WO2018122105A1 - Protective case for components of a bag system - Google Patents

Protective case for components of a bag system Download PDF

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Publication number
WO2018122105A1
WO2018122105A1 PCT/EP2017/084153 EP2017084153W WO2018122105A1 WO 2018122105 A1 WO2018122105 A1 WO 2018122105A1 EP 2017084153 W EP2017084153 W EP 2017084153W WO 2018122105 A1 WO2018122105 A1 WO 2018122105A1
Authority
WO
WIPO (PCT)
Prior art keywords
protective case
bag system
filtration unit
bag
biological fluid
Prior art date
Application number
PCT/EP2017/084153
Other languages
French (fr)
Inventor
Quentin BREBANT
Nicolas COASNE
Maxime DELY
Laurent Ducoroy
Original Assignee
Maco Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Maco Pharma filed Critical Maco Pharma
Publication of WO2018122105A1 publication Critical patent/WO2018122105A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
    • A61M1/0227—Multiple bag systems for separating or storing blood components with filters and means for securing the filter against damage, e.g. during centrifugation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • A61M1/3633—Blood component filters, e.g. leukocyte filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0427—Platelets; Thrombocytes
    • 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
    • B04B5/0407—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles
    • B04B2005/0435—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles with adapters for centrifuge tubes or bags

Definitions

  • the invention relates to a protective case for components of a bag system, an assembly comprising such a protective case and a bag system, and a method for treating a biological fluid using a such protective case.
  • the invention applies in particular to the field of transfusion and more particularly to the separation and filtration of blood and blood components.
  • a bag system such as that described in US-4,767,541, comprising a sampling needle.
  • blood a primary bag for collecting blood from a donor, and connected thereto via flexible tubing, secondary bags for receiving the different blood components separated after a centrifugation step.
  • Such a system further comprises and typically at least one filtration unit for removing leukocytes from a blood component.
  • leukocytes increase the risk of immune rejection such as graft-versus-host disease and promote the transmission of infectious agents. It has therefore appeared necessary to eliminate them from the blood components to be transfused.
  • Another bag system makes it possible to prepare a leukocyte-depleted platelet concentrate from a leuco-platelet layer assembly, otherwise known as a buffy coat pool.
  • This system typically includes a plurality of tubings to be sterile connected to pouches containing a buffy coat layer and optionally to a pouch containing an additive solution for preserving platelets.
  • the system further comprises, interconnected by tubings, an assembly bag for collecting the plurality of buffy coats, a filtration unit for removing leukocytes. a platelet concentrate, and a filtrate collection bag. Clamps are arranged on the tubing to control the flow of fluids in the system.
  • this system further comprises a sampling bag and a sampling means in the form of a cannula mounted on a rigid base.
  • centrifugation step it is necessary to introduce into a centrifugation vessel, for example a nacelle centrifugation insert, not only the various flexible bags, but also the filtration unit, the centrifugation container thus loaded. being then placed in the centrifuge.
  • a centrifugation vessel for example a nacelle centrifugation insert
  • the filtration unit and / or certain rigid components such as the means for sampling the sample may be damaged by sliding in the bottom of the centrifugation vessel. , given the acceleration and the speed of centrifugation.
  • the filtration unit comprises a rigid housing
  • centrifugation thereof together with the flexible bags and tubing can induce, by friction, a deterioration of the latter. In some cases, this deterioration causes piercing of a pocket and / or tubing, rendering the system unusable for the separation of blood or components.
  • a rack to be inserted in a centrifugation cup is provided with a central housing in which the filter unit is arranged, the pockets being arranged in compartments on either side of said housing.
  • the presence of the central housing inside the rack limits the space available for the bag system.
  • US 5 456 845 discloses a substantially flat support for a filter unit for insertion into a centrifuge vessel.
  • this substantially flat support comprises an upper recess in which the filtration unit is housed by covering its projecting parts.
  • this support is suitable for filtration units whose inlet and outlet ports are arranged on the same side.
  • the support is said to be of sandwich type, formed of two opposite walls between which the filtration unit can be slid. This type of support, however, does not allow to maintain fixed filter unit during centrifugation.
  • the bag system is placed in a circular cassette comprising cavities for the pockets and cavities for the units and filtration units.
  • the circular cassette is then introduced into the centrifuge and separation apparatus. Masi, the filtration units are not held firmly in this circular cassette.
  • the bag system is directly placed on the rotor of the centrifuge and separation apparatus.
  • the filtration unit of the bag system is disposed in a hollow portion of the rotor of the apparatus, between a rim and the cover.
  • the invention proposes a protective case for protecting the filtration unit and the rigid components of a bagging system from deformation by contact with a centrifugation container during centrifugation, while reducing the risk of damage to the cells. soft pockets of such a system.
  • the invention relates to a protective case for components of a bag system for the treatment of a biological fluid, said bag system being composed of at least one biological fluid filtration unit, said case shield being intended to be placed with the bag system in a centrifugation vessel, said protective case comprising a cavity formed between a base member and a cover member removably placed on said base member, said cavity having a first volume for receiving said filtration unit and at least a second volume, the base member comprising means for holding the filtration unit in said first volume of said cavity, said holding means and the forming member; lid operating together to prevent movement of the filter unit within the protective case, when said filter unit is disposed in said holding means and the cover member is placed on the filter element. based.
  • the invention relates to an assembly comprising a protective case according to the first aspect of the invention and a bag system for the treatment of a biological fluid, said system being composed of at least one filtration unit. of a biological fluid, the filtration unit being held in said protective case by the holding means of the protective case together with the cover member.
  • the invention relates to a method for treating a biological fluid using a bag system composed of at least one biological fluid filtration unit, said method comprising the successive steps of:
  • Figure 1 schematically shows a bag system for the treatment of a biological fluid.
  • Figures 2 and 3 show a schematic perspective view of a protective case in an open state, formed of a base member and a cover member according to a first embodiment of the invention.
  • Figure 4 shows a schematic perspective view of the protective case of Figures 2 and 3 in a closed state, a portion of tubing out of said protective case.
  • Figure 5 shows a schematic and side view of the protective case of Figures 2 and 3 in an open state and a filter unit to be placed in said protective case.
  • Figure 6 shows a schematic and perspective view of the protective case of Figures 2 and 3 in an open state, components of the bag system, exploded view, being placed inside the case.
  • Figure 7 shows a schematic perspective view of a protective case according to a second embodiment of the invention.
  • Figure 8 shows a schematic and front view of the protective case of Figure 7 with components of the bag system disposed therein.
  • the invention relates to a protective case for components of a bag system for the treatment of a biological fluid.
  • the biological fluid is especially blood or a blood component, such as a platelet-rich plasma, a platelet-poor plasma, a red blood cell concentrate, a platelet concentrate, a buffy coat or a platelet lysate.
  • the treatment of a biological fluid comprises in particular the separation of the biological fluid into its various components, for example by centrifugation, and the filtration of said fluid or at least one of its separate components. Filtration involves removing undesirable constituents of the biological fluid. In the context of blood transfusion, the undesirable constituents are in particular leucocytes, prion proteins and / or pathogen inactivation substances.
  • An example of treatment of a biological fluid is to prepare by centrifugation and filtration, a leukocyte-depleted plasma and / or leukocyte-depleted red blood cell concentrate from a whole blood unit.
  • Another treatment is to prepare by centrifugation and filtration a leukocyte depleted platelet concentrate from a buffy coat pool.
  • FIG. 1 represents an example of a bag system 1 used to treat a biological fluid, especially for preparing a leukocyte depleted platelet concentrate from a buffy coat pool.
  • the buffy coat pool is obtained after combining two to eight units of buffy coat from a whole blood donation.
  • the bag system 1 is composed of at least one filtration unit 2 of the biological fluid.
  • the filtration unit of the bag system of Figure 1 is intended to remove leukocytes from a platelet concentrate.
  • the filtration unit 2 comprises a rigid casing provided with at least one inlet orifice 3 and at least one outlet orifice 4, said orifices 3,4 being arranged in an opposite manner, the casing enclosing a porous element interposed between said orifices, said porous member including a leukocyte removal medium.
  • a filtration unit is described in more detail in EP 2 783 717 A1.
  • the housing of the filtration unit 2 is substantially flat in that it comprises two plane faces substantially parallel to each other, the housing having a small thickness relative to the dimensions of the faces.
  • the filtration unit comprises a flexible or semi-rigid outer casing.
  • the bag system 1 is furthermore composed, as flexible components, of at least one primary bag 5 comprising the biological fluid to be filtered and a bag for collecting the filtrate 6, each of said pockets 5, 6 being connected to said filtration unit by a flexible tubing 7.8.
  • the primary bag 5 is connected to the other components of the bag system 1.
  • the primary pocket is connected to the bag system at the time of its use.
  • the bags and tubings are made of a thermoplastic material sterilizable value, such as polyvinyl chloride.
  • the bag system 1 is further composed of at least one clamp 9 arranged on one of said tubing 8 and / or a sample 10 of a fluid sample.
  • the rigid components are made by molding in a thermoplastic material that can be sterilized by steam, for example polycarbonate or polypropylene.
  • the primary bag 5 is connected via a first tube 7 to the filtration unit 2.
  • the filtration unit 2 is connected via a second tubing 8 to the filtrate collection bag 6.
  • the primary bag 5 is in fluid communication with a set of tubing consisting of a main tubing 1 1 and secondary tubing 12 connected to the main tubing.
  • These secondary tubings 12 are intended to be connected in a sterile manner to at least two bags containing a unit of a buffy coat layer and possibly to a bag containing an additive solution for preserving the platelets.
  • the filtrate collection bag 6 is in fluid communication via a third tube 13 to a satellite bag 14 for receiving the air present in the filtrate collection bag 6 and / or collecting a sample fluid contained in the filtrate collection bag 6.
  • the bag system comprises a fourth tubing connected via a three-way connector to the third tubing 13, said fourth tubing being provided with its end of a sampling means 10 of a fluid sample.
  • the sample taken by this means is used for the detection of bacterial contamination (Bact / Alert® System).
  • the sampling means 10 of a fluid sample is in particular formed of a canula mounted on a rigid base. The cannula is covered with an elastomeric sleeve and a protective cap.
  • tubings 8, 13, 15 are provided with a 9, 16, 17 clamp to control the fluid flow inside the bag system.
  • the bag system shown in Figure 1 is said to be closed, in that the various components are assembled together.
  • the primary bag 5 containing the buffy coat pool and optionally the platelet preservative additive solution is centrifuged to obtain a sediment layer of red blood cells and a platelet concentrate supernatant layer.
  • the centrifuged primary bag containing the layers of red blood cells and platelet concentrate is then pressed to dispense the platelet concentrate into the filtrate collection bag 6 via the filtration unit 2, resulting in depleted platelet concentrate. in leucocytes.
  • the protective case of the invention is intended to be placed with the bag system 1 in a centrifuge container, such as an insert or a centrifuge cup.
  • the protective case aims to protect such a bag system composed of at least one filtration unit, the risk of damage incurred during the centrifugation step. More particularly, the protective case aims to protect the filtration unit from the risk of breakage and deformation and the pockets of the risk of piercing.
  • the protective case 18 of the invention comprises a cavity having a first volume for receiving the filtration unit 2 of the bag system 1 and at least a second volume.
  • the cavity of the protective case thus defines a space sufficient to receive, in the first volume, the filtration unit 2 as well as, in the second volume, another component of the bag system.
  • the second volume is an additional space in the space of the first volume to be able to receive a component of the bag system other than the filtration unit, for example a tubing, a clamp and / or a sample collection means. fluid.
  • the protective case is intended to receive the filtration unit of a bag system and certain other small rigid components, with the exception of the pockets which remain outside the protective case.
  • the bag system 1 when the bag system 1 is composed, as flexible components, of at least one primary bag 5 comprising the biological fluid to be filtered and a filtrate collection bag 6 each of said pockets being connected to said filtration unit by a tubing flexible 7,8 respectively, and as rigid components, at least one clamp 9 arranged on one of said tubing 7,8 and / or means 10 for sampling a fluid sample, the second volume of said cavity is intended to receive at least one of said rigid components 9,10 of the bag system 1.
  • the second volume is intended to receive, on the one hand, between one and three clamps 9, 16, 17 arranged on flexible tubings 8, 13, 15 of the bag system 1, and on the other hand the sampling means 10. a fluid sample.
  • the cavity of the protective case is formed between a base member 19 and a cover member 20 removably placed on said base member 19.
  • the protective case 18 is in a closed state ( Figure 4).
  • the protective case in its closed state is placed in a centrifugation vessel, in particular in an insert or bucket for centrifuge nacelle.
  • the protective case 18 When the cover member 20 is moved or moved away from the base member 19, the protective case 18 is in an open state ( Figures 2-3 and 7-8).
  • the protective case 18 in its open state makes it possible to arrange the various components concerned of the bag system 1 in the protective case.
  • the cover member 20 is removably placed on the base member 19, so that the protective case is not disposable and can be used several times, especially at least up to fifty times.
  • Holding means 21 of the filtration unit 2 in the first volume are arranged in said cavity, said holding means 21 being able to prevent any movement of the filtration unit 2 placed inside the holster. protection 18 when said filtration unit 2 is disposed in said holding means 21.
  • the base element 19 comprises the holding means 21 of the filtration unit in the first volume of the cavity, that is to say that the holding means 21 are integral with the base element 19.
  • the holding means 21 and the cover member 20 operate together to prevent movement of the filter unit 2 within the protective case 18, when said filter unit 2 is disposed in said holding means 21 and that the cover member 20 is placed on the base member 19, that is to say when the protective case is closed.
  • the holding means 21 keep in a fixed position the filtration unit 2 inside the case protection.
  • the cover member 20 abuts against the filtration unit placed in the holding means 21, so as to ensure complete immobilization of the filtration unit 2 in its protective case 18.
  • the filtration unit 1 does not crush the bottom of the centrifuge container or the bottom of the protective case, avoiding damage.
  • the holding means 21 are configured so as to have an extended contact surface with the periphery of the filtration unit 2, contributing to the maintenance of the filtration unit in the protective case.
