Technical field

The present disclosure refers to the field of collection of biological samples, in particular to the collection of biological samples through the introduction of suitable devices for the collection within cavities of the human or animal body. The disclosure refers to a device for the collection of biological samples and a method for the collection of biological samples.

Background art

Devices for the collection of biological samples are traditionally used for collecting biological samples from cavities of human or animal body. In particular, among the devices for the collection of known type there are the so-called nasopharyngeal swabs, which are devices provided with a substantially elongated body, typically having a substantially axial extension, which ends with a collection element of biological samples destined to retain a biological sample substantially fluid. Other types of devices for the collection of biological samples are destined to be introduced in cavities different with respect to the nose, for example in the mouth, in the vagina or anus, in order to collect the biological samples here present, such as for example epithelial cells, secretions, etc...

The nasopharyngeal swabs are typically introduced in the nasal cavity through the opening of a naris, and are pushed in the nasal cavity until typically reaching a mucosa present in the nasopharynx, which is substantially placed in correspondence of the rear portion of the nasal cavity, for collecting biological samples, such as epithelial cells, secretions, etc, of the upper respiratory tracts.

After the collection, the nasopharyngeal swab is extracted from the nose and the collected sample can subsequently be placed for example in a reagent, to determ ine the presence or absence of determ ined pathogens, or subjected to other types of analysis.

Since the first months of 2020, the rapid spread of the SARS-CoV2 virus responsible for COVID-19 disease has led to a great diffusion of the use of nasopharyngeal swabs for carrying out screening and/or testing for coronavirus infection.

In the case of screening and/or testing for COVID-19, WTO recommends carrying out nucleic acid amplification tests (NAATs) using a reverse polymerase chain reaction process, on biological samples collected generally via nasopharyngeal swabs.

It has been observed that the correct use of nasopharyngeal swabs increases the reliability of the screening and/or test. In particular, it has been observed that a proper mode of collection of the biological sample, represented by epithelial cells, secretions, or other analytes collected from the upper respiratory tracts, allows to improve the reliability of the screening and/or test, in particular by mitigating the number of false negatives. False negatives are those tests carried out through nasopharyngeal swabs that are negative (i.e. report an apparent absence of traces of SARS-CoV2) although the subject is actually infected. A presence of a large quantity of false negatives determines - at least indirectly - an increase in the spread of the contagion, since a subject who should be placed in isolation is instead free to move around. False negatives are particularly insidious in the case of asymptomatic infection.

It is observed that screening and/or testing for COVID-19 is carried out on people of all ages, both children and adults.

Prior to the spread of SARS-CoV2 virus, nasopharyngeal swabs were used almost exclusively by highly specialized personnel. Nowadays, screening and/or testing with nasopharyngeal swabs are often no longer carried out solely by specialized medical personnel, but mostly by paramedics or pharmacy staff, whose training in this type of collection is generally sub-optimal and lower than that of a doctor. It has been observed in particular that in many cases the training of this personnel is limited to viewing informative videos.

As already noted, the reliability of the screening and/or test depends to a large extent on the correct reaching of the rear mucosa of the nasopharynx, and thus on the correct actuation of the procedure of insertion and collection of the device. On one hand, therefore, an insufficient introduction of a nasopharyngeal swab can then determine an inadequate collection of the desired sample.

On the other hand, it has been observed that an excessive introduction of a nasopharyngeal swab can cause pain and/or trauma to the patient.

Guidelines have therefore been proposed in the state of the art to allow an adequate collection of the sample, but these guidelines are often inhomogeneous with each other and often leave a too much margin of interpretation and uncertainty in the operators.

It is known that the distance between the opening of the naris and the rear mucosa of the nasopharynx, which determines the optimal depth of introduction of the device for the collection, is variable from subject to subject.

This distance also varies depending on further factors related to the specific anatomical conformation of the different subjects and therefore results to be not predictable in a sufficiently precise way.

The purpose of the present disclosure is to provide a device for the collection, a container for devices for the collection and/or a collection method which are able to overcome the limitations of the known art and in particular to improve the reliability of the screening and/or test following the introduction of the device into a body cavity.

Summary

The Applicant has observed that the correct depth of insertion of the nasopharyngeal swab for the carrying out of screening and/or diagnostic tests to assess infections with viruses that may be found in the upper airways, be they SARS-Cov2 type viruses or others, is mainly related to the age of the subject upon whom the screening and/or test by means of the nasopharyngeal swab is carried out.

Studies carried out by the inventors have proven that this distance increases with the increase of the age of the subject and at a determined age, substantially stabilizes. The Applicant has also observed that this correct depth can be estimated in a sufficiently precise way as a function of the distance between the tip or end of the naris and a determined part of the ear.

The object of the present disclosure is now described in some of its salient aspects, which can be combined with each other or with portions of the detailed description and/or claims.

According to a first aspect it is herein described a device (1 ) for the collection and the transfer of samples of biological material, comprising:

- an elongated body (2), at least partially extending along a main development direction (X) substantially axial and comprising at least a gripping portion (2i) destined to be grasped by a user and at least an end portion (2e),

- a collection element (3) connected to the elongated body (2) in substantial correspondence of said end portion (2e) and provided with an its own end portion, and configured to collect and/or absorb a quantity of a sample of biological material present in a cavity of the body of a patient (20), at least the collection element (3) being configured to be introduced inside a cavity of the body of the patient (20), for example to be introduced inside the nasal cavity and/or the nasopharynx of the patient (20); wherein the elongated body (2) comprises a first graduated scale (4) having at least a first measurement marking (4i) positioned at a first distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to a first distance value representing a first plurality of measurement data of a distance (D) present between a first portion and a second portion of the body of a respective first plurality of study subjects having a first biographic age, or belonging to a first predetermined biographic ages range, optionally wherein said first portion and said second portion are a first and a second portion of a cavity of the body of said study subjects; said first measurement marking (4i) being configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20). According to another non-limiting aspect, the device (1 ) wherein the elongated body (2) comprises a second graduated scale (4’) having at least a first measurement marking (4i) positioned at a first distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to a first distance value representing a first plurality of measurement data of a distance (D) present between a first portion and a second portion of the body of a respective first plurality of study subjects having a first biographic age, or belonging to a first predetermined biographic ages range, optionally wherein said first portion and said second portion are a first and a second portion of a cavity of the body of said study subjects.

According to another non-limiting aspect, said first measurement marking (4i) is configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4’) comprises a second measurement marking (4i) positioned at a second distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to a second distance value representing a first plurality of measurement data of a distance (D) present between the first portion and the second portion of the body of a respective second plurality of study subjects having a second biographic age, or belonging to a second predetermined biographic ages range, said second measurement marking (4i) being configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the device (1 ) is a pediatric device for the collection and the transfer of samples of biological material. According to another non-limiting aspect, the first graduated scale (4) and the second graduated scale (4’) are associated to distances (D) object of measurement on study subjects of different ethnicity or population and/or on subjects having respectively male and female gender and being destined to be used respectively for patients (20) of different ethnicity or population and/or on patients (20) of respectively male and female gender.

