RU2817126C1 - Releasing plug, container provided with plug, and associated release method - Google Patents

Abstract

FIELD: packing and storage.

SUBSTANCE: group of inventions relates to closing elements for containers for collection and storage of biological samples. Disclosed is a release plug for detachable connection with a container and configured to contain and selectively release a substance in the container. Stopper comprises: a first housing configured for direct connection to the container and comprising a connecting element suitable for providing removable attachment of the stopper in accordance with the opening of the container, with determination of the first installation configuration of the plug on the container, in which the plug closes the container. Plug also comprises a second housing connected to the first housing and made with possibility of movement relative to it and forming with the first housing at least one reservoir made with possibility to contain substance. Reservoir is isolated from the environment in at least the first closed configuration of the plug. Besides, the plug includes a closing element making at least a part of the tank wall and facing inside the container in the mounting configuration. Closing element is configured for selective opening, with determination of at least a second open configuration of the plug, by the action of the opening element, different from the plug and placed inside the container, to bring the reservoir into communication with the inside of the container. Also disclosed are versions of a kit for collecting and storing biological samples and a method of distributing substances in a releasable plug or in a kit.

EFFECT: higher reliability of closure and simplified design.

23 cl, 20 dwg

Description

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

The present invention relates to the field of closure elements for containers and, in particular, relates to a release plug. The present invention also relates to a container provided with the above-mentioned stopper, and also relates to a method for releasing a substance in the container.

BACKGROUND OF THE ART

Release stoppers are stoppers for containers suitable for storing substances in liquid or solid form, such as powder form, to be released under certain conditions, such as in the container to which the stopper is connected. Release plugs of the known type typically comprise a first operating configuration in which the substance is contained in a recess of a defined volume in the plug, and a second operating configuration in which the recess is open allowing the substance to be released. Typically, the release of the substance occurs in a container in a configuration in which the stopper is held by the container.

Stoppers of the known type may have a movable part, usually not one that is directly connected to the container itself, which exhibits rupture elements suitable for opening the membrane, which provides communication of the recess with the external environment.

Such plugs may accidentally open and release the substance. The opening may be made either with the stopper properly attached to the container or with the stopper free from the container. If a substance is harmful or has the potential to degrade, releasing the substance from its container may be hazardous or result in decomposition and significant wastage of the substance.

It should be noted that release plugs are often used not only by professional users, but also by private users and can be used by children.

In the field of collecting and/or storing and/or analyzing biological and microbiological samples, it is known to use tubes or, more generally, stoppered containers that contain biological samples, either in bulk or deposited through the sampling element.

It is also known that samples of biological material may be exposed to reagents that may be toxic or otherwise toxic.

In some types of analysis, the use of the reagent must be subordinated to use in a closed environment, i.e. with direct release inside the container, for reasons of chemical reaction, reagent degradation or user safety. However, some reagents are very expensive, and dispersing them - in addition to the risk of the above-mentioned problems - can also be associated with significant costs.

US Patent Application 2013/0092690 discloses a biological sample container equipped with a stopper suitable for containing the agent; The stopper has an ampoule and a perforation element that moves inside the stopper body. If the stopper is not handled properly and, in particular, if it is compressed along its longitudinal axis, the contents of the ampoule may be inadvertently released with consequent risk to the user and/or unavoidable dispersion of the agent contained in the ampoule.

It should be noted that this section is presented only to show some of the problems that the subject matter of the invention is intended to solve. Embodiments of the invention that may be described in this section should not be understood as part of the prior art simply because they have been described in this section.

It has also been noted that many release plugs are designed with a large number of individual parts, each equipped with O-rings, which influence the design and installation complexity of the plug itself. These O-rings in particular are made of silicone or rubber, which over time can lose their plastic deformability, with a consequent risk of leakage of the substance contained in the plug. In addition, such silicone or rubber material may be chemically incompatible with or otherwise react with certain substances or reagents present in the plug reservoir. The applicant in fact noted that stoppers containing substances were often stored for long periods of time, even longer than a year.

It is an object of the present invention to provide a release plug, a container for the plug, and a kit containing the container, the plug, and a biological sample collection element that will help overcome the disadvantages described above.

BRIEF DESCRIPTION OF THE INVENTION

The objects of the present invention are described below with reference to certain aspects aimed at describing the main characteristics of the invention. The aspects described herein may be combined with each other, in alternative and/or cumulative combinations, and/or with portions of the detailed description or related claims.

According to an aspect, there is provided a release plug (1) suitable for and/or designed to be removably connected to a container (30), configured to contain and selectively release a substance (S) in the container (30), wherein the plug (1) comprises:

- a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for providing removable fastening of the plug (1) in accordance with the opening of the container (30), defining a first installation configuration of the plug on a container in which, preferably, a stopper closes the container;

- a second body (1b) connected to and movable relative to the first body (1a), preferably movable axially and translationally along a predetermined axis (X) of the plug (1) and defined by the first body (1a) at least one reservoir (20) configured to contain a substance (S), wherein the reservoir (20) is isolated from the external environment in at least a first closed plug configuration,

- a closing element (15) constituting at least part of the wall of the container (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened and/or destroyed, defining at least a second open configuration of the plug, by the action of a perforation or opening element (40, 41, 42), different from the plug (1) and located inside the container (30), to bring the reservoir (20) into communication with the interior of the container (30).

In accordance with another non-limiting aspect, the stopper contains:

- a first closed configuration in which said reservoir (20) is isolated from the external environment, and

- a second open configuration in which said reservoir (20) communicates with the external environment,

wherein said membrane (15) or deformable partition is configured to be opened by means of a perforation or opening element (40, 41, 42) separate from said plug (1).

According to the present invention, "breakable" means a closure element (15), a portion of which may be destroyed such that its integrity can no longer be restored, and/or in which the first closed plug configuration can no longer be restored.

According to another non-limiting aspect, the closure element (15) comprises or is a membrane or deformable partition and is optionally provided with a weakening part.

According to another non-limiting aspect, the closure element (15) is located on the first body (1a) and/or is an integral part of the first body (1a) and/or, at least when the plug is in the first closed configuration, the closure element (15) is an integral part first building (1a).

According to another non-limiting aspect, the closure element (15) is a waterproof element configured and specifically designed to retain solids, in particular powders, liquids and/or gases.

According to another non-limiting aspect, at least a lower portion (28) of the second housing is movably positioned within the first housing to form a reservoir (20).

According to another non-limiting aspect, the plug includes a tapered portion or element (14), optionally located on the first body (1a), suitable for assisting in guiding and/or actuating at least a portion of the perforation element (40, 41, 42) towards the closure element (15), wherein the tapered portion (14) is placed in a position that is longitudinally outer with respect to the membrane (15) and/or faces towards the closing element (15).

According to another non-limiting aspect, the closure element (15) is configured to be selectively opened and/or ruptured, defining at least a second open configuration of the plug, through the action of a perforation or opening element (40, 41, 42) different from the plug (1) and different from the container and/or movably, optionally removably, placed inside the container.

According to another non-limiting aspect, the stopper (1) is a stopper for containers (30) of biological materials.

According to another non-limiting aspect, the stopper (1) is a stopper made of an opaque material.

According to another non-limiting aspect, the second body (1b) includes a cavity (6) configured to provide removable engagement of the end portion of the perforation or opening element (40, 41, 42), in particular for removably engaging the end portion of the perforation or opening element (40 , 41, 42) by contrast injection; wherein the plug is configured to provide contrast administration only when it is in an open configuration, in particular in substantial proximity or in accordance with a minimum axial extent configuration.

According to another non-limiting aspect, the reservoir (20) is supported between the first housing (1a), in particular at least the side wall of the first housing (1a), and the second housing (1b), in particular, the bottom (28) of the second housing (1b) more specifically, centrally limited by the lower part (28) of the first housing, and/or wherein the lower part (28) of the second housing (1b) is inserted at least partially inside the reservoir (20).

According to another non-limiting aspect, the tapered portion or element (14) is an integral part of the first body (1a) and is substantially funnel-shaped and is accessible from within the container (30) and/or when the plug is installed on said container.

According to another non-limiting aspect, the closure element is configured to withstand pressure applied to the reservoir (20) by axial compression of the second body (1b) relative to the first body (1a), optionally manually applied by the user; the closing element contains a weakening part suitable for destruction by the first mechanical contrast applied by the perforating or opening element (40, 41, 42).

According to another non-limiting aspect, in said open configuration it is possible to at least partially release the substance (S) into the container (30) and/or the stopper is configured to release the substance into the container (30) in the open configuration, in particular by storing, at connection with the container (30), isolating the entire volume defined by the container (30) - reservoir (20) assembly, isolated from the external environment and/or, in particular, by ensuring the release of the substance exclusively through the opening created by the destruction of the membrane (15).

According to another non-limiting aspect, the stopper includes a closure element retaining element configured to prevent the closure element (15) from being released and/or falling inside the container (30), the retaining element in particular being configured to retain the closure element (15) within the first housing (1a).

According to another non-limiting aspect, the retaining element includes a shoulder (15s) against which the closing element (15) rests or folds when in contrast with the perforation or opening element (40, 41, 42).

According to another non-limiting aspect, the arm (15s) is located in substantial compliance with the channel between the reservoir (20) and the closure element (15) itself.

According to another non-limiting aspect, in an open operating configuration, the closure element (15) is held by a shoulder (15s) and captured between the channel and a portion of the perforation or opening element (40, 41,42) located within the channel.

According to another non-limiting aspect, in said open operating configuration, the membrane (15) is held by a shoulder (15s) and captured between the channel and a portion of the perforation or opening element (40, 41, 42) located within the channel.

According to another non-limiting aspect, the closure element (15) is designed to be broken without releasing fragments or parts.

According to another non-limiting aspect, the membrane (15) is rigid or substantially rigid.

According to another non-limiting aspect,

- the second body (1b) is movable relative to the first body (1a) and determines, through its axial movement, at least the configuration of the maximum axial extent of the plug (1) along the longitudinal axis (X) and the configuration of the minimum axial extent of the plug (1) along the longitudinal axes (X);

- the first closed configuration contains the configuration of the maximum axial extent, and the second open configuration contains the configuration of the minimum axial extent;

- the second open configuration is carried out in accordance with a longitudinal extent, optionally substantially intermediate, between the longitudinal extent corresponding to the maximum extent configuration and the longitudinal extent corresponding to the minimum longitudinal extent configuration.

According to another non-limiting aspect, the first body (1a) includes an upper cavity (1c) laterally limited by a side wall, and a lower cavity, which are separated from each other by the presence of a closing element (15).

According to another non-limiting aspect, the plug (1) is suitable and/or designed for removable connection with the head of the container (30), and/or the first body (1a) is configured and intended for removable connection with the head of the container (30).

In accordance with another non-limiting aspect, the first body (1a) is configured to be rigidly connected and/or fixed to the head of the container (30) and/or is configured to abut the head of the container (30).

According to another non-limiting aspect, the second housing (1b) is configured to be installed in correspondence with the upper cavity (1c) of the said first housing (1a).

According to another non-limiting aspect, the second housing (1b) includes an intermediate section containing a sealing and linear movement limiting element (2), configured to determine the retention of the volume of the reservoir (20) and limit the stroke of the second housing (1b) relative to the first housing (1a) between the configuration maximum linear extent and configuration of the minimum linear extent of the plug.

According to another non-limiting aspect, the second body includes an upper part (25) and a lower part (28), relative to which the intermediate section is located in the longitudinal direction.

According to another non-limiting aspect, the diameter essentially defined by the radially outer section of the sealing element (2) is significantly larger than the diameter defined by the upper part (25) and/or the lower part (28) of the second body (1b).

According to another non-limiting aspect, the sealing element (2) includes, optionally at the first upper height, a shoulder (2s) configured to engage in use with a retaining portion (23) protruding from the inner surface of the side wall of the first body (1a), wherein the engagement between the holding part (23) and the arm (2s) is such that it is impossible to completely remove the second body (1b) from the first body (1a) when the latter has been previously inserted.

- According to another non-limiting aspect, the sealing element (2) includes a limiting wall (2g) specifically configured to define a seal and contain the volume of the reservoir (20), the limiting wall having a shape that also determines the limitation of movement of the second body (1b) relative to the first body (1a) in the minimum axial extent configuration.

According to another non-limiting aspect, the boundary wall (2g) is a radially outer portion extending on a circular profile defined along a section orthogonal to said longitudinal axis (X), and optionally includes a radially outer portion with a rounded profile.

According to another non-limiting aspect, the inner surface of the side wall of the first body (1a) is a cutout (17) located inside the upper cavity, wherein the limiting wall (2g) is a part configured to be inserted into said cutout (17).

According to another non-limiting aspect, the above portion is a shape following one of the cutouts.

According to another non-limiting aspect, the first body (1a) includes an annular recess, optionally located at a substantially intermediate height between the minimum and maximum height defined by the first body (1a), and/or located at a height substantially corresponding to the height at which the closure element is located (15); wherein the annular recess is configured to accelerate the cooling of the first housing (1a), in particular the part of the first housing (1a), according to which it is located relative to the end parts of the first housing (1a).

According to another non-limiting aspect, the first housing (1a) includes a pressure relief element (29) configured to allow a predetermined volume of air to be removed upon insertion of the second housing (1b) into the first housing (1a).

According to another non-limiting aspect, the pressure relief element (29) is configured to allow the removal of a predetermined volume of air when the second housing (1b) is inserted into the first housing (1a) in an inoperative installation configuration of the second housing (1b) into the first housing (1a), without influencing the sealing of the reservoir (20) itself when at least the maximum axial extension configuration is reached.

According to another non-limiting aspect, in the maximum axial extent configuration, the limiting wall (2g) is at a lower or higher internal height relative to the minimum or greater internal height accepted by the pressure relief element.

According to another non-limiting aspect, the pressure relief element (29) includes a cutout located in correspondence with the head portion of the inner surface of the side wall of the first body (1a) and/or located in correspondence with the head portion of the upper cavity (1c).