  • the protective case 18 is intended to receive the filtration unit 2 and some rigid components 9, 10, 16, 17 of a bag system 1, the pockets 5, 6, 14 of said system remaining outside the box. the protective case.
  • the flexible pouches 5, 6, 14 are isolated from the rigid components of the bag system, reducing the risk of damage to the bags by contact with the rigid components.
  • the protective case 18 comprises at least one lateral opening 22 to allow the passage of at least one flexible tubing 7,8,13,15, so as to arrange the pockets 5,6 of the bag system 1 outside of the protective case 18.
  • the protective case includes several side openings.
  • the protective case 18 comprises between one and three lateral openings 22, 23, 24, disposed on one side of the protective case, respectively.
  • One of the sides of the protective case 18 advantageously does not include a lateral opening and corresponds to the side of the protective case intended to face the bottom of the centrifugation container when the case is used. protection.
  • the protective case 18 is for example made of a thermoplastic elastomer type polymer material.
  • the shore A hardness of the polymer material is chosen in the range from 80 to 100, in particular from 90 to 95, and more particularly 95 Shore A. If the hardness is too low, less than 80 Shore A, the case protection is deformed during the centrifugation used to separate the blood components.
  • the hardness is too high, for example greater than 95 shore A, the protective case is rigid and is likely to be broken or deformed during centrifugation as well as the rigid components of the bag system.
  • a good compromise between the resistance to deformation and the respect of the entirety of the flexible bags is a protective case made of a material having a hardness of about 95 shore A.
  • Figures 2 to 6 show a first embodiment of a protective case 18 according to the invention.
  • the base member 19 comprises a bottom wall 25 extended by a peripheral side wall 26.
  • the bottom wall 25 of the base member 19 is substantially planar and comprises a plurality of ribs 27 which stiffens the base member 19. Some of these ribs 27 are advantageously extended on the peripheral side wall 26 of the element. base 19 to make it even more resistant to deformation.
  • the bottom wall 25 of the base member 19 is substantially rectangular in shape.
  • the holding means 21 of the filtration unit 2 are arranged on the inner surface of said bottom wall 25 of the base element 19.
  • the holding means 21 are formed of one or more protrusions 28 whose dimensions and arrangement correspond to the external dimensions of the filtration unit 2 so as to maintain it by a tight fit in said base member 19.
  • Said projections 28 forming the holding means extend vertically from the bottom wall 25 of the base member 19.
  • the holding means 21 are formed of four projections 28 arranged along the four sides of a virtual square.
  • the filtration unit 2 has a substantially square shape, the internal dimensions of the virtual square substantially corresponding to the external dimensions of the filtration unit.
  • the filtration unit 2 is held flat in said holding means 21.
  • the ribs 29 situated inside the virtual square make it possible to raise the filtration unit 2 above the bottom wall of the base element, so that the flat faces of the filtration unit 2 are substantially parallel to the bottom wall 25 of the base member 19, despite the rigid tube portions forming the inlet 3 and outlet 4 of the filtration unit 2 which protrude from the rigid housing, as it can be seen in Figure 5.
  • a buttress 30 in the form of a triangular rib is arranged against each of the projections 28.
  • the filtration unit 2 comprises an inlet orifice 3 and an outlet orifice 4, arranged in opposite directions.
  • the holding means 21 are advantageously arranged such that the inlet orifice 3 and / or the outlet orifice 4 of the filtration unit 2 are distant from the peripheral lateral wall 26 of the element
  • the inlet ports 3 and 4 of the outlet of the filtration unit 2 are sufficiently remote from the peripheral side wall 26 of the protective case to be able to bend the tubings easily.
  • the first volume of the cavity of the protective case 18 is delimited in part by the holding means 21 of the filtration unit 2.
  • the second volume is the remaining space of the cavity outside the first volume.
  • the second volume of the cavity is sufficiently large to be at least partially occupied by the rigid components 9, 10, 16, 17 of the bag system 1, in particular the clamps 9, 16, 17, the sampling means 10 of a sample of fluid and tubing portions 7,8,13,15, but not by the flexible bags that remain outside the protective case.
  • the peripheral side wall 26 of the base member 19 comprises a notch forming with the cover member placed on the base member, a side opening 22 of the protective case 18. .
  • the cover member 20 comprises a bottom wall 31 and a peripheral side wall 32.
  • the bottom wall 31 of the cover member 20 is substantially rectangular in shape. As shown in FIG. 3, the bottom wall 31 of the cover member 20 is substantially planar and comprises a plurality of ribs 33 which stiffens the cover member 20.
  • the bottom wall 31 of the cover member 20 comprises at least one retaining rib 34 arranged so as to face one face of the filtration unit 2 when the latter is placed in the holding means. 21 of the base member 19 and when the cover member 20 is placed on the base member 19.
  • This holding rib 34 is notably higher than the other ribs which are useful for making the forming element more solid. lid.
  • the bottom wall 31 of the cover member 20 comprises one or more retaining ribs 34,35 which cooperate with the holding means 21 to prevent any movement of the filtration unit 2 inside the protective case 18, when the filtration unit 2 is disposed in said holding means 21 and the cover member 20 is placed on the base member 19.
  • These retaining ribs 34, 35 are opposite a flat face of the filtration unit 2, so as to keep the filtration unit flat in the protective case 18.
  • the bottom wall 31 of the cover member 20 comprises two retaining ribs 34,35.
  • These retaining ribs 34, 35 cooperate with the holding means 21 to immobilize the filtration unit 2 in the protective case 18 when it is in a closed state.
  • FIG. 4 shows the protective case 18 in its closed state, i.e. when the cover member 20 is placed on the base member 19.
  • peripheral side wall 32 of the cover member extends vertically on at least one extension portion 36, and in particular at a corner of said peripheral side wall 32 of the cover member 20.
  • This extension portion 36 fits exactly between a pair of ribs 37a, 37b arranged on the peripheral side wall 26 of the base member 19, in particular at a corner of said peripheral side wall 26 of the base member 19.
  • the cover member 20 includes four extension portions 36 at each corner of the cover member, said extension portions entering between four pairs.
  • ribs 37a, 37b arranged at each corner of the base member of the protective case.
  • the protective case 18 When the base member 19 and the cover member 20 are joined together, the protective case 18 has substantially a rectangular parallelepiped shape.
  • Figures 7 and 8 show a second embodiment of a protective case 18 according to the invention.
  • the base member 19 comprises a base body 38 having at least a first recess 39 whose geometry corresponds to the geometry of the filtration unit 2, said first recess 39 forming the holding means 21 of the filtration unit.
  • the first volume of the cavity of the protective case 18 is delimited in part by this first recess 39.
  • this first recess 39 ensures the maintenance of the filtration unit 2 inside the base member 19 by tight fit.
  • the base element 19 further comprises at least one second recess 40, 41, 42 whose geometry corresponds to the geometry of at least one of the rigid components of the bag system and / or to a portion of flexible tubing of the bag system.
  • the base body 38 comprises a second recess 40 for receiving a clamp 9 of the bag system 1 and a third and fourth recess 41, 42 for receiving tubing portions 7 of the bag system 1.
  • the second recess 40 has a substantially rectangular shape.
  • the third and fourth recesses 41, 42 for the tubing portions 7 have an open channel shape. The geometry of each of said recesses 40, 41, 42 ensures the tight fit of the rigid component of the bag system 1 or the tubing portion that the recess is intended to receive.
  • the cover member 20 of the protective case of the second embodiment comprises a cover body 43 which bears on the filtration unit 2 when it is arranged in the first embodiment. recess 39 forming holding means 21 and that the protective case is in a closed state.
  • the cover body 43 and the first recess cooperate to immobilize the filtration unit 2 in the protective case 18.
  • the cover body 43 comprises at least one recess 44,45,46 whose geometry corresponds to the geometry of at least one of the rigid components of the bag system and / or to a portion of flexible tubing of the system to pockets 1.
  • the lid body 43 includes a first recess 44 for receiving the fluid sample sampling means 10 and tubing portions 13 of the bag system 1.
  • the lid body 43 further comprises a second recess 45 intended to receive the rigid tube portion forming one of the inlet and outlet openings 4 of the filtration unit 2 when the protective case 18 is closed. .
  • a third recess 46 in the lid body 43 is intended to receive the tubular portion 7 passing above the filtration unit 2 in the base body 19, when the protective case 18 is closed.
  • the second volume of the cavity of the protective case 18 is delimited at least in part by the recess or recesses 44, 45, 46 for receiving at least one rigid component of the bag system and / or the flexible tubing portions.
  • the base member 19 and the cover member 20 are joined together by a hinge 47.
  • the base member and the cover member are distinct in that they are separate when the protective case is in an open state.
  • the cover body 43 comes into contact with one of the plane faces of the unit filter 2, thus cooperating with the holding means 21 to prevent any movement of the filtration unit 2 inside the closed case 18.
  • the base element 19 and the cover member 20 are held together by means of at least one stud 48, for example of circular shape, arranged on one of said elements 19,20 and which fits by shape fit in a recess 49 arranged on the other of said elements.
  • at least one stud 48 for example of circular shape, arranged on one of said elements 19,20 and which fits by shape fit in a recess 49 arranged on the other of said elements.
  • the base element 19 and the cover member 20 of the protective case 18 have substantially the shape of a trapezium, so as to form a protective case 18 having substantially the shape of a trapezoidal prism in its closed state. This particular shape facilitates the introduction of the protective case in a centrifuge container.
  • the protective case has a rectangular parallelepiped shape.
  • the invention relates to an assembly comprising a protective case 18 according to the first aspect of the invention and a bag system 1 intended for the treatment of a biological fluid, said bag system being composed of at least a filtration unit 2 of a biological fluid, the unit filter 2 being held in said protective case by the holding means 21 of the protective case together with the cover member 20.
  • the bag system 1 of the assembly is further composed as flexible components at least one primary bag 5 comprising the biological fluid to be filtered and a bag for collecting the filtrate 6, each of said pockets 5, 6 being connected to said filtration unit 2 by a flexible tubing 7, respectively, and as rigid components, at least one clamp 9 arranged on one of said tubing 8 and / or a sampling means 10 of a fluid sample.
  • the primary bag 5 is connected to the tubing 7 of the bag system or is sterile connected to the bag system at the time of use.
  • the pockets 5, 6, 14 of the bag system are arranged outside said protective case 18.
  • all the rigid components 9, 10, 16, 17 of the bag system 1 are arranged inside the protective case 18.
  • the protective case 18 is closed, the assembly is ready to be placed in a centrifuge container such as a centrifuge insert or bucket.
  • the package including the protective case and the bag system can be placed in all types of commercially available centrifuge pods and insert inserts.
  • the protective case has substantially the same dimensions as the cushioning foam used to maintain vertically the pockets of the bag system in the centrifugation vessel.
  • the protective case replaces the cushioning foam, making the use of such a foam unnecessary.
  • the space taken in the centrifuge container by the assembly formed of the bag system and the protective case is therefore substantially the same as that taken by the bag system and cushioning foam.
  • the invention in its third aspect relates to a method of treating a biological fluid using a bag system 1 composed of at least one filtration unit 2 of the biological fluid, said method comprising the successive steps of:
  • the transfer of the separated phases by centrifugation is carried out outside the centrifuge, before or jointly with the filtration step.
  • the bag system 1 is furthermore composed, as flexible components, of at least one primary bag 5 comprising the biological fluid to be filtered and a bag for collecting the filtrate 6, each of said pockets 5,6 being connected to said filtration unit 2 by a flexible tubing 7,8, and as rigid components, of at least one clamp 9 arranged on one of said tubing 8 and / or a sampling means 10 of a fluid sample.
  • the method for treating a biological fluid further comprises, before the step of placing the bag system 1 in the centrifugation vessel, the step of disposing at least one of the rigid components 9,10 , 16,17 in the protective case 18, said flexible pockets 5,6 remaining outside said protective case 18.
  • all the rigid components 9,10,16,17 of the bag system 1 are arranged inside the protective case 18.
  • the protective case 18 is placed in the centrifuge container, parallel to the pockets 5, 6 of the bag system 1 so as to keep the filtration unit 2 parallel to the pockets and perpendicular to the axis. of rotation during centrifugation.
  • the biological fluid is blood or a blood component.
  • the biological fluid treatment comprises separating an assembly of buffy coat platelet concentrates into platelet concentrate and filtering said platelet concentrate for depletion into leukocytes.
  • This treatment is carried out with the bag system shown in FIG. 1 or an equivalent bag system comprising said filtration unit 2.

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Abstract

The invention concerns a protective case (18) for components of a bag system intended for treating a biological fluid, said bag system consisting of at least one filtration unit (2) for filtering the biological fluid, said protective case (18) comprising a cavity having a first space intended to receive said filtration unit (2) and at least one second space, said cavity being formed between a base element (19) and an element forming a lid (20) positioned removably on said base element (19), holding means for holding the filtration unit in said first space being arranged in said cavity, said holding means and the element forming a lid (20) operating in combination to prevent any movement of the filtration unit (2) inside the protective case (18), when said filtration unit (2) is arranged inside said holding means.

Description

Etui de protection pour composants d'un système à poches  Protective case for components of a bag system
L'invention concerne un étui de protection pour composants d'un système à poches, un ensemble comprenant un tel étui de protection et un système à poches, ainsi qu'une méthode de traitement d'un fluide biologique à l'aide d'un tel étui de protection. The invention relates to a protective case for components of a bag system, an assembly comprising such a protective case and a bag system, and a method for treating a biological fluid using a such protective case.
L'invention s'applique notamment au domaine de la transfusion et plus particulièrement à la séparation et la filtration du sang et des composants sanguins. The invention applies in particular to the field of transfusion and more particularly to the separation and filtration of blood and blood components.
