EP2193775B1 - Flexible container for medical use - Google Patents

Abstract

The container has two walls defining an internal volume (11), receiving a fluid e.g. medical solution, upper portion (12) and a lower portion (13) of the container. The internal volume is formed between the upper and lower portions. Concave necking portions (18, 18') are provided on lateral edges of the container. The necking portions are connected to the upper and lower portions by connection portions (19, 19'), where ratio between depth and height of the necking portions is in an interval between 0 and 0.2. Independent claims are also included for the following: (1) a method for reinforcing a flexible container for medical use (2) a reconstruction assembly comprising container.

Description

The present invention relates to a flexible container for medical use. It also relates to a reconstitution assembly comprising such a flexible container, in particular for the administration for medical purposes of a mixture of a liquid contained in this container and of an active agent, for example a powder, contained in a second container such as a bottle.

Flexible pouches are very widely used in the medical field to contain and deliver medical products.

These pockets are particularly advantageous in that their constituent material is inert with respect to the medical products they receive and in that they are very little permeable to air and fluids thereby protecting the contents of the poached.

In addition, these flexible pouches flatten as delivery of their content which allows medical staff to see at a glance the amount of fluid remaining in the flexible bag at any time.

The Figure 1 shows such a flexible pouch 1 of the prior art. This pocket is formed of two flat sheets of plastic material such as polyvinyl chloride (PVC) or polypropylene, which are welded on their periphery 2 to define an internal volume 3 for receiving and containing a medical solution.

This pocket 1 further comprises a port 4 to access the medical solution, this port 4 being located and held in place between the two flat sheets at the lower end of the pocket.

An orifice 5 in the upper part of the bag 1 makes it possible to suspend the latter on a support member such as a fixing hook.

The welded lateral edges 6 laterally delimiting the internal volume 3 of the flexible pouch 1 are rectilinear.

However, it can be observed, after delivery of the contents of the flexible bag 1, a "trapping" of a more or less important fraction of the medical solution in the flexible bag 1.

This loss of medical solution has several origins.

The first is an adhesion of the drops of the medical solution with the inner walls of the bag 1. The suction generated during the delivery of the contents of the bag 1 is not sufficient to overcome this adhesion.

The second is the formation of folds in the pocket 1 envelope, which are cavities in which a fraction of the medical solution is literally trapped.

These folds appear during the filling of the flexible bag 1 with the medical solution and their formation is further accentuated during the sterilization step of the bag due to the softening of the materials temperature.

The third is the shape of the lower end of the pocket carrying the solution to be delivered to the port 4. As an illustration, the zone 7 surrounding the orifice of the port 4 in contact with the medical solution, is often more or less horizontally facilitating the retention of part of the medical solution.

As a result, the prescribed amount of the medical solution is not delivered to the patient. This difference between the amount needed and the amount actually delivered to the patient can be serious for one's health.

On the other hand, the standards for carrying flexible bags, such as those provided by the American Society for testing and Materials (ASTM) test, require a low-temperature impact test.

While these tests are not a particular problem for flexible PVC bags, they are critical for pockets made of other materials such as polypropylene.

Indeed, the appearance of leaks, after testing, often occurs in areas of the pocket where folds have formed during the filling of the latter, these folds having been further accentuated by steam sterilization.

Moreover, these tests are all the more critical as the mass of the pocket, and therefore its volume, is important.

However, polypropylene tends to gradually replace PVC in the manufacture of flexible pouches for medical use because of its high inertia vis-à-vis medical solutions.

As a result, this "transport" test of the flexible pouches becomes critical and can cause rejection or claim causes.

Furthermore, it is known from the prior art to use flexible bags having an internal volume much greater than the volume of fluid to be stored in order to prevent the formation of folds during the filling of these bags and their sterilization.

However, such a method of filling goes against the economic interests of flexible pouch manufacturers since the amount of plastic material needed to receive a given volume of fluid is not optimized. (see for example the embodiment of the document JP-A-2005131221 who is trying to solve this problem).

