EP2782543B1 - Blood plasma collecting flask - Google Patents

Description

The present invention relates to a blood plasma collection bottle made of plastic for storing blood plasma in the frozen state with a bottle body having a bottleneck on its upper side.

Blood plasma collection containers have been known in the form of plastic bags for many years and have proven themselves through the use of materials such as ethylene-vinyl acetate (EVA) and polyethylene (PE) during freezing. The disadvantage of blood plasma collection containers in the form of blood bags is the poor handling, as they can not be set up without tools or special designs and also there is a risk that they will be damaged in the frozen state when dropped. In addition, they bulge out unchecked, so that the amount is difficult to control.

For this reason in the DE 20 2007 012 912 U1 proposed to use blood plasma collection bottles made of plastic, the bottle body in horizontal section has a cross-section rectangular basic shape and has on its upper side a closed by a cover bottle neck. On the cover plate two connection points are provided, one of which is provided a connection point for filling the bottle body with blood plasma and the other connection point of the venting and sampling is used. On the cover plate, a lid can be fastened to protect the connection points. This has two slots, which serve the implementation of fixed at the connection points hoses.

During the plasma dispensing, the lid is in a position where the tubing passes unhindered through the slots. After completion of the plasma donation, the tubes are cut off and welded. To fix the free ends of the cut tubes, the lid is rotated, pulling the free ends into the lid.

Although the known blood plasma collection bottle has proven itself in practice, efforts are still being made to further improve functionality and manageability.

EP 2 433 608 also describes a plastic blood plasma collection bottle for storing blood plasma in the frozen state.

Object of the present invention is therefore to design a blood plasma collection bottle made of plastic for the storage of plasma in the frozen state of the type mentioned so that their handling is improved. In particular, the operability is simplified and the dimensional stability can be increased.

This object is achieved according to the present invention in that are provided on the upper side of the bottle body on opposite sides of the bottle neck and laterally spaced from this connection points with connecting pieces, wherein the one connection point filling the bottle body with blood plasma and the sampling is used and to the connecting piece this connection point is provided with an L-shaped connector, whose one connector leg is connected to the connection piece and whose other connector leg is directed towards the bottle neck and carries a hose, and wherein the other connection point serves for aeration or venting of the bottle body and at the connecting piece of this connection point a preferably hydrophilic sterile filter is provided.

According to the invention, a connection point is designed such that it serves to fill the bottle body with blood plasma and to take the sample. At this connection point, an L-shaped connector is provided, whose one connector leg is directed towards the bottleneck. The other connection piece is used only for venting when filling with blood plasma or the ventilation during sampling, so that both processes can be carried out easily. This connection piece is equipped with a preferably hydrophilic sterile filter. This can be inserted in the connection piece.

The L-shaped connectors are permanently attached to the connecting piece. For example, the connectors may be glued or welded to the spigot. Preferably, however, they are non-detachable and self-sealingly fixed to the connecting piece by means of a latching connection. For this purpose, corresponding sealing surfaces can be formed on the connecting piece and the L-shaped connectors, which come into contact with each other in particular under pressure when the L-shaped connectors are fixed to the connecting piece. The sealing surfaces may be provided, for example, at the upper edge of the connecting piece and a corresponding annular surface on the inside of the connector.

At the hose which is connected to the sampler connection point, a sample tube or pilot tube is usually used for sampling. According to one embodiment of the present invention, the hose carries at least one pilot bag at its end, the pilot bag having a vent in which a hydrophilic frit is provided. In this embodiment, the sampling takes place in a simple manner in that the blood plasma collection container is tilted so that liquid flows from the container into the pilot bag. Subsequently, the pilot bag is sealed by its container-side end is welded. Furthermore, the vent is closed. This is preferably formed in a tubular Abschweißende the pilot bag, in which also the hydrophilic frit is positioned, so that the vent opening can be closed by welding the Abschweißendes.

