(19)
(11)EP 2 618 865 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
21.10.2015 Bulletin 2015/43

(21)Application number: 11776688.1

(22)Date of filing:  20.09.2011
(51)Int. Cl.: 
A61M 1/36  (2006.01)
B01L 3/14  (2006.01)
(86)International application number:
PCT/DK2011/050354
(87)International publication number:
WO 2012/037942 (29.03.2012 Gazette  2012/13)

(54)

CONTAINER FOR USE WHEN PRODUCING A MULTI-LAYERED BLOOD PRODUCT

BEHÄLTER ZUR VERWENDUNG BEI DER HERSTELLUNG EINES MEHRSCHICHTIGEN BLUTPRODUKT

RÉCIPIENT DESTINÉ À ÊTRE UTILISÉ LORS DE LA PRODUCTION D'UN PRODUIT SANGUIN MULTI-COUCHES


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 20.09.2010 DK 201000841

(43)Date of publication of application:
31.07.2013 Bulletin 2013/31

(60)Divisional application:
14163852.8 / 2754457

(73)Proprietor: Reapplix APS
3460 Birkerød (DK)

(72)Inventors:
  • LUNDQUIST, Rasmus
    DK-2700 Brønshøj (DK)
  • HOLM, Niels Erik
    DK-3460 Birkerød (DK)

(74)Representative: Pálsson, Ingólfur et al
Chas. Hude A/S Patent H.C. Andersens Boulevard 33
1780 Copenhagen V
1780 Copenhagen V (DK)


(56)References cited: : 
WO-A1-2010/020254
US-A- 3 894 952
US-A1- 2010 155 319
WO-A2-03/092894
US-A1- 2008 023 414
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Technical Field



    [0001] The present invention relates to a container to be used for preparing making a multi-layered blood product by centrifugation, said container comprising a substantially cylindrical body with a closed bottom and a top having a filling opening as well as a filter device, which is slidable inside the container.

    Background



    [0002] WO 2010/020254 discloses how to prepare a multi-layered blood product by centrifugation of blood. First, the blood is placed in a container, and the coagulation of the blood is activated during or after placing the blood in the container. During the centrifugation, the components of the blood are separated from each other and produce a three-layered blood product, which in sequential order comprises a first layer, which substantially comprises fibrin, a second, intermediate layer, which substantially comprises thrombocytes, and a third layer, which substantially comprises leukocytes. This three-layered blood product forms a coherent pad, which is separated from serum and erythrocytes. The blood product or the blood pad is suitable for the treatment of wounds. By placing the third layer closest to the wound, the wound is kept substantially aseptic as the leukocytes of the third layer counter infection and attract other cells including macrophages. The second layer substantially comprising thrombocyte contains growth-promoting factors, which stimulate the healing of the wound, whereas the third layer, which comprises substantially fibrin, offers an effective protection against contamination from the surroundings, just as the content of growth-promoting factors of the first layer is released in time. The blood product in question is suitable for autogenic use. Due to a large internal strength, density towards liquids and gasses, the blood product is also suitable for use in other surgical procedures, such as anastomosis, hernioplasties and orthopaedics.

    [0003] US 2008/0023414 discloses a container unit for separating blood into a lighter and a heavier constituent by centrifugation. The container unit comprises a tubular body with an interior, a closed bottom and an open top closed by means of a closure. The inner dimension of the tubular body slightly tapers as seen from the top toward the bottom. A separating device is arranged in the interior of the tubular body at the top thereof. The separating devices is circumferentially deformable and engages sealingly to the inner surface of the tubular body. When using the container unit, blood is introduced into the interior below the separating device. When the separating device is subjected to centrifugation the separating device moves downwards towards the bottom until it has moved a preselected distance. The lighter constituent flows upwards through the separating device to be situated above the separating device while the heavier constituent is situated below the separating device.

    [0004] US 2010/0155319 discloses a separation assembly for separating a fluid such as blood into a heaver fraction and lighter fraction. The separation assembly comprises a tubular body having a closed bottom end and an open upper and closed by a closure. A separator is displaceably arranged in the interior of the tubular body. The separator comprises a float and ballast, the float and the ballast being connected by bellows sealingly engaging the inner surface of the tubular body when not being subjected to centrifugal force. The overall density of the separator is between that of the heavier and lighter fraction. When using the sensation assembly, blood is introduced into the interior of the tubular body below the separator, the separator being initially situated at the top end adjacent the closure. When subjected to centrifugation, the diameter of the bellows decreases and the separator moved downwards toward the bottom until it, due to its overall density, is situated between the lighter and the heavier fraction, the lighter fraction being situated above and the heavier fraction below the separator.

    Disclosure of the Invention



    [0005] The object of the invention is to provide a container, which is especially suitable for use when preparing said blood product.

    [0006] According to the invention, this is achieved by filling opening being closed by a penetrable membrane, that the filter device comprises a substantially planar mesh and a supporting buoyancy body, and that means are provided for releasable fixation of the filter device adjacent to the bottom of the container. Correspondingly, the present invention provides a container according to claim 1.

