EP2782543A1

EP2782543A1 - Blood plasma collecting flask

Info

Publication number: EP2782543A1
Application number: EP12790854.9A
Authority: EP
Inventors: Reinhard Rettinghaus; Hubert Franzaring; Uwe Taborski; Jürgen Schulz
Original assignee: Deutsche Gesellschaft fuer Humanplasma mbH
Current assignee: Octapharma Plasma GmbH
Priority date: 2011-11-22
Filing date: 2012-11-15
Publication date: 2014-10-01
Anticipated expiration: 2032-11-15
Also published as: CN203263807U; US9381134B2; EP2782543B1; US20140324011A1; WO2013076007A1; DE202011052056U1

Abstract

The invention relates to a blood plasma collecting flask consisting of plastic for storing blood plasma in a frozen state, comprising a flask body (1), which has a flask neck (2) on the upper face thereof, wherein connection points (7a, 7b) having connection pieces (8) are provided on the upper face of the flask body (1) on opposite sides of the flask neck (2) and laterally spaced apart from same, of which connection points one connection point (7a) is used to fill the flask body (1) with blood plasma and the other connection point (7b) is used for taking samples, and substantially L-shaped connectors (9) are provided at the connection points (7a, 7b), wherein each connector limb is connected to the connection piece (8) of the flask body (1) and the other connector limb points towards the flask neck (2) and bears a tube (10).

Description

DESCRIPTION

Blood plasma collection bottle

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 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 on its upper side has 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 passage 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.

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 one aspect of the 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, one of which serves to connect the bottle body with blood plasma and the other connection point of the Sampling and in that L-shaped connectors are provided at the connection points in wesent-, wherein in each case one connector leg is connected to the connecting piece of the bottle body and the other connector leg is directed to the bottle neck and carries a hose. According to a further aspect of the invention, the object is achieved in that 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 the connecting piece of this connection point, an L-shaped connector is provided, one of the connector leg is connected to the connecting piece and the other connector leg is directed to the bottleneck and carrying a hose, and wherein the other connection point of ventilation or venting of the bottle body is used and to the connecting piece This connection point a preferably hydrophilic sterile filter is provided.

According to the invention, the connection points are arranged on the left and right of the neck of the bottle and not on the bottleneck itself as in the prior art, as a result of which the overall height is reduced. Substantially L-shaped connectors are provided at the connection points for filling and for sampling in such a way that tubes connected to the connectors extend over the bottleneck. This configuration makes the arrangement as a whole compact.

In this case, one connection point can serve for filling the bottle body with blood plasma and the other connection point for sampling and / or deaeration. Alternatively, it is possible to design a connection point in such a way that it serves to fill the bottle body with blood plasma and to take the sample, so that an L-shaped connector needs to be provided only at this connection point. The other connecting piece is then used exclusively for venting when filling with blood plasma or the ventilation during sampling, so that both processes are carried out easily can. 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 pieces and the L-shaped connectors which come into contact with one another, in particular under pressure, when the L-shaped connectors are fixed to the connecting pieces. 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 sampling point, a sample tube or pilot tube is usually mounted 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. The pilot bag is then closed by welding off its container-side end. 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 Abschweiß- Shen 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 junction serves both the filling of the bottle body with blood plasma and the sampling, the tube connected to the corresponding connector must branch, with the one free end to be connected to the blood plasma apparatus other free end to be attached to the pilot tube or pilot bag.

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 / tubes 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 bottle neck. In addition, the lid may have holding webs on the inside, which engage over and position the long connector legs / hose sections 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. there the locking 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 a release of the lid is prevented from the bottleneck on. In this embodiment, the cover is in the delivery state detachably attached to the bottle neck, ie it is locked in the upper, first latching 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 if the flat or slightly inwardly curved areas have a hexagonal shape whose bases are located at the transition areas of the side surfaces to the top and bottom of the bottle body and are preferably designed so hexagonal evenly that the zwi - See the bases lying 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.