In another non-limiting aspect, the stopper is made of a plastic material that is resistant to acids and/or corrosives and/or is characterized in that it is made of a biocompatible plastic material that does not release substances upon contact with biological samples.

In accordance with another non-limiting aspect, the stopper is made of a biodegradable material, in particular a biodegradable plastic material.

According to another non-limiting aspect, the first body (1a) includes a gripping portion provided with elements configured to provide friction against the user's hand or fingers.

According to another non-limiting aspect, the first body (1a) includes a plurality of recesses or grooves located, in particular, along a direction suitably parallel to the direction substantially defined by the longitudinal axis (X).

In accordance with another non-limiting aspect, the second body (1b) has a recess (5), optionally bell-shaped, configured to connect with the bottom of the reservoir (20) and having a shape substantially corresponding to the shape defined by the bottom of the said reservoir (20).

According to another non-limiting aspect, said recess (5) opens onto a cavity (6) configured to removably engage the end portion of the perforation or opening element (40, 41, 42) by contrast insertion; said plug is configured to provide contrast administration only when it is in an open configuration, in particular in significant proximity or in accordance with a minimum axial extension configuration.

According to another non-limiting aspect, said cavity (5) opens onto cavity (6), wherein cavity (6) has a plurality of retaining ribs (7) of a perforation or opening element (40, 41, 42).

According to another non-limiting aspect, the cavity (6) is provided with ribs (7) extending radially towards the center of the cavity itself and/or substantially aligned along an axis substantially coinciding with the longitudinal axis of the plug (1), said ribs (7) configured to apply a frictional force when inserting and removing a portion of the perforation or opening element (40, 41, 42) relative to the cavity (6) and to facilitate the transfer of at least a portion of the substance (S) from the reservoir (20) to the outside.

According to another non-limiting aspect, the first body (1a) includes a side wall provided on one of its outer surfaces with a grip portion (1z), optionally characterized by corrugations and/or ribs configured to facilitate friction between the user's fingers, at least when attaching the plug described herein onto the container (30).

According to another non-limiting aspect, the gripping portion (1a) is located at the base or bottom of the side wall.

According to another non-limiting aspect, the first housing (1a) includes a cooling assisting portion configured to equalize the cooling of the first housing (1a) upon implementation; optionally, the cooling promoting part is located essentially in the intermediate region of the first housing (1a).

According to another non-limiting aspect, the cooling assisting portion includes an annular recess (1y) optionally extending around the entire perimeter of the side wall of the first housing (1a).

According to another non-limiting aspect, the substance (S) contains a solid material, optionally in granular and/or powder form, and/or a liquid material, optionally a gelatinous material and/or Newtonian and non-Newtonian fluids, and/or contains an airy material, optionally in gaseous and /or vapor form.

According to another non-limiting aspect, the release plug (1) is a disposable plug.

According to another non-limiting aspect, the second body (1b) includes at least one rib (3), preferably a plurality of ribs (3), wherein said rib (3) is configured to accommodate and/or limit displacement of the second body (1b) relative to the first body ( 1a), optionally to limit the possibility of tilting the axis of the second body (1b) relative to the axis of the first body (1a).

According to another non-limiting aspect, said at least one rib (3) is located in the upper part (25) of the second body (1b) and extends radially from the side wall of the upper part (25), resulting in - upon insertion of the second body (1b) into the first housing (1a) - in substantial contact with the inner surface of the side wall of the first housing (1a).

According to another non-limiting aspect, said side wall of the first body (1a) contributes to the formation of a cavity into which the second body (1b) is inserted.

According to another non-limiting aspect, at least one rib (3) is located on top of the intermediate section, which contains a compaction and linear movement limiting element (2).

According to another aspect, a kit is provided comprising:

- container (30) capable of being closed using a release plug (1),

- an element (40, 41, 42) for collecting and storing a biological sample, suitable for implementing a perforation or opening element for the release plug (1),

- a release plug (1) suitable for removable connection with the container (30) and configured to contain and release a substance (S) in the container (30), wherein the release plug (1) is a plug suitable for and/or intended for removable connection with the container (30) and configured to contain and selectively release the substance (S) in the container (30), wherein the plug (1) contains:

- a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for providing removable fastening of the plug (1) in accordance with the opening of the container (30), defining a first installation configuration of the plug on a container in which, preferably, a stopper closes the container;

- a second body (1b) connected to and movable relative to the first body (1a), preferably movable axially and translationally along a predetermined axis (X) of the plug (1) and defined by the first body (1a) at least one reservoir (20) configured to contain a substance (S), wherein the reservoir (20) is isolated from the external environment in at least a first closed plug configuration,

- a closing element (15) constituting at least part of the wall of the container (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened and/or destroyed, defining at least a second open configuration of the plug, by the action of a perforation or opening element (40, 41, 42), different from the plug (1) and located inside the container (30), to bring the reservoir (20) into communication with the interior of the container (30).

According to another non-limiting aspect, the perforation or opening element (40, 41, 42) includes a rod (40), and the set has a dimensional relationship, in particular, the difference between the longitudinal extent of the container (30) and the longitudinal extent of the rod (40), in particular , the difference in the longitudinal extent along the axis (X) of the axial extent of the container (30) along the specified axis (X) relative to the axial extent of the rod (40) along the same axis; the longitudinal extent of the rod (40) relative to the longitudinal extent of the container (30) is such that when the rod (40) is inserted into the container (30), it can enter the closure element (15) so that it can open or collapse.

According to another non-limiting aspect, the rod (40) has such a longitudinal extent that, when positioned within the container (30), it protrudes from a shape defined by the container itself.

In accordance with another aspect, a container (30) for storing a biological sample is provided, comprising a housing configured to be opened in accordance with at least one first part (33) and provided with a side wall and a bottom wall (32) connected with a side wall, wherein the container (30) is configured to receive a device for collecting microbiological samples provided with a swab (42) and a rod, and movably connected to a plug (1) according to one or more of the previous aspects, so as to form a perforation or opening element (40, 41, 42).

In accordance with another non-limiting aspect, the container includes a member (40, 41, 42) for collecting and/or storing biological samples, equipped with a rod (40) and a swab (42), optionally a flock swab, to which the rod (40) is rigidly attached.

According to another non-limiting aspect, the container has a longitudinal extension such that the end portion (41) of the rod opposite the portion whereby the tampon (42) is located after removably attaching the plug (1) to the container (30) defines the perforation of the closure element (15) and partially inserting the end portion (41) of the rod (40) inside the first body (1a).

According to another non-limiting aspect, the container includes a substantially V-shaped bottom portion (32), optionally connected continuously to a side wall of the container (30), wherein in correspondence with the bottom portion (32), the side wall gradually tapers toward the center of the container body (30). ; the lower part (32) is configured to center the rod (40) and/or the swab (42) for collecting biological samples along the longitudinal axis (X) of the container (30).

According to another non-limiting aspect, the lower part (32) cooperates with the guide part (13s, 13v) of the specified plug (1) and, in particular, with the second wall (13s) to help center the rod (40) along the specified longitudinal axis (X).

According to another non-limiting aspect, the container (30) is a container made of a plastic material, optionally made entirely of one plastic material, optionally the plastic material is biocompatible and/or does not release substances in contact with the biological sample.

In accordance with another aspect, there is provided a method of distributing substances within a release plug in accordance with one or more of the preceding aspects and/or a set in accordance with one or more of the preceding aspects, comprising the following steps:

- the step of positioning the substance inside the first body (1a) of the plug (1), so that the substance is deposited in the reservoir (20) delimited by the closing element (15);

- the subsequent step of positioning the second housing (1b) at least partially inside the first housing (1a), so that by positioning the containment of the reservoir (20) and the substance is ensured within a closed volume separated from the external environment.

According to another non-limiting aspect, at least the step of positioning the substance within the first body (1a) of the stopper and/or the subsequent step of positioning the second body (1b) at least partially inside the first body (1a) are steps performed automatically by the stopper assembly machine.

According to another non-limiting aspect, the method further includes the step of connecting the stopper (1) to the container (30), and as a result of the connection, the container (30) is provided with a closed and limited volume, in accordance with its opening, due to the presence of the stopper (1).

According to another non-limiting aspect, the method further includes the step of applying pressure to the second body (1b) of the plug (1), after or in combination with which an axial compression of the plug (1) is determined, causing the second body (1b) to be gradually inserted into the first body (1a), gradually introducing the second housing (1b) inside the first housing (1a), determining a corresponding gradual reduction in the volume of the reservoir (20) and gradually distributing the substance inside the container (30).

According to another aspect, there is provided a method for distributing substances within a container (30), in particular a container for samples of biological and/or microbiological material, by means of a release plug in accordance with one or more of the preceding aspects, said method comprising:

- the step of connecting the plug (1) to the container (30), and as a result of the connection, the container (30) is provided with a closed and limited volume, in accordance with its opening, due to the presence of the plug (1),

- the step of positioning the perforation or opening element (40, 41, 42) inside the container (30),

- whereby, due to the connection of the plug (1) with the container (30) and/or with the perforation or opening element (40, 41, 42), a perforation of the closing element (15) is formed to bring the inside of the container (30) into direct communication with the reservoir ( 20),

- the stage of applying pressure to the second body (1b) of the plug (1), after or in combination with which the axial compression of the plug (1) is determined, causing the gradual introduction of the second body (1b) inside the first body (1a), the gradual introduction of the second body (1b ) inside the first housing (1a), determining the corresponding gradual reduction in the volume of the container (20) and gradually distributing the substance inside the container (30).

According to another non-limiting aspect, perforation or opening or rupture of the closure element (15) defines at least partial detachment of the closure element (15) from the first body (1a), of which the closure element (15) is an integral part at least until the perforation or opening or rupture.

According to another non-limiting aspect, by connecting the plug (1) to the perforation or opening element (40, 41, 42), a perforation or hole or rupture of the closure element (15), optionally a perforation or hole or rupture of the membrane (15) or deformable baffles of the plug (1), thus bringing the inside of the container (30) into direct communication with the reservoir (20).

In accordance with another non-limiting aspect, the perforation, opening or rupture of the closure element (15) occurs before the plug (1) engages on the container (30) and/or before the plug (1) directly engages on the container (30).

According to another non-limiting aspect, the perforation of the closure element (15), in particular the membrane (15) or deformable partition, occurs before the plug (1) is gradually screwed onto the container (30).

According to another non-limiting aspect, by connecting the stopper (1) to the container (30), a perforation of the membrane or deformable partition is created, caused by the end portion of the perforation or opening element (40, 41, 42) only when located inside the container (30).

According to another non-limiting aspect, the connection of the stopper (1) on the container (30) includes a removable connection of the first body (1a) of the stopper (1) on the container (30), in particular, a removable connection of the first body (1a) with the head of the container (30 ).

According to another non-limiting aspect, when the plug (1) is connected to the container (30), the first body (1a) is rigidly connected and/or attached to the head of the container (30) and/or abuts the head of the container (30).

According to another non-limiting aspect, the removable connection of the plug (1) on the container (30) involves gradually screwing the plug (1), in particular the first body (1a) of the plug (1) onto the container (30).

According to another non-limiting aspect, perforation, opening or rupture of the closure element (15) occurs after the plug (1) engages with the container (30) and/or after the plug (1) directly engages with the container (30), optionally after axial compression of the assembly, formed by the plug (1) and the container (30), and/or after at least partially screwing the plug (1) onto the container (30).

According to another non-limiting aspect, the perforation of the closure element (15), in particular the membrane (15) or deformable partition, occurs by gradually screwing the plug (1) onto the container (30).

According to another non-limiting aspect, the completion of the gradual screwing of the plug (1) onto the container (30) determines the completion of the step of connecting the plug (1) to the container (30), and the container (30) is provided with a closed and limited volume in accordance with one of its openings, due to the presence of a plug (1).

According to another non-limiting aspect, after the closure element (15) is perforated, the end portion (41) of the perforation or opening element (40, 41, 42) is inserted at least partially inside the first body (1a) and determines the retention of the closure element (15) on and/or or inside the first housing (1a), in particular, determines the engagement of the closing element (15) between itself, the side surface of the substance displacement channel (S) and the shoulder (15s), located in substantial correspondence with the specified displacement channel.

In accordance with another non-limiting aspect, the gradual axial compression of the plug (1) ends in accordance with the configuration of the minimum axial extension of the plug (1), wherein the second body (1b) is designed for the maximum part inserted into the first body (1a), wherein optionally the second the housing (1b) is completely inserted into the first housing (1a); in said configuration of minimum axial extent, the reservoir (20) is for a maximum portion, optionally substantially completely, emptied of substance (S).

According to another non-limiting aspect, according to the minimum axial extension configuration, the second body (1b) is in a block position relative to the first body (1a) such that axial extensions of the plug (1) are functionally impossible; the position of the block is determined by the engagement of the locking ring (28p) of the second body (1b) in accordance with the annular recess present in correspondence with the inner surface of the side wall of the first body (1a).

According to another non-limiting aspect, the progressive axial compression of the plug (1) determines the sliding of the flexible skirt (2g) of the second body (1b) on the inner surface of the side wall of the first body (1a) in a direction substantially determined by the longitudinal axis (X) of the plug, beyond by which a seal of liquid and/or gas and/or powdery material is determined in such a way as to ensure leakage of at least part of the substance (S) only from the open channel due to the rupture of the closing element (15).

According to another non-limiting aspect, under axial compression, the sliding of the skirt (2g) occurs through its elastic deformation, after which the radially outer part of the said skirt (2g) exerts on the inner surface of the side wall of the first body (1a) a force oriented essentially in an orthogonal direction relative to the direction advancement of the second housing (1b) inside the first housing (1a), caused by the axial compression itself.

According to another non-limiting aspect, the method includes permanently engaging an end portion (41) of a perforation or opening element (40, 41, 42) in accordance with a cavity (6) formed in accordance with a second body (1b), said permanently engaging occurs as a result of significant axial compression of the plug (1) and, optionally, occurs at or near the minimum axial extent configuration of the plug (1).

