Release stopper, container provided with the stopper, and kit, and release method related thereto

Abstract

1. A release stopper (1) removably coupled to a container (30) for containing and releasing a substance (S) into the container, the stopper comprising: a first body (1a) configured to be directly coupled to the container and comprising a coupling element (10) that enables removably fastening the stopper onto the container; a second body (1b) axially movable relative to the first body along a predetermined axis (X) of the stopper and cooperating with the first body to define a reservoir (20) that constitutes a reservoir for the substance, temporarily isolated from the external environment; and a membrane (15) that constitutes at least a part of a wall of the reservoir, which is openable and / or rupturable to allow communication between the reservoir and the external environment, the stopper comprising a first closed configuration in which the reservoir is isolated from the external environment and a second open configuration in which the reservoir is in communication with the external environment, the membrane being configured to be opened by a perforation or opening element (40, 41, 42) separate from the stopper.

Description

Technical Field

[0001] The present disclosure relates to the field of closure elements for containers, and more particularly to release stoppers. The present disclosure also relates to a container provided with the stopper mentioned above, and also to a method for releasing a substance in the container.

Background Art

[0002] A release stopper is a stopper for a container suitable for storing a liquid or solid in a shape, for example, a powder-shaped substance, for releasing into a container, for example, under determined conditions, such as a container associated with the stopper. Known types of release stoppers typically include a first operating configuration in which the substance is housed in a recess of a predetermined volume within the stopper, and a second operating configuration in which the recess is opened to allow release of the substance. Typically, the release of the substance takes place within the container in a configuration where the stopper is constrained to the container.

[0003] Known types of stoppers can typically show a movable part that is not directly connected to the container itself, which shows a breaking element suitable for opening a membrane that communicates the recess with the external environment.

[0004] Such a stopper can be opened unintentionally and release the substance. The opening can be done using a stopper properly fixed to the container or a stopper free from the container. If the substance is harmful or prone to decomposition, the release of the substance from the container can be dangerous or result in decomposition, and as a result, the substance may become substantially unusable.

[0005] It should be noted that release stoppers are often used not only by professional operators but also by individual users and may be handled by children.

[0006] In the field of collection and / or storage and / or analysis of biological and microbiological samples, it is known to use test tubes, or more generally containers closable by stoppers, in which the biological samples contained are free or deposited by sampling elements.

[0007] It is also known that samples of biological material may need to be subjected to treatment with reagents that can be toxic or toxic in another form.

[0008] For certain types of analysis, the use of reagents must follow their use in a closed environment, i.e., direct release inside the container, for reasons of chemical reaction, reagent decomposition, or operator safety. Nevertheless, certain reagents are very expensive and their dispersion can involve significant costs in addition to the risks of causing the problems mentioned above.

[0009] From US Patent Application Publication No. 2013 / 0092690, a container for biological samples with a stopper suitable for containing a drug is known. The stopper has an ampoule and a piercing element that moves inside the stopper housing. When the stopper is improperly operated, especially when pressurized along its longitudinal axis, the contents of the ampoule are inadvertently released, resulting in a risk that the operator is exposed to danger and / or the drug contained in the ampoule may inevitably disperse.

[0010] Note that this section is presented only to show some of the problems that the object of the present invention is intended to address. Embodiments that may be described in this section should not be understood as part of the state of the art solely because they are described herein.

[0011] In addition, many release stoppers are provided with a structure having a large number of separate parts with sealing rings provided thereon, which has been observed to cause structural and mounting complexity of the stopper itself. These sealing rings are made of silicone or rubber-like materials that can potentially lose their plastic deformation ability over time, resulting in a risk of leakage of the substances contained within the stopper. Additionally, this silicone or rubber-like material may not be chemically compatible with some of the substances or reagents present within the reservoir of the stopper, or may react in another way. The applicant has actually observed that stoppers for containing substances are often stored for long periods, even longer than one year.

[0012] An object of the present disclosure is to describe a release stopper, a container for the stopper, and a kit comprising a container, a stopper, and elements for collecting a biological sample that are useful for solving the drawbacks described above.

Summary of the Invention

[0013] Next, the objects of the present disclosure are described with reference to several aspects that aim to describe the main features of the present invention. The aspects described herein can be combined with each other in alternative and / or cumulative combinations, and / or with parts of the detailed description or the relevant claims.

[0014] According to one aspect, a release stopper (1) suitable for removably coupling to a container (30) and / or so intended, configured to contain a substance (S) and selectively release it into the container (30), the stopper (1) comprising: A first body (1a) configured to be directly coupled to the container (30) and comprising a coupling element (10), the coupling element (10) being suitable for enabling removable fastening of the stopper (1) corresponding to the opening of the container (30), defining a first mounting configuration of the stopper on the container, where preferably the stopper closes the container, and the first body (1a); At least one reservoir (20) that is coupled to the first body (1a), is movable, preferably axially and translationally movable along a predetermined axis (X) of the stopper (1), and is configured to contain a substance (S), defining the second body (1b) together with the first body (1a), wherein the reservoir (20) is isolated from the external environment in at least a first closed configuration of the stopper, the second body (1b) and, A closing element (15) that forms at least a part of the wall of the reservoir (20) and faces the inside of the container (30) in the mounting configuration, and is selectively opened by the action of a perforating or opening element (40, 41, 42) housed in the container, different from the stopper (1), so as to put the reservoir (20) in communication with the inside of the container (30), Open A discharge stopper (1) is described, comprising a closing element (15) that is configured to be enabled and / or destructible and defines at least a second open configuration of the stopper.

[0015] According to another non-limiting aspect, the stopper has, A first closed configuration in which the reservoir (20) is isolated from the external environment, and, A second open configuration in which the reservoir (20) communicates with the external environment, and includes, The membrane (15) or the folding partition is configured to be opened by a perforating or opening element (40, 41, 42) different from the stopper (1).

[0016] According to the present disclosure, "destructible" means a closing element (15) that can be partially damaged so that its integrity can no longer be restored and / or the first closed configuration of the stopper can no longer be restored.

[0017] According to another non-limiting aspect, the closing element (15) comprises or is a membrane or a folding partition, and is optionally provided with a weakened portion.

[0018] According to another non-limiting aspect, the closing element (15) is arranged on and / or is integral with the first body (1a), and / or when at least the stopper is in the first closed configuration, the closing element (15) is integral with the first body (1a).

[0019] According to another non-limiting aspect, the closing element (15) is a waterproof element configured and in particular designed to hold solids, in particular powders, liquids and / or gases.

[0020] According to another non-limiting aspect, at least the lower part (28) of the second body is movably received inside the first body so as to define a reservoir (20).

[0021] According to another non-limiting aspect, the stopper comprises a tapered part or element (14), optionally arranged on the first body (1a), suitable for directing and / or driving at least a part of the piercing elements (40, 41, 42) towards the closing element (15), the tapered part (14) being arranged in a position longitudinally outside with respect to the membrane (15) and / or facing the closing element (15).

[0022] According to another non-limiting aspect, the closing element (15) is selectively Open configured to be enabled and / or destructible by the action of piercing or opening elements (40, 41, 42) movably and optionally removably received inside the container, different from the stopper (1) and different from the container, defining at least a second open configuration of the stopper.

[0023] According to another non-limiting aspect, the stopper (1) is a stopper for a container (30) of biological substances.

[0024] According to another non-limiting aspect, the stopper (1) is a stopper made of an opaque material.

[0025] According to another non-limiting aspect, the second body (1b) is configured to enable removable engagement of the terminal portion of the piercing or opening element (40, 41, 42), in particular, for removable engagement of the terminal portion of the piercing or opening element (40, 41, 42) by opposed introduction, and comprises a cavity (6). The stopper is configured to enable opposed introduction only when in the open configuration, in particular when substantially proximate to or corresponding to the axial minimum extension configuration.

[0026] According to another non-limiting aspect, the reservoir (20) is confined between the first body (1a) and the second body (1b), in particular the lower portion (28) of the second body (1b), by at least the lateral wall of the first body (1a). More specifically, it is centrally delimited by the lower portion (28) of the first body, and / or the lower portion (28) of the second body (1b) is at least partially introduced inside the reservoir (20).

[0027] According to another non-limiting aspect, the tapered portion or element (14) is integral with the first body (1a), is substantially funnel-shaped, and is configured to be accessible from inside the container (30) and / or when the stopper is installed in the container.

[0028] According to another non-limiting aspect, the closing element is configured to withstand pressure caused by axial pressurization of the second body (1b) with respect to the first body (1a), optionally manually caused by an operator. The closing element comprises a weakened portion suitable for first breaking by mechanical opposition caused by the piercing or opening element (40, 41, 42).

[0029] According to another non - limiting aspect, in the open configuration, the substance (S) is at least partially released inside the container (30), and / or the stopper is configured to release the substance (S) into the container (30) when in the open configuration. In particular, when coupled to the container (30), by keeping the entire isolation of the volume defined by the container (30) - reservoir (20) assembly isolated from the external environment, and / or by causing the release of the substance only through the opening defined in particular by the rupture of the membrane (15), it is configured to release the substance (S) into the container (30).

[0030] According to another non - limiting aspect, the stopper comprises a retaining element of a closing element configured to prevent the release and / or fall of the closing element (15) inside the container (30). The retaining element is in particular configured to hold the closing element (15) inside the first body (1a).