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 shows a blood plasma collection bottle according to the present invention

Invention in front view;

FIG. 2 shows the blood plasma collection bottle from FIG. 1 in an exploded perspective view; 3 shows the blood plasma collection bottle of Figure 1 in a perspective view obliquely from below;

FIG. 4 shows the blood plasma collection bottle from FIG. 1 viewed from below;

FIG. 5 shows the blood plasma collection bottle from FIG. 1 in plan view; on an enlarged scale, the upper area of the blood plasma collection bottle with the lid removed; the blood plasma collection bottle of Figure 1 in a side view; in perspective view of the lid of the blood plasma collection bottle obliquely from below; in an enlarged perspective view of the upper portion of a blood plasma collection bottle with an attached thereto L-shaped connector; the upper portion of the blood plasma collection bottle with two attached L-shaped connectors; an L-shaped connector in an enlarged perspective view; the upper portion of the blood plasma collection container with a lid fixed thereto; and the upper portion of a blood plasma collection container having two pilot bags 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 on its upper side a bottle neck 2 with a top provided cover plate 2a carries. As can be clearly seen in the drawing, the side surfaces of the bottle body 1 each have a flat portion 3 of hexagonal shape whose bases 3a, 3b lie at the transition areas of the side surfaces to the top and bottom of the bottle body 1, wherein the lying between the bases 3a, 3b corners E approximately to nnittiger height of the bottle body. 1 are positioned. 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 middle of the hexagonal area 3 having a depth of approximately 1.5 mm with respect to the edges of the hexagonal area 3. As a result of this embodiment, a type of preload is achieved which counteracts buckling of the bottle body 1 when it is filled with blood plasma.

Furthermore, the bottle body 1 has a total of four stiffening beads 5 which extend around the bottle body 1, two stiffening beads 5 being 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.

On the upper side of the bottle body 1, two connection points 7a, 7b are provided on opposite sides of the bottle neck 2 and laterally spaced therefrom, of which the one connection point 7a filling the bottle body 1 with blood plasma is used and the other connection point 7b of the venting and sampling is used. 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 ter.

As can be seen in particular Figures 9 to 1 1, 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 is pressed onto a connecting piece 8. Furthermore, it is shown in FIG. 11 that on the inner side of the connectors 9 there is in each case formed a sealing surface 9a which comes into sealing contact with a sealing surface 8b at the upper edge of the corresponding connecting piece 8 and under pressure when the connector 9 is connected to the connecting piece 8 is fixed.

At the points away from the connecting piece 8 connector legs hoses 10 are attached. The arrangement is made such that the From the connecting piece 8 pioneering connector legs 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 figure 6, the hoses 10 are shown in the abgeschweißten state, in which the hose ends are located directly above the cover plate 2a. When not welded, the tubes 10 are much longer.

On the cover plate 2a of the bottle neck 2, a lid 1 1 is fixed. This is designed in such a way that in the fixed state it engages over the sections of the tubes 10 projecting beyond the neck 2 of the bottle and protects it against access from the outside. Specifically, the lid 1 1 the hoses 10 associated and open to the underside of the lid, 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 1 1 fixed to the bottle neck 2 becomes. As shown in FIG. 12, the cover 1 1 can also be made so wide that it surrounds the L-shaped connectors 9.

The fixation of the lid 1 1 on the bottle neck 2 via a latching mechanism, when the lid 1 1 is pressed from above onto the bottle neck 2. In this case, the latching mechanism comprises a first detent position in which the lid 1 1 can be released again from the bottle neck 2, and a second detent position in which a release of the lid 1 1 of the bottle neck 2 is substantially no longer possible. Specifically, locking lugs 13 are formed on the lower, open lid edge, which come when depressing the lid 1 1 on the bottle neck 2 with the outer edge region of the cover plate 2 engage, are elastically expanded and resiliently spring back on further depression of the lid 1 1 and under production the first detent position, the cover plate 2a engage behind. In the figure 8 can be clearly seen that the locking lugs 13 in Substantially extend over the entire lower edge region of the lid 1 1. The required elasticity for widening the lid 1 1 receives through 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 1 1 are bent manually outward.

