ITPD20080333A1 - SEALABLE SAFETY KIT WITH CONTAINER FOR TUBES, VIALS OR OTHER MEDICAL-SANITARY DEVICES - Google Patents

Description

TITLE

SEALABLE SAFETY KIT WITH CONTAINER FOR

TEST TUBES, VIALS OR OTHER MEDICAL AND HEALTHCARE DEVICES

DESCRIPTION

This patent relates to containers for use in hospitals, analysis laboratories, sampling points or for therapeutic communities in general and in particular concerns a new sealable and disposable safety kit, with container for test tubes, vials or other medical-sanitary devices. .

It is known the use, in the medical-hospital setting, of test tubes, vials or other containers, for the collection of organic fluids, biological samples, taken from the patient for analysis purposes.

The sample of organic origin to be analyzed is introduced into said test tubes or vials, during collection from the patient.

Subsequently, each of said test tubes or vials, intended to contain the sample to be analyzed, is marked with one or more labels, on which, for example, the name and / or identification code of the patient and / or the type is indicated. analysis to be performed on the sample taken and / or its provenance, and / or any other information necessary for the laboratory and the sampler.

The labeling of the tubes and / or vials is carried out before collection, so that the medical or nursing staff in charge of the collection already has the exact number of test tubes and / or vials to use, each with precise indications regarding the collection to be performed, and additional labels necessary to identify other medical devices or devices for collection.

After collection, said test tubes and / or vials, or other containers intended to contain the samples to be analyzed, are sent to the analysis laboratory. If the specially printed identification labels were applied manually to the relative tube or vial after the collection, there would be the risk of confusing the tubes or vials of different patients or of different types, thus generating serious errors, with possible consequences for the health of the patient. patient and / or delays in the execution of the analyzes or in the initiation of appropriate therapy with the need to repeat the sampling.

On the other hand, it is not uncommon that even the manually marked tubes or vials, prior to collection, can be confused with each other, resulting in errors and even delays in the execution and communication of the results of the analyzes.

Furthermore, as established by recent legislative measures, procedures have been implemented for the execution of health checks for the absence of drug addiction and the use of narcotic and / or psychotropic substances in workers, in order to prevent or ascertain the causes of accidents related to carrying out job duties at risk.

These procedures involve the collection and execution of specific analyzes on organic samples taken from a subject, and in particular of urine samples or keratin matrix samples, i.e. typically hair or hair, and must be managed in such a way as to guarantee confidentiality. , respect and dignity of the subject subject to assessment.

The biological samples taken from the subject must first be separated into two or more aliquots, typically three, each containing a predefined quantity of sample sufficient to allow the correct execution of the analysis operations, where the required analyzes are performed on at least a first aliquot, while at least a second aliquot must be kept in an appropriate manner for the possible repetition of the analysis, in the case of a positive ascertainment of the use of narcotic or psychotropic substances, if the subject under investigation requests a review within the permitted terms.

To ensure total correctness in the execution of the procedures, these samples taken must therefore be properly labeled and properly stored, for example under vacuum and / or in a controlled temperature environment.

It is therefore of fundamental importance, both for the patient's health, and to guarantee the high reliability of the results of the tests, that, for each patient or subject subjected to one or more samples of biological material, appropriate devices, correctly selected, are used. and labeled and of which it is also possible to trace the lot over time. The subject of this patent is a new sealable and disposable safety kit with container for test tubes and / or vials or other medical devices and one or more identification labels, particularly for hospital use, in analysis laboratories, sampling points or in the community. therapeutic in general.

The aim of the present invention is to contain the test tubes and / or vials and / or other medical-surgical devices and / or other auxiliary labels, relating to a single subject, ensuring that the biological samples and the material contained in the kit are marked and separated with security from those of other subjects, also allowing the possible affixing of further specific indications relating to the identification of the subject, the procedures to be applied, the type and destination of the material contained.

Another object of the present invention is to prevent confusion between test tubes and / or vials of different subjects.

Another object of the present invention is to prevent the loss of the test tubes and / or vials and / or the sampling material.

Another object of the present invention is to prevent the malicious acts of exchanging or removing or manipulating the test tubes and / or vials without leaving evidence of these operations.