According to another non-limiting aspect, said distance (D) is the distance present between an opening or end of a naris (11 ) of said first plurality and/or second plurality of study subjects and a predetermined rear portion of the nasopharyngeal arch and/or present between an ear (10), optionally the tragus or lobe or opening of the ear canal (1 Ot), and an opening or end of a naris (11 ) of said first plurality and/or second plurality of study subjects and/or present between an ear (10), optionally the tragus or lobe or opening of the ear canal (1 Ot), and the philtrum (12) of said first plurality and/or second plurality of study subjects and/or present between a front-higher point of the philtrum or of the naris contour and the shape, optionally a rear arch, of the nasopharynx of said first plurality and/or second plurality of study subjects.

According to another non-limiting aspect, said distance (D) is the distance present between an opening or end of a naris (11 ) of said first plurality and/or second plurality of study subjects and a predetermined rear portion of the nasopharyngeal arch is determined by means of a measurement carried out on at least a diagnostic image comprising at least one among one or more radiographies, or one or more tomographies, one or more magnetic resonances, one or more ultrasonographies.

According to another non-limiting aspect, said cavity is one among a buccal, anal, vaginal, auricular, urethral cavity of the subject (20).

According to another non-limiting aspect, the first and the second measurement marking (4i) are reciprocally spaced for a predefined distance along said main development direction.

According to another non-limiting aspect, said at least a first and a second measurement marking (4i) extend at least partially, preferably mainly, along a substantially oblique direction, optionally along a substantially orthogonal direction, with respect to the main development direction.

According to another non-limiting aspect, the plurality of measurement markings (4i) comprises non-equidistantly spaced measurement markings and/or the first graduated scale (4) comprises a third measurement marking (4i) positioned at a third distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to a third distance value representing a first plurality of measurement data of a distance (D) present between the first portion and the second portion of the body of a respective third plurality of study subjects having a third biographic age, or belonging to a third predetermined biographic ages range.

According to another non-limiting aspect, said third measurement marking (4i) is configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the second measurement marking is interposed between the first and the third measurement marking.

According to another non-limiting aspect, a distance present between the first measurement marking and the second measurement marking is different with respect to a distance present between the second measurement marking and the third measurement marking.

According to another non-limiting aspect, said biographic age is a paediatric and/or development age.

According to another non-limiting aspect, at least one among said first measurement marking (4i), said second measurement marking (4i) or said third measurement marking (4i) is indicative of a minimum age of use of said device, and optionally is indicative of, or corresponding to, an age substantially comprised between 3 and 5 years, or is indicative of a substantial stabilization age, according to the age, of the distance (D) present between said first portion and said second portion. According to another non-limiting aspect, said et substantial stabilization age is substantially comprised between 9 and 13 years, preferably between 10 and 12 years, more preferably substantially equal to 11 years.

According to another non-limiting aspect, at least one between the first graduated scale (4) or the second graduated scale (4’) is at least partially etched, and/or realized through recesses or concavities, on said elongated body (2) and/or is at least partially in relief on said elongated body (2) and/or is fixed, impressed, molded, co-molded or painted on said elongated body (2).

According to another non-limiting aspect, at least one between the first graduated scale (4) and said second graduated scale (4’) is realized in a material at least partially different with respect to the material with which is realized said elongated body (2).

According to another non-limiting aspect, the elongated body (2) presents at least a first color.

According to another non-limiting aspect, at least part of at least one between said first graduated scale (4) and said second graduated scale (4’) presents at least a second color different with respect to said first color.

According to another non-limiting aspect, the elongated body (2) comprises a central portion (2c) positioned between said gripping portion (2i) and said end portion (2e).

According to another non-limiting aspect, at least one between the first graduated scale (4) or the second graduated scale (4’) extends at least partially in said central portion (2c) and/or at least one between the first graduated scale (4) or the second graduated scale (4’) extends at least partially in said gripping portion (2i), the graduated scale being configured and specifically destined to address, in use, the user to grasp the elongated body (2) in correspondence of at least a measurement marking (4i) of said plurality of measurement markings (4i).

According to another non-limiting aspect, the device (1 ) has a length at least equal to 10cm, and preferably at least equal to 12 cm or more preferably at least equal to 14cm, and/or the elongated body (2) presents a substantially constant transversal section along its extension along said main development direction (X) or presents a transversal section variable along its extension along said main development direction (X); optionally the elongated body (2) presenting a transversal section substantially circular or inscribable in a circumference, said transversal section substantially circular or said circumference having a diameter comprised between 1 ,5mm and 3mm, more preferably comprised between 2mm and 2,5mm.

According to another non-limiting aspect, the elongated body (2) is substantially flexible, and/or is realized at least partially in a natural or plastic material, and/or realized through a molding, optionally through an injection molding or a co-molding, and/or a 3D printing process, and/or the elongated body (2) is realized as a single piece.

According to another non-limiting aspect, at least one between the first graduated scale (4) or the second graduated scale (4’) is integral with said elongated body (2), optionally at least one between said first graduated scale (4) and said second graduated scale (4’) being integrally realized with said elongated body (2), optionally through said molding process, optionally injection molding or co-molding, and/or the 3D printing.

According to another non-limiting aspect, the first graduated scale (4) and the second graduated scale (4’) are associated to distances (D) object of measurement on study subjects of different ethnicity or population and/or on subjects having respectively male and female gender and being destined to be used respectively for patients (20) of different ethnicity or population and/or on patients (20) of respectively male and female gender.

According to the present disclosure it is also realized a method of production of a device (1 ) for the collection and the transfer of samples of biological material, comprising:

- a first plurality of measurement and/or calculation steps of a respective first plurality of measurement data of a distance (D) present between a first portion and a second portion of the body of a respective first plurality of study subjects having a first biographic age, or belonging to a first predetermined biographic ages range, optionally wherein said first portion and said second portion are a first and a second portion of a cavity of the body of said study subjects; - a first step of analysis, preferably of statistic type, of said first plurality of measurement data for defining a first graduated scale (4) comprising at least a first measurement marking (4i) indicating a first distance value representing said first plurality of measurement data and said first biographic age or said first predetermined biographic ages range;

- a step of production of said device (1 ) for the collection and the transfer of samples of biological material, comprising:

- a step of realization and/or assembly of an elongated body (2), at least partially extending along a main development direction (X) substantially axial and comprising at least a gripping portion (2i) destined to be grasped by a user and at least an end portion (2e), and

- a step of production and/or assembly of a collection element (3) in substantial correspondence of said end portion (2e) of the elongated body (2), the collection element being provided with an its own end portion and being configured to collect and/or absorb a quantity of a sample of biological material present in a cavity of the body of a patient (20), at least the collection element (3) being configured to be introduced inside a cavity of the body of the patient (20), for example to be introduced inside the nasal cavity and/or the nasopharynx of the patient (20); wherein the step of production of the elongated body (2) comprises a step of realization, on said elongated body (2), of at least said first measurement marking (4i) positioned at a first distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to said first representing distance value, the first measurement marking (4i) being configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the method comprises a second plurality of measurement and/or calculation steps of a respective second plurality of measurement data of said distance (D) present between the first portion and the second portion of the body of a respective second plurality of study subjects having a second biographic age or belonging to a second predetermined biographic ages range, optionally wherein said first portion and said second portion are a first and a second portion of a cavity of the body of said study subjects.

