ARTICLE FOR BIOLOGICAL ANALYSIS

The present invention generally relates to the field of analysis, for example
5 biological analysis. More specifically, the present invention relates to a package for an
analysis device.
In the field of analysis, in particular that of biological analysis, it is common
practice to use single-use sterile devices packaged in individual packages. This is the case
10 for example for blood sampling devices, such asssyringes or needles, surface-sampling
devices such as swabs, and culture media seeding devices, such' as disposable oeses. It is
also common practice to find reagents packaged in single-use packages.
Most of the time, the packages for these devices are made up of two plastic films
sealed to one another around their perimeter, with one of the two being generally
15 transparent. One of the two films can also be a metal film, such as an aluminium film or a
multilayer film made up for example of an aluminium layer and of a plastic layer.
This type of package can be opened in different ways. The first consists. in
'separating the two films which make up the package. To this end, an area at which the
two films are not sealed, generally in a comer, allows each of these to be gripped in order
20 to separate them. The handling of this type of package is not always very easy. Indeed, the
step of separating the two films can sometimes be tricky as a result of the difficulty of
gripping the two films. &&*use of protective gloves by the handler makes this step even
trickier. Furthermore, once the two films have detached, the analysis device may slide out
of the package and fall. It then becomes unusable.
25 A second way of opening the package consists in using the analysis device, when
this is rigid, to pierce one of the two films which make up the package. It is evident that at
least one of the films must have a limited breaking resistance to allow the analysis device
to pierce it. To this end, the device is pressed against one of the two films of the package.
Such a package is, for example, described in document US-3,036,700. Preferably, the film
30 described in this document and intended to be pierced includes a weakened area to
facilitate piercing. Such an opening means requires that the analysis device be a device
which is rigid and sufficiently robust to withstand the stress.
A third way of opening the package consists in placing a blunt object inside the
package, said object en4bling the piercing of one of the two films which make up the
package. Such a package is for example described in document US-4,739,881. The main
problem constituted by such an assembly is the risk incurred by the handler when opening
the package. Indeed, the handler can easily injure himselflherself with the blunt object
when the latter pierces the package.
In view of the technical problems raised by the state of the art considered above,
one of the essential objectives of the present invention is to provide an article especially
for biological analysis, including a package and an hnalysis device inside, allowing simple
opening of the package, whether the analysis device is rigid or flexible; such opening
being able to be performed with one hand.
Another objective of the present invention is to provide an article especially for
biological analysis, the opening of the packaging of which does not entail a risk of
injuring the handler.
Another objective of the present invention is an article especially for biological
analysis which allows easy gripping of the analysis device, once the package is opened..
These objectives amongst others are resolved by. the present invention, which
primarily relates to an article, especially for biological analysis, said article comprising:
afirstsheet,
a second sheet, superimposed on said first sheet,
said fust &d*second sheets being joined on all of their sides in order to
form a sealed package,
- -
at least one analysis device, placed inside said sealed package;
a rigid desiccation means,
wherein the desiccation means also constitutes a means of perforating the first or second
layer of said package, in order to access the analysis device.
In an advantageous embodiment of the article according to the invention, the
desiccation means is a solid polymer material containing a desiccant.
Preferably, the desiccation means is substantially rectangular parallelepiped in
shape. Such a shape is particularly suitable for optimising the perforation of the package.

