Abstract:
The invention relates to a method and apparatus for the automatic handling of bag systems in an installation. The method includes the steps of loading at least one bag system having a primary bag containing a body fluid such as blood and a secondary bag into a handling device, wherein the bag system is placed in a position such that no filtering of the body fluid takes place; automatically actuating the handling device so that the bag system is moved to a position wherein filtering occurs; and unloading the bag system from in the handling device when all the filtrate is received in the secondary bag.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a U.S. National Stage of PCT International Patent Application PCT/FR01/02602 filed Aug. 10, 2001, which claims priority from French Application No. FR 00 10534 dated Aug. 10, 2000. 
    
    
     FIELD OF THE INVENTION 
     The invention concerns an automatic handling system for at least one bag system in an installation and the said installation. 
     It applies typically to the case where a fluid, particularly a body fluid, such as blood or a blood component has to be filtered after being collected in the primary bag of a bag system. 
     Accordingly, the bag system comprises, in addition to the primary bag and connected to it in series by means of tubes, at least one filtration unit and at least one secondary bag intended to collect the filtrate. 
     BACKGROUND OF THE INVENTION 
     Filtration by handling, particularly by homogenizing the contents of the primary bag and by turning it manually, the bag system so that the fluid flows from the primary bag to the secondary bag by gravity through the filtration unit is known. 
     But where a large number of such bag systems have to be handled, this method is very time-consuming. 
     Furthermore, in the field of the filtration of blood, the time between the collection of blood and its filtration must be monitored accurately to ensure that the filtrate is of high quality. 
     The manual method described above does not provide for such accurate monitoring, particularly for a large number of bag systems. 
     In addition, human intervention is a source of errors and does not allow for satisfactory traceability of bag systems and their contents, particularly in terms of the time between collection and filtration and in terms of filtration time. 
     SUMMARY OF THE INVENTION 
     The invention is therefore intended to overcome these disadvantages by providing a bag system handling process in an installation which is compact in terms of the number of systems handled, in which human intervention is limited to loading and unloading bag systems before and after filtration respectively and in which bag systems are handled automatically, thus providing for the monitoring of the time between collection and filtration of the fluid. 
     Accordingly, and according to one aspect, the invention provides a automatic handling process for at least one bag system in an installation; the said bag system comprising at least one primary bag containing a fluid, particularly a body fluid, for example blood or a blood component, at least one filtration unit and at least one secondary bag to collect the filtrate, the said process comprising the following steps:
         loading at least one bag system into a handling device, the said bag system being in a position such that filtration of the fluid does not occur;   automatic activation of the handling device so that the bag system is handled to a position in which the fluid flows from the primary bag to the secondary bag passing through the filtration unit, to filter the fluid at a pre-determined time;   unloading the bag system in the handling device when the filtrate has been collected in the secondary bag.       

     According to one embodiment, the process includes, prior to the activation of the handling device, a storage step for the bag system associated with the said device for a pre-determined time. For example, the storage step is performed by transferring the bag system associated with the said handling device to a first storage area. 
     According to one embodiment, the step of activation of the handling device is preceded by a step during which the contents of the bag system are agitated, particularly that of the primary bag. For example, the agitation step may be performed by partial activation of the handling device. 
     According to one embodiment, the process includes, after the activation of the handling device, a step for storing in the bag system associated with the said device for the time required to filter almost all the fluid. For example, the storage step is performed by transferring the bag system associated with the said handling device to a second storage area. 
     As a variant, the end of the storage step is controlled by means for detecting the end of filtration. 
     According to one embodiment, the process also includes one or more steps of identification of the bag system and/or handling device in the installation. For example, the identification step includes the reading and/or recording of data concerning the handling device, the bag system, the contents of the primary bag and the personnel that used the bag system. 
     As a variant, the data are contained in an electronic device associated with the handling device and/or the bag system, the various steps being controlled as a function of data read during the identification step. 