Afin de séparer le sang en ses composants sanguins tels que le plasma, les globules rouges et les plaquettes, il est connu d'utiliser un système à poches, tel que celui décrit dans le document US-4 767 541 , comprenant une aiguille de prélèvement du sang, une poche primaire destinée à recueillir le sang d'un donneur, et, reliées à celle-ci par l'intermédiaire de tubulures souples, des poches secondaires destinées à recevoir les différents composants sanguins séparés après une étape de centrifugation. Un tel système comprend en outre et classiquement au moins une unité de filtration destinée à éliminer les leucocytes d'un composant sanguin. En effet, les leucocytes augmentent le risque de rejet immunitaire tel que la maladie du greffon contre l'hôte et favorisent la transmission d'agents infectieux. Il est donc apparu nécessaire de les éliminer des composants sanguins à transfuser. In order to separate the blood into its blood components such as plasma, red blood cells and platelets, it is known to use a bag system, such as that described in US-4,767,541, comprising a sampling needle. blood, a primary bag for collecting blood from a donor, and connected thereto via flexible tubing, secondary bags for receiving the different blood components separated after a centrifugation step. Such a system further comprises and typically at least one filtration unit for removing leukocytes from a blood component. In fact, leukocytes increase the risk of immune rejection such as graft-versus-host disease and promote the transmission of infectious agents. It has therefore appeared necessary to eliminate them from the blood components to be transfused.
Un autre système à poches, divulgué par exemple dans le document EP 2 783 717 A1 , permet de préparer un concentré de plaquettes déleucocyté à partir d'un assemblage de couches leuco-plaquettaires, autrement appelé pool de buffy-coats. Ce système comprend typiquement une pluralité de tubulures à connecter de façon stérile à des poches contenant une couche leuco- plaquettaire et éventuellement à une poche contenant une solution additive pour conserver les plaquettes. Le système comprend en outre, reliées entre elles par des tubulures, une poche d'assemblage pour recueillir la pluralité de couches leuco-plaquettaires, une unité de filtration destinée à éliminer les leucocytes d'un concentré plaquettaire, et une poche de recueil de filtrat. Des clamps sont agencés sur les tubulures afin de contrôler l'écoulement des fluides dans le système. Optionnellement, ce système comprend en outre une poche d'échantillonnage et un moyen de prélèvement de l'échantillon sous forme d'une canule montée sur une embase rigide. Another bag system, disclosed for example in EP 2 783 717 A1, makes it possible to prepare a leukocyte-depleted platelet concentrate from a leuco-platelet layer assembly, otherwise known as a buffy coat pool. This system typically includes a plurality of tubings to be sterile connected to pouches containing a buffy coat layer and optionally to a pouch containing an additive solution for preserving platelets. The system further comprises, interconnected by tubings, an assembly bag for collecting the plurality of buffy coats, a filtration unit for removing leukocytes. a platelet concentrate, and a filtrate collection bag. Clamps are arranged on the tubing to control the flow of fluids in the system. Optionally, this system further comprises a sampling bag and a sampling means in the form of a cannula mounted on a rigid base.
L'utilisation de tels systèmes à poches fait intervenir successivement une étape de centrifugation, à l'aide d'une centrifugeuse, pour séparer le sang en ses différents composants, une étape de séparation, à l'aide d'une presse, pour transférer les différents composants séparés dans les poches dédiées des systèmes à poches et une étape de filtration d'au moins un composant du sang séparé, afin d'en éliminer les leucocytes. The use of such bag systems involves successively a centrifugation step, using a centrifuge, to separate the blood into its various components, a separation step, using a press, to transfer the different components separated in the dedicated pockets of the bag systems and a step of filtering at least one component of the separated blood, in order to eliminate the leucocytes therefrom.
Lors de l'étape de centrifugation, il est nécessaire d'introduire dans un récipient de centrifugation, par exemple un insert pour nacelle de centrifugation, non seulement les diverses poches souples, mais également l'unité de filtration, le récipient de centrifugation ainsi chargé étant ensuite placé dans la centrifugeuse. Or il s'avère que, lors de cette étape de centrifugation, l'unité de filtration et/ou certains composants rigides tels que le moyen de prélèvement de l'échantillon, risquent d'être endommagés en glissant dans le fond du récipient de centrifugation, compte-tenu de l'accélération et de la vitesse de centrifugation. En outre, et notamment lorsque l'unité de filtration comprend un boîtier rigide, la centrifugation de celle-ci conjointement avec les poches souples et les tubulures peut induire, par frottement, une détérioration de ces dernières. Dans certains cas, cette détérioration provoque un percement d'une poche et/ou d'une tubulure, ce qui rend le système inutilisable pour la séparation du sang ou des composants. During the centrifugation step, it is necessary to introduce into a centrifugation vessel, for example a nacelle centrifugation insert, not only the various flexible bags, but also the filtration unit, the centrifugation container thus loaded. being then placed in the centrifuge. However, it turns out that, during this centrifugation step, the filtration unit and / or certain rigid components such as the means for sampling the sample may be damaged by sliding in the bottom of the centrifugation vessel. , given the acceleration and the speed of centrifugation. In addition, and particularly when the filtration unit comprises a rigid housing, centrifugation thereof together with the flexible bags and tubing can induce, by friction, a deterioration of the latter. In some cases, this deterioration causes piercing of a pocket and / or tubing, rendering the system unusable for the separation of blood or components.
Pour remédier à ces problèmes, différentes solutions ont déjà été proposées. D'abord, il a été proposé, comme dans le document US 2003/0004453, de maintenir l'unité de filtration sur l'une des poches du système à poches à l'aide d'une bandelette solidaire de la poche afin d'éviter que l'unité de filtration ne glisse dans le fond du récipient de centrifugation lors de la centrifugation. To remedy these problems, various solutions have already been proposed. First, it has been proposed, as in document US 2003/0004453, to maintain the filtration unit on one of the pockets of the bag system using a strip secured to the pocket in order to prevent the filter unit from slipping into the bottom of the centrifuge bowl during centrifugation.
Cependant, cette solution ne permet pas d'éviter les dommages causés par le contact des unités de filtration rigides sur les poches et tubulures souples lors de la centrifugation. II a ensuite été imaginé différents supports pour unité de filtration à fixer à l'extérieur des nacelles de centrifugation comme dans le document US 2002/0046967. However, this solution does not prevent the damage caused by the contact of the rigid filtration units on the pockets and flexible tubes during centrifugation. It was then imagined different media for filtration unit to be fixed outside the centrifuge nacelles as in US 2002/0046967.
Cependant, cette solution présente l'inconvénient de nécessiter de développer un support particulier pour chaque type de nacelle. However, this solution has the disadvantage of requiring the development of a particular support for each type of nacelle.
Dans le document EP 0 654 303, un portoir à insérer dans un godet de centrifugation est pourvu d'un logement central dans lequel l'unité de filtration est disposée, les poches étant disposées dans des compartiments de part et d'autre dudit logement. Cependant, la présence du logement central à l'intérieur du portoir limite la place disponible pour le système à poches. In EP 0 654 303, a rack to be inserted in a centrifugation cup is provided with a central housing in which the filter unit is arranged, the pockets being arranged in compartments on either side of said housing. However, the presence of the central housing inside the rack limits the space available for the bag system.
Le document US 5 456 845 décrit un support sensiblement plat pour unité de filtration à insérer dans un récipient de centrifugation. Dans une réalisation, ce support sensiblement plat comprend un évidement supérieur dans lequel l'unité de filtration est logée en recouvrant ses parties saillantes. Cependant, ce support est adapté pour des unités de filtration dont les orifices d'entrée et sortie sont disposés d'un même côté. Dans une variante, le support est dit de type sandwich, formé de deux parois opposées entre lesquelles l'unité de filtration peut être glissée. Ce type de support ne permet cependant pas de maintenir fixe l'unité de filtration durant la centrifugation. US 5 456 845 discloses a substantially flat support for a filter unit for insertion into a centrifuge vessel. In one embodiment, this substantially flat support comprises an upper recess in which the filtration unit is housed by covering its projecting parts. However, this support is suitable for filtration units whose inlet and outlet ports are arranged on the same side. In a variant, the support is said to be of sandwich type, formed of two opposite walls between which the filtration unit can be slid. This type of support, however, does not allow to maintain fixed filter unit during centrifugation.
D'autre part, il existe des appareils particuliers réalisant à la fois la centrifugation et la séparation des composants sanguins. Ces appareils, tels que par exemple ceux décrits dans les documents WO 2010/061863, US 2002/0020680 et WO 03/089027, nécessitent d'utiliser des systèmes à poches spécialement conçus pour être utiliser avec chacun de ces appareils. Par exemple, dans le document WO 2010/061863, le système à poches est monté de fabrication dans une cassette qui intègre un support pour unité de filtration. La cassette avec le système à poches est ensuite placée dans un support de cassette avant d'être introduit dans l'appareil de centrifugation et séparation. Cette cassette n'est pas utilisable avec les centrifugeuses classiques. On the other hand, there are particular devices performing both centrifugation and separation of blood components. These devices, such as for example those described in WO 2010/061863, US 2002/0020680 and WO 03/089027, require the use of bag systems specifically designed to be used with each of these devices. For example, in WO 2010/061863, the bag system is manufactured in a cassette that incorporates a support for filtration unit. The cassette with the bag system is then placed in a cassette holder before being introduced into the centrifuge and separation apparatus. This cassette is not usable with conventional centrifuges.
Dans le document US 2002/0020680, le système à poches est placé dans une cassette circulaire comprenant des cavités pour les poches et des cavités pour les unités les unités de filtration. La cassette circulaire est ensuite introduite dans l'appareil de centrifugation et séparation. Masi, les unités de filtration ne sont pas maintenues fixement dans cette cassette circulaire. In US 2002/0020680, the bag system is placed in a circular cassette comprising cavities for the pockets and cavities for the units and filtration units. The circular cassette is then introduced into the centrifuge and separation apparatus. Masi, the filtration units are not held firmly in this circular cassette.
Dans le document WO 03/089027, le système à poches est directement placé sur le rotor de l'appareil de centrifugation et séparation. Dans une réalisation, l'unité de filtration du système à poches est disposée dans une partie creuse du rotor de l'appareil, entre un rebord et le couvercle. In WO 03/089027, the bag system is directly placed on the rotor of the centrifuge and separation apparatus. In one embodiment, the filtration unit of the bag system is disposed in a hollow portion of the rotor of the apparatus, between a rim and the cover.
L'invention propose un étui de protection permettant de protéger l'unité de filtration et les composants rigides d'un système à poches de la déformation par contact avec un récipient de centrifugation lors de la centrifugation, tout en réduisant les risques d'endommagement des poches souples d'un tel système. The invention proposes a protective case for protecting the filtration unit and the rigid components of a bagging system from deformation by contact with a centrifugation container during centrifugation, while reducing the risk of damage to the cells. soft pockets of such a system.
Selon un premier aspect, l'invention concerne un étui de protection pour composants d'un système à poches destiné au traitement d'un fluide biologique, ledit système à poches étant composé d'au moins une unité de filtration du fluide biologique, ledit étui de protection étant destiné à être placé avec le système à poches dans un récipient de centrifugation, ledit étui de protection comprenant une cavité formée entre un élément de base et un élément formant couvercle placé de façon amovible sur ledit élément de base, ladite cavité ayant un premier volume destiné à réceptionner ladite unité de filtration et au moins un second volume, l'élément de base comprenant des moyens de maintien de l'unité de filtration dans ledit premier volume de ladite cavité, lesdits moyens de maintien et l'élément formant couvercle opérant conjointement pour empêcher tout mouvement de l'unité de filtration à l'intérieur de l'étui de protection, lorsque ladite unité de filtration est disposée dans lesdits moyens de maintien et que l'élément formant couvercle est placé sur l'élément de base. According to a first aspect, the invention relates to a protective case for components of a bag system for the treatment of a biological fluid, said bag system being composed of at least one biological fluid filtration unit, said case shield being intended to be placed with the bag system in a centrifugation vessel, said protective case comprising a cavity formed between a base member and a cover member removably placed on said base member, said cavity having a first volume for receiving said filtration unit and at least a second volume, the base member comprising means for holding the filtration unit in said first volume of said cavity, said holding means and the forming member; lid operating together to prevent movement of the filter unit within the protective case, when said filter unit is disposed in said holding means and the cover member is placed on the filter element. based.
Selon un deuxième aspect, l'invention concerne un ensemble comprenant un étui de protection selon le premier aspect de l'invention et un système à poches destiné au traitement d'un fluide biologique, ledit système étant composé d'au moins une unité de filtration d'un fluide biologique, l'unité de filtration étant maintenue dans ledit étui de protection par les moyens de maintien de l'étui de protection conjointement avec l'élément formant couvercle. According to a second aspect, the invention relates to an assembly comprising a protective case according to the first aspect of the invention and a bag system for the treatment of a biological fluid, said system being composed of at least one filtration unit. of a biological fluid, the filtration unit being held in said protective case by the holding means of the protective case together with the cover member.
L'invention concerne selon un troisième aspect, un procédé de traitement d'un fluide biologique à l'aide d'un système à poches composé d'au moins une unité de filtration du fluide biologique, ledit procédé comprenant les étapes successives de : According to a third aspect, the invention relates to a method for treating a biological fluid using a bag system composed of at least one biological fluid filtration unit, said method comprising the successive steps of:
- disposer l'unité de filtration dans un étui de protection selon le premier aspect de l'invention,  placing the filtration unit in a protective case according to the first aspect of the invention,
- placer dans un récipient de centrifugation le système à poches avec l'étui de protection dans lequel l'unité de filtration est disposée,  placing in a centrifugation container the bag system with the protective case in which the filtration unit is arranged,
- centrifuger dans une centrifugeuse le système à poches placé dans ledit récipient de centrifugation de sorte à séparer le fluide biologique en au moins une phase de surnageant et une phase de sédiment,  centrifuging in a centrifuge the bag system placed in said centrifugation vessel so as to separate the biological fluid into at least one supernatant phase and a sediment phase,
- retirer le système à poches centrifugé du récipient de centrifugation, - remove the centrifuged bag system from the centrifuge vessel,
- retirer l'unité de filtration de l'étui de protection, - remove the filter unit from the protective case,
- filtrer l'une des phases séparées au travers de l'unité de filtration retirée de l'étui de protection.  filtering one of the separated phases through the filtration unit removed from the protective case.