According to a particular embodiment, one of said first and second sheets includes
a preferential folding area.
According to another particular embodiment, one of said first and second sheets
5 includes an analysis device gripping area.
The biological analysis device contained in the package can advantageously be a
reaction strip.
Preferably, the reaction strip bears antibiotics in the form of a concentration
gradient.
According to another particular embodiment, at least one of said first and second
sheets comprises an aluminium layer.
Advantageously, one of said first and second sheets comprises an aluminium polymer composite laminate.
Another object of the present invention relates to the use of an article according to
the invention for biological analysis.
The aims and advantages of the present invention will be better understood in light
of the following detailed description, which is given with reference to the drawings in
which:
Figure 1 shows a top view of an article for biological analysis according to the
invention. 25 Figure 2 shows a longitudinal cross-section view along axis A-A of the article for
biological analysis shown in figure 1.
Figure 3 shows a longitudinal cross-section along axis A-A of the article for
biological analysis shown in figure 1, after folding and opening of the package.
Figure 4A shows a perspective view of the article for biological analysis according
30 to the invention, after folding and opening of the package.
Figure 4B shows a top view of the article for biological analysis according to the
invention, after complete folding.
The article 10 according to the invention is shown in top view in figure 1. This
7
article has a substantially rectangular general shape, with a substantially flat part 101 and
a substantially bulging part 102. As can be seen in figure 2, which shows a cross-section
of article 10 shown in figure 1, the flat part 101 in fact constitutes a peripheral area at
5 which the first sheet 12 and the second sheet 14 constituting the package are joined. The
sheets 12 and 14 are joined by thermosealing. For its part, the bulging part 102 defines the
inner cavity 13 of the package. It appears clearly in figure 2 that this bulging part 102 is
essentially constituted by a moulding of the first .sheet 12, which is the upper sheet in this
figure 2. To this end, the first sheet 12 is preferably constituted of a flexible water-
10 impermeable material. Such a film may be an aluminium - plastic composite laminate
(oriented polyamide (oPA), Polyvinyl chloride (PVC)), havitig the ability to be cold
formed and with a minimal breaking resistance. Such films are well known and largely
. used in packaging in particular of medications, commonly referred to as blister packaging.
Films marketed by the company AMCOR under the FORMPACK@ mark may be cited -
15 by way of example.
The sheet 14, which is the lower sheet in figure 2 is, for its part, substantially flat.
It is a capping sealing sheet. It must furthermore have low breaking resistance properties.
'Indeed, this sheet is intended to be pierced to make it possible to access the biological
analysis device 18 contained in the package. Such a sheet is advantageously an aluminium
20 sheet which has sealing properties, notably by adding onto the aluminium a polymer layer
which enables sealing. Fibs marketed by the company AMCOR under the reference
DD133 may be cited by &a$ of example.
A desiccation means 16 and an analysis device 18 are present inside the cavity 13.
. .
The desiccation means 16 serves to absorb any humidity trapped in the cavity 13 when the
25 sheets 12 and 14 are sealed. It is constituted here of a solid polymer material which
contains a desiccant. One such material is for example that marketed by the company CSP
~ e c h n o l o ~ iuensde~r the Activ-Polymer@ mark. It is furthermore described in document
WO-A-00163288.
The fact that the material constituting the desiccation means 16 is present in this
30 form is essential in the present invention. Indeed, it thus makes it possible to use said
desiccation means 16 as a means of perforating the package, such as described inji-a. To
this end, the desiccation means is preferably substantially rectangular parallelepiped in its
..
d
general shape. Indeed, it appears that this shape permits optimised package opening,
!
notably due tb the fact that this opening arrangement is relatively wide, enabling easy
access to the analysis device 18.
- As far as the biological analysis device 18 is concerned, this may be in the form of
a reaction strip. By way of example, such a reaction strip may be a strip bearing
antibiotics in the form of a concentration gradient. Such a strip is marketed by the
applicant under the EtestB mark.
It should furthermore be noted that if in the embodiment of the article according to
the invention, described here in connection with figures 1 to 4A, the device is in the form
of a single strip, it may nevertheless certainly be possible to envisage placing several
superimposed strips inside the package.
Returning to the first sheet 12, this has a particular shape, as explained supra. This
can be clearly seen in figure 2. Indeed, it has a left part with reliefs, whereas its right part
is relatively flat.
With regard to the left part, it should firstly be noted that it has an area 20 with a
limited projection. It follows from this that, at this point, the space between the sheets 12
and 14 is relatively limited. This area makes it possible to position the desiccation means
,16 very precisely. Indeed, in this area, the end 16 1 of the desiccation means is sandwiched
between the sheets 12 and 14. It is therefore possible to hold the desiccation means in
20 place without using any gluing means whatsoever, and an adhesive in particular.
The left part, in relief, then has two more pronounced bulging areas 21 and 22
separated by a substantiah~wctilineaarn d transverse notch 23. This arrangement makes it
possible to concentrate the stresses on the notch 23, when the package is folded to open it.
The folding forces exerted on the package are shown in the figure by the arrows F1, F2
25 and F3. The concentration of the forces of action on the notch 23, results in a transverse
fold. This is clearly shown in figures 3 and 4A.
Furthermore, the notch 23 has a second function. During the folding of the
package such as explained above, the notch 23 which is in contact with the desiccation
means 16, acts as a lever arm exerting pressure on said desiccation means. This pressure
30 is passed onto the fiee end 162 of said desiccation means 16, which then pierces the
second sheet 16, thus resulting in the opening of the package.

CLAIMS
1. An article (1 O), especially for biological analysis, said article comprising:
a first sheet (12),
a second sheet (14), superimposed on said first sheet (12), said first and
second sheets being joined on all of their sides in order to form a sealed
package,
at least one analysis device (1 8), placed inside said package;
a rigid desiccation means (16), also constituting a means of perforating
the first or second sheet of said package, in order to access the analysis
device (1 8),
one of said first and second sheets (12, 14) contains a notch (23) which constitutes a
preferential folding area.
2. The article (10) according to the preceding claim, wherein the desiccation
means (1 6) is a solid polymer material containing a desiccant.
3. The article (10) according to one of the preceding claims, wherein the
desiccation means (16) is substantially rectangular parallelepiped in shape.
4. The article (10) according to one of the preceding claims, wherein one of said
first and second sheets (1!2;.14) includes an analysis device gripping area.
5. The article (lo), according to one of the preceding claims, wherein the
biological analysis device (1 8) is a reaction strip.
6. The article (10) according to the preceding claim, wherein the reaction strip
bears antibiotics in the form of a concentration gradient.
7. The article (10) according to one of the preceding claims, wherein at least one
of said frrst and second sheets (12, 14) comprises an aluminium layer.
8. The article (10) according to one of the preceding claims, wherein at least one
of said fust and second'sheets (12, 14) comprises an aluminium - polymer composite
laminate.
9. The use of an article (10) according to one of claims 1 to 8 for biological
analysis.