According to another non-limiting aspect, the method comprises a second step of analysis, preferably of statistic type, of said second plurality of measurement data for defining said first graduated scale (4) comprising furthermore at least a second measurement marking (4i) indicating a second distance value representing said second plurality of measurement data and said second biographic age or said second predetermined biographic ages range.

According to another non-limiting aspect, the step of production of the elongated body (2) comprises a step of realization, on said elongated body (2), of at least a second measurement marking (4i) positioned at a second distance from said end portion (2e) of the body, or from the end portion of the collection element, equal or related in a predetermined way to said second representing distance value.

According to another non-limiting aspect, the second measurement marking (4i) is configured to, and destined to, provide, to the patient or to the operator an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the method comprises a repetition of said first plurality of measurement steps and of said first step of analysis for defining a multiplicity of plurality of measurement data of said distance (D) corresponding to respective multiplicities of study subjects having respective and among them different biographic ages or biographic ages ranges, for defining said graduated scale (4) comprising a corresponding multiplicity of distance values representing said respective biographic ages or biographic ages ranges.

According to another non-limiting aspect, the step of production of the elongated body (2) comprises a step of realization, on said elongated body (2), of a plurality of measurement markings (4i) related to said graduated scale (4) and positioned at respective distances from said end portion (2e) of the body, or from the end portion of the collection element, equal or related in a predetermined way to said multiplicity of representing distance values.

According to another non-limiting aspect, the plurality of measurement marking (4i) is configured to, and destined to, provide, to an operator an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, at least one between said first and/or second step of analysis comprises at least a calculation, optionally an electronic calculation, of an expected value, and/or of at least one among an arithmetical average, a weighted average, a weighted average, of at least a first part of said plurality of measurement data, said part comprising measurement data univocally associated to study subjects having a same age and/or ages range a same gender and/or belonging to a same ethnicity or population, said calculation determining the generation of said first representing distance value.

According to another non-limiting aspect, said cavity is the nasal cavity and/or the nasopharyngeal cavity.

According to another non-limiting aspect, the method comprises another step of analysis, preferably of statistic type, of said first plurality of measurement data for defining a first graduated scale (4) comprising at least a first measurement marking (4i) indicating a first distance value representing said first plurality of measurement data and said first biographic age or said first predetermined biographic ages range.

According to another non-limiting aspect, the plurality of measurement marking (4i) is configured to, and destined to, provide an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of said collection element (3) within said cavity of the body of the patient (20).

According to another non-limiting aspect, the step of production, on said elongated body (2), of said first graduated scale (4) and/or of said second graduated scale (4’) comprises a realization of at least a first measurement marking of the plurality of measurement markings (4i) positioned at a first distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to said first distance representing value, the first measurement marking (4i) being configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the step of production, on said elongated body (2), of said first graduated scale (4) and/or of said second graduated scale (4’) comprises a realization of a second measurement marking (4i) positioned at a second distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to a second distance representing value, the second measurement marking (4i) being configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the step of production, on said elongated body (2), of said first graduated scale (4) and/or of said second graduated scale (4’) comprises a realization of a third measurement marking positioned at a third distance from the end portion (2e) of the body or from the end portion of the collection element, equal or related in a predetermined way to a third distance representing value, the second measurement marking (4i) being configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth (100) of the elongated body (2) and of the collection element (3) within said cavity of the body of the patient (20) according to the age of the patient (20).

According to another non-limiting aspect, the first measurement marking and the second measurement marking (4i, 4i) are reciprocally spaced for a predefined distance along said main development direction (X).

According to another non-limiting aspect, said at least a first and a second measurement marking (4i, 4i) extend at least partially, preferably mainly, along a substantially oblique direction, optionally along a substantially orthogonal direction, with respect to the main development direction (X).

According to another non-limiting aspect, the step of production, on said elongated body (2), of said first graduated scale (4) and/or of said second graduated scale (4’) comprises a realization of a plurality of measurement markings (4i, 4i) non-equidistantly spaced.

According to another non-limiting aspect, the step of production, on said elongated body (2), of said first graduated scale (4) and/or of said second graduated scale (4’) determines the realization of the second measurement marking in a position interposed between the first and the third measurement marking.

According to another non-limiting aspect, the step of production, on said elongated body (2), of said first graduated scale (4) and/or of said second graduated scale (4’) is such that a distance present between the first measurement marking and the second measurement marking is different with respect to a distance present between the second measurement marking and the third measurement marking.

According to another non-limiting aspect, the method comprises the realization of at least one between the first graduated scale (4) and the second graduated scale (4’) with a step of etching and/or realization through recesses or concavities, on said elongated body (2) and/or realization partially in relief on said elongated body (2) and/or fixing, impressing, molding, co-molding, or painting on said elongated body (2).

According to another non-limiting aspect, the method comprises a step of realization of at least one between said first graduated scale (4) and said second graduated scale (4’) in a material at least partially different with respect to the material with which is realized said elongated body (2).

According to another non-limiting aspect, the elongated body (2) presents at least a first color. According to another non-limiting aspect, at least part of said first graduated scale (4) and/or of said second graduated scale (4’) presents at least a second color different with respect to said first color.

According to another non-limiting aspect, the step of production of the elongated body (2) comprises the realization of a central portion (2c) positioned between said gripping portion (2i) and said end portion (2e).

According to another non-limiting aspect, the realization of at least one between said first graduated scale (4) and said second graduated scale (4’) takes place extending at least one between said first graduated scale (4) and said second graduated scale (4’) at least partially in said central portion (2c) and/or takes place extending at least one between said first graduated scale (4) and said second graduated scale (4’) at least partially in said gripping portion (2i).

According to another non-limiting aspect, at least one between said first graduated scale (4) and said second graduated scale (4’) is configured and specifically destined to address, in use, the user to grasp the elongated body (2) in correspondence of at least a measurement marking (4i) of said plurality of measurement markings (4i).

