EP4280967A1

EP4280967A1 - Device for the collection of a saliva sample

Info

Publication number: EP4280967A1
Application number: EP22704795.8A
Authority: EP
Inventors: Andrea Gardumi
Original assignee: Comedical Srl
Current assignee: Comedical Srl
Priority date: 2021-01-21
Filing date: 2022-01-18
Publication date: 2023-11-29
Also published as: IT202100001025A1; WO2022157620A1

Abstract

The device (1) for the collect ion of a saliva sample comprises: at least one container (2) for the collection of a saliva sample (3), in turn, comprising at least one inlet opening (4) made on one end of the same; at least one mouthpiece element (5) associated with the inlet opening (4) and intended, in use, to be placed in contact with the mouth (6) of a user (7); wherein the mouthpiece element (5) is associated in a sliding manner with the container (2) and is movable, as a result of a force applied thereto by a user, between: a pickup position wherein the mouthpiece element (5) is arranged at least partly protruding from the container (2); and a withdrawal position wherein the mouthpiece element (5) is retracted and inserted into the container (2).

Description

DEVICE FOR THE COLLECTION OF A SALIVA SAMPLE

Technical Field

The present invention relates to a device for the collection of a saliva sample. Background Art

It is well known that tests based on saliva samples are currently of crucial importance in the diagnosis of pathological and infectious states.

These tests are particularly important in the control of epidemics because the collection of biological material is simple and non-invasive, but at the same time they allow obtaining precise and accurate results in several clinical and pathological states.

Generally, the devices for the collection of a saliva sample comprise a collection container provided with an inlet opening through which the saliva sample is introduced.

The introduction of the saliva sample can be done in several ways.

The first way, for example, is to put the user’s mouth in contact with the inlet opening. In this way, the saliva sample is introduced into the container through the direct contact of the user’s mouth with the latter; this greatly increases the risk of environmental contamination of the saliva sample, since the user’s mouth is in contact with the inlet opening.

Alternatively, a second mode consists in associating a mouthpiece element with the inlet opening by the interposition of coupling means.

Users place their mouth in contact with the mouthpiece element and, once the introduction of the saliva sample is completed, they remove the latter and close the container, placing a closure element over the inlet opening.

Such a solution is described in patent document no. US9498191.

However, the device described in the aforementioned document has several drawbacks including the fact that the association and removal of the mouthpiece element increase the risk of contamination of the saliva sample besides the risk of dispersion of the same.

The mouthpiece element, in fact, is associated with the inlet opening in a removable manner by means of temporary coupling means which do not ensure the tightness thereof.

Again, the fact that the mouthpiece element must be handled prior to use increases the risk of contamination of the saliva sample.

Description of the Invention

The main aim of the present invention is to devise a device for the collection of a saliva sample which can significantly reduce, compared to known devices, the risk of contamination of the saliva sample itself.

Within this aim, one object of the present invention is to devise a device for the collection of a saliva sample which allows avoiding handling parts thereof prior to use, thus ensuring preservation of the saliva sample.

Another object of the present invention is to devise a device for the collection of a saliva sample which allows the mentioned drawbacks of the prior art to be overcome within a simple, rational, easy and effective to use as well as affordable solution.

The aforementioned objects are achieved by the present device for the collection of a saliva sample having the characteristics of claim 1.

Furthermore, the aforementioned objects are achieved by the present kit for the collection of a saliva sample having the characteristics of claim 12.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a device for the collection of a saliva sample, illustrated by way of an indicative, yet non-limiting example, in the accompanying tables of drawings wherein: Figure 1 is an exploded view of the device according to the invention;

Figure 2 is a cross-sectional view along the plane II of the device according to the invention in Figure 1 ;

Figure 3 is a front view of the device according to the invention in the picking position.

Figure 4 is a cross-sectional view along the plane IV of the device according to the invention in Figure 3;

Figure 5 is a front view of the device according to the invention in the withdrawal position;

Figure 6 is a cross-sectional view along the plane VI of the device according to the invention in Figure 5;

Figure 7 is a front view of the device according to the invention in the closed configuration;

Figure 8 is a cross-sectional view along the plane VIII of the device according to the invention in Figure 7 ;

Figure 9 is a front view of the device according to the present invention in the closed configuration;

Figure 10 is a cross-sectional view along the plane X of the device according to the present invention in Figure 9;

Figure 11 is a schematic representation of the device according to the invention in the configuration of normal use.

Embodiments of the Invention

With particular reference to these figures, reference numeral 1 globally indicates a device for the collection of a saliva sample.

The device 1 for the collection of a saliva sample comprises: a container 2 for the collection of a saliva sample 3, in turn, comprising at least one inlet opening 4 made on one end of the same; a mouthpiece element 5 associated with the inlet opening 4 and intended, in use, to be placed in contact with the mouth 6 of a user 7.