    [0007] This container allows for providing of a vacuum in the interior thereof before use. The penetrable membrane allows for easy filling of the container with blood directly from a person, who is to use the blood product. A double needle may be used for the filing, i.e. a needle, which has a cutting edge in both ends, often produced as a thin tube with a needle in both ends. At the same time, the vacuum ensures that the blood is subjected to forces, which may promote the necessary coagulation process, if necessary in combination with the material of which the container is made. The substantially planar mesh of the filter device provides a collecting surface for the blood product during the centrifugation whilst at the same time, heavier parts of the blood, which are still floating, can flow through the mesh down beneath said mesh as the centrifugation is carried out with the bottom of the container facing away from the axis of rotation of the centrifuge. When the blood product has collected above or on the mesh of the filter device, the filter device is appropriately released when stopping the centrifugation or during the subsequent resumption of the centrifugation. This means that the filter device carrying the blood product moves upwards in the container during passing of the liquid blood component, which was situated above the filter device in the container prior to the release of the filter device. When the blood product has moved upwards to the surface of the liquid component in the container, the centrifugation is stopped and the blood product appropriately removed by means of forceps after opening the container appropriately by removing the top. The use of a filter device for collecting the blood product reduces the centrifugation time and the forces compared to a centrifugation without a filter device. The removal of the blood product is facilitated by a filter device with a buoyancy body, which is arranged such that during the centrifugation, the blood product during the continued centrifugation is lifted to the surface of the liquid in the container. The blood product has such strength that it may be removed by means of forceps and applied at a desired spot, e.g. on a wound.

    [0008] According to the invention, the filling opening may have a transverse wall placed between the membrane and the inside of the container and having a small passage. Thereby, the blood Is subjected to especially great transverse forces during the filling of the container and the presence of a vacuum in the inside of the container. These transverse forces promote the initiation of the coagulation process.

    [0009] Furthermore, according to the invention, the penetrable membrane may have an annular, protruding and plug-like part at the bottom surface thereof, said plug-like part being adapted to face the inside of the container, and that at the side facing the membrane, the transverse wall has an annular flange extending around the passage and interacting with the protruding plug-like part of the membrane in a tight-fitting way.

    [0010] According to the invention, the filling opening may have a transverse wall placed between the membrane and the inside of the container, said transverse wall having a relatively small, penetrable wall thickness. The small wall thickness prevents the needle from being blocked during penetration of the needle of the blood collection set. This wall thickness will depend on the material used. If the membrane is made of Polypropylene, the membrane thickness Is preferably less than 0.5 mm. The advantage of the transverse wall without a passage is that the material used will be less permeable than penetration membranes, which are typically made of rubber materials and relatively permeable. In order to ensure a stabile vacuum over time, a membrane of a sealing material will be an advantage.

    [0011] In addition to this, according to the invention, the substantially planar mesh (16) of the filter device may have a downwardly extending skirt, and the buoyancy body is a closed capsule, which is received in the cavity defined by the skirt, and that spacing means are provided for fixing the capsule in a distance from both the bottom surface of the mesh and the inner surface of the skirt. Thereby, an especially easy way is achieved for the filter device to move easily in a free-flowing state inside the container to the surface of the liquid present in the container. The spacing means ensure that the liquid flowing through the filter device during centrifugation can pass the capsule easily and thereby through the filter device during the centrifugation process.

    [0012] Advantageously, the spacing means between the mesh and the buoyancy body may be radially extending ribs or rods at the bottom surface of the mesh. Advantageously, these ribs or rods are formed integrally with the mesh.

    [0013] Furthermore, the spacing means between the buoyancy body and the skirt may be projections at the lateral face of the buoyancy body and are formed with evenly distributed distances relative to each other along the circumference of the buoyancy body. Advantageously, these projections may be formed integrally with the buoyancy body.

    [0014] According to the invention, the capsule forming the buoyancy body is formed by two flat-bottomed bowls engaging each other in a telescope-like way with the bottoms facing away from each other, sealing means being provided for tightly sealing the two bowls together. Thereby, an especially simple and easily manufactured capsule is achieved.

    [0015] According to the invention, along the periphery, the skirt of the lifter device may have a number of yielding flaps arranged interspaced and each having a radial protruding projection for frictional interaction with the inner face at the container, whereby a good fixation of the filter device is achieved at the bottom of the container before use.

    [0016] More appropriately, according to the invention, the container with bottom and top may be rotationally-symmetrically shaped around the longitudinal axis of the cylindrical body, and that the top and the cylindrical body Including the bottom are separately formed parts, said parts being adapted to be close-fittingly coupled.

    [0017] More appropriately, according to the invention, the mesh of the filter device including the skirt may be integrally formed.

    [0018] According to the invention, the means for releasable fixation of the filter device adjacent to the bottom of the container may comprise two cups adapted to be inserted into each other with the mouths facing in the same direction, and where the inner cup is provided with holes for reception of respective slidable squeeze pin extending radially inwardly, the outermost ends of the squeeze pins being adapted to cooperate in a cam follower-like way with the edge of the outer cup when the cups are inserted into each other, whereas the inner most ends of the squeeze pins are adapted to press the wall of the container radially inwards when placing the container with the filter device in the inner cup and thereby fix the filler device in close proximity of the bottom of the container until the two cups are pulled away from each other again. Thereby, an especially simple way for fixation of the filter device at the bottom of the container is achieved as long as desired during the centrifugation.

    [0019] Especially appropriate, according to the invention, outer cup may be adapted to be a fixed part of a holder for reception of the container during the centrifugation, and that the cups are telescoped under the influence of the centrifugal force during the centrifugation. Subsequently, the release of the filter device takes place by removing the container with the inner cup from the outer cup and thereafter, the container is placed in the outer cup again without the inner cup with the pins or alternatively with a stabilising second cup without pins.