     As a variant, an identification step is performed when loading the bag system into the installation to read, in particular, data concerning the contents of the primary bag, the time for the activation of the handling device may be controlled as a function of data read during the identification step and, in particular, according to the sampling time. In addition, the activation of the handling device may also be controlled as a function of the temperature of the fluid to be filtered. 
     As a variant, an identification step is performed when unloading the bag system, particularly to record data concerning the filtration. 
     According to one embodiment, a plurality of bag systems are handled in the same handling device; for example, between 10 and 30 bag systems and multiple bag systems are handled in the same installation at the same time. For example, between 500 and 5000 bag systems. 
     According to a second aspect, the invention provides an installation to implement the process described above, which includes:
         a handling device capable of receiving at least one bag system,   means of activation capable of activating the handling device from a position in which the fluid in the associated bag system is not filtered to a position in which filtration occurs;   an area for loading the bag system into the handling device;   an area for unloading the bag system associated with the handling device;   an area for activating the handling device in which activation means are provided;
 
the said installation comprising at least one, main, motorized running track along which the handling device is moved from the loading area to the unloading area, through the activation area, and at least one unit for controlling the movements of the handling device.
       

     According to one variant, the loading and unloading areas are the same. 
     According to one embodiment, the installation further comprises a first and a second storage areas, in which the bag system associated with the handling device is stored before and after filtration respectively. In this case, the storage areas may be formed by at least one section of the secondary, motorized running track. 
     According to one embodiment, the installation also comprises an area for the agitation of the contents of the bag system, the said agitation area being fitted with agitation means. For example, the agitation area is identical to the area for the activation of the handling device and the activation means are also agitation means. 
     According to variants, the installation may also include:
         means for detecting the completion of filtration, the said detection means being connected to the control unit;   means for identification of the bag system and/or the handling device capable of reading and/or writing data from into the electronic device associated with the said bag system, the said means of identification being connected to the control unit.   Means for determining the temperature of the fluid to be filtered, the said determination means being connected to the control unit,       

    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other purposes and advantages of the invention shall appear during the description below, with reference to the drawings appended. 
         FIG. 1  shows a top view in diagrammatic form of the fixed structure of an automatic handling installation according to the invention, including a main, motorized running track, which is a closed loop and nine sections of secondary, motorized track, which are laid perpendicular to the longest section of the said loop. 
         FIG. 2  shows a side view in diagrammatic form of an embodiment of a handling device for ten bag systems, each comprising a primary bag, a filtration unit and a secondary bag, the said device being suspended from the main running track. 
         FIG. 3  is a profile view of the handling device shown in FIG.  2 . 
         FIG. 4  shows a side view in diagrammatic form of two handling devices similar to those shown in FIG.  2  and which move together, one behind the other, on the main running track. 
         FIG. 5  shows a side view in diagrammatic form of five handling devices similar to that shown in  FIG. 2 , on a section of secondary track forming the storage area. 
         FIG. 6  shows a top view in diagrammatic form of an embodiment of the means to agitate the contents of the bag system associated with a handling device according to FIG.  2 . 
         FIGS. 7   a  to  7   c  show side views in diagrammatic form of an embodiment of activation means capable of activating a handling device according to  FIG. 2 , from a position in which the fluid in the associated bag system is not filtered to a position in which the fluid is filtered, and three steps of this operation. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     An automatic handling installation according to the invention includes a fixed structure  1  and handling devices  2 , in which the bag systems  3  are held. 
     The handling devices  2  are associated with the fixed structure  1  so that they may be moved along the said structure  1  on the one hand and, activated to filter the fluid on the other hand. 
     In the embodiment shown in the figures, the handling devices  2  are transferred along the fixed structure  1  overhead, that is the handling devices  2  are suspended from the fixed structure  1  without touching the floor  4  on which the fixed structure  1  is installed. 
     However, another form of transfer is possible, particularly by placing the handling devices  2  on a conveyor, for example of the endless belt type, or by ensuring that the handling devices  2  can be moved on the ground, by means of wheels for example. 