It is specified that the device 1 according to the present invention is usable for laboratory tests carried out on saliva samples to identify markers of pathological conditions, such as e.g. pathologies of viral or bacterial origin, such as states of psychophysical alteration.

According to the invention, the mouthpiece element 5 is associated in a sliding manner with the container 2 and is movable, as a result of a force applied thereto by a user 7, between: a pickup position (Figures 3, 4, and 11), wherein the mouthpiece element 5 is arranged at least partly protruding from the container 2; and a withdrawal position (Figures 5-10), wherein the mouthpiece element 5 is retracted and inserted into the container 2.

The mouthpiece element 5 comprises an introduction opening 8 of the saliva sample 3 and a drain opening 15 of the saliva sample, opposite the introduction opening 8 and coupled to the container 2.

The introduction opening 8 and the drain opening 15 are made on the ends of the mouthpiece element 5.

In addition, the mouthpiece element 5 comprises an internal volume 14 which is in fluidic communication with the container 2 to allow the deposit of the saliva sample 3 in the container 2.

The internal volume 14 is adapted to allow the passage of the saliva sample 3 which, as a result of gravity, flows from the introduction opening 8 to the container 2.

Preferably, the mouthpiece element 5 has an elongated shape coaxial to the container 2, the mouthpiece element 5 being insertable in the container 2 substantially to size.

The container 2 and the mouthpiece element 5 have a circular cross section.

In other words, the container 2 and the mouthpiece element 5 have a substantially cylindrical conformation.

Preferably, the container 2 is of the type of a laboratory tube which is known to the technician in the field.

In more detail, the mouthpiece element 5 comprises a main body 9 and an introduction portion 10 arranged, in use, above the main body 9.

Preferably, the container 2 is made at least partly of polystyrene.

It cannot be ruled out from the scope of the present disclosure that the container 2 comprises one or more stabilizing substances which are adapted to ensure the preservation of the saliva sample 3.

Advantageously, the mouthpiece element 5 is made at least partly of polypropylene.

It cannot, however, be ruled out from the scope of the present disclosure that the mouthpiece element 5 and the container 2 are made of the same material.

As visible in the figures, the mouthpiece element 5 has a smaller diameter than the container 2.

Advantageously, the main body 9 has a smaller diameter than the diameter of the container 2 and of the introduction portion 10.

In turn, in parallel, the introduction portion 10 has a larger diameter than the main body 9 and equal to the diameter of the container 2.

Furthermore, the device 1 comprises at least one vent hole 11 made on the mouthpiece element 5 and adapted to allow air to escape during the introduction of the saliva sample 3 in the container 2.

As visible in the figures, the device 1 comprises a plurality of vent holes 11 made on the mouthpiece element 5.

The vent holes 11 are homogeneously arranged along the longitudinal direction of development of the mouthpiece element 5.

Furthermore, the device 1 comprises at least two stiffening fins 12 associated with the mouthpiece element 5 on portions of the latter opposite each other.

Preferably, the device 1 comprises a plurality of stiffening fins 12 associated with the main body 9.

In more detail, in the picking position, the stiffening fins 12 allow the mouthpiece element 5 to be maintained in a position protruding from the container 2.

According to a preferred embodiment of the device 1, each stiffening fin 12 is located on one of the vent holes 11; the stiffening fins 12 are provided with a through gap, not visible in detail in the figures, adapted to allow venting of the air insufflated by the user 7 during the introduction of the saliva sample 3 in the device 1.

In other words, a stiffening fin 12 is placed on each vent hole 11.

This means that each stiffening fin 12 is in fluidic communication with the internal volume of the mouthpiece element 5.

In addition, the stiffening fins 12 are adapted to allow the mouthpiece element 5 to be balanced in the withdrawal position.

In other words, the stiffening fins 12 are adapted to allow the mouthpiece element 5 not to move, by tilting, when inserted inside the container 2 but to remain in a vertical position.

In this regard, it should be noted that the mutual distance between two stiffening fins 12 is substantially equal to the diameter of the container 2.

As can be seen in Figures 3 and 4, during the insertion of the mouthpiece element 5 inside the container 2, i.e. during the switch from the picking position to the withdrawal position, the stiffening fins 12 are in sliding contact with the internal surface of the container 2.

In other words, the stiffening fins 12 are insertable substantially to size, or with a slight interference, inside the container 2, remaining locked therein.

In addition, the device 1 comprises at least one closure element 13 associable with the inlet opening 4 when the mouthpiece element 5 is in the withdrawal position (Figures 7-10).

The closure element 13 is of the type of a screw-on cap of a type known to the technician in the field and provided with a stop portion 18 adapted to fit to size in the inlet opening so as to ensure the watertight closure thereof.

