WO2008053503A1

WO2008053503A1 - System of controlling (diagnosis) and conservation of human samples

Info

Publication number: WO2008053503A1
Application number: PCT/IT2007/000105
Authority: WO
Inventors: Claudio Filippo Maria Trovato
Original assignee: Cooper & Nichols Associates Ltd
Priority date: 2006-11-03
Filing date: 2007-02-16
Publication date: 2008-05-08
Also published as: EP2117438A1; ITCL20060039A1

Abstract

The invention is a diagnostic device inserted into a kit (container with caps and seals) comprising the whole product subjected to the invention and make up together one single device. It is intended to collect, control /diagnose and conserve a human sample. The container is made up of more internal sections, the bigger of which allows the insertion of more single or multiple strips, for rapid diagnosis, placed in the diagnostic device, consent the operator to visualize also more than ten diagnostic inquiries. The other sections, meanwhile the device is closed and sealed, become distinct between them, and are used to keep sealed human sample in order to make successive diagnostic controls as to control test or medico-legal inquiries ruled over an administrative, sanitary or judicial authority.

Description

Description system of controlling (diagnosis) and conservation of human samples ^"

Technical field

The present invention refers to a diagnostic device inserted into a kit (container with caps and seals for closing) comprising the whole product subjected to the invention and make up together one single inseparable device. It is intended to collect, control/diagnose and conserve a human sample. The kit (container) is made up of more sections, or internal compartments, the bigger of which allows the insertion of more single or multiple strips, for rapid diagnosis, placed in the diagnostic device, consent the operator to rapidly visualize also more than ten diagnostic inquiries. The other sections (compartments), meanwhile the device is closed and sealed, become distinct and independent between them, and are used to keep sealed human sample in order to make possible successive diagnostic controls also as to control test or medico-legal inquiries ruled over an administrative, sanitary or judicial authority. Strips, specially constructed for this diagnostic device, with measures (length, width and thickness) corresponding to the type of diagnostic device, are strips made up of different superposed components where in the inferior part, there, is an absorbent component that carries along the human sample on the reactive part of the strip. The detected substance gives a test line and when the test works perfectly, another coloured line parallel to the other one appears (control line). The-presence of the one control line gives on the one hand a positive outcome of the test so as to determine drugs assumption and on the other hand a negative outcome when there are two visible coloured lines in parallel (control line and test line). As regards determining and detecting other diagnosis and substances (also performed with this system), the test is positive if there are two coloured lines (test line and control line), on the contrary the test is negative if there is only one coloured line (control line). The invention is especially intended to rapid visualization and to the detection of physiological and/or pathological states and therefore used in the field of rapid and non-invasive diagnosis (IVD). It allows to collect a human sample (usually¹ urine), contemporaneously and directly diagnose the physiological and/or pathological state to find. The whole kit,- not only does it allow to make immediate reliable and accurate controls, being composed of more sections or compartments, but is also useful for keeping the human sample sealed for other possible diagnostic controls so as to on the one hand control test or medico-legal inquiries ruled over an administrative, sanitary or judicial authority in order to grant a use in military field or, on the other hand, so as to medico-legal reason, hygienic and sanitary reason too. For example, one can as well refer to the determination of a woman's pregnancy state as drugs assumption of employees, particularly linked to security, servicemen, etc..'. and successively to the possibility to take other samples for subsequent inquiries (ex.: if in presence of a positive outcome or in case of appeals), having other sealed compartments, independent between them where the human sample is conserved. It is not presently available a product which is simultaneously rapid, reliable, of simple use, not very expensive. The existing devices, known and present on the market, are products, methods and/or systems which are different just as well in their functioning as productive technique, are only used for the collecting and conservation of human sample that is exclusively used for the collecting and the diagnosis of human sample. Not any single tlevice independent of other kits and without the assistance of other products is able to simultaneously carry out direct collecting, diagnosis and the control and conservation of human sample. Therefore this device is subjected to a new invention and consents to have a new product free of limits and flaws of existing products, systems and devices.

Background art

Devices intended only to collect and conserve human sample:

Trie present method of collecting and conservation of human sample, present on the market, consents to collect human sample, to seal the container and later, gives the possibility to use its four compartments in a single way in order to take samples and therefore use the content however one wants to use it. It does not allow the contextual analysis and diagnosis of the sample in the same device.