In FIGS. 6 and 8, it can further be clearly seen that an upwardly 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 1 1 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 1 1 is pushed beyond the first detent position further 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, it can be clearly seen in FIG. 7 that the cover 11 carries retaining clips 18 for the detachable attachment of sample tubes 19 on its upper side.

In the state of delivery, the lid 1 1 is fixed on the bottleneck 2 via the upper, first latching point. After the blood plasma collection bottle has been filled in the usual way, the lid 1 1 is removed, and then the tubes 10 are welded so that they find space under the lid 1 1. After welding off the lid 1 1 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 1 1 is prevented. Thus, the hoses 10 are inaccessible for subsequent manipulation. Finally, FIG. 13 shows an embodiment in which, instead of sampling tubes, two pilot bags 20 are connected to the sampling 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 collecting container 1 and the taking of the sample take place via a common connection point 7c, FIG Hose 10 another branch on which then takes place the filling of the bottle.

Claims

1. Blood plasma collection bottle made of plastic for storing blood plasma in the frozen state with a bottle body (1) attached to its

Has a bottleneck (2), characterized in that at the top of the bottle body (1) on opposite sides of the bottle neck (2) and laterally spaced from this connection points (7a, 7b) are provided with connecting pieces (8), of which the a connection point (7a) for filling the bottle body (1) with blood plasma is used and the other connection point (7b) of the sampling and that at the connection points (7a, 7b) substantially L-shaped connectors (9) are provided, in each case one connector leg is connected to the connecting piece (8) of the bottle body (1) and the other connector is to be donated! directed to the bottleneck (2) and carrying a hose (10).

2. Blood plasma collection bottle made of plastic for storing blood plasma in the frozen state with a bottle body (1) having at its top a bottle neck (2), characterized in that at the top of the bottle body (1) on opposite sides of the bottle neck (2) and laterally spaced from this connection points (7c, 7d) are provided with connecting pieces (8), wherein the one connection point (7c) for filling the bottle body (1) with blood plasma and the sampling is used and at the connecting piece (8) of this connection (7c) an L-shaped connector (9) is provided, whose one connector leg is connected to the connection piece (8) and whose other connector leg is directed towards the bottle neck (2) and carries a hose (10), and wherein the other connection point ( 7d) the ventilation or venting of the bottle body (1) and serves at the connecting piece (8) this connection point (7d) is provided a preferably hydrophilic sterile filter.

3. blood plasma collection bottle according to claim 1 or 2, characterized in that at least one L-shaped connector (9) on the associated

Connecting piece (8) by means of a locking connection is held insoluble and self-sealing.

4. blood plasma collection bottle according to claim 3, characterized in that on the connecting piece (8) and the L-shaped connector (9) corresponding sealing surfaces (8b, 9b) are formed, which come into contact with each other in particular under pressure when the L-shaped connector

(9) is fixed to the connecting piece (8).

5. blood plasma collection bottle according to claim 4, characterized in that the hose (10) which is connected to the L-shaped connector (9) at the sampling point serving connection (7b, 7c), at its free end at least one pilot bag (20 ) and is connected thereto, wherein the pilot bag (20) has a vent opening (23) in which a hydrophilic frit (24) is provided.

6. blood plasma collection bottle according to claim 5, characterized in that the pilot bag (20) has a tubular Abschweißende (22), at the free end of the vent opening (23) is formed and in which the hydrophilic frit (24) is positioned.

7. blood plasma collection bottle according to claim 5 or 6, characterized in that two pilot bag (20) with the hose (10) which is connected to the connector (9) of the connection point (7b, 7c) for sampling, are connected via a corresponding, in particular Y-shaped connecting hose (21).

