11 Publication No:
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`(To be used only for
`reproduction orders)
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`2 346 238
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`PATENT APPLICATION
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`FRENCH REPUBLIC
`____
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`NATIONAL INSTITUTE
`OF INDUSTRIAL
`PROPERTY
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`PARIS
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`No 76 10195
`21
`______________________________________________________________
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`54
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`Container for biological liquid in particular
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`International Classification (Int. Cl. 2). B 65 D 77/06, 81/18/1 61 M 1/100
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`Filing Date.......................................... 2 April 1976, at 15:35
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`Priority Claimed:
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`A1
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`51
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`22
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`33 32 31
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`41
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`D Stationers: IMPRIMERIE NATIONALE, 27 rue de la Convention - 75732 PARIS CEDEX 15
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`.../...
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`Date that application was made
`available to the public......................... BOPI [French Official Industrial Property Bulletin] -
` “Lists” No 43 of 28-10-1977
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`Applicant: Company called: RHONE-POULENC INDUSTRIES, resident in France.
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`Invention of: Jacques Calzia and André Sausse.
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`Owner: Idem 71
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`Representative: Aline Bouvy. Rhône Poulenc. Patent Department. Careers
`Research Centre.
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`______________________________________________________________
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`This invention, the result of collaboration between Messrs Jacques
`CALZIA and André SAUSSE, relates to a container for liquid, used particularly
`in the medical field. This container is advantageously used for the storage of
`biological liquids and in particular for the storage of blood.
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`Usually, in the medical field, glass bottles or possibly flexible plastic
`pouches are used for the storage of biological liquids. In the opinion of the
`users, these two methods of storage have their drawbacks.
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`Glass bottles have drawbacks of handling and storage since they risk,
`on the one hand, being broken and, on the other, they represent a significant
`weight. Moreover, during filling and emptying, a blood/air interface is created,
`which increases the risks of bacterial contamination of the blood and the risks
`of gaseous embolism. However, glass bottles have the advantage of being
`rigid and can easily be normalised and standardised, furthermore, they can be
`completely emptied.
`When full, flexible pouches have a repellent appearance for handling;
`moreover, any contact with a sharp or pointed object risks tearing them. They
`also have the drawback of being difficult to normalise and standardise (in fact
`two theoretically identical pouches rarely have the same volume). Moreover,
`on emptying, the flexible walls often form folds that retain the blood and thus
`flexible pouches may not be completely emptied. Flexible pouches have the
`advantage, however, on filling or emptying, of preventing the formation of a
`blood/air interface.
`The aim of this invention is to provide a container for liquid, which, on
`the one hand, avoids the drawbacks inherent in glass bottles and flexible
`pouches and, on the other, has their respective advantages.
`One aim of the invention is therefore to provide a container that prevents,
`on filling or emptying, the appearance of a liquid/gas interface.
`Another aim of the invention is to provide a container for liquid that is
`both light and strong, easy to handle and store and that can be normalised and
`standardised.
`Moreover, another aim of the invention is to provide a container that can
`be mass-produced using a process that can be automated.
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`A container for liquid, particularly for biological liquid, has now been
`invented, characterised in that it comprises a rigid shell delimiting a closed
`internal space, at least one deformable membrane integral with said shell and
`dividing the closed internal space into at least two compartments, means of inlet
`and/or outlet of fluid from outside the shell into and/or out of each compartment
`of the closed internal space.
`the
`from
`invention will emerge
`the
`A better understanding of
`accompanying figures, which illustrate various embodiments by way of
`example, schematically and not to scale.
`Figure 1 is a general elevation view of a first embodiment of the container
`according to the invention.
`Figure two is a sectional view in a diametral plane perpendicular to the
`jointing plane of a container according to Figure 1.
`Figures 3 I, II, III are sectional views in a diametral plane perpendicular
`to the jointing plane of a container according to Figure 1 when empty, being
`filled and full.
`Figure 4 is a front view of a container according to a second embodiment
`of the container according to the invention.
`Figure 5 is a front view of a container according to a third embodiment.
`Figure 6 is a sectional view in a diametral plane perpendicular to the
`jointing plane of a container according to a fourth embodiment.
`Figure 7 represents a variation of use of a container according to the
`invention.
