Abstract:
A process for treating the hemorrhage fluids of a patient at the time of a surgical procedure with the aim of carrying out an autotransfusion, includes a stage for recovering the hemorrhage fluids with simultaneous introduction of agents such as anticoagulant and/or diluting agents, at least one stage for the mechanical separation/concentration of this hemodiluted hemorrhage fluid in order to concentrate its content in red blood cells and partially purify it, this phase being collected in a sterile manner so as to be fit for injecting back to the patient. Also described is the related device.

Description:
BACKGROUND OF THE INVENTION 
   The present invention covers an autotransfusion process and an autotransfuser device with separation of aqueous and blood phase and removable bags. 
   A highly performing single use autotransfuser device is known and has been the object of an application for a French patent under No 2 600 537. 
   Such an autotransfuser device is particularly useful in certain circumstances when known hospital procedures are inappropriate. It is well recognized that in case of a delicate surgical procedure, whether due to length or high risk of haemorrhage, practitioners organize for appropriate quantities of blood. 
   This type of practice is admissible for planned procedures, in medically equipped sites, and close to properly supplied blood banks. 
   Nevertheless, one can remark on the high cost and sometimes difficult supply especially for some more specific blood groups. Moreover, once the blood has been delivered, stocks unused during the procedure cannot be kept for long, presently not beyond 35 days, thus requiring the proper management of dates and generating heavy administrative constraints for medical centres whose vocation this is not. 
   It is also known that in some countries, it is difficult in the case of a blood transfusion to have any certainties as to the quality and purification_of the blood, which puts transfused patients at risk. There could in particular be potential contamination with HIV virus, hepatitis, tuberculosis or syphilis, as well as with undetected or undetectable pathogens such as non conventional pathogens. 
   Moreover, in case of transfusion, it is more judicious to recover and transfuse back at least part of an individual&#39;s own blood, with his or her antibodies and all of his or her other molecules, rather than injecting him or her with blood from a blood bank. 
   There are also other situations, especially natural disasters or war situations, when the supply of blood is made impossible by the actual quantities required. Autotransfusion then remains the only solution. 
   Some populations do not accept to be transfused with blood from another person for religious reasons, personal convictions or other reasons. Once again, in such cases autotransfusion is the only way of saving lives. 
   It is necessary to recall as well that in the case of accidents, the time available for intervention can be very short and in such short intervals, supply from a blood bank is extremely difficult not to say impossible, especially so in countries without the organizations or structures for collecting, controlling and implementing blood transfusion. In such cases, autotransfusion with the recovery of haemorrhage blood represents an option which is immediately available. 
   It is necessary to distinguish two special applications, the first one intra operative and the second post operative, some procedures being concerned by both applications, with an autotransfusion during the procedure which is continued after the procedure through the recovery of the haemorrhaged blood with an outside drain, usually during the 6 hours following the procedure.
         In the case of the intra operative transfusion, it is necessary to be able to reinject the recovered blood directly to the patient, almost in continuous mode. As is known, this blood must necessarily be diluted when collected and anti-coagulant products must be added in order to preserve its transfusional quality.       

   These actions seem necessary because when using a vector liquid for the haemorrhage blood recovered, the red blood cells can thus be protected from direct physical traumas when coming into mechanical contact with filters and other tubing. This dilution in a vector liquid also reduces the contact of red blood cells with air thus restricting their haemolysis significantly. The recovered blood must then be reinjected into the patient&#39;s body but there are some major issues to be faced. 
   In the case of over diluted blood one may cause hypervolemia phenomena due to these overly important transfused liquids and hypocoagulability due to the transfusion of an excess of anti-coagulant products. 
   In order to avoid this occurrence, it is necessary to use extremely complex and expensive equipment to extract the haemodilution liquids, called washing/centrifugal machines. 
   Moreover, when carrying out an autotransfusion with blood that has been extracted directly and only diluted and complemented with anti-coagulant products, there is a risk of injecting activated or degraded biological substances likely to produce side effects. On might find histamines, kallicreins or kinins, more or less degraded plasma factors, which it is better to remove or else small proteins issued from cell traumas. 