It would therefore be advantageous to have a flexible pouch whose internal volume corresponds to the volume of fluid to be stored, without the losses of fluid found with the pockets of the prior art.

The objective of the present invention is therefore to provide a flexible pouch which is simple in its design and in its operating mode, economic and allowing a significant reduction in the formation of folds or even a suppression of the latter, during filling and sterilization of these soft pouches.

Another object of the present invention is a flexible pouch allowing a good grip for the reconstitution of medication, for example by means of a transfer set.

For this purpose, the invention as claimed relates to a flexible container for medical use comprising at least two superimposed walls and interconnected at least at their periphery, the walls thus connected defining an internal volume for receiving a fluid, an upper portion and a lower portion of the container, this internal volume being placed between the upper and lower portions of this container, the container further comprising at least one access element to this internal volume.

According to the invention, the parts of the walls thus connected which define the internal volume comprise on each of the lateral edges of the container a portion of necking, said necking portions being placed substantially vis-à-vis and directed towards each other to form a tightening of the internal volume. The necking portions are further connected to at least one of said upper and lower portions of this container by at least one connecting portion.

The term "necking portion", a portion of the walls thus connected which generates a decrease in the width of the container on a given area thereof and thus creates a tightening of the internal volume.

The term "these necking portions are placed substantially vis-à-vis" that these necking portions are placed vis-à-vis or approximately vis-à-vis, for example at +/- 10% in height.

The internal volume of the container comprising one or more compartments, the tightening produced by the necking portions placed substantially vis-à-vis, is placed in one of said compartments outside the intersection area of two successive compartments. This tightening therefore does not function to delimit two successive compartments but only to reduce or even eliminate the appearance of marked folds.

The presence of said at least one connecting portion connecting the necking portion to at least one of the upper and lower portions of the flexible container advantageously ensures a minimum capacity to the flexible container. It is indeed necessary that the removal of the marked folds appearing after filling the container by forming the necking portions, does not operate at the expense of the capacity, or filling volume, of the container. This capacity is preferably equal to at least 50% of the capacity of the same container without any portion of necking.
Thus, for a flexible container with an _{initial capacity} of 545 ml V having no portion of necking, the necking portions are advantageously determined so as to remove the marked folds and to ensure a capacity of at least about 280 ml.
Of course, it will preferably seek necking portions for which the capacity of the flexible container is close to the _{initial capacity} V of the flexible container without any necking portion. The presence of said at least one linking portion implies that the necking portion does not not directly connecting the upper and lower portions of said container on each of the side edges of the container.

For purely illustrative purposes, the walls of the container may be connected by welding.

It is observed that the shape of the flexible container of the invention is advantageously favorable to its handling and handling.

• les portions de striction sont des portions concaves, Avantageusement, mais non obligatoirement, ces portions concaves sont placées de manière à former un resserrement situé de manière sensiblement centrale au volume interne.

De préférence, ces portions de striction présentent uniquement une forme arrondie telle qu'une forme d'arc de cercle.

• chacune de ces portions de striction a une profondeur p et une hauteur H telle que le rapport p/H est compris dans l'intervalle ]0, 0,2] et encore mieux compris dans l'intervalle [0,05 , 0,11] +/- 10%,

On entend par "profondeur", la distance séparant le sommet de la portion de striction concave de sa base. Dans le cas d'une striction ayant une forme d'arc de cercle, la profondeur serait la flèche de cet arc de cercle tandis que la hauteur H serait la corde sous tendant cet arc.
Le rapport p/H est mesuré pour la portion de striction concave uniquement. Bien entendu, le nombre zéro est exclu de cet intervalle.
On évite avec un tel intervalle de valeurs pour le rapport p/H de générer un "effet de pointe" susceptible d'induire la formation de pliure, par exemple une pliure reliant directement les portions de striction entre elles. Cet "effet de pointe" conduirait désavantageusement au résultat inverse recherché.
Cet intervalle de valeurs pour le rapport p/H permet également de garantir une contenance optimale de la poche en raison de la présence d'au moins une portion de liaison.