Preferably, two pilot bags are connected to the hose of the connection point for the venting and sampling via a corresponding, in particular Y-shaped connecting hose. In the embodiment in which a connection site serves both to fill the bottle body with blood plasma and to take the sample, the tube connected to the corresponding connector must branch, with one free end to be connected to the blood plasma apparatus and to the other free one End the pilot tubes or pilot bags are attached.

In a manner known per se, a lid can be fixed or fixable to the bottleneck and in particular to a cover flap closing the top of the bottle. This is designed such that it engages over the bottle neck protruding portions of the tubes in the fixed state and so positioned. The cover can be designed so that it overlaps in the fixed state, the connection points and also protects from access from the outside.

In an embodiment of the invention it is provided that the cover has the connectors / hoses associated and open towards the lid bottom recesses, which engage with the projecting over the bottle neck tube sections and are penetrated by these, when the lid is fixed to the neck of the bottle. In addition, the lid may have on the inside holding webs, which engage over the long connector legs / hose sections and position when the lid is fixed to the bottle neck.

Preferably, a latching mechanism is provided, via which the lid is fixed to the bottle neck and in particular the cover plate when the lid is pressed onto the bottleneck from above. In this case, the latching mechanism according to a further aspect of the invention, a first detent position, in which the lid can be released again from the bottle neck, and a second detent position, in which the lid is further pressed onto the bottle neck than in the first detent position and in the a release of the lid is prevented from the bottleneck on. In this embodiment, the cover is releasably attached to the bottleneck as delivered, i. he is locked in the upper, first resting point. This makes it possible to detach the lid for filling the blood plasma collection bottle and then welding off the connectors from the bottleneck. After welding off the lid can then be finally fixed to the bottle neck by being brought into the second detent position in which a release is no longer possible.

In an embodiment of this embodiment it can be provided that latching noses are formed on the lower, open edge of the lid, which engage when pressing the lid on the bottleneck with a retaining web formed on the bottleneck and in particular the outer edge region of the cover, are elastically expanded and at resiliently spring back further impressions and engage behind the retaining web to produce the first detent position.

Furthermore, it can be provided that at the top of the bottle neck and in particular the cover plate an upright projecting web and the lid inside a corresponding to the web receptacle are formed, which engage with each other when the lid is pressed onto the bottle neck and that The web and the recording locking elements of the locking mechanism are formed, which come into engagement with each other in the second detent position.

In this case, a latching opening may be formed in the web, in which engages a receiving side provided latching element in the second detent position.

In an embodiment of the invention it is provided that retaining elements, in particular holding clips for the detachable attachment of sample tubes, are provided on the lid and in particular on the top side of the lid. This embodiment offers the possibility to deliver the sample tubes as a unit with the blood plasma collection bottle.

In a development of the blood plasma collection bottle according to the invention, the side surfaces of the bottle body can each define a flat or slightly inwardly curved region, followed by rounded areas to the end surfaces. It has been shown that bottle bodies shaped in this way are particularly dimensionally stable. This is especially true when the areas are slightly curved inward, with the dome having a maximum depth of 2mm, especially 1.5mm from the edges of the dome. The inward curvature a kind of bias is achieved, which counteracts buckling of the bottle body during filling. The stability of the bottle is further increased when the flat or slightly inwardly curved portions have a hexagonal shape whose bases are at the transitional areas of the side surfaces lie to the top and bottom of the bottle body and are preferably configured such hexagonal evenly that the lying between the bases corners are positioned approximately at the central height of the bottle body. The bottle body then has a shape obtained by flattening an oval or round body, in which case the sides of the hexagonal faces lying between the bases are slightly rounded.

Furthermore, the bottle body may include a plurality of stiffening beads that extend around the bottle body and are preferably positioned to function, at least in part, as a level indicator. For this purpose, a total of four stiffening beads may be formed on the bottle body, wherein in particular two stiffening beads are provided on the upper bottle body half and two stiffening beads in the lower bottle body half.

