released, the lower part 4 of the chamber will be able to engage the shaft 21 of the drive means 20, and the device will be soon ready to operate.
Quel que soit le mode d'exécution choisi, on remarque que le moyen d'ouverture 40 permet également le maintien de l'interstice 38 dans sa position d'ouverture en évitant ainsi sa fermeture intempestive durant tout le temps nécessaire à l'utilisation du dispositif.Whatever the embodiment chosen, it will be noted that the opening means 40 also allows the gap 38 to be maintained in its open position, thus avoiding its inadvertent closing during the time necessary for using the device.
Grâce au filtre 39, au moyen de fermeture 40 et au coulissement possible de l'une ou l'autre des deux parties principales 30, 10 du dispositif entre deux positions relativement rapprochées, il est possible de conditionner puis de stériliser, en position de fermeture, le dispositif de la présente invention dans son emballage et de garantir la stérilité de ce dispositif jusqu'à son utilisation.Thanks to the filter 39, the closure means 40 and the possible sliding of one or the other of the two main parts 30, 10 of the device between two relatively close positions, it is possible to condition and then sterilize, in the closed position , the device of the present invention in its packaging and to ensure the sterility of this device until its use.
Afin de contrôler la pression du fluide gazeux, il est également prévu que le canal d'admission 34 puisse être raccordé à un organe commun, donc non représenté, de contrôle ou de régulation de la pression au sein de ce canal. En variante, on mentionnera que cet organe pourrait être complété ou remplacé par un organe de contrôle ou de régulation du débit du fluide gazeux. Avantageusement ces moyens de contrôle permettent de s'assurer du bon fonctionnement de la chambre de centrifugation en détectant par exemple une éventuelle fuite non maîtrisée ou un étranglement anormal, voire une obstruction totale ou un blocage de l'ouverture 11. On notera que la surpression au sein de la chambre de centrifugation peut typiquement être de l'ordre de 0.1 à 100 millibars pour que la fonction principale du fluide gazeux puisse être remplie correctement .In order to control the pressure of the gaseous fluid, it is also provided that the inlet channel 34 can be connected to a common, and therefore not shown, control or pressure regulation member within this channel. Alternatively, it will be mentioned that this member could be supplemented or replaced by a control member or regulating the flow of the gaseous fluid. Advantageously, these control means make it possible to ensure the proper functioning of the centrifugation chamber by detecting for example a possible uncontrolled leak or an abnormal throttling, or even a total obstruction or blockage of the opening 11. It will be noted that the overpressure within the centrifuge chamber can typically be of the order of 0.1 to 100 millibars for the main function of the gaseous fluid can be filled correctly.
En référence aux illustrations schématiques données aux figures 1 et 3, on remarque que le canal d'admission 34 du fluide gazeux se termine en amont par une membrane de protection 45 qui ferme au moins partiellement ce canal. Constituée d'un matériau souple et élastique, cette membrane peut se présenter selon deux configurations possibles.With reference to the schematic illustrations given in FIGS. 1 and 3, it will be noted that the inlet channel 34 of the gaseous fluid terminates upstream by a protective membrane 45 which at least partially closes this channel. Made of a flexible and elastic material, this membrane can be in two possible configurations.
Selon la première configuration, la membrane de protection 45 ferme hermétiquement le canal d'admission 34 dans le but de garantir la stérilité de l'ensemble du dispositif lorsqu'il n'est pas encore raccordé à la source de fluide gazeux pour lequel il est destiné. Ainsi, la membrane de protection 45 et le dispositif de fermeture 40 permettent d'assurer la non-contamination du dispositif de la présente invention dès l'instant où il est sorti de son emballage stérile, non représenté, et jusqu'au moment où il est raccordé à la source de fluide gazeux via le canal d'admission 34. Pour ce faire, il est prévu que cette membrane de protection puisse être transpercée comme il en est fait référence à la figure 3.According to the first configuration, the protective membrane 45 hermetically closes the inlet channel 34 in order to guarantee the sterility of the entire device when it is not yet connected to the source of gaseous fluid for which it is intended. Thus, the protective membrane 45 and the closure device 40 make it possible to ensure the non-contamination of the device of the present invention as soon as it is removed from its sterile packaging, not shown, and until it is is connected to the source of gaseous fluid via the inlet channel 34. For this purpose, it is provided that this protective membrane can be pierced as is referred to in FIG.