In accordance with another aspect, there is provided the use of a stopper in accordance with one or more of the preceding aspects for use on containers configured and/or specifically intended to contain a biological and/or microbiological sample, and/or the use of a stopper in accordance with one or more of the preceding aspects for the content of substances suitable for interaction and/or allowing the analysis of samples of biological and/or microbiological materials.

According to another aspect, there is provided a machine for assembling a plug 1 in accordance with one or more of the present aspects, the machine comprising handling elements configured to perform the operation of positioning and/or pouring a substance (S) into the first body (1a) of the plug (1 ) such that the substance (S) is deposited in the reservoir (20) formed by the closing element (15); wherein the manipulating elements are also configured to perform a subsequent operation of positioning the second housing (1b) at least partially in the first housing (1a) in such a way that by means of positioning the retention of the reservoir (20) and the substance is determined in a closed volume, separate from the external environment, and the manipulating elements are configured to carry out the operation of positioning the second body (1b) automatically, after positioning and/or pouring the substance (S) into the first body (1a).

According to another aspect, there is provided a release plug (1) suitable for and/or designed to be removably connected to a container (30), configured to contain and selectively release a substance (S) in the container (30), wherein the plug (1) comprises:

- a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for providing removable fastening of the plug (1) in accordance with the opening of the container (30), defining a first installation configuration of the plug on a container in which, preferably, a stopper closes the container;

- a closing element (15) constituting at least part of the wall of the container (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened and/or destroyed, defining at least a second open configuration of the plug, through the action of a perforation or opening element (40, 41, 42), other than the plug (1) and located inside the container (30), to bring the reservoir (20) into communication with the interior of the container (30), wherein

- the plug contains a closure indicator (10k) suitable for engagement on the container (30).

In accordance with another non-limiting aspect, the closure indicator (10k) is configured and/or designed to provide contrast on the container (30) so as to assist in sealing the interior cavity of the container (30).

In accordance with another non-limiting aspect, the closure indicator (10k) is configured to enable the user to identify a configuration in which the plug (1) is correctly installed on the container (30) so as to complete sealing and/or sealing of the internal cavity.

In accordance with another non-limiting aspect, the closure indicator (10k) is suitable for engaging or corresponding to a counter-closure indicator (30k) disposed on the container (30), defining the closed configuration of the container (30).

In accordance with another non-limiting aspect, the closure indicator (10k) is suitable for engaging or corresponding to a counter-closure indicator (30k) located on the container (30), defining the configuration of complete closure of the container (30) and/or sealing and/or complete restriction of the internal container volume (30).

According to another non-limiting aspect, the closure indicator (10k) is a member protruding from the wall of the plug (1), optionally a ring protruding from the wall of the plug (1), and the counter-closure indicator (30k) includes a recess, optionally an annular recess, located on the container (30 ).

According to another non-limiting aspect, the closure indicator (10k) is a recess located on the wall of the plug (1), optionally an annular recess located on the wall of the plug (1), and the counter-closure indicator (30k) includes an element protruding from the wall of the container (30), optional ring protruding from the side of the container (30).

According to another aspect, a kit is provided comprising:

- a release plug (1) in accordance with one or more of the preceding aspects, and

- a container (30) provided with an internal cavity that is closed by means of a release plug (1) to form a predetermined closed volume, wherein the container (30) contains a closure counter-indicator (30k) located on one of its walls and suitable for engagement with the indicator ( 10k) closure located on the release plug (1), at least in a closed configuration of use, wherein the engagement of the closure indicator (10k) on the plug (1) determines the closed configuration of the container (30), optionally complete closure of the container (30) and/ or sealing and/or completely limiting the internal volume of the container (30).

In another non-limiting aspect, the container (30) includes threads (34) whereby the plug (1) removably engages itself and the closure indicator (30k) is positioned in accordance with the threads (34) of the container (30) and /or near it.

According to another non-limiting aspect, the thread (34) is formed in accordance with the neck of the container (30) and/or substantially in part of the end thereof.

According to another non-limiting aspect, the container (30) is a threaded outer container and/or provided with an external thread (34) formed on the outer surface of a side surface of the container (30); optionally the thread (34) extends radially to the outside of the container itself.

According to another non-limiting aspect, the container (30) is an internally threaded container and/or is provided with an internal thread (34) formed on the inner surface of a side surface of the container (30); optionally the thread (34) extends radially towards the interior of the container itself.

According to another non-limiting aspect, the plug (1) includes a counter thread (10) suitable for engagement with the threads (34) of the container (30), and a closure indicator (10k) of the plug (1) is positioned in accordance with the counter thread (10) and/or or next to it.

According to another non-limiting aspect, the plug (1) is an internally threaded plug, and optionally a counter thread (10) is positioned in correspondence with the inner surface of the outer side wall of the plug (1).

According to another non-limiting aspect, the stopper (1) includes a cavity suitable for removably housing at least a portion of the container (30), in particular the end portion of the container (30), wherein the cavity (11) is optionally an annular cavity.

According to another non-limiting aspect, the inner surface of the outer side wall of the plug (1) faces the cavity (11).

According to another non-limiting aspect, a counter thread (10) is positioned in correspondence with the cavity (11).

According to another non-limiting aspect, the guide portion (13s, 13v) includes an annular wall (13v) internally delimiting the cavity (11), in particular internally delimiting the annular cavity (11).

According to another non-limiting aspect, a counter thread (10) is located on the annular wall (13v).

According to another non-limiting aspect, in a closed configuration in which the closure indicator element engages the closure counter-indicator (30k), at least local elastic deformation of the container and/or plug and/or a portion of the wall of the plug and/or container occurs, whereby a closing indicator element and/or a closing counter-indicator (30k) is present, and/or at least local elastic deformation of the closing indicator and/or a closing counter-indicator (30k) occurs.

According to another aspect, there is provided a method for opening a release plug (1), optionally a release plug (1) in accordance with one or more of the preceding aspects, comprising:

- the step of introducing a perforation or opening element (40, 41, 42) into the container (30) through an opening of the container itself, wherein said opening is suitable for removably placing a release plug (1) in such a way that this perforating or opening element (40, 41 , 42) is removable from the container (30) and/or is at least partially movable inside the container (30),

- the step of positioning the release plug (1) essentially in accordance with the opening of the container (30),

and

- as a result of the positioning step, the closing element (15), suitable for allowing the opening of the reservoir (20) of the release plug (1), is opened and/or torn and/or broken by said perforation or opening element (40, 41, 42), allowing release by at least part of a predetermined amount of substance (S) contained within the reservoir (S) within the container (30) by applying a force between the release plug (1) and the container (30).

According to another aspect, a method is provided for opening a release plug (1) suitable and/or designed for removable connection with a container (30), configured to contain and selectively release a substance (S) in the container (30), the plug (1) comprising:

- a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for providing removable fastening of the plug (1) in accordance with the opening of the container (30), defining a first installation configuration of the plug on a container in which, preferably, a stopper closes the container (30);

- a closing element (15) constituting at least part of the wall of the container (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened and/or destroyed, defining at least a second open configuration of the plug, through the action of a perforation or opening element (40, 41, 42), other than the plug (1) and located inside the container (30), to bring the reservoir (20) into communication with the interior of the container (30), wherein

- the plug (1) optionally contains a closure indicator (10k) suitable for engaging or in accordance with a closure indicator (30k) located on the container (30) defining the closure configuration of the container (30),

wherein the method includes the following steps:

- the step of introducing a perforation or opening element (40, 41, 42) into the container (30) through an opening of the container itself, wherein said opening is suitable for removably placing a release plug (1) in such a way that this perforating or opening element (40, 41 , 42) is removable from the container (30) and/or is at least partially movable inside the container (30),

- the step of positioning the release plug (1) essentially in accordance with the opening of the container (30),

and

- as a result of the positioning step, the closing element (15) is opened and/or torn and/or broken by said perforation or opening element (40, 41, 42), allowing the release of at least part of a predetermined amount of substance (S) contained within the reservoir (20) inside the container (30), by applying a force between the release plug (1) and the container (30).

According to another non-limiting aspect, the positioning step includes positioning the end portion of the perforation or opening element (40, 41, 42) in substantial contact with the closing element (15) of the release plug (1), and applying a force between the release plug (1) and container (30) designed to provide opening and/or rupture and/or destruction of the closing element (15), including compression, in particular axial compression, between the release plug (1) and the container (30) such that the end part of the perforated or opening element determines the destruction of at least part of the closing element (15) and the subsequent reduction in the overall longitudinal extent of the assembly formed by the release plug (1) and the container (30), and/or determines the introduction of the end part of the perforation or opening element (40, 41, 42 ) plug (1) inside the tank (20).

According to another non-limiting aspect, the positioning step includes direct connection between the release plug (1) and the container (30) with which their surfaces come into direct and mutual contact; optionally a positioning step including a direct connection between the release plug (1) and the container (30), with which the mutual threads (10, 34) come into direct contact and engage with each other, and after the positioning step the closure element (15) is opened and/or is torn and/or broken by the perforation or opening element (40, 41, 42) as a result of and due to the step of screwing the release plug (1) onto the container (30), in which at least part of the plug (1) rotates relative to the container ( thirty).

According to another non-limiting aspect, the perforation or opening element (40, 41, 42) includes a rod (40) with a substantially axial extension; said rod (40) is designed to break at least in a predetermined position, in particular in a weakening part defined by a notch or notch.

According to another non-limiting aspect, the method includes the step of breaking the rod (40), and the step of breaking the rod is carried out after the step of inserting the perforation or opening element (40, 41, 42) into the container (30).

In accordance with another aspect, a member (40, 41, 42) for collecting and storing biological and/or microbiological samples is described, comprising a rod (40) with a substantially axial extension and a swab (42), optionally a flock swab, which is made in accordance with the end of the rod, or to which the rod (40) is firmly and/or rigidly attached; element (40, 41, 42) for collecting and storing biological and/or microbiological samples is characterized in that the rod (40) is at least partially hollow and is configured to allow the passage of a substance, in particular a fluid, between the first part of the element for storage of biological and/or microbiological samples (40, 41, 42) and the second part essentially in accordance with or proximity to the tampon (42) by passing a substance, in particular a fluid, between the internal cavity (41i) of the rod (40) and the outer surface the rod itself (40).

According to another non-limiting aspect, the element (40, 41, 42) for collecting and storing biological and/or microbiological samples comprises a first transmission channel (40k), optionally a first set of transmission channels (40k) and at least a second transmission channel (40f), optionally a second set of transmit channels (40f); wherein the first transmission channel (40k) and the second transmission channel (40f), optionally the first set of transmission channels (40k) and the second set of transmission channels (40f), are in communication with the cavity (41i).

According to another non-limiting aspect, the first part is an end part (41) of the rod (40) opposite the part of the rod (40) in accordance with which the tampon (42) is located.

According to another non-limiting aspect, the cavity (41i) extends at least between:

- a first height or part of the rod (40) in accordance with which the first transmission channel (40k) is located, optionally between the first height or part of the rod (40) where the first set of transmission channels (40k) is located, and

- a second height or part of the rod (40), in accordance with which a second transmission channel (40f) is present, optionally a second height or part of the rod (40), in accordance with which a second set of transmission channels (40f) is present.

According to another non-limiting aspect, the element (40, 41, 42) for collecting and storing biological and/or microbiological samples is configured and designed to allow at least partial leakage of a substance (S), in particular a fluid, from the release plug reservoir , optionally from the release plug reservoir in accordance with one or more aspects described herein.

According to another non-limiting aspect, said release plug is a plug (1) comprising:

- a first body (1a) configured to be directly connected to a container (30) for biological and/or microbiological samples and containing a connecting element (10) suitable for providing removable fastening of the stopper (1) in accordance with the opening of the container (30), determining a first installation configuration of the plug on the container, in which, preferably, the plug closes the container (30);

- a closing element, optionally a membrane (15) or a deformable partition, constituting at least part of the wall of the reservoir (20) and facing the inside of the container (30) in an installation configuration, and the closing element, optionally a membrane (15) or a deformable partition, is configured to selective opening and/or destruction, with determination of at least a second open configuration of the plug, through the action of the element (40, 41, 42) for collecting and storing biological and/or microbiological samples, optionally when placed inside the container, to bring the reservoir (20) into communication with the inside of the container.

In accordance with another non-limiting aspect, the first transfer channel (40k), optionally the first set of transfer channels (40k), is located at such a height that when the rod (40) is inserted into the release plug reservoir, it is located inside the said reservoir.

In accordance with another non-limiting aspect, the first transmission channel (40k) coincides with the cavity (41i) and/or the first transmission channel (40k) is axial with respect to the cavity (41) and/or the cavity (41i) extends to the end portion of the rod hole ( 40) on the head of the rod.

In accordance with another non-limiting aspect, a first set of transmission channels (40k) is located radially on the rod (40) and/or a second set of transmission channels is located radially on the rod (40).

According to another non-limiting aspect, the second transfer channel (40f) or the second set of transfer channels (40f) is located at the height at which the tampon (42) is present and/or suspended and/or surrounded by the tampon (42).

According to another non-limiting aspect, a second transfer channel (40f) or a second set of transfer channels (40f) is positioned in correspondence with a portion of the shaft (40) other than the portion of the shaft (40) at which the tampon (42) is present.

In accordance with another aspect, a kit is provided comprising a release plug (1) in accordance with one or more aspects described herein, and an element (40, 41, 42) for collecting and storing biological and/or microbiological samples in accordance with one or more aspects described herein. here aspects.

In accordance with another non-limiting aspect, the kit also includes a container (30) capable of being closed using a release plug (1).