• les portions de liaison sont des portions non concaves,

Ces portions non concaves peuvent être linéaires ou sensiblement linéaires. Elles peuvent ainsi être placées verticalement ou de manière inclinée.
Alternativement, ces portions non concaves peuvent encore être des portions bombées vers l'extérieur du volume interne. Par exemple, ces portions peuvent être arrondies vers l'extérieur.

• la portion supérieure comporte au moins un trou pour suspendre le récipient,
• la portion supérieure délimitant le volume interne à son extrémité supérieure, la partie de ladite portion supérieure en contact avec le volume interne a une forme concave,

Alternativement, cette partie de la portion supérieure en contact avec le volume interne a une forme convexe.

• la portion inférieure délimitant le volume interne à son extrémité inférieure, la partie de ladite portion inférieure en contact avec ledit volume interne a une forme en V pour éviter le piégeage d'une fraction dudit fluide destiné à être reçu dans ledit volume interne, les branches dudit V formant un angle compris entre 45° et 85° par rapport à un plan vertical passant par la pointe dudit V,

De préférence, cet angle est compris entre 60° et 70°.

• les parois sont réalisées en polypropylène, polyoléfine, polyamide, en PVC plastifié ou souple, copolymère éthylène-alcool vinylique (EVOH), dépôt d'oxyde en couche mince ou encore en une combinaison d'au moins deux de ces éléments,
• le volume interne de ce récipient peut comporter un ou plusieurs compartiments,

Lorsque le volume interne du récipient souple comporte deux compartiments par exemple, le compartiment supérieur et le compartiment inférieur qui est en communication de fluide avec l'élément d'accès au volume interne du récipient comprennent chacun des portions de striction afin de permettre une délivrance de l'ensemble du contenu de ces compartiments.
Les compartiments sont alors séparés par un joint tel qu'une soudure pelable pour permettre la mise en communication de fluide des deux compartiments.

• les parois comportent de plus sur au moins une partie de leur surface externe une couche bloquant ou absorbant les rayons UV,
• l'extrémité de la partie de l'élément d'accès placée dans la portion inférieure a une forme évasée.

Cette forme évasée permet avantageusement de guider le fluide contenu dans le volume interne du récipient vers l'extrémité de l'élément d'accès placée à l'extérieur du récipient souple.
Les pentes de cette forme évasée forment, de préférence, un prolongement de la partie de la portion inférieure délimitant le volume interne du récipient souple à son extrémité inférieure.In various particular embodiments of this flexible container, each having its particular advantages and susceptible to many possible technical combinations:

• the necking portions are concave portions. Advantageously, but not necessarily, these concave portions are placed so as to form a narrowing located substantially centrally to the internal volume.

Preferably, these necking portions have only a rounded shape such as an arcuate shape.

• each of these necking portions has a depth p and a height H such that the ratio p / H is in the range] 0, 0.2] and even more preferably in the range [0.05, 0.11 ] +/- 10%,

The term "depth" means the distance separating the vertex from the portion of concave necking of its base. In the case of a necking having a shape of arc of circle, the depth would be the arrow of this arc of circle while the height H would be the string under tending this arc.
The ratio p / H is measured for the portion of concave necking only. Of course, the number zero is excluded from this interval.
With such a range of values for the ratio p / H, it is avoided to generate a "peak effect" capable of inducing fold formation, for example a fold directly connecting the necking portions to one another. This "peak effect" would disadvantageously lead to the opposite result sought.
This range of values for the ratio p / H also makes it possible to guarantee an optimal capacity of the pocket because of the presence of at least one connecting portion.