Dans cette figure 3, cette membrane de protection peut, si nécessaire, également être appliquée sur une garniture 46 solidaire de la partie terminale amont du canal d'admission 34. En effet, il est prévu que le dispositif de la présente invention puisse être raccordé à une machine 50 de traitement de fluides sanguins. La paroi de la machine comprendra alors par exemple un embout tubulaire 51 de perforation de la membrane de protection 45. Après perforation de cette membrane, l'insertion de cet embout circulaire au travers de la membrane va provoquer une déformation naturelle de celle-ci jusqu'à présenter une lèvre élastique 47. Cette lèvre va entourer l'embout tubulaire et venir s'y plaquer en faisant office de joint d' étanchéité . Utilement, un tel joint empêchera le fluide gazeux de s'échapper hors de la garniture 46. Cette même machine, est équipée des moyens nécessaires pour produire ou se raccorder à une source de fluide gazeux sous pression, de préférence stérile ou pré-stérilisé .In this FIG. 3, this protective membrane may, if necessary, also be applied to a lining 46 integral with the upstream end portion of the inlet channel 34. Indeed, it is provided that the device of the present invention can be connected to a machine 50 for treating blood fluids. The wall of the machine will then comprise, for example, a tubular tip 51 for perforating the protective membrane 45. After perforation of this membrane, the insertion of this circular tip through the membrane will cause a natural deformation thereof until 'to present an elastic lip 47. This lip will surround the tubular tip and come to be plated by acting as joint sealing. Usefully, such a seal will prevent the gaseous fluid from escaping out of the liner 46. This same machine is equipped with the means necessary to produce or connect to a source of gaseous fluid under pressure, preferably sterile or pre-sterilized.
Selon la seconde configuration possible de cette membrane, il est prévu qu'elle soit pourvue d'une ouverture circulaire de diamètre inférieur à celui de l'embout tubulaire 51, et que de ce fait elle ne ferme que partiellement le canal d'admission 34. Dans ce cas, 1' étanchéité de la garniture 46 ne sera réalisée qu'après insertion de l'embout tubulaire au travers de l'ouverture circulaire ménagée au préalable au sein de cette membrane, grâce à la lèvre élastique 47 que constitue la partie périphérique de l'ouverture circulaire. De la même manière, cette lèvre va se plaquer automatiquement contre l'embout tubulaire en raison du diamètre de ce dernier qui est supérieur à celui de l'ouverture circulaire ménagée au préalable dans la membrane.According to the second possible configuration of this membrane, it is expected that it is provided with a circular opening of diameter smaller than that of the tubular nozzle 51, and that it therefore only partially closes the inlet channel 34 In this case, sealing of the lining 46 will only be performed after insertion of the tubular endpiece through the circular opening formed beforehand within this membrane, thanks to the elastic lip 47 that constitutes the part peripheral of the circular opening. In the same way, this lip will be automatically pressed against the tubular end because of the diameter of the latter which is greater than that of the circular opening previously formed in the membrane.
Le but visé par l'agencement de cette membrane est alors avant tout d'assurer l' étanchéité entre l'embout tubulaire 51 et le dispositif pendant son fonctionnement. Elle permet d'éviter que le fluide gazeux injecté dans le canal 34a ne s'échappe du dispositif avant d'être passé par la chambre de centrifugation 10.The purpose of the arrangement of this membrane is then above all to ensure the seal between the tubular nozzle 51 and the device during its operation. It makes it possible to prevent the gaseous fluid injected into the channel 34a from escaping from the device before being passed through the centrifugation chamber 10.
Lors du raccordement du dispositif jetable à la machineWhen connecting the disposable device to the machine
50, l'embout tubulaire 51 d'une part permet le percement de la membrane 45 ou l'élargissement de son ouverture circulaire existante, et d'autre part fait office de canal d'amenée du fluide gazeux au sein du canal d'admission 34.50, the tubular end piece 51 on the one hand allows the piercing of the membrane 45 or the widening of its existing circular opening, and on the other hand acts as a channel for supplying the gaseous fluid within the admission channel 34.