According to another non-limiting aspect, the step of production of the elongated body (2) determines the production of an elongated body having a length at least equal to 10cm, and preferably at least equal to 12 cm or more preferably at least equal to 14cm, and/or having a substantially constant transversal section along its extension along said main development direction (X) or presents a transversal section variable along its extension along said main development direction (X); optionally the elongated body (2) presenting a transversal section substantially circular or inscribable in a circumference, said transversal section substantially circular or said circumference having a diameter comprised between 1 ,5mm and 3mm, more preferably comprised between 2mm and 2,5mm.

According to another non-limiting aspect, the step of production of the elongated body (2) comprises the realization of said elongated body in a flexible material, and/or at least partially in a natural or plastic material, and/or through a molding, optionally through an injection molding or a co-molding, and/or a 3D printing process, and/or as a single piece. According to another non-limiting aspect, the method comprises realizing at least one between the first graduated scale (4) and the second graduated scale (4’) integrally with said elongated body (2), optionally said first graduated scale (4) and/or said second graduated scale (4’) being integrally realized with said elongated body (2), optionally through said molding, optionally injection molding or co-molding, and/or the 3D printing process.

According to another non-limiting aspect, in the at least the first and/or the second measurement step, the measurement of said distance (D) present between an opening or an end of a naris (11 ), as first portion of the body of said first plurality and/or second plurality of study subjects, and a predetermined rear portion of the nasopharyngeal arch as second portion of the body of said first plurality and/or second plurality of study subjects, is carried out on a diagnostic image comprising at least one among one or more radiographies, or one or more tomographies, one or more magnetic resonances, one or more ultrasonographies.

According to the present disclosure it is described a device obtained by means of the method according to one or more of the aspects herein described.

According to the present disclosure it is furthermore described the use of the device (1 ) according to one or more of the aspects herein described for collecting samples of biological material from a nasal cavity.

In particular, according to the present disclosure it is furthermore herein described the use of the device (1 ) according to one or more of the aspects herein described for the execution of tests for the presence of bacteria and/or viruses, optionally for the execution of tests for the presence of coronaviruses, optionally of the SARS-CoV-2 type.

Figures

The object of the present disclosure will be described in the detailed description, which refers to some preferred embodiments of the device 1. In particular, such preferred embodiments are described with reference to the attached figures; a brief description of the figures is hereinafter provided.

Figure 1 shows a lateral view of a device according to the present disclosure. Figure 2 shows a profile view of a human face from which it is possible to determine a distance D between the nose and the ear, which is associated to an introduction depth of the device of figure 1 .

Figure 3 shows a sectional view of part of the device object of the present disclosure, in a specific embodiment.

Figure 4 shows a specific embodiment of the device object of the present disclosure, wherein a plurality of measurement markings of a graduated scale are etched or recessed.

Figure 5 shows a specific embodiment of the device object of the present disclosure, wherein the plurality of measurement markings protrudes outside the elongated body.

Figure 6 shows a specific embodiment of the device object of the present disclosure, wherein the plurality of measurement markings is of a color different with respect to the color of the elongated body.

Figure 7 shows a specific embodiment of the device object of the present disclosure, wherein the plurality of measurement markings is arranged, partially, obliquely with respect to a main development direction of the elongated body.

Figure 8 shows a specific and non-limiting embodiment of the device object of the present disclosure, wherein it is present a double graduated scale, preferably used for differentiating an introduction depth in relation to a biographic age of male subjects with respect to female subjects.

Detailed description

With reference to figure 1 , with reference number 1 is indicated as a whole a device 1 for the collection and the transfer of samples of biological material. For the purposes of the present disclosure, for “biological material” it is intended a material, for example wet material, in particular and not limiting thereto fluid and/or liquid, containing at least one between a secretion of a tissue, a tissue sample, tissue cells, blood, etc ... , of a human or animal being. In a preferred embodiment, the device 1 is mainly destined to allow the collection of biological samples from a nasal cavity, in particular from a portion of mucosa of the nasal cavity and/or nasopharynx. The device 1 here described can be advantageously used, for example, for the carrying out of screening and/or test of presence of coronavirus, in particular, and non-limiting thereto, of virus of SARS- CoV2 type (base variant and its subsequent variants). The device 1 here described realizes therefore a so-called nasopharyngeal swab.

The device 1 comprises an elongated body 2, mainly and at least partially extending along a main development direction (axis) X substantially axial.

The elongated body 2 is preferably realized in plastic material; this technical feature allows to have an elongated body 2 that is extremely economical to produce. The elongated body 2 is substantially flexible, in order to adapt at least partially to a curvature of the nasal cavity, the naris and/or the nasopharynx.

The Applicant observes furthermore that the flexibility of the elongated body 2 also allows to reduce the risk of injury should the elongated body 2 be introduced into a body cavity to a greater extent with respect to the one required, and/or avoids the risk of rupture of the elongated body 2 within the cavity, in particular where this flexibility characteristic is associated with a substantially elastic behaviour.

For example, the elongated body 2 can have a substantially circular transversal section, and develop along the axis X with a substantially constant diameter, e.g. and not limiting thereto comprised between 1.5mm and 3mm, more preferably comprised between 2mm and 2.5mm. When not of circular transversal section, the shape of the transversal section can be enclosed in a circumference whose diameter respects the limits described above.

This should not be understood in a limiting way, since in an alternative embodiment, the elongated body 2 can have a diameter, or more generally a transversal section, of non-constant area as one moves along the axis X. When realized in plastic material, the elongated body 2 can be realized by moulding, in particular by injection moulding or co-moulding. In an embodiment, the elongated body 2 can be realized by a 3D printing process.

The 3D printing process can be conveniently carried out by using a polymeric plastic material, for example and not limiting thereto, such as polyester type, for example PBT, or PEEK, or PPS, or polycarbonate, or ABS, or PVC, or PMMA. It is to be understood that where in the present disclosure reference is generically made to a plastic material, the specific types of plastic material described herein in connection with 3D printing of the elongated body can be equivalently used, alternatively or in addition to other specifically described types of material.

Suitable heating temperatures of the plastic material used for 3D printing or for the moulding techniques described above will be chosen by the technician according to the specific chemical composition of the material itself.

The elongated body 2 comprises at least a gripping portion 2i destined to be grasped by a user and an end portion 2e; the end portion 2e is opposed with respect to the gripping portion 2i. In particular, the elongated body 2 comprises a central portion 2c positioned between said gripping portion 2i and said end portion 2e.

The gripping portion 2i can be equipped with elements destined to increase a grip with the hand, in particular the fingers, of the user; in particular the gripping portion 2i can comprise a knurling.

The user can be a health professional, in particular a doctor or a paramedic, for example a nurse, or a pharmacist. The specific profession of the person referred to herein as "user" is not to be understood in a limiting way; the differentiation between "user" and "subject" is provided merely for the purpose of descriptive clarity. The user can also be the subject 20, in particular when the latter performs a self-test via said device 1 .