[0031] According to another non - limiting aspect, the retaining element comprises a shoulder (15s) against which the closing element (15) leans or folds when facing a perforating or opening element (40, 41, 42).

[0032] According to another non - limiting aspect, the shoulder (15s) is arranged substantially corresponding to the channel between the reservoir (20) and the closing element (15) itself.

[0033] According to another non - limiting aspect, in the opening operation configuration, the closing element (15) is held by the shoulder (15s) and is trapped between the channel and a part of the perforating or opening element (40, 41, 42) arranged in the channel.

[0034] According to another non - limiting aspect, in the opening operation configuration, the membrane (15) is held by the shoulder (15s) and is trapped between the channel and a part of the perforating or opening element (40, 41, 42) arranged in the channel.

[0035] According to another non - limiting aspect, the closing element (15) is configured to break without releasing chips or parts.

[0036] According to another non - limiting aspect, the membrane (15) is rigid or substantially rigid.

[0037] According to another non - limiting aspect, The second body (1b) is movable relative to the first body (1a), and its axial movement defines at least an axially maximum extended configuration of the stopper (1) along the longitudinal axis (X) and an axially minimum extended configuration of the stopper (1) along the longitudinal axis (X). The first closed configuration includes the axially maximum extended configuration, and the second open configuration includes the axially minimum extended configuration. The second open configuration occurs corresponding to an optionally substantially intermediate longitudinal extension between the longitudinal extension corresponding to the maximum extended configuration and the longitudinal extension corresponding to the longitudinal minimum extended configuration.

[0038] According to another non - limiting aspect, the first body (1a) comprises an upper cavity (1c) laterally delimited by lateral walls that are separated from each other by the presence of the closing element (15) and a lower cavity.

[0039] According to another non - limiting aspect, the stopper (1) is suitable and / or is defined to be removably coupled to the head portion of the container (30), and / or the first body (1a) is configured and defined to be removably coupled to the head portion of the container (30).

[0040] According to another non - limiting aspect, the first body (1a) is configured to be rigidly joined and / or fixed to the head portion of the container (30) and / or is configured to abut against the head portion of the container (30).

[0041] According to another non - limiting aspect, the second body (1b) is configured to be installed corresponding to the upper cavity (1c) of the first body (1a).

[0042] According to another non - limiting aspect, the second body (1b) comprises an intermediate section, and the intermediate section comprises a sealing and linear translation limiting element (2) configured to seal the volume of the reservoir (20) and to limit the stroke of the second body (1b) relative to the first body (1a) between a linear maximum extension configuration and a linear minimum extension configuration.

[0043] According to another non - limiting aspect, the second body comprises an upper portion (25) and a lower portion (28) into which the intermediate section is longitudinally inserted.

[0044] According to another non - limiting aspect, the diameter substantially defined by the radially outermost section of the sealing element (2) is significantly larger than the diameter defined by the upper portion (25) and / or the lower portion (28) of the second body (1b).

[0045] According to another non - limiting aspect, the sealing element (2) optionally comprises a shoulder (2s) configured to engage, at a first upper height, with a retaining portion (23) protruding from the inner surface of the lateral wall of the first body (1a), and the engagement between the retaining portion (23) and the shoulder (2s) is such that the second body (1b) cannot be completely withdrawn from the first body (1a) when the second body (1b) is pre - inserted.

[0046] According to another non - limiting aspect, the sealing element (2) comprises a partition wall (2g) specifically configured to seal and enclose the volume of the reservoir (20), and the partition wall has a structure such that it also limits the translation of the second body (1b) relative to the first body (1a) in the axial minimum extension configuration.

[0047] According to another non - limiting aspect, the partition wall (2g) has a radially outer portion that extends on a circular contour defined along a section orthogonal to the longitudinal axis (X), and optionally includes a radially outer portion having a rounded contour.

[0048] According to another non - limiting aspect, the inner surface of the side wall of the first body (1a) has an undercut (17) disposed within the upper cavity, and the partition wall (2g) has a portion configured to introduce itself into the undercut (17).

[0049] According to another non - limiting aspect, the portion mentioned above has a shape that follows one of the undercuts.

[0050] According to another non - limiting aspect, the first body (1a) optionally includes an annular recess disposed at a height that is substantially intermediate between the minimum height and the maximum height defined by the first body (1a) and / or at a height corresponding substantially to the height at which the closing element (15) is located. The annular recess is configured to accelerate the cooling of the first body (1a), particularly of the portion of the first body (1a) where the annular recess is disposed corresponding to the end portion of the first body (1a).

[0051] According to another non - limiting aspect, the first body (1a) comprises a pressure - relief element (29) configured to allow a predetermined amount of air to be discharged when the second body (1b) is introduced into the first body (1a).

[0052] According to another non - limiting aspect, the pressure - relief element (29) is configured to allow a predetermined amount of air to be discharged when the second body (1b) is introduced into the first body (1a) in a non - operative mounting configuration of the second body (1b) within the first body (1a), without affecting the airtightness of the reservoir (20) itself when at least reaching the maximum axial extension configuration.

[0053] According to another non-limiting aspect, in the axially maximum extension configuration, the partition wall (2g) is at a lower or equal inner height relative to the minimum or greater inner height taken by the pressure relief element.

[0054] According to another non-limiting aspect, the pressure relief element (29) is provided with notches and is arranged corresponding to the head portion of the inner surface of the lateral wall of the first body (1a) and / or corresponding to the head portion of the upper cavity (1c).

[0055] According to another non-limiting aspect, the stopper is realized by a plastic material resistant to acids and / or corrosive substances and / or a biocompatible plastic material that does not release substances when in contact with biological samples.

[0056] According to another non-limiting aspect, the stopper is realized by a biodegradable material, particularly a biodegradable plastic material.

[0057] According to another non-limiting aspect, the first body (1a) comprises a gripping portion provided with elements that can enable friction with the hand or finger of the operator.

[0058] According to another non-limiting aspect, the first body (1a) comprises a plurality of recesses or knurling arranged along a direction clearly parallel to a direction substantially defined by the longitudinal axis (X).

[0059] According to another non-limiting aspect, the second body (1b) optionally has a bell-shaped recess (5), and the recess (5) is configured to be coupled to the bottom of the reservoir (20) and has a shape that substantially follows the shape defined by the bottom of the reservoir (20).

[0060] According to another non-limiting aspect, the recess (5) opens onto a cavity (6) configured to allow a removable engagement of the end portion of a piercing or opening element (40, 41, 42) by opposed introduction. The stopper is configured to allow opposed introduction only when in an open configuration, in particular when substantially close to or corresponding to an axial minimum extension configuration.

[0061] According to another non-limiting aspect, the cavity (5) opens onto a cavity (6) which has a plurality of restraint ribs (7) for a piercing or opening element (40, 41, 42).

[0062] According to another non-limiting aspect, the cavity (6) is provided with ribs (7) which extend radially towards the center of the cavity itself and / or are substantially aligned along an axis which substantially coincides with the longitudinal axis of the stopper (1), the ribs (7) exerting a frictional force in the insertion and extraction of a part of the piercing or opening element (40, 41, 42) with respect to the cavity (6) and being configured to assist the transfer of at least a part of the substance (S) from the reservoir (20) to the outside.

[0063] According to another non-limiting aspect, the first body (1a) comprises a side wall on one of its outer surfaces provided with a gripping portion (1z), the gripping portion (1z) optionally featuring knurling and / or ribs configured to facilitate the friction of the user's finger when coupling the stopper container (30) described at least herein.

[0064] According to another non-limiting aspect, the gripping portion (1a) is arranged inside or in the lower part of the base of the side wall.

[0065] According to another non-limiting aspect, the first body (1a) comprises a cooling promoting portion configured to equalize cooling when cooling of the first body (1a) is achieved, and optionally, the cooling promoting portion is arranged in a substantially intermediate region of the first body (1a).

[0066] According to another non-limiting aspect, the cooling promotion part optionally comprises an annular recess (1y) extending over the entire circumference of the side wall of the first body (1a).

[0067] According to another non-limiting aspect, the substance (S) optionally comprises a solid material in granular and / or powder form and / or optionally a gelatinous material and / or a liquid material of Newtonian and non-Newtonian fluids, and / or optionally a gaseous material in gaseous and / or vapor form.

[0068] According to another non-limiting aspect, the release stopper (1) is a disposable stopper.

[0069] According to another non-limiting aspect, the second body (1b) comprises at least one rib (3), preferably a plurality of ribs (3). The rib (3) suppresses and / or limits the offset of the second body (1b) with respect to the first body (1a), and optionally is configured to limit the possibility of inclination of the axis of the second body (1b) with respect to the axis of the first body (1a).

[0070] According to another non-limiting aspect, the at least one rib (3) is arranged within the upper part (25) of the second body (1b), radially away from the side wall of the upper part (25), so that when the second body (1b) is introduced into the first body (1a), it substantially contacts the inner surface of the side wall of the first body (1a).

[0071] According to another non-limiting aspect, the transverse wall of the first body (1a) contributes to defining a cavity into which the second body (1b) is introduced.

[0072] According to another non-limiting aspect, the at least one rib (3) is arranged above an intermediate section comprising a sealing and linear translation limiting element (2).