En référence à la figure 4, celle-ci représente schématiquement un agrandissement de la partie centrale d'une variante du dispositif de la présente invention. Plus précisément, cette figure montre un détail d'un second mode de réalisation du col 12 de la chambre de centrifugation, dans lequel est engagé l'organe statique 30 d'admission/évacuation. Ce dernier est illustré dans une position initiale, dite position de fermeture, qui correspond par exemple à la position dans laquelle se trouve le dispositif lorsqu'on le sort de son emballage de conditionnement. Sur cette figure, on remarquera que la voie de fuite du fluide gazeux hors de la chambre de centrifugation se fait par un interstice 38 aux formes sinueuses . La forme en labyrinthe donnée à cet interstice est définie par l'agencement de chicanes 36 qui occupent au moins en partie l'espace de cet interstice. Ces chicanes peuvent être solidaires soit de l'organe statique 30, soit du col 12 de la chambre de centrifugation, soit encore en partie de l'organe statique 30 et en partie de cette chambre comme illustré dans la figure 4.Referring to Figure 4, it shows schematically an enlargement of the central portion of a variant of the device of the present invention. More precisely, this figure shows a detail of a second mode embodiment of the neck 12 of the centrifuge chamber, in which is engaged the static member 30 of admission / evacuation. The latter is illustrated in an initial position, called the closed position, which corresponds for example to the position in which the device is located when it leaves its packaging packaging. In this figure, it will be noted that the leakage path of the gaseous fluid out of the centrifugation chamber is via a gap 38 with sinuous shapes. The labyrinth shape given to this gap is defined by the arrangement of baffles 36 which occupy at least part of the space of this interstice. These baffles may be integral with either the static member 30 or the neck 12 of the centrifugation chamber, or still partly of the static member 30 and partly of this chamber as shown in Figure 4.
Avantageusement, l'agencement de ces chicanes permet, pour un même débit de gaz, d'augmenter la perte de charge au sein de la voie d'échappement constituée par l'interstice 38. Ainsi, la surpression dans la chambre de centrifugation en sera d'autant plus importante. Avantageusement encore, l'agencement de telles chicanes permet d'améliorer l'étanchéité du dispositif jetable, en particulier à l'endroit où l'organe statique 30 traverse le col 12 de la chambre de centrifugation. La forme que prend l'interstice 38 peut être plus ou moins complexe en fonction du nombre, de la position et de la forme des chicanes 36.Advantageously, the arrangement of these baffles makes it possible, for the same gas flow rate, to increase the pressure drop within the exhaust path constituted by the gap 38. Thus, the overpressure in the centrifugation chamber will be all the more important. Advantageously, the arrangement of such baffles improves the sealing of the disposable device, particularly where the static member 30 passes through the neck 12 of the centrifuge chamber. The shape that the gap 38 takes can be more or less complex depending on the number, the position and the shape of the baffles 36.
Selon un mode de réalisation préféré, les pièces de ce dispositif sont destinées à être réalisées par injection d'une matière plastique dans un moule. Les dimensions de la chambre de centrifugation sont de l'ordre de 20 à 200 mm de longueur pour un diamètre compris entre 10 et 100 mm environ. De plus, les pièces qui constituent ce dispositif sont majoritairement de forme cylindrique ce qui facilite leur injection. La réalisation d'un tel dispositif par le biais d'un procédé d'injection s'accorde donc parfaitement à ce type de mise en œuvre, en raison de ses petites dimensions, de son caractère à usage unique et des impératifs visant à obtenir des coûts de fabrication limités.According to a preferred embodiment, the parts of this device are intended to be made by injection of a plastic material into a mold. The dimensions of the centrifugation chamber are of the order of 20 to 200 mm in length for a diameter of between 10 and 100 mm approximately. In addition, the parts that constitute this device are mainly cylindrical in shape which facilitates their injection. The realization of such a device by the This injection method is therefore perfectly suited to this type of implementation because of its small size, its single-use nature and the imperatives of obtaining limited manufacturing costs.
Enfin, on mentionnera encore que l'objet de la présente invention pourrait également être utilisé à des fins d'analyses sanguines à partir d'échantillons ou encore pour effectuer d'autres manipulations sanguines telles que le lavage des globules rouges, à des fins d' autotransfusion notamment, ou de déglycérolisation des globules rouges congelés . Finally, it will also be mentioned that the subject of the present invention could also be used for blood analysis purposes from samples or else to perform other blood manipulations such as the washing of red blood cells, for the purpose of autotransfusion in particular, or deglycerolization of frozen red blood cells.