According to another non-limiting aspect, the container (30) is a container in accordance with one or more aspects described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of the present invention will be described below in preferred and non-limiting embodiments of the invention, described with reference to the accompanying drawings, in which:

- fig. 1 illustrates a side view of a stopper according to the present invention connected to a container for housing and/or storing a biological sample;

- fig. 2 illustrates a side view of a first body of a plug object according to the present invention;

- fig. 3 illustrates a side view of a second body of a plug object according to the present invention;

- fig. 4 illustrates a sectional view of the second plug body, the section being taken along lines AA of FIG. 3;

- fig. 4a illustrates a first embodiment of a radially outer part of the second housing;

- fig. 4b illustrates a second embodiment of a radially outer part of the second housing;

- fig. 5 illustrates a sectional view of the first plug body, the section being taken along lines AA of FIG. 2;

- fig. 5a illustrates a detail of the part from FIG. 5, observed along a section orthogonal to the section of FIG. 5;

- fig. 6 illustrates a sectional view of the part from FIG. 5;

- fig. 7 illustrates an additional sectional detail from FIG. 5;

- fig. 8 illustrates a sectional view along lines A-A of FIG. 1, in which a plug object according to the present invention can be observed in a configuration of maximum axial extension and in a closed configuration in which it stores substance S;

- fig. 9 illustrates a detailed cross-sectional view of the first body and the second body of the plug when it is in its maximum axial extension configuration;

- fig. 10 illustrates a section of a container for containing and/or storing a biological sample, equipped with an element for collecting and storing biological material and equipped with a rod and a swab;

- fig. 11 illustrates an intermediate operating configuration in which the stem of the biological material collection and storage element is proximate to a membrane that is part of the first plug body;

- fig. 12 illustrates an intermediate operating configuration in which the rod has broken a membrane that is partially tilted with respect to the longitudinal axis of the plug, and in which this configuration temporarily follows the configuration shown in FIG. eleven;

- fig. 13 illustrates a configuration following that of FIG. 12, in which the membrane, now broken, is sandwiched between the rod of the biological material collection and storage element and the shoulder formed on the first body;

- fig. 14 illustrates a cross-sectional view of a container-stopper assembly showing a rod located within the container and partially inserted into the first stopper body;

- fig. 15 illustrates a cross-sectional view of a container-stopper assembly showing a substance applied to the bottom of the container after the at least one membrane has ruptured;

- fig. 16 illustrates a detailed sectional view corresponding to FIG. 15, in which the first body 1a and the second body 1b are mutually arranged in a configuration of minimum axial extent;

- fig. 17 illustrates a sectional view of a release plug in connection with a container;

- fig. 18, fig. 19 and fig. 20 illustrates an embodiment of a rod object according to the present invention.

IMPLEMENTATION OF THE INVENTION

The present invention relates to a release plug 1 suitable, in particular for connection to a container 30, for example and not limited to a tube, for containing and/or storing a biological sample that can be submitted at a later time for one or more analyses. In particular, the connection between the stopper according to the present invention and the container 30 occurs in accordance with the opening of the container itself, which, in the embodiment described here and shown in the accompanying drawings, is also the only opening of the container itself. This opening is located in the head portion of the container 30, and the release plug 1 is configured and/or designed to be removably connected to the head portion.

The release plug object 1 according to the present invention is called a "release plug" because it is configured to contain a substance S inside one of its reservoirs and to release a substance S from its reservoir into a container 30 in a predetermined manner. The substance S contained in the reservoir is a substance , which may be a fluid, in particular liquid, or in solid form, for example granular and/or powder form.

The substance S described above may be or contain, in addition to solid and liquid, also a gelatinous substance and/or may contain Newtonian and/or non-Newtonian liquids and/or may be or contain gases or vapors. Therefore, the plug object of the present invention is capable of containing any form of substance without limitation. In particular, the plug object according to the present invention may also be suitable and/or designed to contain a substance S that emits ionizing radiation.

In fig. 1 shows a plug with a first and second body, respectively designated by position numbers 1a and 1b, movable relative to each other in accordance with the main sliding direction, defined in particular by the X-axis of the plug 1 itself. The X-axis represents the longitudinal axis of the plug, and for For convenience of description, the longitudinal axis of the container 30 will also be considered. In more detail, the first body 1a is configured to engage directly with the container 30 centered about the X-axis. The connection that is implemented between the first body 1a and the container 30 is such that the first body 1a is configured to the possibility of rigid connection and/or fastening to the head part of the container 30, that is, abutment in the head part of the container 30.

In the present description, reference will sometimes be made to the heights adopted by parts and components; where the heights are indicated as minimum and maximum, these heights will be for the parts shown in the accompanying drawings, in particular the container 30 is positioned vertically with the stopper 1 located on the head. Heights may also be defined as internal and external to various parts of the stopper or container, in particular its ends.

In the embodiment of the invention described herein, the second body 1b slides relative to the first by linear movement along said X-axis, but this configuration should not be understood as limiting, since the reciprocating movement, in particular, the reciprocating sliding between the first body 1a and the second body 1b, may occur through a combined movement in which the resulting movement along the X-axis is achieved by screwing or rotating the second body 1b on a counter-thread formed on the first body 1a.

Plug 1 has a first operative configuration in which it is suitable for containing a substance within a limited volume reservoir 20 and in which the reservoir 20 is closed to the outside environment, and a second operative configuration in which it is suitable for releasing a substance contained within the reservoir 20 during external environment. The reservoir 20 is formed by the connection between the first housing 1a and the second housing 1b, in particular, generally limited laterally by the inner surface of the side wall of the first housing 1a, at the bottom by the wall of the first housing 1a and the deformable partition, and at the top by the part of the housing 1b that comes into contact - in particular, seamlessly with the inner surface of the side wall of the first housing 1a.

As will be better described in the following portion of the description, the release of substance S from the reservoir 20 into the external environment occurs, in a preferred, although not limiting, operating configuration, with release into the container 30. In a preferred embodiment of the invention, the relative mobility existing between the first housing 1a and the second plug body 1b is such that a plurality of relative positions can be adopted between the maximum axial extent configuration 1 and the minimum axial extent configuration of the plug 1. Preferably, the maximum axial extent position is part of the first operating configuration, while the second operating configuration comprises a minimum axial extension configuration axial length. In any case, both the first operating configuration and the second operating configuration comprise intermediate axial extent configurations between the maximum axial extent configuration and the minimum axial extent configuration. The maximum axial extent configuration is also the rest configuration for plug 1. This specifies that the switching between the first operating configuration and the second operating configuration occurs in an intermediate axial extent configuration between the minimum and maximum. In other words, the second open configuration takes place according to a longitudinal extent preferably substantially intermediate between the longitudinal extent corresponding to the maximum extent configuration and the longitudinal extent corresponding to the minimum longitudinal extent configuration. This aspect provides particular safety of use since it prevents, for example, that minimal forces on the plug body that cause axial compression may inadvertently determine immediate switching between the first and second operating configurations.

The transition from the first operating configuration to the second operating configuration is achieved by breaking at least the closing element, which is represented in the embodiment described here and, in particular, in the accompanying drawings, is a membrane 15 or a deformable partition, selectively opened and/or broken and/ or perforated, which in the first operating configuration is thus intact and extends seamlessly to define a wall or part of a wall that contributes, together with other walls, to limiting the volume of the reservoir 20; in the second operating configuration, the membrane 15 or deformable partition, for at least a portion thereof, no longer exhibits continuity with the walls with which it arrives and therefore allows the release of substance within the container 30.

The membrane 15 or deformable partition is mounted on the first body 1a and is part of the first body 1a itself; at least when in a closed configuration, this membrane 15, or deformable partition, is an integral part of the first housing 1a.

The membrane 15, or deformable partition, is impermeable to liquids and/or gases and therefore constitutes a barrier.

Therefore, the plug 1, which is the object of the present invention, is a plug in which the destruction of the membrane 15 or deformable partition is provided by an external element made removable inside the container 30, which represents for the purposes of the present invention the perforation or opening element of the plug 1, and more specifically, perforation or opening of the membrane 15 or deformable partition, which is all marked with reference numbers 40, 41, 42; this perforation or opening element is, in particular, an element for collecting and storing biological and/or microbiological samples, and actually determines the destruction of the membrane 15 or deformable partition, being the final part of the above-mentioned element. Therefore, it is not and cannot be caused by a component of the stopper itself, but, on the contrary, by an element other than the container and/or movably, in particular removably, placed inside the container.

The membrane 15 or deformable partition described herein cannot be replaced in a closed configuration, and once opened or otherwise destroyed, it can no longer be reconfigured in a configuration that allows a new closure of the reservoir 20; therefore, this makes the stopper 1 according to the present invention a disposable stopper. Once the membrane 15 or deformable partition has been opened, ruptured, or otherwise destroyed in the manner described, the closed configuration of the reservoir 20 can no longer be restored.

As shown in FIG. 11 and fig. 5, it can be seen that the first body 1a has an upper cavity 1c and a lower cavity 14, separated from each other by the presence of a membrane 15 or deformable partition located in accordance with a short channel that seamlessly connects the reservoir 20 to the lower cavity 14; inside the upper cavity, thanks to the connection with the second body 1b, a reservoir 20 is formed, suitable for containing the above-mentioned substance. The upper cavity 1c is divided into two parts, designated by position numbers 1r and 20'; the first part (upper) of the upper cavity faces directly to the upper opening of the first body 1a; the second part (lower) of the upper cavity 1c is located in a substantially central area of the first body and is in communication with the first part, but according to the present invention it is ideally separated from it in accordance with a cutout, which will be better described in the next part of the description.

The top portion is a substantially cylindrical side surface having a first diameter; the lower part is a side surface, substantially cylindrical or slightly flared, having a diameter in any case smaller than that of the upper part.

The first housing 1a externally comprises a side wall provided with a gripping part 1z, preferably characterized by corrugation, with ribs located essentially along the direction given by the X-axis (as shown in the accompanying drawings) or transverse elements (solution not shown) or more generally elements , suitable for promoting friction between the user's fingers at least when attaching the plug described herein to the container 30. The gripping portion 1z is also useful for facilitating the gripping of a manipulator or spindle, for example, by an automatic handling machine. In the configuration shown in the accompanying drawings, this gripping portion 1z is located in the base section of the side wall. Otherwise, the upper portion of the outer surface of the side wall of the first body 1a is preferably, but not limited to, smooth.

Between the lower section and the upper part of the above-mentioned outer strip, the applicant has implemented an annular recess 1y, preferably defined on a connecting curve, the cavity of which has no corner points and/or extends along the entire perimeter of the side surface of the side wall of the first body 1a; this annular recess 1y is preferably intended to standardize the cooling of the first body 1a during implementation. The applicant noted that the part of the side wall essentially corresponding to the annular recess 1y has a large thickness, and therefore it is the part that, when cooled after fusing or molding the plastic material with which the first body is made, will cool later, resulting in will be even more temperature sensitive compared to, for example, the top and bottom ends of the same housing. The applicant has discovered that this difference in cooling time can lead - especially in the case of areas of high thickness and/or density of the material - to the formation of cracks, even invisible, which can weaken the structure of the product and/or lead to the leakage of part of the substance contained in the reservoir 20 Thus, such a recess 1y has the task of reducing the amount and/or density of material in the longitudinally central area of the first body 1a, which helps to guarantee the final strength of the body itself. The annular recess 1y is preferably present, but its presence is not necessarily to be understood as strictly required.

The aforementioned plastic material with which the first body is formed is a plastic material resistant to acids and/or corrosive substances, in particular such as may be contained within the reservoir 20, and is preferably, without limitation, a biocompatible material, i.e. of such a nature as not to release substances upon contact with biological samples.

Viewing the first body 1a in cross-section, it can be seen how the side wall, in substantial axial correspondence with the gripping portion 1z, faces an annular cavity 11, within which there is a counter thread 10 capable of engaging when used with a thread 34 present on the outer surface an upper portion 33 of the side wall of the container 30. This portion defines the head portion of the container 30. The annular cavity 11 is configured to receive at least a portion of the container 30, in particular a portion of the end of the container. The gripping portion 1z is formed in accordance with a portion of the outer side wall of the first body 1, which in turn is an outer surface (where the gripping portion is present) and an inner surface facing the annular cavity 11. In the embodiment of the invention illustrated in In the accompanying drawings, a counter thread 10 is formed on this inner surface of the outer side wall of the first body 1a. Thus, the plug 1 according to the present invention has an internal thread. The threads provided on the stopper and on the container 30 provide a non-limiting example of connecting elements between the stopper and the container, wherein the closure of the container is determined primarily by the rotational movement of at least a portion of the stopper 1 relative to the container 30 (in particular, rotation about the longitudinal axis X) , which turns, precisely because of the thread, into linear movement along the longitudinal axis X of the plug 1 relative to the container itself. The first body 1a also has a guide portion 13s, 13v suitable for guiding and temporarily holding at least the biological sample collection and/or storage member rod 40. The counter-thread 10 implements a removable connecting element to provide temporary fixation of the plug 1 on the container 30.

The rod 40 described herein and illustrated in the accompanying drawings is a generally elongated body which in a particular embodiment is provided with a tampon 42 of, for example, but not limited to, flock material. In a specific embodiment, said tampon 42 may be removable from the shaft 40 in accordance with one or more weakening portions located on the body of the shaft 40 itself, which may also be retractable within the tampon 42.

The annular cavity 11 has an annular crown section, the maximum (or outer) radius of which is set by the inner surface of the side wall of the housing itself, and the minimum (or inner) radius is set by the guide part 13v, 13s.

Said guide portion 13s, 13v in particular comprises a first annular wall 13v (which, when viewed in general form, defines a substantially circular outer perimeter) which substantially extends along the direction defined by the X-axis, and a second flared wall 13s , and preferably with a circular cross-section suitable for defining a funnel-shaped recess 14 convex inwardly of the first body 1a and concave outwardly, which realizes a conical element or portion, particularly accessible from the inside of the container 30, suitable for guiding the end portion of the rod 40 toward the opening, covered with a membrane 15 or a deformable partition. The annular wall 13v helps to limit the annular cavity 11, in particular by delimiting its internal profile.