[0073] According to another aspect, a kit, A container (30) configured to be closed by a discharge stopper (1), Elements (40, 41, 42) for the collection and storage of biological samples, suitable for realizing a piercing or opening element for the discharge stopper (1), A discharge stopper (1) suitable for being removably coupled to the container (30), configured to contain a substance (S) and to discharge it into the container (30), which is suitable and / or intended to removably fasten the container (30) and is configured to contain the substance (S) and selectively discharge it into the container (30), the stopper (1) being A first body (1a) configured to be directly coupled to the container (30) and provided with a coupling element (10), the coupling element (10) being suitable for enabling the removable fastening of the stopper (1) corresponding to the opening of the container (30), defining a first mounting configuration of the stopper on the container, wherein preferably the stopper closes the container, the first body (1a), A second body (1b) coupled to and movable relative to the first body (1a), preferably axially and translationally movable along a predetermined axis (X) of the stopper (1), defining at least one reservoir (20) together with the first body (1a) and configured to contain the substance (S), the reservoir (20) being isolated from the external environment in at least a first closed configuration of the stopper, the second body (1b), A closing element (15) forming at least part of the wall of the reservoir (20) and facing the inside of the container (30) in the mounting configuration, the closing element (15) being selectively Open Configured to be possible and / or destructible, defining at least a second open configuration of the stopper, a kit comprising the stopper (1) comprising the closing element (15) is described.

[0074] According to another non - limiting aspect, the piercing or opening element (40, 41, 42) comprises a rod (40), and in the kit, there is a dimensional ratio, in particular a difference, between the longitudinal extension of the container (30) and the longitudinal extension of the rod (40), more particularly, the difference between the longitudinal extension along the axis (X) of the axial extension of the container (30) along the axis (X) and the longitudinal extension of the axial extension of the rod (40) along the same axis. The longitudinal extension of the rod (40) is such that, when the rod (40) is introduced into the container (30), with respect to the longitudinal extension of the container (30), the closing element (15) can be opened or damaged, i.e., the rod (40) can interfere with the closing element (15).

[0075] According to another non - limiting aspect, the rod (40), when arranged inside the container (30), has a longitudinal extension such that the rod protrudes from the shape defined by the container itself.

[0076] According to another non - limiting aspect, there is described a container (30) for the storage of biological samples, which is openable corresponding to at least one of its own first parts (33), and comprises a body provided with a transverse wall and a bottom wall (32) coupled to the transverse wall (30), and the container (30) is configured to be removably coupled to a stopper (1) according to one or more of the foregoing aspects so as to implement a piercing or opening element (40, 41, 42).

[0077] According to another non - limiting aspect, the container comprises elements (40, 41, 42) for the collection and / or storage of biological samples, provided with a rod (40) and a swab (42), optionally a flocked swab with the rod (40) rigidly attached thereto.

[0078] According to another non - limiting aspect, the container has a longitudinal extension such that, after removably coupling the stopper (1) to the container (30), the piercing of the closing element (15) and the partial introduction of the end (41) of the rod (40) into the first body (1a) are performed by the end portion (41) of the rod on the side opposite to the portion where the swab (42) is located.

[0079] According to another non-limiting aspect, the container comprises a substantially "V" shaped bottom (32) optionally connected without interrupting the lateral walls of the container (30), and corresponding to the bottom (32), the lateral walls taper gradually towards the center of the body of the container (30). The bottom (32) is configured to center a rod (40) and / or a swab (42) along the longitudinal axis (X) of the container (30) for collecting a biological sample.

[0080] According to another non-limiting aspect, the bottom (32) cooperates with the guide portions (13s, 13v) of the stopper (1), in particular the second wall (13s), in order to contribute to the centering of the rod (40) along the longitudinal axis (X).

[0081] According to another non-limiting aspect, the container (30) is a container realized in a plastic material, optionally realized in only a single plastic material, and optionally the plastic material is biocompatible and / or does not release substances in contact with the biological sample.

[0082] According to another aspect, a method for the distribution of substances in a release stopper according to one or more of the foregoing aspects, and / or a kit according to one or more of the foregoing aspects are described, the method comprising the following steps: placing the substance in the first body (1a) of the stopper (1) such that the substance accumulates in a reservoir (20) delimited by a closure element (15); a subsequent step of placing at least partially the second body (1b) within the first body (1a), the placement causing the reservoir (20) and the containment of the substance to be within a closed volume separated from the external environment.

[0083] According to another non-limiting embodiment, at least the step of disposing a substance within the first body (1a) of the stopper and / or the subsequent step of disposing the second body (1b) at least partially within the first body (1a) are performed automatically by a stopper assembly machine.

[0084] According to another non-limiting aspect, the method further includes a step of coupling the stopper (1) to the container (30), whereby the container (30) is provided with a closed and limited volume due to the presence of the stopper (1) corresponding to an opening therein.

[0085] According to another non-limiting aspect, the method further comprises the step of exerting pressure on the second body (1b) of the stopper (1) after or in conjunction with the axial pressurization of the stopper (1), thereby causing a gradual introduction of the second body (1b) into the first body (1a), which causes a corresponding gradual reduction in the volume of the reservoir (20) and a gradual dispensing of the substance (S) into the container (30).

[0086] Thus, according to another aspect, there is provided a method for dispensing material in a container (30), in particular a container for a sample of biological and / or microbiological material, via a release stopper according to one or more of the previous aspects, comprising: - coupling the stopper (1) to the container (30), whereby the container (30) is provided with a closed and limited volume due to the presence of the stopper (1) corresponding to its opening; Placing a piercing or opening element (40, 41, 42) inside the container (30), - piercing the closure element (15) so as to put the inside of the container (30) in direct communication with the reservoir (20) by coupling the stopper (1) to the container (30) and / or the piercing or opening element (40, 41, 42); A step of applying pressure to the second body (1b) of the stopper (1) after and / or in conjunction with axial pressurization of the stopper (1), thereby causing progressive introduction of the second body (1b) into the first body (1a), and progressive introduction of the second body (1b) into the first body (1a) effects a corresponding progressive reduction in the volume of the reservoir (20) and progressive dispensing of the substance within the container (30). A method is described which includes this step.

[0087] According to another non-limiting aspect, at least partial separation of the closure element (15) from the first body (1a) is effected by perforation or opening or breaking of the closure element (15), the closure element (15) being an integral part of the first body (1a) at least prior to perforation or opening or breaking.

[0088] According to another non-limiting aspect, perforation or opening or breaking of the closure element (15) is effected by coupling of the stopper (1) with a perforating or opening element (40, 41, 42), and optionally perforation or opening or breaking of a membrane (15) or a folding partition of the stopper (1) such as to place the interior of the container (30) in direct communication with the reservoir (20) is effected.

[0089] According to another non-limiting aspect, perforation or opening or breaking of the closure element (15) is effected before the stopper (1) engages the container (30) and / or before the stopper (1) is directly coupled to the container (30).

[0090] According to another non-limiting aspect, perforation of the closure element (15), in particular a membrane (15) or a folding partition, is effected before the stopper (1) is progressively screwed into the container (30).

[0091] According to another non-limiting aspect, perforation of the membrane or folding partition is effected by the end portion of the perforating or opening element (40, 41, 42) only when the stopper (1) is disposed within the container (30) by coupling of the stopper (1) with the container (30).

[0092] According to another non - limiting aspect, the coupling of the stopper (1) on the container (30) includes a removable coupling of the first body (1a) of the stopper (1) onto the container (30), in particular a removable coupling of the first body (1a) to the head portion of the container (30).

[0093] According to another non - limiting aspect, when the stopper (1) is coupled onto the container (30), the first body (1a) is rigidly joined and / or fixed to and / or abuts against the head portion of the container (30).

[0094] According to another non - limiting aspect, the removable coupling of the stopper (1) onto the container (30) includes a progressive screwing of the stopper (1), in particular of the first body (1a) of the stopper (1), onto the container (30).

[0095] According to another non - limiting aspect, the piercing or opening or breaking of the closing element (15) is carried out optionally after the engagement of the stopper (1) onto the container (30) and / or after the direct coupling of the stopper (1) onto the container (30), and / or after the axial pressing of the assembly formed by the stopper (1) and the container (30), and / or after at least a partial screwing of the stopper (1) onto the container (30).

[0096] According to another non - limiting aspect, the piercing of the closing element (15), in particular of the membrane (15) or of the folding partition, is carried out by a progressive screwing of the stopper (1) onto the container (30).

[0097] According to another non - limiting aspect, upon completion of the progressive screwing of the stopper (1) onto the container (30), the coupling step between the stopper (1) and the container (30) is completed, and the container (30) is provided, corresponding to one of its openings, with a volume that is closed and delimited by the presence of the stopper (1).

[0098] According to another non - limiting aspect, following the piercing of the closing element (15), the end portion (41) of the piercing or opening element (40, 41, 42) is at least partially introduced inside the first body (1a), holds the closing element (15) on and / or inside the first body (1a), and in particular the closing element (15) is trapped between the lateral surface of the channel for discharging the substance (S) itself and a shoulder (15s) arranged substantially corresponding to said discharge channel.