Devices intended only to collect and to control/diagnose human sample:

Other four methods are used to collect human sample and are intended to diagnose: there are all cups/containers for collecting human sample. Inside, one or more strips are placed in one of the surfaces and are intended to determine drugs assumption. The lower part of the strip placed in the container has an absorbent pad which carries along human sample on the reactive part of the strip. It shows a line called test line and when the test functions perfectly, another coloured line parallel to the other one appears (contrdT line). The presence of the one control line gives a positive result to the test for the determination of drugs assumption. On the contrary, for other diagnosis and substances to determine and detect, the test is positive if there are two coloured lines (test line and control line), otherwise the test is negative if it shows one coloured line only (control line). These devices allow the only diagnosis of drugs assumption and other diagnosis correlated which are described here below:

1. the first known method consents to collect and diagnose. It is not intended to collect the samples and one must be careful not to exceed the level and the maximum quantity of sample to introduce in the cup. It means that one must collect sample with another cup or test tube or something else. It is not intended to conserve the sample, sealed for security, in order to take successive samples, and therefore ulterior diagnostic inquiries.

2. the second method, known and present on the market, is similar to the first one as far as use, features, functionality and limits are concerned.

3. the third method differs from the first and second because it gives the possibility to collect the human sample in the same cup: strips are on the cap, which presents two supporting feet on its surface. After collecting urine into the cup, it is closed with the cap, then the container must be tilted^* and leaned against the two supporting feet. This could not make pass the maximum level indicated on the container, nonetheless the sample immerged in the container has passed a certain level and quantity. Anyway, it does not consent to conserve the sample, sealed for security, so as to take successive samples and therefore to make ulterior diagnostic inquiries.

4. the fourth and last method of collecting and controlling/diagnosis consists of a container with the cap that can not be sealed. The peculiarity of this method is that the strips are in a part of the container which is an internal compartment initially differentiated and isolated. Only after having collected the human sample, with a "key", a hole opens and according to the principle of communicating vessels, it consents to bring a part of human sample to the strips, which does not, also in this case, allow the exceeding of a maximum level of sample in the part that contains the strips. Therefore, this method is not intended to conserve the sample so as to take successive sample and so to make ulterior diagnostic inquiries and is therefore equivalent to the methods referred to previous 1,2,3 points.

Disclosure of invention

System of rapid diagnostic detection with lateral flow technique on human sample (urines or else) called "U-SGRICH, system of collecting, control (diagnosis) and conservation of human samples¹'" (generally urines) so as to contextually make a diagnostic use in one single ^

manoeuvre with one single product. It is a container in which the user directly collects his own sample to be analysed (generally urines). Inside this container, there is another container containing the strips (strip used for rapid diagnosis or IVD), which in few minutes and by the contact with the sample, will give the result that the sanitary operator wants to diagnose. The main container will be closed with an internal cap and then with an ulterior cap which will be sealed with a security strip and which will not allow alterations. The sealing is numbered, and so the two caps must be codified with codified references of identifying data of the user who is subjected to diagnostic inquiry. Successively, the sanitary authority or judicial authority or administrative authority which controls the user or the user himself or whoever being concerned, will be able to have ulterior compartments, single and independent, of the container-collector of the sample, so as to take part of the preserved and codified sample in order to obtain confirmations for diagnostic analysis that are made. This process of taking successive samples is made without manipulating the seal. The invention is intended to solve the problem of secure and guaranteed collecting of human samples which may give an immediate and direct diagnostic result, of conserving the human samples for successive controls, is intended to eliminate the different steps, the different products and the different manoeuvres which must be made at present to achieve the same result of taking sample, collecting, control, diagnosis and ulterior possibility to take sample and confirming diagnosis ensuring: discretion of data, guarantee of non alteration of the sample and assurance that the used sample always corresponds to the user himself, procedural simplicity because it gives the possibility to make everything with one single product so consenting to reduce dangerous wastes. There is therefore a new product and a new process, safer and simpler. Another problem that is solved, besides the guarantees listed above, is also the guarantee of sanitary and hygienic security and fewer possibilities of infection thanks to the safer and simpler procedural use. It is actually established that every manoeuvre discarded in the processes of manipulations of human samples, potentially contaminated, reduces the possibility of infections for the operators. _{^ ^}

Best mode for carrying out the invention

Analysis of the achieved result

System of rapid diagnostic detection with lateral flow technique on human sample (urine or else) called "U-SGRICH" or referring to its complete designation it is called "U-SGRICH: system of collecting, controlling (diagnosis) and conservation of human samples"(generally urine) so as to make a diagnostic use in one single manoeuvre with one single product.

