ITMO20090093A1 - BAG FOR CONTAINMENT AND FREEZING OF STEM CELLS - Google Patents

Description

Description of Patent for Industrial Invention entitled:

“BAG FOR THE CONTAINMENT AND FREEZING OF STEM CELLS”.

DESCRIPTION

The present invention refers to a bag for containing and freezing stem cells.

As known, stem cells are primitive non-specialized cells with the unique ability to transform into any other type of cell in the body. Stem cells can be of various types and are generally classified into cord cells, or cells taken from the umbilical cord of a newborn, or peripheral cells, or cells taken with selective apheresis from the peripheral venous system or bone marrow.

The stem cells, after being taken from the umbilical cord or from the donor, are subjected to some treatments and / or the addition of suitable additives and solutions (plasma, saline solution, DMSO and more) and subsequently collected inside special bags to be then cryopreserved, i.e. stored in liquid nitrogen at a temperature approximately between -130 ° C and -190 C.

The bags used comprise an envelope which defines a chamber for containing the stem cells and which can be associated with means of introduction and withdrawal.

According to a recently established law, called the "blood law", on each bag containing stem cells must then be applied a label bearing a series of indications in accordance with the guidelines and regulations in force (identification data of the donor and of the cells themselves, production batches of the bags, date of collection, expiration date, date of production of the cells, etc, etc.

Since it is essential to preserve the integrity of the stem cells contained in the bags and prevent them from coming into contact with "contaminating" or mutagenic agents that could in any way cause damage, pollution or mutations of the stem cells themselves, all the elements that are used to the labeling must be appropriately selected and certified.

To date, there are types of paper and ink for certified labels on the market, the use of which is safe and does not in any way compromise the "quality" of the cells contained in the bags.

Similarly, however, there is no type of certified glue that can be safely used for the labeling of bags containing stem cells.

In fact, the glues on the market today contain solvents capable of crossing the wall of the envelope that forms the bag and on which the labels are applied, and thus contaminate the cells contained within it. Although most stem cell production and storage institutes apply, despite the risks listed above, the labels directly on the envelope that contains the cells, some precautions can be used to avoid the risk of damage or mutation or contamination.

In particular, the most widely used solution consists in inserting the bags containing the cells in special removable bag covers, before placing them in the liquid nitrogen, and in applying the identification labels on these bag covers externally after having properly closed them by welding.

However, this solution has some drawbacks.

In fact, the labels applied externally to the bag covers can tear, detach or detach during the handling of the bags and especially during their storage immersed in liquid nitrogen. This can therefore lead to the relative bag being devoid of the identification label or that the latter is damaged and therefore not legible. Obviously, a bag without its identification label or with an unreadable label is unusable, as it does not allow to trace the donor and the properties of the cells it contains, and must therefore be destroyed.

Since before carrying out a stem cell transplant it is advisable to verify that the recipient or recipient is compatible with the cells contained within a bag, it is essential to carry out compatibility tests.

Since these tests must be performed without opening the bag containing the cells in any way, generally, when the stem cells are placed inside the bag, some samples previously separated from the bag itself are also added, which are then cryopreserved inside the bag. inside of the same metal container also containing the corresponding bag and relative bag cover. These stem cell samples are indispensable for carrying out the necessary compatibility tests with a possible recipient.

However, it frequently happens that the free samples contained inside these metal containers accidentally escape from them during their handling. This consequently implies that the samples are no longer available or in any case that they are no longer traceable with certainty to the corresponding bag.

When the number of available samples runs out, the relative bag of stem cells must be destroyed as it is no longer usable, due to the complex donation procedure known to the technician in the field, without having previously tested its compatibility with the recipient . Known types of bags, moreover, can be equipped with an appendix arranged below the stem cell containment chamber, suitable for housing a bar code that refers to a management system for controlling the bags.

This appendix, however, in addition to not providing the necessary space for housing the label showing all the above data, also increases the external dimensions of the bag, thus complicating its handling and storage inside the relative metal containers. It therefore obviously follows that the increase in the size of this appendix for the application of identification labels as well would lead to an excessive increase in the external dimensions of the bag, with inevitable space consumption and an increase in management and storage costs.