Figur 1

eine Blutplasmasammelflasche gemäß der vorliegenden Erfindung in Vorderansicht;

Figur 2

die Blutplasmasammelflasche aus Figur 1 in perspektivischer Explosionsansicht;

Figur 3

die Blutplasmasammelflasche aus Figur 1 in perspektivischer Darstellung von schräg unten;

Figur 4

die Blutplasmasammelflasche aus Figur 1 von unten betrachtet;

Figur 5

die Blutplasmasammelflasche aus Figur 1 in Draufsicht;

Figur 6

in vergrößerter Darstellung den oberen Bereich der Blutplasmasammelflasche bei entferntem Deckel;

Figur 7

die Blutplasmasammelflasche aus Figur 1 in einer Seitenansicht;

Figur 8

in perspektivischer Darstellung den Deckel der Blutplasmasammelflasche von schräg unten;

Figur 9

in vergrößerter perspektivischer Ansicht den oberen Bereich einer Blutplasmasammelflasche mit einem daran fixierten L-förmigen Konnektor;

Figur 10

den oberen Bereich der Blutplasmasammelflasche mit zwei daran befestigten L-förmigen Konnektoren;

Figur 11

einen L-förmigen Konnektor in vergrößerter perspektivischer Darstellung;

Figur 12

den oberen Bereich des Blutplasmasammelbehälters mit einem daran fixierten Deckel; und

Figur 13

den oberen Bereich eines Blutplasmasammelbehälters mit zwei Pilotbeuteln, welche mit einem der Konnektoren verbunden sind.

With regard to further advantageous embodiments of the invention, reference is made to the dependent claims and the following description of an embodiment with reference to the accompanying drawings. In the drawing shows:

FIG. 1

a blood plasma collection bottle according to the present invention in front view;

FIG. 2

the blood plasma collection bottle FIG. 1 in a perspective exploded view;

FIG. 3

the blood plasma collection bottle FIG. 1 in perspective view obliquely from below;

FIG. 4

the blood plasma collection bottle FIG. 1 viewed from below;

FIG. 5

the blood plasma collection bottle FIG. 1 in plan view;

FIG. 6

on an enlarged scale, the upper area of the blood plasma collection bottle with the lid removed;

FIG. 7

the blood plasma collection bottle FIG. 1 in a side view;

FIG. 8

in perspective view of the lid of the blood plasma collection bottle obliquely from below;

FIG. 9

in an enlarged perspective view of the upper portion of a blood plasma collection bottle with an attached thereto L-shaped connector;

FIG. 10

the upper portion of the blood plasma collection bottle with two attached L-shaped connectors;

FIG. 11

an L-shaped connector in an enlarged perspective view;

FIG. 12

the upper portion of the blood plasma collection container with a lid fixed thereto; and

FIG. 13

the upper portion of a blood plasma collection container with two pilot bags, which are connected to one of the connectors.

In the drawing, a blood plasma collection bottle for storing blood plasma in the frozen state according to the present invention is shown. The blood plasma collection bottle is made of plastic, in particular polyethylene (PE) and has a bottle body 1, which has a cross-section rectangular basic shape in horizontal section and carries on its upper side a bottle neck 2 with a top provided cover plate 2a. As can be clearly seen in the drawing, the side surfaces of the bottle body 1 each define a flat portion 3 of hexagonal shape, the bases 3a, 3b lie at the transition areas of the side surfaces to the top and bottom of the bottle body 1, wherein between the bases 3a, 3b lying corners E are positioned approximately at the central height of the bottle body 1. In this case, the sides 3c, 3d, 3e, 3f of the hexagonal surface 3 lying between the base sides 3a, 3b are slightly rounded off. On the flat side surfaces of the bottle body 1 close to the end faces, which have a rounded shape. Overall, therefore, the bottle body 1 has a shape that is obtained when flattening a base round or oval shape. It can not be seen in the drawing that the flat areas 3 can also be slightly curved inwards, the curvature in the center of the hexagonal area 3 having a depth of about 1.5 mm with respect to the edges of the hexagonal area 3. By this configuration, a kind of bias is achieved, which counteracts buckling of the bottle body 1 when filling with blood plasma.