As shown in detail in FIG. 17, corresponding to a predetermined portion of the first annular wall 13v, preferably corresponding to an upper portion of the annular wall 13v, there is a ring 10k that extends in a substantially semicircular profile from the outer surface of this annular wall 13v. The ring 10k, located adjacent to the counter thread 10 of the plug 1, is an integral part and/or part of the annular wall 13v itself and, in particular, is made using the same material that is actually obtained in the manufacturing process of the first body 1a. So this 10k ring is seamlessly connected to the 13v ring wall. This ring 10k is intended primarily to optimize the closure of the stopper 1 on the container 30 and, in particular, is intended to be placed in a corresponding recess on the neck of the container 30. This recess, when the ring 10k has a semicircular profile, has in turn a concavity of a semicircular shape.

In use, when a screwing step is performed in which the plug 1 is screwed onto the container 30, completion of the screwing is ensured by the engagement of the ring 10k with a recess present on the neck of the container 30 itself. When the ring 10k and therefore the annular wall 13v is made of a sufficiently rigid plastic material, as the ring 10k engages the notch present on the neck of the container 30, a sound, particularly a “click”, may be heard, which helps the user to understand that completion of screwing has been achieved.

In a preferred and non-limiting embodiment of the plug according to the present invention, completion of screwing the plug to the container 30 is achieved by inserting a ring 10k in accordance with a corresponding recess on the neck of the container 30 and contacting the bottom wall of the annular cavity 11 with the top edge of the container 30. Preferably, as shown in the accompanying drawings, the rear wall of the annular cavity 11 is located essentially in the orthogonal direction relative to the X-axis.

Applicant points out that the presence of the ring 10k configured to detect completion of the closure of the plug relative to the container can also ignore the presence of a second body 1b configured to move relative to the first body 1a. For this reason, according to the present invention, the release plug 1 can be configured to be suitable for and/or removably connected to the container 30 and configured to contain and selectively release substance S in the container 30, the plug 1 comprising:

- a first body 1a configured to be directly coupled to the container 30 and comprising a connecting element 10 suitable for allowing the plug 1 to be removably secured in correspondence with an opening of the container 30 defining a first mounting configuration of the plug on the container, preferably the plug closing the container;

- a closure element 15 constituting at least a portion of the container wall 20 and facing the interior of the container 30 in a mounting configuration, wherein the closure element 15 is configured to be selectively opened and/or destroyed defining at least a second open configuration of the plug through a perforating or opening action an element 40, 41, 42, different from the plug 1 and placed inside the container, for communicating the reservoir 20 with the inside of the container; wherein:

- the plug includes a closure indicator 10k suitable for engaging on or in accordance with a counter-closure indicator 30k located on the container 30 defining the closed configuration of the container 30.

In particular, the closure indicator 10k is represented by the aforementioned ring, and the closure counter-indicator element is represented by the aforementioned recess located on the neck of the container 30. Applicant indicates that the opposite configuration can also be implemented in which a ring 10k is located on the neck of the container 30 and a ring 10k is located on the plug 1. corresponding notch. Both of these configurations provide the above technical result.

A set may also be provided which, in addition to the release plug 1 in the previously mentioned configuration, contains a container 30 provided with an internal cavity closed by the release plug 1 to determine a predetermined closed volume, wherein the container 30 includes a closure counter-indicator 30k located on one of walls thereof, and suitable for engagement with a closure indicator 10k located on the plug 1 in at least one closed use configuration, wherein engagement of the closure indicator 10k on the plug 1 defines a closed configuration of the container 30, optionally completely closing the container 30 and/or sealing and/or complete limitation of the internal volume of the container 30.

It should be noted that the above combination of the closure indicator element - the closure counter indicator 30k in various alternative embodiments can implement an element suitable for sealing and completely limiting the internal volume of the container 30, in particular when the wall of the stopper and the container on which they are mutually located (or , alternatively, or in combination of their particular implementation and/or constituent material) is such that it provides relative elastic deformation such that, in the closed configuration in which the closure indicator element engages the closure counter indicator 30k, at least local elastic deformation of the container and/or stopper and/or part of the wall of the stopper and/or container, according to which an element of the closure indicator and/or closure counter-indicator 30k is present, and/or at least local elastic deformation of the closure indicator and/or counter-indicator 30k occurs closing. In the specific case of the embodiment of the release plug 1 described in the present invention, this elastic deformation can be ensured by the fact that the bodies of the plug 1 and the container 30 are made of plastic, and can be facilitated by the fact that the closure counter-indicator 30k, represented by an annular recess, is located in corresponding to the neck of the container 30, and thus in a generally open area susceptible to a certain degree of elasticity. This elastic deformation is a deformation that allows contact between the stopper 1 and the container 30 to be obtained in such a way that the force is developed substantially in a transverse direction, preferably orthogonal, with respect to the longitudinal axis X, so as to ensure a safe sealing of the internal volume of the container 30.

The presence of a combination of a closure indicator 10k - a counter-closure indicator 30k should not be considered limiting since the closure indicator 10k may rest on the inner surface of the side surface of the container 30 also in an alternative embodiment, wherein this inner surface does not have a counter-closure indicator 30k, in any case achieving technical result of facilitating sealing and/or complete closure of the cavity of the container itself 30.

As can be seen from the attached drawings, the funnel-shaped recess 14 is located in a longitudinally outer position relative to the membrane 15 or deformable partition, the latter resulting in a position more rearward or equivalently at a higher height relative to the height at which the recess 14 is located. This hole has a diameter slightly larger than than the diameter adopted by the rod 40. The upper part of the rod 40 is precisely the above-mentioned external element, which can cause the destruction of the membrane 15 or the deformable partition. More specifically, the membrane 15 or deformable partition extends orthogonally with respect to the X-axis and is preferably, without limitation, implemented as an integral part of the second wall 13s, and therefore is substantially rigid and strong enough to withstand pressure that may be caused by the user's action on the second building 1b is at least random. The second wall 13s is provided with an inner surface that defines a lower wall of the tank 20, which is laterally limited by a wall of circular or cylindrical cross-section.

The second wall 13s is flared in such a way that, moving along the X axis towards the base of the plug 1, the diameter of the circle defined by it along a section taken on a plane orthogonal to the above-mentioned X axis gradually increases. In other words, the wall 13s is convex upward, that is, towards the head portion of the first body 1a.

The side wall of the first housing 1a extends smoothly up to the head of the housing itself and defines an upper recess, which corresponds to the upper cavity and which is limited below by the second wall 13s, namely its upper surface and the cavity in which the membrane 15 is present. The upper recess is suitable for accommodating at least part of the second body 1b and is shaped to allow sliding relative to the first body 1a. In particular, as can be seen, for example, in FIG. 15 or fig. 16, the upper cavity 1c is sized to accommodate the entire second body 1b when it is in the minimum axial extension configuration of the plug 1.

According to the end, the upper cavity 1c is a tapered portion 1i configured to receive by contrast at least a portion of the second body 1b, and also configured to retain at least a portion of the second housing 1b within the upper recess. Thus, such a narrowed portion 1i allows the stroke of the second body to be limited to a maximum axial extension configuration, causing an indirect determination of the maximum volume occupied by the reservoir 20 when the plug 1 is in said maximum axial extension configuration. If one looks at the upper cavity 1c in a section orthogonal to the X-axis, it can be seen that moving from the upper end to the membrane 15 or deformable partition after the first subsection with a constant diameter, the light of the said upper recess gradually decreases, and the diameter circles gradually decrease until a given height is reached depths within the same upper notch 1r. Such a predetermined depth height is shown schematically in FIG. 5 and fig. 16 with reference number Q. Thus, the inner surface 23 of the side wall of the first body defines the surface of a tapered section that ends in correspondence with the shoulder 24 with an annular wall portion oriented along a plane substantially orthogonal to the direction defined by the X-axis that defines the stopping point for part of the second body 1b. Lastly, when inserted by contrast insertion, in particular with elastic deformation of one of its elements, inside the upper recess 1r, the aforementioned arm 24 can no longer be removed from the recess 1r itself. The reduction in diameter caused by the arm 24 does not cause plastic deformation of any part of the second body 1b when inserted into the first body 1a.

As already mentioned, between the first and second sections of the upper cavity there is a "V"-shaped cutout 17 of an annular shape, which is configured to accommodate part of the second body 1b, in particular when the plug 1 is in a minimum axial extension configuration. Said V-shaped cutout 17 acts as a stop for the aforementioned part of the second body 1b, so that with the gradual reduction in the axial extent of the plug 1b caused by the introduction of the second body 1b inside the body 1a, such part of the second body 1b comes in contrast to the apex V formed by the cutout 17, which causes the second body 1b to stop sliding along the aforementioned longitudinal axis X.

Applicant notes that in the maximum axial extension configuration, the shoulder 1s present on the outer side surface of the second body 1b is located opposite the shoulder 24 present on the inner side surface of the first body 1a, and that in such a configuration, a portion of the lower part 28 of the second body 1b is partially inserted into the lower part of the upper cavity of the first housing 1a.

The applicant noted that during the installation phase, unintended pressures may arise in the tank 20 caused by the connection of the second housing 1b on the inner surface of the previously mentioned lower section. To reduce the negative effect of such pressure, the applicant has provided an upper section, in particular the head section of the first body 1a, with a pressure reduction cut-off shown in FIG. 11 reference number 29; This pressure relief cut is preferably, although not limited to, oriented in a direction substantially parallel to the direction defined by the X-axis and is configured to allow pressure relief within the reservoir 20 when not in use, i.e., during installation, without affecting sealing of the reservoir 20 itself when at least the maximum axial extension configuration has been achieved.

In a specific non-limiting embodiment of the invention, the plug according to the present invention has selective locking elements specifically configured to cause the movement of the first body relative to the second body to be blocked when it is in a configuration other than a closed configuration and/or other than a configuration of maximum axial extension and/or after opening the reservoir 20. These sample block elements may include, for example, an annular cutout 20k located generally in accordance with the V-shaped undercuts 17, and, in particular, on the inner surface of the side wall of the lower section 20'; This cutout 20k is advantageously configured to accommodate a contrast ring 28p, which, if present, extends radially from the side surface of the lower portion 28 of the second housing 1b. Said impact ring also implements a portion of said selective blocking elements. In a preferred and non-limiting embodiment of the invention, the concavity received by the annular cutout 20k is of equal and opposite shape to the convex received by the contrast ring 28P. The contrast ring 28p and the annular cutout 20k cooperate with each other to ensure that when the plug is in the minimum axial extent configuration, insertion of the contrast ring 28p within the annular cutout 20k determines the locking of the plug in the specified minimum axial extent configuration. Thanks to this aspect, it is possible to prevent the unintentional return of the plug in axial configurations of greater axial extent, for example by popping out, caused by an increase in pressure inside the container and/or a decrease in pressure in the external environment, which can occur, for example, if a container with a screwed-on plug is carried to a height or in airplane. Furthermore, thanks to this aspect, it is possible to ensure that the “used” plug always has the same external, unambiguous geometry, compatible with automatic handling devices of biological material containers, which, for example, using mechanical or optical sensors are able to detect differences in size between the plug, in which the substance S is still present in the reservoir 20, and the "used" plug, in which, due to axial compression between the first and second body, the size of the plug itself is reduced. In particular, this aspect allows the plug 1 to be easily moved through automatic unlocking devices.

In a particular embodiment of the invention, shown in the drawings appended to this description, the side wall of the reservoir 20 is not perfectly cylindrical, but is flared; the diameter of its section - along a plane orthogonal to the X axis - gradually decreases as it moves from the head part to the second wall 13s.

Rupture of the membrane 15 or deformable partition through the top of the rod 40 occurs in the modes described in detail below and shown in FIG. 11, 12 and 13.

The destruction of the membrane 15 or deformable partition is achieved by means of the upper part of the rod 40, previously placed inside the container 30, as schematically shown in FIG. 10. At this first stage, the membrane 15 or deformable partition is not damaged, as shown in FIG. eleven.

The rupture of the membrane 15 or the deformable partition is determined by the ratio, in particular, by the difference in size between the longitudinal extent of the container 30 and the longitudinal extent of the rod 40, more precisely, the difference in the longitudinal extent along the X axis of the axial extent of the container 30 along the X axis relative to the axial extent of the rod 40 along the same axis . The length of the rod 40 must be sufficient so that when it is inserted into the container 30, it can touch the membrane 15 or deformable partition so that it can open or collapse.

In a non-limiting embodiment of the invention, the gradual screwing of the threads 10 of the plug 1 onto the threads 34 on the outer surface of the side wall of the container 30 causes the plug 1 to gradually move closer to the rod 40 itself; the upper part of the rod is guided by the wall 13s towards the hole in which the membrane 15 or deformable partition is located. It should be noted that the guide acting on the side wall 13s is properly determined by its conformation and does not require special attention from the user. Thanks to this aspect, the rods 40, also not axially aligned along the X-axis and/or inclined relative to the X-axis, can be suitably precisely directed towards the opening in which the membrane 15 or deformable partition is located, by simply and sequentially screwing the plug onto the container. With successive screwing, a state is reached in which the upper end of the rod 40 comes into mechanical contrast with the membrane 15, and subsequent and further screwing of the plug determines the destruction of the membrane 15 or the deformable partition (this situation is schematically represented in Fig. 12).

At this stage, this destruction determines the opening of the tank 20 described above, followed by direct communication of the tank 20 with the container 30.

Thus, in the above-described embodiment, the mere support of the plug 1 on the container 30 is not sufficient to cause the membrane 15 or the deformable partition to collapse to allow the container 20 to be opened.

In an alternative embodiment of the invention to the previous one, as the plug 1 approaches the container 30, before the threads 10 engage with the threads 34 of the plug 1, the plug 1 remains "butted" against the rod 40, in particular, at its opposite end section relative to the part where the tampon is located. . In particular, this support may be provided by the fact that the rod 40 is of sufficient length to extend beyond the shape defined by the container 30. The support is provided with the end portion of the rod 40 resting on the membrane 15 or deformable partition. The mass of the plug 1 is not sufficient to destroy the membrane 15 or the deformable partition. Additional pressure on the plug, in particular on the first body 1 of the plug itself, is required to destroy the membrane 15 or deformable partition by opening the reservoir 20. At this moment, part of the rod 40 penetrates into the first body 1a, which determines the possibility of connecting the thread 10 with the thread 34 plugs 1. The gradual screwing of the first body 1a of the plug 1 onto the container 30 determines the gradual and always greater insertion of the rod 40 into the first body 1a.