Superficially, the elongated body 2, in particular in correspondence of the gripping portion 2i, can be equipped with elements (for example knurling) destined to increase the grip with the fingers and/or palm of the user's hand. In an embodiment, at least part of the gripping portion 2i can be provided with a rubberized edge.

The device 1 comprises also a collection element 3 connected to the elongated body 2 in substantial correspondence of the end portion 2e. The collection element 3 is configured and specifically destined to allow to absorb and/or retain a quantity of a sample of biological material, in particular of a secretion which develops in the in the upper airways of a subject. The collection element 3 is configured to be introduced inside the nasal cavity and/or nasopharynx of a subject.

For the purposes of the present disclosure, for “nasopharynx” it is intended the upper portion of the pharynx that extends from the base of the skull until the upper surface of the soft palate. The nasopharynx includes the space between the inner narises and the soft palate, and lies above the oral cavity. The nasopharynx comprises, in particular, the adenoid portion. The nasopharynx is surrounded by the Waldeyer ring.

Preferably, but non-limiting thereto, the collection element 3 is configured and specifically destined to allow the collection of at least 40ml, or 50ml, or 70ml, or 100ml of fluid. This ensures a collection of fluid sufficient for carrying out in a reliable way further tests, in particular diagnostic type tests and more in particular nucleic acid amplification tests (NAAT) with a reverse polymerase chain reaction process. This makes the collection element 3 suitable for the collection of samples for carrying out screening and/or test of presence of coronavirus.

In a specific embodiment, the collection element 3 can be pre-inhibited or impregnated with a substance, in particular with a reagent.

In a preferred embodiment, the collection element 3 comprises a plurality of fibers provided with hydrophilic capability. The collection element 3 could be for example a flocked swab, a wound fiber swab, a sponge swab or a swab in another absorbing material. In case of a flocked swab, the flocking process is such as to allow the deposit of fibers in an electrostatic field, that allows to deposit the fibers in an ordered way, perpendicularly to the surface of the end portion 2e of the elongated body.

In an embodiment, fibers are selected from a list of materials comprising synthetic and natural materials, and in particular from a list of materials comprising at least one between: rayon, polyester, polyamide, carbon fiber, alginate, cotton, silk or mixtures of them, sponge.

In a preferred embodiment, but non-limiting thereto, at least part of the end portion 2e protrudes inside the collection element 3; more in particular, the Applicant has conceived a specific embodiment wherein the end portion 2e extends up to in substantial correspondence of the distal end 3d of the collection element 3. The latter surrounds then at least part of said end portion 2e. This particular embodiment is represented in figure 3.

In order to promote a uniformity of collection of the biological sample, in an embodiment the collection element 3 is preferably but not limiting thereto of cylindrical and/or truncated cone shape; in a non-limiting embodiment, the distal portion 3d is substantially rounded and this contributes to reduce the risk of inadvertently injuring or damaging part of the nasal cavity and/or nasopharynx during the introduction and/or extraction of the device 1 .

The elongated body 2 comprises at least a first graduated scale 4 comprising a plurality of measurement markings 4i. In a simplified embodiment, not shown in the annexed figures, the elongated body 2 comprises a single measurement marking 4i. Each measurement marking 4i of the plurality of measurement markings (or, in the simplified case, the single measurement marking) indicates an age, or an ages range, of a plurality of study subjects having a first biographic age or belonging to a first predetermined biographic ages range. As it will be better explained in the following portion of the description, the age, or age range, are associated to a distance D present between a first portion and a second portion of the body of at least one study subject, in particular of the plurality of study subjects that have been used for defining the point on which the measurement markings 4i are to be positioned.

As it will be better clarified in the following portion of the description, the distance D is preferably a distance present between an opening or an end of a naris 11 of a plurality of study subjects and a predetermined rear portion of the nasopharyngeal arch, and is determined by a measurement carried out on a diagnostic image comprising at least one among one or more radiographies, or one or more tomographies, one or more magnetic resonances, one or more ultrasonographies.

Preferably, the first graduated scale 4 extends at least partially in the central portion 2c and/or extends at least partially in the gripping portion 2i.

The first graduated scale 4 is configured and specifically destined to address, in use, the user to grasp the elongated body 2 in correspondence of at least a measurement marking of the plurality of measurement markings 4i. In particular, the measurement markings 4i (or in the simplified case, the single measurement mark 4i) are configured to, and destined to, provide, to the patient 20 itself - if he performs the collection operation - or to the operator (for example a doctor, a paramedic or a pharmacist) an at least visual and/or tactile indication of a predefined and predetermined introduction depth (numerical reference 100) of the elongated body 2 and of the collection element 3 within the cavity of the body of the patient 20 according to the age of the patient 20 itself.

A specific embodiment of the device herein described therefore comprises a first measurement marking 4i which univocally associates a first specific age of the first plurality of study subjects (for example, 7 years) or a first ages range of the first plurality of study subjects (for example, 7-9 years) with a distance D, in particular with a first distance D1 , detected between the first measurement marking 4i and the end portion 2e of the elongated body and/or between the first measurement marking 4i and the predefined portion of the collection element 3, which preferably is the end portion of the mentioned collection element 3 and which is opposite the gripping portion 2i.

Such embodiment comprises also a second measurement marking 4i which univocally associates a second specific age of the second plurality of study subjects or a second ages range of the first plurality of study subjects with a distance D, in particular with the second distance D2, detected between the second measurement marking 4i and the end portion 2e of the elongated body and/or between the second measurement marking 4i and the predefined portion of the collection element 3, which preferably is the end portion of the mentioned collection element 3 which is opposite the gripping portion 2i.

There may clearly be a third measurement marking 4i which univocally associates a third specific age of a third plurality of study subjects with a distance D, in particular with the third distance D3, detected between the third measurement marking 4i and the end portion 2e of the elongated body and/or between the third measurement marking 4i and the predefined portion of the collection element 3 which is the end portion of the mentioned collection element 3 which is opposite the gripping portion 2i. If the first age is lower than the second age and is in turn lower than the third age, the following relationship exists among the distances D1 , D2, D3: D1 < D2 < D3.

Even in the light of the figures, it is clear that the second measurement marking is interposed between the first and the third measurement marking.

As shown in figure 1 , and more in detail in the various embodiments shown in figures 4-7, the graduated scale 4 is configured and destined to supply an at least visual indication of a preferred introduction depth (indicated with reference 100) at least of the collection element 3 inside the nasal cavity and/or nasopharynx, in particular in relation to a conformation of the nasal cavity and/or nasopharynx and/or in relation to an intervening distance D (shown in figure 2).