    [0020] Especially appropriate, spring means may be provided between the two cups for moving them automatically away from each other again when stopping the centrifugation, whereby the release of the filter device takes place automatically.

    [0021] According to the invention, the inside wall of the outer cup may be provided with at least one groove for co-operation with a guide pin on the inner cup, so that the inner cup is turned a first distance during a telescoped movement of the cups and a subsequent displacement of the cups in a direction away from each other again during a first centrifugation phase and is turned a second distance during a second telescoped movement during a subsequent centrifugation phase, and in that in the end, the squeeze pins are placed opposite each their groove in the outer cup, such that they are released and remain unaffected during a continued centrifugation of the container. Thereby, the release or disengaging of the filter device follows completely automatically simply by stopping the centrifugation, and the centrifugation may be continued without the filter device being retained at the bottom of the container.

    [0022] Furthermore, according to the invention, the squeeze pins may be designed to function as guide pins while interacting with corresponding grooves in the outer cup.

    [0023] Furthermore, according to the invention, at a level above the mesh, the filter device may carry an easily releasable reinforcement means for the blood product, whereby the inside of the blood product is provided with a reinforcement means, which may function as a reinforcement of the blood product and if desired, be used in connection with a possible sewing on of the blood product to the place of use.

    [0024] Finally, according to the invention the reinforcement means may be fixed by means of gravity, whereby it is released especially easy from the filter device by removing the filter device.

    Brief Description of the Drawing(s)



    [0025] The invention is explained in detail below with reference to the drawings, in which

    Fig. 1 shows a cross section of an embodiment of a container according to the invention,

    Fig. 2 shows a cross section of another embodiment of a container according to the invention placed in an inner and an outer cup for fixation of the filter device at the bottom of the container.

    Fig. 3 is the same as Fig. 2, but seen in another diagonal section and with the filter device being shown schematically, and viewed from the side,

    Fig. 4 is a cross sectional view showing a squeeze pin, and

    Fig. 5 shows a schematic view of a part of the inside of the outer cup shown in Fig. 2 and 3.


    Detailed description of the invention



    [0026] The container shown in Fig. 1, which is provided with the general reference number 1, comprises a rotational-symmetrical cylindrical body 2 made in one piece with a bottom 3. At the top or at the other end, the cylindrical body 2 is closed by means of a detachable top 4, which is tightly sealed to the cylindrical body 2 by means of a seal 5. The top 4 is also rotationally-symmetrically formed and has a truncated cone-shaped wall 6, which, in the direction way from the cylindrical body 2, extends into an annular, radially extending wall 7, which is delimited by two annular, axially extending flanges 8 and 9, of which the outer flange 8 has a slightly longer axial direction than the inner flange 9. At the bottom, the inner flange 9 is formed integrally with a radially extending wall 10 being centrally provided with an axially extending narrow massage 11 and ending on the surface facing the inside of the container 1 in a substantially truncated cone-shaped projection 12 formed integrally with the radial wall 10. At the top, the top 4 carries a circular, penetrable membrane 13 substantially formed as a disc, but on the one side having an annular protruding part 14, which interacts with the inner flange 9 at the top 4 in a plug-like way. Along the inner side of the outer flange 8, the membrane 13 abuts the outer flange 6 tight-fittingly at the top 4. It may be received in an annular recess in the outer flange 8 (not shown).

    [0027] inside the container 1, there is a loosely fitted filter device shown by the general reference number 15. At the top, it comprises a grid or mesh-shaped part 16, which is formed integrally with an annular skirt 17. In the cavity defined by the skirt 17, a capsule-shaped buoyancy body 18 is received, which is formed by two joined cups 19 and 20 formed such that they define a cavity 21 tight-fittingly, if necessary by using an in-termediate sealing ring (not shown). Along the periphery of the buoyancy body 18, projections 22 and 23 are formed with appropriate distance from each other, which maintain the buoyancy body 18 in a distance from the skirt 17 but frictionally engaged therewith. The buoyancy body 18 is also maintained in an appropriate distance from a grid or mesh-shaped part 16 by means of projections 24, 25 and 26, which are formed as one piece with the grid or mesh-shaped part 16.

    [0028] Along the skirt 17, yielding flaps 27 are formed with appropriate distances from each other by means of axially extending apertures 28 and 29 (see Fig. 3). The flaps 27 between the two apertures 28 and 29 have a projection 30 at the free end, which protrudes in a radial direction. As a result of the projections 30 abutting the inner side of the cylindrical body, these flanges 27 with projections 30 allow for fixation of the filter device 15 at the bottom of the container 1 during transportation. This fixation is achieved by means of friction only.

    [0029] In the embodiment shown in Fig. 1, upwardly protruding holding means 31, 32 and 33 are formed with appropriate distances from each other at the top of the grid or mesh-shaped part 16 of the filter device 15, said protruding holding means 31, 32 and 33 being adapted to support a reinforcement mesh 34, which is appropriately carried by abutting contact faces on the holding means 31, 32 and 33 due to gravity and is in frictional engagement with with the holding means 31, 32 and 33.

    [0030] In Fig. 2, the container 1 is shown in an embodiment without a reinforcement mesh, but with means for releasable fixation of the filter device 15 at the bottom of the container 1 during a centrifugation process. These means comprise two cups. an inner cup 35 and an outer cup 36, which are formed to be able to be inserted into each other with the mouth facing in the same direction. In a level along the circumference of the inner cup 15, appropriately spaced holes 37 and 38 are formed for reception of their respective squeeze pin 39 and 40, adapted to be fixed by means of friction in the respective holes 37 and 38 in the embodiment shown.