     The fixed structure  1  shown in  FIGS. 1 and 2  in particular, includes two types of rail, the first of which  5  is installed substantially over the second one  6 . The two types of rails  5 ,  6  are combined at a given distance from each other and are supported by a carrier structure  7 . The first type of rail  5  is intended to allow for the driving of handling devices  2 , it is therefore known as the “tractor”, whereas the second type  6 , is intended to support the handling devices  2  suspended from it, and is therefore known as the “carrier”. 
     The rails of the first and second types  5 ,  6  are, for example, made of steel or similar, so as to be capable of withstanding the forces set up by the weight and movement of the handling devices  2 . The rails  5 ,  6  are either straight or curved and are welded together for example, to form running and drive tracks for the handling devices  2 . 
     In the embodiment shown in  FIG. 1 , the fixed structure  1  includes a main motorized running track  8 , which is a closed loop and nine sections of secondary motorized track  9 , which are placed substantially perpendicularly to the longest section of the said loop. 
     The fixed structure  1  is maintained at a height greater than that of the handling devices  2  by means of posts  10  mounted in the floor  4 , so that the said devices  2  can move freely without touching the floor  4 . 
     Although this embodiment is not described specifically here, the fixed structure  1  may include more than one main track  8  and a different number of secondary tracks  9 , which may be laid out differently in relation to each other. 
     In fact, those skilled in the art may adjust the architecture of the fixed structure  1  according to its specific constraints and, in particular, the number of handling devices  2 , the nature of the fluids to be filtered, the presence of storage areas and the location for the installation. 
     In the embodiment described, the handling devices  2  moving on the main track  8  may be diverted by means of a switching system  11  to one of the secondary tracks  9  and vice versa. 
     Accordingly, a switching system  11  is provided at each intersection between a secondary track  9  and the main track  8 ; that is, at the end of each of the secondary tracks  9 . 
     The drive of the main running track  8  and secondary tracks  10  in the form of a drive device combined with the tractor rail  5  is described hereinunder. 
     In the embodiment shown in  FIG. 2 , this device includes a closed loop cable  12  which is driven in translation in parallel to the tractor rail  5 , by means of a motor  13 . 
     Accordingly, the main track  8  comprises a motor-driven pulley  14  and three idler pulleys  15  and each of the secondary tracks  9  comprises a motor-driven pulley  14  and an idler pulley  15 . In this case, the movement of the handling devices  2  along the main track  8  is circular whilst that along a secondary track  9  is linear between two points on the main track  8  respectively, in the direction shown by the arrows in FIG.  1 . 
     Mobiles  16  are fixed on to the cable  12  so that they are moved by it. The mobiles  16  comprise wheels  17 , which are laid in the groove  18  of the tractor rail  5  so that the mobile  16  is guided during its movements. In addition, the mobile  16  comprises gripping means  19  extending towards the carrier rail  6  and which are capable of engaging an additional part associated with a handling device  2  to transfer the movement of the cable  12  of the said device  2 . 
     As shown in  FIG. 2  in particular, the gripping means  19  consist of folding fingers  20  which are activated from a position in which they engage in a dog point  21  of a handling device  2  to a position in which they are disengaged and vice versa. 
     The gripping means  19  may be activated by a system of cams (not shown) which is supported by a moving part thus enabling the folding fingers  20  to move so that they engage/disengage in dog point  21 . 
     In this example, the switching systems  11  include systems of cams to engage/disengage the dog points  21  of the handling devices  2  of the main running track  8  when changing track. 
     The number and/or position of the mobiles  16  on the cable  12  is defined particularly depending on the number of handling devices  2  and the type of movements required. For example, the mobiles  16  may be arranged equidistant from each other so that the distance between two successive devices  2  is defined and fixed. This distance may be different depending on the tracks concerned, particularly that between the main track  8  and the secondary tracks  9 . 
     An embodiment of a handling device  2  according to the invention is described below, in reference to  FIGS. 2 and 3  in particular. 