Another object of the present invention is to allow the samples to be traced even during their eventual transport, for example from the place of sampling to the analysis laboratory.

Another purpose of the present invention is to make it possible to verify that the samples have been correctly stored, from the time of collection to the time of analysis.

These and other direct and complementary purposes are achieved by the new sealable and disposable safety kit, comprising at least one container for test tubes and / or vials or other medical-health devices, for hospital use or for therapeutic communities in general, one or more identification labels for each of said test tubes, at least one closure and identification label and at least one portable and personal reader for reading the identification data relating to the kit itself and its contents.

Said container is made of preferably plastic material and includes one or more openings for the introduction of the objects to be contained. In the preferred solution, said container has a parallelepiped shape, with an opening obtained on the upper wall.

The new kit includes, placed inside said container, one or more test tubes and / or vials and / or containers in general for biological samples, of the normal-closing, sealable or vacuum-sealed type, said containers being in turn adequately marked with identification labels, and / or additional auxiliary identification labels for application on further containers subsequently added and / or other medical-sanitary devices and / or other documentation relating to the sampling / analysis procedures and to the subjects involved.

Said opening of the container is for example closed and sealed by means of said closing element made for example with paper, plasticized paper or plastic.

Said closing element can be, for example, an adhesive or partially adhesive sheet, ie provided with a layer of adhesive glue distributed at least in correspondence with the contact surface with said container.

For example, said element or sheet is adhesive only at the edges, where it comes into contact with the flat edges of said opening of the container.

In this way, the intentional or accidental spillage of the material contained in the container is prevented.

It is envisaged that said closure element is identification of said container, on which the name and / or identification codes of the subject and / or of the health worker and / or the type and quantity of samples to be taken and / or the date of collection and / or the collection center and / or other information useful for medical, nursing or technical staff, such as the identification of the procedure to be applied to the sample contained, the identification of the portion of the sample contained, etc. . Said data can for example be reported in the form of a bar code or other type of code that can be quickly read and stored by means of said portable and personal reader of the healthcare operator and / or of the personnel assigned to transport and / or storage of the samples. and / or the personnel of the analysis laboratory.

The container, thus prepared, is delivered to the subject or to the medical, technical or nursing staff, who use it in the ward or in the sampling place or in the sampling points or in analysis laboratories.

The procedure for depositing the test tubes and / or vials or other medical-sanitary devices inside the container can be carried out manually or, preferably, by using automatic devices.

For example, it can be envisaged that said container, moving on a sliding belt, passes through a first station in which the test tubes and / or vials and / or auxiliary labels and / or other labels are deposited inside the container itself. medical-sanitary devices necessary for the execution of the sampling.

Subsequently, the container in question crosses a station in which said closing element is applied to the opening of the container, printed with all the information mentioned above, for closure and identification.

The assigned personnel, after having carried out the sampling as indicated on the container label, by using the tubes or containers contained therein correctly, reads each test tube using its own reader, replaces these tubes in the container and closes it by means of said label or closing element, also proceeding with the reading of the identification data shown on the closing element itself.

It is also expected that the new kit also includes, preferably, at least one additional safety label for the final sealing of the kit. Said safety closing element is preferably of the anti-burglary type, ie it immediately highlights any trace of opening or attempted opening.

In this way, the risk of loss of the test tubes and / or vials is absolutely avoided, as well as the risk of subjecting the subject to inappropriate checks, caused by errors in the preliminary phase of sampling.

Furthermore, the risk that the test tubes may be intentionally replaced in order to exchange the samples taken with other samples, for example to falsify the results of the tests to be carried out, is prevented. Said closing element preferably comprises a protruding tab and one or more incisions or perforations, so that said sealed container can be opened by tearing, to use the contained material. It is also possible to print the identification data of the patient / subject or of the material contained in the container on this tab.

The new kit can also be conveniently used as a safety element after collection, in the subsequent phases of transport to the analysis laboratories.

For this purpose, it is also possible to provide, alternatively or in combination with said anti-burglary safety seal label, the use of a further lid separate or integral with the container and which is applied to the container, to seal the same, after the tear-off opening of said closing and identification element or sheet.