• the connecting portions are non-concave portions,

These non-concave portions may be linear or substantially linear. They can thus be placed vertically or inclined.
Alternatively, these non-concave portions may still be curved portions towards the outside of the internal volume. For example, these portions may be rounded outward.

• the upper portion has at least one hole for suspending the container,
• the upper portion delimiting the internal volume at its upper end, the portion of said upper portion in contact with the internal volume has a concave shape,

Alternatively, that portion of the upper portion in contact with the internal volume has a convex shape.

• the lower portion defining the internal volume at its lower end, the portion of said lower portion in contact with said internal volume has a V-shaped shape to avoid trapping a fraction of said fluid intended to be received in said internal volume, the branches said V forming an angle between 45 ° and 85 ° with respect to a vertical plane passing through the tip of said V,

Preferably, this angle is between 60 ° and 70 °.

• the walls are made of polypropylene, polyolefin, polyamide, plasticized or flexible PVC, ethylene-vinyl alcohol copolymer (EVOH), thin film oxide or a combination of at least two of these elements,
• the internal volume of this container may comprise one or more compartments,

When the internal volume of the flexible container has two compartments for example, the upper compartment and the lower compartment which is in fluid communication with the access element to the internal volume of the container each comprise necking portions to allow a delivery of the entire contents of these compartments.
The compartments are then separated by a seal such as a peelable weld to allow fluid communication of the two compartments.

• the walls further include on at least a portion of their outer surface a layer blocking or absorbing UV rays,
• the end of the portion of the access member in the lower portion has a flared shape.

This flared shape advantageously allows the fluid contained in the internal volume of the container to be guided towards the end of the access element placed outside the flexible container.
The slopes of this flared shape preferably form an extension of the portion of the lower portion delimiting the internal volume of the flexible container at its lower end.

The invention also relates to a method of strengthening a flexible container for medical use, to prevent the formation of folds during filling of said container, said flexible container having an internal volume for receiving a liquid.

According to the invention, at least one necking portion is formed on each of the lateral edges of said container, the necking portions of said lateral edges being placed substantially opposite one another to define a tightening of the internal volume of the container.

The internal volume of the container comprising one or more compartments, forming the constriction in one of said compartments outside the intersection area of two successive compartments.
This tightening therefore does not function to delimit two successive compartments but strengthen the flexible container to reduce or eliminate the appearance of marked folds.

The internal volume of the container having several compartments, such tightness is formed in each of said compartments.

For purely illustrative purposes, this method comprises a first superposition step of at least two sheets, then a step of assembling these sheets at least on their periphery to form the lateral edges, the necking portions and the upper and lower ends. said container. Prior to assembling the lower end, at least one access member is placed in the internal volume between the at least two sheets. For example, the walls of the container can be connected by welding.

Advantageously, the container comprising upper and lower ends delimiting the internal volume, the necking portions are connected to at least one of said upper and lower ends by at least one connecting portion. This connecting portion may be non-concave. It can thus be linear or substantially linear. It can also be placed vertically or inclined or not.

Advantageously, these necking portions are concave portions. Preferably, these necking portions have only a rounded shape such as an arcuate shape.

Preferably, each necking portion is chosen so that it has a depth p and a height H such that the ratio p / H is in the range] 0, 0.2] and even better understood in the interval [0.05, 0.11] +/- 10%.
The term "depth" means the distance separating the vertex from the portion of concave necking of its base. In the case of a necking having a shape of arc of circle, the depth would be the arrow of this arc of circle while the height H would be the string under tending this arc.

The invention also relates to a reconstitution assembly comprising a container as described above and a transfer set connected to an access element to the internal volume of this container.