8. blood plasma collection bottle according to one of the preceding claims, characterized in that a cover (1 1) on the bottle neck (2) and in particular on a bottle neck (2) on its upper side closing cover plate (2a) is fixed or fixable, and the lid (1 1) is designed such that in the fixed state over the bottle neck (2) protruding portions of the hose (10) and the tubes (10) overlaps and protects against access from the outside.

9. blood plasma collection bottle according to claim 8, characterized in that the lid (1 1) is designed such that it in the fixed state, the connection points (7a, 7b, 7c, 7d) overlaps and protects against access from the outside.

10. blood plasma collection bottle according to claim 8 or 9, characterized in that the lid (1 1) the hose (10) or the hoses (10) and associated with the underside of the lid open recesses, the / of the hose (10) or ., the hoses (10) is taken or become, when the lid (1 1) is fixed to the bottle neck.

11. Blood plasma collection bottle according to one of claims 8 to 10, characterized in that the cover (1 1) on the inside holding webs up, which the over the bottle neck (2) projecting hose (10) or via the bottle neck (2) protruding hoses (10) overlap and position when the lid (1 1) is fixed to the bottle neck (2).

12. blood plasma collection bottle according to one of claims 8 to 1 1, characterized in that a latching mechanism is provided via which the lid (1 1) on the bottle neck (2) and in particular the cover plate (2a) is fixed when the lid (1 1) from above the bottle neck (2) is pressed, wherein the latching mechanism has a first detent position, in which the (1 1) lid can be released again from the bottle neck (2), and a second detent position, in which the lid (1 1) further on the bottle neck (2) is pressed as in the first detent position and in the release of the Cover (1 1) of the bottle neck (2) is prevented has.

13. blood plasma collection bottle according to claim 12, characterized in that on the lower, open lid edge locking lugs (13) are formed when pressing the lid (1 1) on the bottle neck (2) with a on the bottleneck (2) formed holding web and In particular, the outer edge region of the cover plate (2a) engage, are elastically widened and elastically spring back upon further pressing and engage behind the retaining web to produce the first detent position.

14. Blood plasma collection bottle according to claim 12 or 13, characterized in that at the top of the bottle neck (2) and in particular the cover plate (2a) an upright projecting web (14) and on the inside of the lid a to the web (14) corresponding receptacle (15) are formed, which engage with each other when the lid (1 1) on the bottle neck (2) is pressed, and that on the web (14) and the receptacle (15) locking elements (16, 17) of the locking mechanism are formed, which come into engagement with each other in the second detent position.

15. blood plasma collection bottle according to claim 14, characterized in that in the web (14) has a latching opening (16) is formed, in which in the second detent position a receiving side provided latching element (17) engages.

16. blood plasma collection bottle according to one of claims 8 to 15, characterized in that on the lid (1 1) and in particular the

Lid top holding elements, in particular holding clips (18) for releasably attaching sample tube (19) are provided.

17 blood plasma collection bottle according to one of the preceding claims, characterized in that the side surfaces of the bottle body (2) each define a flat or slightly inwardly curved portion (3), followed by the end faces rounded areas.

18. Blood plasma collection bottle according to claim 17, characterized marked, that the side surfaces of the bottle body (2) each define a slightly inwardly curved portion (3), wherein the curvature has a maximum depth of 2 mm, in particular of 1, 5 mm.

19. Blood plasma collection bottle according to claim 17 or 18, character- ized in that the flat or slightly inwardly curved areas

(3) have a hexagonal shape whose bases (3a, 3b) lie at the transition areas of the side surfaces to the top and bottom of the bottle body (1), in particular the flat or slightly curved areas (3) have a uniform hexagonal shape such in that the corners (E) located between the base sides (3a, 3b) are positioned approximately at the central height of the bottle body (1).

20. blood plasma collection bottle according to claim 19, characterized in that the lying between the bases (3a, 3b) sides of the hexagonal gonal areas (3) are slightly rounded.