[0099] According to another non - limiting aspect, the progressive axial pressurization of the stopper (1) ends corresponding to the minimum axial extension configuration of the stopper (1), the second body (1b) has its largest part introduced inside the first body (1a), and optionally, the second body (1b) is completely introduced inside the first body (1a). In said minimum axial extension configuration, the reservoir (20) is, in the case of the largest part, optionally substantially completely free of the substance (S).

[0100] According to another non - limiting aspect, corresponding to the minimum axial extension configuration, the second body (1b) is in a blocking position with respect to the first body (1a) such that the axial extension of the stopper (1) is operationally impossible. The blocking position is determined by the engagement of the stop ring (28p) of the second body (1b) with an annular recess existing corresponding to the inner surface of the lateral wall of the first body (1a).

[0101] According to another non - limiting aspect, due to the progressive axial pressurization of the stopper (1), the flexible skirt (2g) of the second body (1b) slides on the inner surface of the side wall of the first body (1a) in a direction substantially specified by the longitudinal axis (X) of the stopper, whereby the seal of the liquid and / or gas and / or powder material is made so as to allow at least a part of the substance (S) to leak only from the open channel by the destruction of the closing element (15).

[0102] According to another non - limiting aspect, by axial pressurization, the sliding of the skirt (2g) occurs due to the elastic deformation of the skirt (2g), and then the radially outer portion of the skirt (2g) exerts a force on the inner surface of the lateral wall of the first body (1a) in a direction substantially orthogonal to the forward direction of the second body (1b) within the first body (1a) caused by the axial pressurization itself.

[0103] According to another non - limiting aspect, the method includes the non - removable engagement of the end portion (41) of the piercing or opening element (40, 41, 42) corresponding to the cavity (6) realized corresponding to the second body (1b), and the non - removable engagement occurs as a result of the substantial axial pressurization of the stopper (1), and optionally occurs substantially corresponding to or in proximity to the minimum axial extension configuration of the stopper (1).

[0104] According to another aspect, the use of a stopper according to one or more of the foregoing aspects for use in a container configured to contain and / or specifically intended to contain a biological and / or microbiological sample, and / or the use of a stopper according to one or more of the foregoing aspects for containing a substance suitable for enabling the reaction and / or analysis of a sample of biological and / or microbiological material is described.

[0105] According to another aspect, a machine for assembling the stopper 1 according to one or more of this aspect, the operation element is configured to at least perform an operation of disposing and / or injecting the substance (S) into the first body (1a) of the stopper (1) such that the substance (S) is deposited in the reservoir (20) delimited by the closing element (15), the operation element is also configured to perform a subsequent operation of disposing at least partially the second body (1b) into the first body (1a), whereby, by this arrangement, the reservoir (20) and the containment of the substance within the closed volume, separated from the external environment, are effected, and the operation element is configured to automatically perform the operation of disposing the second body (1b) following the placement and / or injection of the substance (S) in the first body (1a), the machine is described.

[0106] According to another aspect, as used herein, a discharge stopper (1) suitable and / or intended to be removably coupled to a container (30), configured to contain a substance (S) and selectively discharge it into the container (30), the stopper (1) A first body (1a) configured to be directly coupled to the container (30) and comprising a coupling element (10), the coupling element (10) being suitable to enable a removable fastening of the stopper (1) corresponding to the opening of the container (30), defining a first mounting configuration of the stopper on the container, where preferably the stopper closes the container, the first body (1a), and A closing element (15) forming at least part of the wall of the reservoir (20) and facing the inside of the container (30) in the mounting configuration, selectively by the action of a perforating or opening element (40, 41, 42) housed in the container, different from the stopper (1), to put the reservoir (20) in communication with the inside of the container (30), Open Comprising a closing element (15) configured to be enabled and / or destructible, defining at least a second opening configuration of the stopper, The discharge stopper (1) is described, the stopper comprising a closing indicator (10k) suitable to engage on the container (30).

[0107] According to another non - limiting aspect, the closure indicator (10k) is configured and / or intended to create an opposition on the container (30) so as to contribute to the sealing of the inner cavity of the container (30).

[0108] According to another non - limiting aspect, the closure indicator (10k) is configured to enable a user to identify a configuration in which the stopper (1) is properly installed on the container (30) so as to complete the sealing and / or isolation of the inner cavity.

[0109] According to another non - limiting aspect, the closure indicator (10k) is suitable for engaging or corresponding to a mating closure indicator (30k) placed on the container (30) that determines the closed configuration of the container (30).

[0110] According to another non - limiting aspect, the closure indicator (10k) is suitable for engaging or corresponding to a mating closure indicator (30k) disposed on the container (30), and determines the fully closed configuration of the container (30) and / or the sealing and / or complete partitioning of the internal volume of the container (30).

[0111] According to another non - limiting aspect, the closure indicator (10k) is an element protruding from the wall of the stopper (1), optionally a ring protruding from the wall of the stopper (1), and the mating closure indicator (30k) comprises a recess disposed in the container (30), optionally an annular recess.

[0112] According to another non - limiting aspect, the closure indicator (10k) is a recess disposed in the wall of the stopper (1), optionally an annular recess disposed in the wall of the stopper (1), and the mating closure indicator (30k) comprises an element protruding from the wall of the container (30), optionally a ring protruding from the side of the container (30).

[0113] According to another aspect, a kit comprising A release stopper (1) according to one or more of the foregoing aspects, and a container (30) provided with an inner cavity closable by the release stopper (1) to define a predetermined closed volume portion, the container (30) being arranged on one of its walls and having a mating closure indicator (30k) suitable for engaging with a closure indicator (10k) arranged on the release stopper (1) at least in a closed use configuration, the engagement of the closure indicator (10k) on the stopper (1) causing a closed configuration of the container (30), optionally a complete closure of the container (30), and / or a sealing and / or a complete partitioning of the inner volume portion of the container (30), is described.

[0114] According to another non-limiting aspect, the container (30) comprises a screw (34) to which the stopper (1) correspondingly engages removably on itself, and the mating closure indicator (30k) is arranged corresponding to and / or in the vicinity of the screw (34) of the container (30).

[0115] According to another non-limiting aspect, the screw (34) is realized corresponding to the neck portion of the container (30) and / or within a part of its substantial end.

[0116] According to another non-limiting aspect, the container (30) is a male-threaded container and / or is provided with a male thread (34) realized on the outer surface of the lateral surface of the container (30). Optionally, the screw (34) extends radially towards the outside of the container itself.

[0117] According to another non-limiting aspect, the container (30) is a female-threaded container and / or is provided with a female thread (34) realized on the inner surface of the lateral surface of the container (30). Optionally, the screw (34) extends radially towards the inside of the container itself.

[0118] According to another non-limiting aspect, the stopper (1) comprises a mating thread (10) suitable for engaging with the thread (34) of the container (30), and the closing indicator (10k) of the stopper (1) is arranged corresponding to and / or in the vicinity of the mating thread (10).

[0119] According to another non-limiting aspect, the stopper (1) is a female-threaded stopper, and optionally the mating thread (10) is arranged corresponding to the inner surface of the outer side wall of the stopper (1).

[0120] According to another non-limiting aspect, the stopper (1) comprises a cavity suitable for removably accommodating at least a part of the container (30), in particular the terminal part of the container (30). The cavity (11) is optionally an annular cavity.

[0121] According to another non-limiting aspect, the inner surface of the outer side wall of the stopper (1) faces the cavity (11).

[0122] According to another non-limiting aspect, the mating thread (10) is arranged corresponding to the cavity (11).

[0123] According to another non-limiting aspect, the guide parts (13s, 13v) comprise an annular wall (13v) that delimits the cavity (11) inwardly, in particular an annular cavity (11) inwardly.

[0124] According to another non-limiting aspect, the mating thread (10) is arranged on the annular wall (13v).

[0125] According to another non-limiting aspect, in the closed configuration where the closing indicator element is engaged with the mating closing indicator (30k), there is at least local elastic deformation in at least a part of the wall of the stopper and / or the container, and / or the closing indicator and / or the mating closing indicator (30k) corresponding to the presence of the container and / or the stopper, and / or the closing indicator element and / or the mating closing indicator (30k).

[0126] According to another aspect, a method of releasing the release stopper (1), optionally the release stopper (1) according to one or more of the foregoing aspects, comprising: introducing a piercing or opening element (40, 41, 42) inside the container (30) through an opening of the container itself, said opening being suitable for removably accommodating the release stopper (1) such that this piercing or opening element (40, 41, 42) is removable from the container (30) and / or is at least partially movable inside the container (30); placing the release stopper (1) substantially corresponding to the opening of the container (30); As a result of the placing step, a closing element (15) suitable for enabling the opening of the reservoir (20) of the release stopper (1) is opened and / or damaged and / or destroyed by said piercing or opening element (40, 41, 42), enabling the release of at least a portion of a predetermined amount of substance (S) accommodated inside the reservoir (S) inside the container (30) by the exertion of a force between the release stopper (1) and the container (30). A method is described.

