GB1591989A

GB1591989A - Container containing blood

Info

Publication number: GB1591989A
Application number: GB38140/77A
Authority: GB
Original assignee: Solco Basel AG
Current assignee: ICN Switzerland AG
Priority date: 1976-09-16
Filing date: 1977-09-13
Publication date: 1981-07-01
Also published as: DE2741398A1; FR2364664B1; IE45883B1; IT1085417B; CH625416A5; JPS5338189A; IE45883L; BE858691A; FR2364664A1

Abstract

The container has an upper part A, a lower part B and a tubular middle piece C connecting the two parts A and B. Furthermore, there are connections 1, 2, 3, 4 for the withdrawal and transfusion of blood. After the container is filled with blood it is sealed in an air-tight manner and stored in a refrigerator at about +4 DEG C. Erythrocyte sedimentation has taken place after a few hours, so that a clamp can be placed above the buffy coat separating the erythrocytes from the plasma. The undesirable diffusion of haemoglobin and potassium from the erythrocytes into plasma is effectively prevented. If necessary, the buffy coat can be isolated with a second clamp and withdrawn with a syringe. If and when required, erythrocytes and plasma can be mixed in the container or used separately.

Description

(54) CONTAINER CONTAINING BLOOD (71) We, SOLCO BASELAG, a Swiss body Corporate, of Gellertstrasse 18, CH4052 Basle, Switzerland, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed to be particularly described in and by the following statement: This invention relates to a container containing blood, more particularly of the type employed for storing blood for transfusion.

Transfusions of blood or blood components may be effected with whole blood, erythrocyte or red blood cells, or with plasma. Erythrocyte transfusion is gaining favour and separations of whole blood into erythrocyte and plasma components are accordingly being made more and more regularly.

After whole blood has been stored for about eight hours at about 2 to 60C, erythrocyte and plasma components will normally have separated. After some days a layer, known as buffycoat, forms at the interface between the erythrocyte and plasma components. Buffycoat is inclined to block filters provided in infusion sets. It is accordingly of advantage if buffycoat is removed or otherwise isolated from other components prior to infusion.

Additionally, after blood has been stored for a time, diffusion of potassium and haemoglobin from the erythrocyte component into the plasma component takes place. Potassium in higher concentrations and haemoglobin are toxic. It would be of benefit to prevent such diffusion into the plasma component.

Using a container embodying the present invention, infusion of any one of whole blood, erythrocyte component or plasma component can be performed and furthermore blood components which have separated can be sealed off from one another if desired.

In accordance with the invention, there is provided a container containing blood and comprising a first container element, a second container element, a conduit for connecting together the bottom of the first container element and the top of the second container element, and means for withdrawing a blood component from each of the container elements, the first and second container elements being so disposed and of such a volume that when the container is held vertically with the first container element above the second container element and the blood components have separated from one another, the first container element contains only the plasma component of the blood and the second container element contains only or mainly the erythrocyte component of the blood and the conduit being of such a length and volume that the interface between plasma and erythrocyte is situated in the conduit or can be displaced into the conduit from the second container element the conduit being closable to optionally seal off the blood components from one another.

The conduit may be of flexible material and hence closable by clamping together the walls of the conduit. Clamp means, such as a clip, may be provided for clamping together the walls of the conduit. Advantageously, the entire container, i.e. both the first and second container elements, are of a flexible material and the conduit is formed integrally with the first and second container elements.

The invention will now be described with reference to the accompanying drawings showing, by way of example, two alternative constructions of a blood container in accordance with the invention.

In the drawings, Figures 1 and 2 show side views of containers made up of flattened flexible tubular plastics material.

The containers of Figures 1 and 2 comprise a first container element 10 and a second container element 12. A conduit 14 is provided for connecting together the bottom of the first container element 10 and the top of the second container element 12.

Tubing 16, which would normally be provided with a needle at its free end (not shown) is provided for introducing blood into the container elements 10 and 12. It will be appreciated that blood filled into the first container element 10 through tubing 16 will flow into the second container element 12 through conduit 14 and both container elements will accordingly be filled.