    [0031] The outer cup 36 has a slanting surface 41 along the upper edge for interaction with the squeeze pins 39 and 40 during telescoping of the cups, the slanting surface 41 displacing the squeeze pins radially inwards in a cam follower-like way. The two cups 35 and 36 are formed in such a way that they may be easily displace in a direction to wards each other and away from each other. The displacement away from each other may be facilitated by means of a schematically shown spring 54. The pins 39 and 40 are dimensioned in such a way that they push the wall of the cylindrical body 2 of the container 1 somewhat inwards to such an extent that the filter device 15 is fixed at the bottom of the container 1 during the use thereof.

    [0032] Appropriately, the outer cup 36 may be a fixed cup in a centrifuge such that during centrifugation, the container 1 is placed therein together with the inner cup 35 and pressed down towards the bottom of the outer cup 36 during centrifugation.

    [0033] The container according to the invention is used in the following way. At an appropriate point in time before the container 1 is brought into use, vacuum is established in the container 1 in an appropriate way. When using the container 1. the membrane 13 is penetrated with a needle, which is connected to a human vein via an appropriate pipe. Assisted by the vacuum in the container 1, the blood flows into the cavity under the membrane 13 at the top 4 of the container 1, from where it is sucked through the relatively narrow passage 11 and into the inside of the container 1 as the vacuum therein subjects the blood to large shear forces in the passage, whereupon the blood is sprayed into the interior of the container 1. Thereby, the initiation of the coagulation process of the blood is facilitated, possibly further facilitated by means of the material, of which the container 1 is made. When the container 1 has been supplied with an appropriate amount of blood, the needle is removed from the membrane 13, and the container 1 is placed in the inner cup 35. Together with the inner cup 35, it is placed in the outer cup 36 in a centrifuge. When the centrifugation is started, the inner cup 35 is pressed down towards the bottom of the outer cup 36, normally at the same time as the axis of the container is moved into a horizontal or radial position relative to the axis of rotation of the centrifuge.

    [0034] During the centrifugation, as mentioned above, the three-layered blood product is produced after an appropriate amount of time (e.g. 8 minutes) and an appropriate application of force. Thereafter, the centrifuge is stopped and the squeeze pins 39. 40 are removed, whereupon the centrifugation is resumed. As a result of removing the squeeze pins 39 and 40, the fitter device 15 can now move upwards towards the surface of the liquid, especially as a result of the presence of the buoyancy body 18. Thereby, the blood product is moved upwards, whereas the surrounding liquid passes through and past the filter device down towards the bottom of the container 1. When, or a short time after, the filter device has reached the surface of the liquid at the top of the container, or has been stopped when reaching the top 1, the centrifugation is stopped and the container is removed from the centrifuge. Thereafter, the top 4 is removed from the upper part of the container 1, and the blood product is now ready to be removed from the container and placed on the desired spot on a patient.

    [0035] In connection with the presence of the reinforcement mesh shown in Fig. 1, this will, with an appropriate placement on the filter device 15, be placed on an appropriate place in the blood product, e.g. in the first layer, which comprises mainly fibrin as this layer is the strongest layer.

    [0036] Instead of having to remove the squeeze pins manually, they may be preloaded in a direction radially outwards relative to the inner cup. For example, the squeeze pins may be formed as shown in Fig. 4, which shows a section of the inner cup 35, seen in a large scale and with a squeeze pin 42 comprising a bolt-like part 43, the head 44 of said bolt-like part facing towards the inside of the cup, and a nut 45 having a threaded blindhole supplied with a thread for reception of the bolt 43. The bolt-like part 43 has a rounded surface for interaction with the slanting surface 41 on the outer cup. By means of a spring 47, the squeeze pin 42 is preloaded in a position in which the head 44 is aligned with the inside of the cup 35. Here, the boit 44 abuts an annular stop face 48 integrally formed with the cup 35.

    [0037] As soon as the outer cup 36 no longer presses the squeeze pin 42 towards the container 1 in the inner cup 35, the head 44 of the pin 42 is pulled away from its engagement with the container 1.

    [0038] Instead of manually having to remove the container 1 together with the inner cup 35 from the outer cup 36 and thereby ensure the release of the filter device 15, this process may also be carried out automatically. As shown in Figs. 3 and 5, this may for example take place by forming a groove 49 in the inside of the outer cup 36. This groove is illustrated in Fig. 3 by means of a dotted line. The groove 49 is designed to interact with a guide pin 50, which is fixed to the inner cup 35 in addition to the squeeze pins, which are not shown in Fig. 3. The groove 49 may have a course as shown in Fig. 5. This course may entail that at first, the guide pin 50 together with the inner cup 35 and the container 1 therein are moved axially downwards in the outer cup 36 until the squeeze pins are activated. During the continued movement of the pin 50, the inner cup 35 is thereafter, moved from a position a (see Fig. 5) to a position b, where the inner cup 35 with the container 1 is placed during the centrifugation until the blood-product is produced. When stopping or braking the centrifugation, the pin 50 is moved from position b to position c as a result of the action of the spring 54, and in connection with a resumption of the centrifugation, the pin 50 is now moved further down in the outer cup 36 to the position d. During this moving of the position of the pin 50, the inner cup 35 is turned so far along the inside of the outer cup 36 that the squeeze pins are positioned opposite a groove 51, which is formed in the outer cup 36 and shown by dotted lines in Fig. 5. The position of the squeeze pins 42 opposite this groove 51 means that by means of their respective springs 47, they are disengaged from the container 1 and thereby release the filter device. The centrifugation process continues with the guide pin 50 in the position d shown in Fig. 5 until the filter device has moved up to the surface of the liquid in the container 1.