   SUMMARY OF THE INVENTION 
   Intra operatively, the process of this invention thus consists in recovering the blood, diluting it and injecting it with anti-coagulant products simultaneously at the time of collection and in proportion with the quantity collected and then filtering it and separating the liquid phase from that containing the red blood cells thus enabling on the one hand a concentration of the latter phase to be reinjected and on the other hand a recovery of the liquid phase to be eliminated.
         for a post operative intervention, the blood is collected directly with a drain and the liquid thus running is not processed in any way, whether by dilution or addition of anticoagulant products, as in this case it is obviously ready for reinjection provided the collection is carried out under sterile conditions.       

   This invention proposes a single use device which enables an implementation in intra or post operative conditions, independently, and also the use of the same device in the case of a procedure requiring a continuation of the autotransfusion process from the intra operative into the postoperative stage. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The procedure and the associated device are now described in details in a specific, non restrictive implementation, with reference to the accompanying drawings, in which: 
       FIG. 1  is a view of the complete device, equipped with its per operative layer; 
       FIG. 2  is a detailed perspective view of the means for separating/concentrating and of the means for recovering the red blood cells on one side and the haemodilution and anti-coagulant liquids on the other, 
       FIG. 3  is a view of the postoperative layer of the device. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1  represents the means  10  for collecting a patient&#39;s blood during a procedure, with the base  12  of the device subject of this invention and a removable head  14  employed for intra operative use according to the invention. 
   The means  10  used for collecting the blood are known per se and are composed of a suction cannula  16  for haemorrhage blood, integrated means  18  for dosage of diluting and anti-coagulant agents  20  and an evacuation tube  22 . 
   The means  28  for dosage enable the continuous addition of the required quantity of diluting and anticoagulant agents  20  in proportion to the blood volume collected. 
   The evacuation tube  22  is connected to a connection piece  24  at the top of the removable head  14 . 
   This connection piece leads to a filter  26 , with a 40 μm mesh to give an idea. 
   This filter  26  is affixed to the top part of the head  14 . 
   This filter is placed above a funnel-shaped collector  28  with an outlet  30 . 
   A separation/concentration filter  32  is mounted on this outlet by means of its admission tube  34 . 
   This separation/concentration filter  32  is equipped with a first outlet  36  and a second outlet  38 . The membrane of this filter, made up of a polymer or of cellulose, is hydrophilic and has a porosity of around 0.5 to 5 μm. 
     FIG. 2  usefully shows that the separation/concentration filter is a flexible pouch integrating a membrane  M  that divides it into two chambers, V 1  and V 2 . 
   This membrane is able to retain red blood cells in chamber V 1  on the inlet side and let other liquids flow through to chamber V 2 . 
   For this reason, the first outlet  36  is connected to chamber V 1  in its lower part thus enabling the evacuation of concentrated red blood cells that can represent between 50 and 60% of the volume, associated with a fraction of the liquids. 
   The first outlet  36  is equipped with an opening and closing system  40 . 
   The second outlet is connected to volume V 2 . 
   This second outlet is mounted on a penetrative connection piece  42 . This connection piece  42  is connected to a connection piece  44  mounted on means  46  for collecting liquids  48 , in this case a flexible pouch. This flexible pouch can contain a large volume even though its size has been reduced on the drawings for practical purposes. It must be able to receive any excess haemodilution liquid recovered through filter  32  during a procedure, and not require to be substituted. 
   These means  46  for collecting liquids are equipped with a suction connection piece  50  which can be fitted with a vacuum source. 
   The first outlet  36  is connected via an inlet connection piece  52  to collection means  54  for the concentrated blood fraction. These means  54  are in fact a flexible pouch. The inlet connection piece  52  is equipped with a connection which enables simultaneous removal of the pouch and sealing of the said pouch so as to prevent any blood leakage and/or prevent the contact of the concentrated blood fraction contained in the collection means  54  with open air. 
   Such a pouch, according to this invention, includes a cap with two inverted threads so that when part of the cap is screwed to seal the pouch the very rotation of the cap triggers the disconnection of the connection piece on which it was initially screwed. The pouch remains immobile during this rotating manoeuvre. 
   Base  12  is also equipped with a connection piece  56  fitted with a valve to break the vacuum inside the base. 