• un premier corps de transfert comprenant une première extrémité et une deuxième extrémité, cette première extrémité étant destinée à être reliée au récipient souple tel que décrit précédemment, ce premier corps de transfert comprenant un premier conduit central logeant une première extrémité au moins d'un perforateur mobile, cette première extrémité comprenant un élément de perçage, un premier élément d'étanchéité étant destiné à empêcher la communication de fluide entre le récipient souple et ce premier corps de transfert, cette première extrémité étant destinée à être placée dans le conduit central en retrait de l'élément d'étanchéité de sorte que ce premier élément d'étanchéité est non percé dans une position inactivée de ce set de transfert,
• un deuxième corps de transfert comprenant une première extrémité et une deuxième extrémité, la première extrémité ayant un élément d'attache pour recevoir et fixer un deuxième récipient, le deuxième récipient étant fermé par un deuxième élément d'étanchéité, le deuxième corps de transfert comprenant un deuxième conduit central logeant la deuxième extrémité au moins de ce perforateur mobile, cette extrémité comprenant un élément de perçage, les premier et deuxième conduits centraux étant coaxiaux, le deuxième conduit central débouchant dans l'élément d'attache pour permettre le passage de la deuxième extrémité vers le deuxième élément d'étanchéité, la deuxième extrémité étant destinée à être placée dans le deuxième conduit en retrait du deuxième élément d'étanchéité de sorte que le deuxième élément d'étanchéité est non percé dans une position inactivée du set de transfert,

• au moins une partie du deuxième corps de transfert étant déplaçable le long d'un axe de déplacement d'une position inactivée du set de transfert où ladite partie du deuxième corps de transfert est partiellement insérée dans la deuxième extrémité du premier corps de transfert à une position activée du set de transfert où une communication de fluide entre le récipient souple et le deuxième récipient est établie,
• des moyens d'entraînement coopérant avec le perforateur mobile pour déplacer ce perforateur au moins en rotation le long de l'axe de déplacement lors du déplacement de ladite partie de la position inactivée à la position activée,
• ce perforateur étant destiné à percer d'abord l'élément d'étanchéité fermant le second récipient puis l'élément d'étanchéité du récipient souple lors de son déplacement.

Such a transfer set has, for example, been described by the present applicant in the patent application. EP 1 849 883 whose content is fully incorporated in this application. This transfer set includes:

• a first transfer body comprising a first end and a second end, this first end being intended to be connected to the flexible container as described above, this first transfer body comprising a first central duct housing a first end of at least one perforator mobile, this first end comprising a piercing element, a first sealing element being intended to prevent the communication of fluid between the flexible container and the first transfer body, this first end being intended to be placed in the central conduit recessed of the sealing element so that this first sealing element is not pierced in an inactivated position of this transfer set,
• a second transfer body including a first end and a second end, the first end having an attachment member for receiving and securing a second container, the second container being closed by a second sealing member, the second transfer body comprising a second central duct housing the second end at least of this mobile perforator, this end comprising an element of drilling, the first and second central ducts being coaxial, the second central duct opening into the fastener element to allow the passage of the second end towards the second sealing element, the second end being intended to be placed in the second led back from the second sealing element so that the second sealing element is not pierced in an inactivated position of the transfer set,

• at least a part of the second transfer body being displaceable along an axis of displacement of an inactivated position of the transfer set where said part of the second transfer body is partially inserted into the second end of the first transfer body at a activated position of the transfer set where fluid communication between the flexible container and the second container is established,
• driving means cooperating with the mobile perforator to move this perforator at least in rotation along the axis of displacement during the displacement of said part of the inactivated position to the activated position,
• this perforator being intended to pierce first the sealing element closing the second container and then the sealing element of the flexible container during its displacement.

Advantageously, the second container is a bottle comprising an active substance to be reconstituted.