    [0039] The groove shown in Fig. 5 may have various shapes, but it must have such a shape that it is ensured that the guide pin 50 is moved along the inside of the outer cup 36 such that the squeeze pins are moved into a groove 51. Appropriately, the groove 51 extends the entire axial length of the inside wall of the outer cup 36 and naturally, there are a number of grooves 51 corresponding to the number of squeeze pins 42 in the inner cup 35.

    [0040] In a preferred embodiment of the invention, the container is made of polyamide, whereas the other parts are made of polypropylene. The reinforcement mesh may be made of Polyglactine, which is a commonly-used degradable suture material. It may also be made of nylon. Depending on the density, it is placed loosely on top of the filter device or by using light barbs. Alternatively, it may also simply be placed anywhere in the container as due to its density, it may move downwards and into engagement with the blood product during the centrifugation.

    [0041] In the shown embodiment of the invention, the transverse wall 10 at the top 4 Is, as mentioned, designed with a passage 11. Alternatively, the passage 11 may be omitted. In such case, both the penetrable membrane 11 and the transverse wall 10 are penetrated with a needle during the injection of blood. A suitable diameter of the passage 11 is 0.4 mm.

    [0042] The invention has been described referring to preferred embodiments. Many changes may be made without deviating from the scope of the Invention. As an example, the hole-delimiting parts of the mesh may have various cross-sectional shapes, but it is preferred that they have a convex shape on the surface facing the blood product.


    Claims

    1. Container to be used for preparing a multi-layered blood product by centrifugation, said container comprising a substantially cylindrical body (2) with a closed bottom (3) and a top (4) having a filling opening as well as a filter device (15) which is slidable inside the container (1), and means (35, 36, 39, 40, 42) for releasable fixation of the filter device (15) adjacent to the bottom (3) of the container (1) the filling opening being closed by a penetrable membrane (13), characterised in that the filter device (15) comprises a substantially planar mesh (16) providing a collecting surface for the blood product during the centrifugation and a supporting buoyancy body (18), for lifting the blood product collected above or on the mesh of the filter device, to the surface of the liquid in the container during centrifugation of the container.
     
    2. Container according to any of the preceding claims, characterised in that the substantially planar mesh (16) of the filter device (15) has a downwardly extending skirt (17), and the buoyancy body (18) is a closed capsule, which is received in the cavity defined by the skirt (17), and that spacing means (22, 23, 24, 25, 26) are provided for fixing the capsule (18) in a distance from both the bottom surface of the mesh (16) and the inner surface of the skirt (17).
     
    3. Container according to claim 3, characterised in that the spacing means (24, 25 and 26) between the mesh (16) and the buoyancy body (18) are radially extending ribs or rods at the bottom surface of the mesh (16).
     
    4. Container according to claim 3 or 4, characterised in that the spacing means (22, 23) between the buoyancy body (18) and the skirt (17) are projections at the lateral face of the buoyancy body (18) and are formed with evenly distributed distances relative to each other along the circumference of the buoyancy body (18).
     
    5. Container according to claim 3, characterised in that the capsule forming the buoyancy body (18) is formed by two flat-bottomed bowls (19, 20) engaging each other in a telescope-like way with the bottoms facing away from each other, sealing means being provided for tightly sealing the two bowls (19 and 20) together.
     
    6. Container according to claim 3, 4, 5 or 6, characterised in that along the periphery, the skirt (17) of the filter device (15) has a number of yielding flaps (27) arranged interspaced and each having a radial protruding projection (30) for frictional interaction with the inner face of the container (1).
     
    7. Container according to one or more of the claims 1 - 7, characterised in that the container (1) with bottom (3) and top (4) is rotationally-symmetrically shaped around the longitudinal axis of the cylindrical body (2), and that the top (4) and the cylindrical body (2) including the bottom (3) are separately formed parts, said parts being adapted to be close-fittingly coupled.
     
    8. Container according to one or more of the claims 3, characterised in that the mesh of the filter device (15) including the skirt (17) are integrally formed.
     
    9. Container according to one or more of the claims 1 - 9, and where at least the cylindrical body (2) of the container is made of an elastically yielding material, characterised in that the means for releasable fixation of the filter device (15) adjacent to the bottom (3) of the container (1) comprise two cups (35, 36) adapted to be inserted into each other with the mouths facing in the same direction, and where the inner cup (35) is provided with holes (37, 38) for reception of respective slidable squeeze pin (39, 40, 42) extending radially inwardly, the outermost ends of the squeeze pins (39, 40, 42) being adapted to cooperate in a cam follower-like way with the edge (41) of the outer cup (36) when the cups (35, 36) are inserted into each other, whereas the inner most ends of the squeeze pins (39, 40 ,42) are adapted to press the wall of the container radially inwards when placing the container (1) with the filter device (15) in the inner cup (35) and thereby fix the filter device (15) in close proximity of the bottom (3) of the container (1) until the two cups (35, 36) are pulled away from each other again.
     