   This base is also equipped with a connection piece  58  which enables the creation of vacuum inside the base. This connection piece is controlled via opening/closing means  60  connected to a vacuum source. 
   The head  14  is also equipped with a device for the creation of vacuum in its inner chamber with a connection piece  62  at the top of head  14 , themselves connected to opening/closing means  60  connected to a vacuum source 
   The common vacuum source is connected to an interface  66  placed between base  12  and head  14 . This interface is tightly joined to base  12  and head  14 . This interface  66  is equipped with a gasket for base  12  and a gasket for head  14  as well as with mechanical and removable attachment means  68  to link it with the same base and head. 
   This interface is fitted with a unique multifunction control  70  that enables a gathering of opening/closing means  40 ,  60 , and  64 . In the implementation represented, this control is composed of a duct  72  equipped with a piston fitted with connection pieces, internal ways and appropriate seals, not shown yet in the reach of the man skilled in the art who knows the functionalities required and described above. This piston can be manoeuvred from the outside of the device with a knob  74  showing the necessary indications and markings. It is also connected via a connection piece  76  to a general vacuum source that can be identical to the one used for other needs. 
   The functioning of the device just described above, is now described in intra-operative use. 
   The device is connected to a vacuum source via connection piece  76 . A pouch  54  is placed inside base  12 . This pouch is sterile and connected tightly in a way that enables later disconnection and automatic sterile sealing. 
   In parallel, a flexible pouch  46  is also connected to connection piece  44 , without the requirement for a sterile environment as the fluids recovered are meant to be destroyed. Nevertheless, for practical aseptic, handling reasons, this pouch may also be equipped with a cap identical to that of pouch  54 , a cap that enables the sealing of the pouch while simultaneously disconnecting the connection piece to which it is initially screwed. 
   Connection piece  56  is closed. Knob  74  is manoeuvred into a position that will create a vacuum in base  12  and head  14  through connection piece  62 . 
   Pouch  46  is also connected to a vacuum source via its connection piece  50 . This module is symbolized theoretically, and thus simplified, yet in practice, as it is a flexible pouch, it is necessary to place it in a vessel where depression is created in the same way as for base  12 . This enables a separation of the walls of the pouch and generates a vacuum in the pouch thus ensuring that it fills up instead of the walls of said pouch sticking to each other. 
   The practitioner proceeds with the suction of the fluids flowing from the patient with cannula  16 . 
   At the same time, one or more anti-coagulant agents and one or more diluting agents enable a processing of the fluids so as to avoid the degradation of red blood cells. 
   With the depression, liquids are sucked in by head  14  and flow through connection piece  24  and filter  26  which is able to retain the largest particles, beyond 40 μm. 
   The filtrate, sucked in by the depression in head  14 , is collected in collector  28  before flowing through separation/concentration filter  32 . 
   The red blood cells and a fraction of the liquids are retained by the membrane of this filter and directed, due to the depression generated in base  12 , towards pouch  54 . 
   Filtrate  48 , which comes from separation/concentration filter  32 , which has an average porosity lower than 5 μm, is sucked into pouch  46  because of the depression in said pouch. This filtrate  48  is free of red blood cells. 
   When pouch  54 , which contains the haemodiluted and concentrated blood is full, the knob, activated in the appropriate way, enables to maintain vacuum in head  14  while interrupting the vacuum in base  12 . 
   The depression is also maintained in collection pouch  46 . The vacuum in the base is interrupted through manoeuvring connection piece  56 . 
   The mechanical means for fitting head  14  to the top part of interface  66 , on the one hand, and for fitting base  12  to the lower part of this interface  66 , on the other, make it possible to separate said head and base. 
   The manoeuvre of connexion  52  on collection pouch  54  makes it possible to close this first pouch and remove it and to immediately replace it with another pouch if necessary. 
   The head is once again fitted to base  12  and, by moving knob  74 , base  12  can be depressed again after the appropriate manoeuvre of connection piece  56  in closing position. 
   Collector  28  holds a buffer position during this pouch-substitution operation without any interruption for the practitioner. 
   The pouch containing the concentrated blood can be kept or used immediately for transfusing the blood thus collected to the patient during the procedure, as the blood is perfectly appropriate for this transfusion. One notes that this blood is concentrated and avoids the side effects encountered with previous devices. 