Furthermore, the bottle body 1 has a total of four stiffening beads 5, which extend around the bottle body 1, wherein two stiffening beads 5 are provided in the upper bottle body half and two stiffening beads 5 in the lower bottle body half. The upper two stiffening beads 5 act as a level indicator.

On the underside of the bottle body 1, three adjustable feet 4 are provided, by which it is ensured that the flat blood plasma collection bottle can be stably placed.

At the top of the bottle body 1, two connection points 7a, 7b are provided on opposite sides of the bottle neck 2 and laterally spaced therefrom, one of which 7a serves to fill the bottle body 1 with blood plasma and the other connection point 7b serves for venting and sampling. At the connection points 7a, 7b firmly connected to the bottle body 1 connecting piece 8 are provided, on which L-shaped connectors 9 are held insoluble.

Alternatively, the bottle body 1 may have two connection points 7c, 7d, of which one connection point 7a serves both for filling the bottle body 1 with blood plasma and for sampling. As can be seen from FIG. 9, in this case only an attachment piece 8 of the connection point 7c serving for filling and sampling is provided with an L-shaped connector 9. The connecting piece 8 of the other connection point 7d is used only for loading and bleeding the bottle body 1. In the connecting piece 8, a non-illustrated hydrophilic sterile filter is housed.

How the particular FIGS. 9 to 11 can be seen, the L-shaped connectors 9 are fixed to the connecting piece 8 by a latching mechanism. For this purpose, in the lower end region of the connecting piece 8 an outwardly projecting latching shoulder 8a and the inside of the connectors 9 a corresponding latching lug 9a is formed, which engages the latching shoulder 8a latching when a connector 9 pressed onto a connecting piece 8 becomes. Furthermore, in FIG. 11 shown that on the inside of the connectors 9 each have a sealing surface 9a is formed, which comes to a sealing surface 8b at the upper edge of the corresponding connecting piece 8 sealingly and under pressure into contact when the connector 9 is fixed to the connecting piece 8.

At the points away from the connecting piece 8 connector legs hoses 10 are attached. The arrangement is made such that the connector legs pointing away from the connecting piece 8 are directed to the bottle neck 2, so that the tubes 10 held thereon extend over the cover plate 2a of the bottle neck 2. In the FIG. 6 the hoses 10 are shown in the welded state, in which the hose ends are located directly above the cover plate 2a. In unabgeschweißtem state, the tubes 10 are significantly longer.

On the cover plate 2a of the bottle neck 2, a lid 11 is fixed. This is designed such that it overlaps in the fixed state over the bottle neck 2 projecting portions of the tubes 10 and protects against access from the outside. Specifically, the lid 11 the hoses 10 associated and the lid bottom side open, slot-shaped recesses 12, which come into engagement with the projecting over the bottle neck 2 tube sections and are penetrated by these when the lid 11 is fixed to the bottle neck 2. Like in the FIG. 12 is shown, the lid 11 may also be formed so wide that it surrounds the L-shaped connectors 9.

The fixing of the lid 11 to the bottle neck 2 via a latching mechanism when the lid 11 is pressed from above onto the bottle neck 2. In this case, the latching mechanism comprises a first detent position, in which the lid 11 are released again from the bottle neck 2 can, and a second detent position in which a release of the lid 11 of the bottle neck 2 is substantially no longer possible. Specifically, latching lugs 13 are formed on the lower, open lid edge, which come when depressing the lid 11 on the bottle neck 2 with the outer edge region of the cover plate 2 engage, are elastically expanded and elastically spring back on further depression of the lid 11 and to produce the first Detent position engage behind the cover plate 2a. In the FIG. 8 is clearly visible that the locking lugs 13 extend substantially over the entire lower edge region of the lid 11. The required elasticity for widening the cover 11 is replaced by the recesses 12 for the tubes 10. The engagement between the locking lugs 13 and the cover plate 2a can be solved again by the lower edge regions of the lid 11 are bent manually outwards.