Conventional means, referred to generally by reference numerals 18, for withdrawing a blood component from each of the container elements are provided. The blood component, it is to be understood, can be any one of whole blood, plasma component or erythrocyte component.

The means for withdrawing blood component may for example comprise short lengths of tubing 20 leading into the top and bottom of the first and second container elements respectively.

The lengths of tubing are normally sealed closed at 19 with plastics material through which a trocar may be passed to gain access to the contents of the container elements. Each of the container elements is most conveniently provided with two alternative access means.

Collection sachets 17 connected to the short lengths of tubing 20 are provided within the container elements. The free ends of the short lengths of tubing are sealed closed by seals 15 to prevent contamination. The seals may be broken by pulling apart tabs 23.

The respective volumes of the first and second container elements 10 and 12 and the length and volume of the conduit 14, in accordance with the invention, should be such that, after filling the container elements 10 and 12 with blood, storing of the container in a refrigerator with the first container element 10 above the second container element 12 leads to the first container element 10 being completely filled with plasma, the second container element 12 being completely filled with erythrocyte, the conduit containing the interface between the plasma and erythrocyte. The storage is best done by hanging the container from a hang tab provided on the top of the first container element 10. The conduit should be of a length and volume sufficient to ensure that the surface dividing plasma from erythrocyte and the buffy coat at this interface is situated in the conduit 14. I-lowever, it is to be understood that volume adjustments can be made by squeezing the flexible constructions shown in the drawings so that displacement of the interface between plasma and erythrocyte can be effected.

The conduit 14 shown in the drawings is of flexible material and may hence be closed by clamping together the walls of the conduit.

It will be readily appreciated that in order to prevent a volume of erythrocyte becoming entrapped in the first container element 10, it is desirable that the bottom of the first container element be inclined downwardly towards the conduit 14. Similarly, it is desirable that the top of the second container element 12 be inclined downwardly from the conduit 14.

In the construction shown in Figure 1 of the drawings, a first seal 22 across the width of the tubular plastics material defines a top of both the container as a whole and the first container element 10. A second seal 24 inclined downwardly from one edge 25 of the flattened tubular plastics material to a point 26 short of the other edge 27 of the flattened tubular plastics material defines a downwardly inclined bottom of the first container element 10 and an opening 29 to the conduit 14. A third seal 28, parallel to the edge 27 of the flattened tubular plastics material leads downwardly from point 26 and defines the conduit 14. A fourth seal 30 inclined downwardly from the lower end 32 of the third seal 28 to edge 25 of the flattened tubular plastics material defines a downwardly inclined top of the second container element 12 and an opening 34 to the conduit 14. A fifth seal 36 across the width of the flattened tubular plastics material defines a bottom of both the container as a whole and the second container element 12.

In the construction shown in Figure 2, the first and fifth seals 22 and 36, are the same as in Figure 1. The second, third and fourth seals, however, are pairs of seals 24a, 24b, 28a, 28b, and 30a and 30b respectively.

As in the construction shown in Figure 1, the construction shown in Figure 2 has a downwardly inclined bottom of the first container element 10 and a downwardly inclined top of the second container element 12. The conduit 14 is however centrally located.

In the construction of Figure 1, a slit 40 is provided through which a clamping device such as a clip may be passed. In the construction of Figure 2, a pair of slits 40a and 40b is provided for the same purpose.

Once erythrocyte and plasma components have separated out, a clamp or clip may be employed to seal the conduit 14 and hence separate the two components. Advantageously, such a clamp would be placed immediately above the interface between erythrocyte and plasma. This clamping can best be done shortly after erythrocyte and plasma components have separated, e.g. after about 8 hours. In this manner diffusion of toxic substances from the erythrocyte component into the plasma component can be prevented. Delivery of blood to hospitals can conveniently be made with this one clamp in place. The attending physician then has the option of several types of infusion.

