Device for collecting a biological sample and method for collecting a biological sample

Abstract

An apparatus (1) for the collection and transfer of a sample of biological material, comprising at least an elongate body (2) having a gripping portion (2i) to be gripped by a user and at least an end portion (2e), a collection element (3) having a unique end portion and configured to collect and / or aspirate a defined quantity of a sample of biological material present within a cavity of a patient's body (20), the collection element (3) being configured to be introduced into the cavity of the patient's body, the collection element (3), comprising, the elongate body (2) comprises a first graduated scale (4) having at least a first measurement marking (4i) located at a first distance from the end portion (2e) of the body or the end portion of the collection element, the first distance being equal to a first distance value representing a first plurality of measurement data of a distance (D) existing between a first part and a second part of the body of each of a first plurality of subjects having a first biological age or belonging to a first predetermined biological age range, or related in a predetermined manner, optionally, the first part and the second part being a first part and a second part of a cavity of the body of the subject, the first measurement marking (4i) being configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongate body (2) and the collection element (3) within the cavity of the patient's body depending on the age of the patient to the patient or the operator.

Description

Technical Field

[0001] The present disclosure relates to the field of collection of biological samples, in particular to the collection of biological samples by introducing a suitable device for collection into a cavity of the human or animal body. The present disclosure relates to a device for collecting a biological sample and a method for collecting a biological sample.

Background Art

[0002] Devices for collecting biological samples have traditionally been used to collect biological samples from cavities of the human or animal body. In particular, among the known types of devices for collection, there is the so-called nasopharyngeal swab, which is a device with a substantially elongated body, typically having a substantially axial extension, ending with a collection element for biological samples intended to hold the biological sample substantially in a fluid. Other types of devices for collecting biological samples are adapted to be introduced into different cavities with respect to the nose, such as the mouth, vagina or anus, in order to collect the biological samples present therein, such as epithelial cells, secretions and the like.

[0003] The nasopharyngeal swab is typically introduced into the nasal cavity through the opening of the nostril and pushed into the nasal cavity until it typically reaches the mucosa present in the nasopharynx, which substantially corresponds to the posterior part of the nasal cavity, in order to collect biological samples such as epithelial cells and secretions of the upper respiratory tract.

[0004] After collection, the nasopharyngeal swab is removed from the nose and the collected sample can subsequently be placed, for example, in a reagent or subjected to other types of analysis in order to determine the presence or absence of a determined pathogen.

[0005] Since the first few months of 2020, due to the rapid spread of the SARS-CoV2 virus that causes the COVID-19 disease, the use of nasopharyngeal swabs for performing screening and / or testing for coronavirus infections has become widespread.

[0006] In the case of COVID-19 screening and / or testing, the WTO generally recommends performing nucleic acid amplification testing (NAAT) using reverse polymerase chain reaction on biological samples taken via nasopharyngeal swabs.

[0007] The correct use of nasopharyngeal swabs has been recognized to enhance the reliability of screening and / or testing. In particular, the appropriate manner of collecting biological samples represented by epithelial cells, secretions, or other analytes collected from the upper respiratory tract has been recognized to make it possible to improve the reliability of screening and / or testing, especially by reducing the number of false negatives. A false negative is when the test performed using a nasopharyngeal swab is negative (i.e., reports no trace of SARS-CoV2) even though the subject is actually infected. The presence of a large number of false negatives determines, at least indirectly, the spread of the infection because the subjects who should be isolated can instead move around freely. False negatives are particularly insidious in the case of asymptomatic infections.

[0008] COVID-19 screening and / or testing has been recognized to be performed on people of all ages, both children and adults.

[0009] Before the spread of the SARS-CoV2 virus, nasopharyngeal swabs were used almost exclusively by highly specialized staff. Today, screening and / or testing using nasopharyngeal swabs is no longer often performed only by specialized medical personnel; most are performed by paramedics or pharmacy staff, and the training for this type of collection is generally not optimal and is lower than that of physicians. In particular, it has been recognized that in many cases, the training of this staff is limited to watching helpful videos.

[0010] As already mentioned, the reliability of screening and / or testing depends largely on accurate access to the posterior mucosa of the nasopharynx and thus the accurate operation of the device insertion and collection procedures.

[0011] Therefore, on the one hand, if the introduction of the nasopharyngeal swab is insufficient, it may be determined that the collection of the desired sample is insufficient.

[0012] On the other hand, it has been recognized that excessive introduction of the nasopharyngeal swab can cause pain and / or trauma to the patient.

[0013] Therefore, guidelines for enabling appropriate sample collection have been proposed in the state of the art, but these guidelines are often non-uniform with each other, have too much room for interpretation, and often leave uncertainty for the operator.

[0014] The distance between the nostril opening and the posterior mucosa of the nasopharynx, which determines the optimal depth of introduction of the device for collection, is known to vary for each subject.

[0015] This distance also varies depending on further factors related to the specific anatomical structure of different subjects, and thus results in a non-predictable outcome in a sufficiently accurate manner.

[0016] An object of the present disclosure is to provide a device for collection, a container for the device for collection, and / or a collection method that can overcome the limitations of the known art and, in particular, can improve the reliability of screening and / or testing after introducing the device into the body cavity.

[0017] Summary

[0018] The applicant has noticed that the accurate insertion depth of a nasopharyngeal swab for performing a screening and / or diagnostic test for evaluating infection by a virus that may be found in the upper respiratory tract, whether it is the SARS-Cov2 virus or another virus, is mainly related to the age of the subject on whom the screening and / or test by the nasopharyngeal swab is performed.

[0019] The studies carried out by the inventor have demonstrated that this distance increases with the increase in the age of the subject and stabilizes substantially at the determined age.

[0020] The applicant has also noticed that this exact depth can be estimated in a sufficiently accurate manner as a function of the distance between the tip or end of the nostril and the determined part of the ear.

[0021] The objectives of the present disclosure are herein described in some of its remarkable aspects that can be combined with each other or with parts of the detailed description and / or the claims.

[0022] According to a first aspect, there is herein described a device (1) for the collection and transfer of a sample of biological material, comprising: - an elongated body (2) having at least a gripping portion (2i) and at least an end portion (2e) that extends at least partially axially along a main extension direction (X) and is intended to be gripped by a user; - a collection element (3) connected to the elongated body (2) substantially corresponding to the end portion (2e), having its own end portion, and configured to collect and / or aspirate a defined quantity of a sample of biological material present in a cavity of the body of a patient (20), wherein at least the collection element (3) is configured to be introduced into a cavity of the body of the patient (20), for example, into the nasal cavity and / or nasopharynx of the patient (20);

[0023] Here, the elongated body (2) is located at a first distance from an end portion (2e) of the body or an end portion of the collection element, and has a first biological age, or is equal to a first distance value representing a plurality of first measurement data of a distance (D) existing between a first part and a second part of each first plurality of bodies to be studied belonging to a first predetermined biological age range, or is related in a predetermined manner, and comprises a first graduated scale (4) having at least a first measurement marking (4i), optionally, the first part and the second part are the first and second parts of a cavity of the body to be studied.

[0024] The first measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, according to the age of the patient (20).

[0025] According to another non-limiting aspect, in the device (1), the elongated body (2) comprises a second graduated scale (4') having at least a first measurement marking (4i) located at a first distance from an end portion (2e) of the body or an end portion of the collection element, and is equal to a first distance value representing a plurality of first measurement data of a distance (D) existing between a first part and a second part of each first plurality of bodies to be studied having a first biological age or belonging to a first predetermined biological age range, or is related in a predetermined manner, optionally, the first part and the second part are the first and second parts of a cavity of the body to be studied.

[0026] According to another non-limiting aspect, the first measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, according to the age of the patient (20).

[0027] According to another non-limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4') is positioned at a second distance from an end portion of the body (2e) or an end portion of the collection element, and is equal to a second distance value representing a first plurality of measurement data of a distance (D) existing between a first part and a second part of each of a second plurality of subjects having a second biological age or belonging to a second predetermined biological age range, or comprises a second measurement marking (4i) related in a predetermined manner, the second measurement marking (4i) being configured and intended to provide at least a visual and / or tactile indication of a predetermined and predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, according to the age of the patient (20).

[0028] According to another non-limiting aspect, the device (1) is a pediatric device for the collection and transfer of samples of biological material.