`Figure 8 represents another variation of use of a container according to
`the invention.
`The container (1) shown in Figures 1 and 2 comprises a substantially
`rigid shell (2) that delimits a closed internal space. This shell (2) consists of two
`substantially hemispherical elements (3, 4), each provided with a rim (5, 6),
`substantially perpendicular to their axis. These two elements (3, 4) grip a
`deformable membrane (7) between their rims (5, 6). Preferably the deformable
`membrane (7) is preformed and substantially hemispherical and, when the
`container (1) is empty, marries up with the internal surface of one of the
`elements (3) or (4). The membrane can also be elastic and deform under the
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`action of the pressure of one fluid or the other contained in the compartments
`(12, 13).
`The assembly of the two elements (3, 4) and the membrane (7) is
`achieved in a sealed manner by any know means, such as gluing or welding,
`along a substantially diametral jointing plane (8). The rims (5, 6) then form a
`collar (9) round the container (1). Advantageously, this collar (9) is provided
`with suspension means such as one or more orifices (10, 11) or one or more
`hooks, which are then fixed onto the collar (9).
`The deformable membrane (7) separates the closed internal space into
`two compartments (12, 13), each provided with a manifold (14, 15) for
`connection to a fluid tube. These manifolds can be provided with shut-off
`means of any known type such as a valve, or a plug, or can even be sealed.
`There now follows a description of the filling and emptying of a container
`(1) according to Figures 1 and 2, used as a blood storage unit.
`Figure 3 represents a sectional view in a plane perpendicular to the
`jointing plane (8) of a container (1) empty (Figure 3-I), being filled (Figure 3-II)
`and full (Figure 3-III).
`The container (1) being empty (Fig. 3-I), the deformable membrane (7)
`marries up with the internal surface of the element (4). The container (1) is then
`connected by means of the manifolds (14) on one side and (15) on the other
`respectively to a tube (16) provided with means (17) to aspirate the air
`contained in the compartment (12) and to a blood supply tube (18) (this tube
`(18) can either be connected to a patient or connected to a larger blood storage
`container).
`The air aspiration means (17) can, for example, be in the form of a pump.
`In the empty container (1), the deformable membrane (7) marries up with
`the internal surface of element (4), compartment (12) occupies the entire closed
`internal space delimited by the rigid shell, compartment (13) thus having a
`volume of practically zero. The pump (17) is switched on and the air contained
`in compartment (12) is aspirated, which causes the deformable membrane (7)
`of element (4) to move towards element (3). There occurs at the same time an
`aspiration of blood, conveyed by the tube (18), which starts to fill the
`compartment (13) (Figure 3-II).
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`The pump (17) is switched off when the container is full, i.e. when the
`deformable membrane (7) marries up with the internal surface of element (3),
`compartment (13) then occupies all of the closed internal space delimited by
`the rigid shell (Figure 3-III), the compartment (12) then has a volume of
`practically zero.
`Using the means provided for the purpose, the manifolds (14) and (15)
`are then closed and the tubes (16) and (18) are disconnected.
`For the entire duration of filling the container, the creation of a blood/air
`interface has been avoided. In fact the deformable membrane (7) has followed
`the change in volume of the blood in the containers from the outlet of manifold
`(15) to the level of manifold (14). The deformable membrane (7) has therefore
`replaced the blood/air interface.
`The container is emptied as follows:
`The manifold (15) is connected to a pipe for transferring blood, to a
`patient for example, the manifold (14) is connected to an air supply pipe.
`Through the manifold (14), air is injected into the compartment (12), which
`causes the deformable membrane (7) of the element (3) to move towards the
`element (4), thus the blood contained in the compartment (13) is pushed
`through the manifold (15).
`Throughout the entire duration of emptying the container, the creation of
`a blood/air interface has been prevented. In fact the deformable membrane (7)
`has followed the change in volume of the blood in the container from manifold
`(14) to the outlet of manifold (15). The deformable membrane (7) has thus
`replaced the blood/air interface.
`The flow rate of injection of air into the compartment (12) can
`advantageously be regulated, which results in the regulation of the outlet flow
`rate of the blood through the manifold (15).
`The filling and emptying of the container according to the invention using
`air as the fluid in the compartment (12) has been described above; clearly any
`other gas or even a liquid can be used.