It has been observed that there is a statistical correlation, in some cases an identity, between the distance D present between an opening or end of a naris 11 of a plurality of study subjects and a predetermined rear portion of the nasopharyngeal arch and the distance D between an ear 10, in particular the tragus or lobe or opening of the ear canal 10t, and an opening of the naris 11 of the first plurality of study subjects and/or present between an ear 10, in particular the tragus or lobe or opening of the ear canal 10t, and the philtrum 12 of the first plurality of study subjects. In use this distance D, detected then by the cephalogram, becomes approximately indicative of the distance between the above-mentioned parts of the body for the patient 20.

The graduated scale 4 allows the quantitative detection of the distance between at least part of the plurality of measurement markings 4i and said at least one between said end portion 2e and said collection element 3.

Considering the evolution of the distance D as a function of the age, or age interval, of the subject, in an embodiment the distance present between the first measurement marking and the second measurement marking may be different with respect to a distance present between the second measurement marking and the third measurement marking.

Although this should not be understood in a limiting way, in an embodiment, the graduated scale 4 possesses at least a first measurement marking 4i positioned in substantial proximity of the collection element 3, in particular in substantial contact with the latter. This makes it possible to introduce the device 1 for very short depths 100.

The Applicant has in particular observed that the distance D detected by the cephalogram or, equivalently, the distance present between an ear 10, in particular the tragus or lobe or opening of the ear canal 10t, and an opening, or end, of the naris 11 of a generic subject 20 or, as in the present case, of the study subject, and/or present between an ear 10, in particular the tragus or lobe or opening of the ear canal 10t, and the philtrum 12 of a generic patient 20 or, as in the present case, of the study subject, varies with the variation of the age of the subject and is substantially comprised between 4cm, more preferably 4,5cm and 10,5cm, more preferably 10cm. In particular it has been observed that between 4 and 5 years old, this distance D is substantially equal to 5 or 6 cm, and increases substantially proportionally until 11 -12 years; in correspondence of this age the distance D stabilizes around a mean value substantially comprised between 8cm and 10cm. Consequently, the graduated scale 4 extends such as to determine lengths until at least 10cm.

In order to allow a correct grasping of the elongated body 2, and in order also to allow to reach a correct introduction of the device 1 until reaching the collection element 3 the rear mucosa of the nasopharynx, preferably the device 1 presents a length at least equal to 12cm, and preferably at least equal to 13 cm or 14cm. Thanks to this aspect, in particular together with the presence of the graduated scale 4, it is possible to produce the elongated body 2 in a single size, by limiting then the production costs, and using said elongated body 2 for reaching, without damaging and/or hurting and/or causing discomfort, substantially the rear mucosa of the nasopharynx both in adults and in children.

The plurality of measurement markings 4i comprises at least a first and a second measurement marking 4i reciprocally spaced for a predefined distance along the main development direction X. At least a first and a second measurement marking 4i extend at least partially, preferably mainly, along a substantially oblique direction, optionally along a substantially orthogonal direction, with respect to the main development direction X. In particular figures 4-6 show embodiments wherein measurement markings 4i extend substantially orthogonally with respect to the main development direction, whereas the figure 7 shows an embodiment wherein the measurement markings 4i extend substantially obliquely and partially parallel to said main development direction.

In figure 4 it is shown an embodiment wherein the first graduated scale 4 is at least partially etched on the elongated body 2, and realizes therefore at least a recess, in particular a plurality of recesses, in correspondence of measurement markings 4i. The etching process is not described here because it is known; however, in an embodiment the etching is actually a concavity deriving from a molding or 3D printing process of the elongated body 2.

In figure 5 it is shown an embodiment wherein the first graduated scale 4 is in relief on said elongated body 2. Said first graduated scale 4 can be fixed and/or impressed in any known method. Also in this case, the etching can be a convexity deriving from a molding process (in particular co-molding) or 3D printing of the elongated body 2.

The Applicant in particular observes that the first graduated scale 4 can therefore be realized integrally with the elongated body 2, then as a single piece. It is observed also that the elongated body 2, also thanks to the molding or 3D printing process can be integral, then realized as a single piece. This contributes to increase the robustness and uniformity of mechanical properties thereof along its extension.

In figure 6, it is shown an embodiment wherein the first graduated scale 4 is painted on said elongated body 2. In particular, the elongated body 2 possesses at least a first color and at least part of the first graduated scale 4 possesses a second color different with respect to the first color.

In figures from 4 to 7, the transversal section of the elongated body 2 is substantially circular and the measurement markings 4i extend along an arc of circumference smaller than the circumference itself. This should not be understood in a limiting way, since in an alternative embodiment the measurement markings 4i are developed along the entire circumference. When the elongated body 2 assumes a shape different with respect to the one having a circular transverse section, it will therefore be clear that the measurement markings 4i can develop along at least a part (for example, a side) of the perimeter or transverse development of the elongated body 2, or alternatively they can develop along the entire perimeter or transverse development of the elongated body 2.

It is observed, in particular, that the graduated scale 4 can be realized in a material at least partially different with respect to the material with which the elongated body 2 is realized.

The present disclosure also refers to a method of production of a device 1 for the collection and the transfer of samples of biological material.

The method object of the present disclosure first of all comprises a first plurality of measurement and/or calculation steps of a respective first plurality of measurement data of a distance D present between a first portion and a second portion of the body of a respective first plurality of study subjects having a first biographic age, or belonging to a first predetermined biographic age range, in particular wherein said first portion and said second portion are a first and a second portion of a cavity of the body of said study subjects. In this step it is considered for example about 8-year-old Caucasian children and a cephalogram is performed in order to detect the above-mentioned distance D between the first and second portion of the body, well described above. The plurality of the measurement steps comprises a plurality of measurements carried out on at least a diagnostic image comprising at least one among one or more radiographies, or one or more tomographies, one or more magnetic resonances, one or more ultrasonographies.

The method comprises a first step of analysis, preferably of statistic type, of the first plurality of measurement data for defining at least a first graduated scale 4 comprising at least a first measurement marking 4i indicating a first distance value representing said first plurality of measurement data and said first biographic age or said first predetermined biographic ages range. As it will be better clarified in the following portion of the description, the step of analysis is a step of statistical analysis that is destined to determine at which precise point of the elongated body to position a measurement marking indicating an average distance D between the first and second portion of the body representing the statistically determined value for said distance on a multitude of study subjects.

The method comprises a step of production of the device 1 for the collection and the transfer of samples of biological material, comprising first of all a step of realization and/or assembly of the elongated body 2, extending at least partially along the main substantially axial development direction X and comprising at least the gripping portion 2i destined to be grasped by a user and at least an end portion 2e.

The method comprises a step of production and/or assembly of a collection element 3 in substantial correspondence of said end portion 2e of the elongated body 2. The step of production and/or assembly of the collection element can be part of the above-mentioned step of production, or can be a different step with respect to the above-mentioned step of production.

The collection element 3 is provided with an own end portion and is configured to collect and/or absorb a quantity of a sample of biological material present in a cavity of the body of a patient 20 and is configured to be introduced into a cavity of the body of the patient 20.