Components and materials!

Urine collector so as to make diagnostic tests.

The product consists of 6 components.

-The first component is a container-collector of urines divided internally by different compartments. It is made of supple plastic material as polypropylene.-table n.l (it refers to a container made of four compartments)-

-The second component is the first cap (internal cap) intended to close the different compartments of the container-collector of urines and make them impervious. It is also made of supple plastic material as polypropylene, -table n.2-

-The third component is the second external upper cap intended to definitively close the container-collector of urines and keep fixed the internal cap. This component is also made of supple plastic material as polypropylene.-table n.3-

-The fourth component is a plastic and/or metal strip (seal for securing guarantee) passing between two rings of the external upper cap and two rings of the container-collector. At one end there is a band with identifying progressive numeration. It is a closing intended to seal the container-collector with the external upper cap so as not to allow alterations of the container and the content (it is a seal of guarantee present on the market).

-The fifth component is a key intended to break each compartment of the container-collector so as to extract part of the urine enclosed in the compartment of the container-collector. It is made ofrigid^Jplastic rriaterial.-table n.4-

-the sixth component is a rapid test container on membrane (strip) in order to, by the reaction with the collected human sample, determine a pathological or physiological state (ex: different pathologies, physiological states, presence of hormones or dysfunctions, drugs assumption, etc...). The strip specially created for this diagnostic device, with measures (length, width and thickness) corresponding to the diagnostic device's type called U-SGRICH, is a strip made of different components superimposed wherein the inferior part there is an absorbent component which carries along the human sample on the..reactive part of the strip. The detected substance gives a' test line and, when the test functions perfectly, it appears another colored line parallel to the other (control line). The presence of the only control line gives a positive result to the test with regards to the determining of drugs assumption and negative when there are two visible parallel colored lines (control line and test line). Otherwise for other diagnosis and _g

substances to determine and detect, the test is positive when there are two colored lines (test line and control line), on the other hand the" test is negative if there is one single colored line (control line) .Different diagnosis can be inserted on the strip itself (there will be the test line as well as the usual control line), -table n.5 (it is pointed out a container of 10 compartments)- l.This component or diagnostic device is placed in one of the compartments of the urine container-collector so as to be able to react with urines without alterations and without the possibility of falsification of the results.

2. This cassette (box) could be immerged in the urines because sealed by means of ultrasonics and so impermeable.

3. This cassette encloses on the inside a multiple number of strips, generally up to ten (strip test made of a cardboard layer in which is assembled, in the central part, the strip in which reactive substances and the controlling substance allowing the good functioning of the test are sprayed. In the inferior part to the membrane a part soaked with conjugate is assembled, at the end of the inferior part there is a porous and spongy part intended to absorb the human sample (generally urine) and make it slide along the strip so as to, crossing the strip, it arrives on the membrane where, if the detected substance is present, there will be the reaction and the visibility of the result of the test, at the end of the superior part another component made of absorbent material is assembled in order to detect the excess of humidity. It consents the human sample to wet the test as far as necessary so that the reaction will be achieved on the test strip and therefore to make the test functioning, for this reason the strip sticks out the cassette about 5 mm with at the end of the inferior part made of porous and spongy material.This part of the strip, at the entrance of the cassette, is squeezed by a step which narrows the entrance of the cassette, keepsTstill the strip and allows precisely the passage of the only human sample required to the reaction. 4.This component is made of trasparent plastic material that is polystyrene.