`All variations, obvious to a person skilled in the art, form part of this
`invention. Some inventive variations are described below by way of non-limiting
`examples.
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`Each compartment can comprise two manifolds one of which can thus
`be used as the inlet and the other as the outlet for the fluid in the compartment.
`The container according to the invention shown in Figure 4 is similar to
`the container shown in Figure 1. It comprises feet (19) that allow the container
`to be placed on a surface without the need to use a support.
`The container (1) shown in Figure 5 is polyhedral in shape. Such a
`container has the advantage of being able to be placed directly on a flat surface.
`The container (1) according to the invention and shown in Figure 6 has
`a substantially cylindrical rigid shell, the cylinder being provided at its ends with
`generally spherical caps.
`This container comprises two deformable membranes (20, 21) gripped
`at the jointing planes (22, 23) between the cylindrical area (24) and the
`spherical caps (25, 26).
`These deformable membranes divide the closed internal space into
`three compartments (27, 28, 29), each compartment being equipped with at
`least one manifold. Thus, for example, the injection of air into compartment
`(29) allows the fluid that compartments (27) and (28) contain to be
`simultaneously pushed out.
`Figure 7 represents a container according to the invention used
`simultaneously as a storage container for an aspirated fluid and for an injected
`fluid. This container is similar to the one previously described and shown in
`Figure 1, however each compartment has two manifolds, the manifolds (30, 31)
`for compartment (12), the manifolds (32, 33) for compartment (13). On
`simultaneously blocking, for example by a cam device, one manifold of each
`compartment for example, as shown in Figure 7, the manifold (31) for
`compartment (12) and the manifold (33) for compartment (13), an injection of
`fluid through manifold (30) into compartment (12) causes the fluid contained in
`compartment (13) to be pushed out through manifold (33). After filling
`compartment (12) and emptying compartment (13), manifolds (30) and (33) are
`blocked and manifolds (31) and (32) are opened, then fluid can again be
`aspirated through manifold (32) into compartment (13) and simultaneously
`compartment (12) can be emptied through manifold (31).
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`According to the variation shown in Figure 8, the container (1) according
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`to the invention comprises one compartment (13) provided with two manifolds
`(34, 35) and one compartment (12) provided with one manifold (36). The
`manifolds (34) and (35) are used for the inlet and outlet of fluid.
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`Any variation in the volume of fluid contained in compartment (13)
`causes the movement of membrane (7) and hence the inlet or outlet of air
`through the manifold (36) which vents into the free air. Thus the fluid of the
`circuit contained in compartment (13) can under no circumstances come into
`contact with the air. This container can be used as a pressure regulator of a
`fluid circuit or as an expansion tank. Such a container could advantageously
`be used in an extracorporeal blood circuit.
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`The variations described above by way of example could of course be
`combined together without departing from the scope of this invention.
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`The rigid shell of the container according to the invention can be made
`of various rigid or semi-rigid materials and covered in a material compatible with
`the biological liquids likely to be contained in the container. Examples of
`materials that could be used are natural or synthetic rubbers, nylon or
`elastomers, for instance organopolysiloxane elastomers that can be vulcanised
`at ambient temperature can be used. The use of thermoplastic materials such
`as polyethylene, polystyrene and polycarbonates is preferred. It is particularly
`advantageous to lacquer the internal surface likely to be in contact with blood
`or a biological liquid, by depositing a thin layer of silicone elastomer thereon,
`particularly in accordance with the technique described in the French patent
`published under number 1 126 573.
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`The deformable membrane can be made of various materials that are
`flexible, fluid-tight, elastic or non-elastic and may also be covered in a material
`compatible with the biological liquids likely to be contained in the container. As
`in the case of the rigid shell, natural or synthetic rubbers, nylons or elastomers
`can be used; for example, organopolysiloxane elastomers that can be
`vulcanised at ambient temperature can be used. It is preferable to use
`thermoplastic materials such as polyethylene, polystyrene and polycarbonates.
`It is also particularly advantageous to lacquer one or several of its surfaces.
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`The deformable membrane can also be such that it is bistable, which
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`means that its form is stable both when it marries up with the internal surface
`of one of the elements and when it marries up with the internal surface of the
`other element. A “stable form” means that after having been substantially
`deformed, the deformable membrane spontaneously returns to its original
`position.