[0029] According to another non-limiting aspect, the first graduated scale (4) and the second graduated scale (4') are associated with a distance (D) to be measured of a subject, having different ethnic groups or populations, and / or having genders of male and female respectively, for use respectively in patients (20) of different ethnic groups or populations and / or patients (20) of genders of male and female respectively.

[0030] According to another non - limiting aspect, the distance (D) is the distance existing between the opening or end portion of the nostril (11) of the first plurality of subjects and / or the second plurality of subjects and a predetermined rear portion of the nasopharyngeal arch, and / or the distance existing between the ear (10), optionally the tragus or the antihelix or the opening of the external auditory canal (10t), and the opening or end portion of the nostril (11) of the first plurality of subjects and / or the second plurality of subjects, and / or the distance existing between the ear (10), optionally the tragus or the antihelix or the opening of the external auditory canal (10t), and the philtrum (12) of the first plurality of subjects and / or the second plurality of subjects, and / or the distance existing between the front upper point of the philtrum or the nostril contour and the shape of the nasopharynx of the first plurality of subjects and / or the second plurality of subjects, optionally the posterior arch.

[0031] According to another non - limiting aspect, the distance (D) is the distance existing between the opening or end portion of the nostril (11) of the first plurality of subjects and / or the second plurality of subjects and a predetermined rear portion of the nasopharyngeal arch, and is determined by measurements performed on at least diagnostic images including at least one of one or more radiographs, or one or more tomographies, one or more magnetic resonances, one or more ultrasonic examinations.

[0032] According to another non - limiting aspect, the cavity is one of the cavities of the oral cavity, anus, vagina, auricle, urethra of the subject (20).

[0033] According to another non - limiting aspect, the first measurement marking (4i) and the second measurement marking (4i) are spaced apart from each other by a predetermined distance along the main expansion direction.

[0034] According to another non - limiting aspect, the at least first measurement mark (4i) and the second measurement mark (4i) extend at least partially, preferably mainly, substantially along an oblique direction, optionally along a direction substantially orthogonal to the main expansion direction, with respect to the main expansion direction.

[0035] According to another non-limiting aspect, the plurality of measurement markings (4i) include measurement markings at non-equidistant intervals, and / or the first scaled scale (4) is located at a third distance from the end portion of the body (2e) or the end portion of the collection element and has a third biological age or belongs to a third predetermined biological age range, equal to or related in a predetermined manner to a third distance value representing a first plurality of measurement data of the distance (D) existing between the first and second portions of each third plurality of subjects' bodies. Or it includes a third measurement marking (4i).

[0036] According to another non-limiting aspect, the third measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, depending on the age of the patient (20).

[0037] According to another non-limiting aspect, the second measurement marking is inserted between the first measurement marking and the third measurement marking.

[0038] According to another non-limiting aspect, the distance existing between the first measurement marking and the second measurement marking is different from the distance existing between the second measurement marking and the third measurement marking.

[0039] According to another non-limiting aspect, the biological age is a pediatric and / or developmental age.

[0040] According to another non-limiting aspect, at least one of the first measurement marking (4i), the second measurement marking (4i), or the third measurement marking (4i) indicates the minimum age of use of the device, optionally indicates or corresponds to an age substantially between 3 and 5 years, or indicates a substantial stabilization age of the distance (D) existing between the first portion and the second portion depending on the age.

[0041] According to another non-limiting aspect, the substantial stabilization age is substantially equal to 9 to 13 years old, preferably 10 to 12 years old, more preferably substantially 11 years old.

[0042] According to another non-limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4’) is realized on the elongated body (2) at least partially by etching, and / or realized through recesses or depressions, and / or at least partially embossed on the elongated body (2), and / or fixed, engraved, molded, co-molded, or painted on the elongated body (2).

[0043] According to another non-limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4’) is realized with at least partially different materials with respect to the material of which the elongated body (2) is realized.

[0044] According to another non-limiting aspect, the elongated body (2) exhibits at least a first color.

[0045] According to another non-limiting aspect, at least a part of at least one between the first graduated scale (4) and the second graduated scale (4’) exhibits at least a second color different with respect to the first color.

[0046] According to another non-limiting aspect, the elongated body (2) comprises a central portion (2c) located between the gripping portion (2i) and the end portion (2e).

[0047] According to another non - limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4') extends at least partially within the central portion (2c), and / or at least one between the first graduated scale (4) and the second graduated scale (4') extends at least partially within the gripping portion (2i). The graduated scale is specifically configured such that, in use, the user grips the elongate body (2) corresponding to at least one of the plurality of measurement markings (4i).

[0048] According to another non - limiting aspect, the device (1) has a length equal to at least 10 cm, preferably equal to at least 12 cm, or more preferably equal to at least 14 cm. Further, and / or the elongate body (2) presents a substantially constant cross - section along its extension along the main extension direction (X), or presents a variable cross - section along its extension along the main extension direction (X). Optionally, the elongate body (2) has a cross - section that is substantially circular or is printable on the circumference, the cross - section being substantially circular or the diameter of the circumference being from 1.5 mm to 3 mm, more preferably from 2 mm to 2.5 mm.

[0049] According to another non - limiting aspect, the elongate body (2) is substantially flexible, and / or is at least partially realized in a natural or plastic material, and / or is realized by molding, optionally by injection molding or co - molding, and / or is realized by a 3D printing process, and / or the elongate body (2) is realized as a single part.

[0050] According to another non-limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4’) is integral with the elongated body (2), and optionally, at least one between the first graduated scale (4) and the second graduated scale (4’) is integrally realized with the elongated body (2) via the shaping process, optionally injection molding or co-molding, and / or 3D printing.

[0051] According to another non-limiting aspect, the first graduated scale (4) and the second graduated scale (4’) are associated with the distance (D) to be measured of the object to be measured for the subjects respectively intended to be used for patients (20) of different ethnic groups or groups and / or patients (20) of male and female genders respectively, and these subjects have different ethnic groups or groups of research subjects, and / or male and female genders respectively.

[0052] According to the present disclosure, a production method of the device (1) for collecting and transferring a sample of biological material is also realized, including the following: - The first plurality of measurements and / or calculation steps of the first plurality of measurement data of the distance (D) existing between the first part and the second part of the body of each of the first plurality of research subjects having a first biological age or belonging to a first predetermined biological age range, wherein the first part and the second part are the first part and the second part of the cavity of the body of the research subject, the first plurality of measurements and / or calculation steps; - The first step of analyzing the first plurality of measurement data to define a first graduated scale (4) including at least the first measurement marking (4i) indicating the first distance value representing the first plurality of measurement data and the first biological age or the first predetermined biological age range, preferably the first step of a statistical type; - The production step of the device (1) for collecting and transferring a sample of biological material, wherein: - The realization and / or assembly process of an elongated body (2) having at least a gripping portion (2i) and at least an end portion (2e) that extends at least partially axially substantially along the main extension direction (X) and is intended to be gripped by a user, - The production and / or assembly process of a collection element (3) that substantially corresponds to the end portion (2e) of the elongated body (2), the collection element having its own end portion and being configured to collect and / or absorb a certain amount of sample of biological material present in a cavity of a patient's (20) body, and at least the collection element (3) being configured to be introduced into a cavity of the patient's (20) body, for example, configured to be introduced into the nasal cavity and / or nasopharynx of the patient (20), including, The process of producing the elongated body (2) includes the step of realizing at least the first measurement marking (4i) located on the elongated body (2) at a first distance from the end portion (2e) of the body or the end portion of the collection element and equal to or related in a predetermined manner to the first display distance value, and the first measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined introduction depth (100) of the elongated body (2) and the collection element (3) in the cavity of the patient's (20) body according to the age of the patient (20) to the patient or the operator.

[0053] According to another non-limiting aspect, the method includes a second plurality of measurements and / or calculation steps of second plurality of measurement data of distances (D) existing between a first part and a second part of the body of each second plurality of subjects having a second biological age or belonging to a second predetermined biological age range, and optionally, the first part and the second part are a first part and a second part of a cavity of the subject's body.

[0054] According to another non - limiting aspect, this method includes a second step of preferably statistical type analysis of the second plurality of measurement data for defining the first graduated scale (4), and further comprises at least a second measurement marking (4i) indicating the second plurality of measurement data and a second distance value representing the second biological age or the second predetermined biological age range.

[0055] According to another non - limiting aspect, the step of producing the elongated body (2) includes the step of implementing at least a second measurement marking (4i) on the elongated body (2) which is located at a second distance from the end portion (2e) of the body or from the end portion of the collection element and is equal to or related in a predetermined manner to the second indicated distance value.