    10. Container according to claim 10, characterised in that the squeeze pins (42) are spring-preloaded into a radially viewed outer position, wherein their inner ends are level with the inner face of the inner cup (35).
     
    11. Container according to claim 10 or 11, characterised in that the outer cup (36) is adapted to be a fixed part of a holder for reception of the container (1) during the centrifugation, and that the cups (35, 36) are telescoped under the influence of the centrifugal force during the centrifugation.
     
    12. Container according to claim 10, 11 or 12, characterised in that a spring means (54) is provided between the two cups (35, 36) for moving them automatically away from each other again when stopping the centrifugation.
     
    13. Container according to claim 10, 11, 12 or 13, characterised in that the inside wall of the outer cup (36) or the outer wall of the inner cup (35) is provided with at least one groove (49) for co-operation with a guide pin (50) on the inner cup (35), so that the inner cup (35) is turned a first distance during a telescoped movement of the cups (35, 36) and a subsequent displacement of the cups in a direction away from each other again during a first centrifugation phase and is turned a second distance during a second telescoped movement during a subsequent centrifugation phase, and in that in the end, the squeeze pins (42) are placed opposite each their groove (51) in the outer cup (36), such that they are released and remain unaffected during a continued centrifugation of the container (1).
     
    14. Container according to one or more of the claims 1 - 14, characterised in that at a level above the mesh (16), the filter device (15) carries an easily releasable reinforcement means (34) for the blood product.
     


    Ansprüche

    1. Behälter zur Verwendung in der Herstellung eines mehrschichtigen Blutprodukts durch Zentrifugation, jener Behälter umfassend einen im Wesentlichen zylindrischen Körper (2) mit einem geschlossenen Boden (30) und einem Oberteil (4) mit einer Befüllungsöffnung sowie einer Filtervorrichtung (15), die innerhalb des Behälters (1) verschiebbar ist , und Mittel (35, 36, 39, 40, 42) zur lösbaren Fixierung der Filtervorrichtung (15), die benachbart zum Boden (3) des Behälters (1) sind, wobei die Befüllungsöffnung durch eine durchdringbare Membran (13) verschlossen ist, dadurch gekennzeichnet, dass die Filtervorrichtung (15) ein im Wesentlichen ebenes Netz, das eine Sammeloberfläche für das Blutprodukt während der Zentrifugation bereitstellt, und einen unterstützenden Auftriebskörper (18) zum Heben des darüber oder auf dem Netz der Filtervorrichtung gesammelten Blutprodukts an die Oberfläche der Flüssigkeit im Behälter während der Zentrifugation des Behälters umfasst.
     
    2. Der Behälter entsprechend irgendeinem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das im Wesentlichen ebene Netz (16) der Filtervorrichtung (15) eine sich nach unten erstreckende Schürze (17) hat und der Auftriebskörper (18) eine geschlossene Kapsel ist, die in den durch die Schürze definierten Hohlraum aufgenommen wird, und dass Abstandsmittel (22, 23, 24, 25, 26) zum Fixieren der Kapsel (18) in einem Abstand sowohl zur Bodenfläche des Netzes (16) als auch zur Innenfläche der Schürze (17) bereitgestellt sind.
     
    3. Der Behälter entsprechend Anspruch 3, dadurch gekennzeichnet, dass die Abstandsmittel (24, 25 und 26) zwischen dem Netz (16) und dem Auftriebskörper (18) radial verlaufende Rippen oder Stangen auf der Bodenfläche des Netzes (16) sind.
     
    4. Der Behälter entsprechend Anspruch 3 oder 4, dadurch gekennzeichnet, dass die Abstandshalter (22, 23) zwischen dem Auftriebskörper (18) und der Schürze (17) Überstände auf der Seitenfläche des Auftriebskörpers (18) sind und mit gleichmäßig verteilten Abständen relativ zueinander entlang dem Umfang des Auftriebskörpers (18) formiert sind.
     
    5. Der Behälter entsprechend Anspruch 3, dadurch gekennzeichnet, dass die Kapsel, die den Auftriebskörper (18) bildet, durch zwei Flachbodenschalen (19, 20) gebildet wird, die in einer teleskopartigen Art und Weise mit den voneinander abgewandten Böden ineinander greifen, wobei Verschlussmittel zum miteinander Verschließen der zwei Schalen (19 und 20) bereitgestellt sind.
     
    6. Der Behälter entsprechend Anspruch 3, 4, 5 oder 6, dadurch gekennzeichnet, dass die Schürze (17) der Filtervorrichtung (15) eine Anzahl von mit Abstand angeordneten nachgebenden Klappen (27) entlang des äußeren Randes hat und jede einen radial vorstehenden Überstand (30) zur Reibungswechselwirkung mit der Innenfläche des Behälters (1) hat.
     
    7. Der Behälter entsprechend einem der Ansprüche 1-7, dadurch gekennzeichnet, dass der Behälter (1) mit dem Boden (3) und dem Oberteil (4) rotationssymmetrisch um die Längsachse des zylindrischen Körpers (2) geformt ist und dass das Oberteil (4) und der zylindrische Körper (2) einschließlich dem Boden (3) einzeln gebildete Teile sind, wobei jene Teile angepasst sind, um eng anliegend verbunden zu sein.
     
    8. Der Behälter entsprechend einem oder mehr der Ansprüche 3, dadurch gekennzeichnet, dass das Netz der Filtervorrichtung (15), das die Schürze (17) umfasst, aus einem Stück gebildet sind.
     