[0127] According to another aspect of the present invention, a method of releasing a release stopper (1) adapted to be removably coupled to and / or defined as such to a container (30) and configured to contain and selectively release a substance (S) inside the container (30), the stopper (1) comprising: a first body (1a) configured to be directly coupled to the container (30) and provided with a coupling element (10), suitable for enabling a removable fastening of the stopper (1) corresponding to the opening of the container (30), defining a first mounting configuration of the stopper on the container, where preferably the stopper closes the container (30); a first body (1a); A closing element (15) that forms at least part of the wall of the reservoir (20) and faces the inside of the container (30) in the mounting configuration, the closing element (15) being different from the stopper (1) and being selectively Open configured to be openable and / or destructible by the action of a perforating or opening element (40, 41, 42) housed inside the container, and comprising a closing element (15) that defines at least a second open configuration of the stopper, The stopper (1) optionally comprises a closing indicator (10k), the closing indicator (10k) being adapted to engage or corresponding to a mating closing indicator (30k) arranged on the container (30) and defining a closed configuration of the container (30), The method is introducing a perforating or opening element (40, 41, 42) inside the container (30) through an opening of the container itself, the opening being suitable for movably accommodating the release stopper (1) such that the perforating or opening element (40, 41, 42) is removable from the container (30) and / or at least partially movable inside the container (30); arranging the release stopper (1) substantially corresponding to the opening of the container (30); As a result of the arranging step, the closing element (15) is opened and / or damaged and / or destroyed by the perforating or opening element (40, 41, 42), enabling the release of at least a portion of a predetermined amount of substance (S) housed inside the reservoir (20) inside the container (30) by the exercise of force between the release stopper (1) and the container (30). The method is described.

[0128] According to another non - limiting aspect, the placing step includes placing the end portion of the piercing or opening element (40, 41, 42) in substantial contact with the closing element (15) of the release stopper (1), and the exercise of a force intended to cause the opening and / or breakage and / or destruction of the closing element (15) between the release stopper (1) and the container (30) is such that the end portion of the piercing or opening element causes at least partial weakening of the closing element (15) and subsequent reduction of the overall longitudinal extension of the assembly formed by the release stopper (1) and the container (30), and / or introduction of the end portion of the piercing or opening element (40, 41, 42) inside the reservoir (20) of the stopper (1), including pressurization, particularly axial pressurization, between the release stopper (1) and the container (30).

[0129] According to another non - limiting aspect, the placing step includes a direct connection between the release stopper (1) and the container (30), wherein their surfaces are in direct contact with each other. Optionally, the placing step includes a direct connection between the release stopper (1) and the container (30) where the mating screws (10, 34) are in direct contact and engage with each other. After the placing step, the closing element (15) is damaged and / or broken and / or opened by the piercing or opening element (40, 41, 42) as a result of the step of screwing the release stopper (1) onto the container (30), in which at least a part of the stopper (1) rotates relative to the container (30).

[0130] According to another non - limiting aspect, the piercing or opening element (40, 41, 42) comprises a rod (40) having a substantially axial extension. The rod (40) is breakable at least at a predetermined position, particularly at a weakened portion identified by a recess or notch.

[0131] According to another non - limiting aspect, the method includes a step of breaking the rod (40), and the step of breaking the rod is carried out after the step of introducing the piercing or opening element (40, 41, 42) inside the container (30).

[0132] According to another aspect, there are elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples, comprising a rod (40) having a substantially axial extension, and a swab (42), optionally realized corresponding to the end of the rod or a flocked swab to which the rod (40) is firmly and / or rigidly attached. The elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples are such that the rod (40) is at least partially hollow, and by allowing a substance, in particular a fluid, to pass between the inner cavity (40i) of the rod (40) and the outer surface of the rod (40) itself, it is configured to allow a substance, in particular a fluid, to pass between a first part of the elements (40, 41, 42) for storing biological and / or microbiological samples and a second part substantially corresponding to or adjacent to the swab (42). The elements (40, 41, 42) are described.

[0133] According to another non - limiting aspect, the elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples comprise a first transfer duct (40k), optionally a first set of transfer ducts (40k), and at least a second transfer duct (40f), optionally a second set of transfer ducts (40f). The first transfer duct (40k) and the second transfer duct (40f), optionally the first set of transfer ducts (40k) and the second set of transfer ducts (40f), communicate with a cavity (41i). According to another non - limiting aspect, the first part is the end portion (41) of the rod (40) on the opposite side of the part of the rod (40) where the swab (42) is correspondingly arranged.

[0134] According to another non - limiting aspect, the cavity (41i) is at least a first height or part of the rod (40) where the first transfer duct (40k) is correspondingly located, optionally the first height or part of the rod (40) where the first set of transfer ducts (40k) is located, and The second transfer duct (40f) extends between the second height or portion of the rod (40) with which it correspondingly exists, and optionally, between the second height or portion of the rod (40) with which a second set of transfer ducts (40f) correspondingly exists.

[0135] According to another non - limiting aspect, the elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples are configured and intended to cause at least a partial leakage of a substance (S), in particular a fluid, from the reservoir of the release stopper, optionally from the reservoir of the release stopper according to one or more of the aspects described herein.

[0136] According to another non - limiting aspect, the release stopper is the stopper (1), a first body (1a) having a coupling element (10) and configured to be directly coupled to the container (30) for biological and / or microbiological samples, the coupling element being suitable to enable a removable fixation of the stopper (1) corresponding to the opening of the container (30), defining a first mounting configuration of the stopper on the container, where preferably the stopper closes the container (30), and the first body (1a); a closing element, optionally a membrane (15) or a folding partition, which forms at least a part of the wall of the reservoir (20) and faces the inside of the container (30) in the mounting configuration, the closing element, optionally the membrane (15) or the folding partition being configured to be enabled and / or destructible by the action of the elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples when optionally housed inside the container, Open defining at least a second opening configuration of the stopper, and the stopper (1) comprising the closing element, optionally the membrane (15) or the folding partition.

[0137] According to another non-limiting aspect, the first transfer duct (40k), optionally the first set of transfer ducts (40k), is arranged at a height such that when the rod (40) is introduced into the reservoir of the ejection stopper, the rod is located inside the reservoir.

[0138] According to another non-limiting aspect, the first transfer duct (40k) coincides with the cavity (41i) and / or the first transfer duct (40k) is axial with respect to the cavity (41), and / or the cavity (41i) extends to the end portion of the rod (40) and opens to the head portion of the rod.

[0139] According to another non-limiting aspect, the first set of transfer ducts (40k) is arranged radially on the rod (40) and / or the second set of transfer ducts is arranged radially on the rod (40).

[0140] According to another non-limiting aspect, the second transfer duct (40f) or the second set of transfer ducts (40f) is arranged at the height where the swab (42) is present and / or covers the swab (42) and / or is surrounded by the swab (42).

[0141] According to another non-limiting aspect, the second transfer duct (40f) or the second set of transfer ducts (40f) is placed corresponding to a portion of the rod (40) different from the portion of the rod (40) where the swab (42) correspondingly exists.

[0142] According to another aspect, a kit is described that comprises an ejection stopper (1) according to one or more of the aspects described herein and elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples according to one or more of the aspects described herein.

[0143] According to another non-limiting aspect, the kit also comprises a container (30) configured to be closed by the ejection stopper (1).

[0144] According to another non-limiting aspect, the container (30) is a container according to one or more of the aspects described herein.

[0145] Next, the objects of the present disclosure are described in the preferred non-limiting embodiments described with reference to the accompanying drawings.

Brief Description of the Drawings

[0146]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 4a

Figure 4b

Figure 5

Figure 5a

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

DETAILED DESCRIPTION OF THE INVENTION

[0147] The present disclosure shows a release stopper 1 suitable for being coupled to a container 30, such as but not limited to a test tube, for containing and / or storing a biological sample and / or, in some cases, for being submitted to one or more analyses at a subsequent instant. In particular, the coupling between the stopper object of the present disclosure and the container 30 is made corresponding to the opening of the container itself, which in the embodiments described herein and represented in the attached figures also represents the only opening of the container itself. This opening is within the head portion of the container 30, and the release stopper 1 is configured and / or intended to be removably coupled to the head portion.

[0148] The release stopper 1 object of the present disclosure is called a "release stopper" because it is configured to contain a substance S inside one of its reservoirs and to release the substance S from its reservoir into the container 30 in a predetermined manner. The substance S contained in the reservoir can be a fluid, particularly a liquid, or a solid form, such as a granular and / or powder form.

[0149] In addition to solids and liquids, the aforementioned substance S can be or can include a gel-like substance, and / or can include Newtonian and / or non-Newtonian fluids, and / or can be or can include a gas or vapor. Therefore, the stopper object of the present disclosure can contain substances in any form without limitation. In particular, the stopper object of the present disclosure can also be suitable for containing a substance S that emits ionizing radiation and / or can be intended to contain it.

[0150] Figure 1 shows a stopper having a first body and a second body, indicated by reference numerals 1a and 1b respectively, which are movable relative to each other, particularly in a main sliding direction defined by the axis X of the stopper 1 itself. The axis X represents the longitudinal axis of the stopper and, for the sake of convenience of explanation, can also be considered as the longitudinal axis of the container 30. Specifically, the first body 1a is configured to engage directly with the container 30 in a manner centered with respect to the axis X. The connection realized between the first body 1a and the container 30 is such that the first body 1a is firmly integrated and / or fastened to the head portion of the container 30, i.e., it is configured to abut against the head portion of the container 30.