If erythrocyte infusion is desired, this may be done by employing only the contents of the second container element. If such infusion is desired and buffycoat has already formed and it is desired to infuse erythrocyte component free of buffycoat, a further clamp may be placed below the buffycoat, which is thus isolated from each of the erythrocyte and plasma components. Buffycoat may then be removed from the conduit 14, for example by means of a syringe. Where whole blood infusion is desired, this may be carried out by mixing together erythrocyte and plasma components by alternately pressing together the first and second container elements 10 and 12. The container elements would normally not be filled completely, which enables mixing of components.

It will be appreciated that such mixing could be affected after removal of buffycoat.

Another alternative for whole blood infusion is to simultaneously infuse from both the first and second container elements via a mixer device (not shown) such as one simply involving Y-piece tubing. Such infusion can of course be effccted after havin6 clamped off buffycoat in the conduit. The first and second container elements would then be suspended from a point in the conduit 14 and the top of the first container element would then be folded down to a position adjacent the bottom of the second container element.

WHAT WE CLAIM IS: 1. A container containing blood and comprising a first container element, a second container element, a conduit for connecting together the bottom of the first container element and the top of the second container element, and means for withdrawing a blood component from each of the container elements, the first and second container elements being so disposed and of such a volume that when the container is held vertically with the first container element above the second container element and the blood components have separated from one another, the first container element contains only the plasma component of the blood and the second container element contains only or mainly the erythrocyte component of the blood, and the conduit being of such a length and volume that the interface between plasma and erythrocyte is situated in the conduit or can be displaced into the conduit from the second container element, the conduit being closable to optionally seal off the blood components from one another.

2. A container according to claim 1, in which the conduit is of a flexible material and hence closable by clamping together the walls of the conduit.

3. A container according to claim 2, in which the first and second container elements are of a flexible material and in which the conduit is formed integrally with the first and second container elements.

4. A container according to claim 3, in which the first and second container elements and the conduit are defined by a flattened flexible tubular plastics material having a first seal across the width of the tubular plastics material defining a top of the container, a second seal inclined downwardly from one edge of the flattened tubular plastics material to a point short of the other edge of the flattened tubular plastics material and defining a downwardly inclined bottom of the first container element and an opening to the conduit from the first container element, a third seal substantially parallel to said other edge of the flattened tubular plastics material leading downwardly from said point and defining the conduit, a fourth seal inclined downwardly from the lower end of said third seal to said one edge of the flattened tubular plastics material and defining a downwardly inclined top of the second container element and an opening to the conduit from the second container element, and a fifth seal across the width of the flattened tubular plastics material and defining a bottom of the container.

5. A container according to claim 3, in which the first and second container elements and the conduit are defined by a flattened flexible tubular plastics material having a first seal across the width of the tubular plastics material and defining a top of the container, a pair of second seals inclined downwardly from opposing edges of the tubular plastics material to points towards the centre of the flattened tubular plastics material and together defining a downwardly inclined bottom of the first container element and an opening to the conduit from the first container element, a pair of third seals substantially parallel to the edges of the flattened tubular plastics material leading downwardly from said points and defining the conduit, a pair of fourth seals inclined downwardly and leading outwardly from the lower ends of said pair of third seals to the edges of the flattened tubular plastics material and together defining a downwardly inclined top of the second container element and an opening to the conduit from the second container element, and a fifth seal across the width of the flattened tubular plastics material defining a bottom of the container.

6. A container containing blood, substantially as herein described with reference to the accompanying drawings.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. the conduit. The first and second container elements would then be suspended from a point in the conduit 14 and the top of the first container element would then be folded down to a position adjacent the bottom of the second container element. WHAT WE CLAIM IS:

1. A container containing blood and comprising a first container element, a second container element, a conduit for connecting together the bottom of the first container element and the top of the second container element, and means for withdrawing a blood component from each of the container elements, the first and second container elements being so disposed and of such a volume that when the container is held vertically with the first container element above the second container element and the blood components have separated from one another, the first container element contains only the plasma component of the blood and the second container element contains only or mainly the erythrocyte component of the blood, and the conduit being of such a length and volume that the interface between plasma and erythrocyte is situated in the conduit or can be displaced into the conduit from the second container element, the conduit being closable to optionally seal off the blood components from one another.