The main task of the present invention is to devise a bag for the containment and freezing of stem cells that allows the easy and safe application of the identification label to the bag itself, as required by the relevant regulations, without this in any way way to contaminate or damage the cells contained within it.

An object of the present invention is to devise a bag for containing and freezing stem cells which allows the identification label to be safely applied directly to the bag and to prevent it from accidentally detaching or damaging during the handling of the bag itself or during storage in liquid nitrogen.

Another object of the present invention is to prevent the samples used for compatibility tests from escaping from the relative container at the time of extraction of the latter or during its handling.

Yet another object of the present invention is to provide a bag for containing and freezing stem cells which allows the identification label to be safely applied and which at the same time substantially maintains the external dimensions of the bags used up to now. , in such a way that it can be cryopreserved inside the same containers currently in use for this purpose.

Another purpose of the present invention is to devise a bag for containing and freezing stem cells which allows to overcome the aforementioned drawbacks of the prior art in the context of a simple, rational, easy and effective use and low cost solution.

Not the least object of the present invention is to provide a bag for containing and freezing stem cells which, for the same volume of the containment chamber, has a reduced external bulk compared to known bags, while respecting all the required requirements. by the regulations in force and allowing easy management of the bags themselves.

The aforementioned purposes are achieved by the present bag for containing and freezing stem cells, comprising an envelope defining a chamber for containing stem cells and associable with injection / withdrawal means, characterized in that it comprises protection means integrally associated with said casing and adapted to support at least one label identifying the characteristics of the stem cells contained in said containment chamber.

Other characteristics and advantages of the present invention will become more evident from the description of a preferred, but not exclusive, embodiment of a bag for containing and freezing stem cells, illustrated by way of indication, but not of limitation, in the accompanying drawings. in which:

Figure 1 is a front view of a bag with respective bag cover according to the invention;

Figure 2 is a perspective view of a bag according to the invention in a first embodiment;

Figure 3 is a perspective view of a bag according to the invention in a second embodiment.

With particular reference to these figures, the reference number 1 globally indicates a bag for containing and freezing stem cells.

The bag 1 comprises a casing 2 defining a chamber 3 for containing the stem cells and associable with input / withdrawal means not shown in the figures. More particularly, the containment chamber 3 is provided with an inlet port 4 which can be associated with inlet means not shown in the figures and which can be closed, for example by welding, to isolate the containment chamber from the outside and not allow the exit of the cells. Furthermore, the bag 1 is provided with one or more fittings 5 which can be opened, for example by tear-off, and can be associated with relative withdrawal or reinfusion means.

According to the invention, the bag 1 comprises protection means associated integrally with the envelope 2 and able to support at least one label 6 identifying the characteristics of the stem cells contained in the containment chamber 3. More particularly, the information reported on the label 6 they include all the information required by current legislation, such as, for example, the name and surname of the donor, his date of birth, the date of collection of the cells and a bar code that reports to a management system.

Advantageously, the protection means comprise at least one substantially sheet-like protection element 7 integrally associated with the casing 2, externally to it.

More particularly, the protection element 7 can be superimposed on the casing 2 in correspondence with the containment chamber 3.

Preferably, the protection element 7 is made of transparent material, in such a way as to allow the reading of the label 6 also from the outside. Conveniently, but not necessarily, the material that constitutes the protection element 7 is the same as that constitutes the casing 2. An example of material suitable for making the casing 2 and / or the protection element 7 is the etavinyl acetate (EVA).

In a first embodiment, represented in figure 2, the protection means consist of a single protection element 7 associated with the casing 2.

In this embodiment, the protection element 7 is associated with the casing 2 with at least one side of it 7a. The opposite side 7b can also be associated with the casing 2 or, in an alternative embodiment, detached from the casing 2 and therefore free to move, for a limited angle, around the side 7a welded to the casing itself. .