The Applicant points out that the diameter of the membrane 15 or deformable partition, or equivalently the diameter of the hole defined by the second wall 13s, is larger, in particular significantly larger, than the diameter of the part of the rod 40 inserted therein; due to this aspect, it is possible to have liquid leakage or equivalently passage of substance from the reservoir 20 into the container 30. Although the present invention has so far discussed the diameter of the membrane 15 and the rod body 40, it should be understood that the latter may have a shape other than circular, e.g. polygonal, in which case the size of the hole must in any case be larger than the cross-sectional dimension that the insertion rod section 40 has along a plane orthogonal to the X-axis. Between the hole and the body of the rod 40 there is no contrast insertion, but a substantially free insertion, in which, incidentally, the rod 40 is free to rotate or has a gap within the hole itself. The Applicant noted that when used, particularly when working with samples of biological material, it is necessary to prevent the dispersion of unwanted material within the container 30. Among this unwanted material is a membrane 15 or deformable partition, which, therefore, when destroyed, is preferably retained within the stopper 1 according to the present invention. Among the technical solutions suitable for achieving this result, the applicant has implemented a membrane 15 or a deformable partition in the form of a thin plastic wall, located orthogonal to the X-axis and designed to break without releasing fragments. In addition to this aspect, the applicant has constructed a membrane 15 or deformable partition in a non-uniform and/or asymmetrical shape, but provided with a weakening part, preferably in a position corresponding to connection with the side wall of the hole. The weakening is preferably carried out by reducing the local thickness of the membrane 15 or the deformable partition itself.

Optionally, but without limitation, the stopper 1 according to the present invention includes a membrane or deformable partition retaining element 15 configured to prevent the membrane from being released and/or falling into the container 30. In the embodiment of the invention shown in the accompanying drawings, this retaining element includes a protrusion made near the channel that connects the tank 20 to the outside. In detail, the channel accessed by the membrane 15 or deformable partition is provided with a shoulder 15 suitable for holding the membrane 15 or deformable partition curved so as to be substantially located in a plane parallel to the X-axis. This arm is preferably diametrically opposed to the weakening portion. As shown in the sequence of FIG. 11, 12 and 13, when the weakening part of the membrane 15 or the deformable partition is destroyed due to the effect caused by screwing the plug 1 on the container body 30, the membrane gradually bends in accordance with one of its connecting parts with the arm 15s in the direction indicated by arrow P; As the insertion of rod 40 progresses, the membrane transitions from a configuration substantially orthogonal to the X-axis, through a configuration inclined with respect to the X-axis, to a configuration in which it is substantially parallel to the X-axis and sandwiched between the side surface of the hole and the rod 40 itself. Thus, the presence of the shoulder 15s makes it impossible for the membrane 15 or the deformable partition inside the container 30 to collapse after it is destroyed, even if the portion adjacent to the shoulder 15s is completely destroyed by bending. In a preferred, non-limiting embodiment of the invention, the membrane 15 or deformable partition has a weakening part, optionally located diametrically opposite the connecting part with the shoulder 15s.

The second housing 1b is shown schematically in FIG. 3 (side view) and Fig. 4 (sectional view along lines A-A from Fig. 3). The second housing 1b acts as a piston and helps determine, in use, the compression of the volume of the reservoir 20, which holds, in particular, the substance inside the recess itself, and the increase in leakage through the opening after the destruction of the membrane 15, or, if present, also the auxiliary membrane 19.

The second body 1b includes an upper part 25, a lower part 28 axially opposite to the upper part 25, and an intermediate element 2 or sealing element located in the longitudinal direction between these two parts. The upper part 25 has an at least partially cylindrical shape with a first characteristic diameter and, in accordance with its intermediate part, has a linear movement limiting element 2, which includes a first upper arm 2s with a second characteristic diameter larger than the first. In fig. 4 two characteristic diameters are designated as d1 and d2 respectively. In other words, in the second body 1b there is an intermediate section between the lower part and the upper part, and this intermediate section contains a linear movement limiting element and a sealing element, in particular, a linear movement limiting element along the X axis.

In the embodiment of the invention shown in the accompanying drawings, the upper part 25 of the second body 1b includes a plurality of ribs, designated 3, which extend radially from the above-mentioned upper part. These ribs are, for example, visible in FIG. 3, and as shown in this drawing, they are preferably, but not limited to, arranged with an orientation, for one of their directions of maximum extent, substantially parallel to the X-axis. The set of ribs 3 at the point of maximum radial extent defines a perimeter defined by a circle, the diameter of which is greater than the above-mentioned first characteristic diameter d1. The purpose of these ribs 3 is to optimize the alignment of the second body 1b relative to the first body 1a with respect to the X-axis and/or to help reduce, ideally, the possibility of the second body oscillating about the X-axis of the plug, positioning itself in such a way that one of its axes are inclined relative to the axis of the first housing 1a. Thanks to this aspect, the sealing of the intermediate element or sealing element is optimized even when unintentional forces act on the second body 1b in a direction significantly inclined relative to the X-axis itself. The radially outermost part of the ribs 3 is substantially in contact with the inner surface of the side wall of the first body 1a.

The wall extending from the shoulder defines a substantially V-shaped annular cutout 2i, which is limited at the bottom by a dividing wall 2g, which again connects with the bottom 28 of the cylindrical or slightly truncated cone of the second body 1b, forming an acute angle with it. When looking at the second housing 1b from the front and in section along a plane parallel to the X-axis, the partition wall 2g slopes downwards, that is, towards the bottom of the reservoir 20, which is limited by the channel providing access to the membrane 15. In particular, when looking at the partition wall 2g along a section on a plane parallel to the longitudinal axis X, this wall is oriented in the facing V direction with its apex up. The applicant noted that the downward slope allows for sealing in the event of increased pressure within the reservoir 20. In fact, in the event of increased pressure, the force applied by the latter will tend to "open" the dividing wall 2g, which, however, is laterally limited by the side wall. For this reason, the frictional force increases as the pressure inside the tank 20 increases. Thus, the partition wall implements a structure capable of increasing the sealing and/or contrast force with respect to the inner surface of the side wall of the first body 1a in accordance with the increase in the pressure inside the tank.

The Applicant notes that the maximum diameter of the lower part 28 of the second housing 1b is significantly less than the diameter defined by the side wall of the lower part 20' of the upper cavity 1c of the first housing 1a. The light (ring) that is present between the two elements allows the substance to leak beyond the dovetail shaped undercut 17.

The partition wall 2g extends radially from the cylindrical portion of the second body 1b such that the radially outermost portion thereof has a third characteristic diameter d3 larger than the second characteristic diameter d2; this third characteristic diameter d3 is only slightly larger than the second characteristic diameter, being relatively larger in size by about 1% to 2%.

The dividing wall 2g, which extends around the entire circumference of the corresponding part of the second body 1b, defines a skirt that provides relative elastic flexibility to be able to bend towards the lower cylindrical part of the second body 1b so as to at least allow the second body to be inserted inside the first building 1a. In particular, the flexibility of the partition wall 2g should be such that, during the bending described above, the third characteristic diameter d3, which is essentially identified by it in the resting state, is temporarily reduced by 10% - 20%, for example, and preferably by 15%, without rupture , and then returned substantially by elastic release to the same third diameter d3. Conveniently, at least this partition wall 2g is made of a suitable plastic material. However, the plug embodiment described here is such that the entire second body 1b is made in one piece from a plastic material, for example, for molding. As with the first body 1a, the second body 1b is also preferably made of a plastic material resistant to acids and/or corrosives, in particular such as may be contained within the reservoir 20, and preferably, without limitation, a biocompatible material, i.e. e. of such a nature as not to release substances upon contact with biological samples.

The limiting wall 2g acts as a scraper capable of applying compaction of liquid and powder or granular material even during the action of linear movement along the X-axis, which is determined during the compression movement of the second body 1b. Due to this aspect, the closure of the reservoir 20 suitable for containing the above-mentioned substance S occurs without the aid of any deformable sealing ring or O-ring, and this contributes to simplifying the implementation of the plug according to the present invention, reducing the number of separable components and optimizing the economics of production, especially on a large scale.

Therefore, the reservoir 20 in which the substance can be contained is determined between:

- a cylindrical annular portion defined between the outer surface of the side wall of the second housing 1b below the dividing wall 2g, and the inner surface of the upper side wall portion 1r of the first housing 1a;

- (upper) dividing wall 2g;

- (through the ring light present between the lower part 28 of the second body 1b and the side wall of the lower part 20' of the upper cavity 1c of the first body 1a) the outer surface of the lower part 28 of the second body 1b and the inner surface of the side wall delimiting the lower part 20' of the above-mentioned upper cavity 1c of the first building 1a;

- second wall 13s;

- an opening part and a corresponding membrane 15 or a deformable partition.

In other words, the reservoir 20 has a complex shape including an annular leak portion that defines an upper region and a lower region substantially connected to each other, the leak portion being defined by a size difference, such as a difference in diameter, between the portion (in particular, the lower part) of the second body 1b when inserted into the upper cavity 1c of said first body 1a and part of the inner surface of the side wall of the first body 1a.

The radially outermost portion of the limiting wall 2g may have a substantially pointed shape, as is the case in FIG. 4a, or a rounded profile, as in the case of FIG. 4b. The Applicant has discovered that the rounded profile improves the sealing of the boundary wall 2g on the inner surface of the side wall of the first housing 1a, reduces scratches on the latter, and improves the ease of installation after installing the second housing 1b inside the first housing 1a. The rounded profile also reduces the risk of plastic deformation of the edge portion of the boundary wall 2g, which might otherwise occur during installation. This rounding may take the form of a circular sector or another defined shape on a curve without corner points.

Unlike the boundary wall 2g, the ring defined by the first upper arm 2s is not flexible and is preferably configured to maintain centering of the second body 1b within the cavity of the first body 1a.

As can be clearly seen in Fig. 4, the lower part of the second body 1b is a bell-shaped recess 5 formed by the inner surface of the side wall of the lower part, which is inclined relative to the X-axis so that the bell mouth present in correspondence with the lower end part of the second body 1b has a larger diameter, or maximum, and the recessed head of the bell has a smaller diameter in relation to the above-mentioned maximum diameter.

The applicant has made the shape of the bell 5 in a special way, and this bell is a shape that corresponds to the shape that the tank 20 presents in its lower part, and which is, in particular, provided by the second wall 13s (in particular, its inner surface) and the opening that she defines. Due to this aspect, when the second body 1b is inserted for the maximum portion inside the first body 1a, defining the above-mentioned minimum axial extension configuration, the lower annular perimeter 4f defined by the mouth of the bell 5 rests on the apex of the cutout that the second wall 13s defines in the tank 20. For careful measurements and design clearance in this configuration, the bell surface defined by the inner wall surface is at least partially and preferably substantially completely supported by the inner surface of the second wall 13s of the first housing 1a, and at the same time, also the limit wall 2g is substantially supported by the undercut 17. This condition is illustrated in FIG. 15 and fig. 16. Due to this aspect, during the axial compression stage of the plug, the compressive action of the substance contained in the reservoir 20 occurs, thereby minimizing, ideally to zero, the amount of substance that remains in the plug 1 when it is in the minimum axial extension configuration.

In accordance with the head of the bell 5, a housing 6 is obtained, suitable for housing the usable part of the end of the rod 40, in particular holding it by contrast insertion; For this purpose, the inner surface of the housing 6 is provided with a plurality of holding ribs 7, preferably, but not limited to, each located in a direction parallel to the direction defined by the X-axis and extending in a direction towards the center of the housing 6 itself, defined by the X-axis. Thus, when the second housing 1b is pushed inside the first body 1a sufficiently, the upper end portion of the rod 40 is inserted into the body 6 and remains held. Therefore, when the operator removes the stopper 1 from the container 30, he also holds the rod 40 together with the stopper itself, which at this point acts as a handle for the rod 40, which preferably reduces the risk of contamination between the rod and the operator and conveniently prevents contamination of the latter through parts of the biological sample , present on the rod and/or residues of the substance.

The accompanying drawings, particularly FIGS. 8, 10, 14 and 15, show a specific embodiment of a container 30 which is essentially a tube for collecting and/or storing and/or analyzing biological samples, preferably made of a plastic material, e.g. , and without limitation PP or PET or other plastic material, preferably designed so as not to release substances into the biological sample when contained therein. In particular, this may be a plastic tube, optionally transparent, for example and without limitation, having dimensions of 12 mm x 80 mm. This form should not be understood as limiting. In the illustrated embodiment, container 30 is a substantially cylindrical body open at one end (top end) where threads 34 are present.

Applicant notes that, in substantial accordance with the rupture of the membrane 15, the plug 1 according to the present invention begins to screw onto the container 30 such that the thread-counter-thread connection, together with the optional but preferred presence of the O-ring 10k, ensures a watertight connection between the container 30 and the plug 1, which prevents dust, liquids and gas from escaping from the container and stopper. For this purpose, the threaded and counter-threaded connections described here preferably have a double thread type. This allows for high feed rates along the X-axis and reduces loosening of the sidewall stand section that would otherwise be possible with a single thread.

Applicant notes that the threaded connection may be such that the threads 34 extend from the body of the container 30 or form recesses formed on the body of the container 30. In particular, in the embodiments of the invention described and shown in the accompanying drawings, the thread 34 is present on the outer surface of the side wall of the container 30 (thus the container can be said to have an external thread) and extends radially from such outer surface. This configuration should not be understood as limiting, since - in a further embodiment - the threaded connection of the container 30 can be located on the inner surface of the side wall of the container 30, and this should not be understood as limiting. If a thread is present on the inner surface of the side wall of the container 30, and therefore the container 30 has an internal thread, a solution may be provided in which the thread extends radially inward, in particular towards the center of the container 30, or is implemented through recesses on the inner surface of the side wall container 30. Likewise, if the thread is provided on the inner surface of the side wall of the container 30, the counter thread 10 present on the plug 1 according to the present invention can be implemented either on the outer surface of the plug 1 itself or, alternatively, on the annular wall 13v.