This lid is of the perimeter sealing type, with perimeter teeth that snap along all or part of the edge of the container, and can also be equipped with a side tab with perforations on the upper part of said lid, for the opening of at least part of the additional cover itself.

The subsequent removal of said supplementary cover causes either the breakage of said teeth, so that the cover cannot be repositioned again or that its manipulation is evident.

It is also envisaged that said labels of said containers and / or said auxiliary labels for additional containers and / or said labels of said container and / or said anti-burglary security sealing labels include a bar code printed on them, with the data of reference.

It can also be envisaged that at least one radio frequency device is also placed on one or more of said labels and / or on said container, for tracking and identification of the kit and its contents.

It is also envisaged that the new safety kit may also include one or more additional labels suitable for being applied on the forms related to the kit, and where one or more identification data and / or one or more data relating to the / and analysis procedures or on particular precautions.

For example, the use of at least one label on the report to be delivered to the patient is envisaged, at least one label on the doctor's report and at least one label on the report for the analysis laboratory.

Said reports can be printed with the aid of a printer connected, for example wirelessly, to said readers.

The sealed container, together with the report for the analysis laboratory, is then placed in a sealable envelope, preferably thermal, in turn equipped with its own identification code, for example a bar code or radio frequency labels (RFI), which is read using your personal portable player.

Said bag can then be sent to the laboratory or adequately stored, and where the storage conditions of the samples are also recorded by means of said reader.

It can also be envisaged that the personnel assigned to transport the samples can also be equipped with said personal portable reader for tracing the material transported by it and recording the transport conditions.

In the attached tables a practical embodiment of the invention is presented, by way of non-limiting example.

Figure 1 shows the container, while figure 2 shows the completely closed and sealed safety kit.

Figures 2a and 2b show two views, upper and lower, of the closing and identification element or sheet.

Figure 3 shows the partially open kit, while Figure 4 shows the closed container with additional lid.

Figure 4a schematises the method of closing the supplementary cover.

Figure 5 shows the new kit with a burglar-proof security seal label in place of the additional cover.

Figure 6 schematically illustrates the use of an auxiliary label contained in the kit for sealing a container for collecting urine, before sampling the aliquots to be placed in the test tubes.

The new kit (K) includes a container (C) having a parallelepiped, cubic or other shape and equipped with at least one upper opening (A) for the introduction of test tubes and / or vials (O) and / or containers (Q) in general and / or auxiliary labels (E) for additional containers (Q) and / or other medical-sanitary devices.

The kit (K) also includes a label or element (F) for closure and identification, on which the identification data (S) of the patient / subject and / or the content and / or other information necessary for the collector are printed.

For example, said identification data can be reported on said closing element (F) in a bar code (S) in addition to the name and / or signature of the patient / subject (S1) and / or of the healthcare personnel (S2).

Said label or element (F) is an adhesive sheet, where, for example, the adhesive layer (T) is distributed at the contact surface between said sheet (F) and the edge (C1) of said upper opening (A) of the container (C).

Said label or closing element (F) comprises at least one tab (L), on which the identification data of the patient / subject or of the contents of the container can be reported, and one or more incisions or perforations (P) to allow the opening of the sealed container.

In particular, said incisions or perforations (P) allow to lift at least one part (F1) of said element (F), to allow access to the inside of the container (C).

Said kit (K) also includes at least one auxiliary label (E) suitable to be used for the tamper evident sealing of the containers (Q) for urine collection, of the type with sampling probe (Q1).

Such sealing is, for example, necessary in the event that urination has been insufficient and requires integration by the subject to be subjected to the analysis.

After the opening of said closing element (F), it is expected to be able to seal the container (C) again by using a label or anti-burglary sealing element (V).

Said anti-burglary label (V), to be applied to further closure of said container (C) as illustrated in figure 5, is conveniently equipped with at least one window (V1) suitable for being placed in correspondence with said bar code (S), for allow the display and reading of the code itself.

Alternatively, it is envisaged to use, for example, an additional lid (R), detached or integral with said container (C) as shown in Figure 4.

Said supplementary lid (R) is of the perimeter sealing type, i.e. it comprises a plurality of teeth (R1), distributed along its perimeter, which snap-fit along all or part of the edge (C1) of the container, preferably in correspondence with the corners.