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`The deformable membrane can also be a semi-permeable membrane of
`a known type, thus the exchanges between the fluids located on either side of
`the membranes can occur by dialysis.
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`The containers according to the invention are simple to produce on an
`industrial scale. For example, by thermoforming, one or more elements can be
`obtained from a sheet or film, the rims being cut for example at the same time
`as thermoforming. Each element is then provided with one or more manifolds,
`for example by gluing or welding, around the orifices made in each element.
`The deformable membrane is formed, by thermoforming for example, creating
`a rim around it. The deformable membrane is placed on the first element so
`that its rim marries up with the rim of this first element, the second element is
`then arranged in a manner similar to the first element. The assembly of these
`two elements gripping the membrane is then sealed, by any known means,
`such as by ultrasound welding the rims of the elements that grip the membrane
`between them.
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`After the normal operations of checking, wrapping and sterilisation, by
`irradiation for example, the container according to the invention is then ready
`for use.
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`Containers for liquid, particularly biological liquid, according to the
`invention have numerous advantages that are particularly advantageous when
`the biological liquid is blood.
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`In fact, as we have seen above, this container prevents, during filling or
`emptying, the appearance of an interface, for example a gas/liquid interface.
`This advantage is of particular interest when the liquid contained in the
`container is blood since all risks of bacterial contamination thereof as well as
`the risks of gaseous embolism are avoided.
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`The containers according to the invention also have the advantage of
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`being easy to standardise and normalise. Moreover, they can be fully emptied
`since the fluid that is injected into one of the compartments to ensure that the
`fluid contained in the other compartment is emptied brings the deformable
`membrane into contact with the internal surface of the element that delimits the
`latter. Consequently, no folds form in the deformable membrane, avoiding the
`risk of liquid being retained.
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`Moreover, the containers according to the invention have the advantage
`of being light and strong so are easy to handle and store.
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`These containers also have the advantage of being capable of being
`made of materials such that they can be totally destroyed by incineration, which
`is an additional advantage for use in a hospital environment.
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`The containers according to the invention are particularly advantageous
`to be used to store biological liquids and in particular to store blood.
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`CLAIMS
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`1) Container for liquid, particularly for biological liquid, characterised in
`that it comprises a rigid shell delimiting a closed internal space, at least one
`deformable membrane integral with said shell and dividing the closed internal
`space into at least two compartments and means of inlet and/or outlet of fluid
`from outside the shell into and/or out of each compartment of the closed internal
`space.
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`2) Container according to claim 1, characterised in that it comprises a
`rigid shell consisting of at least two elements that grip in their jointing plane at
`least one deformable membrane, the assembly of the elements and the
`membrane being achieved in a sealed manner, the said membrane dividing the
`closed internal space into at least two compartments, each provided with at
`least one manifold for connection to a source and/or to a discharge of fluid.
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`3) Container according to one of claims 1 or 2, characterised in that the
`deformable membrane is made of a fluid-tight material.
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`4) Container according to one of claims 1 or 2, characterised in that the
`deformable membrane is made of a material that is semi-permeable to fluids.
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`5) Use of a container according to any one of claims 1 to 4 as a blood
`storage container.
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`6) Use of a container according to any one of claims 1 to 4 as a pressure
`regulator of an extracorporeal blood circuit.
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`TRANSLATOR’S DECLARATION
`
`I, Jennifer Clay of Morningside IP residing at 27 Pickhurst Rise,
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`West Wickham, Kent BR4 OAB UK am a French language translator
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`with over 30 years of experience translating technical, legal,
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`and business documents from French to English. Being fluent
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`in both the French and English languages,
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`I certify under
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`penalty of perjury under the laws of the United States that:
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`1.
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`To the best of my knowledge and belief,
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`the preceding
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`document is a true and correct English translation of French
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`Patent Publication No.
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`2 346 238.
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`2. All statements made herein of my own knowledge are true
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`and that all statements made on information and belief are
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`believed to be true; and
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`3. Thisdeclarationwasmadewithknowledgethatwillfulfalse
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`statements and the like so made are punishable by fine or
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`imprisonment or both under 18 U.S.C. § 1001.
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`Date: 6th January 2016
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`Translator Name:
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`Jennifer Clay
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