The protection element 7 defines two faces 8 opposite each other, one of which facing outwards, on which the label 6 is applied, and the other facing the envelope 2.

Conveniently, the protection element 7 is associated with the casing 2 at the perimeter edge 9 of the latter.

In the second embodiment, the protection means comprise two protection elements 7 associated with each other in correspondence with two connection areas 10a and 10b, of which a first connection area 10a and a second connection area 10b, distinct from each other by define a pocket 11 for housing the label 6.

Advantageously, the protection elements 7 are associated with the casing 2, by welding or similar techniques, with at least one connection area 10a, 10b.

More particularly, in the embodiment shown in Figure 3, the connection elements 7 are associated with the casing 2 with a connection zone 10a, 10b while the other connection zone 10b, 10a is free and detached from the casing 2 .

The protection elements 7 are therefore free to rotate with respect to the casing 2, for a limited angle of rotation, around the connection area 10a, 10b welded to the casing itself.

Preferably, the connection areas 10a and 10b are defined at two opposite sides of the protection elements 7.

More particularly, the protection elements 7 are associated with the casing 2 at the perimeter edge 9 of the latter. However, an alternative embodiment is not excluded which provides for the fixing of both the connection areas 10a and 10b to the casing 2. Conveniently, in this second embodiment, the protection elements 7 can be associated with each other also in correspondence with at least a third connection area, not shown in the figures and arranged substantially transversal with respect to the connection areas 10a and 10b. More particularly, the third connection zone can be defined in correspondence with one of the sides of the protection elements 7 contiguous to the sides in correspondence with which the connection zones 10a and 10b are defined.

Advantageously, the bag 1 comprises at least one sample 12, preferably a plurality, for the execution of compatibility tests associated integrally with the envelope 2 and separable from it.

The samples 12 comprise suction means 13 communicating with the stem cell containment chamber 3 and closable, by welding or similar techniques, to isolate the samples themselves from the containment chamber 3. More particularly, the suction means 13 consist for example by a compressible wall capable of varying the volume of the relative sample 12 by creating a depression which sucks up the cell suspension contained in the containment chamber 3.

The operation of the present invention is as follows.

After entering the stem cells and any additives and / or solutions inside the containment chamber 3 through the inlet port 4, the latter is closed by welding. In the same way, after having aspirated, by means of the aspiration means 13, a part of the cell suspension contained in the containment chamber 3 inside the samples 12, and having let the air contained inside out, the latter are isolated from the containment chamber itself. The containment chamber 3 is therefore isolated from the outside.

The label 6 can be applied to the bag 1, using the protection means according to the invention, before or after filling it with the cell suspension. Generally, the label 6 is applied to the bag 1 before placing the stem cells inside the containment chamber 3.

More particularly, in the first embodiment shown in Figure 2, the label 6 can be applied, using any type of glue or adhesive means on the market, on the external face 8 defined by the protection element 7.

In this way, the glue applied to the label 6 is not in direct contact with the casing 2 but with the protection element 7, which therefore acts as a barrier between the glue and the casing 2.

After applying the label 6, the protection element 7 is made to adhere to the envelope 2 so that the bag 1 can be placed inside a bag cover 14, subsequently hermetically sealed and able to be placed inside a bag. a metal container not shown in the figures for storage in liquid nitrogen.

In the second embodiment shown in Figure 3, the label 6 can be applied on one of the external faces defined by the protection elements 7 or, preferably, positioned inside the housing pocket 11, with or without glue or adhesive means. .

To facilitate the insertion of the label 6 inside the pocket 11 it is also possible, in this case, to make the protection elements 7 rotate around the connection area 10a, 10b associated with the casing 2, thus facilitating the opening of the pocket itself, and then make the protection elements 7 adhere to the envelope 2 again for subsequent positioning inside the relative bag cover 14.

In this second embodiment, therefore, the label 6 is retained by the protection elements 7, both in the variant which provides only the connection areas 10a and 10b and in the one with also the third connection area, so that it can be omitted the use of glue or adhesive means to secure the label 6 to the bag 1. Preferably, the opening / s of the pocket 11 are welded so as to avoid accidental leakage of the label itself.