[0056] According to another non - limiting aspect, the second measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's body to the patient or the operator, depending on the age of the patient (20).

[0057] According to another non - limiting aspect, this method includes the first plurality of measurement steps and a repetition of the analysis of the first step, defining a multiplicity of measurement data of the distance (D), the plurality of measurement data corresponding to respective multiplicities of subjects having respective different biological ages or biological age ranges, and defining the graduated scale (4) including corresponding multiplicity of distance values representing the respective biological ages or biological age ranges.

[0058] According to another non - limiting aspect, the step of producing the elongated body (2) includes the step of implementing a plurality of measurement markings (4i) on the elongated body (2) which are related to the graduated scale (4) and are located at respective distances from the end portion (2e) of the body or from the end portion of the collection element and are equal to or related in a predetermined manner to the plurality of indicated distance values.

[0059] According to another non - limiting aspect, a plurality of measurement markings (4i) are configured and intended to be provided to an operator to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body, depending on the age of the patient (20).

[0060] According to another non - limiting aspect, at least one of the first step and / or the second step of the analysis includes the calculation of at least an expected value, and / or an arithmetic mean, a weighted mean, a weighted average of at least a first portion of the plurality of measurement data, optionally including electronic calculation, the portion including measurement data uniquely associated with subjects belonging to the same age and / or age range, the same gender and / or the same ethnicity or group, and the calculation determines the generation of the first display distance value.

[0061] According to another non - limiting aspect, the cavity is the nasal cavity and / or the nasopharyngeal cavity.

[0062] According to another non - limiting aspect, the method includes another step of analyzing the first plurality of measurement data, preferably in a statistical type, to define a first graduated scale (4) including at least a first measurement marking (4i) indicating the first plurality of measurement data and a first distance value representing the first biological age or the first predetermined biological age range.

[0063] According to another non - limiting aspect, a plurality of measurement markings (4i) are configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body.

[0064] According to another non-limiting aspect, the step of producing the first graduated scale (4) and / or the second graduated scale (4’) on the elongated body (2) is located at a first distance from an end portion (2e) of the body or an end portion of the collection element, and includes the realization of at least a first measurement marking (4i) equal to or related in a predetermined manner to the first distance representing a value, the first measurement marking (4i) being configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, according to the age of the patient (20).

[0065] According to another non-limiting aspect, the step of producing the first graduated scale (4) and / or the second graduated scale (4’) on the elongated body (2) is located at a second distance from an end portion (2e) of the body or an end portion of the collection element, and includes the realization of a second measurement marking (4i) equal to or related in a predetermined manner to the second distance representing a value, the second measurement marking (4i) being configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, according to the age of the patient (20).

[0066] According to another non-limiting aspect, the step of producing the first graduated scale (4) and / or the second graduated scale (4’) on the elongated body (2) is located at a third distance from an end portion (2e) of the body or an end portion of the collection element, and includes the realization of a third measurement marking equal to or related in a predetermined manner to the third distance representing a value, the second measurement marking (4i) being configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body to the patient or the operator, according to the age of the patient (20), and being provided as such.

[0067] According to another non-limiting aspect, the first measurement marking and the second measurement marking (4i, 4i) are spaced apart from each other by a predetermined distance along the major extension direction (X).

[0068] According to another non-limiting aspect, the at least first measurement marking and the second measurement marking (4i, 4i) extend at least partially, preferably mainly, substantially obliquely along, optionally, a direction substantially orthogonal to the major extension direction (X).

[0069] According to another non-limiting aspect, the step of producing the first graduated scale (4) and / or the second graduated scale (4’) on the elongate body (2) includes the realization of a plurality of measurement markings (4i, 4i) arranged at non-equidistant intervals.

[0070] According to another non-limiting aspect, the step of producing the first graduated scale (4) and / or the second graduated scale (4’) on the elongate body (2) determines the realization of a second measurement marking at a position inserted between the first measurement marking and the third measurement marking.

[0071] According to another non-limiting aspect, the step of producing the first graduated scale (4) and / or the second graduated scale (4’) on the elongate body (2) is such that the distance existing between the first measurement marking and the second measurement marking is different from the distance existing between the second measurement marking and the third measurement marking.

[0072] According to another non-limiting aspect, this method includes the step of realizing at least one between the first graduated scale (4) and the second graduated scale (4’) on the elongated body (2) through etching and / or recesses or recesses, and / or the step of realizing it in a partially relief form on the elongated body (2), and / or the step of fixing, engraving, molding, co-molding, or painting on the elongated body (2).

[0073] According to another non-limiting aspect, this method includes the step of realizing at least one between the first graduated scale (4) and the second graduated scale (4’) with a material that is at least partially different with respect to the material from which the elongated body (2) is realized.

[0074] According to another non-limiting aspect, the elongated body (2) exhibits at least a first color.

[0075] According to another non-limiting aspect, at least a part of the first graduated scale (4) and / or at least a part of the second graduated scale (4’) exhibit at least a second color different from the first color.

[0076] According to another non-limiting aspect, the production process of the elongated body (2) includes the step of realizing a central part (2c) located between the gripping part (2i) and the end part (2e).

[0077] According to another non-limiting aspect, the realization of at least one between the first graduated scale (4) and the second graduated scale (4’) is carried out at least partially over at least one between the first graduated scale (4) and the second graduated scale (4’) in the central part (2c), and / or is carried out at least partially over at least one between the first graduated scale (4) and the second graduated scale (4’) in the gripping part (2i).

[0078] According to another non-limiting aspect, at least one between the first graduated scale (4) and the second graduated scale (4’) is configured and specifically designated such that, in use, the user grips the elongated body (2) corresponding to at least one measurement marking (4i) among the plurality of measurement markings (4i).

[0079] According to another non-limiting aspect, the production process of the elongated body (2) has a length equal to at least 10 cm, preferably equal to at least 12 cm, or more preferably equal to at least 14 cm, and / or determines the production of an elongated body having a substantially constant cross-section along its extension along the main expansion direction (X), or showing a variable cross-section along its extension along the main expansion direction (X). Optionally, the elongated body (2) has a substantially circular cross-section or is printable on the circumference, and the cross-section is substantially circular or the diameter of the circumference is from 1.5 mm to 3 mm, more preferably from 2 mm to 2.5 mm.

[0080] According to another non-limiting aspect, the process of producing the elongated body (2) includes realizing the elongated body, optionally as a single piece, with a flexible material and / or at least partially with a natural or plastic material and / or by molding, optionally by injection molding or co-molding, and / or by a 3D printing process.

[0081] According to another non-limiting aspect, the method includes the step of integrally realizing at least one between the first graduated scale (4) and the second graduated scale (4’) with the elongated body (2). Optionally, the first graduated scale (4) and / or the second graduated scale (4’) are integrally realized with the elongated body (2) via the optional molding, optionally injection molding or co-molding, and / or the 3D printing process.

[0082] According to another non-limiting aspect, in at least the first measurement step and / or the second measurement step, the measurement of the distance (D) existing between the opening or end portion of the nostril (11) as the first part of the first plurality and / or the second plurality of bodies of the subjects of interest, and a predetermined rear part of the nasopharyngeal arch as the second part of the first plurality and / or the second plurality of bodies of the subjects of interest, is performed on a diagnostic image including at least one of one or more radiographs, or one or more tomographies, one or more magnetic resonances, one or more ultrasonic examinations.

[0083] According to the present disclosure, devices obtained by the method according to one or more aspects described herein are described.

[0084] According to the present disclosure, the use of a device (1) according to one or more of the aspects described herein for collecting a sample of biological material from the nasal cavity is further described.

[0085] In particular, according to the present disclosure, for the purpose of performing a test for the presence of bacteria and / or viruses, optionally for the presence of coronavirus, optionally for the presence of SARS-CoV-2 type, the use of a device (1) according to one or more of the aspects described herein is further described herein.

Brief Description of the Drawings

[0086] The object of the present disclosure is explained in the detailed description with reference to some preferred embodiments of device 1. In particular, such preferred embodiments are explained with reference to the accompanying drawings. A brief description of the figures is provided below.

Figure 1

Figure 2

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[0087] Detailed Description of the Invention

[0088] Referring to FIG. 1, a device 1 for the collection and transfer of a sample of biological material is generally indicated by reference numeral 1. For the purposes of the present disclosure, "biological material" includes at least one of materials such as human or animal tissue, tissue samples, tissue cells, secretions such as blood, and is intended to particularly include, without limitation, fluid and / or liquid wet materials.