The opposite end (bottom end) of the container 30 is designated by a V-shaped bottom part 32, in which, in particular, the side wall gradually tapers towards the center of the container body 30, which in the attached drawings is centered on the X-axis described above. The bottom part 32 is made with the ability to center the rod 40 and/or swab 42 for collecting biological samples along the X-axis; therefore, the V-shape of the lower portion 32 cooperates with the guide portion 13s, 13v and in particular with the second wall 13s to assist in centering the rod 40 along the X-axis. Optionally, although not limitingly, the V formed by the lower portion 32 is not has vertices, and the shape adopted by the lower part 32 is a truncated V-shape. In this case, the wall defining the lower portion has a central section located on a plane orthogonal to the X-axis plane. The bottom of the container 30 may be coated with a culture medium in use.

One or more support legs 31, which implement a support skirt, may be present at the lower end of the container 30 to hold said container 30 in an upright position. The support legs 31 may be integrally formed with the container body 30, for example, during a molding process, and may also be integrally formed with the bottom portion 32 such that they can be joined to each other seamlessly. In addition, the support legs 31 may be formed from a ring connection with the side wall of the container 30.

The body of the plug 1 is preferably made of a plastic material resistant to acids and/or corrosive substances, and/or made of a biocompatible plastic material so as not to release substances upon contact with biological samples. In a particular embodiment, the plastic material with which the stopper is formed is opaque and, therefore, the substance S cannot be seen from the outside of the stopper itself. By concealing Substance S and not allowing it to freely transfer into container 30, the risk that certain subjects, including children, who potentially have access to stopper 1 described herein, will ingest or otherwise come into contact with Substance S is reduced. Use of opaque The plug is also preferred when the substance S contained in the reservoir 20 is photosensitive, since the risk of degradation of the substance S itself is thus reduced, even when the plug according to the present invention must remain for a long time in areas exposed to light.

Although the release plug 1 with threads for connection with the container 30 has been described so far, this specific specification is not intended to be limiting; In fact, in an embodiment of the invention not shown in the accompanying drawings, the removable connection can be realized by means of clips placed on the plug 1 and suitable for engagement with the undercuts present on the container 30, or, conversely, by means of clips placed on the container 30 and suitable for engaging undercuts present on the outer surface of the plug 1. It should be noted that the clamps may be configured to cause significant compression of the plug 1 relative to the container 30 during closure, which results in a decrease in the axial extent along the X-axis of the assembly formed by the plug 1 and container 30 to indirectly cause membrane 15 to be perforated by this compression or reduction in axial extent.

When installing a plug, 1 user or even a machine first performs the following steps:

- the step of positioning the substance inside the first body 1a of the plug 1 in such a way that the substance is deposited in the reservoir 20 delimited by the specified membrane 15 or deformable partition;

- the subsequent step of positioning the second housing 1b at least partially inside the first housing 1a in such a way that, through said positioning, the retention of the reservoir 20 and the substance is determined within a closed volume separated from the external environment.

The Applicant notes that at least two of the above steps can be implemented using the plug assembly machine 1; Thanks to this aspect, it is possible to install a large number of plugs 1 in a very short time. The plug assembly described herein may alternatively be performed by an operator who performs the following operations, or it may alternatively be performed by a specific operator of the plug manufacturer 1.

In particular, placing the substance S in the first body 1a may involve pouring a fluid, gelatinous material or solid material into the first body 1a such that the fluid or solid material is first deposited onto the membrane or deformable partition and then fills a portion of the overlying portions of the cavity , defined in the first building 1a. In addition, positioning the substance S in the first housing 1a may include introducing two primary substances capable of reacting to form a gas or vapor, which can be captured in the reservoir 20 due to the seal implemented by the second housing 1b. When casting is carried out by said machine, this casting may be carried out taking into account a given casting time (known as the flow of fluid or solid material from the machine to the plug 1) or a difference in the mass of fluid or solid material in the reservoir of said machine, so as to have a given and constant transfer of matter. In a particular embodiment of the invention, the machine may include gripping elements for holding the first body 1a in a predetermined position and other elements for inserting the second body 1b at least partially inside the first body 1a, as described above.

When this successive step has been completed, and in particular when, by inserting the second body inside the first body, the volume of the reservoir 20 has been properly defined and isolated, the plug is ready for use.

When used through the biological sampling and storage element, the operator first takes the biological sample of interest and places it inside the container, ensuring that the biological sampling and storage element is positioned so that the swab 42 is located at the bottom of the container itself. When culture medium is contained within container 30, swab 42 may be conveniently placed in contact with the culture medium itself.

In a subsequent connection step, the plug 1 is connected to the container 30 and to the element for collecting and storing biological material, and after completion of the connection, the container 30 has a closed and limited volume corresponding to one of its openings due to the presence of the plug 1. As a result of the connection of the plug 1 with container 30, in particular, due to interaction with the rod 40 contained in the container 30, and through axial compression between the plug 1 and the container 30, a perforation of the membrane or deformable partition is created, providing direct communication between the interior of the container 30 and the reservoir 20. It should be noted that that after perforation of the membrane 15, the sealing action exerted by the restrictive wall 2g does not allow the release of the substance S inside the container 30 as a whole: although leakage may be present even without the action of pressure in the direction of the configuration of the minimum axial extent, it is actually necessary to continue to apply the pressure force to the second body 1b to complete the release.

In accordance with a particular embodiment of the biological material collection and storage element, in particular with respect to the longitudinal extent of the rod 40 compared to the longitudinal extent of the container 30 into which the collection element is inserted, perforation of the membrane 15 or deformable partition occurs either before contact between the threads 34 and counter thread 10, or after such contact. Thus, in the first case, the connecting step first detects perforation or opening or rupture of the membrane 15 or the deformable partition and, after relative sliding between the rod 40 and the plug 1, in particular the relative sliding between the rod 40 and the first body 1a of the plug 1, the connection between thread 34 and counter-thread 10, and therefore direct engagement between plug 1 and container 30, after which plug 1 can actually be screwed onto container 30, finally holding rod 40. Consequently, plug 1 is in engagement with container 30 (hence direct connection) only after perforation, opening or fracture of the membrane 15 or the deformable partition. The Applicant indicates in particular that perforation or opening or fracture of the membrane 15 or deformable partition determines at least partial, optionally complete, detachment of the membrane 15 or deformable partition from the first body 1a, of which the closing element is an integral part (at least before the perforation, opening or breaking).

In the second case, the step of perforating or opening the membrane 15 or deformable partition occurs as a result of the engagement between the thread 34 and the counter thread 10. In this case, the removable connection involves gradually screwing the plug, in particular the first body 1a of the plug 1 onto the container 30, and perforating the membrane 15 or a deformable partition occurs by gradually screwing the plug 1 onto the container 30.

To release the substance S within the volume of the container 30, the user acts on the second body by exerting a pressure subsequent to or accompanied by an axial compression of the plug 1, causing the second body 1b to be progressively inserted into the first body 1a. The gradual insertion of the second body 1b inside the first body 1a with axial sliding along the X-axis determines a corresponding gradual decrease in the volume of the reservoir 20 and a gradual distribution of the substance inside the container 30, which ends when the minimum axial extension configuration is reached; in this configuration, the reservoir 20 is substantially emptied and substantially all of the substance S is contained in the container 30.

The gradual axial compression of the plug 1 causes the restrictive wall 2g (or at least a portion thereof, or a radially outermost or end portion) to slide on the inner surface of the side wall of the first body 1a in a direction substantially determined by the longitudinal axis X of the plug. Sliding determines the sliding friction between the radially outermost or end portion of the boundary wall 2g and the above-mentioned inner surface, and due to this friction, as well as due to the low roughness of the inner surface, a seal of liquid and/or gas and/or powdery material is determined so that ensure the leakage of substance S only from the open channel through a rupture of the membrane 15 or a deformable partition. Thus, elastic deformation of at least part of the limiting wall 2g occurs, after which the radially outer part of the said limiting wall 2g exerts on the inner surface of the side wall of the first housing 1a a force oriented essentially in an orthogonal direction relative to the direction of advancement of the second housing 1b inside the first housing 1a caused by the axial compression itself, or, equivalently, a force oriented substantially in an orthogonal direction to the longitudinal axis X of the plug. It should be noted that in order to hold the seal towards the external environment, that is, to limit the volume of the reservoir 20, the sealing ring is not made of rubber or silicone material. Preferably, the absence of components in the silicone material and/or rubber reduces the risk of interaction and/or incompatibility with the substance contained in the reservoir 20, since the entire body of the plug 1 is made of a single plastic material; this also allows the plug 1 described here to be flexible when used with different types of substances, since comparison with possible interactions must only be made between the substance S and the specific type of plastic material used. Additionally, the absence of components such as O-rings or similar silicone material reduces the risk of cracking, allowing for long-term shelf life. The absence of O-rings or similar elements made from silicone material also helps reduce the cost of manufacturing the plugs described here.

Therefore, the end portion 41 is at least partially inserted into the first body 1a and causes the membrane 15 or deformable partition to be retained within the first body 1a, in particular by engaging the membrane 15 between itself, the side surface of the displacement channel of the substance and the arm 15s located substantially in according to the specified displacement channel.

The connection between the plug 1 and the container 30 is such that the insertion of the end portion 41 into the first body 1a and into the container 20 is sufficient to ensure engagement within the body 6 obtained at the end of the bell 5; in considerable proximity to the configuration of the minimum axial extent, so that the end portion 41 is inserted by contrast into the body 6, and due to the action of the ribs 7 it remains there.

Preferably, according to the minimum axial extent configuration, the second body 1b results in a locking position with respect to the first body 1a, such as the axial extent of the plug 1, which is functionally impossible; in other words, the locking position is determined by engaging the locking ring 28s of the second body 1b in accordance with the existing annular recess in accordance with the inner surface of the side wall of the first body 1a. Consequently, a condition arises that the end portion 41 of the rod 40 and the second body 1b are double and/or simultaneously locked relative to the first body 1a.

Applicant notes that when a reactant substance is introduced into the body of the container 30, the release of substance S from the reservoir 20 into the container 30 may cause a chemical reaction. Therefore, it should be noted that the separation of two chemical reagents from each other using the stopper 1 described here allows the user to initiate a chemical reaction only when necessary and in complete safety, since the stopper 1 is firmly screwed to the body of the container 30.

Applicant notes that the characteristic function of perforating the membrane 15 or deformable septum through the rod 40 when a perforating or opening element, in particular a swab for collecting biological and/or microbiological material described herein, is introduced into the container 30, can be applied not only to stoppers 1 , marked by the presence of a second body 1b as described above, but also to plugs which, according to the embodiment of the invention described below, comprise:

- a first body 1a configured to be directly connected to the container 30 and comprising a connecting element 10 suitable for allowing removable fixation of the stopper 1 in accordance with the opening of the container 30 defining a first installation configuration of the stopper on the container, and preferably the stopper covers the container 30 ;

- a closing element (in particular, a membrane 15 or a deformable partition) constituting at least part of the wall of the reservoir (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element ((in particular, a membrane 15 or a deformable partition)) configured to selectively open and/or break, determining at least a second open configuration of the plug, through the action of a perforation or opening element (40, 41, 42), other than the plug (1) and located inside the container (30), to bring tank (20) into communication with the inside of the container (30).

In particular, the method of perforating the membrane 15 or deformable partition through the above-mentioned rod 40 can also be applied to plugs that, in combination with the above characteristics, include a closure indicator 10k suitable for engaging or in accordance with a counter-closure indicator 30k located on the container 30 determining the closure container configuration 30.

Thus, the method includes:

- the step of inserting a perforation or opening element 40, 41, 42 into the container 30 through an opening of the container itself, said hole being suitable for receiving a release plug 1, so that the perforating or opening element 40, 41, 42 is removable from the container 30 and/or is at least partially movable within the container 30,

- the step of positioning the release plug (1) generally in accordance with the opening of the container (30).

After the positioning step, the closure element (in particular, the membrane 15 or the collapsible partition) is opened and/or torn and/or broken by the perforation or opening element 40, 41, 42, allowing the release of at least a partial amount of a predetermined amount of substance S contained within the reservoir S inside the container 30, by applying a force between the release plug 1 and the container 30.

In a non-limiting embodiment of the invention, the rod 40 may be provided with an at least partially hollow body and configured to pass the substance S from the reservoir 20 to the tampon 42, in particular, with the ability to pass the substance S from the reservoir 20 to a position substantially corresponding to or close to tampon 42. Thus, a substance, in particular a fluid, passes between the cavity 41i inside the rod 40 and the surface outside the rod 40.

Therefore, an embodiment of the biological and/or microbiological material collection element comprises a rod 40 comprising a cavity 41i having a substantially axial extent that communicates with at least one first opening, in particular a first transfer channel 40k, preferably a first set of transfer ports channels 40k and at least a second opening, in particular a second transfer channel 40f, preferably a second set of transfer channels 40f.

In a particular embodiment of the invention, the cavity 41i thus extends at least between a first height (or equivalently, a first portion of the rod 40) at which a first transfer channel 40k, or, if present, a first set of transfer channels 40k, is present, and a second height (or the second part of the rod 40), on which there is a second transfer channel, or, if present, a second set of transfer channels 40f. In the embodiments of the invention shown in the accompanying drawings, the first height or first portion corresponds substantially to the end portion of the shaft 40, designated by numeral 41, which is substantially opposite to the portion of the shaft 40 in accordance with which the tampon 42 is present.