Functioning:

The employee delivers the container-collector (table n.l) and the caps to the user to whom diagnostic inquiries will be made. The user collects his own urine streaming straight into the container-collector and places the internal cap (table n.2) writing over his own identifying data. Then together with the operator he puts the external cap (table n.3) over which user's identifying data are indicated and put the sealing. Simultaneously, passed at least 5 minutes, the operator will be able to gather the resujjs.of the diagnostic inquiry required watching the container-collector on the lateral part where it is possible to see the collecting strips box ^

through (table n.5) and where are actually inserted the reacting strips. Together, operator and user, write the user's data and the results of the diagnosis over an appointed collecting file in more copies. The operator will be able now to conserve the container-collector called U- SGRICH and so to make consecutively, if necessary or requested (by the user, for other diagnostic necessities, by administrative^sanitary or judicial authority, by everyone being assigned) ulterior diagnostic controls with the security and guarantee that, meanwhile, no alterations or falsifications of the sample or user's data can be practised, hi every steps (collecting, closing of the U-SGRICH, diagnosis and preservation of the U-SGRICH) user and operator are always present. Functionality of the product:

- Allows the confidentiality of the collected data.

-^"Allows an immediate and secure lecture of the test outcome, unequivocally attributable to the only patient himself.

- Allows simplicity in the functioning and in the use, so as to eliminate different steps to the operator, who, to the present state of thejirt, should have collected urine sample, and then made, with another manoeuvre, the test using another container, test tubes or, with a container yet containing the test act so as not to wet the central part of the test where is positioned the membrane which, if excessively wet it wouldn't be able to give the result anymore.

- Allows to collect data without manipulations making the attribution of the test to the patient sure.

- It is the only system that includes one or more multiple tests comprised in a container- collector of urines wherein the test could be fully immersed into the urines being impermeable.

- It is the only system that can be sealed for a safe archive.

- It is the only system that includes one or more multiple tests comprised in a container- collector of urines which allows to have the result archived together with urines sample in three other compartments and these urines can be successively used for ulterior necessity of deepening of the achieved result or for ulterior diagnostic inquiries also required by judicial authority.

- To have the test with the result together with the human sample gives the safety that no manipulations or alterations can be made so consenting to a safe, reliable and undeniable inquiry through judicial authority.

- At present tests are made with one or more containers, and also with multiple tests in box that are not impermeable and can not be immersed and sealed in the same container of the collected sample. Therefore it discards and goes beyond the disadvantages and the limits present on other known devices on the market.

- This system, closed and sealed in one single package, contains everything essential for its functioning, and in one single product includes the different systems and products present on the market and for these present systems it is necessary to have different products by different producers too.

- This system, closed and sealed in one single package containing everything is necessary for its functioning, as described before, consents therefore to eliminate more manoeuvres of the operator, more and different components whichever laboratory or diagnostic operator should individually acquired and from different producers not guarantying the functionality and the compatibility and not allowing easiness, simplicity, functionality and briefness in the fulfilment stage too. Therefore this consents to consequently reduce administrative times for the supplying of the different components of the different producers, times of execution and the presence of different materials which, among other, also involves major attention in reference to problems due to listing, depositing, stocking and successively material refusal.

- It simplifies and reduces the procedural manoeuvres to the operator reducing the possibilities of infections.

- The 'single package consents to reduce Jhe scraps and the consequent expensive waste of dangerous materials contributing to the environmental security and in the working field.

- As for the considerations listed above, the "U-SGRICH" system is definitely less expansive onerous of other systems.

- As for the considerations listed above, the "U-SGRICH" system is definitely more functional, reliable and unique of its kind determining an improvement in quality, functionality and an improved and different quality of the use so as to have a new product, new and better functioning uses.

Brief description of the figures

Figure n.l

Container-collector of human sample with a view in section, from above and from lateral superior outside.

Figure n.2

Drawings referred to internal cap of the container-collector of human sample. Superior view and in section.

Figure n.3

Drawings referred to the external cap of the container-collector of human sample. Superior view and in section.

Figure n.4

Key for the opening of the three compartments of the container-collector of human sample so as to have the possibility to take three different samples of the human sample.

Figure n.5

Container enclosing reactive strips (strips/rapid tests on membrane) and its cap. Superior view and in section.