D'autres objets et avantages de l'invention apparaîtront au cours de la description qui suit, en référence aux dessins annexés dans lesquels : La figure 1 représente de façon schématique un système à poches destiné au traitement d'un fluide biologique. Other objects and advantages of the invention will become apparent from the description which follows, with reference to the appended drawings in which: Figure 1 schematically shows a bag system for the treatment of a biological fluid.
Les figures 2 et 3 représentent une vue schématique et en perspective d'un étui de protection dans un état ouvert, formé d'un élément de base et d'un élément formant couvercle selon une première réalisation de l'invention. Figures 2 and 3 show a schematic perspective view of a protective case in an open state, formed of a base member and a cover member according to a first embodiment of the invention.
La figure 4 représente une vue schématique et en perspective de l'étui de protection des figures 2 et 3 dans un état fermé, une portion de tubulure sortant dudit étui de protection. Figure 4 shows a schematic perspective view of the protective case of Figures 2 and 3 in a closed state, a portion of tubing out of said protective case.
La figure 5 représente une vue schématique et de profil de l'étui de protection des figures 2 et 3 dans un état ouvert ainsi qu'une unité de filtration destinée à être placée dans ledit étui de protection. Figure 5 shows a schematic and side view of the protective case of Figures 2 and 3 in an open state and a filter unit to be placed in said protective case.
La figure 6 représente une vue schématique et en perspective de l'étui de protection des figures 2 et 3 dans un état ouvert, des composants du système à poches, en vue éclatée, étant placés à l'intérieur de l'étui. La figure 7 représente une vue schématique et en perspective d'un étui de protection selon une deuxième réalisation de l'invention. Figure 6 shows a schematic and perspective view of the protective case of Figures 2 and 3 in an open state, components of the bag system, exploded view, being placed inside the case. Figure 7 shows a schematic perspective view of a protective case according to a second embodiment of the invention.
La figure 8 représente une vue schématique et de face de l'étui de protection de la figure 7 avec des composants du système à poches disposés à l'intérieur. Figure 8 shows a schematic and front view of the protective case of Figure 7 with components of the bag system disposed therein.
Selon un premier aspect, l'invention concerne un étui de protection pour composants d'un système à poches destiné au traitement d'un fluide biologique. According to a first aspect, the invention relates to a protective case for components of a bag system for the treatment of a biological fluid.
Le fluide biologique est notamment le sang ou un composant sanguin, tel qu'un plasma riche en plaquettes, un plasma pauvre en plaquettes, un concentré de globules rouges, un concentré de plaquettes, une couche leuco-plaquettaire ou encore un lysat plaquettaire. Le traitement d'un fluide biologique comprend notamment la séparation du fluide biologique en ses différents composants, par exemple par centrifugation, et la filtration dudit fluide ou de l'un au moins de ses composants séparés. La filtration consiste à éliminer les constituants indésirables du fluide biologique. Dans le cadre de la transfusion sanguine, les constituants indésirables sont en particulier les leucocytes, les protéines à prions et/ou les substances d'inactivation des pathogènes. Un exemple de traitement d'un fluide biologique consiste à préparer par centrifugation et filtration, un plasma appauvri en leucocytes et/ou un concentré de globules rouges appauvri en leucocytes à partir d'une unité de sang total. Un autre traitement consiste à préparer par centrifugation et filtration, un concentré de plaquettes appauvri en leucocytes à partir d'un pool de couches leuco- plaquettaires. The biological fluid is especially blood or a blood component, such as a platelet-rich plasma, a platelet-poor plasma, a red blood cell concentrate, a platelet concentrate, a buffy coat or a platelet lysate. The treatment of a biological fluid comprises in particular the separation of the biological fluid into its various components, for example by centrifugation, and the filtration of said fluid or at least one of its separate components. Filtration involves removing undesirable constituents of the biological fluid. In the context of blood transfusion, the undesirable constituents are in particular leucocytes, prion proteins and / or pathogen inactivation substances. An example of treatment of a biological fluid is to prepare by centrifugation and filtration, a leukocyte-depleted plasma and / or leukocyte-depleted red blood cell concentrate from a whole blood unit. Another treatment is to prepare by centrifugation and filtration a leukocyte depleted platelet concentrate from a buffy coat pool.
La figure 1 représente un exemple d'un système à poches 1 utilisé pour traiter un fluide biologique, notamment pour préparer un concentré de plaquettes appauvri en leucocytes à partir d'un pool de couches leuco-plaquettaires. Le pool de couches leuco-plaquettaires est obtenu après réunion de deux à huit unités de couches leuco-plaquettaires issues d'un don de sang total. FIG. 1 represents an example of a bag system 1 used to treat a biological fluid, especially for preparing a leukocyte depleted platelet concentrate from a buffy coat pool. The buffy coat pool is obtained after combining two to eight units of buffy coat from a whole blood donation.
En relation avec la figure 1 , le système à poches 1 est composé d'au moins une unité de filtration 2 du fluide biologique. In connection with FIG. 1, the bag system 1 is composed of at least one filtration unit 2 of the biological fluid.
L'unité de filtration du système à poches de la figure 1 est destinée à éliminer les leucocytes d'un concentré plaquettaire. The filtration unit of the bag system of Figure 1 is intended to remove leukocytes from a platelet concentrate.
L'unité de filtration 2 comprend un boîtier rigide muni d'au moins un orifice d'entrée 3 et d'au moins un orifice de sortie 4, lesdits orifices 3,4 étant agencés de façon opposée, le boîtier renfermant un élément poreux interposé entre lesdits orifices, ledit élément poreux renfermant un milieu de déleucocytation. Une telle unité de filtration est décrite plus en détail dans le document EP 2 783 717 A1 . Le boîtier de l'unité de filtration 2 est sensiblement plat en ce qu'il comprend deux faces planes sensiblement parallèles entre elles, le boîtier présentant une faible épaisseur par rapport aux dimensions des faces. The filtration unit 2 comprises a rigid casing provided with at least one inlet orifice 3 and at least one outlet orifice 4, said orifices 3,4 being arranged in an opposite manner, the casing enclosing a porous element interposed between said orifices, said porous member including a leukocyte removal medium. Such a filtration unit is described in more detail in EP 2 783 717 A1. The housing of the filtration unit 2 is substantially flat in that it comprises two plane faces substantially parallel to each other, the housing having a small thickness relative to the dimensions of the faces.
En variante non représentée, l'unité de filtration comprend une enveloppe extérieure souple ou semi-rigide. In variant not shown, the filtration unit comprises a flexible or semi-rigid outer casing.
Le système à poches 1 est composé en outre, en tant que composants souples, d'au moins une poche primaire 5 comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat 6, chacune desdites poches 5,6 étant reliée à ladite unité de filtration par une tubulure souple 7,8. Sur la figure 1 , la poche primaire 5 est connectée de fabrication aux autres composants du système à poches 1 . En variante non représentée, la poche primaire est connectée au système à poches au moment de son utilisation. The bag system 1 is furthermore composed, as flexible components, of at least one primary bag 5 comprising the biological fluid to be filtered and a bag for collecting the filtrate 6, each of said pockets 5, 6 being connected to said filtration unit by a flexible tubing 7.8. In FIG. 1, the primary bag 5 is connected to the other components of the bag system 1. In variant not shown, the primary pocket is connected to the bag system at the time of its use.
Les poches et les tubulures sont réalisées dans un matériau thermoplastique stérilisable à la valeur, comme par exemple le polychlorure de vinyle. En tant que composants rigides, le système à poches 1 est composé en outre d'au moins un clamp 9 agencé sur l'une desdites tubulures 8 et/ou d'un moyen de prélèvement 10 d'un échantillon de fluide. The bags and tubings are made of a thermoplastic material sterilizable value, such as polyvinyl chloride. As rigid components, the bag system 1 is further composed of at least one clamp 9 arranged on one of said tubing 8 and / or a sample 10 of a fluid sample.
Les composants rigides sont réalisés par moulage dans un matériau thermoplastique stérilisable à la vapeur, comme par exemple le polycarbonate ou le polypropylène. The rigid components are made by molding in a thermoplastic material that can be sterilized by steam, for example polycarbonate or polypropylene.
Plus particulièrement sur le système de la figure 1 , la poche primaire 5 est connectée par l'intermédiaire d'une première tubulure 7 à l'unité de filtration 2. L'unité de filtration 2 est connectée par l'intermédiaire d'une deuxième tubulure 8 à la poche de recueil du filtrat 6. More particularly on the system of FIG. 1, the primary bag 5 is connected via a first tube 7 to the filtration unit 2. The filtration unit 2 is connected via a second tubing 8 to the filtrate collection bag 6.
Pour la préparation du pool de couches leuco-plaquettaires, la poche primaire 5 est en communication fluidique avec un ensemble de tubulures constitué d'une tubulure principale 1 1 et de tubulures secondaires 12 branchées sur la tubulure principale. Ces tubulures secondaires 12 sont destinées à être connectées de façon stérile à au moins deux poches contenant une unité d'une couche leuco- plaquettaire et éventuellement à une poche contenant une solution additive de conservation des plaquettes. For the preparation of the buffy coat pool, the primary bag 5 is in fluid communication with a set of tubing consisting of a main tubing 1 1 and secondary tubing 12 connected to the main tubing. These secondary tubings 12 are intended to be connected in a sterile manner to at least two bags containing a unit of a buffy coat layer and possibly to a bag containing an additive solution for preserving the platelets.
La poche de recueil du filtrat 6 est en communication fluidique par l'intermédiaire d'une troisième tubulure 13 à une poche satellite 14 destinée à recevoir l'air présent dans la poche de recueil du filtrat 6 et/ou au recueil d'un échantillon du fluide contenu dans la poche de recueil du filtrat 6. The filtrate collection bag 6 is in fluid communication via a third tube 13 to a satellite bag 14 for receiving the air present in the filtrate collection bag 6 and / or collecting a sample fluid contained in the filtrate collection bag 6.
Afin de prélever des échantillons du fluide contenu dans la poche de recueil du filtrat, le système à poches comprend une quatrième tubulure 15 branchée par l'intermédiaire d'un connecteur trois voies sur la troisième tubulure 13, ladite quatrième tubulure 15 étant pourvue à son extrémité d'un moyen de prélèvement 10 d'un échantillon de fluide. L'échantillon prélevé par ce moyen est utilisé pour la détection d'une contamination bactérienne (Système Bact/Alert®). Le moyen de prélèvement 10 d'un échantillon de fluide est notamment formé d'une canule montée sur une embase rigide. La canule est recouverte d'un manchon élastomère et d'un capuchon protecteur. In order to take samples of the fluid contained in the filtrate collection bag, the bag system comprises a fourth tubing connected via a three-way connector to the third tubing 13, said fourth tubing being provided with its end of a sampling means 10 of a fluid sample. The sample taken by this means is used for the detection of bacterial contamination (Bact / Alert® System). The sampling means 10 of a fluid sample is in particular formed of a canula mounted on a rigid base. The cannula is covered with an elastomeric sleeve and a protective cap.
Certaines tubulures 8,13,15 sont pourvues d'un clamp 9,16,17 pour contrôler l'écoulement fluidique à l'intérieur du système à poches. Some tubings 8, 13, 15 are provided with a 9, 16, 17 clamp to control the fluid flow inside the bag system.
Le système à poches représenté sur la figure 1 est dit clos, en ce que les différents composants sont assemblés entre eux de fabrication. Pour la mise en œuvre du traitement, la poche primaire 5 contenant le pool de couches leuco-plaquettaires et éventuellement la solution additive de conservation des plaquettes est centrifugée pour obtenir une couche sédimentaire de globules rouges et une couche de surnageant de concentré plaquettaire. La poche primaire 5 centrifugée contenant les couches de globules rouges et de concentré plaquettaire est ensuite pressée afin d'envoyer le concentré plaquettaire dans la poche de recueil du filtrat 6 via l'unité de filtration 2, permettant d'obtenir un concentré de plaquettes appauvri en leucocytes. The bag system shown in Figure 1 is said to be closed, in that the various components are assembled together. For carrying out the treatment, the primary bag 5 containing the buffy coat pool and optionally the platelet preservative additive solution is centrifuged to obtain a sediment layer of red blood cells and a platelet concentrate supernatant layer. The centrifuged primary bag containing the layers of red blood cells and platelet concentrate is then pressed to dispense the platelet concentrate into the filtrate collection bag 6 via the filtration unit 2, resulting in depleted platelet concentrate. in leucocytes.
L'étui de protection de l'invention est destiné à être placé avec le système à poches 1 dans un récipient de centrifugation, telle qu'un insert ou un godet de centrifugation. The protective case of the invention is intended to be placed with the bag system 1 in a centrifuge container, such as an insert or a centrifuge cup.
L'étui de protection vise à protéger un tel système à poches composé d'au moins une unité de filtration, des risques d'endommagement encourus lors de l'étape de centrifugation. Plus particulièrement, l'étui de protection vise à protéger l'unité de filtration du risque de casse et de déformation et les poches du risque de percement. The protective case aims to protect such a bag system composed of at least one filtration unit, the risk of damage incurred during the centrifugation step. More particularly, the protective case aims to protect the filtration unit from the risk of breakage and deformation and the pockets of the risk of piercing.
En relation avec les figures 2 à 8, l'étui de protection 18 de l'invention comprend une cavité ayant un premier volume destiné à réceptionner l'unité de filtration 2 du système à poches 1 et au moins un second volume. In connection with FIGS. 2 to 8, the protective case 18 of the invention comprises a cavity having a first volume for receiving the filtration unit 2 of the bag system 1 and at least a second volume.