The first transfer channel 40k, or, if present, the first set of transfer channels 40k, is preferably located in substantial correspondence with the first end portion of the rod 40, in particular, located at such a height that when the rod 40 is inserted inside the reservoir 20, this first transfer channel 40k, or, if present, the first set of transfer channels 40k, allows the passage of substance S within the cavity 41i.

In the embodiment of the invention shown in FIG. 18, a first set of transfer channels 40k extends radially around the perimeter of the side surface area of the rod 40, and a second set of transfer channels 40f extends radially around the perimeter of the side surface area of the rod 40. This embodiment allows, for example, and without limitation, the dispersion of a substance through the second set transfer channels 40F evenly across the tampon 42, providing uniform wetting and reducing the risk that sectors of the tampon 42 may be poorly saturated with the substance.

In particular, the second set of transfer channels 40f allows the substance contained in the reservoir 20 to flow at a slightly higher height and in substantial contact with the tampon 42. Preferably, in the embodiment of the invention shown in FIG. 19, the tampon 42 is a flock tampon and is arranged around a portion of the non-cavity rod 40 41i that is inserted therein.

Alternatively, in the embodiment of the invention shown in FIG. 19, the first transfer channel 40k is an axial hole, particularly a head hole coaxial with the cavity 41i, provided at the end of the rod 40. Although in FIG. 19 shows a solution with one second transmission channel 40F, this solution can be combined with the presence of a second transmission channel or multiple transmission channels in any of the embodiments of the invention described above.

In a further embodiment of the invention shown in FIG. 20, the second transfer channel 40f, or - if present - the second set of transfer channels 40f, is located at the height at which the tampon 42 is present. Thus, the second transfer channel 40f or the second set of transfer channels 40f overhangs and/or is surrounded by the tampon 42; Thus, this embodiment of the invention allows transfer from the reservoir and direct wetting of the tampon 42 with a radially more internal part. The embodiment of the invention described herein may be combined with a first transmission channel 40k or a first set of transmission channels 40k in accordance with any of the embodiments of the invention described herein.

When there is a first and/or second set of transmission channels 40K, 40F, a plurality of transmission channels belonging to the same set may be located at the same or different heights. In particular, a plurality of transfer channels may be located in an axial direction along the maximum extension direction of the inner cavity 41i (or, equivalently, the rod body).

The hollow rod in the embodiments of the invention described herein may be connected to a release plug provided with a first and second housing configured to reciprocate, in particular, to be connected to a release plug such as one of the objects of the present invention, or it may also be connected to a conventional release plug provided with a reservoir and a partition or membrane that is ruptured to release the substance contained therein, such as those described above.

The invention is not limited to the embodiments shown in the drawings. For this reason, it should be understood that where features mentioned in the claims are accompanied by reference numbers, those reference numbers are included for the sole purpose of enhancing the clarity of the claims and are in no way intended to be a limitation of the claims themselves.

Finally, it will be apparent that additions, modifications or variations obvious to one skilled in the art may be applied to the subject matter of the present invention without thereby departing from the scope of protection as defined by the appended claims.

Claims (65)

1. A release plug (1) designed for removable connection with a container (30) and configured to contain and selectively release a substance (S) in the container (30), wherein the plug (1) contains: - a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for providing removable fastening of the plug (1) in accordance with the opening of the container (30), defining a first installation configuration of the plug on a container in which a stopper closes the container; - a second housing (1b) connected to the first housing (1a) and configured to move relative to it and forming with the first housing (1a) at least one reservoir (20) configured to accommodate a substance (S), wherein the reservoir ( 20) isolated from the external environment in at least the first closed plug configuration, - a closing element (15) constituting at least part of the wall of the reservoir (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened, defining at least a second open configuration of the plug, by the action of an opening member other than a plug (1) located inside the container (30) to bring the reservoir (20) into communication with the interior of the container (30). 2. The plug according to claim 1, wherein the second body (1b) is configured to move axially and translationally relative to the first body along a predetermined axis (X) of the plug (1) and at least the lower part of the second body (1b) is positioned to move inside the first housing (1a) to form a reservoir (20). 3. A plug according to claim 1 or 2, wherein the reservoir (20) is held between the first body (1a) and the second body (1b). 4. The plug according to claim 2 or 3, comprising a tapered portion (14) located on the first body (1a) suitable for driving at least a portion of the opening element towards the closing element (15), wherein the tapered portion (14 ) is placed in a position that is external in the longitudinal direction with respect to the closing element (15), and the tapering part (14) is an integral part of the first body (1a), has a funnel shape and is accessible from inside the container (30). 5. A stopper according to any one of the preceding claims, wherein the closing element (15) is configured to be selectively opened, defining at least a second open configuration of the stopper, by the action of an opening element different from the stopper (1) and different from the container, and removably located inside the container. 6. A plug according to any one of the preceding paragraphs, wherein the second body (1b) comprises a cavity (6) configured to provide removable engagement of the end portion of the opening element by contrast insertion; the plug is configured to provide contrast administration only when in an open configuration, in proximity to, or consistent with a minimum axial extent configuration. 7. A stopper according to any one of the preceding paragraphs, wherein the first body (1a) is removably connected to the head part of the container (30). 8. Stopper according to any of the previous paragraphs, and: - the closing element (15) is located on the first body (1a) and is an integral part of the first body (1a); And - the closing element (15) is a waterproof element configured and specifically designed to retain solids, liquids and/or gases. 9. Stopper according to any of the previous paragraphs, and: - the closing element is a membrane (15) or a deformable partition equipped with a weakening part; wherein the plug is configured to release the substance into the container (30) in an open configuration by keeping, when connected to the container (30), insulating the entire volume defined by the container (30)-reservoir (20) assembly, isolated from the external environment. 10. A stopper according to any one of the preceding claims, comprising a closing element retaining element configured to prevent the closing element (15) from being released and/or falling inside the container (30); wherein the holding element comprises a shoulder (15s) on which the closing element (15) rests or folds when in contrast with the opening element. 11. The plug according to claim 10, wherein in the open operating configuration the closing element (15) is held by the shoulder (15s) and captured between the channel and a part of the opening element located inside the channel. 12. Cork according to any of the previous paragraphs, and: - the second body (1b) is movable relative to the first body (1a) and determines, by its axial movement, at least the configuration of the maximum axial extent of the plug (1) along the longitudinal axis (X) and the configuration of the minimum axial extent of the plug (1) along the longitudinal axes (X); - the first closed configuration contains the configuration of the maximum axial extent, and the second open configuration contains the configuration of the minimum axial extent; - the second open configuration is carried out in accordance with a longitudinal extent intermediate between the longitudinal extent corresponding to the maximum extent configuration and the longitudinal extent corresponding to the minimum longitudinal extent configuration. 13. Cork according to any of the previous paragraphs, and: - the sealing element (2) contains a shoulder (2s) configured to engage in use with a holding part (23) protruding from the inner surface of the side wall of the first body (1a), the engagement being between the holding part (23) and the shoulder ( 2s) is such that it makes it impossible to completely remove the second housing (1b) from the first housing (1a) when the latter has been previously inserted, and - the sealing element (2) contains a limiting wall (2g) specifically configured to define a seal and hold the volume of the tank (20), wherein the limiting wall has a shape that also determines the limitation of the movement of the second body (1b) relative to the first body (1a) in configurations of minimum axial extent. 14. A plug according to any one of the preceding claims, wherein the first body (1a) comprises an annular recess (1y) located at an intermediate height between the minimum and maximum height defined by the first body (1a); wherein the annular recess (1y) is configured to accelerate the cooling of the first housing (1a). 15. Cork according to any of the previous paragraphs, and: - the first housing (1a) contains a pressure relief element (29), configured to provide removal of a predetermined volume of air when the second housing (1b) is inserted into the first housing (1a), - wherein the pressure relief element (29) is configured to allow the removal of a predetermined volume of air when the second housing (1b) is inserted into the first housing (1a) in the non-operating installation configuration of the second housing (1b) into the first housing (1a), without affecting on the tightness of the reservoir (20) itself, when at least the configuration of the maximum axial extent is achieved. 16. A kit for storing a biological sample, containing: - a container (30) for storing the biological sample, and - a release plug (1) designed for removable connection with the container (30) and configured to contain and selectively release the substance (S) in the container (30), wherein the plug (1) contains: - a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for providing removable fastening of the plug (1) in accordance with the opening of the container (30), defining a first installation configuration of the plug on a container in which a stopper closes the container; - a second housing (1b) connected to the first housing (1a) and configured to move relative to it and forming with the first housing (1a) at least one reservoir (20) configured to accommodate a substance (S), wherein the reservoir ( 20) isolated from the external environment in at least the first closed plug configuration, - a closing element (15) constituting at least part of the wall of the reservoir (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened, defining at least a second open configuration of the plug, by the action of an opening element other than a stopper (1) located inside the container (30) to bring the reservoir (20) into communication with the interior of the container (30), wherein said opening element forms a device for collecting microbiological samples, and container (30) contains a housing configured to be opened at least in accordance with at least one of its first part (33) and provided with a side wall and a bottom wall (32) connected to the side wall, wherein the container (30) is made with the ability to accommodate said opening element, which contains a tampon (42) and a rod (40), and to be movably connected to a stopper (1); wherein the container (30) has such a longitudinal extent and the shape of its lower wall (32) and is designed in such a way that the end part (41) of the rod, opposite to the part in accordance with which the tampon (42) is located, after the removable connection of the plug (1 ) with the container (30) determines the perforation of the closing element (15) and the insertion of the end part (41) of the rod (40) into the first body (1a). 17. The set according to claim 16, comprising a V-shaped lower part (32), and in accordance with the lower part (32) the side wall gradually tapers towards the center of the container body (30); the lower part (32) is configured to center the rod (40) and the tampon (42) along the longitudinal axis (X) of the container (30), the lower portion (32) cooperates with the guide portion (13s, 13v) of said plug (1) to assist in centering the rod (40) along said longitudinal axis (X). 18. A kit for collecting and storing biological samples, containing: - a container (30) capable of being closed using a release plug (1) according to claim 1, - an element for collecting and storing a biological sample, forming an opening element for the release plug (1), - a release plug (1) suitable for removable connection with the container (30) and configured to contain and release the substance (S) in the container (30), wherein the release plug (1) is a plug suitable for removable connection with the container (30) and configured to contain and selectively release a substance (S) in the container (30), wherein the release plug (1) comprises: - a first body (1a) configured to be directly connected to the container (30) and containing a connecting element (10) suitable for allowing the plug (1) to be removably secured in accordance with the opening of the container (30), defining a first installation configuration of the plug on the container, the stopper closing the container; - a second body (1b) connected to the first body (1a) and movable relative to it, movable axially and translationally along a predetermined axis (X) of the plug (1) and defining with the first body (1a) at least one reservoir (20) configured to contain a substance (S), wherein the reservoir (20) is isolated from the external environment in at least a first closed plug configuration, - a closing element (15) constituting at least part of the wall of the reservoir (20) and facing the inside of the container (30) in an installation configuration, wherein the closing element (15) is configured to be selectively opened, defining at least a second open configuration of the plug, by the action of an opening element other than a stopper (1) located inside the container (30) to bring the reservoir (20) into communication with the interior of the container (30), wherein the container (30) contains a body configured to be opened at least in accordance with at least one of its first part (33) and provided with a side wall and a bottom wall (32) connected to the side wall, wherein the container (30) is made capable of receiving an opening element for collecting and storing a biological sample, provided with a swab (42) and a rod, and being movably connected to a release plug (1) so as to form an opening element, wherein the container (30) has such a longitudinal extent and the shape of its lower wall (32) and is designed in such a way that the end part (41) of the opening element rod, opposite to the part in accordance with which the tampon (42) is located, after the removable connection of the plug (1) with the container (30) determines the perforation of the closing element (15) and the insertion of the end part (41) of the rod (40) into the first body (1a). 19. A method for distributing substances in a release plug according to claim 1 or a set according to claim 18, including the following steps: - the step of positioning the substance inside the first body (1a) of the plug (1), so that the substance is deposited in the reservoir (20) delimited by the closing element (15); - the subsequent step of positioning the second housing (1b) inside the first housing (1a), so that by positioning it is ensured that the reservoir (20) and the substance are contained within a closed volume, separated from the external environment. 20. The method according to claim 19, including: - the step of connecting the plug (1) to the container (30), and as a result of the connection, the container (30) is provided with a closed and limited volume, in accordance with its opening, due to the presence of the plug (1), - the stage of positioning the opening element inside the container (30), - whereby, due to the connection of the plug (1) with the container (30) and with the opening element, an opening of the closing element (15) is formed to bring the inside of the container (30) into direct communication with the reservoir (20), - the stage of applying pressure to the second body (1b) of the plug (1), in combination with which the axial compression of the plug (1) is determined, causing the gradual introduction of the second body (1b) inside the first body (1a), and the gradual introduction of the second body (1b) inside the first housing (1a) determines the corresponding gradual decrease in the volume of the reservoir (20) and the gradual distribution of the substance inside the container (30). 21. Kit for collecting and storing biological and/or microbiological samples, including: - release plug (1) according to claim 1; - an element for collecting and storing biological and/or microbiological samples, forming an opening element and containing a rod (40) with an axial extension and a swab (42), which is made at one end of the rod or to which the rod (40) is firmly attached; wherein the opening element is characterized in that the rod (40) is hollow and configured to allow the passage of a substance between the first part of the opening element and the second part in correspondence with or proximity to the tampon (42) by passing the substance between the cavity (41i) inside the rod (40) and a surface outside the rod (40) itself, wherein the opening element is configured to allow the substance (S) to leak out of the reservoir (20) of the release plug (1). 22. The set according to claim 21, wherein the opening element comprises a first transmission channel (40k) and at least a second transmission channel (40f); wherein the first transmission channel (40k) and the second transmission channel (40f) are in communication with the cavity (41i). 23. Set according to claim 22, and: - the second transmission channel (40f) is located at the height at which the tampon (42) is present, or is surrounded by the tampon (42); or - the second transmission channel (40f) is located on a part of the rod (40) different from the part of the rod (40) on which the tampon (42) is present.