In detail, in the proximity of the inlet opening 4, the container 2 is provided with a thread 16 configured to couple to the closure element 13 by screwing.

In a second aspect, the present invention relates to a kit for the collection of a saliva sample 3 comprising: the device 1 ; a watertight resealable containment enclosure, not shown in detail in the figures, for the containment of the device itself and adapted to avoid environmental contamination and the possible dispersion of the saliva sample 3 in the environment.

The operation of the present invention is as follows.

The user 7 opens the containment enclosure by pulling out the device 1.

Upon removal from the respective enclosure, the device 1 is in the picking position (Figures 3 and 4), i.e. it has the mouthpiece element 5 which is arranged protruding from the container 2.

The introduction portion 10 is placed in contact with the mouth 6 of the user 7 who proceeds to introduce the saliva sample 3, through the introduction opening 8, inside the containment volume 14.

The breath of the user 7, introduced into the internal volume 14 along with the saliva sample 3, exits the mouthpiece element 5 through the vent holes 11.

At the same time, flowing by gravity, the saliva sample 3 settles at the bottom of the container 2.

At this point, the user 7 places the mouthpiece element 5 in the withdrawal position.

In other words, the mouthpiece element 5 is pushed towards the bottom of the container 2 until it is completely introduced into the container itself. This means that, in the withdrawal position, the introduction portion 10 is arranged internally of the container 2, i.e., it is arranged flush with the introduction opening 8.

Next, the user 7 proceeds to screw the closure element 13 onto the thread 16 made in the proximity of the inlet opening 4.

The saliva sample 3, is introduced into the containment volume 14 through the inlet opening 4.

It has in practice been ascertained that the described invention achieves the intended objects.

In particular, the fact is emphasized that the particular expedient of providing for the synergistic combination of a container and of a mouthpiece element associated therewith in a sliding manner allows significantly reducing the risk of dispersion of the saliva sample.

In addition, the fact that the user’s mouth comes into contact with a portion of the mouthpiece element spaced apart from the container’s inlet opening allows greatly reducing the risk of contamination of the saliva sample by preventing the inlet opening from coming into contact with the user’s wetted parts.

Additionally, the device according to the present invention is configured to undergo sterilization processes.

Claims

8

1) Device (1) for the collection of a saliva sample, comprising: at least one container (2) for the collection of a saliva sample (3), in turn, comprising at least one inlet opening (4) made on one end of the same; at least one mouthpiece element (5) associated with said inlet opening (4) and intended, in use, to be placed in contact with the mouth (6) of a user (7); characterized by the fact that said mouthpiece element (5) is associated in a sliding manner with said container (2) and is movable, as a result of a force applied thereto by a user, between: a pickup position wherein said mouthpiece element (5) is arranged at least partly protruding from said container (2); and a withdrawal position wherein said mouthpiece element (5) is retracted and inserted into said container (2).

2) Device (1) according to claim 1, characterized by the fact that said mouthpiece element (5) comprises an introduction opening (8) of said saliva sample (3) and a drain opening (15) of said saliva sample (3), opposite said introduction opening (8) and coupled to said container (2).

3) Device (1) according to one or more of the preceding claims, characterized by the fact that said mouthpiece element (5) comprises an internal volume (14) which is in fluidic communication with said container (2) to allow the deposit of said saliva sample (3) in said container (2).

4) Device (1) according to one or more of the preceding claims, characterized by the fact that said mouthpiece element (5) has an elongated shape coaxial to said container (2), said mouthpiece element (5) being insertable in said container (2) substantially to size.

5) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one vent hole (11) made on said mouthpiece element (5) and adapted to allow air to escape during the introduction of said saliva sample (3) into said container (2).

6) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises a plurality of vent holes (11) made on said 9 mouthpiece element (5).

7) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least two stiffening fins (12) associated with said mouthpiece element (5) on portions of the latter opposite each other.

8) Device (1) according to one or more of the preceding claims, characterized by the fact that each of said stiffening fins (12) is placed on one of said vent holes (11), said stiffening fins (12) being provided with a through gap adapted to allow said air to escape during the introduction of said saliva sample (3) in said mouthpiece element (5).

9) Device (1) according to one or more of the preceding claims, characterized by the fact that said container (2) and said mouthpiece element (5) have a circular cross section.

10) Device (1) according to one or more of the preceding claims, characterized by the fact that the mutual distance between two of said stiffening fins (12) is substantially equal to the diameter of said container (2).

11) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one closure element (13) associable with said inlet opening (4) when said mouthpiece element (5) is in said withdrawal position.

12) Kit for the collection of a saliva sample comprising: at least one device (1) according to one or more of the preceding claims; at least one watertight resealable containment enclosure for the containment of said device (1).