     The handling device  2  comprises a frame made up of three cross members made of steel or similar, for example top  22 , left  23  and right  24  cross members respectively, forming three sides of a rectangle. 
     Two hangers  25 ,  26  are secured to the outer face of the top cross member  22  to allow for the attachment of the handling device  2  on the carrier rail  6  of the fixed structure  1 . 
     Accordingly, the end of the hangers opposite the upper cross member  22  is fitted with wheels  27  which are engaged in groove  28  of the carrier rail  6  to guide the movements of the handling device  2 . 
     A dog point  21  is installed on one of the hangers  26  near the wheels  27  and projects from the groove  28  of the carrier rail  6 , to enable it to engage in the gripping means  19  of the mobile  16 , as described above. 
     In the embodiment, the hanger  26  comprising the dog point  21  is therefore active in terms of the movement of the handling device  2  whilst the other hanger  25  is passive. 
     Nevertheless a different number of active and/or passive hangers  25 , 26  may be provided. 
     Within this framework and associated with the left cross member  23  on the one hand and the right cross member  24  on the other hand, two rotating shafts  29 , 30  are provided. The two shafts  29 , 30  are substantially parallel and spaced at a distance D apart. 
     Each end of the shafts  29 , 30  is fitted with a toothed wheel  31  capable of being fitted with a chain  32  to control the rotation of each of the two shafts  29 , 30 . Although the embodiment described comprises two chains  32  and four toothed wheels  31 , only one chain  32  and two toothed wheels  31  may be provided or another device to control the rotation of the two shafts  29 , 30  may be devised by those skilled in the art. 
     Each of the shafts  29 , 30  comprises means of attachment  33  for the bag systems  3 . For example, the bags of a bag systems  3  conventionally include eyelets in which a hook forming the means of attachment  33  may be inserted. 
     In the embodiment shown, ten means of attachment  33  are provided on each shaft  29 , 30 , opposite each other, so as to be able to associate ten bag systems  3  in each handling device  2 . 
     The bag systems  1  comprise a primary bag containing fluid, particularly a body fluid, for example blood or a blood component, at least one filtration unit  35  and one secondary bag  36  to collect the filtrate, the bags  34 , 36  and the filtration unit  35  being connected to each other by tubes  37 . 
     In this case, the installation may be a closed circuit with filtration and collection of the filtered fluid being carried out when the handling device  2  is activated. 
     When loading the bag system  1 , the primary bag  34  is associated with the lower shaft  30  and the secondary bag  36  with the top shaft  29  by means of attachment means  33  (see FIG.  2 ). In this position, filtration of the fluid by gravity does not take place. 
     In the embodiment shown, the ten bag systems  3  are placed substantially in parallel to each other with their filtration unit  35  between the two shafts  29 , 30 ; the space defined between the two shafts  29 , 30  being empty. However, an endless belt may be provided to support the filtration units  35 . 
     The bag systems  3  may be identical and/or different, in particular, they may include other bags, other filtration units or any other devices required to treat the fluid before and/or after filtration. 
     In a special example, the primary bag  34  contains whole blood and the filtration unit  35  is capable of eliminating leucocytes. In this case, the bag system  3  may also include a first and a second satellite bags connected in series to the secondary bag. In this embodiment, the filtration is carried out in an installation according to the invention then, after unloading the bag system  3 , the secondary bag  36  is centrifuged to collect the red blood cell concentrate and the plasma in the first and secondary satellite bags respectively. 
     Depending on the nature and/or the geometry of the bag systems  3  to be installed in the handling devices  2 , the distance D may be adjustable, in particular, by providing adjustment means capable of having shafts  29  or  30  slide in relation to each other. 
     The operation of such a handling device  2  using a first jack  38  and a second jack  39 , of the pneumatic or rack and pinion type for example (see  FIG. 7   a  to  7   c ) is described below. 
     The jacks  38 , 39  are installed in an area of the installation, known as the activation area  40  of the handling device  2 , in which the gripping means  19  are disengaged so that the said device  3  cannot be moved. 
