Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1493—Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor

Definitions

• the invention relates to a collecting bag of a fluid, to a bag system (s) comprising at least one such pocket as well as to their use.
• the whole blood can then be treated in a bag system, in particular by centrifugation and / or filtration, so as to separate the blood into its different constituents.
• Collection pockets are already known comprising an outer envelope formed by two sheets of flexible plastic material assembled on their periphery so as to define an interior volume, said outer envelope being provided with at least one orifice arranged to allow feeding and distribution of the fluid or its components.
• a tubing is associated on the one hand with an inlet orifice of the collection bag and on the other hand with means for collecting blood, for example formed by a needle, which are introduced into a donor's vein.
• the collection bag To increase the storage time of the blood, it is conventional for the collection bag to be filled prior to collection with an anticoagulant and / or blood storage solution.
• One of the problems which then arises is to achieve, as the blood arrives in the collection bag, a homogeneous mixture between the solution contained in the bag and the blood.
• the blood and the solution are mixed during the sampling, conventionally by shaking the bag.
• the purpose of the mixture is in particular to make Ca + ions of the blood meet with the citric ions of the anticoagulant and / or preservation solution.
• tests show that under these conditions the blood coagulation is not saturated with a satisfactory bottle, for example with a view to filtering whole blood. which are different by their density, their temoerature and their volume
• the intensity of agitation being constant during the sampling, the more the bag fills and the less agitation created by turbulence conducive to mixing the contents of the bag
• this poor homogenization involves the formation of blood clots which are detrimental for the filtration of blood or its components since they tend to clog the filtering medium.
• the invention therefore aims to remedy these drawbacks by proposing a collection bag which makes it possible to reduce the formation of blood clots, in particular by improving the production of the mixture between the anticoagulant and / or preservation solution and the blood drawn.
• the invention provides a document for collecting a fluid, in particular whole blood of the type comprising an outer envelope formed by two sheets of flexible plastic material assembled on their periphery so as to define an interior volume, said outer envelope. being provided with at least one orifice arranged to allow the supply and distribution of the fluid in which at least one insert is fixed in the interior volume of the pocket so as to define on either side of said insert at least two sub-volumes in the interior volume said insert being arranged to form a partial obstacle to the flow of fluid inside said interior volume, leaving at least one passage of fluid between said sub-volumes
• the bag contains an anticoagulant and / or solution for preserving the fluid intended to be collected.
• I insert is torme a Pande ⁇ e material
• the insert is formed from two strips of material associated with one another so as to leave a passage of fluid between them
• the insert is formed by a plurality of strips of material associated in the form of a grid so as to define a multitude of fluid passages
• the strips of material are formed from flexible plastic, in particular the same as that forming the outer envelope.
• the insert is arranged substantially transversely, being fixed in the vicinity of the zone for assembling the two sheets.
• the invention provides a pocket system (s) comprising at least ii a collection pocket as described above, in which the collection pocket is connected, by means of an inlet orifice , has means for withdrawing the fluid, and via an outlet orifice, to a filtration unit or to one or more other bags
• the bag system comprises, combined downstream of the filtration unit, a set of bags allowing the separation of the blood into its various constituents.
• one of the pockets of the set is a collection pocket as described above
• the invention relates to the use of a collection pocket as described above or of a pocket system (s) as described above, in which the collection pocket is agitated so that I insert can contribute to the homogenization of the fluid contained in the pocket
• Figure 1 shows an elevational and flat view of a first embodiment of a collection bag according to the invention
• Figure 2 is a perspective view in cross section along the line II-II of Figure 1
• Figure 3 is a perspective representation of a second embodiment of an insert intended to be inserted in a collection pocket
• Figure 4 is a perspective representation of a third embodiment of an insert intended to be inserted in a collection bag.
• Figure 5 is a schematic view, in elevation and flat, of a pocket system (s) comprising a collection pocket according to the invention.