Claims

REVENDICATIONS
1. Dispositif jetable de centrifugation sanguine pour séparer ou également laver des constituants du sang comprenant une chambre de centrifugation (10) présentant un axe de révolution (2) ainsi qu'une ouverture (11) traversée par ce dernier et ménagée dans une partie supérieure (3) de ladite chambre de centrifugation (10), des moyens de guidage (22) en rotation de ladite chambre de centrifugation (10) destinés à venir en prise avec cette dernière contre une bande de roulement (13), des moyens d'entraînement (20) en rotation de cette chambre de centrifugation autour de son axe de révolution (2), au moins un organe statique (30) d'admission/évacuation engagé dans ladite chambre de centrifugation (10) par son ouverture (11) et comprenant au moins un canal d'amenée (31) dudit sang et au moins un canal de sortie (32, 33) d'un constituant de ce sang, caractérisé en ce que ledit organe statique (30) d'admission/évacuation comprend au moins un canal d'admission (34) d'un fluide gazeux sous pression débouchant à l'intérieur de la chambre de centrifugation (10) et en ce qu'un interstice (38) est ménagé dans ladite ouverture (11) entre la chambre de centrifugation (10) et l'organe statique (30) d'admission/évacuation pour l'échappement dudit fluide gazeux hors de cette chambre de centrifugation (10) .1. Disposable blood centrifugation device for separating or also washing blood constituents comprising a centrifugation chamber (10) having an axis of revolution (2) and an opening (11) traversed by the latter and arranged in an upper part (3) of said centrifuge chamber (10), means (22) for rotating said centrifuge chamber (10) to engage said centrifuge chamber against a tread (13), means for driving (20) in rotation of this centrifugation chamber around its axis of revolution (2), at least one static inlet / outlet member (30) engaged in said centrifuge chamber (10) by its opening (11) and comprising at least one supply channel (31) of said blood and at least one outlet channel (32, 33) of a constituent of said blood, characterized in that said static admission / evacuation member (30) comprises at least one least one intake channel (34) of a flu a gaseous form under pressure emerging inside the centrifugation chamber (10) and in that a gap (38) is formed in said opening (11) between the centrifugation chamber (10) and the static member (30). ) of admission / evacuation for the exhaust of said gaseous fluid out of this centrifugation chamber (10).
2. Dispositif selon la revendication 1, caractérisé en ce que la chambre de centrifugation (10) ou/et l'organe statique (30) d'admission/évacuation coulisse le long de l'axe de révolution (2) entre une position de fermeture de l'interstice (38) et une position d'ouverture de ce dernier.2. Device according to claim 1, characterized in that the centrifugation chamber (10) or / and the static member (30) of admission / evacuation slides along the axis of revolution (2) between a position of closing the gap (38) and an opening position thereof.
3. Dispositif selon la revendication 1 ou 2, caractérisé en ce qu'il comprend un moyen de fermeture hermétique (40) de l'interstice (38). 3. Device according to claim 1 or 2, characterized in that it comprises a sealing means (40) of the gap (38).
4. Dispositif selon la revendication 3, caractérisé en ce que ledit moyen de fermeture (40) est constitué par un épaulement (41) et/ou par une portée (42) pouvant s'emboîter dans l'ouverture (11) de ladite chambre de centrifugation (10).4. Device according to claim 3, characterized in that said closing means (40) is constituted by a shoulder (41) and / or by a bearing surface (42) which can fit into the opening (11) of said chamber centrifugation (10).
5. Dispositif selon la revendication 2, caractérisé en ce qu'il comprend un moyen d'ouverture automatique de l'interstice (38) .5. Device according to claim 2, characterized in that it comprises means for automatically opening the gap (38).
6. Dispositif selon la revendication 5, caractérisé en ce que ledit moyen d'ouverture est constitué par la pression exercée par ledit fluide gazeux sur ledit moyen de fermeture (40) .6. Device according to claim 5, characterized in that said opening means is constituted by the pressure exerted by said gaseous fluid on said closure means (40).
7. Dispositif selon la revendication 5, caractérisé en ce que ledit moyen d'ouverture est constitué par une portion conique (60) adjacente à ladite bande de roulement (13) .7. Device according to claim 5, characterized in that said opening means is constituted by a conical portion (60) adjacent to said tread (13).
8. Dispositif selon la revendication 1, caractérisé en ce que des chicanes (36) occupent au moins en partie l'espace de l'interstice (38).8. Device according to claim 1, characterized in that baffles (36) occupy at least partly the space of the gap (38).
9. Dispositif selon la revendication 1, caractérisé en ce que le canal d'admission (34) du fluide gazeux est pourvu d'au moins un filtre (39) à usage unique de stérilisation du fluide gazeux.9. Device according to claim 1, characterized in that the inlet channel (34) of the gaseous fluid is provided with at least one filter (39) for single use sterilization of the gaseous fluid.
10. Dispositif selon la revendication 1, caractérisé en ce qu'une membrane de protection (45) ferme au moins partiellement le canal d'admission (34) en amont de celui- ci .10. Device according to claim 1, characterized in that a protective membrane (45) at least partially closes the inlet channel (34) upstream thereof.
11. Dispositif selon la revendication 10, caractérisé en ce que ladite membrane de protection (45) autorise l'insertion en son sein d'un embout tubulaire (51).11. Device according to claim 10, characterized in that said protective membrane (45) allows the insertion within it of a tubular nozzle (51).
12. Dispositif selon la revendication 11, caractérisé en ce que ladite membrane de protection (45) forme une lèvre élastique (47) entourant l'embout tubulaire (51) lorsque la membrane de protection est traversée par ce dernier.12. Device according to claim 11, characterized in that said protective membrane (45) forms a lip resilient (47) surrounding the tubular tip (51) when the protective membrane is traversed by the latter.
13. Dispositif selon la revendication 1, caractérisé en ce que le canal d'admission (34) du fluide gazeux est raccordé à un organe de contrôle ou de régulation de la pression régnant au sein de ce canal et/ou à un organe de contrôle ou de régulation du débit du fluide gazeux. 13. Device according to claim 1, characterized in that the inlet channel (34) of the gaseous fluid is connected to a control member or regulating the pressure prevailing within this channel and / or to a control organ or regulating the flow of the gaseous fluid.
EP06817753A 2005-12-21 2006-12-14 Disposable device for centrifugation of blood Not-in-force EP1965925B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06817753A EP1965925B1 (en) 2005-12-21 2006-12-14 Disposable device for centrifugation of blood