In the FIGS. 6 and 8th Furthermore, it can be clearly seen that an upright projecting web 14 is formed on the upper side of the cover plate 2a and a receptacle 15 corresponding to the web 14 is formed on the inner side of the cover, which engage with one another when the cover 11 is pressed onto the bottle neck 2. In this case, 14 resting latching opening 16 is formed on the web, with which a receiving side provided latching tooth 12 engages when the lid 11 is pushed beyond the first detent position on the bottle neck 2 in the second detent position. The engagement region between the latching opening 16 and the latching tooth 17 is not accessible from the outside, so that a release of this connection is prevented.

Finally, in the FIG. 7 clearly recognizable that the lid 11 carries at its top retaining clips 18 for releasably attaching sample tube 19. In the delivery state, the lid 11 is fixed on the bottleneck 2 via the upper, first latching point. After the blood plasma collection bottle has been filled in a conventional manner, the lid 11 is removed, and then the tubes 10 are welded so that they fit under the lid 11. After welding, the lid 11 is again attached to the bottle neck 2 and thereby depressed so far that a fixation on the second detent position takes place, so that a renewed removal of the lid 11 is prevented. Thus, the hoses 10 are inaccessible for subsequent manipulation.

In the FIG. 13 Finally, an embodiment is shown in which instead of sampling tube two pilot bags 20 are connected to the sampler serving connector 9. Specifically, the hose 10, which is connected to the free end of the L-shaped connector 9 at the sampling point serving connection 7 b, connected at its free end via a Y-shaped connecting hose 21 with the two pilot bags 20. These engage with a Abschweißende in the Y-shaped connecting tube 21 sealing and are firmly connected to this. At its opposite end region, the pilot bags 20 have a hose-like Abschweißende 22 with a vent opening 23, wherein in the Abschweißende 22, a hydrophilic frit 24 is housed.

In this embodiment, the sampling is carried out in a simple manner in that the blood plasma collection container is tilted so that liquid flows from the bottle body 1 into the two pilot bags 20 until the hydrophilic frit 24 closes. Subsequently, the pilot bags 20 are welded at their two Abschweißenden 22.

Instead of the Y-shaped connecting tube 21 may also be provided a connecting tube with three or more ports, the other ports then form ventilation openings in which hydrophilic sterile filter or frits are provided, via which air can escape from the bottle body 1 during the filling of the blood plasma collection container ,

In the case of a blood plasma collection container according to FIG. 9 , in which both the filling of the blood plasma collection container 1, as well as the sampling takes place via a common connection point 7c, the hose 10 has a further branch, via which then the filling of the bottle takes place.

Claims (13)