     The chains  32  are fitted with means forming sockets for the rod  42  of the jacks  38 , 39 , for example in the form of stops  41   a ,  41   b , which project from the handling device  2 . There are, for example, two stops  41   a ,  41   b  and they are installed on one of the chains  32 , at a distance approximately equal to D. 
       FIG. 7   a  shows the handling device  2  in a position in which the fluid is not filtered. In this position, the primary bag  34  is installed above the secondary bag  36  so that the fluid cannot flow between the two bags  34 ,  36  by gravity. 
     To activate the handling device  2 , the first jack  38  engages on the top stop  41   a  to move it over a distance of D, the second jack  39  being disengaged. 
     During this movement, the stop  41   a  drives the chain  32  and therefore the two shafts  29 ,  30  through toothed wheels  31  and therefore the associated bag systems  3 . The bag systems  3  are now in a position ( FIG. 7   b ) in which the primary bag  34  is above the secondary bag  36  so that the fluid flows and is therefore filtered by gravity. 
     In a third step, the first jack  38  is disengaged and the second jack  39  is engaged on the second stop  41   b . The first jack  38  is moved towards its initial position whilst the second jack  39  is moved to complete the turning of the bag systems  3  in the handling device  2  ( FIG. 7   c ). 
     A process using an installation according to the installation is described below. 
     In the example of use described, the motor  13  which drives the cable  12  of the main track  8  runs continuously so that the handling devices  2  which are engaged above it on mobiles  16  move at a constant speed. 
     However, this movement may be made at a non-constant speed and/or discontinuously by adjusting the speed of the motor  13 . 
     The use is described for a single handling device  2  related to the installation; it is understood that these steps are performed continuously and in parallel for a large number of handling devices  2  so that the installation provides for the processing of 500 to 5000 bag systems  3  simultaneously. 
     In a first step, the bag systems  3  are loaded into a handling device  2 . 
     Accordingly, an area  43  is provided in the installation to which the personnel responsible for loading has easy access and in which the handling device  2  to be loaded cannot be moved. 
     Such a loading area  43  may consist of a section of non motorized track on which the handling device  2  moving on the main track  8  is diverted. The mobile  16  which moves the handling device  2  on the main track  8  is disengaged by means of a switching system  11 . 
     The operator can then load the fixed handling device  2  with the bag systems  3  containing the fluid to be filtered, the said systems  3  being placed in a position in which filtration does not occur. 
     During this loading, a step to identify the bag systems  3  and/or the handling device  2  is performed. 
     Accordingly, the bag systems  3  and/or the handling device  2  may be fitted with an electronic device  44  capable of recording and/or generating data to monitor the bag system  3  and/or its contents. 
     The operator reads the data in the electronic devices  44  using a scanning device, the said scanning device being connected to a control unit  45  of the installation, consisting of an electronic controller for example. 
     Depending on the data read, the control unit  45  calculates the time and/or place of storage for the handling device  2  in the installation. 
     In particular, the data read concerning, in particular, the contents of the primary bag  34  and the time at which the primary bag was filled, that is the time the sample of fluid was taken. In fact, it is well known that a blood component should be filtered within a pre-determined time span after being collected. 
     Once loading and identification have been completed, the operator moves, manually for example, the handling device  2  to a second switching system  11 , which allows the said device  2  to be returned to the main track  8  by engaging a mobile  16  on the dog point  21  to move it along the said track  8 . 
     In this case, the handling device  2  is moved along the main track  8  towards the storage area  9  which has been determined by the control unit  45  (see FIG.  4 ). 
     When the handling device  2  arrives on the switching system  11  of the storage area  9  selected, the control unit  45  activates the said system  11  so that the handling device  2  is diverted to the secondary track  9  and the mobile  16  that moves it is disengaged. 
     The handling device  2  is now on the secondary track  9 , with other handling devices  2 , waiting to be activated (see FIG.  5 ). 