[0089] In a preferred embodiment, the main purpose of device 1 is to enable the collection of biological samples from the nasal cavity, in particular from a part of the mucosa of the nasal cavity and / or nasopharynx. The device 1 described herein can be advantageously used, for example, for screening and / or testing for the presence of coronaviruses, in particular, but not limited to, the SARS-CoV2 virus (the basic variant and its subsequent variants). Accordingly, the device 1 described herein implements what is known as a nasopharyngeal swab.

[0090] Device 1 comprises an elongated body 2 that extends mainly and at least partially along a main deployment direction (axis) X that is substantially axial.

[0091] The elongated body 2 is preferably realized in a plastic material, and this technical feature makes it possible to have an elongated body 2 that is extremely economical to produce. The elongated body 2 is substantially flexible in order to at least partially conform to the curvature of the nasal cavity, nostrils and / or nasopharynx.

[0092] The applicant realizes that the flexibility of the elongated body 2 makes it possible to reduce the risk of injury when the elongated body 2 is introduced into the body cavity to a greater extent than is required for the elongated body 2, and / or, in particular, when this flexibility characteristic is substantially related to elastic behavior, to avoid the risk of rupture of the elongated body 2 within the cavity.

[0093] For example, the elongated body 2 can have a substantially circular cross-section and expand along the axis X with a substantially constant diameter, for example, but not limited to, 1.5 mm to 3 mm, more preferably 2 mm to 2.5 mm. If the cross-section is not circular, the shape of the cross-section can be enclosed within a circumference whose diameter follows the above limits.

[0094] In an alternative embodiment, the elongated body 2 should not be understood in a limiting sense, as it can have a non-constant diameter of the area, or more generally a cross-section, when moving along the axis X. When realized in a plastic material, the elongated body 2 can be realized by molding, in particular injection molding or co-molding. In one embodiment, the elongated body 2 can be realized by a 3D printing process.

[0095] The 3D printing process can be conveniently carried out, for example, by using polymer plastic materials such as polyester types, such as PBT, or PEEK, or PPS, or polycarbonate, or ABS, or PVC, or PMMA, but is not limited thereto. In the present disclosure, when generally referring to plastic materials, the specific types of plastic materials described herein in relation to the 3D printing of the elongated body are understood to be usable alternatively or in addition to other specifically described types of materials equivalently.

[0096] The appropriate heating temperature of the plastic material used for 3D printing or the molding techniques described above is selected by the technician according to the specific chemical composition of the material itself.

[0097] The elongated body 2 comprises at least a gripping portion 2i for the user to grip and an end portion 2e. The end portion 2e is opposite to the gripping portion 2i. In particular, the elongated body 2 comprises a central portion 2c located between the gripping portion 2i and the end portion 2e.

[0098] The gripping portion 2i can comprise elements intended to increase the gripping by the user's hand, in particular the fingers.

[0099] In particular, the gripping portion 2i can comprise a knurled part. The user can be a healthcare professional, in particular a doctor or a paramedic, for example, a nurse, or a pharmacist. The specific profession of the person referred to here as the "user" should not be understood in a limiting sense. The distinction between "user" and "subject" is provided merely to clarify the description. The user can also be the subject 20, particularly when the subject 20 performs a self-test via the device 1.

[0100] Superficially, the elongated body 2 can be equipped with elements (e.g., a knurled portion) intended to increase the gripping by the fingers and / or the palm of the user's hand, particularly corresponding to the gripping portion 2i. In one embodiment, a rubberized edge can be provided on at least a part of the gripping portion 2i.

[0101] The device 1 also comprises a collection element 3 connected to the elongated body 2 substantially corresponding to the end portion 2e. The collection element 3 is configured to be able to absorb and / or hold a sample of a certain amount of biological material, in particular a sample of secretions developing in the upper airway of the subject, and is specifically determined. The collection element 3 is configured to be introduced inside the nasal cavity and / or nasopharynx of the subject.

[0102] For the purposes of the present disclosure, by "nasopharynx" is intended the upper part of the pharynx extending from the base of the skull to the upper surface of the soft palate. The nasopharynx includes the space between the internal nares and the soft palate and is above the oral cavity. The nasopharynx particularly includes the adenoid part. The nasopharynx is surrounded by the Waldeyer ring.

[0103] Preferably, but not limited to this, the collection element 3 is configured and specifically determined to enable the collection of at least 40 ml, or 50 ml, or 70 ml, or 100 ml of fluid. This ensures the collection of sufficient fluid to perform further tests, particularly diagnostic tests, and more specifically nucleic acid amplification tests (NAAT) using reverse polymerase chain reaction processing in a reliable manner. Thereby, the collection element 3 is suitable for the collection of samples for screening and / or testing for the presence of the coronavirus.

[0104] In certain embodiments, the collection element 3 can be pre-inhibited or impregnated with a substance, particularly a reagent.

[0105] In a preferred embodiment, the collection element 3 comprises a plurality of fibers with hydrophilic capabilities. The collection element 3 may be, for example, a flocked swab, a wound fiber swab, a sponge swab, or a swab of another absorbent material. In the case of a flocked swab, the flocking process is such that it enables the deposition of fibers, which enables the fibers to be deposited in a regular manner perpendicular to the surface of the end portion 2e of the elongated body.

[0106] In one embodiment, the fibers are selected from a list of materials including synthetic and natural materials, and in particular from a list of materials including at least one of the following: rayon, polyester, polyamide, carbon fiber, alginate, cotton, silk or mixtures thereof, sponge.

[0107] In a preferred embodiment, at least a part of the end portion 2e protrudes inside the collection element 3, but is not limited thereto. More specifically, the applicant has contemplated a particular embodiment in which the end portion 2e extends substantially corresponding to the distal end 3d of the collection element 3. The latter surrounds at least a part of the end portion 2e. This particular embodiment is shown in Figure 3.

[0108] To promote the uniformity of collection of biological samples, in one embodiment, the collection element 3 is preferably, but not limited to, in the shape of a cylinder and / or a frustum of a cone. In a non-limiting embodiment, the distal portion 3d is substantially rounded, which contributes to reducing the risk of inadvertently injuring or damaging a part of the nasal cavity and / or nasopharynx during the introduction and / or removal of the device 1.

[0109] The elongated body 2 comprises at least a first graduated scale 4 with a plurality of measurement markings 4i. In a simplified embodiment not shown in the accompanying drawings, the elongated body 2 comprises a single measurement marking 4i. Each measurement marking 4i of the plurality of measurement markings (or a single measurement marking in the case of simplification) indicates the age or age range of a plurality of subjects having a first biological age or belonging to a first predetermined biological age range. As will be better explained in the following part of the description, the age or age range is associated with a distance D existing between a first part and a second part of the body of a plurality of subjects used to define at least one subject, in particular the point where the measurement marking 4i is arranged.

[0110] As will be made clearer in the following description, the distance D is preferably the distance existing between the opening or end of the nostrils 11 of a plurality of subjects and a predetermined posterior part of the nasopharyngeal arch, and is determined by measurements made on diagnostic images including at least one of one or more radiographies, or one or more tomographies, one or more magnetic resonances, or one or more ultrasounds.

[0111] Preferably, the first graduated scale 4 extends at least partially into the central portion 2c and / or at least partially into the gripping portion 2i.

[0112] The first graduated scale 4 is configured and specifically designated such that, in use, the user grips the elongated body 2 corresponding to at least one of the plurality of measurement markings 4i.

[0113] In particular, the measurement marking 4i (or, in the case of simplification, a single measurement marking 4i) is configured and intended to provide at least a visual and / or tactile indication of a predefined predetermined insertion depth (numerical reference 100) of the elongate body 2 and the collection element 3 within the cavity of the patient 20's body, depending on the age of the patient 20 himself, to the patient 20 himself (when the patient performs the collection operation) or to an operator (e.g., a physician, paramedic or pharmacist).

[0114] Thus, a particular embodiment of the device described herein comprises a first measurement marking 4i, the first measurement marking 4i being a first specific age (e.g., 7 years) of a first plurality of subjects or a first age range (e.g., 7 - 9 years) of a first plurality of subjects, between the first measurement marking 4i and the end 2e of the elongate body, and / or between the first measurement marking 4i and a predetermined portion of the collection element 3 (preferably the end portion of the collection element 3 described above, the portion opposite the gripping portion 2i), is uniquely associated with the detected distance D, in particular the first distance D1.