• la figure 1 montre de manière schématique une poche souple de l'art antérieur;
• la figure 2 représente schématiquement un récipient souple selon un premier mode de réalisation de l'invention;
• la Figure 3 montre une vue partielle d'un récipient souple selon un deuxième mode de réalisation de l'invention ;
• la Figure 4 montre une vue partielle de l'empreinte d'un élément de moule servant à la réalisation de la portion inférieure d'un récipient souple selon un troisième mode de réalisation de l'invention ;

The invention will be described in more detail with reference to the accompanying drawings in which:

• the figure 1 shows schematically a flexible pouch of the prior art;
• the figure 2 schematically represents a flexible container according to a first embodiment of the invention;
• the Figure 3 shows a partial view of a flexible container according to a second embodiment of the invention;
• the Figure 4 shows a partial view of the cavity of a mold element used for producing the lower portion of a flexible container according to a third embodiment of the invention;

The Figure 2 shows a flexible and flexible container according to a particular embodiment of the invention.

This container 10 comprises at least two sheets of multilayer materials superimposed and welded together at their periphery. As an illustration, it may comprise two welded sheets of multilayer materials comprising at least one polyolefin film conforming to the prescriptions of the pharmacopoeia.

These sheets thus connected define an internal volume 11 for receiving a fluid, the medical solution, an upper portion 12 and a lower portion 13 of this container.

The upper 12 and lower 13 portions are formed by welding the walls of the container. They are therefore not likely to receive a fluid and are, in this sense, distinct from the internal volume 11. However, they each have a portion in contact with the internal volume 11 delimiting the upper and lower ends of the latter.

The upper portion 12 comprises at least one hole 14 to ensure the suspension of this container 10 on a support member for the delivery of the medical solution contained in the internal volume 11.

The lower part 13 of the container comprises a port 15 allowing access to the internal volume 11 of the container. This access port 15 is, in known manner, between the thus connected walls of the container 10. It is here placed in the center of the lower portion 13 of the flexible container. This access port 15 comprises an upper orifice 16 intended to be placed in contact with the medical solution contained in the internal volume 11 of the container and a lower portion 17 projecting from the container 10 and intended to allow attachment temporarily or definitive of a coupling member of a transfer set or an intravenous line.

The internal volume 11 is placed between the upper portions 12 and lower 13 of the container.

The parts of the walls thus connected which define the internal volume 11 comprise on each of the lateral edges of the container 10 a concave portion 18, 18 '. These concave portions 18, 18 'are placed facing each other and directed toward one another to form a tightening of the internal volume 11.

These concave portions 18, 18 'are connected to the upper portions 12 and lower 13 of the container by a connecting portion 19, 19' which is here linear and vertical.

The ratio of the depth p of each of these concave portions to the height H of these concave portions is equal to 0.1 +/- 10%.

The portion 20 of the upper portion 12 delimiting the internal volume 11 at its upper end has a concave shape.

The Figure 3 shows a partial view of a flexible pouch according to another embodiment of the invention. The elements of the Figure 3 bearing the same references as the elements of the Figure 2 represent the same objects.

This flexible pouch was made from a plastic sheath such as plasticized PVC. It comprises at its base two chimneys 21, 22 which are welded between two faces of the sheath when are welded by the upper (not shown) and lower 23 portions of the closure of the pocket.

These chimneys 21, 22 are tubular sections providing fluid communication between the internal volume 24 for receiving a fluid from the pocket and the outside of the pocket. These chimneys can in known manner be used as "injection site" for one of them and "perfusion site" for the second.

The Figure 4 shows a partial view of the cavity of a mold element used for producing the lower portion of a flexible container according to a third embodiment of the invention. This lower portion is intended to receive a single access port to the internal volume of the flexible container.

The portion 25 of the lower portion 26 delimiting the internal volume of the flexible container at its lower end, has a shape of half ellipse.

This portion 25 of the lower portion 26 delimiting the internal volume at its lower end therefore does not necessarily have rectilinear slopes inclined or not, but may have on the contrary a variable curvature from the lateral edges of the container to the access port to guide and route the fluid contained in the internal volume of the container to this port.

In one embodiment of the present invention, the filling behavior of a flexible pouch of the state of the art (filling volume: 470 ml) and a pouch of the present invention as described in FIG. as described above (filling volume: 430 ml).