In particular, the step of production of the elongated body 2 comprises a step of realization, of at least a first measurement marking 4i realized on the elongated body and positioned at a first distance from the end portion 2e of the body or from the end portion of the collection element, equal or related in a predetermined way to the first representing distance value.

The first measurement marking 4i is configured to, and destined to, provide, to the patient or to an operator, an at least visual and/or tactile indication of a predefined and predetermined introduction depth 100 of the elongated body 2 and of the collection element 3 within said cavity of the body of the patient 20 according to the age of the patient 20.

Preferably, but not limiting thereto, the method comprises a second plurality of measurement and/or calculation steps of a respective second plurality of measurement data of said distance D present between the first portion and the second portion of the body of a respective second plurality of study subjects having a second biographic age or belonging to a second predetermined biographic ages range, in particular wherein the first portion and the second portion are a first and a second portion of a cavity of the body of said study subjects. For example this second plurality of measurement steps can be carried out on 9-year-old subjects, to check whether, and how, statistically, the distance D changes between the first and the second portion itself of the body considered in the first plurality of measurement steps carried out on 8-year-old subjects.

It then follows a second step of analysis, preferably of statistic type, of the second plurality of measurement data for defining the graduated scale 4 comprising furthermore at least a second measurement marking 4i indicating a second distance value representing said second plurality of measurement data and said second biographic age or said second predetermined biographic ages range.

The step of production of the elongated body 2 comprises a step of realization, on the elongated body 2, of at least said second measurement marking 4i positioned at a second distance from said end portion 2e of the body, or from the end portion of the collection element, equal or related in a predetermined way to said second representing distance value.

In a preferred embodiment, the method comprises a repetition of the first plurality of measurement steps and of the first step of analysis for defining a multiplicity of plurality of measurement data of the distance D corresponding to respective multiplicities of study subjects having respective and among them different biographic ages or biographic ages ranges, for defining the graduated scale 4 comprising a corresponding multiplicity of distance values representing said respective biographic ages or biographic ages ranges.

The step of production of the elongated body 2 comprises a step of realization, on the elongated body 2, of a plurality of measurement markings 4i related to the graduated scale 4 and positioned at respective distances from said end portion 2e of the body, or from the end portion of the collection element, equal or related in a predetermined way to said multiplicity of representing distance values; the plurality of measurement marking 4i is configured to, and destined to, provide, to an operator an at least visual and/or tactile indication of a predefined and predetermined introduction depth 100 of the elongated body 2 and of the collection element 3 within the cavity of the body of the patient 20 according to the age of the patient 20.

The specific technical procedure with which the elongated body 2 is realized depends mainly on the material and/or morphology of the elongated body itself. The step of production and/or assembly of the collection element 3 depends in particular on the specific morphology and/or material with which it is realized the collection element 3 and for this reason is not specifically described herein.

The method comprises furthermore a step of connection of the collection element 3 to the elongated body 2 in substantial correspondence of said end portion 2e. In detail, in an embodiment, the step of connection may comprise a superimposing of the collection element 3 on the elongated body 2.

The step of production of the elongated body 2 comprises a step of production, on the elongated body 2, of the graduated scale 4 comprising a plurality of measurement markings 4i whose characteristics have been described above.

The above-mentioned repetition allows to ensure a greater reliability in the calculation of the distance D, allowing in particular to mitigate the negative effects deriving from study subjects whose distance characteristics are actually out of the average with respect to other study subjects of the same age.

To this end, the method comprises a calculation, in particular an electronic calculation, of an expected value, and/or of at least one among an arithmetical average, a weighted average, a weighted average, of at least a first part of the plurality of measurement data, which comprises measurement data univocally associated to study subjects having a same age and/or ages range a same gender and/or belonging to a same ethnicity or population.

This calculation determines the generation of the first representing distance value.

In the method herein described, the above-mentioned calculation determines the generation of a first averaged distance D value associated to the first portion of the plurality of measurement data.

As a result of the above-described steps, the plurality of measurement markings 4i comprises a first measurement marking positioned at a first distance from the end portion 2e of the elongated body and/or from a predefined portion of the collection element 3, preferably the end of the collection element 3 opposite to the gripping portion 2i, corresponding to the first average value of distance D, and comprises a second measurement marking positioned at a second distance from the end portion 2e of the elongated body and/or from the predefined portion of the collection element 3, preferably the end of the collection element 3 opposite to the gripping portion 2 i, corresponding to the second average value of distance D.

The Applicant has performed a survey procedure involving the execution of 323 cephalograms acquired for orthodontic purposes in 152 male and 171 female subjects aged between 4 and 14 years.

For each of said cephalograms, the shortest distance between the most anterosuperior point of the philtrum or outline of the naris and the shape, in particular the posterior arch, of the nasopharynx was selected; this distance was measured in a predetermined measurement unit (millimeters) parallel to the palatal plane. Descriptive statistics of the measurements were calculated separately for each age group.

The following table shows a detail of the results obtained by the inventors for subjects of different age samples.

The above table confirms what has been previously indicated, i.e. that studies carried out by the inventors have shown that this distance increases as the age of the subject increases and at a determined age, it substantially stabilizes.

The above table also confirms that some differences of depth exist between the population of males and females for a certain age, but for determining a substantially unambiguous scale, it is possible to disregard this difference of depth.

The above table shows that there is no statistical difference between the depth of the nasal cavity for subjects between 7 and 8 years and between 8 and 9 years. The above table also shows that there is no statistical difference between the depth of the nasal cavity for subjects aged between 11 and 14.

According to the above table, a device 1 with a graduated scale 4 provided with 6 measurement markings 4i, relating to the ages of 4, 5, 6, 7, 9, 11 years or more, could thus be realized. It is also observed that the distance between a measurement marking and the other is not constant; in fact between the first and the second measurement marking there is a distance of 7 mm, whereas between the third and the fourth measurement marking there is only a distance of 3 mm. The above table shows that after 11 years substantially the depth of the nasal cavity is stabilized. From the experimental data obtained by the inventors, a subject aged 11 years or older could therefore be considered as an adult subject. In any event, the studies specifically carried out by the inventors are inherent to a device 1 for the collection and the transfer of samples of biological material of pediatric type. The present disclosure also concerns a method of determination of a correct depth of insertion of a device 1 for the collection and the transfer of samples of biological material, preferably according to what is described herein. This method allows to determine a correct depth of insertion of the device 1 .

A first step consists in detecting the age of the patient 20 who has to undergo the procedure of insertion of the device described herein. This detection is carried out for example manually, by means of an orally asked question, or from written data manually collected from the patient 20, or is carried out at least partially electronically with an access to an electronic database containing biographic data of the patient 20, or by means of a scan of at least part of an identity document of the patient 20.