     It is understood that the control unit  45  adjusts the flow of handling devices  2  on the secondary tracks  9  so that they are disengaged in chronological order of activation. 
     The activation device  2  is also moved on the secondary storage track  9  by the mobiles  16  which engage and disengage on the dog point  21 . 
     In a special example, the motor  13  that drives the cable  12  of the secondary tracks  9  is activated discontinuously by the control unit  45  and according to storage/removal from storage requirements. 
     The removal of storage of the handling device  2  is controlled by the control unit  45 , particularly according to the time elapsed since sampling. 
     As a variant, means for measuring the temperature of the fluid (not shown) are provided in the storage area  9  to trigger removal from storage when the temperature of the fluid is within the optimum operating range of the filtration unit  35 . 
     The measuring means are, for example, of the infrared type and the optimum operating range is typically between 18° C. and 22° C. for the filtration of the whole blood. 
     During the removal from storage step, the handling device  2  is moved to a switching system  11  which enables the said device  2  to be returned to the main track  8  by engaging a mobile  16  above it to move it to an agitation area  46 . 
     In a first variant, the bag systems are agitated by a system of plates  47  operated by jacks  48  so that the bags  34 ,  36  are pressed alternatively (see FIG.  6 ). 
     In this variant, the handling device  2  is immobilized for example on a section of track parallel to the main track  8  and connected to it by switching systems  11 . Immobilization is carried out opposite to the plates  47  then the jacks  48  are activated so that the plates  47  are moved in translation with an oscillating movement, guide means  49  being provided to assist such movements. The plates  47  therefore press the bag systems  3 , and particularly the primary bags  34 , to put the various components of the fluid back into suspension. 
     The handling device  2  is then moved to an activation area  40  on the main track  8 . 
     In a second variant, the agitation area  46  and the activation area  40  are the same, with agitation being performed by partial activation of the handling device  2 . 
     In the activation area  40 , the device  2  is immobilized for example on a section of track parallel to the main track  8  and connected to it by switching systems  11 . Immobilization is Carried out opposite to the first and second jacks  38 ,  39 , which activate it as described above. 
     In the second variant and prior to complete activation, partial and alternating activation is performed to return the components of the fluid into suspension. 
     Accordingly, the jacks  38 ,  39  are of the double-acting type to ensure that the bag systems  3  are turned over partially several times, for example between the initial position and half the distance D, and vice versa. 
     Such partial activation should be performed over a distance so that the fluid does not enter the filtration unit  35  to avoid the start of filtration. 
     Once agitation and activation are complete, the handling device  2  is moved along the main track  8  to a secondary track  9  to be stored for the time required for the filtration of almost all the fluid. 
     Where the filtration time is short and/or the time for movement from the activation area  40  to the unloading area  50  is long, the second storage area may not be provided so that filtration takes place along the main track  8 . 
     When the second storage area is provided, it may be fitted with means to detect the completion of filtration (not shown) which since they are connected to the control unit  45 , control the exit of the device  2  from the second storage area. The device  2  is then moved along the main track  8  towards the unloading area  50 . 
     In addition, these determination means may be used to detect any problems during filtration, for example filtration that is too quick or too slow. 
     These determination means are, for example, of the optical type to detect the presence or absence of fluid in the tube  37  or to measure the thickness of bags  34 ,  36 . 
     Once filtration is complete, the handling device  2  is moved to the unloading area  50  which, in the embodiment shown in the figures, is the same as the loading area  43 . 
     The operator removes the bag systems  3  from the handling device  2  so that the filtered fluid may be used in a conventional way. 
     During this unloading step, the operator may also write data into the electronic device  44  of the bag systems  3  and/or the handling device  2 . 
     These different steps consisting in reading writing data ensure the traceability of the fluids treated, in particular, all data may be stored in a central unit connected to the control unit  45  of the installation to retain a trace of all operations performed. 
     In addition, the succession of operating steps and the management of the flow of handling devices  2  are performed automatically by the control unit  45  as a function of such data.