La cavité de l'étui de protection définit ainsi un espace suffisant pour réceptionner, dans le premier volume, l'unité de filtration 2 ainsi que, dans le second volume, un autre composant du système à poches. Le second volume est un espace supplémentaire à l'espace du premier volume pour pouvoir recevoir un composant du système à poches autre que l'unité de filtration, par exemple une tubulure, un clamp et/ou un moyen de prélèvement d'un échantillon de fluide. L'étui de protection est destiné à recevoir l'unité de filtration d'un système à poches et certains autres petits composants rigides, à l'exception des poches qui restent à l'extérieur de l'étui de protection. The cavity of the protective case thus defines a space sufficient to receive, in the first volume, the filtration unit 2 as well as, in the second volume, another component of the bag system. The second volume is an additional space in the space of the first volume to be able to receive a component of the bag system other than the filtration unit, for example a tubing, a clamp and / or a sample collection means. fluid. The protective case is intended to receive the filtration unit of a bag system and certain other small rigid components, with the exception of the pockets which remain outside the protective case.
Par exemple, outre l'unité de filtration 2, lorsque le système à poches 1 est composé, en tant que composants souples, d'au moins une poche primaire 5 comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat 6, chacune desdites poches étant reliée à ladite unité de filtration par une tubulure souple 7,8 respectivement, et en tant que composants rigides, d'au moins un clamp 9 agencé sur l'une desdites tubulures 7,8 et/ou d'un moyen de prélèvement 10 d'un échantillon de fluide, le second volume de ladite cavité est destiné à réceptionner l'un au moins desdits composants rigides 9,10 du système à poches 1 . For example, in addition to the filtration unit 2, when the bag system 1 is composed, as flexible components, of at least one primary bag 5 comprising the biological fluid to be filtered and a filtrate collection bag 6 each of said pockets being connected to said filtration unit by a tubing flexible 7,8 respectively, and as rigid components, at least one clamp 9 arranged on one of said tubing 7,8 and / or means 10 for sampling a fluid sample, the second volume of said cavity is intended to receive at least one of said rigid components 9,10 of the bag system 1.
En particulier le second volume est destiné à réceptionner d'une part, entre un et trois clamps 9,16,17 agencés sur des tubulures souples 8,13,15 du système à poches 1 , et d'autre part le moyen de prélèvement 10 d'un échantillon de fluide. In particular, the second volume is intended to receive, on the one hand, between one and three clamps 9, 16, 17 arranged on flexible tubings 8, 13, 15 of the bag system 1, and on the other hand the sampling means 10. a fluid sample.
Selon l'invention, la cavité de l'étui de protection est formée entre un élément de base 19 et un élément formant couvercle 20 placé de façon amovible sur ledit élément de base 19. Lorsque l'élément formant couvercle 20 est placé sur l'élément de base 19, l'étui de protection 18 est dans un état fermé (figure 4). Une fois que les composants concernés du système à poches sont disposés dans l'étui de protection 18, l'étui de protection dans son état fermé est placé dans un récipient de centrifugation, notamment dans un insert ou godet pour nacelle de centrifugation. According to the invention, the cavity of the protective case is formed between a base member 19 and a cover member 20 removably placed on said base member 19. When the cover member 20 is placed on the base member base element 19, the protective case 18 is in a closed state (Figure 4). Once the relevant components of the bag system are disposed in the protective case 18, the protective case in its closed state is placed in a centrifugation vessel, in particular in an insert or bucket for centrifuge nacelle.
Lorsque l'élément formant couvercle 20 est déplacé ou éloigné de l'élément de base 19, l'étui de protection 18 est dans un état ouvert (figures 2-3 et 7-8). L'étui de protection 18 dans son état ouvert permet de disposer les différents composants concernés du système à poches 1 dans l'étui de protection. When the cover member 20 is moved or moved away from the base member 19, the protective case 18 is in an open state (Figures 2-3 and 7-8). The protective case 18 in its open state makes it possible to arrange the various components concerned of the bag system 1 in the protective case.
L'élément formant couvercle 20 est placé de façon amovible sur l'élément de base 19, de sorte que l'étui de protection n'est pas à usage unique et peut être utilisé plusieurs fois, notamment au moins jusqu'à cinquante fois. Des moyens de maintien 21 de l'unité de filtration 2 dans le premier volume sont agencés dans ladite cavité, lesdits moyens de maintien 21 étant aptes à empêcher tout mouvement de l'unité de filtration 2 placée à l'intérieur de l'étui de protection 18 lorsque ladite unité de filtration 2 est disposée dans lesdits moyens de maintien 21 . En particulier, l'élément de base 19 comprend les moyens de maintien 21 de l'unité de filtration dans le premier volume de la cavité, c'est-à-dire que les moyens de maintien 21 sont solidaires de l'élément de base 19. The cover member 20 is removably placed on the base member 19, so that the protective case is not disposable and can be used several times, especially at least up to fifty times. Holding means 21 of the filtration unit 2 in the first volume are arranged in said cavity, said holding means 21 being able to prevent any movement of the filtration unit 2 placed inside the holster. protection 18 when said filtration unit 2 is disposed in said holding means 21. In particular, the base element 19 comprises the holding means 21 of the filtration unit in the first volume of the cavity, that is to say that the holding means 21 are integral with the base element 19.
De plus, les moyens de maintien 21 et l'élément formant couvercle 20 opèrent conjointement pour empêcher tout mouvement de l'unité de filtration 2 à l'intérieur de l'étui de protection 18, lorsque ladite unité de filtration 2 est disposée dans lesdits moyens de maintien 21 et que l'élément formant couvercle 20 est placé sur l'élément de base 19, c'est-à-dire lorsque l'étui de protection est fermé. In addition, the holding means 21 and the cover member 20 operate together to prevent movement of the filter unit 2 within the protective case 18, when said filter unit 2 is disposed in said holding means 21 and that the cover member 20 is placed on the base member 19, that is to say when the protective case is closed.
Lorsque l'unité de filtration 2 est disposée dans lesdits moyens de maintien 21 , l'étui de protection 18 étant fermé, les moyens de maintien 21 font rester dans une position fixe l'unité de filtration 2 à l'intérieur de l'étui de protection. De plus, lorsque l'étui de protection 18 est fermé, l'élément formant couvercle 20 vient en appui contre l'unité de filtration placée dans les moyens de maintien 21 , de sorte à assurer une immobilisation complète de l'unité de filtration 2 dans son étui de protection 18. When the filtration unit 2 is disposed in said holding means 21, the protective case 18 being closed, the holding means 21 keep in a fixed position the filtration unit 2 inside the case protection. In addition, when the protective case 18 is closed, the cover member 20 abuts against the filtration unit placed in the holding means 21, so as to ensure complete immobilization of the filtration unit 2 in its protective case 18.
Ainsi, lors de la centrifugation par exemple, l'unité de filtration 1 ne s'écrase pas au fond du récipient de centrifugation ni au fond de l'étui de protection, évitant d'être endommagée. En particulier, les moyens de maintien 21 sont configurés de sorte à posséder une surface de contact étendue avec la périphérie de l'unité de filtration 2, contribuant au maintien de l'unité de filtration dans l'étui de protection. Thus, during centrifugation for example, the filtration unit 1 does not crush the bottom of the centrifuge container or the bottom of the protective case, avoiding damage. In particular, the holding means 21 are configured so as to have an extended contact surface with the periphery of the filtration unit 2, contributing to the maintenance of the filtration unit in the protective case.
L'étui de protection 18 est destiné à réceptionner l'unité de filtration 2 et certains composants rigides 9,10,16,17 d'un système à poches 1 , les poches 5,6,14 dudit système restant à l'extérieur de l'étui de protection. Ainsi, le poches souples 5,6,14 sont isolés des composants rigides du système à poches, réduisant le risque d'endommagement des poches par contact avec les composants rigides. L'étui de protection 18 comprend au moins une ouverture latérale 22 pour permettre le passage d'au moins une tubulure souple 7,8,13,15, de sorte à arranger les poches 5,6 du système à poches 1 à l'extérieur de l'étui de protection 18. The protective case 18 is intended to receive the filtration unit 2 and some rigid components 9, 10, 16, 17 of a bag system 1, the pockets 5, 6, 14 of said system remaining outside the box. the protective case. Thus, the flexible pouches 5, 6, 14 are isolated from the rigid components of the bag system, reducing the risk of damage to the bags by contact with the rigid components. The protective case 18 comprises at least one lateral opening 22 to allow the passage of at least one flexible tubing 7,8,13,15, so as to arrange the pockets 5,6 of the bag system 1 outside of the protective case 18.
Pour faciliter la mise en place des composants concernés dans l'étui de protection, l'étui de protection comprend plusieurs ouvertures latérales. En particulier, l'étui de protection 18 comprend entre une et trois ouvertures latérales 22,23,24, disposées sur un côté de l'étui de protection, respectivement. To facilitate the placement of the relevant components in the protective case, the protective case includes several side openings. In particular, the protective case 18 comprises between one and three lateral openings 22, 23, 24, disposed on one side of the protective case, respectively.
L'un des côtés de l'étui de protection 18 ne comprend avantageusement pas d'ouverture latérale et correspond au côté de l'étui de protection destiné à être en regard du fond du récipient de centrifugation lors de l'utilisation de l'étui de protection. One of the sides of the protective case 18 advantageously does not include a lateral opening and corresponds to the side of the protective case intended to face the bottom of the centrifugation container when the case is used. protection.
L'étui de protection 18 est par exemple réalisé dans un matériau polymère de type élastomère thermoplastique. The protective case 18 is for example made of a thermoplastic elastomer type polymer material.
Avantageusement, la dureté shore A du matériau polymère est choisie dans la plage allant de 80 à 100, en particulier de 90 à 95, et plus particulièrement 95 Shore A. Si la dureté est trop faible, inférieure à 80 shore A, l'étui de protection est déformé lors de la centrifugation mise en œuvre pour séparer les composants sanguins. Advantageously, the shore A hardness of the polymer material is chosen in the range from 80 to 100, in particular from 90 to 95, and more particularly 95 Shore A. If the hardness is too low, less than 80 Shore A, the case protection is deformed during the centrifugation used to separate the blood components.
Plus la dureté est élevée, plus le risque est élevé d'endommager les composants du système à poches en contact avec l'extérieur de l'étui de protection lors de la centrifugation mise en œuvre pour séparer les composants sanguins. En outre, si la dureté est trop élevée, par exemple supérieure à 95 shore A, l'étui de protection est rigide et est susceptible d'être cassé ou déformé pendant la centrifugation au même titre que les composants rigides du système à poches. The higher the hardness, the greater the risk of damaging the components of the bag system in contact with the outside of the protective case during the centrifugation used to separate the blood components. In addition, if the hardness is too high, for example greater than 95 shore A, the protective case is rigid and is likely to be broken or deformed during centrifugation as well as the rigid components of the bag system.
Un bon compromis entre la résistance à la déformation et le respect de l'intégralité des poches souples est un étui de protection réalisé dans un matériau ayant une dureté d'environ 95 shore A. A good compromise between the resistance to deformation and the respect of the entirety of the flexible bags is a protective case made of a material having a hardness of about 95 shore A.
Les figures 2 à 6 représentent une première réalisation d'un étui de protection 18 selon l'invention. Figures 2 to 6 show a first embodiment of a protective case 18 according to the invention.
Dans cette première réalisation, l'élément de base 19 comprend une paroi de fond 25 prolongée par une paroi latérale périphérique 26. In this first embodiment, the base member 19 comprises a bottom wall 25 extended by a peripheral side wall 26.
La paroi de fond 25 de l'élément de base 19 est sensiblement plane et comprend une pluralité de nervures 27 qui rigidifie l'élément de base 19. Certaines de ces nervures 27 se prolongent avantageusement sur la paroi latérale périphérique 26 de l'élément de base 19 afin de le rendre encore plus résistant à la déformation. The bottom wall 25 of the base member 19 is substantially planar and comprises a plurality of ribs 27 which stiffens the base member 19. Some of these ribs 27 are advantageously extended on the peripheral side wall 26 of the element. base 19 to make it even more resistant to deformation.
Sur les figures 2 à 6, la paroi de fond 25 de l'élément de base 19 est de forme sensiblement rectangulaire. In Figures 2 to 6, the bottom wall 25 of the base member 19 is substantially rectangular in shape.
Les moyens de maintien 21 de l'unité de filtration 2 sont agencés sur la surface intérieure de ladite paroi de fond 25 de l'élément de base 19. The holding means 21 of the filtration unit 2 are arranged on the inner surface of said bottom wall 25 of the base element 19.
En particulier, les moyens de maintien 21 sont formés d'une ou plusieurs saillies 28 dont les dimensions et la disposition correspondent aux dimensions extérieures de l'unité de filtration 2 de sorte à la maintenir par ajustement serré dans ledit élément de base 19. In particular, the holding means 21 are formed of one or more protrusions 28 whose dimensions and arrangement correspond to the external dimensions of the filtration unit 2 so as to maintain it by a tight fit in said base member 19.
Lesdites saillies 28 formant le moyen de maintien s'étendent verticalement à partir de la paroi de fond 25 de l'élément de base 19. Sur la figure 2, les moyens de maintien 21 sont formés de quatre saillies 28 disposées suivant les quatre côtés d'un carré virtuel. Dans ce cas, l'unité de filtration 2 possède une forme sensiblement carrée, les dimensions intérieures du carré virtuel correspondant sensiblement aux dimensions extérieures de l'unité de filtration. Said projections 28 forming the holding means extend vertically from the bottom wall 25 of the base member 19. In Figure 2, the holding means 21 are formed of four projections 28 arranged along the four sides of a virtual square. In this case, the filtration unit 2 has a substantially square shape, the internal dimensions of the virtual square substantially corresponding to the external dimensions of the filtration unit.
