The present invention relates generally to the field of analysis for example biological analysis. More specifically, the present invention relates to an integrated analysis device that can be fitted to a container of a sample to be analyzed.
In the analysis field, in particular that of biological analysis, the problem is regularly posed of the safety of the technician that handles the samples, particularly because of the risks of contamination that exist during the abstraction of an aliquot for the purpose of an analysis.
Thus, the risks run by the technician that has to abstract an aliquot from a pouch of blood intended for transfusion, in order to verify the harmlessness of this sample are known. Pouches of blood are containers that are far from easy to handle because of their flexible walls. The result of this is that the people who handle these pouches of blood may very easily come into contact with the sample and risk being contaminated if the latter is not free from pathogenic agents.
Contamination may also occur in the reverse direction. Specifically, it happens that, during the abstraction of biological liquids, such as urines, suspected of being contaminated, the person carrying out the abstraction contaminates the sample himself, making it impossible to provide a reliable diagnosis based on said sample.
In the case of food samples for the purposes of quality control, it is also very important to ensure that no parasitical contamination is caused by the technician who is in charge of the analysis. In addition, the food sample is frequently placed in a culture that has been made. This placing in a culture usually consists in placing the sample in a plastic pouch containing a culture medium, which makes it possible to develop microorganisms, in particular bacteria. After an incubation time necessary for microorganism development, one or more aliquot abstractions of the culture medium are carried out in order to perform a microbiological analysis. Aliquot abstractions are usually carried out by opening the pouch at the orifice for the insertion of the food sample and of the culture medium. Such a process is often critical to carry out because the technician responsible for this procedure must simultaneously keep the pouch open, hold the pouch closure device and the pipette which he uses to suck out the culture medium. Furthermore, such handling conditions substantially lengthen the analysis time. When the number of samples is large, productivity may thereby be seriously impaired.
Analysis devices designed to be connected to a biological sample container have already been described. This is the case, for example, of the analysis device of document WO-A-03/030739. The analysis device described in this application consists of a pouch, containing the analysis reactant, with a connection tube allowing the analysis device to be connected to the biological sample container.
Document DE-A-35 04 527 also describes an analysis device in the form of a pouch containing the analysis reactant, with a connection tube; said device being designed to be connected to a pouch of urine.
Although this type of device partially solves the problems identified hereinabove, it nevertheless comprises a certain number of disadvantages. The main disadvantage is that it can be used only with a container also comprising a connection tube to which said device may be fitted. Although this type of container is widely used in the medical field, it is virtually nonexistent in the agrobusiness quality control field in which the containers are much simpler.
The result of this is that this type of device can be fitted only to a limited number of containers, more specifically dedicated to the medical field.
Another disadvantage of this type of device is that it comprises a tube of fluid connection with the outside of the pouch. Even though this tube is initially stoppered, there is nevertheless a risk that the closure device of the tube may break, placing the pouch in communication with the ambient air; this may form a major source of contamination or of impairment of the analysis device.
Finally, a last disadvantage of such a device is that it does not make it possible to totally eliminate the risks of contamination of the technician at the moment of connecting the device to the biological sample container.
With regard to the technical problems raised by the prior art considered hereinabove, one of the essential objectives of the present invention is to provide a low cost analysis device that can be simply fitted to any type of container enclosing samples of the biological sampling type or samples for the purpose of quality control; such containers being, for example, pouches or sacs made of flexible plastic.
Another objective of the present invention is to provide an analysis device which, when it is fitted to said containers, limits the handling actions of the sample contained in the container, thereby limiting the risks of contamination, either of the person handling the sample, or of the sample itself.
Another objective of the present invention is to provide an analysis device that is less subjected to the risk of contamination or of impairment.
Another objective of the present invention is to provide an analysis device that makes it possible to dispense, if necessary, with the use of sampling equipment of the pipette or syringe type.
Another objective of the present invention is to provide an analysis device that makes it possible to reduce the time necessary for analyzing the sample.
Another objective of the present invention is to provide an analysis device making it possible to carry out different types of analysis.
Another objective of the present invention is to provide an analysis device which, being associated with the container of the sample to be analyzed, allows a better traceability of the analysis result.
Another objective of the present invention is to provide an analysis device which makes it possible to retrieve the sample or an aliquot abstraction of the sample for later analysis.
Another objective of the present invention is to provide an analysis device that makes it possible to take a sample through the flexible wall of a container, while keeping said container sealed.
A final objective of the present invention is also to provide a container designed to enclose a biological sample, said container permanently incorporating an analysis device, thus limiting the handling of the sample and making the analysis easier.