• a collection bag 1 of a fluid comprises an outer casing 2 formed of two sheets 3, 4 of plastic material assembled, for example by welding, on their periphery so as to define a volume inside.
• the sheets 3, 4 are formed from flexible, biocompatible, weldable and selectable plastic material, for example polyvinyl chloride.
• Such a collection bag 1 is in particular intended for collecting whole blood drawn from a donor using collection means 5, for example formed by a needle.
• the outer casing 2 is provided with an inlet orifice 6 intended to receive eta ⁇ che the upstream part of a tube 7 comprising at its downstream end the sampling means 5
• This embodiment makes it possible to put in communication the sampling means 5 and the interior volume of the bag 1 so as to be able to supply the bag 1 with fluid
• An outlet orifice 8 is also arranged on the outer casing 2 to allow the distribution of the fluid.
• Tubing 9 can then be associated with the outlet orifice 8 so as to be able to supply fluid to a pocket system (s) 10 such as , for example, the one described in the rest of this description
• a pocket system (s) 10 such as , for example, the one described in the rest of this description
• the two orifices 6, 8 are arranged on the same dimension of the envelope 2, but they can be arranged differently, for example on two opposite or adjacent dimensions of the envelope 2 Similarly, it can be provided that a single orifice 6 8 serving both for I supply and distribution of the fluid
• upstream and downstream are defined respectively with respect to the direction of circulation of the fluid from the withdrawal means 5 to the outlet orifice 8, via the collection pocket 1
• two other orifices 1 1, 12 are conventionally arranged on the same dimension 13 of the envelope 2 as the inlet 6 and outlet 8 ports.
• the two orifices 1 1, 12 are closed off sealed and sterile by a device 14 which can be torn in the event that the operator wishes to use them as! -> second inlet and / or outlet port
• the collection bag 1 which has just been described constitutes a unitary assembly which can be incorporated into a more complex system which comprises for example other bags, tubes, clamps or filters.
• An example of such a system has 0 pocket (s) 10 is described by ia suite
• At least one insert 15 is fixed in the interior volume of the pocket 1 so as to define on either side of said insert at least two sub-volumes 16, 17 in the interior volume, said insert 15 being arranged to form a partial obstacle to - I fluid flow inside said interior volume leaving at least one fluid passage between said sub-volumes 16, 17
• the fluid can then communicate freely between the sub-volumes 16, 17 in particular I insert 15 has no filtering function but has a function similar to that of a stirring blade when the bag 1 is agitated
• the insert is intended to promote mixing between the fluid and an anticoagulant and / or preservation solution when the bag 1 is subjected to appropriate movements such as those created during the agitation of the bag.
• the solution is introduced into the bag 1 before it is supplied with fluid, but it can be introduced, via an inlet orifice in the bag 1, substantially at the same time or after the fluid.
• the insert 15 is formed of a strip of material 18 made of flexible plastic material which is welded between the two sheets 3, 4 in the vicinity of their assembly zone.
• the materials forming the insert 1 and the sheets 3, 4 are identical so as to facilitate welding.
• the insert 15 is arranged substantially transversely (in the direction U shown in FIG. 1) relative to the pocket 1 so as to define a first sub-volume 16 disposed on the side of the inlet 6 and outlet 8 and a second sub-volume 17 opposite the first 16 with respect to the insert 15.
• the two sub-volumes 16, 17 are then defined on either side of the insert 15 and are delimited by the corresponding parts of the outer envelope 2.
• the insert 15 leaves two fluid passages 19, 20 between these two sub-volumes 16, 17.
• the first 19 is defined between the first sheet 3 and the insert 15, the second 20 between the insert 15 and the second sheet 4.
• a second strip of material 21, which may or may not be identical to the first 18, is arranged adjacent to that described in relation to the first embodiment, so as to form an insert 15
• the insert 15 is welded in a sealed manner between the two sheets 3, 4 of the pocket 1.
• this welding is carried out made so as to combine the two sheets 3 4 and the two strips of material 18, 20 in a single step
• the two sub-volumes 16, 17 are the same as those defined above. It is distributed on either side of the insert 15 in the direction VL insert 1 5 then leaves three passages of fluid between these two. sub-volumes 16 17 the first 19 between sheet 3 and the first strip 18, the second 22 between the two strips 18 21 and the third 20 between the second strip 21 and sheet 4
• the insert 15 is formed from a plurality of material strips 18 23 associated in the form of a grid so as to define a multitude of fluid passages 24
• the insert 15 represented in FIG. 4 comprises three strips of material 18 as defined in the first embodiment and several strips of material 23 arranged substantially perpendicular to these three strips 18 and spaced from one another The association of this set of strip of material 18, 23 is produced, for example by welding, prior to fixing the insert 15 in the pocket 1