L'unité de filtration 2 est maintenue à plat dans lesdits moyens de maintien 21 . Les nervures 29 situées à l'intérieur du carré virtuel permettent d'élever l'unité de filtration 2 au-dessus de la paroi de fond de l'élément de base, de sorte à ce que les faces planes de l'unité de filtration 2 soient sensiblement parallèles à la paroi de fond 25 de l'élément de base 19, malgré les portions de tubes rigides formant l'orifice d'entrée 3 et sortie 4 de l'unité de filtration 2 qui font saillie du boîtier rigide, comme on peut le voir sur la figure 5. Avantageusement, afin de rendre les saillies 28 formant les moyens de maintien 21 plus solides, un contrefort 30 sous forme d'une nervure triangulaire est arrangé contre chacune des saillies 28. The filtration unit 2 is held flat in said holding means 21. The ribs 29 situated inside the virtual square make it possible to raise the filtration unit 2 above the bottom wall of the base element, so that the flat faces of the filtration unit 2 are substantially parallel to the bottom wall 25 of the base member 19, despite the rigid tube portions forming the inlet 3 and outlet 4 of the filtration unit 2 which protrude from the rigid housing, as it can be seen in Figure 5. Advantageously, in order to make the projections 28 forming the holding means 21 more solid, a buttress 30 in the form of a triangular rib is arranged against each of the projections 28.
Sur la figure 6, l'unité de filtration 2 comprend un orifice d'entrée 3 et un orifice de sortie 4, agencés de façon opposée. Dans ce cas, les moyens de maintien 21 sont agencés avantageusement de sorte que l'orifice d'entrée 3 et/ou l'orifice de sortie 4 de l'unité de filtration 2 soient distants de la paroi latérale périphérique 26 de l'élément de base 19. En particulier, les orifices d'entrée 3 et sortie 4 de l'unité de filtration 2 sont suffisamment éloignés de la paroi latérale périphérique 26 de l'étui de protection pour pouvoir plier les tubulures facilement. In FIG. 6, the filtration unit 2 comprises an inlet orifice 3 and an outlet orifice 4, arranged in opposite directions. In this case, the holding means 21 are advantageously arranged such that the inlet orifice 3 and / or the outlet orifice 4 of the filtration unit 2 are distant from the peripheral lateral wall 26 of the element In particular, the inlet ports 3 and 4 of the outlet of the filtration unit 2 are sufficiently remote from the peripheral side wall 26 of the protective case to be able to bend the tubings easily.
Dans cette réalisation, le premier volume de la cavité de l'étui de protection 18 est délimité en partie par les moyens de maintien 21 de l'unité de filtration 2. Le second volume est l'espace restant de la cavité en dehors du premier volume. In this embodiment, the first volume of the cavity of the protective case 18 is delimited in part by the holding means 21 of the filtration unit 2. The second volume is the remaining space of the cavity outside the first volume.
Le second volume de la cavité est suffisamment grand pour être au moins en partie occupé par les composants rigides 9,10,16,17 du système à poches 1 , notamment les clamps 9,16,17, le moyen de prélèvement 10 d'un échantillon de fluide et les portions de tubulures 7,8,13,15, mais pas par les poches souples qui restent à l'extérieur de l'étui de protection. The second volume of the cavity is sufficiently large to be at least partially occupied by the rigid components 9, 10, 16, 17 of the bag system 1, in particular the clamps 9, 16, 17, the sampling means 10 of a sample of fluid and tubing portions 7,8,13,15, but not by the flexible bags that remain outside the protective case.
Comme illustré sur les figures 2 à 4, la paroi latérale périphérique 26 de l'élément de base 19 comprend une entaille formant avec l'élément formant couvercle placé sur l'élément de base, une ouverture latérale 22 de l'étui de protection 18. As illustrated in FIGS. 2 to 4, the peripheral side wall 26 of the base member 19 comprises a notch forming with the cover member placed on the base member, a side opening 22 of the protective case 18. .
En particulier, entre une et trois entailles sont agencées dans la paroi latérale périphérique 26 de l'élément de base, formant entre une et trois ouvertures latérales 22,23,24. In particular, between one and three notches are arranged in the peripheral side wall 26 of the base member, forming between one and three lateral openings 22,23,24.
Selon la première réalisation de l'étui de protection 18, l'élément formant couvercle 20 comprend une paroi de fond 31 et une paroi latérale périphérique 32. According to the first embodiment of the protective case 18, the cover member 20 comprises a bottom wall 31 and a peripheral side wall 32.
Sur les figure 2 à 6, la paroi de fond 31 de l'élément formant couvercle 20 est de forme sensiblement rectangulaire. Comme représenté sur la figure 3, la paroi de fond 31 de l'élément formant couvercle 20 est sensiblement plane et comprend une pluralité de nervures 33 qui rigidifie l'élément formant couvercle 20. In Figures 2 to 6, the bottom wall 31 of the cover member 20 is substantially rectangular in shape. As shown in FIG. 3, the bottom wall 31 of the cover member 20 is substantially planar and comprises a plurality of ribs 33 which stiffens the cover member 20.
Avantageusement, la paroi de fond 31 de l'élément formant couvercle 20 comprend au moins une nervure de maintien 34 agencée de sorte à être en regard d'une face de l'unité de filtration 2 lorsque cette dernière est placée dans les moyens de maintien 21 de l'élément de base 19 et lorsque l'élément formant couvercle 20 est placé sur l'élément de base 19. Cette nervure de maintien 34 est notamment plus haute que les autres nervures qui sont utiles pour rendre plus solide l'élément formant couvercle. Advantageously, the bottom wall 31 of the cover member 20 comprises at least one retaining rib 34 arranged so as to face one face of the filtration unit 2 when the latter is placed in the holding means. 21 of the base member 19 and when the cover member 20 is placed on the base member 19. This holding rib 34 is notably higher than the other ribs which are useful for making the forming element more solid. lid.
Plus particulièrement, la paroi de fond 31 de l'élément formant couvercle 20 comprend une ou plusieurs nervures de maintien 34,35 qui coopèrent avec les moyens de maintien 21 pour empêcher tout mouvement de l'unité de filtration 2 à l'intérieur de l'étui de protection 18, lorsque l'unité de filtration 2 est disposée dans lesdits moyens de maintien 21 et que l'élément formant couvercle 20 est placé sur l'élément de base 19. More particularly, the bottom wall 31 of the cover member 20 comprises one or more retaining ribs 34,35 which cooperate with the holding means 21 to prevent any movement of the filtration unit 2 inside the protective case 18, when the filtration unit 2 is disposed in said holding means 21 and the cover member 20 is placed on the base member 19.
Ces nervures de maintien 34,35 sont en regard d'une face plane de l'unité de filtration 2, de sorte à maintenir à plat l'unité de filtration dans l'étui de protection 18. These retaining ribs 34, 35 are opposite a flat face of the filtration unit 2, so as to keep the filtration unit flat in the protective case 18.
Dans une réalisation particulière représentée sur la figure 3, la paroi de fond 31 de l'élément formant couvercle 20 comprend deux nervures de maintien 34,35. In a particular embodiment shown in Figure 3, the bottom wall 31 of the cover member 20 comprises two retaining ribs 34,35.
Ces nervures de maintien 34,35 coopèrent avec les moyens de maintien 21 pour immobiliser l'unité de filtration 2 dans l'étui de protection 18 lorsqu'il est dans un état fermé. These retaining ribs 34, 35 cooperate with the holding means 21 to immobilize the filtration unit 2 in the protective case 18 when it is in a closed state.
La figure 4 représente l'étui de protection 18 dans son état fermé, c'est-à-dire quand l'élément formant couvercle 20 est placé sur l'élément de base 19. FIG. 4 shows the protective case 18 in its closed state, i.e. when the cover member 20 is placed on the base member 19.
Sur la figure 4, l'élément de base 19 et l'élément formant couvercle 20 sont assemblés entre eux de façon amovible par emboîtement. In Figure 4, the base member 19 and the cover member 20 are joined together releasably by interlocking.
Pour ce faire, la paroi latérale périphérique 32 de l'élément formant couvercle se prolonge verticalement sur au moins une portion de prolongation 36, et notamment à un coin de ladite paroi latérale périphérique 32 de l'élément formant couvercle 20. To do this, the peripheral side wall 32 of the cover member extends vertically on at least one extension portion 36, and in particular at a corner of said peripheral side wall 32 of the cover member 20.
Cette portion de prolongation 36 s'insère exactement entre une paire de nervures 37a, 37b agencées sur la paroi latérale périphérique 26 de l'élément de base 19, notamment à un coin de ladite paroi latérale périphérique 26 de l'élément de base 19. This extension portion 36 fits exactly between a pair of ribs 37a, 37b arranged on the peripheral side wall 26 of the base member 19, in particular at a corner of said peripheral side wall 26 of the base member 19.
Comme représenté sur les figures 2 et 3, l'élément formant couvercle 20 comprend quatre portions de prolongation 36 à chaque coin de l'élément formant couvercle, lesdites portions de prolongation entrant entre quatre paires de nervures 37a, 37b agencées à chaque coin de l'élément de base de l'étui de protection. As shown in Figures 2 and 3, the cover member 20 includes four extension portions 36 at each corner of the cover member, said extension portions entering between four pairs. ribs 37a, 37b arranged at each corner of the base member of the protective case.
Lorsque l'élément de base 19 et l'élément formant couvercle 20 sont assemblés entre eux, l'étui de protection 18 possède sensiblement une forme de parallélépipède rectangle. When the base member 19 and the cover member 20 are joined together, the protective case 18 has substantially a rectangular parallelepiped shape.
Les figures 7 et 8 représentent une deuxième réalisation d'un étui de protection 18 selon l'invention. Figures 7 and 8 show a second embodiment of a protective case 18 according to the invention.
Dans cette réalisation, l'élément de base 19 comprend un corps de base 38 ayant au moins un premier évidement 39 dont la géométrie correspond à la géométrie de l'unité de filtration 2, ledit premier évidement 39 formant les moyens de maintien 21 de l'unité de filtration. In this embodiment, the base member 19 comprises a base body 38 having at least a first recess 39 whose geometry corresponds to the geometry of the filtration unit 2, said first recess 39 forming the holding means 21 of the filtration unit.
Le premier volume de la cavité de l'étui de protection 18 est délimité en partie par ce premier évidement 39. The first volume of the cavity of the protective case 18 is delimited in part by this first recess 39.
La géométrie de ce premier évidement 39, c'est-à-dire la forme et les dimensions, assure le maintien de l'unité de filtration 2 à l'intérieur de l'élément de base 19 par ajustement serré. The geometry of this first recess 39, that is to say the shape and dimensions, ensures the maintenance of the filtration unit 2 inside the base member 19 by tight fit.
Dans cette réalisation, l'élément de base 19 comprend en outre au moins un deuxième évidement 40,41 ,42 dont la géométrie correspond à la géométrie de l'un au moins des composants rigides du système à poches et/ou à une portion de tubulure souple du système à poches. In this embodiment, the base element 19 further comprises at least one second recess 40, 41, 42 whose geometry corresponds to the geometry of at least one of the rigid components of the bag system and / or to a portion of flexible tubing of the bag system.
Sur la figure 7, le corps de base 38 comprend un deuxième évidement 40 pour réceptionner un clamp 9 du système à poches 1 et un troisième et quatrième évidement 41 ,42 pour réceptionner des portions de tubulure 7 du système à poches 1 . Le deuxième évidement 40 possède une forme sensiblement rectangulaire. Les troisième et quatrième évidements 41 ,42 pour les portions de tubulure 7 possèdent une forme de canal ouvert. La géométrie de chacun desdits évidements 40,41 ,42 assure le maintien par ajustement serré du composant rigide du système à poches 1 ou de la portion de tubulure que l'évidement est destiné à réceptionner. In FIG. 7, the base body 38 comprises a second recess 40 for receiving a clamp 9 of the bag system 1 and a third and fourth recess 41, 42 for receiving tubing portions 7 of the bag system 1. The second recess 40 has a substantially rectangular shape. The third and fourth recesses 41, 42 for the tubing portions 7 have an open channel shape. The geometry of each of said recesses 40, 41, 42 ensures the tight fit of the rigid component of the bag system 1 or the tubing portion that the recess is intended to receive.
En relation avec les figures 7 et 8, l'élément formant couvercle 20 de l'étui de protection de la deuxième réalisation comprend un corps de couvercle 43 qui vient en appui sur l'unité de filtration 2 lorsqu'elle est disposée dans le premier évidement 39 formant moyens de maintien 21 et que l'étui de protection est en état fermé. Ainsi, le corps de couvercle 43 et le premier évidement coopèrent pour immobiliser l'unité de filtration 2 dans l'étui de protection 18. In relation to FIGS. 7 and 8, the cover member 20 of the protective case of the second embodiment comprises a cover body 43 which bears on the filtration unit 2 when it is arranged in the first embodiment. recess 39 forming holding means 21 and that the protective case is in a closed state. Thus, the cover body 43 and the first recess cooperate to immobilize the filtration unit 2 in the protective case 18.
En particulier, le corps de couvercle 43 comprend au moins un évidement 44,45,46 dont la géométrie correspond à la géométrie de l'un au moins des composants rigides du système à poches et/ou à une portion de tubulure souple du système à poches 1 . In particular, the cover body 43 comprises at least one recess 44,45,46 whose geometry corresponds to the geometry of at least one of the rigid components of the bag system and / or to a portion of flexible tubing of the system to pockets 1.
Sur la figure 7, le corps de couvercle 43 comprend un premier évidement 44 pour recevoir le moyen de prélèvement 10 d'un échantillon de fluide et des portions de tubulure 13 du système à poches 1 . Le corps de couvercle 43 comprend en outre un deuxième évidement 45 destiné à recevoir la portion de tube rigide formant l'un des orifices d'entrée 3 et de sortie 4 de l'unité de filtration 2 lorsque l'étui de protection 18 est fermé. In FIG. 7, the lid body 43 includes a first recess 44 for receiving the fluid sample sampling means 10 and tubing portions 13 of the bag system 1. The lid body 43 further comprises a second recess 45 intended to receive the rigid tube portion forming one of the inlet and outlet openings 4 of the filtration unit 2 when the protective case 18 is closed. .