[0115] Such an embodiment also includes a second measurement marking 4i that uniquely associates a second specific age of a second plurality of subjects or a second age range of a first plurality of subjects with the distance D, in particular the second distance D2, detected between the second measurement marking 4i and the end portion 2e of the elongate body and / or between the second measurement marking 4i and a predetermined portion of the collection element 3 (preferably the end portion of the collection element 3 opposite the gripping portion 2i).

[0116] Obviously, there may also be a third measurement marking 4i that uniquely associates a third specific age of a third plurality of subjects with the distance D, in particular the third distance D3, detected between the third measurement marking 4i and the end 2e of the elongate body and / or between the third measurement marking 4i and a predetermined portion of the collection element 3, which is the end portion of the collection element 3 opposite the gripping portion 2i. When the first age is lower than the second age and lower than the third age, the following relationship exists among the distances D1, D2, and D3. D1 <= D2 <= D3 (D1 is greater than or equal to D2, and D2 is greater than or equal to D3.)

[0117] Referring to the drawings, it is also clear that the second measurement marking is inserted between the first measurement marking and the third measurement marking.

[0118] As shown in FIG. 1 and more particularly in the various embodiments shown in FIGS. 4-7, the graduated scale 4 is configured and intended to provide at least a visual indication of at least a preferred insertion depth (indicated by reference numeral 100) of the collection element 3 within the nasal cavity and / or nasopharynx, particularly with respect to the structure of the nasal cavity and / or nasopharynx and / or with respect to the intervening distance D (shown in FIG. 2).

[0119] A statistical correlation, and in some cases an identity, has been observed between the distance D existing between the opening or end of the nostrils 11 of a plurality of subjects and a predetermined posterior portion of the nasopharyngeal arch, and the distance D existing between the ear 10, particularly the opening of the tragus or antitragus or external auditory canal 10t, and the opening of the first plurality of subjects' nostrils 11, and / or the distance D existing between the ear 10, particularly the opening of the tragus or antitragus or external auditory canal 10t, and the philtrum 12 of the first plurality of subjects. In use, this distance D is detected by a cephalogram and comes to approximately indicate the distance between the above-mentioned parts of the body with respect to the patient's 20.

[0120] The graduated scale 4 enables a quantitative detection of the distance between at least some of the plurality of measurement markings 4i and the at least one between the end portion 2e and the collection element 3.

[0121] Considering the variation of the distance D as a function of the age or age interval of the subject, in one embodiment, the distance existing between the first measurement marking and the second measurement marking may be different with respect to the distance existing between the second measurement marking and the third measurement marking.

[0122] Although this should not be understood in a limiting sense, in one embodiment, the graduated scale 4 has at least a first measurement marking 4i positioned substantially close to, and in particular substantially in contact with, the collection element 3. This makes it possible to introduce the device 1 to a very short depth 100.

[0123] The applicant has observed in particular that the distance D detected by means of a cephalogram, or equivalently the distance existing between the concha or the opening of the ear 10, in particular the tragus or the ear canal 10t, and the opening or the end of the nostril 11 of a general subject 20, or in this case of the subject under study, and / or the distance existing between the concha or the opening of the ear 10, in particular the tragus or the ear canal 10t, and the philtrum 12 of a general patient 20, or in this case of the subject under study, varies with the variation in the age of the subject and is substantially included between 4 cm, more preferably between 4.5 cm and 10.5 cm, more preferably between 4 cm and 10 cm. In particular, between 4 and 5 years of age, this distance D has been observed to be substantially equal to 5 cm or 6 cm and to increase substantially proportionally up to 11 to 12 years of age. Corresponding to this age, the distance D stabilizes around an average value composed substantially between 8 cm and 10 cm. Thus, the graduated scale 4 extends so as to define a length of at least 10 cm.

[0124] In order to enable accurate gripping of the elongate body 2 and also to enable accurate introduction of the device 1 until it reaches the collection element 3 of the posterior mucosa of the nasopharynx, preferably the device 1 exhibits a length equal to at least 12 cm, preferably equal to at least 13 cm or 14 cm. Thanks to this aspect, in particular with the presence of the graduated scale 4, it is possible to produce a single-size elongate body 2 by using said elongate body 2 without causing damage and / or pain and / or discomfort in order to substantially reach the posterior mucosa of the nasopharynx in both adults and children while limiting production costs.

[0125] A plurality of measurement markings 4i includes at least a first measurement marking 4i and a second measurement marking 4i that are spaced apart from each other by a predetermined distance along a main extension direction X. At least the first measurement marking 4i and the second measurement marking 4i extend at least partially, preferably mainly, substantially obliquely, and optionally substantially orthogonally, along a direction substantially oblique to the main extension direction X. In particular, FIGS. 4 to 6 show an embodiment in which the measurement markings 4i extend substantially orthogonally to the main extension direction, while FIG. 7 shows an embodiment in which the measurement markings 4i extend substantially obliquely and partially parallel to the main extension direction.

[0126] FIG. 4 shows an embodiment in which a first scaled scale 4 is at least partially etched on an elongated body 2, thus realizing at least one recess, particularly a plurality of recesses, corresponding to the measurement markings 4i. Since the etching process is known, it will not be described here. However, in one embodiment, the etching is actually a recess resulting from the shaping or 3D printing process of the elongated body 2.

[0127] FIG. 5 shows an embodiment in which the first scaled scale 4 is in relief on the elongated body 2. The first scaled scale 4 can be fixed and / or engraved by any known method. Also, in this case, the etching may be convex resulting from a shaping process (in particular, co - shaping) or 3D printing of the elongated body 2.

[0128] The applicant particularly acknowledges that the first scaled scale 4 can thus be realized integrally with the elongated body 2 and then as a single part. Also, thanks to the shaping or 3D printing process, it is recognized that the elongated body 2 can be integrated and then realized as a single part. This contributes to the improvement of the robustness and uniformity of its mechanical properties along its extension.

[0129] In FIG. 6, an embodiment is shown in which a graduated scale 4 with a first scale is painted on the elongated body 2. In particular, the elongated body 2 has at least a first color, and at least a part of the graduated scale 4 with the first scale has a second color different from the first color.

[0130] In FIGS. 4 to 7, the cross-section of the elongated body 2 is substantially circular, and the measurement markings 4i extend along an arc of a circumference smaller than the circumference itself. In another embodiment, the measurement markings 4i extend along the entire circumference, so this should not be understood in a limiting sense. If the elongated body 2 exhibits a shape different from having a circular cross-section, then it will be apparent that the measurement markings 4i can extend along at least a part (e.g., one side) of the perimeter of the elongated body 2, or along the entire perimeter or transverse extension of the elongated body 2.

[0131] In particular, it is recognized that the graduated scale 4 can be realized with a material that is at least partially different with respect to the material of the elongated body 2.

[0132] The present disclosure also refers to a method of producing the device 1 for the collection and transfer of samples of biological materials.

[0133] The method subject of the present disclosure includes, first, a first plurality of measurements and / or calculation steps of respective first plurality of measurement data of the distance D existing between a first part and a second part of the body of each first plurality of research subjects having a first biological age or belonging to a first predetermined biological age range. In particular, the first part and the second part are the first part and the second part of the cavity of the body to be measured. In this step, for example, a white child of 8 years old is considered, and a head photograph is taken to detect the above-mentioned distance D between the above-mentioned first part and the second part of the body. The plurality of measurement steps include a plurality of measurements performed on at least one diagnostic image including at least one of one or more radiographs, or one or more tomographies, one or more magnetic resonances, one or more ultrasonic examinations.

[0134] This method includes a first step of analyzing a first plurality of measurement data, preferably a statistical type, in order to define at least a first graduated scale 4 including at least a first measurement marking 4i indicating the first plurality of measurement data and a first distance value representing a first biological age or a first predetermined biological age range. As will be more clearly apparent in the following part of the description, the step of analysis is a step of statistical analysis intended to determine at which exact point of the elongated body to position a measurement marking indicating an average distance D between a first part and a second part of the body, which represents a value statistically determined for said distance on a number of subjects.

[0135] This method includes a production step of the device 1 for the collection and transfer of a sample of biological material, first including a realization and / or assembly step of an elongated body 2 which at least partially extends along a substantially axial main extension direction X and includes a gripping part 2i which is at least intended to be gripped by a user and at least an end part 2e.

[0136] This method includes a production and / or assembly step of a collection element 3 which substantially corresponds to the end part 2e of the elongated body 2. The production and / or assembly step of the collection element can be part of the above-mentioned production step or can be a step different from the above-mentioned production step.