It may also have a side tab (R2) and perforations (R3) on the top, for the tear-open opening of at least a part of the additional cover (R) itself.

The reopening of said supplementary cover (R) causes the breakage of said teeth (R1).

Therefore, with reference to the preceding description and to the attached tables, the following claims are expressed.

These are the schematic modalities sufficient for the skilled person to realize the invention, consequently, in concrete application there may be variations without prejudice to the substance of the innovative concept.

Therefore, with reference to the above description and the attached tables, the following claims are expressed.

Claims (12)

CLAIMS 1. Safety kit (K) for test tubes and / or vials (O) and / or containers (Q) in general and / or other medical-health devices for use in hospitals, private laboratories, sampling points or for therapeutic communities in gender, characterized by the fact of including: <•> at least one container (C) with at least one opening (A) for the introduction of said test tubes and / or vials and / or containers (O) and / or medical devices in general; <•> at least one label or element (F) for closing and sealing said opening (A), and where on said element (F) one or more identification data (S), in clear or in code, relating to a subject or patient and / or healthcare personnel and / or the content and / or intended use of the content and / or the provenance and / or any other information requested by the collector; <•> one or more test tubes and / or vials (O) and / or containers and / or medical-sanitary devices in general for the collection of biological samples of the subject, on which one or more identification data can be reported (S); <•> one or more auxiliary labels (E), on which one or more identification data (S) can be reported, for the labeling of one or more additional containers (Q) and / or forms related to the sampling and / or to the collection and / or devices for analysis; <•> at least one label (V) or element (R) for security anti-burglary sealing, for the final sealing of the kit; <•> at least one reader for reading said identification data (S). 2. Safety kit (K), as per claim 1, characterized by the fact that said reader of said identification data (S) is portable and can be customized exclusively for medical personnel and / or personnel assigned to transport and / or storage and / or analysis of samples. 3. Safety kit (K), according to claims 1, 2, characterized in that it comprises one or more radiofrequency devices applied to said container (A) and / or to one or more of said containers (O, Q) and / or on one or more of said labels (E, F, V), for tracking and identification of the kit and its contents. 4. Safety kit (K), according to the preceding claims, characterized in that it comprises one or more of said auxiliary labels (E) suitable for being applied on the forms related to the kit. 5. Safety kit (K), according to the preceding claims, characterized in that it comprises one or more of said auxiliary labels (E) adapted to be applied for sealing containers (Q) for collecting urine. 6. Safety kit (K), as per the preceding claims, characterized in that it comprises at least one envelope or container in general, suitable for containing said container (C) closed and sealed, containing the samples, and at least one report, for the transport and / or storage of the samples up to the place and time of the analysis and possibly uniquely identified by bar codes and / or radio frequency labels (RFI). 7. Safety kit (K), as per the preceding claims, characterized in that said label or closing element (F) is an adhesive sheet comprising one or more incisions or perforations (P) and / or other systems operating for the tear-open opening of at least one part (F1) of said label or element (F), for access inside said container (C). 8. Safety kit (K), as per the preceding claims, characterized by the fact of being disposable. 9. Security kit (K), as per the preceding claims, characterized by the fact that said label (V) or element (R) for anti-burglary security sealing allows the display of the identification data (S) shown on said label or element (F ) closing. 10. Safety kit (K), as per the preceding claims, characterized in that said anti-burglary safety sealing element comprises a cover (R), in turn equipped with: a plurality of teeth (R) distributed throughout or part of the perimeter of said lid (R) and able to snap into place along all or part of the edge (C1) of said container (C) and where the subsequent removal of said lid (R) causes the breakage of said teeth (R1) ; a lateral tab (R2) for gripping and perforations (R3), for the tear-open opening of at least a part of said additional cover (R). 11. Safety kit (K), according to the preceding claims, characterized in that said identification data (S) are printed in the step preceding or following the closing and / or sealing of said container (C). 12. Safety kit (K), as per the preceding claims, characterized in that it is positioned on a sliding belt and / or in another automatic device, for the introduction of said containers (O) and / or auxiliary labels (E, F, V) and / or medical-sanitary devices and / or for the application of said label or closing adhesive element (F).