Un troisième évidement 46 dans le corps de couvercle 43 est destiné à recevoir la portion de tubulure 7 passant au-dessus de l'unité de filtration 2 dans le corps de base 19, lorsque l'étui de protection 18 est fermé. Le second volume de la cavité de l'étui de protection 18 est délimité au moins en partie par le ou les évidements 44,45,46 destinés à réceptionner au moins un composant rigide du système à poches et/ou les portions de tubulure souple. Dans cette deuxième réalisation, l'élément de base 19 et l'élément formant couvercle 20 sont assemblés entre eux par une charnière 47. En variante, l'élément de base et l'élément formant couvercle sont distincts en ce qu'ils sont séparés lorsque l'étui de protection est dans un état ouvert. Lorsque l'unité de filtration 2 est disposée immobilisée dans le premier évidement 39 formant moyen de maintien 21 et lorsque l'étui de protection 18 est fermé, le corps de couvercle 43 vient en contact avec l'une des faces planes de l'unité de filtration 2, coopérant ainsi avec les moyens de maintien 21 pour empêcher tout mouvement de l'unité de filtration 2 à l'intérieur de l'étui fermé 18. A third recess 46 in the lid body 43 is intended to receive the tubular portion 7 passing above the filtration unit 2 in the base body 19, when the protective case 18 is closed. The second volume of the cavity of the protective case 18 is delimited at least in part by the recess or recesses 44, 45, 46 for receiving at least one rigid component of the bag system and / or the flexible tubing portions. In this second embodiment, the base member 19 and the cover member 20 are joined together by a hinge 47. In a variant, the base member and the cover member are distinct in that they are separate when the protective case is in an open state. When the filtration unit 2 is arranged immobilized in the first recess 39 forming holding means 21 and when the protective case 18 is closed, the cover body 43 comes into contact with one of the plane faces of the unit filter 2, thus cooperating with the holding means 21 to prevent any movement of the filtration unit 2 inside the closed case 18.
L'élément de base 19 et l'élément formant couvercle 20 sont maintenus assemblés à l'aide d'au moins un tenon 48, par exemple de forme circulaire, agencé sur l'un desdits éléments 19,20 et qui s'emboîte par ajustement de forme dans un creux 49 agencé sur l'autre desdits éléments. The base element 19 and the cover member 20 are held together by means of at least one stud 48, for example of circular shape, arranged on one of said elements 19,20 and which fits by shape fit in a recess 49 arranged on the other of said elements.
Comme illustré sur les figures 7 et 8, l'élément de base 19 et l'élément formant couvercle 20 de l'étui de protection 18 possèdent sensiblement la forme d'un trapèze, de sorte à former un étui de protection 18 possédant sensiblement la forme d'un prisme trapézoïdal dans son état fermé. Cette forme particulière facilite la mise en place de l'étui de protection dans un récipient de centrifugation. As illustrated in FIGS. 7 and 8, the base element 19 and the cover member 20 of the protective case 18 have substantially the shape of a trapezium, so as to form a protective case 18 having substantially the shape of a trapezoidal prism in its closed state. This particular shape facilitates the introduction of the protective case in a centrifuge container.
En variante, l'étui de protection possède une forme de parallélépipède rectangle. Alternatively, the protective case has a rectangular parallelepiped shape.
Selon un deuxième aspect, l'invention concerne un ensemble comprenant un étui de protection 18 selon le premier aspect de l'invention et un système à poches 1 destiné au traitement d'un fluide biologique, ledit système à poches étant composé d'au moins une unité de filtration 2 d'un fluide biologique, l'unité de filtration 2 étant maintenue dans ledit étui de protection par les moyens de maintien 21 de l'étui de protection conjointement avec l'élément formant couvercle 20. Le système à poches 1 de l'ensemble est composé en outre, en tant que composants souples, d'au moins une poche primaire 5 comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat 6, chacune desdites poches 5,6 étant reliée à ladite unité de filtration 2 par une tubulure souple 7,8 respectivement, et en tant que composants rigides, d'au moins un clamp 9 agencé sur l'une desdites tubulures 8 et/ou d'un moyen de prélèvement 10 d'un échantillon de fluide. La poche primaire 5 est connectée de fabrication à la tubulure 7 du système à poches ou est connectée de façon stérile au système à poches au moment de l'utilisation. Dans l'ensemble formé du système à poches 1 et de l'étui de protection 18, les poches 5,6,14 du système à poches sont arrangées à l'extérieur dudit étui de protection 18. According to a second aspect, the invention relates to an assembly comprising a protective case 18 according to the first aspect of the invention and a bag system 1 intended for the treatment of a biological fluid, said bag system being composed of at least a filtration unit 2 of a biological fluid, the unit filter 2 being held in said protective case by the holding means 21 of the protective case together with the cover member 20. The bag system 1 of the assembly is further composed as flexible components at least one primary bag 5 comprising the biological fluid to be filtered and a bag for collecting the filtrate 6, each of said pockets 5, 6 being connected to said filtration unit 2 by a flexible tubing 7, respectively, and as rigid components, at least one clamp 9 arranged on one of said tubing 8 and / or a sampling means 10 of a fluid sample. The primary bag 5 is connected to the tubing 7 of the bag system or is sterile connected to the bag system at the time of use. In the assembly formed of the bag system 1 and the protective case 18, the pockets 5, 6, 14 of the bag system are arranged outside said protective case 18.
Avantageusement, tous les composants rigides 9,10,16,17 du système à poches 1 sont arrangés à l'intérieur de l'étui de protection 18. Dans le cas du système à poches représenté sur la figure 1 , cela signifie que l'unité de filtration 2, les clamps 9,16,17 et le moyen de prélèvement 10 d'un échantillon de fluide sont disposés dans l'étui de protection 18. Lorsque l'étui de protection 18 est fermé, l'ensemble est prêt à être placé dans un récipient de centrifugation tel qu'un insert ou godet de centrifugation. Advantageously, all the rigid components 9, 10, 16, 17 of the bag system 1 are arranged inside the protective case 18. In the case of the bag system shown in FIG. 1, this means that the filtration unit 2, the clamps 9, 16, 17 and the sampling means 10 of a fluid sample are arranged in the protective case 18. When the protective case 18 is closed, the assembly is ready to be placed in a centrifuge container such as a centrifuge insert or bucket.
Il n'est pas nécessaire d'adapter ou de modifier le récipient de centrifugation. L'ensemble comprenant l'étui de protection et le système à poches peut être placé dans tous les types de godet et d'insert pour nacelles de centrifugation disponibles commercialement. It is not necessary to adapt or modify the centrifuge container. The package including the protective case and the bag system can be placed in all types of commercially available centrifuge pods and insert inserts.
Avantageusement, l'étui de protection possède sensiblement les mêmes dimensions que la mousse de calage utilisée pour maintenir à la verticale les poches du système à poches dans le récipient de centrifugation. Ainsi, l'étui de protection remplace la mousse de calage, rendant inutile l'utilisation d'une telle mousse. L'espace pris dans le récipient de centrifugation par l'ensemble formé du système à poches et de l'étui de protection est donc sensiblement le même que celui pris par le système à poches et la mousse de calage. Advantageously, the protective case has substantially the same dimensions as the cushioning foam used to maintain vertically the pockets of the bag system in the centrifugation vessel. Thus, the protective case replaces the cushioning foam, making the use of such a foam unnecessary. The space taken in the centrifuge container by the assembly formed of the bag system and the protective case is therefore substantially the same as that taken by the bag system and cushioning foam.
L'invention dans son troisième aspect concerne un procédé de traitement d'un fluide biologique à l'aide d'un système à poches 1 composé d'au moins une unité de filtration 2 du fluide biologique, ledit procédé comprenant les étapes successives de : The invention in its third aspect relates to a method of treating a biological fluid using a bag system 1 composed of at least one filtration unit 2 of the biological fluid, said method comprising the successive steps of:
disposer l'unité de filtration 2 dans un étui de protection 18 selon le premier aspect de l'invention,  arranging the filtration unit 2 in a protective case 18 according to the first aspect of the invention,
- placer dans un récipient de centrifugation, le système à poches 1 avec l'étui de protection 18 dans lequel l'unité de filtration 2 est disposée, placing in a centrifugation vessel the bag system 1 with the protective case 18 in which the filtration unit 2 is arranged,
centrifuger dans une centrifugeuse le système à poches 1 placé dans ledit récipient de centrifugation de sorte à séparer le fluide biologique en au moins une phase de surnageant et une phase de sédiment,  centrifuging in a centrifuge the bag system 1 placed in said centrifugation vessel so as to separate the biological fluid into at least one supernatant phase and a sediment phase,
- retirer le système à poches 1 centrifugé du récipient de centrifugation, retirer l'unité de filtration 2 de l'étui de protection 18, withdrawing the centrifuged bag system 1 from the centrifugation vessel, removing the filtration unit 2 from the protective case 18,
filtrer l'une des phases séparées au travers de l'unité de filtration 2 retirée de l'étui de protection. Selon une réalisation, le transfert des phases séparées par centrifugation est réalisé en dehors de la centrifugeuse, préalablement ou conjointement à l'étape de filtration.  filtering one of the separated phases through the filtration unit 2 removed from the protective case. According to one embodiment, the transfer of the separated phases by centrifugation is carried out outside the centrifuge, before or jointly with the filtration step.
Comme illustré à titre d'exemple sur la figure 1 , le système à poches 1 est composé en outre, en tant que composants souples, d'au moins une poche primaire 5 comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat 6, chacune desdites poches 5,6 étant reliée à ladite unité de filtration 2 par une tubulure souple 7,8, et en tant que composants rigides, d'au moins un clamp 9 agencé sur l'une desdites tubulures 8 et/ou d'un moyen de prélèvement 10 d'un échantillon de fluide. As illustrated by way of example in FIG. 1, the bag system 1 is furthermore composed, as flexible components, of at least one primary bag 5 comprising the biological fluid to be filtered and a bag for collecting the filtrate 6, each of said pockets 5,6 being connected to said filtration unit 2 by a flexible tubing 7,8, and as rigid components, of at least one clamp 9 arranged on one of said tubing 8 and / or a sampling means 10 of a fluid sample.
Dans ce cas, le procédé de traitement d'un fluide biologique comprend en outre, avant l'étape de placer le système à poches 1 dans le récipient de centrifugation, l'étape de disposer l'un au moins des composants rigides 9,10,16,17 dans l'étui de protection 18, lesdites poches souples 5,6 restant à l'extérieur dudit l'étui de protection 18. En particulier, tous les composants rigides 9,10,16,17 du système à poches 1 sont disposés à l'intérieur de l'étui de protection 18. In this case, the method for treating a biological fluid further comprises, before the step of placing the bag system 1 in the centrifugation vessel, the step of disposing at least one of the rigid components 9,10 , 16,17 in the protective case 18, said flexible pockets 5,6 remaining outside said protective case 18. In particular, all the rigid components 9,10,16,17 of the bag system 1 are arranged inside the protective case 18.
Dans une mise en œuvre, l'étui de protection 18 est placé dans le récipient de centrifugation, parallèlement aux poches 5,6 du système à poches 1 de sorte à maintenir l'unité de filtration 2 parallèle aux poches et perpendiculaire à l'axe de rotation pendant la centrifugation. In one embodiment, the protective case 18 is placed in the centrifuge container, parallel to the pockets 5, 6 of the bag system 1 so as to keep the filtration unit 2 parallel to the pockets and perpendicular to the axis. of rotation during centrifugation.
Dans cette position, le risque d'endommagement de l'unité de filtration est réduit. In this position, the risk of damage to the filter unit is reduced.
Dans un exemple particulier, le fluide biologique est le sang ou un composant sanguin. In a particular example, the biological fluid is blood or a blood component.
Plus particulièrement, le traitement du fluide biologique comprend la séparation d'un assemblage de couches leuco plaquettaires en concentré plaquettaire et la filtration dudit concentré plaquettaire en vue de l'appauvrir en leucocytes. Ce traitement est réalisé avec le système à poches représenté sur la figure 1 ou un système à poches équivalent comprenant ladite unité de filtration 2. More particularly, the biological fluid treatment comprises separating an assembly of buffy coat platelet concentrates into platelet concentrate and filtering said platelet concentrate for depletion into leukocytes. This treatment is carried out with the bag system shown in FIG. 1 or an equivalent bag system comprising said filtration unit 2.

Claims

REVENDICATIONS
1 . Etui de protection (18) pour composants d'un système à poches (1 ) destiné au traitement d'un fluide biologique, ledit système à poches étant composé d'au moins une unité de filtration (2) du fluide biologique, ledit étui de protection (18) étant destiné à être placé avec le système à poches (1 ) dans un récipient de centrifugation, ledit étui de protection (18) comprenant une cavité formée entre un élément de base (19) et un élément formant couvercle (20) placé de façon amovible sur ledit élément de base (19), ladite cavité ayant un premier volume destiné à réceptionner ladite unité de filtration (2) et au moins un second volume, caractérisé en ce que l'élément de base (19) comprend des moyens de maintien (21 ) de l'unité de filtration dans ledit premier volume de ladite cavité, lesdits moyens de maintien (21 ) et l'élément formant couvercle (20) opérant conjointement pour empêcher tout mouvement de l'unité de filtration (2) à l'intérieur de l'étui de protection (18), lorsque ladite unité de filtration (2) est disposée dans lesdits moyens de maintien (21 ) et que l'élément formant couvercle (20) est placé sur l'élément de base (19). 1. Protective case (18) for components of a bag system (1) for the treatment of a biological fluid, said bag system being composed of at least one filter unit (2) of the biological fluid, said bag protector (18) being adapted to be placed with the bag system (1) in a centrifuge container, said protective case (18) comprising a cavity formed between a base member (19) and a cover member (20) releasably disposed on said base member (19), said cavity having a first volume for receiving said filter unit (2) and at least a second volume, characterized in that the base member (19) comprises holding means (21) of the filter unit in said first volume of said cavity, said holding means (21) and the cover member (20) operating together to prevent movement of the filter unit (2 ) inside of the protective case (18), when said filter unit (2) is disposed in said holding means (21) and that the cover member (20) is placed on the base member (19).