   Moreover this concentrated blood brings in a cell stock which increases the oxygenation potential of the tissues of the patient&#39;s body. 
   The present invention also plans for a head for drainage and recovery of haemorrhage blood in the postoperative stage. 
   The elements common to both stages bear the same reference while the new parts are identified by the addition of 100 to the reference number. 
   In post operative situation, the practitioner has placed a drain to recover haemorrhage blood which is very good quality blood. This blood, which is not subject to coagulation does not require any specific processing except for a filtration through a filter with an average porosity below 40 μm. We know that the volumes collected can vary between 0.5 and 2 litres which is very significant for a patient after an operation. 
   The blood thus collected, provided it is collected under appropriate aseptic conditions, can be directly injected back to the patient. 
   In this case, the device represented on  FIG. 3  includes an identical base  12 , an identical interface  66  and a different head  114 . 
   This head  114  only includes a filter  126  with a mesh of about 40 μm. 
   Connection piece  162  used to create vacuum in head  114  is retained, still connected by a connection piece  64  to means for opening and closing via the single multifunction control. 
   Under the filter, a collector  128  is also fitted and runs, via connection piece  130 , and through interface  66 , directly into base  12 , through connection piece  52  whose opening and closing are also controlled by the single multifunction control. The separation/concentration filter is eliminated. 
   As in the previous case, connection piece  52  receives collection means  54 , in this case a flexible pouch. 
   Connection piece  42  is also eliminated on the head since there are no more means for collecting liquids: as no addition is carried out there is no concentration to effect. 
   Head  114  is of course fitted with a connection piece  124  to enable its connection to the drain. 
   The pouch of collection means  54  can be removed to inject back its content as in the previous case. 
   The depression in head  114  is maintained to recover the fluids from the drain while the vacuum in the base is broken by a manoeuvre at the level of connection piece  56 , after manipulating knob  74  in order to interrupt the depression in base  12 . 
   The pouch is simultaneously removed and closed. 
   A new pouch is positioned and, with connection piece  56  closed, the new depression in the base triggers the filling in of the new pouch. 
   As previously, one notes that the collector and part of the volume of the head enable to ensure a buffer function and the continuous collection of fluids from the drain while the pouch in base  12  is being changed. 
   The time for collecting this haemorrhage blood cannot exceed 6 hours after the operation. 
   It is now possible to recap on the numerous advantages of this device. 
   One notes that the general architecture enables a standardisation of the various modules, i.e. base  12  and interface  66 , which are common, as well as both heads,  14  for the intra operative system and  114  for the post operative one. 
   These four modules make it possible to respond to many situations. 
   In the intra operative phase, the device enables a new implementation which is the ongoing processing of the blood to enable its immediate transfusion to the patient. 
   From a medical point of view, such a device avoids hypo-coagulability syndromes due to transfusion of excess quantities of anti-coagulant agents, as well as reducing the transfusion of activated or degraded biological substances likely to generate side effects. Moreover, the blood thus injected back after concentration contributes to the input of a cell stock which increases the oxygenation potential of the tissues of the patient&#39;s organism. 
   The invention authorizes the recovery of pouches containing collected blood or drained fluids in the best conditions, as they are filled, for immediate use, and this without ever interrupting the operation of the device. 
   The recovery of residual fluids from the concentration stage in the intra operative phase is also carried out directly in flexible pouch-type containers without any manipulation, checking or soiling of any kind. 
   The device remains compact despite its numerous functionalities which is an asset in a medical environment. 
   The manipulation with only one single multifunction knob is extremely simple and prevents any error of handling as can happen when several pieces must be manipulated, and in a given order, when there are other more important actions to be carried out at the same time. This eliminates the stress related to the use of such a device, thus enabling the staff to focus on simultaneous or complementary actions. 
   This device can be improved even more with the integration of an additional filter to remove the leukocytes from the blood which comes from the first 40 μm filter. In this case, such a leukocyte depleting filter is fitted to outlet  36  of separation/concentration filter  32  for the intra operative head and/or to outlet  130  in the case of postoperative head  114 . 
   For the present invention, apart from being fitted with a connection piece which ensures simultaneous sealing upon removal, the recovery pouch can also feature an outlet with a seal to be perforated at time of use.