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05405717A EP1800754A1 (en) 2005-12-21 2005-12-21 Disposable blood centrifuge
PCT/CH2006/000701 WO2007071086A1 (en) 2005-12-21 2006-12-14 Disposable device for centrifugation of blood
EP06817753A EP1965925B1 (en) 2005-12-21 2006-12-14 Disposable device for centrifugation of blood

Publications (2)

Publication Number Publication Date
EP1965925A1 true EP1965925A1 (en) 2008-09-10
EP1965925B1 EP1965925B1 (en) 2012-02-08

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EP05405717A Withdrawn EP1800754A1 (en) 2005-12-21 2005-12-21 Disposable blood centrifuge
EP06817753A Not-in-force EP1965925B1 (en) 2005-12-21 2006-12-14 Disposable device for centrifugation of blood

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP05405717A Withdrawn EP1800754A1 (en) 2005-12-21 2005-12-21 Disposable blood centrifuge

Country Status (4)

Country Link
US (1) US8070666B2 (en)
EP (2) EP1800754A1 (en)
AT (1) ATE544524T1 (en)
WO (1) WO2007071086A1 (en)

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EP1683579A1 (en) 2005-01-25 2006-07-26 Jean-Denis Rochat Disposable device for the continuous separation by centrifugation of a physiological liquid
EP1800754A1 (en) * 2005-12-21 2007-06-27 Jean-Denis Rochat Disposable blood centrifuge
EP1911520A1 (en) * 2006-10-10 2008-04-16 Jean-Denis Rochat Disposable set for separating blood or for washing blood components
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
US9308314B2 (en) 2011-04-08 2016-04-12 Sorin Group Italia S.R.L. Disposable device for centrifugal blood separation
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
EP3291917B1 (en) 2015-05-07 2020-02-26 Biosafe S.A. A device, system and method for the continuous processing and separation of biological fluids into components
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Also Published As

Publication number Publication date
US20080264841A1 (en) 2008-10-30
EP1800754A1 (en) 2007-06-27
EP1965925B1 (en) 2012-02-08
US8070666B2 (en) 2011-12-06
ATE544524T1 (en) 2012-02-15
WO2007071086A1 (en) 2007-06-28

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