Furthermore, if compatibility tests are to be carried out with a potential recipient, once the bag cover 14 containing the bag 1 has been removed and opened, one of the samples 12 must be cut off and cut off. the casing 2 and then hermetically closed the containment chamber 3.

In practice, it has been found that the described invention achieves the proposed aims and in particular it is emphasized that it prevents the solvents, additives, etc ... contained in the means for fixing the identification label to the bag from penetrating into the bag. inside the stem cell containment chamber, damaging them, contaminating them or causing mutations.

The bag according to the invention is therefore significantly safer than the bags currently used for storing and freezing stem cells as it defines a sort of protective barrier interposed between the label and the envelope inside which the cells are contained. stem cells.

Furthermore, in the embodiment that involves the insertion of the identification label inside the housing pocket separated from the envelope that contains the stem cells, it is even possible to avoid the application of glue or adhesive means to the label. Furthermore, the bags for containing and freezing stem cells according to the invention guarantee the traceability and connection of the bags to the relative samples for compatibility tests. These samples, in fact, being integrally associated with the envelope that defines the cell containment chamber, can no longer accidentally escape from the metal container during the extraction, handling and opening of the container itself. Furthermore, the bags according to the invention ensure that the content of the samples is the same as the bag housed in the same container.

In this way, the bag according to the invention also allows to comply with the requirements of the blood law, according to which the samples that are used for the compatibility tests must be connected integrally to the envelope that contains the stem cells.

Last but not least, the bag according to the invention, while respecting all the requisites envisaged by the blood law regarding the use and application of the identification labels, is of limited size with respect to known bags, thus facilitating their handling and storage. storage in the relative containers.

Claims (14)

CLAIMS 1) Bag (1) for the containment and freezing of stem cells, comprising a casing (2) defining a containment chamber (3) for the stem cells and associable with injection / withdrawal means, characterized in that it comprises protection means (7) integrally associated with said casing (2) and able to support at least one label (6) identifying the characteristics of the stem cells contained in said containment chamber (3). 2) Bag (1) according to claim 1, characterized in that said protection means comprise at least one substantially sheet-like protection element (7) associated integrally with said envelope (2), externally thereto. 3) Bag (1) according to claim 2, characterized in that said protection element (7) is made of transparent material. 4) Bag (1) according to claim 2 or 3, characterized in that said protection element (7) can be superimposed on said casing (2) in correspondence with said containment chamber (3). 5) Bag (1) according to one or more of claims 2 to 4, characterized in that said protection element (7) is associated with at least one side of it (7a) to said casing. 6) Bag (1) according to one or more of claims 2 to 5, characterized by the fact that said protection element (7) is associated with said casing (2) at the perimeter edge (9) of the latter. 7) Bag (1) according to claim 2 or 4, characterized in that said protection means comprise two of said protection elements (7) associated with each other in correspondence with at least two distinct connection areas (10a, 10b) to define a pocket (11) for housing said label. 8) Bag (1) according to claim 7, characterized in that said protection elements (7) are associated with said casing (2) with at least one of said two connection areas (10a, 10b). 9) Bag (1) according to one or more of claims 7 to 8, characterized in that said protection elements (7) are associated with said envelope (2) in correspondence with its perimeter edge (9). 10) Bag (1) according to one or more of claims 7 to 9, characterized in that said protection elements (7) are associated with each other also in correspondence with a third connection area. 11) Bag (1) according to one or more of the preceding claims, characterized by the fact of comprising at least one sample (12) for carrying out the compatibility tests associated with said envelope (2) and separable from it. 12) Bag (1) according to claim 11, characterized in that said sample (12) comprises suction means (13) communicating with said containment chamber (3) and closable to isolate the sample itself from said containment chamber (3) ). 13) Bag (1) according to claim 12, characterized in that said suction means (13) comprise at least one compressible wall adapted to vary the volume of said sample (12). 14) Bag (1) according to one or more of claims 11 to 13, characterized in that it comprises a plurality of said samples