Autotransfusion method and autotransfusion device with phase separation and concentration, comprising removable bags
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.
1. A treatment device for processing haemorrhage fluids of a patient during or after a surgical procedure, comprising:
a head ( 14 , 114 ) including a means ( 26 , 126 , 32 ) for processing the haemorrhage fluid;
a base module, comprising a base ( 12 );
and a liaison interface ( 66 ) comprising a housing and a multifunction control housed within the housing, the housing being attachable to each of the head ( 14 , 114 ) and the base ( 12 ),
wherein the base ( 12 ) includes a means ( 54 ) for sterile collection of at least part of a liquid flowing from the head,
wherein the head ( 14 , 114 ) is removably mounted to the module to enable access to said collection means ( 54 ), and
wherein said multifunction control includes i) opening/closing means ( 40 ) of said base ( 12 ), ii) means for the connection of the base ( 12 ) to a vacuum source, and iii) means for connection of said at least one head ( 14 ) to the vacuum source.
2. The treatment device as in claim 1 , wherein the head is one of an intra operative head ( 14 ) and a post operative head ( 114 ), each of said intra operative head ( 14 ) and said post operative head ( 114 ) configured to mount on the liaison interface ( 66 ) of the base module.
3. The treatment device as in claim 2 , wherein the means for processing the haemorrhage fluids from intra operative head ( 14 ) are equipped with filtration means ( 26 ) and separation/concentration means ( 32 ) fitted with a first outlet ( 36 ) configured to evacuate red blood cells and a fraction of the liquids and a second outlet ( 38 ) connected to means ( 46 ) for collecting red blood cell-free liquids.
4. The treatment device as in claim 3 , wherein the means for collecting red blood cell-free liquids ( 48 ) comprise a pouch equipped with a vacuum unit ( 50 ).
5. The treatment device as in claim 4 , wherein the means ( 54 ) for sterile collection of at least part of the liquid flowing out of head ( 14 ) include a flexible pouch removably mounted on an inlet connection piece ( 52 ) fitted with a connection configured to be simultaneous sealed upon removal of said pouch in order to prevent any leakage of blood and/or any exposure of a content of said pouch to open air.
6. The treatment device as in claim 3 , wherein the separation/concentration means ( 32 ) include a flexible pouch including a membrane M for separating the flexible pouch into two chambers V 1 and V 2 , said membrane being configured to retain the red blood cells in chamber V 1 on the inlet side under a connection piece ( 34 ) and able to let other liquids flow towards chamber V 2 , the separation/concentration means ( 32 ) connected by connection pieces ( 42 , 44 ) to means ( 46 ) for collecting red blood cell-free liquids ( 48 ).
7. The treatment device as in claim 3 , wherein the means ( 54 ) for sterile collection of at least part of the liquid flowing out of head ( 14 ) include a flexible pouch removably mounted on an inlet connection piece ( 52 ) fitted with a connection configured to be simultaneous sealed upon removal of said pouch in order to prevent any leakage of blood and/or any exposure of a content of said pouch to open air.
8. The treatment device as in claim 3 , further comprising:
a filter configured for removing leukocytes placed in any of the intra operative head ( 14 ) the post operative head ( 114 ).
9. The treatment device as in claim 3 , further comprising:
a filter configured for removing leukocytes placed in any of the intra operative head ( 14 ) the post operative head ( 114 ).
10. The treatment device as in claim 3 , further comprising:
a filter configured for removing leukocytes placed in any of the intra operative head ( 14 ) the post operative head ( 114 ).
11. The treatment device as in claim 3 , further comprising:
a filter configured for removing leukocytes placed in any of the intra operative head ( 14 ) the post operative head ( 114 ).
12. The treatment device as in claim 2 , wherein the separation/concentration means ( 32 ) include a flexible pouch including a membrane M for separating the flexible pouch into two chambers V 1 and V 2 , said membrane being configured to retain the red blood cells in chamber V 1 on the inlet side under a connection piece ( 34 ) and configured to let other liquids flow towards chamber V 2 , the separation/concentration means ( 32 ) connected by connection pieces ( 42 , 44 ) to means ( 46 ) for collecting red blood cell-free liquids ( 48 ).
13. The treatment device as in claim 12 , wherein the means for collecting red blood cell-free liquids ( 48 ) comprises a pouch equipped with a vacuum unit ( 50 ).
14. The treatment device as in claim 12 , wherein the means ( 54 ) for sterile collection of at least part of the liquid flowing out of head ( 14 ) include a flexible pouch removably mounted on an inlet connection piece ( 52 ) fitted with a connection configured to be simultaneous sealed upon removal of said pouch in order to prevent any leakage of blood and/or any exposure of a content of said pouch to open air.
15. The treatment device as in claim 2 , wherein the means ( 54 ) for sterile collection of at least part of the liquid flowing out of head ( 14 ) include a flexible pouch removably mounted on an inlet connection piece ( 52 ) fitted with a connection configured to be simultaneous sealed upon removal of said pouch in order to prevent any leakage of blood and/or any exposure of a content of said pouch to open air.
16. The treatment device as in claim 1 , wherein the means ( 54 ) for sterile collection of at least part of the liquid flowing out of head ( 14 ) include a flexible pouch removably mounted to an inlet connection piece ( 52 ) fitted with a connection configured to be simultaneously sealed upon removal of said pouch in order to prevent any leakage of blood and/or any exposure of a content of the collection means ( 54 ) to open air.
17. The treatment device as in claim 16 , wherein the connection comprises a cap with two inverted threads so that a part of the cap is screwable, and the pouch is sealable by a rotation of the cap that simultaneously disconnects the cap from the connection piece ( 52 ).
18. The treatment device as in claim 1 , further comprising:
a filter for removing leukocytes placed in the head ( 14 , 114 ) .
19. The treatment device as in claim 1 , wherein the liaison interface is configured to rest on said base ( 12 ) and support the head ( 14 , 114 ) on a first interface of said liaison interface, the first interface configured for removably receiving the head, and a second interface opposite the first interface configured for removably mounting to the base ( 12 ).
20. The treatment device as in claim 19 , wherein the first interface includes a first gasket for the head ( 14 , 114 ), and the second interface includes a second gasket for the base ( 12 ).