After filling these pockets, one can observe the presence of many folds on the flexible bag of the state of the art, especially on the side edges of this pocket. These folds are further accentuated after autoclave sterilization of the flexible pouch thus filled. The flexible pouch of the present invention does not have these folds.

With the soft bags of the prior art, there will be distinguished the appearance of two types of folds after filling the flexible bag with the medical solution. Folds called "marked", that is to say, pronounced or very pronounced, and secondary folds called "unmarked".

Unmarked folds are folds that fade after the sterilization step of the flexible pouch and its contents.

The marked folds are folds that remain after sterilization of the flexible bag and its contents, and which, therefore, are able to generate a weakness of the pocket and thus the appearance of leaks in the "transport" test.

The flexible container of the present invention aims in particular the removal of marked folds.

Next will be described another embodiment of the present invention for a flexible container having a height H between the upper and lower portions of 183 mm. <u> TABLE I </ u> depth (in mm) Height (in mm) radius of curvature of the arc (in mm) p / H number of marked folds number of unmarked folds capacity (in ml) 0 0 infinite - 2 plurality 545 5 73 150 0.07 2 plurality 535 10 113 150 0.09 1 3 520 10 139 225 0.07 0 4 489 15 133 150 0.11 0 4 428 20 143 150 0.14 0 4 365 25 163 150 0.15 0 2 304

The initial capacity of a container identical in size but not having necking portions is 545 ml.

It is clear from the reading of Table I that the container comprising necking portions having a p / H ratio of 0.07 (circular arc having a radius of curvature of 225 mm) has no pronounced wrinkles and has a capacity optimal of the order of 90% of the volume of the container without any portion of necking.

Claims (10)

1. A flexible container for medical use comprising at least two superposed walls connected to each other at least at their periphery, said walls thus connected defining an inner volume (11) intended to receive a fluid, an upper portion (12) and a lower portion (13) of said container, said inner volume (11) being placed between said upper portion (12) and lower portion (13) of said container, said container also comprising at least one access element (15) for accessing said inner volume (11),
   the parts of the walls thus connected that define said inner volume (11) comprise on each of the lateral sides of said container, a striction portion (18, 18'), said striction portions (18, 18') being substantially placed opposite and facing each other to form a contraction of said inner volume (11),
   said striction portions (18, 18') are connected to at least one of said upper potion (12) and lower portion (13) of said container by at least one linking portion (19, 19'), and
   characterised in that each of said striction portions (18, 18') being a concave portion, has a depth p and a height H so that the ratio p/H falls between the range ]0, 0.2].
2. A container according to claim 1, characterised in that said ratio p/H falls between 0.05 and 0.11 +/- 10%.
3. A container according to any one of claims 1 to 2, characterised in that said linking portions (19, 19') are non-concave portions.
4. A container according to claim 3, characterised in that said non-concave portions are linear or substantially linear.
5. A container according to any one of claims 1 to 4 characterised in that, with said upper portion defining the inner volume (11) at its upper end, the part of said upper portion in contact with said inner volume (11) has a concave or convex shape.
6. A container according to any one of claims 1 to 5 characterised in that, with said lower portion (13) defining the inner volume (11) at its lower end, the part of said lower portion (13) in contact with said inner volume (11) is V-shaped to avoid a fraction of said fluid to be received in said inner volume (11) from becoming trapped, the branches of said V shape forming an angle of between 45° and 85° in relation to a vertical plane passing by the point of said V shape.
7. A container according to claim 6, characterised in that said angle is between 60° and 70°.
8. A container according to any one of claims 1 to 7, characterised in that the end of the part of said access element (15) placed in said lower portion (13) has a flared shape.
9. A container according to any one of claims 1 to 8, characterised in that the inner volume of said container comprises one or several compartments.
10. A reconstitution assembly comprising a container according to any one of claims 1 to 9 and a transfer set connected to an access element (15) for accessing said inner volume (11) of said container.

Images