    9. Der Behälter entsprechend einem der Ansprüche 1-9, und wobei mindestens der zylindrische Körper (2) des Behälters aus einem elastisch nachgebenden Material gemacht sind, dadurch gekennzeichnet, dass die Mittel zur lösbaren Fixierung der Filtervorrichtung (15), die an den Boden (3) des Behälters (1) angrenzen, zwei Becher (35, 36) umfassen, die angepasst sind, um ineinander mit den Öffnungen in dieselbe Richtung zeigend gesteckt zu werden, und wobei der innere Becher (35) mit Löchern (37, 38) zur Aufnahme von entsprechenden verschiebbaren Druckbolzen (39, 40, 42) versehen ist, die sich radial nach innen erstrecken, wobei die äußersten Enden der Druckbolzen (39, 40, 42) angepasst sind, um in einer Nockenstößel-artigen Weise mit dem Rand (41) des äußeren Bechers (36) zusammenwirken, wenn die Becher (35,36) ineinander gesteckt sind, wobei die innersten Enden der Druckbolzen (39, 40, 42) angepasst sind, um die Wand des Behälters radial nach innen zu drücken wenn der Behälter (1) mit der Filtervorrichtung (15) in den inneren Becher (35) gestellt wird und dabei die Filtervorrichtung (15) in unmittelbarer Nähe des Bodens (3) des Behälters (1) fixiert bis die zwei Becher (35, 36) wieder auseinander gezogen werden.
     
    10. Der Behälter entsprechend Anspruch 10, dadurch gekennzeichnet, dass die Druckbolzen (42) in einer radial gesehen äußeren Position federvorgespannt sind, wobei ihre inneren Enden auf gleicher Höhe mit der Innenfläche des inneren Bechers (35) sind.
     
    11. Der Behälter entsprechend Anspruch 10 oder 11, dadurch gekennzeichnet, dass der äußere Becher (36) angepasst ist, um ein fixierter Teil einer Halterung zur Aufnahme des Behälters (1) während der Zentrifugation zu sein, und dass die Becher (35,36) unter der Einwirkung der Zentrifugalkraft während der Zentrifugation zusammengeschoben werden.
     
    12. Der Behälter entsprechend Anspruch 10, 11 oder 12, dadurch gekennzeichnet, dass ein Federmittel (54) zwischen den zwei Bechern (35, 36) bereitgestellt ist, um sie automatisch voneinander weg zu bewegen wenn die Zentrifugation gestoppt wird.
     
    13. Der Behälter entsprechend Anspruch 10, 11, 12 oder 13, dadurch gekennzeichnet, dass die Innenwand des äußeren Bechers (36) oder die Außenwand des inneren Bechers (35) mit mindestens einer Nut (49) zum Zusammenwirken mit einem Führungsbolzen (50) auf dem inneren Becher (35) versehen ist, so dass der innere Becher (35) während einer teleskopartigen Bewegung der Becher (35, 36) um eine erste Strecke gedreht wird und einer nachfolgenden Verschiebung der Becher in eine entgegengesetzte Richtung wiederum während einer ersten Zentrifugationsphase, und um eine zweite Strecke während einer zweiten teleskopartigen Bewegung während einer nachfolgenden Zentrifugationsphase gedreht wird, und dadurch, dass letztlich die Druckbolzen (42) jeweils gegenüber ihrer Nut (51) im äußeren Becher (36) platziert sind, so dass sie gelöst werden und während einer fortgeführten Zentrifugation des Behälters (1) unberührt bleiben.
     
    14. Der Behälter entsprechend einem oder mehr der Ansprüche 1- 14, dadurch gekennzeichnet, dass die Filtervorrichtung (15) auf einer Ebene über dem Netz (16) leicht lösbare Versteifungsmittel (34) für das Blutprodukt trägt.
     


    Revendications

    1. Contenant destiné à être utilisé dans la préparation d'un produit sanguin multicouche par centrifugation, ledit contenant comprenant un corps sensiblement cylindrique (2) avec un fond fermé (3) et un dessus (4) qui présente une ouverture de remplissage ainsi qu'un dispositif de filtration (15) qui peuvent coulisser à l'intérieur du contenant (1), et des moyens (35, 36, 39, 40, 42) destinés à fixer de manière libérable le dispositif de filtration (15) adjacent au fond (3) du contenant (1), l'ouverture de remplissage étant fermée par une membrane pénétrable (13), caractérisé en ce que le dispositif de filtration (15) comprend une maille sensiblement plane (16) qui fournit une surface de collecte du produit sanguin au cours de la centrifugation, et un corps flottant de support (18), destiné à relever le produit sanguin collecté au-dessus de la maille du dispositif de filtration, ou sur celle-ci, jusqu'à la surface du liquide dans le contenant au cours de la centrifugation du contenant.
     
    2. Contenant selon la revendication précédente, caractérisé en ce que la maille sensiblement plane (16) du dispositif de filtration (15) présente une jupe qui s'étend vers le bas (17), et le corps flottant (18) est une capsule fermée, qui est reçue dans la cavité définie par la jupe (17), et en ce que des moyens d'espacement (22, 23, 24, 25, 26) sont prévus de façon à fixer la capsule (18) à une certaine distance du fond de la maille (16) et de la surface intérieure de la jupe (17).
     
    3. Contenant selon la revendication 3, caractérisé en ce que les moyens d'espacement (24, 25 et 26) entre la maille (16) et le corps flottant (18) sont des nervures ou des tiges qui s'étendent de manière radiale au niveau de la surface inférieure de la maille (16).
     