Claims

_1Q

Claims

1) CLAIM 1 System of rapid diagnostic-detecting with lateral flow technique over human sample (urine or else) called "U-SGRICH" made of container-collector, that is cup for collecting human sample comprising more sections, or compartments, differentiated (in the bigger compartment is located the box or device containing the reactive strips appropriate for rapid diagnosis or IVD, the other compartments include the rest of the collected human sample and to be used separately for ulterior diagnostic inquiries of administrative, sanitary or medicolegal nature) as illustrated in figure n.l, internal cap as in figure n.2, external cap as in figure n.3, key for the opening of the compartments containing the human sample as in figure n.4, box or device containing the reactive strips as in figure n.5.

2) CLAIM 2 System of collecting, controlling (diagnosis) and conservation of human samples (generally urines) (see figure n.l) intended to contextually make a diagnostic use in one single manoeuvre, with one single product.

3)' CLAIM 3 Container-collector in which the user directly collects his own sample to analyse (generally urines) (see figure n.l). This container, made of plastic material, presents more compartments which, closed with the two caps, internal (figure n.l) and external (figure n.2), result completely isolated and independent. The oval compartment, and bigger than the other compartments too, is the component where is placed the box or device seen in figure n.5 which will contain the strips or reactive strips for diagnostic determining. The other compartments have at the inferior end a form which allows, with the key referred to figure n.4, its opening. The purpose is to preserve for a time the same sample unequivocally subjected to diagnosis and certainly' belonging to the user of that sample and to be able to make ulterior diagnostic inquiries for administrative, judicial, sanitary or medico-legal purposes.

4) CLAIM 4 Container (device or box) enclosing reactive strips (strips/test for rapid diagnosis on membrane or IVD) (see figure n.5 where an example of box with ten compartments is reported) therefore containing the strips that, in this process referred to as U-SGRICH, is placed in the container-collector. This box is multicompartments box. Every compartment consents to insert a strip for rapid diagnostic determining according to the lateral flow technique useful to single or multiple diagnostic determining. This box is welded by ultrasonics with its top after the strips have been inserted. Its conformation and welding make the whole box impermeable and so every compartment in relation to the others and has in the inside a narrowing in the inferior part which, after the welding, retains the strip in a better way, expressly created for this diagnostic device with measures (length, width and thickness) corresponding to diagnostic device's type called U-SGRICH. This narrowing, the impermeability of the box and the specific construction of the strips consent that, in the reactive part of the strip, only arrive the part of human sample necessary to the functionality of the strips.

5) CLAIM 5 Internal cap as in figure n.2 which allows to close the container-collector (figure n.l) and, with the ulterior insertion of the external cap and seal, close and therefore conserve the collected human sample.

6) CLAIM 6 System of collecting, diagnosing and conserving with the product called U- SGRICH subject of this industrial invention according to which: a) the user and the operator are sure to collect, diagnose and preserve ^"a human sample which unequivocally belongs to the registered and codified user. The codification comes over a card of the detected data of the patient and diagnosis, over the internal cap and over the external cap. The system guarantees that all the data and the sample belong to the same user. The system is subsequently guaranteed with the insertion of a seal reporting a progressive numeration which is written on a detection list; b) It is consented to make all the manoeuvres of collecting, diagnosing, controlling and preservation of the human sample eliminating and therefore passing over the inconveniences and the limits present on other devices known and present on the market; c) by using one single multifunctional product it is consented to eliminate products and operative manoeuvres diminishing then the possibilities of infections, the possibility of errors, times, costs and waste; d) the confidentiality, the simplicity of use^ihe impossibility of manipulation and alteration of the user's data and of the human sample are guaranteed; e) it is consented to conserve the performed diagnostic inquiry, as well as the human sample for successive controls as for administrative, judicial, sanitary and medico-legal necessities; f) there is a box or device containing the strips useful for diagnosis in a system that is impermeable and that can not be manipulated being sealed and internal to the product called U-SGRICH.

7) CLAIM 7 System and process of human sample collecting by the way of the product called U-SGRICH.

8) CLAIM 8 System and process of human sample diagnosing with the product and the system called U-SGRICH.

9) CLAIM 9 System and process of human sample conservation with the product and the system called U-SGRICH.

10) CLAIM 10 System and process of collecting, diagnosis/control and conservation of animal samples besides human or else with the product and the system called U-SGRICH.