[0151] In this description, reference is made, in some cases, to the height taken by parts and components. Here, the height is outlined as a minimum and a maximum value, and these heights are intended with respect to the portion represented in the attached figures, particularly in the state where the container 30 is vertically arranged with the stopper 1 placed on the head. The height can also be defined as inner and outer with respect to different parts of the stopper or the container, particularly its own end portions.

[0152] In the embodiment described herein, the second body 1b slides relative to the first body by a linear translation along the axis X, but this configuration should not be understood in a limiting sense, because the mutual movement, particularly the mutual sliding between the first body 1a and the second body 1b, can be effected by a combined movement given by the translation resulting along the axis X and the screwing or rotation of the second body 1b onto the mating thread realized on the first body 1a.

[0153] The stopper 1 is suitable for containing a substance inside the reservoir 20 of a limited volume, and has a first operating configuration in which the reservoir 20 is closed with respect to the external environment and a second operating configuration suitable for releasing the substance contained inside the reservoir 20 to the external environment. The reservoir 20 is defined by the connection between the first body 1a and the second body 1b, and is particularly confined substantially laterally by the inner surface of the side wall of the first body 1a, confined downwardly by the wall of the first body 1a and the folding partition, and confined upwardly by a part of the body 1b that contacts the inner surface of the lateral wall of the first body 1a in a seamless manner.

[0154] As will be better explained in the following part of the description, the release of the substance S from the reservoir 20 to the external environment takes place in a preferred but non-limiting operating configuration, involving release inside the container 30. In a preferred embodiment, the relative mobility existing between the first body 1a and the second body 1b of the stopper is such that a plurality of relative positions can be assumed between the maximum axial extension configuration of the stopper 1 and the minimum axial extension configuration of the stopper 1. Preferably, the maximum axial extension position is part of the first operating configuration and the second operating configuration includes the minimum axial extension configuration. In any case, both the first operating configuration and the second operating configuration include an intermediate axial extension configuration between the maximum axial extension configuration and the minimum axial extension configuration. The maximum axial extension configuration is also the placement configuration of the stopper 1. This determines that the switching between the first operating configuration and the second operating configuration takes place in the intermediate axial extension configuration between the minimum configuration and the maximum configuration. In other words, the second open configuration occurs corresponding to a longitudinal extension preferably substantially intermediate between the longitudinal extension corresponding to the maximum extension configuration and the longitudinal extension corresponding to the minimum longitudinal extension configuration. This aspect allows for a specific safe use, for example, by preventing the immediate switching between the first operating configuration and the second operating configuration from being inadvertently performed by a minimal operation on the body of the stopper that causes axial pressurization.

[0155] The transition from the first operating configuration to the second operating configuration is described herein and, in particular in the embodiments represented in the accompanying figures, selectivelyOpen Provided by the destruction of at least a closure element which is a possible and / or breakable and / or pierceable membrane 15 or a folding partition, the closure element thus being intact in the first operating configuration and extending seamlessly to define a wall or part of a wall which contributes, together with other walls, to defining the volume of the reservoir 20. In the second operating configuration, the membrane 15 or the folding partition no longer shows continuity with the wall it reaches for at least a part of it, thus allowing the release of substances inside the container 30.

[0156] The membrane 15, or the folding partition, is installed on the first body 1a and is part of the first body 1a itself. When in at least the closed configuration, this membrane 15 or the folding partition is integral with the first body 1a.

[0157] The membrane 15, or the folding partition, is impermeable to liquids and / or gases and thus constitutes a barrier.

[0158] Thus, the stopper 1 which is the subject of the present disclosure is a stopper provided by an outer element removably arranged inside the container 30, the destruction of the membrane 15 or the folding partition constituting an element of piercing or opening of the stopper 1 for the purposes of the present disclosure, more specifically an element of piercing or opening of the membrane 15 or the folding partition identified as a whole by the reference numerals 40, 41, 42. This piercing or opening element is in particular an element for the collection and storage of biological and / or microbiological samples, and it is the end part of the above-mentioned element that actually causes the destruction of the membrane 15 or the folding partition. Thus, this is not caused, or cannot be caused, by the components of the stopper itself, but on the contrary, is caused by an element separate from the container and / or movably, in particular removably, housed inside the container.

[0159] The membrane 15 or the folding partition described in this specification is not replaceable in its closed configuration and, once opened or otherwise damaged, can no longer be reconfigured even in a configuration that allows for a new closure of the reservoir 20. As a result, the stopper 1 object of the present disclosure becomes a disposable stopper. After the membrane 15 or the folding partition has been opened, damaged, or otherwise destroyed as described below, the closed configuration of the reservoir 20 can no longer be restored.

[0160] As shown in FIGS. 11 and 5, it is possible to observe that the first body 1a has an upper cavity 1c and a lower cavity 14 that are separated from each other by the presence of a membrane 15 or a folding partition disposed corresponding to a short channel that seamlessly connects the reservoir 20 to the lower cavity 14. Within the upper cavity, a reservoir 20 suitable for containing the aforementioned substance is realized by coupling with the second body 1b. The upper cavity 1c is divided into two portions identified by reference numerals 1r and 20'. The first portion (upper) of the upper cavity directly faces the upper opening of the first body 1a. The second portion (lower) of the upper cavity 1c is located in a substantially central region of the first body and communicates with the first portion, but according to the present disclosure, ideally, it is divided from the first portion corresponding to an undercut that is better defined in the following part of the description.

[0161] The upper portion has a substantially cylindrical lateral surface having a first diameter. The lower portion has a substantially cylindrical or slightly flared lateral surface, in either case having a diameter smaller than the diameter taken by the upper portion.

[0162] The first body 1a comprises a lateral wall provided on the outside with a gripping portion 1z, which gripping portion is preferably characterized by ribs arranged substantially along (as shown in the attached figures) or intersecting (not shown in the solution) in the direction specified by the axis X, or more generally, by elements suitable for facilitating the friction of the user's fingers when coupling the stopper to the container 30 described herein. The gripping portion 1z is also useful for facilitating the gripping of an actuator or a spindle, for example of an automatic handling machine. In the configuration shown in the attached figures, this gripping portion 1z is in the base section of the lateral wall. In another form, the upper section of the outer surface of the lateral wall of the first body 1a is preferably smooth but not limited thereto.

[0163] Between the lower section and the upper portion of the outer band mentioned above, the applicant has preferably realized an annular recess 1y defined on a connecting curve, the cavity of which has no corners and / or extends along the entire perimeter of the lateral surface of the lateral wall of the first body 1a. This annular recess 1y is preferably considered to standardize the cooling of the first body 1a during its realization. The applicant has in fact observed that the portion of the lateral wall substantially corresponding to the annular recess 1y is a portion of greater thickness, and thus, in the cooling after the melting or molding of the plastic material of which the first body is made, it is a portion that cools later and still occurs at a higher temperature, more sensitively than the upper and lower end portions of the same body. The applicant has found that, particularly in the case of regions of high material thickness and / or density, this difference in cooling time can weaken the structure of the product and / or lead to the formation of invisible cracks that can cause leakage of part of the substance contained in the reservoir 20. Thus, such a recess 1y has the role of reducing the amount and / or density of the material within the longitudinal central region of the first body 1a and contributing to ensuring the ultimate robustness of the body itself. Although it is preferred that the annular recess 1y be present, its presence is not to be understood as being strictly essential.

[0164] The above-mentioned plastic material in which the first body is realized is a plastic material resistant to acids and / or corrosive substances, particularly those that can be accommodated inside the reservoir 20, and is preferably, but not limited to, a biocompatible material, that is, a material that does not release substances when in contact with biological samples.

[0165] By observing the first body 1a in cross-section, it is possible to see how the lateral wall substantially corresponding to the axial direction faces the annular cavity 11 in the gripping portion 1z. Inside the annular cavity 11, there is a mating thread 10 that can engage during use with the thread 34 present on the outer surface of the upper portion 33 of the lateral wall of the container 30. This portion identifies the head portion of the container 30. The annular cavity 11 is configured to accommodate at least a part of the container 30, particularly a part of the end of the container. The gripping portion 1z is realized corresponding to a part of the lateral wall outside the first body 1, and this portion further has an outer surface (the surface on which the gripping portion is present) and an inner surface, and the inner surface faces the annular cavity 11. In the embodiment shown in the attached figure, the mating thread 10 is realized on this inner surface of the outer side wall of the first body 1a. Therefore, the stopper 1 object of the present disclosure has a female thread. The threads present on the stopper and on the container 30 realize a non-limiting example of a coupling element between the stopper and the container, and the closing of the container is first of all carried out by a rotational movement of at least a part of the stopper 1 with respect to the container 30 (in particular, a rotation around the longitudinal axis X), and this rotation is accurately transferred by the thread into a linear translation along the longitudinal axis X of the stopper 1 with respect to the container itself. The first body 1a also has guiding portions 13s, 13v suitable for at least temporarily guiding and holding the rod 40 of the element for collecting and / or storing biological samples. The mating thread 10 realizes a removable coupling element to enable temporarily fixing the stopper 1 on the container 30.

[0166] The rod 40 described in this specification and shown in the accompanying drawings is, in a particular embodiment, a substantially elongated body provided, for example but not limited thereto, with a swab 42 of flocked material. In a particular embodiment, this swab 42 can be configured to be separated from the rod 40 corresponding to one or more weakened portions disposed in the body of the rod 40 itself, and the rod 40 can also extend inside the swab 42.