• the insert 15 is welded substantially transversely between the two plastic sheets 3 4 of the bag 1 so as to leave a plurality of fluid passages 24 between the two sub-volumes 16, 17 defined above.
• the pocket 1 comprises a single insert 15 but it is possible to provide several identical or different inserts 1 5, arranged inside the pocket 1 so as to further improve the production of the mixture between the solution o anticoagulant and / or preservation and the fluid removed
• a bag system 10 comprising a collection bag 1 inside I of which an insert 1 5 is fixed.
• the inlet orifice 6 is connected, by means of a first tube 7, to means for withdrawing the fluid 5
• the outlet orifice 8 is connected, by means of a second tube 9, to a filtration unit 25 suitable in particular for leukoreducing whole blood.
• a first 26 and a second 27 satellite bag are connected in series by means of a third 28 and a fourth 29 respectively.
• Such a bag system 10 allows, after collection of whole blood, to carry out in a closed circuit the filtration thereof so as to collect in the first satellite bag 26 whole leukocyte blood.
• the first satellite bag 26 can then be centrifuged so as, for example, to obtain, after transfer, a globular concentrate in the first satellite bag 26 and the blood plasma in the second satellite bag 27.
• the tubes 7, 9, 28 and 29 are breakable and weldable so as to allow, before the centrifugation of the bag 26, to separate the filter 25 and the bag 1 from the system 10 by cutting and welding of tubing 28.
• an insert 15 is fixed within the pocket 26.
• a storage solution can be introduced into the bag 26 after the transfer of the plasma in the pocket 27. This introduction may be carried out in a closed circuit providing that the system 10 also comprises a pocket containing the preservation solution which is in fluid communication with the pocket 26.
• Collection bag 1 contains an anticoagulant and / or fluid preservation solution intended to be collected, for example of the CPD type for collecting whole blood or SAG-Mannitol for that of a globular concentrate.
• the bag 1 When drawing blood from the donor, the bag 1 is agitated so as to mix said solution with the blood, and this from the start of the supply of bag 1 with blood.
• agitation is carried out by partial rotation of the pocket 1 around the axis U represented in FIG. 1
• the fluid passages 19 20, 22, 24 left by the insert then extend substantially perpendicular to the direction U ( direction V shown in figure 1)
• the presence of the insert 15 inside the collection bag 1 then allows better mixing of the blood and the solution during agitation because the fluid flows alternately from the first 16 to the second 17 sub-volume through I through the 10 fluid passages 19, 20, 22, 24
• the insert 15 then forms a partial obstacle to this flow so as to improve the homogenization of the mixture by causing turbulence
• I insert 15 makes it possible to improve
• the anticoagulant and / or preservation solution is introduced, during I agitation of the bag, substantially at the same time or after the fluid 0
• the insert 15 is disposed substantially transversely to the interior of the bag 1
• Another arrangement can however be envisaged, in particular in the case of another method of agitating the bag 1
• the conditions for preserving blood are improved in that, in particular, the formation of blood clots in the whole blood collected is reduced.
• Whole blood can then be filtered in particular in a closed circuit in a system 10 like that described above in a more satisfactory manner by reducing the risks o of clogging of the filtering medium by blood clots.
• the collection bag 1 can be agitated not only during sampling but also before filtration so as to fully benefit from the advantages provided by the invention
• the preservation solution is introduced into the pocket 26 after centrifugation and transfer of the plasma into the pocket 27 then the pocket 26 is agitated, in particular manually by the operator, so as to improve the mixture between the globular concentrate and the preservation solution

Landscapes

• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Hematology (AREA)
• External Artificial Organs (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Bag Frames (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=8848493

Family Applications (1)

Country Status (7)

Families Citing this family (2)

Family Cites Families (6)

• 2000
  • 2000-03-24 FR FR0003802A patent/FR2806621B1/fr not_active Expired - Fee Related
• 2001
  • 2001-03-21 AU AU44293/01A patent/AU4429301A/en not_active Abandoned
  • 2001-03-21 WO PCT/FR2001/000851 patent/WO2001072259A1/fr not_active Application Discontinuation
  • 2001-03-21 EP EP01917206A patent/EP1265580A1/de not_active Withdrawn
  • 2001-03-21 CA CA002403288A patent/CA2403288A1/en not_active Abandoned
  • 2001-03-21 JP JP2001570221A patent/JP2003527930A/ja active Pending
  • 2001-03-21 US US10/239,624 patent/US20030078559A1/en not_active Abandoned

Non-Patent Citations (1)

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