A subsequent step is that of searching, on the graduated scale, for the measurement marking 4i corresponding to the age of the subject. For example, if the subject is 12 years old, the step comprises the search for measurement marking 4i carrying the number “12”. This measurement marking 4i then becomes a reference measurement marking. This step advantageously does not require the use of a measuring instrument, and is therefore extremely easy to perform. The risk of error is very low.

A subsequent step comprises the grasping of the device 1 for the collection and the transfer of samples of biological material in correspondence of the elongated body 2, in particular by placing one end of the operator's fingers in substantial correspondence of the measurement marking 4i corresponding to the age of the subject. Placing the end of the subject's fingers in substantial correspondence of the measurement marking 4i, advantageously allows the fingers to be used as a substantial stop whereby, when the collection element 3 and the portion of the elongated body 2 prior to the reference measurement marking 4i are introduced into the cavity of the subject, the fingertips act substantially as an abutment or stop element, determining the reaching of the correct depth. Alternatively, the collection element 3 and the elongated body 2 may be introduced within the cavity until reaching the correct depth, determined by the reference measurement marking 4i, with a gripping taking place in a portion more distal from the collection element 3 than the reference measurement marking 4i, but in this case the operator shall be able to correctly assess not to exceed an introduction depth greater than the one corresponding to the reference measurement marking 4i, which corresponds to the age of the subject.

Conveniently, the step of introduction comprises a substantially axial movement of the elongated body within the cavity of the subject, but may also comprise, in combination or partially alternative, also the rotation around an axis substantially coincident with the development axis of the elongated body 2 itself. This means that in a non-limiting embodiment, the step of introduction comprises an at least partially composite movement; this composite movement is of the roto- translatory type. It is noted that the step of introduction, since being part of an interaction with the human body, is excluded from claim. This step is however disclosed herein for completeness of description.

Since, as it is indicated in the table, there may be slight differences of cavity depth in relation to the male or female gender of the patient 20, a specific embodiment of the device subject of the present disclosure comprises a first graduated scale 4 and a second graduated scale 4'. Figure 8 shows a specific embodiment of the device 1 provided with a first graduated scale 4 and a second graduated scale 4’.

Also the second graduated scale 4’ comprises a plurality of measurement markings 4i wherein each measurement marking is positioned at a respective distance from the end portion 2e of the body or from the end portion of the collection element, equal or related in a predetermined way to a respective distance value representing a first plurality of measurement data of a distance D present between a first portion and a second portion of the body of a respective first plurality of study subjects having a first biographic age, or belonging to a first predetermined biographic ages range.

The first graduated scale 4 and the second graduated scale 4’ are specifically destined to be used for patients 20 having a different gender and/or belonging to a different ethnicity or population.

The Applicant notes that the characteristics shown for the first graduated scale 4 can be considered applicable for the second graduated scale 4', and for this reason they are not repeated below. It is noted that the first graduated scale and the second graduated scale do not necessarily have to be of the same type; in particular this means that, for example, the measurement markings 4i of the first graduated scale 4i may be in relief and the measurement markings 4i of the second graduated scale 4i may be coloured. This can help to differentiate and simplify the detection of the correct graduated scale. Preferably, but non-limiting thereto, the first graduated scale 4 and the second graduated scale 4' extend in parallel directions. These directions are aligned with the maximum extension direction of the elongated body 2.

Finally, the Applicant notes that if there is a considerable age gap between said two consecutive measurement markings 4i ( for example 3 years, for example with a first measurement marking corresponding to an age of 8 years and with a second measurement marking corresponding to an age of 11 years), if the patient 20 on whom the collection is carried out is aged between the ages corresponding to the two closest measurement markings, a non-limiting step of the method comprises grasping the elongated body 2 on the graduated scale in a position intermediate between said two measurement markings.

The Applicant notes that although the present detailed description specifically refers to the introduction of part of device 1 inside the subject's nose, this specific cavity should not be understood in a limiting manner. The cavity may in fact be one among a buccal, anal, vaginal, auricular, urethral cavity of the subject.

In particular, in fact, this device 1 may be favorably destined to allow the collection of samples of biological material from another cavity of the human or animal body, in particular from the ear, mouth, rectum or urethra. Accordingly, the dimensions, in particular a length and/or a transversal section of the collection element 3, or a length of the elongated body 2, or a transversal section thereof, may be adapted conveniently according to the specific application. The extension of the graduated scale 4 can also be varied accordingly.

Finally, it is noted that although patient 20 has been primarily intended as a “human subject”, this should not be understood in a limiting way; in fact, patient 20 can also be an animal, for example a pet. It is therefore clear that what is the subject matter of the present disclosure should not necessarily be considered to be exclusively intended for human applications, as the aforementioned device 1 may equally be intended for veterinary applications. The device 1 may be sold and/or provided to operators in bulk or enclosed in a container, preferably of a flexible type, which allows the collection element 3 to be kept isolated until use. In an embodiment the collection element 3, and preferably the entire device 1 is sterilized before the introduction into the container. In a non-limiting embodiment, the container is sealed immediately after the introduction of the device 1 . The sealing can be achieved by heat sealing.

Preferably, but not limiting thereto, said container is realized in the form of an envelope. In a non-limiting embodiment, such envelope is made at least partially of plastic material and may at least have a transparent window which allows to verify determined characteristics of the device 1 contained therein.

In a non-limiting embodiment, the device 1 can be provided in a kit comprising a reagent and a test apparatus for verifying the presence of viruses and/or bacteria, for example, for carrying out screening and/or tests by the presence of coronaviruses, in particular, and non-limiting thereto, of SARS-CoV2 type viruses (basic variant and subsequent variants thereof). This testing apparatus is preferably of the disposable type. This allows to keep kit costs limited.

The advantages of the device and method described so far are clear; the correct depth of insertion of the device 1 described herein is made intuitive, since the user only has to place his fingers at the measurement marking 4i corresponding to the age, or otherwise introduce part of the device 1 into the cavity for a depth corresponding to his age; it is no longer necessary to carry out complex calculations of the relationship between age and depth of insertion measured on a length measurement scale (for example cm) which could lead to errors especially if measurements are carried out quickly on a large number of patients 20 by a same operator.

The device here described is economic to be realized, and can therefore be made economically accessible also to poor people or in developing countries.

The graduated scale provided on the device 1 herein described, even if it comprises a single measurement marking 4i, is on average (statistically) reliable, since the process of determining the positioning of the measurement marking 4i and the corresponding age is carried out by means of an analysis realized on a large number of study subjects. The invention is not limited to the embodiments shown in the attached figures; for this reason, the reference marks appearing in the following claims are provided for the sole purpose of increasing the intelligibility of the claims, and shall not be intended in a limiting way. Finally, it is clear that additions, modifications or variants that are obvious to an expert in the art can be applied to the object of the present disclosure, without departing from the scope of protection provided by the claims.

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