    4. Contenant selon la revendication 3 ou la revendication 4, caractérisé en ce que les moyens d'espacement (22, 23) entre le corps flottant (18) et la jupe (17) sont des saillies au niveau de la face latérale du corps flottant (18), et sont formés avec des distances réparties de manière égale les uns par rapport aux autres le long de la circonférence du corps flottant (18).
     
    5. Contenant selon la revendication 3, caractérisé en ce que la capsule qui forme le corps flottant (18) est constituée de deux cuvettes à fond plat (19, 20) qui viennent en prise l'une avec l'autre de façon emboîtée avec les fonds qui se font face en s'éloignant l'un de l'autre, des moyens de scellage étant prévus de façon à sceller ensemble de manière étanche les deux cuvettes (19 et 20).
     
    6. Contenant selon l'une quelconque des revendications 3 à 6, caractérisé en ce que le long de la périphérie, la jupe (17) du dispositif de filtration (15) présente un certain nombre de rabats flexibles (27) disposés de manière espacée, chacun d'eux présentant une saillie radiale (30) destinée à interagir par frottement avec la face intérieure du contenant (1).
     
    7. Contenant selon l'une quelconque des revendications 1 à 7, caractérisé en ce que le contenant (1) avec le fond (3) et un dessus (4), présente une forme symétrique en rotation autour de l'axe longitudinal du corps cylindrique (2), et en ce que le dessus (4) et le corps cylindrique (2) y compris le fond (3), sont des pièces formées de manière séparée, lesdites pièces étant adaptées de façon à être accouplées avec un ajustement sans jeu.
     
    8. Contenant selon la revendication 3, caractérisé en ce que la maille du dispositif de filtration (15) et la jupe (17) sont formées d'une pièce.
     
    9. Contenant selon l'une quelconque des revendications 1 à 9, dans lequel le corps cylindrique (2) au moins du contenant est réalisé dans un matériau flexible de manière élastique, caractérisé en ce que les moyens de fixation libérable du dispositif de filtration (15) adjacents au fond (3) du contenant (1) comprennent deux coupelles (35, 36) adaptées de façon à être insérées l'une dans l'autre, leurs ouverture faisant face à la même direction, et dans lequel la coupelle intérieure (35) est dotée de trous (37, 38) destinés à recevoir une broche de serrage respective qui peut coulisser (39, 40, 42), qui s'étend de manière radiale vers l'intérieur, les extrémités les plus extérieures des broches de serrage (39, 40, 42) étant adaptées de façon à coopérer à la façon d'un galet de came avec le bord (41) de la coupelle extérieure (36) lorsque les coupelles (35, 36) sont insérées l'une dans l'autre, tandis que les extrémités les plus intérieures des broches de serrage (39, 40, 42) sont adaptées de façon à presser la paroi du contenant de manière radiale vers l'intérieur lors du placement du récipient (1) avec le dispositif de filtration (15) dans la coupelle intérieure (35), et fixent de ce fait le dispositif de filtration (15) à proximité immédiate du fond (3) du contenant (1) jusqu'à ce que les deux coupelles (35, 36) soient retirées de nouveau l'une de l'autre.
     
    10. Contenant selon la revendication 10, caractérisé en ce que les broches de serrage (42) sont préchargées par ressort dans une position extérieure quand on regarde de manière radiale, dans lequel leurs extrémités intérieures sont de niveau avec la face intérieure de la coupelle intérieure (35).
     
    11. Contenant selon la revendication 10 ou la revendication 11, caractérisé en ce que la coupelle extérieure (36) est adaptée de façon à être une partie fixe d'un support de réception du contenant (1) au cours de la centrifugation, et en ce que les coupelles (35, 36) s'emboîtent sous l'influence de la force centrifuge au cours de la centrifugation.
     
    12. Contenant selon l'une quelconque des revendications 10 à 12, caractérisé en ce que des moyens formant ressort (54) sont prévus entre les deux coupelles (35, 36) de façon à les éloigner l'une de l'autre de manière automatique lors de l'arrêt de la centrifugation.
     
    13. Contenant selon l'une quelconque des revendications 10 à 13, caractérisé en ce que la paroi intérieure de la coupelle extérieure (36) ou en ce que la paroi extérieure de la coupelle intérieure (35) est dotée d'une rainure (49) au moins destinée à coopérer avec une broche de guidage (50) située sur la coupelle intérieure (35), de telle sorte que la coupelle intérieure (35) soit tournée d'une première distance au cours d'un déplacement d'emboîtement des coupelles (35, 36) et d'un déplacement ultérieur des coupelles dans une direction en s'éloignant l'une de l'autre de nouveau au cours d'une première phase de centrifugation, et soit tournée d'une seconde distance au cours d'un second déplacement d'emboîtement au cours d'une phase ultérieure de centrifugation, et en ce que, à la fin, les broches de serrage (42) sont placées à l'opposé de leur rainure (51) dans la coupelle extérieure (36), de telle sorte qu'elles soient libérées et restent inchangées au cours d'une centrifugation continue du contenant (1).
     
    14. Contenant selon l'une quelconque des revendications 1 à 14, caractérisé en ce qu'à un niveau au-dessus de la maille (16), le dispositif de filtration (15) porte des moyens de renforcement qui peuvent être facilement libérés (34) du produit sanguin.
     




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    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description