These objectives, amongst others, are achieved by the present invention which relates in the first place to an analysis device designed to be associated with a container, comprising a sample to be analyzed, said device comprising essentially:
According to a preferred embodiment, the means designed to create a way for the sample to enter said internal reaction cavity consists of at least one preferred gripping zone, placed on one of said first or second membranes, making it possible to separate said first and second membranes at least partially from one another, in order to make the internal reaction cavity accessible to the sample contained in the container.
According to another embodiment, the means designed to create a way for the sample to enter said internal reaction cavity consists of at least one means designed to act on one of said first or second membranes.
Preferably, this means is a perforation means.
Still more preferably, the perforation means is placed inside the cavity.
According to an alternative embodiment, the means designed to create a way for the sample to enter said internal reaction cavity consists of the second membrane, consisting of a material having a breaking strength value less than that of the material forming the first membrane.
More particularly, this material is included in the group comprising aluminum, copper or any strip that can be laminated.
According to an advantageous variant, the analysis device comprises a septum fixedly attached to the first membrane, at least partially covering the latter.
Preferably, the analysis means is included in the group comprising the porous reaction media such as the small strips for measuring pH, the small immunochromatography strips, the small biochemical substrate strips or any equivalent analysis means.
Another object of the invention relates to a container comprising at least one analysis device as defined hereinabove.
According to a preferred embodiment, the analysis device is fixedly attached to a wall of said container.
According to a first variant of this embodiment, the second membrane of the analysis device is fixedly attached to the wall of the container.
According to a second variant of this embodiment, the second membrane is in direct contact with the sample to be analyzed.
Another object of the present invention relates to a method of analyzing a sample contained in a container, having at least one wall at least partially formed of a material capable of being perforated, said method essentially comprising the following steps:
According to a first variant, step a) is carried out with the aid of the perforation means placed in the internal reaction cavity.
According to a second variant, step a) is carried out with the aid of an independent perforation means of the analysis device.
According to a preferred embodiment of this second variant, step a) consists in perforating the two membranes of the device and the wall of the container with the aid of the perforation means, the septum fixedly attached to the first membrane delimiting the zone of perforation of said first membrane, thus preventing the sample to be analyzed from escaping from the analysis device, once the perforation means has been withdrawn.
Another object of the present invention relates to a method of analyzing a sample contained in a container, said method comprising essentially the steps consisting in:
According to a first embodiment, step b′) consists in perforating the first or the second membrane of the analysis device.
According to a second embodiment, step b′) consists in separating at least partially the first and second membranes, with the aid of the preferred gripping zones placed on said first and second membranes.
Another subject of the present invention relates to the use of an analysis device in order to analyze a sample contained in a container.
The aims and advantages of the present invention will be better understood in the light of the following detailed description made with reference to the drawings in which:
The analysis device as shown in
“Analysis means” means any reaction test making it possible to measure one or more biological and/or physico-chemical parameters of a sample, to display the presence of a contaminant or of a particular marker in said sample.
Thus, as an example and in a manner in no way limiting, the analysis means may be a small reaction strip advantageously used in environmental quality control, such as the physico-chemical analysis of water, the measurement of pH, agrobusiness inspection, such as microbiological inspection, the detection of allergy carriers, bioterrorism, or of course clinical analyses, such as the chemical or microbiological inspection of urines, blood, pregnancy tests. This type of tool is well known to those skilled in the art and widely used both in analysis laboratories and in industry.
On the outer face of the first membrane 12 and level with the spherical zone of the internal reaction cavity, there is a deposit of a material with elastic properties, in the form of a layer 20 of small surface area. This layer 20 plays the role of a septum. The function of this layer will be more amply explained in
A view in partial section along the axis III-III of
When the technician in charge of the analysis decides to carry out the latter, he uses a perforation means, represented in
It follows that the internal reaction cavity 16 of the analysis device 10 then communicates with the inside of the container 22 and is therefore in contact with the sample 28, as shown in
The analysis means 18 being in contact with the sample 28, the analysis can then take place, so that, after the time necessary for the reaction, the technician may read the analysis result on the analysis means through the membrane 12, since the latter is made of transparent material.