2. Etui de protection selon la revendication 1 , caractérisé en ce que le système à poches (1 ) est composé en outre, en tant que composants souples, d'au moins une poche primaire (5) comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat (6), chacune desdites poches (5,6) étant reliée à ladite unité de filtration (2) par une tubulure souple (7,8) respectivement, et en tant que composants rigides, d'au moins un clamp (9) agencé sur l'une desdites tubulures (7,8) et/ou d'un moyen de prélèvement (10) d'un échantillon de fluide, le second volume de ladite cavité étant destiné à réceptionner l'un au moins des composants rigides (9,10) du système à poches. 2. Protective case according to claim 1, characterized in that the bag system (1) is further composed, as flexible components, of at least one primary bag (5) comprising the biological fluid to be filtered and d a filtrate collection bag (6), each of said pockets (5, 6) being connected to said filtration unit (2) by a flexible tubing (7, 8) respectively, and as rigid components, from at least one clamp (9) arranged on one of said tubings (7,8) and / or a means (10) for withdrawing a sample of fluid, the second volume of said cavity being for receiving one at least rigid components (9,10) of the bag system.
3. Etui de protection selon la revendication 2, caractérisé en ce qu'il comprend au moins une ouverture latérale (22) pour permettre le passage d'au moins une tubulure souple (7,8), de sorte à arranger les poches (5,6) du système à poches (1 ) à l'extérieur de l'étui de protection (18). 3. Protective case according to claim 2, characterized in that it comprises at least one lateral opening (22) to allow the passage of at least one flexible tubular (7,8), so as to arrange the pockets (5). 6) of the bag system (1) on the outside of the protective case (18).
4. Etui de protection selon l'une quelconque des revendications 1 à 3, caractérisé en ce que l'élément de base (19) comprend une paroi de fond (25) prolongée par une paroi latérale périphérique (26), lesdits moyens de maintien (21 ) étant agencés sur la surface intérieure de ladite paroi de fond (25) de l'élément de base (19). 4. Protective case according to any one of claims 1 to 3, characterized in that the base member (19) comprises a bottom wall (25) extended by a peripheral side wall (26), said holding means (21) being arranged on the inner surface of said bottom wall (25) of the base member (19).
5. Etui de protection selon la revendication 4, caractérisé en ce que les moyens de maintien (21 ) sont formés d'une ou plusieurs saillies (28) dont les dimensions et la disposition correspondent aux dimensions extérieures de l'unité de filtration (2) de sorte à la maintenir par ajustement serré dans ledit élément de base (19). 5. Protective case according to claim 4, characterized in that the holding means (21) are formed of one or more projections (28) whose dimensions and arrangement correspond to the external dimensions of the filtration unit (2). ) so as to maintain it by interference fit in said base member (19).
6. Etui de protection selon l'une quelconque des revendications 1 à 5, caractérisé en ce que l'élément formant couvercle (20) comprend une paroi de fond (31 ) et une paroi latérale périphérique (32). 6. Protective case according to any one of claims 1 to 5, characterized in that the cover member (20) comprises a bottom wall (31) and a peripheral side wall (32).
7. Etui de protection selon la revendication 6, caractérisé en ce que la paroi de fond (31 ) de l'élément formant couvercle (20) comprend une ou plusieurs nervures de maintien (34,35) qui coopèrent avec les moyens de maintien (21 ) pour empêcher tout mouvement de l'unité de filtration (2) à l'intérieur de l'étui de protection (18), lorsque ladite unité de filtration (2) est disposée dans lesdits moyens de maintien (21 ) et que l'élément formant couvercle (20) est placé sur l'élément de base (19). Protective case according to Claim 6, characterized in that the bottom wall (31) of the cover member (20) comprises one or more holding ribs (34, 35) which cooperate with the holding means ( 21) to prevent movement of the filter unit (2) within the protective case (18), when said filter unit (2) is disposed in said holding means (21) and that lid member (20) is placed on the base member (19).
8. Etui de protection selon l'une quelconque des revendications 1 à 7, caractérisé en ce l'élément de base (19) et l'élément formant couvercle (20) sont assemblés entre eux de façon amovible par emboîtement. 8. Protective case according to any one of claims 1 to 7, characterized in that the base member (19) and the cover member (20) are assembled together releasably by interlocking.
9. Etui de protection selon l'une quelconque des revendications 1 à 3, caractérisé en ce que l'élément de base (19) comprend un corps de base (38) ayant au moins un premier évidement (39) dont la géométrie correspond à la géométrie de l'unité de filtration (2), ledit premier évidement (39) formant les moyens de maintien (21 ) de l'unité de filtration (2). 9. Protective case according to any one of claims 1 to 3, characterized in that the base member (19) comprises a base body (38) having at least a first recess (39) whose geometry corresponds to the geometry of the filtration unit (2), said first recess (39) forming the holding means (21) of the filtration unit (2).
10. Etui de protection selon la revendication 9, caractérisé en ce que le système à poches (1 ) est composé en outre, en tant que composants souples, d'au moins une poche primaire (5) comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat (6), chacune desdites poches (5,6) étant reliée à ladite unité de filtration (2) par une tubulure souple (7,8) respectivement, et en tant que composants rigides, d'au moins un clamp (9) agencé sur l'une desdites tubulures (7,8) et/ou d'un moyen de prélèvement (10) d'un échantillon de fluide, et ledit corps de base (38) comprenant en outre au moins un deuxième évidement (40,41 ,42) dont la géométrie correspond à la géométrie de l'un au moins des composants rigides du système à poches et/ou à une portion de tubulure souple du système à poches. 10. Protective case according to claim 9, characterized in that the bag system (1) is furthermore composed, as flexible components, of at least one primary bag (5) comprising the biological fluid to be filtered and d a filtrate collection bag (6), each of said pockets (5, 6) being connected to said filtration unit (2) by a flexible tubing (7, 8) respectively, and as rigid components, from at least one clamp (9) arranged on one of said tubings (7,8) and / or fluid sample collection means (10), and said base body (38) further comprising at least a second recess (40, 41, 42) whose geometry corresponds to the geometry of at least one of the rigid components of the bag system and / or to a portion of flexible tubing of the bag system.
1 1 . Etui de protection selon l'une des revendications 9 ou 10, caractérisé en ce que l'élément formant couvercle (20) comprend un corps de couvercle (43) ayant au moins un évidement (44,45,46) dont la géométrie correspond à la géométrie de l'un au moins des composants rigides du système à poches et/ou à une portion de tubulure souple du système à poches. 1 1. Protective case according to one of claims 9 or 10, characterized in that the cover member (20) comprises a cover body (43) having at least one recess (44,45,46) whose geometry corresponds to the geometry of at least one of the rigid components of the bag system and / or a flexible tubing portion of the bag system.
12. Etui de protection selon l'une quelconque des revendications 1 à 1 1 , caractérisé en ce que l'élément de base (19) et l'élément formant couvercle (20) sont assemblés entre eux par une charnière. 12. Protective case according to any one of claims 1 to 1 1, characterized in that the base member (19) and the cover member (20) are assembled together by a hinge.
13. Etui de protection selon l'une quelconque des revendications 1 à 12, caractérisé en ce qu'il est réalisé dans un matériau polymère de type élastomère thermoplastique. 13. Protective case according to any one of claims 1 to 12, characterized in that it is made of a thermoplastic elastomer type polymer material.
14. Etui de protection selon l'une quelconque des revendications 1 à 13, caractérisé en ce que la dureté shore A du matériau polymère est choisie dans la plage allant de 80 à 100, en particulier de 90 à 95, et plus particulièrement 95 Shore A. 14. Protective case according to any one of claims 1 to 13, characterized in that the Shore A hardness of the polymer material is chosen in the range from 80 to 100, in particular from 90 to 95, and more particularly 95 Shore AT.
15. Etui de protection selon l'une quelconque des revendications 1 à 14, caractérisé en ce que le fluide biologique est le sang ou un composant sanguin. 15. Protective case according to any one of claims 1 to 14, characterized in that the biological fluid is blood or a blood component.
16. Ensemble comprenant un étui de protection selon l'une quelconque des revendications 1 à 15 et un système à poches (1 ) destiné au traitement d'un fluide biologique, ledit système étant composé d'au moins une unité de filtration (2) d'un fluide biologique, caractérisé en ce que l'unité de filtration (2) est maintenue dans ledit étui de protection (18) par les moyens de maintien (21 ) de l'étui de protection conjointement avec l'élément formant couvercle (20). 16. An assembly comprising a protective case according to any one of claims 1 to 15 and a bag system (1) for the treatment of a biological fluid, said system being composed of at least one filtration unit (2) of a biological fluid, characterized in that the filter unit (2) is held in said protective case (18) by the holding means (21) of the protective case together with the cover member ( 20).
17. Ensemble selon la revendication 16, caractérisé en ce que le système à poches (1 ) est composé en outre, en tant que composants souples, d'au moins une poche primaire (5) comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat (6), chacune desdites poches (5,6) étant reliée à ladite unité de filtration (2) par une tubulure souple (7,8) respectivement, et en tant que composants rigides, d'au moins un clamp (9) agencé sur l'une desdites tubulures (7,8) et/ou d'un moyen de prélèvement (10) d'un échantillon de fluide, lesdites poches (5,6) étant arrangées à l'extérieur dudit étui de protection (18). 17. The assembly of claim 16, characterized in that the bag system (1) is further composed, as flexible components, of at least one primary bag (5) comprising the biological fluid to be filtered and a filtrate collection bag (6), each of said pockets (5, 6) being connected to said filtration unit (2) by a flexible tubing (7, 8) respectively, and as rigid components, of at least one clamp (9) arranged on one of said tubings (7,8) and / or means (10) for sampling a fluid sample, said pockets (5,6) being arranged outside said case protection (18).
18. Procédé de traitement d'un fluide biologique à l'aide d'un système à poches (1 ) composé d'au moins une unité de filtration (2) du fluide biologique, ledit procédé comprenant les étapes successives de : 18. A method of treating a biological fluid using a bag system (1) composed of at least one filtration unit (2) of the biological fluid, said method comprising the successive steps of:
- disposer l'unité de filtration (2) dans un étui de protection (18) selon l'une quelconque des revendications 1 à 15,  - arranging the filtration unit (2) in a protective case (18) according to any one of claims 1 to 15,
- placer dans un récipient de centrifugation le système à poches (1 ) avec l'étui de protection (18) dans lequel l'unité de filtration (2) est disposée, - placing in a centrifuge container the bag system (1) with the protective case (18) in which the filter unit (2) is arranged,
- centrifuger dans une centrifugeuse le système à poches (1 ) placé dans ledit récipient de centrifugation de sorte à séparer le fluide biologique en au moins une phase de surnageant et une phase de sédiment, centrifuging in a centrifuge the bag system (1) placed in said centrifugation vessel so as to separate the biological fluid into at least one supernatant phase and a sediment phase,
- retirer le système à poches (1 ) centrifugé du récipient de centrifugation, withdrawing the centrifuged bag system (1) from the centrifugation vessel,
- retirer l'unité de filtration (2) de l'étui de protection (18), - remove the filter unit (2) from the protective case (18),
- filtrer l'une des phases séparées au travers de l'unité de filtration (2) retirée de l'étui de protection (18).  filtering one of the separated phases through the filtration unit (2) removed from the protective case (18).
19. Procédé selon la revendication 18, caractérisé en ce que le système à poches (1 ) est composé en outre, en tant que composants souples, d'au moins une poche primaire (5) comprenant le fluide biologique à filtrer et d'une poche de recueil du filtrat (6), chacune desdites poches (5,6) étant reliée à ladite unité de filtration (2) par une tubulure souple (7,8) respectivement, et en tant que composants rigides, d'un clamp (9) agencé sur l'une desdites tubulures (7,8) et/ou d'un moyen de prélèvement d'un échantillon de fluide (10), ledit procédé comprenant en outre, avant l'étape de placer le système à poches (1 ) dans le récipient de centrifugation, l'étape de disposer l'un au moins des composants rigides dans l'étui de protection (18), lesdites poches souples (5,6) restant à l'extérieur dudit l'étui de protection (18). Method according to claim 18, characterized in that the bag system (1) is furthermore composed, as flexible components, of at least one primary bag (5) comprising the biological fluid to be filtered and a poached for collecting the filtrate (6), each of said pockets (5, 6) being connected to said filtration unit (2) by a flexible tubing (7, 8) respectively, and as rigid components of a clamp (9). ) arranged on one of said tubings (7,8) and / or fluid sample collection means (10), said method further comprising, prior to the step of placing the bag system (1). ) in the centrifugation vessel, the step of disposing at least one of the rigid components in the protective case (18), said flexible pouches (5, 6) remaining outside said protective case ( 18).
20. Procédé selon l'une des revendications 18 ou 19, caractérisé en ce que le traitement du fluide biologique comprend la séparation d'un assemblage de couches leuco-plaquettaires en concentré plaquettaire en tant que phase de surnageant et la filtration dudit concentré plaquettaire en vue de l'appauvrir en leucocytes. 20. Method according to one of claims 18 or 19, characterized in that the treatment of the biological fluid comprises the separation of an assembly of buffy coat platelet concentrate as supernatant phase and the filtration of said platelet concentrate in to deplete it in leucocytes.
PCT/EP2017/084153 2016-12-29 2017-12-21 Protective case for components of a bag system WO2018122105A1 (en)

Applications Claiming Priority (2)

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FR1670799 2016-12-29
FR1670799A FR3061436B1 (en) 2016-12-29 2016-12-29 PROTECTIVE CASE FOR COMPONENTS OF A POCKET SYSTEM

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US5456845A (en) 1993-02-22 1995-10-10 Asahi Medical Co., Ltd. Method for separating a blood material into blood component products
EP0654303A1 (en) 1993-11-23 1995-05-24 JOUAN, Société Anonyme dite Method for centrifugal treatment of a liquid packed in flexible bags, connected with at least one filter
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WO2010061863A1 (en) 2008-11-28 2010-06-03 Terumo Kabushiki Kaisha Blood bag system and cassette
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3136377A1 (en) * 2022-06-14 2023-12-15 Maco Pharma Holding device for filtration unit of a biological fluid
EP4292621A1 (en) * 2022-06-14 2023-12-20 Maco Pharma Holding device for a biological fluid filtration unit

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