[0137] The collection element 3 is provided with its own end part and is configured to collect and / or absorb a sample of a certain amount of biological material present in a cavity of the patient 20's body and is configured to be introduced into a cavity of the patient 20's body.

[0138] In particular, the step of producing the elongated body 2 includes a step of realizing at least a first measurement marking 4i which is realized on the elongated body, is positioned at a first distance from the end part 2e of the body or from the end part of the collection element, and is equal to or related in a predetermined manner to a first display distance value.

[0139] The first measurement marking 4i is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth 100 of the elongate body 2 and the collection element 3 within the cavity of the body of the patient 20, depending on the age of the patient 20, to the patient or the operator.

[0140] Preferably, but not limited thereto, the method includes a second plurality of measurements and / or calculation steps of the respective second plurality of measurement data of the distance D existing between the first part and the second part of the body of each second plurality of subjects having a second biological age or belonging to a second predetermined biological age range, in particular, the first part and the second part are the first part and the second part of the cavity of the body of the measurement object. For example, these second plurality of measurement steps can be performed on a 9-year-old subject to check whether the distance D changes between the first part of the body considered in the first plurality of measurement steps performed on an 8-year-old subject and the second part itself, and how it changes statistically.

[0141] Subsequently, a second step of preferably statistical type analysis of the second plurality of measurement data for defining the graduated scale 4 follows, which step further includes at least a second measurement marking 4i indicating the second plurality of measurement data and a second distance value representing the second biological age or the second predetermined biological age range.

[0142] The step of producing the elongate body 2 includes the step of realizing at least the second measurement marking 4i on the elongate body 2, which is located at a second distance equal to or related to the second display distance value, in a predetermined manner, from the end portion 2e of the body or from the end portion of the collection element.

[0143] In a preferred embodiment, the method comprises a repetition of a first plurality of measurement steps and a repetition of a first analysis step, the first analysis step defining a multiplicity of measurement data of a distance D corresponding to each multiplicity of subjects having respective different biological ages or biological age ranges, and defining a graduated scale 4 including corresponding multiplicity distance values representing said respective biological ages or biological age ranges. The step of producing the elongate body 2 is related to the graduated scale 4 and includes the step of implementing on the elongate body 2 a plurality of measurement markings 4i located at respective distances from said end portion 2e of the body or from the end portion of the collection element and equal to or related in a predetermined manner to said plurality of indicated distance values. The plurality of measurement markings 4i are configured and intended to provide at least a visual and / or tactile indication to the operator of a predetermined insertion depth 100 of the elongate body 2 and of the collection element 3 within a cavity of the body of the patient 20, depending on the age of the patient 20.

[0144] The specific technical procedure by which the elongate body 2 is implemented depends mainly on the material and / or the form of the elongate body itself.

[0145] The step of producing and / or assembling the collection element 3 depends in particular on the specific form and / or material in which the collection element 3 is implemented and for this reason is not specifically described herein.

[0146] The method further includes the step of connecting the collection element 3 to the elongate body 2 substantially corresponding to said end portion 2e. Specifically, in one embodiment, the connecting step can include superimposing the collection element 3 on the elongate body 2.

[0147] The step of producing the elongate body 2 includes the step of producing on the elongate body 2 a graduated scale 4 having a plurality of measurement markings 4i having the characteristics described above.

[0148] By the above repetition, the reliability of the calculation of the distance D can be enhanced, and in particular, the adverse effects derived from the study subjects that are actually deviated from the average with respect to other study subjects of the same age with the same distance characteristics can be mitigated.

[0149] For this purpose, this method includes the calculation of at least one of the expected value, and / or the arithmetic mean, weighted mean, weighted average of at least the first part of a plurality of measurement data, in particular electronic calculation, and this measurement data includes measurement data uniquely associated with study subjects belonging to the same age and / or age range, the same gender and / or the same ethnicity or group.

[0150] By this calculation, the generation of the first display distance value is determined.

[0151] In the method described in this specification, by the above calculation, the generation of the first average distance D value related to the first part of a plurality of measurement data is determined.

[0152] As a result of the above steps, the plurality of measurement markings 4i include a first measurement marking positioned at a first distance corresponding to the first average value of the distance D from the end portion 2e of the elongated body and / or from a predetermined portion of the collection element 3, preferably from the end portion opposite to the gripping portion 2i of the collection element 3, and a second measurement marking positioned at a second distance corresponding to the second average value of the distance D from the end portion 2e of the elongated body and / or from a predetermined portion of the collection element 3, preferably from the end portion opposite to the gripping portion 2i of the collection element 3.

[0153] The applicant conducted an investigation procedure including the implementation of 323 cephalograms obtained for orthodontic purposes in 152 male and 171 female study subjects aged from 4 to 14 years old.

[0154] For each of the cephalograms, the shortest distance between the most anterosuperior point of the philtrum or the contour of the nostril and the shape of the nasopharynx, particularly the posterior arch, was selected. This distance was measured in a predetermined unit of measurement (millimeters) parallel to the palatal plane. Descriptive statistics of the measurements were calculated separately for each age group.

[0155] The following table shows details of the results obtained by the inventors for subjects in different age samples.

[0156]

Table 1

[0157] The above table also confirms that there is a difference in depth between groups of men and women of a certain age, but this difference in depth can be ignored in order to determine a substantially clear measure. The above table shows that there is no statistical difference in the nasal depth between subjects aged 7 to 8 and subjects aged 8 to 9. The above table also shows that there is no statistical difference in the nasal depth between subjects aged 11 and 14.

[0158] According to this table, a device 1 having a graduated scale 4 with six measurement markings 4i for 4-year-old, 5-year-old, 6-year-old, 7-year-old, 9-year-old, and 11-year-old and above can be realized. It is also recognized that the distance between the measurement markings and other markings is not constant. In fact, there is a distance of 7 mm between the first measurement marking and the second measurement marking, but there is only a distance of 3 mm between the third measurement marking and the fourth measurement marking. The above table shows that the nasal depth is substantially stable after the age of 11. Therefore, from the experimental data obtained by the present inventors, the research subjects aged 11 and above could be regarded as adult research subjects. In any case, the research specifically conducted by the present inventors is specific to the device 1 for the collection and transfer of biological material samples for pediatric use.

[0159] The present disclosure also relates to a method for determining the exact insertion depth of the device 1 for the collection and transfer of biological material samples, preferably according to what is described herein. By this method, the exact insertion depth of the device 1 can be determined.

[0160] The first step is to detect the age of the patient 20 who must undergo the insertion procedure of the device described herein. This detection is performed manually, for example, by questions asked verbally or from written data manually collected from the patient 20, or at least partially electronically by accessing an electronic database containing the biological data of the patient 20, or by scanning at least a part of the patient 20's identity document.

[0161] The next step is to search for the measurement marking 4i corresponding to the age of the research subject on the graduated scale. For example, if the research subject is 12 years old, the step includes the process of searching for the measurement marking 4i having the number "12". This measurement marking 4i serves as the reference measurement marking. This step advantageously does not require the use of measuring instruments and is therefore extremely easy to implement. The risk of error is very low.

[0162] The next step involves gripping the device 1 for the collection and transfer of a sample of biological material corresponding to the elongated body 2, in particular by placing one end of the operator's finger substantially corresponding to the measurement marking 4i corresponding to the age of the subject under study. Placing the end of the finger of the subject substantially corresponding to the measurement marking 4i advantageously allows the finger to be used as a substantial stop, whereby when the collection element 3 and the portion of the elongated body 2 in front of the reference measurement marking 4i are introduced into the cavity of the subject, the fingertip acts substantially as an abutment or stop element that determines reaching the correct depth. Alternatively, the collection element 3 and the elongated body 2 may be introduced into the cavity until they reach the correct depth determined by the reference measurement marking 4i, and the gripping is performed at a portion more distal from the collection element 3 than the reference measurement marking 4i, but in this case, it is assumed that the operator can accurately evaluate so as not to exceed a greater insertion depth than that corresponding to the reference measurement marking 4i corresponding to the age of the subject under study.

[0163] Conveniently, the introduction step includes a substantially axial movement of the elongated body within the cavity of the subject, but may also include, in combination or partially alternatively, a rotation about an axis substantially coinciding with the expansion axis of the elongated body 2 itself. This means that in a non-limiting embodiment, the introduction step includes at least partially a composite movement, which is a rotational-translational type. It should be noted that the introduction stage is excluded from the claims as it is part of the interaction with the human body. However, this step is disclosed herein for the sake of completeness of the description.