Although, in these
A second embodiment of the analysis device according to the invention is represented in
It should be noted that the analysis device 40 may advantageously be independent of the container, although this is not shown in
During the realization of the analysis, the handling technician takes the container in his hands in the vicinity of the analysis device and makes a twisting movement of the latter and therefore of the container 22 in the direction of the arrows B, so that the point of the perforation means 48 comes to perforate the membrane 44 of the analysis device and the anterior wall 24 of the container 22 without perforating the posterior wall 30. Advantageously, the perforation means may comprise a guard making it possible to limit the travel of the latter. When the perforation has taken place, the handler relaxes his pressure so that the analysis device 40 and the container 22 resume their initial shape. The perforation means 48 then resumes its position substantially parallel to the membrane 44. The sample 28, which was, possibly, withdrawn at the twisting zone, then resumes its place and is aspirated into the hole 49, made in the membrane 44 and the anterior wall 24 of the analysis device until it reaches the internal reaction cavity as shown in
A third embodiment of the analysis device according to the invention is shown in
Unlike the first two embodiments described hereinabove, the analysis device 501 represented in figures SA and 5B here forms an integral part of the container 50. The analysis device 501 still comprises two membranes, a first membrane 52, forming the top membrane in
Concerning the bottom membrane 54, it is advantageous for the latter to be made of a material having a reasonably low breaking strength value. Such a material is different from that used to form the top membrane 52 which must have a breaking strength value greater than the membrane 54. Thus, the material forming the membrane 54 may, for example, be a sheet of aluminum, having a thickness of from a few hundredths of a micrometer to a few micrometers and advantageously a few tenths of a micrometer. According to an alternative, this material may also be copper or any strip that can be laminated. The material forming the membrane 52 is, for its part, identical to that used for the embodiments described hereinabove.
To place the analysis device in contact with the sample, it is advantageous to use a perforation means (not shown in
According to a variant of this embodiment, the material forming the membrane 54 may be a breakable material. Thus, the technician who has to carry out the analysis may dispense with using an object of the pincer type to pierce the membrane 54. He simply has to perforate the device with a fingernail or twist it so as to break the membrane.
It should be noted that according to this embodiment and unlike those described hereinabove, the container is manufactured with the analysis device integrated. Specifically, the latter cannot be fitted to one of the walls of the container.
On the other hand, another variant of this embodiment consists in an analysis device manufactured independently of the container, so that it can be slid inside the container, directly in contact with the sample. To carry out the analysis, the analysis device should then be trapped in one of the bottom corners of the container so that the technician handler may perforate the device with the aid of the pincer described hereinabove and do so directly through the container. So that this variant embodiment operates correctly, it is naturally appropriate that the walls of the container resist the perforation, but also that the latter are sufficiently flexible to allow the perforation of the analysis device. It is also appropriate that the walls of the container are transparent so that the analysis result can be read.
A last embodiment is shown in
When the technician handler desires to make the analysis, he grasps the analysis device through the container so as to hold the gripping zone 621 with one hand and the gripping zone 641 with the other hand. In each hand, he therefore holds respectively one of the walls of the container and a gripping zone. By pulling in opposite directions on the gripping zones, the membranes 62 and 64 are separated partially so that the internal reaction cavity 66 is in contact with the sample 28, as shown in
A variant of the analysis device may also be envisaged in which the analysis means may be separated from said device once the analysis has been made. Specifically, since this analysis means comprises a concentrate of the analyzed sample, it may be envisaged to use it to carry out other analyses. These analyses may be, for example, microbiological analyses. The analysis device may then be used to sow a microbiological culture medium on a Petri dish.
The analysis device according to the invention may be adapted to various types of containers, such as blood pouches, sacs used for industrial microbiological analyses and more generally to any container that comprises flexible walls that can be perforated or easily grasped. It therefore constitutes a preferred device for carrying out various analyses on samples that are also very diverse.
Another advantage of the analysis device according to the invention is that it makes it possible to avoid, if necessary, all direct contact with the sample, in case the latter is dangerous.
Number | Date | Country | Kind |
---|---|---|---|
04 51343 | Jun 2004 | FR | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/FR2005/050491 | 6/24/2005 | WO | 00 | 11/29/2006 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2006/008407 | 1/26/2006 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3894845 | McDonald | Jul 1975 | A |
5500375 | Lee-Own et al. | Mar 1996 | A |
5595187 | Davis | Jan 1997 | A |
5788863 | Milunic | Aug 1998 | A |
20020048819 | Alley | Apr 2002 | A1 |
20040191919 | Unger et al. | Sep 2004 | A1 |
Number | Date | Country |
---|---|---|
3504527 | Feb 1986 | DE |
0 678 745 | Oct 1995 | EP |
WO 03030739 | Apr 2003 | WO |
Number | Date | Country | |
---|---|---|---|
20080152541 A1 | Jun 2008 | US |