[0167] The annular cavity 11 has a circular crown section whose maximum (or outer) radius is given by the inner surface of the lateral wall of the body itself and whose minimum (or inner) radius is given by the guide portions 13v, 13s.

[0168] These guide portions 13s, 13v comprise, in particular, a first annular wall 13v (which, when observed in plan view, is characterized in that its outer periphery is substantially circular) substantially extending along the direction specified by the axis X, and a second flare-shaped wall 13s preferably having a circular cross-section, suitable for specifying a funnel-shaped recess 14 that is convex towards the inside of the first body 1a and concave towards the outside. The recess 14 is, in particular, accessible from the inside of the container 30 and realizes a tapered element or portion suitable for directing the end portion of the rod 40 towards an opening closed by a membrane 15 or a folding partition. The annular wall 13v contributes to defining the annular cavity 11, in particular by delimiting its inner contour.

[0169] As shown in detail in Fig. 17, corresponding to a predetermined portion of the first annular wall 13v, preferably to the upper portion of the annular wall 13v, there is a ring 10k that substantially extends from the outer surface of this annular wall 13v with a semi-circular contour. The ring 10k arranged near the mating screw 10 of the stopper 1 is an integral part and / or a part of the annular wall 13v itself, and in particular, is realized with the same material actually derived from the manufacturing process of the first body 1a. Therefore, this ring 10k is joined to the annular wall 13v seamlessly. This ring 10k is mainly designed to optimize the closing of the stopper 1 on the container 30, and in particular, is designed to fit into the corresponding recess in the neck portion of the container 30. This recess has a semi-circular recess when the ring 10k has a semi-circular contour.

[0170] During use, when a screwing step is performed in which the stopper 1 is screwed into the container 30, the completion of the screwing is provided by the engagement of the ring 10k into the recess present in the neck portion of the container 30 itself. When the ring 10k, and thus the annular wall 13v, is realized with a sufficiently rigid plastic material, at the moment of the engagement of the ring 10k into the recess present in the neck portion of the container 30, a sound, particularly a "click sound", can be heard, and this sound helps the operator to understand that the completion of the screwing has been achieved.

[0171] In a preferred non-limiting embodiment of the stopper object of the present disclosure, the completion of the screwing of the stopper onto the container 30 is provided by the introduction of the ring 10k corresponding to the corresponding recess in the neck portion of the container 30 and the contact of the bottom wall of the annular cavity 11 with the upper edge of the container 30. Preferably, as shown in the attached drawings, the rear wall of the annular cavity 11 is substantially arranged in a direction orthogonal to the axis X.

[0172] The applicant also points out that the presence of the ring 10k configured to effect the completion of the closure of the stopper with respect to the container can disregard the presence of the second body 1b movable with respect to the first body 1a. For this purpose, according to the present disclosure, the release stopper 1 can be designed to be suitable for the container 30 and / or designed to be removably coupled to the container 30, to contain the substance S and to be configured to selectively release it into the container 30, and the stopper 1 is, a first body 1a provided with a coupling element 10 and configured to be directly coupled to the container 30, the coupling element being suitable to enable the removable fixing of the stopper 1 corresponding to the opening of the container 30 and defining a first mounting configuration of the stopper on the container, where preferably the stopper closes the container, the first body 1a and, a closing element 15 forming at least part of the wall of the reservoir 20 and facing the inside of the container 30 in the mounting configuration, the closing element 15 being selectively Open configured to be enabled and / or destructible and defining at least a second opening configuration of the stopper, with the closing element 15, the stopper is suitable to engage on or comprise a mating closing indicator 30k placed on the container 30 and determines the closed configuration of the container 30.

[0173] In particular, the closing indicator 10k is represented by the aforementioned ring, while the mating closing indicator element is represented by the aforementioned recess arranged in the neck of the container 30. The applicant points out that the opposite configuration can also be achieved, in which case there is a ring 10k in the neck of the container 30 and a corresponding recess on the stopper 1. All of these configurations achieve the technical effects mentioned above.

[0174] Also, a kit can be defined, which, in addition to the release stopper 1 of the above-described configuration, includes a container 30 having an inner cavity that can be closed by the release stopper 1 to define a predetermined closed volume portion. The container 30 is placed on one of its walls and includes a mating closing indicator 30k suitable for engaging with the closing indicator 10k disposed on the stopper 1 in at least one closed use configuration. By the engagement of the closing indicator 10k on the stopper 1, the closing configuration of the container 30, optionally the complete closing of the container 30, and / or the sealing and / or complete partitioning of the internal volume portion of the container 30 are carried out.

[0175] The above-mentioned combination of the closing indicator element - mating closing indicator 30k in various alternative forms can realize elements suitable for sealing the container 30 and completely partitioning its internal volume portion, especially when the stopper and the wall of the container (alternatively or in combination with their specific realizations and / or constituent materials) in which these elements are mutually arranged are such as to allow relative elastic deformation. It should be noted that this relative elastic deformation exists at least locally in a part of the stopper and / or the wall of the container where the container and / or the stopper and / or the closing indicator element and / or the mating closing indicator 30k correspondingly exist in the closed configuration in which the closing indicator element is engaged with the mating closing indicator 30k, and / or at least locally in the closing indicator and / or the mating closing indicator 30k. In a specific example of the embodiment of the release stopper 1 described in the present disclosure, this elastic deformation can be enabled by the fact that the main bodies of the stopper 1 and the container 30 are realized in plastic, and the mating closing indicator 30k represented by the annular recess can be assisted by being disposed in a region that corresponds to the neck portion of the container 30 and thus can have a certain degree of elasticity and is usually open. This elastic deformation enables obtaining contact between the stopper 1 and the container 30 such that a force is generated in a direction substantially transverse, preferably orthogonal, to the longitudinal axis X so as to enable safe sealing of the inner volume portion of the container 30.

[0176] The closing indicator 10k can also lean against this inner surface of the lateral surface of the container 30 in an alternative embodiment where the inner surface is without the mating closing indicator 30k. Therefore, the presence of the combination of the closing indicator 10k - mating closing indicator 30k should not be intended as a limitation, and in any case, it satisfies the technical effect of assisting in the sealing and / or complete closing of the cavity of the container 30 itself.

[0177] As can be seen from the attached figures, the funnel-shaped recess 14 is placed at a longitudinally outer position with respect to the membrane 15 or the folding partition, and the membrane 15 or the folding partition is, as a result, at a more rearward position or equivalently a higher position with respect to the height at which the recess 14 is located. This opening has a diameter slightly larger than the diameter assumed by the rod 40. The upper part of the rod 40 is precisely the aforementioned outer element that can cause the destruction of the membrane 15 or the folding partition. Specifically, the membrane 15 or the folding partition extends orthogonally to the axis X and is preferably, but not limited thereto, realized as an integral part of the second wall 13s and is thus substantially rigid and strong enough to withstand the pressure that can be caused by the operator's actions on the at least occasional second body 1b. The second wall 13s is provided with an inner surface that defines the bottom wall of the reservoir 20, which is laterally bounded by a wall of circular or cylindrical section.

[0178] The second wall 13s is flared so as to move along the axis X towards the base of the stopper 1, and the diameter of the circumference defined by the second wall 13s along the cross-section cut in a plane orthogonal to the aforementioned axis X appears to be gradually increasing. In other words, the wall 13s is convex upwards, i.e., towards the head part of the first body 1a.

[0179] The lateral wall of the first body 1a extends seamlessly up to the head of the body itself, defining an upper recess which corresponds to the upper cavity and is delimited at the bottom by the second wall 13s, precisely by its upper face, and by the cavity in which the membrane 15 is present inside. The upper recess is suitable for accommodating at least a part of the second body 1b and has a shape which allows sliding with respect to the first body 1a. In particular, as observable for example in Figure 15 or Figure 16, the upper cavity 1c has a size such as to accommodate all of the second body 1b when the stopper 1 is in the minimum axial extension configuration.

[0180] Corresponding to the end, the upper cavity 1c has a tapered portion 1i which is configured to allow the introduction by the opposition of at least a part of the second body 1b and is also configured to hold at least a part of the second body 1b inside the upper recess. Thus, such a tapered portion 1i makes it possible to delimit the stroke of the second body in the sense of the maximum axial extension configuration, thereby indirectly causing the definition of the maximum volume that the reservoir 20 can take when the stopper 1 is in the aforementioned maximum axial extension configuration. By observing the upper cavity 1c in a cross-section orthogonal to the axis X, it can be verified that, moving from the upper end towards the membrane 15 or the folding partition, after a first sub-section having a constant diameter, the light of the upper recess gradually decreases and the perimeter of the diameter gradually decreases until reaching a predetermined depth height within the same upper recess 1r. Such a predetermined depth height is schematically indicated by reference Q in Figures 5 and 16. Thus, the inner face 23 of the lateral wall of the first body defines a tapered cross-sectional surface which corresponds to a shoulder 24 having an annular portion of the wall oriented along a plane substantially orthogonal to the direction identified by the axis X, which determines the stop point of a part of the second body 1b. The second body, when introduced inside the upper recess 1r, in particular by the introduction by opposition with an elastic deformation of one of its elements, can no longer be withdrawn from the recess 1r itself after the aforementioned shoulder 24. The decrease in diameter caused by the shoulder 24 is such as not to cause any plastic deformation of any part of the second body 1b when introduced into the first body 1a.