[0164] As shown in the table, since there may be a slight difference in the depth of the cavity with respect to the gender of the male or female patient 20, a particular embodiment of the device which is the subject of the present disclosure comprises a first graduated scale 4 and a second graduated scale 4'. FIG. 8 shows a particular embodiment of the device 1 comprising a first graduated scale 4 and a second graduated scale 4'.

[0165] Further, the second graduated scale 4' includes a plurality of measurement markings 4i, each measurement marking being located at a respective distance from the end portion 2e of the body or the end portion of the collection element and having a first biological age or belonging to a first predetermined biological age range, equal to or related in a predetermined manner to a respective distance value representing a first plurality of measurement data of the distance D existing between a first part and a second part of the body of a first plurality of subjects.

[0166] The first graduated scale 4 and the second graduated scale 4' are adapted to be used, in particular, for patients 20 having different genders and / or belonging to different ethnic groups or populations.

[0167] The applicant notes that the characteristics shown for the first graduated scale 4 can be considered applicable to the second graduated scale 4', and for this reason will not be repeated hereinafter. It should be noted that the first graduated scale and the second graduated scale do not necessarily have to be of the same type. This means, in particular, that, for example, the measurement markings 4i of the first graduated scale 4i may be embossed, and the measurement markings 4i of the second graduated scale 4i may be colored. This helps to distinguish and simplify the detection of the correct graduated scale. Preferably, but not limited thereto, the first graduated scale 4 and the second graduated scale 4' extend in a parallel direction. These directions coincide with the direction of maximum extension of the elongated body 2.

[0168] Finally, the applicant notes that, if there is a significant age difference between two consecutive measurement markings 4i (for example, a first measurement marking corresponding to an age of 3 years, for example, and a second measurement marking corresponding to an age of 11 years), and if the patient 20 from whom the collection is made is of an age between the ages corresponding to the two closest measurement markings, a non-limiting step of the method includes the step of gripping the elongated body 2 on the graduated scale at a position intermediate the two measurement markings.

[0169] The applicant notes that although the detailed description of the invention refers in particular to introducing a part of device 1 inside the nose of the subject, this particular cavity should not be understood in a limiting way. The cavity may in fact be one of the oral cavity, the anus, the vagina, the auricle, the urethral cavity of the subject under study.

[0170] In particular, in fact, this device 1 is conveniently provided so as to enable the collection of samples of biological material from another cavity of the human or animal body, in particular the ear, the mouth, the rectum or the urethra. Therefore, the dimensions, in particular the length and / or the cross-section of the collection element 3, or the length of the elongated body 2, or its cross-section, can be conveniently adapted according to the specific use. The extension of the graduated scale 4 can also be varied accordingly.

[0171] Finally, it should be noted that the patient 20 is mainly intended as a "human subject", but this should not be understood in a limiting way. In fact, the patient 20 may be an animal, for example a pet. Thus, it is clear that the subject matter of the present disclosure, since the aforementioned device 1 can equally be intended for veterinary use, should not necessarily be considered as intended only for human use.

[0172] Device 1 may be sold and / or provided to the operator in bulk or, preferably, enclosed in a flexible type of container, whereby the collection element 3 is kept isolated until use. In one embodiment, the collection element 3, preferably the whole of device 1, is sterilized before introduction into the container. In a non-limiting embodiment, the container is sealed immediately after the introduction of device 1. The sealing can be done by heat sealing.

[0173] Preferably, but not limited to this, the said container is realized in the form of an envelope. In a non-limiting embodiment, such an envelope can be made at least partially of plastic material and can have at least a transparent window enabling the verification of certain characteristics of the device 1 contained therein.

[0174] In a non-limiting embodiment, the device 1 can be provided in a kit including reagents and test devices for, for example, screening and / or testing for the presence of viruses and / or bacteria, particularly for the presence of SARS-CoV2 virus (its basic variants and subsequent variants), in particular, without limitation, the coronavirus. This test device is preferably of the disposable type. Thereby, the cost of the kit can be suppressed.

[0175] The advantages of the devices and methods described so far are obvious. The user can place a finger on the measurement marking 4i corresponding to the age, or otherwise introduce a part of the device 1 into the cavity only to the depth corresponding to that age. Therefore, the exact insertion depth of the device 1 described herein is considered intuitive. In particular, there is no longer a need to perform complex calculations of the relationship between the age measured with a length measurement scale (e.g., cm) and the insertion depth, which may cause errors when measurements are quickly performed by the same operator on a large number of patients 20.

[0176] The devices described herein are economically realizable and can therefore be economically accessible even to poor people or in developing countries.

[0177] The process of determining the position of the measurement marking 4i and the corresponding age is performed by analysis realized for a large number of research subjects. Therefore, the graduated scale provided on the device 1 described herein is, on average (statistically), reliable even if it includes a single measurement marking 4i.

[0178] The present invention is not limited to the embodiments shown in the accompanying drawings. For this reason, the reference signs appearing in the following claims are provided only for the sole purpose of increasing the understanding of the claims and are not intended in a limiting way.

[0179] Finally, it is obvious that additional, corrective, or modifying changes that are obvious to a person skilled in the art can be applied to the subject matter of the present disclosure without departing from the scope of protection provided by the claims.

Claims

1. A device (1) for collecting and transferring a sample of biological material, comprising an elongated body (2) that extends at least partially along a substantially axial main extension direction (X) and comprises at least a gripping portion (2i) that will be gripped by a user and at least an end portion (2e); a collection element (3) connected to the elongated body (2) substantially corresponding to the end portion (2e), having a unique end portion, and configured to collect and / or absorb the amount of a sample of biological material present in a cavity of a patient's (20) body, wherein at least the collection element (3) is configured to be introduced inside the cavity of the patient's (20) body, for example, configured to be introduced inside the nasal cavity and / or nasopharynx of the patient (20), the collection element (3); comprising; the elongated body (2) comprises a first graduated scale (4) having at least a first measurement marking (4i) located at a first distance from the end portion (2e) of the body or the end portion of the collection element, the first distance being equal to or related in a predetermined manner to a first distance value representing a first plurality of measurement data of a distance (D) existing between a first part and a second part of the body of each of a first plurality of subjects having a first biological age or belonging to a first predetermined biological age range, optionally, the first part and the second part being a first part and a second part of a cavity of the subject's body; the first measurement marking (4i) is configured to and is intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) inside the cavity of the patient's body (20) to the patient or the operator according to the patient's age, a device.

2. The first graduated scale (4) is arranged at a second distance from the end portion (2e) of the body or the end portion of the collection element and comprises a second measurement marking (4i) equal to or related in a predetermined manner to a second distance value representing a first plurality of measurement data of a distance (D) existing between a first part and a second part of the body of each of a second plurality of subjects having a second biological age or belonging to a second predetermined biological age range; The second measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's (20) body, depending on the age of the patient (20), to the patient or the operator, the device according to claim 1.

3. The distance (D) is the distance between the opening or end of the nostril (11) of the first plurality of subjects and / or the second plurality of subjects and a predetermined posterior portion of the nasopharyngeal arch, and / or exists between the ear (10), optionally the tragus or the earlobe or the opening of the external auditory canal (10t), and / or exists between the opening or end of the nostril (11) of the first plurality of subjects and / or the second plurality of subjects and the ear (10), optionally the tragus or the earlobe or the opening of the external auditory canal (10t), and / or exists between the philtrum (12) of the first plurality of subjects and / or the second plurality of subjects, and / or exists between the anterior - upper point of the philtrum or the nostril contour and the shape of the nasopharynx of the first plurality of subjects and / or the second plurality of subjects, optionally the posterior arch, or The cavity is one of the oral cavity, anus, vagina, auricle, urethral cavity of the subject (20), the device according to claim 1 or 2.