1. A blood plasma collecting flask made of plastic for the storage of blood plasma in the frozen state, comprising a flask body (1) which has on its upper side a flask neck (2), wherein connection points (7c, 7d) with connection ports (8) are provided on the upper side of the flask body (1) on opposite sides of the flask neck (2) and spaced apart from the latter to the side, wherein one connection point (7c) is used for filling the flask body (1) with blood plasma and the taking of samples and a substantially L-shaped connector (9) is provided at this connection point (7c), the one connector arm of which being connected to the connecting port (8), and the other connector arm being directed towards the flask neck (2) and bearing a tube (10) and wherein the other connection point (7d) is used for ventilation, characterized in that a preferably hydrophilic sterile filter is provided on the connection port (8) of this connection point (7d).
2. The blood plasma collecting flask according to claim 1, characterized in that at least one L-shaped connector (9) is attached to the associated connection port (8) by means of latch connection in an unreleasable and self-sealing manner, wherein in particular sealing faces (8b, 9b) corresponding to one another are formed on the connection port (8) and the L-shaped connector (9), that come into contact with each other under pressure, when the L-shaped connector (9) is fixed to the connection port (8).
3. The blood plasma collecting flask according to claim 1 to 2, characterized in that the tube (10), that is connected with the L-shaped connector (9) at the connection point (7c) which is used for the taking of samples carries at its free end at least one pilot bag (20) and is connected to the later, wherein the pilot bag (20) has a ventilation opening (23), in which is provided a hydrophilic frit.
4. The blood plasma collecting flask according to claim 3, characterized in that the pilot bag (20) has a tubular welding end (22), at the free end of which the ventilation opening (23) is provided and in which the hydrophilic frit (24) is positioned.
5. The blood plasma collecting flask according to claim 4, characterized in that two pilot bags (20) are connected via a corresponding, in particular Y-shaped connection tube (21) with the tube (10), that is connected with the L-shaped connector (9) of the connection port (7c) for the taking of samples.
6. The blood plasma collecting flask according to any of the preceding claims, characterized in that a lid (11) is fixed or fixable to the flask neck (2), and in particular to a covering plate (2c) closing the flask neck (2) on its upper side, and the lid (11) is designed such that in the fixed state it overlaps the sections of the tube (10) or the tubes (10) and protects them from outer access, wherein in particular the lid (11) is designed such that in the fixed state it projects over the connection points (7a, 7b; 7c, 7d) and protects them from outer access.
7. The blood plasma collecting flask according to claim 8 or 9, characterized in that the lid (11) has notches assigned to the connector tube (10) or the tubes (10) and are open towards the lower side of the lid, which the tube (10) or the tubes (10) pass, when the lid (11) is fixed to the flask neck, and/or that the lid (11) has on the inside holding bars, which overlap the tube (10) or the tubes (10) extending over the flask neck (2) and position them, when the lid (11) is fixed to the flask neck (2).
8. The blood plasma collecting flask according to claim 6 or 7, characterized in that a locking mechanism is provided by means of which the lid (11) is fixed onto the flaks neck (2) and in particular on the cover plate (2a), when the lid (11) is pushed onto the flask neck (2) from above, wherein the locking mechanism has a first locking position, in which the lid can be released again from the flask neck (2), in the second locking position, in which the lid (11) is pushed further onto the flask neck (2) in the first locking position and in which the lid (11) is prevented from being released from the flask neck, wherein in particular lugs (13) are formed on the lower, open lid edge which, upon pushing the lid (11) onto the flask neck (2), engaged with a holding bar formed on the flask neck (2), and in particular onto the outer edge region of the covering plate (2a) are elastically expanded, and when pushed on further spring back elastically and engage behind the holing bar thus establishing the first locking position.
9. The blood plasma collecting flask according to claim 8, characterized in that on the upper side of the flask neck (2) and in particular on the covering plate (2a) a bar (14) projecting uprightly and on the inside of the lid a retainer (15) corresponding to the bar (14) are formed, which engage with one another when the lid (11) is pushed onto the flask neck (2), and that locking elements (16, 17) are formed on the bar (14) and the retainer (15) which engage with one another in the second locking position, wherein in particular a locking opening (16) is formed in the bar (14) in which a locking element (17) provided on the retainer side engages in the second locking position.
10. The blood plasma collecting flask according to any of the preceding claims, characterized in that the lateral faces of the flaks body (2) respectively define a flat or slightly inwardly curved area (3) adjoining which are areas rounded towards the faces surfaces.
11. The blood plasma collecting flask according to claim 10, characterized in that the side faces (2) are defined slightly inwards curved areas, wherein the curvature has a maximum depth of 2 mm, in particular of 1.5 mm.
12. The blood plasma collecting flask according to claim 10 or 11, characterized in that the flat or slightly inwardly curved areas have a hexagonal form, the side faces (3a, 3b) of which lay on the crossover areas of the lateral faces to the upper side and lower side of the flask body (1), wherein in particular the flat or slightly curved areas (3) have a uniformly hexagonal form such that the corners lay between the base sides are positioned approximately half way up the flask body (1).
13. The blood plasma collecting flask according to claim 12, characterized in that the sides of the hexagonal surfaces (3) lying between the base sides (3a, 3b) are slightly rounded.

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