4. The first and second measurement markings (4i) are arranged at a predetermined distance from each other along the main expansion direction (X), and the at least first and second measurement markings (4i) extend at least partially, preferably mainly, substantially obliquely, optionally substantially orthogonally, with respect to the main expansion direction (X), and / or the plurality of measurement markings (4i) includes measurement markings at non-equidistant intervals, and / or The first graduated scale (4) is provided with a third measurement marking (4i) located at a third distance from the end portion (2e) of the body or the end of the collection element, the third distance being equal to or related in a predetermined manner to a third distance value representing a plurality of first measurement data of the distance (D) existing between the first part and the second part of the body of each of a plurality of third study subjects having a third biological age or belonging to a third predetermined biological age range. The third measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined and predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the body of the patient (20) to the patient or the operator, depending on the age of the patient (20). The second measurement marking (4i) is inserted between the first measurement marking (4i) and the third measurement marking (4i). The device according to claim 2 or 3, wherein the distance existing between the first measurement marking (4i) and the second measurement marking (4i) is different from the distance existing between the second measurement marking (4i) and the third measurement marking (4i). **Claim 5** The biological age is a pediatric and / or developmental age, and one of the first measurement marking (4i), the second measurement marking (4i) or the third measurement marking (4i) indicates the minimum age of use of the device, optionally indicating an age including substantially from 3 to 5 years, or corresponding thereto, or indicating a substantially stable age of the distance (D) existing between the first part and the second part depending on the age. The device according to any one of claims 1 to 4, wherein the substantially stable age is substantially equal to 9 - 13 years, preferably 10 - 12 years, more preferably substantially 11 years. **Claim 6** The first graduated scale (4) is at least partially etched on the elongated body (2) and / or realized through recesses or recesses, and / or at least partially embossed on the elongated body (2), and / or fixed, engraved, molded, co-molded, or painted on the elongated body (2), and / or the first graduated scale (4) is realized with at least a partially different material from the material of the elongated body (2). Optionally, the elongated body (2) exhibits at least a first color, and at least a part of the first graduated scale (4) exhibits at least a second color different from the first color. The device according to any one of claims 1 to 5.

7. The elongated body (2) includes a central portion (2c) located between the gripping portion (2i) and the end portion (2e). The first graduated scale (4) extends at least partially within the central portion (2c), and / or the first graduated scale (4) extends at least partially within the gripping portion (2i). The graduated scale is configured and particularly intended to address the user to grip the elongated body (2) corresponding to at least the measuring marking (4i) among the plurality of measuring markings (4i) during use. The device according to any one of claims 1 to 6.

8. Having a length equal to at least 10 cm, preferably equal to at least 12 cm, or more preferably equal to at least 14 cm, and / or the elongated body (2) exhibits a substantially constant cross-section along an extension along the main extension direction (X) or a variable cross-section along an extension along the main extension direction (X). Optionally, the elongated body (2) has a cross-section that is substantially circular or can be engraved on the circumference. The cross-section is substantially circular, or the diameter of the circumference is 1.5 mm to 3 mm, more preferably 2 mm to 2.5 mm. The device according to any one of claims 1 to 7.

9. The elongated body (2) is substantially flexible and / or is at least partially realized in a natural or plastic material and / or is realized by molding, optionally by injection molding or co-molding, and / or by a 3D printing process, and / or the elongated body (2) is realized as a single piece, and the first scaled scale (4) is integral with the elongated body (2), and optionally, the first scaled scale (4) is integrally realized with the elongated body (2) optionally by the molding, optionally by injection molding or co-molding, and / or by a 3D printing process, the device according to any one of claims 1 to 8.

10. The elongated body (2) comprises a second scaled scale (4'), the second scaled scale (4') having at least a first measurement marking (4i), the at least first measurement marking (4i) being located at a first distance from the end portion (2e) of the body or the end portion of the collection element and being equal to or related in a predetermined manner to a first distance value representing a first plurality of measurement data of the distance (D) existing between a first part and a second part of the body of each first plurality of subjects having a first biological age or belonging to a first predetermined biological age range, and optionally, the first part and the second part are a first part and a second part of the cavity of the body of the subject, The at least first measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the body of the patient (20) to the patient or the operator, depending on the age of the patient (20), The first scaled scale (4) and the second scaled scale (4') are associated with the distance (D) to be measured for subjects having different ethnic groups or populations and / or different genders, male and female respectively, and / or patients (20) of different ethnic groups or populations and / or patients (20) of different genders, male and female respectively, for which they are each intended to be used, the device according to any one of claims 1 to 9.

11. A method for producing a device (1) for collecting and transferring a biological material sample, comprising: A first plurality of measurements and / or calculation steps of a first plurality of measurement data of a distance (D) existing between a first part and a second part of a body of each of a first plurality of research subjects having a first biological image age or belonging to a first predetermined biological age range, optionally, the first part and the second part being a first part and a second part of a cavity of the body of the research subject, the first plurality of measurements and / or calculation steps; A first step of analyzing the first plurality of measurement data to define a first graduated scale (4) including at least a first measurement marking (4i) indicating a first distance value representing the first plurality of measurement data and the first biological age or the first predetermined biological age range, preferably a first step of a statistical type; A production step of the device (1) for collecting and transferring a biological material sample; The step of realizing and / or assembling an elongated body (2) having at least a gripping portion (2i) and at least an end portion (2e) that at least partially extends along a main substantially axial expansion direction (X) and is intended to be gripped by a user; The step of producing and / or assembling a collection element (3) substantially corresponding to the end portion (2e) of the elongated body (2), the collection element comprising its own end portion and being configured to collect and / or absorb a sample of a certain amount of biological material present in a cavity of the patient's (20) body, at least the collection element (3) being configured to be introduced inside a cavity of the patient's (20) body, for example, configured to be introduced inside the nasal cavity and / or nasopharynx of the patient (20); Including The step of producing the elongated body (2) includes the step of realizing at least the first measurement marking (4i) located on the elongated body (2) at a first distance from the end portion (2e) of the body or from the end portion of the collection element, equal to or related in a predetermined manner to the first display distance value, wherein the measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the body of the patient (20) to the patient or the operator, depending on the age of the patient (20), A method, comprising. **Claim 12** The method according to claim 11, A second plurality of measurements and / or calculation steps of the respective second plurality of measurement data of the distance (D) existing between the first part and the second part of the body of each second plurality of subjects having a second biological age or belonging to a second predetermined biological age range, optionally, the first part and the second part being the first part and the second part of the cavity of the body of the subject, the second plurality of measurements and / or calculation steps; A second step of analyzing the second plurality of measurement data for defining the first graduated scale (4), preferably a second step of statistical type analysis, further comprising at least a second measurement marking (4i) indicating the second plurality of measurement data and a second distance value representing the second biological age or the second predetermined biological age range; Including, The step of producing the elongated body (2) includes the step of realizing at least the second measurement marking (4i) located on the elongated body (2) at a second distance from the end portion (2e) of the body or from the end portion of the collection element, equal to or related in a predetermined manner to the second display distance value, wherein the second measurement marking (4i) is configured and intended to provide at least a visual and / or tactile indication of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the body of the patient (20) to the patient or the operator, depending on the age of the patient (20), a method. **Claim 13** The method according to claim 11, The step of repeating the first plurality of measurement steps and the analysis of the first step to define a multiplicity of measurement data of the distance (D) corresponding to each multiplicity of subjects having respective different biological ages or biological age ranges, and defining the graduated scale (4) including the corresponding multiplicity of distance values representing each of the respective biological ages or biological age ranges, The step of producing the elongated body (2) includes the step of implementing a plurality of measurement markings (4i) on the elongated body (2), the plurality of measurement markings (4i) being related to the graduated scale (4) and positioned at respective distances from the end portion (2e) of the body or the end portion of the collection element, equal to or related in a predetermined manner to the plurality of display distance values, the plurality of measurement markings (4i) being configured and intended to provide at least a visual and / or tactile indication to the operator of a predetermined insertion depth (100) of the elongated body (2) and the collection element (3) within the cavity of the patient's body according to the age of the patient (20). Claim 14 At least one of the first analysis step and / or the second analysis step includes the calculation of at least an expected value, and / or an arithmetic mean, a weighted mean, a weighted average of at least a first portion of the plurality of measurement data, optionally including electronic calculation, the portion including measurement data uniquely associated with subjects belonging to the same age and / or age range, the same gender and / or the same ethnicity or group, the calculation determining the generation of the first display distance value, the method according to any one of claims 11 to 13. Claim 15 A method according to any one of claims 11 to 14, In the at least first measurement step and / or second measurement step, the measurement of the distance (D) existing between the opening or end of the nostril (11), which is a first part of the body of the first plurality of subjects and / or the second plurality of subjects, and a predetermined posterior part of the nasopharyngeal arch, which is a second part of the body of the first plurality of subjects and / or the second plurality of subjects, is performed on a diagnostic image including at least one of one or more radiographs, or one or more tomographs, one or more magnetic resonances, or one or more ultrasonic examinations.

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