[0181] As already mentioned, there is an annularly shaped "V-shaped" undercut 17 between the first and second sections of the upper cavity, and this undercut 17 is configured to accommodate a part of the second body 1b, particularly when the stopper 1 is in the minimum axial extension configuration.

[0182] This V-shaped undercut 17 functions as a stopper for the aforementioned part of the second body 1b. As a result, with the gradual decrease in the axial extension of the stopper 1b caused by the introduction of the second body 1b into the body 1a, such a part of the second body 1b reaches and opposes the vertex of the V formed by the undercut 17, causing the sliding of the second body 1b along the aforementioned longitudinal axis X to stop.

[0183] The applicant observes that in the maximum axial extension configuration, a shoulder 1s existing on the outer lateral surface of the second body 1b is arranged relative to a shoulder 24 existing on the inner lateral surface of the first body 1a. In such a configuration, a part of the lower portion 28 of the second body 1b is partially introduced into the lower section of the upper cavity of the first body 1a.

[0184] The applicant has observed that during the attachment step, an unintentional pressure caused by the connection of the second body 1b to the inner surface of the aforementioned lower section may occur in the reservoir 20. To reduce the adverse effects of such pressure, the applicant has provided a pressure relief cut, shown in FIG. 11 by reference numeral 29, in the upper section of the first body 1a, particularly in the head section. This pressure relief cut is preferably, but not limited thereto, oriented in a direction substantially parallel to the direction specified by the axis X and is configured to allow the discharge of the pressure inside the reservoir 20 in the non-operating state, i.e., during attachment, without affecting the airtightness of the reservoir 20 itself when at least the maximum axial extension configuration is reached.

[0185] In certain non-limiting embodiments, the stopper object of the present disclosure has a selective blocking element specifically configured to cause a blockage of the movement of the first body relative to the second body when in a configuration different from the closed configuration and / or different from the axial maximum extension configuration and / or following the opening of the reservoir 20. These elements of the selective block can, for example, substantially correspond to the V-shaped undercut 17 and comprise an annular notch 20k disposed particularly on the inner surface of the lateral wall of the lower section 20'. This notch 20k is preferably configured to be able to accommodate an opposing ring 28p that extends radially from the lateral surface of the lower portion 28 of the second body 1b when present. Such an impact ring also realizes a part of the said selective blocking element. In a preferred non-limiting embodiment, the concave surface taken by the annular notch 20k has an equal shape and is opposite to the convex surface taken by the opposing ring 28p. The opposing ring 28p and the annular notch 20k cooperate with each other to enable the locking of the stopper in the above configuration of the minimum axial extension by the opposing introduction of the opposing ring 28p inside the annular notch 20k when the stopper is in the axial minimum extension configuration. In this way, for example, it is possible to prevent the stopper from unintentionally returning in the axial configuration of a greater axial extension due to the pressure increase inside the container and / or the external environmental pressure decrease that may occur when the container with the screwed-in stopper is carried at a high altitude or inside an airplane, which can cause the stopper to pop out. Also, in this way, it is always possible to provide the "used" stopper with the same outer unambiguous geometric shape that can be adapted to an automatic handling device for containers for biological materials. For example, this handling device can detect the difference between the stopper with the substance S still in the reservoir 20 by means of mechanical or optical sensors and the "used" stopper whose size has decreased due to the axial pressurization between the first and second bodies. In particular, in this way, it becomes possible to easily handle the stopper 1 via an automatic uncorking device.

[0186] In a particular embodiment represented in the figures attached to this specification, the lateral wall of the reservoir 20 is not completely cylindrical but is flared. The diameter of its section along a plane orthogonal to the axis X gradually decreases as it progresses from the head portion towards the second wall 13s.

[0187] The destruction of the membrane 15 or the folding partition by the upper portion of the rod 40 is carried out in the form shown in FIGS. 11, 12, and 13 and is described in detail below.

[0188] The destruction of the membrane 15 or the folding partition is achieved by using the upper portion of the rod 40 pre - placed inside the container 30, as schematically shown in FIG. 10. In this first step, as shown in FIG. 11, the membrane 15 or the folding partition is intact.

[0189] The destruction of the membrane 15 or the folding partition is given by the ratio, specifically by the dimensional difference between the longitudinal extension of the container 30 and the longitudinal extension of the rod 40, or more precisely, by the difference between the longitudinal extension of the axial extension of the container 30 along the axis X and the longitudinal extension of the axial extension of the rod 40 along the same axis X. The length of the rod 40 must be sufficient so that when the rod 40 is introduced inside the container 30, it can interfere with the membrane 15 or the folding partition so as to be able to open or damage the membrane 15 or the folding partition.

[0190] In a non-limiting embodiment, by gradually screwing the screw 10 of the stopper 1 into the screw 34 on the outer surface of the lateral wall of the container 30, a gradual approach of the stopper 1 towards the rod 40 itself is effected. The upper portion of the rod is guided by the wall 13s towards the opening where the membrane 15 or the folding partition is present. Here, it is pointed out that the guidance exerted by the lateral wall 13s is appropriately provided by its shape and does not require special attention by the user. In this way, a rod 40 that is not axially aligned along the axis X and / or is inclined with respect to the axis X can be properly and accurately guided towards the opening where the membrane 15 or the folding partition is present by the simple and gradual screwing of the stopper on the container. By the gradual screwing, the upper end of the rod 40 reaches a state of being mechanically opposed to the membrane 15, and by further screwing the stopper thereafter, the membrane 15 or the folding partition is broken (this situation is schematically shown in FIG. 12).

[0191] At this point, due to this breakage, the aforementioned reservoir 20 is opened, and as a result, the reservoir 20 and the container 30 are in direct communication.

[0192] Therefore, in the embodiment described above, merely supporting the stopper 1 on the container 30 is not sufficient to break the membrane 15 or the folding partition so as to enable the opening of the reservoir 20.

[0193] In an embodiment alternative to the previous embodiment, when the stopper 1 approaches the container 30, before the engagement of the screw 10 onto the screw 34 of the stopper 1 can be achieved, the stopper 1 remains "rested" on the rod 40, particularly on the end portion opposite to the portion where the swap is present. In particular, this support can be provided by the fact that the rod 40 is long enough to extend out of the shape defined by the container 30. The support is carried out with the end of the rod 40 resting on the membrane 15 or the folding partition. The weight of the stopper 1 is not sufficient to cause the rupture of the membrane 15 or the folding partition. To break the membrane 15 or the folding partition by opening the reservoir 20, an additional pressure on the stopper, particularly on the first body 1 of the stopper itself, is required. At this point, the intrusion of a part of the rod 40 into the first body 1a is achieved, thereby determining the possibility of joining the screw 10 to the screw 34 of the stopper 1. By the progressive screwing of the first body 1a of the stopper 1 into the container 30, a progressive and always greater introduction of the rod 40 into the first body 1a is carried out.

[0194] The applicant points out that the diameter of the membrane 15 or the folding partition, or equivalently the diameter of the opening defined by the second wall 13s, is larger, and in particular significantly larger, than the diameter of the portion of the rod 40 introduced therein. In this way, it is possible to have liquid leakage, or equivalently the passage of substances from the reservoir 20 to the container 30. In the present disclosure, the diameter has been discussed so far in relation to the main bodies of the membrane 15 and the rod 40. However, the rod 40 can have a shape different from circular, for example polygonal. In that case, it should be understood that the size of the opening must in any case be larger than the size of the section that the introduced portion of the rod 40 has along a plane orthogonal to the axis X. There is no opposed introduction between the opening and the main body of the rod 40, but there is a substantially free introduction. Here, incidentally, the rod 40 rotates freely or has a gap in the opening itself. The applicant has observed that during use, especially when handling samples of biological materials, it is necessary to prevent undesirable materials from being dispersed inside the container 30. Among these undesirable materials, there is the membrane 15 or the folding partition which, when broken, is effectively held inside the stopper 1 object of the present disclosure. Among the technical solutions suitable for achieving this effect, the applicant has realized a membrane 15 or a folding partition in the form of a thin plastic wall arranged orthogonally to the axis X and designed to break without releasing fragments. In addition to this aspect, the applicant has designed a membrane 15 or a folding partition with a non-uniform and / or asymmetric shape, but preferably with a weakened portion provided at a position corresponding to the junction with the lateral wall of the opening. This weakening is preferably achieved by reducing the local thickness of the membrane 15 or the folding partition itself.

[0195] Optionally, but not limited thereto only, the stopper object of the present disclosure comprises a holding element for a membrane 15 or a folding partition configured to prevent the membrane from being released and / or falling into the container 30. In the embodiment represented in the attached figures, this holding element comprises a shoulder realized near the channel connecting the reservoir 20 to the outside. Specifically, the channel to which the membrane 15 or the folding partition provides access is provided with a shoulder 15s, which is suitable for including the membrane 15 or the folding partition bent so as to be substantially arranged in a plane parallel to the axis X. This shoulder is preferably opposite to the weakened part. As shown in the sequences of FIGS. 11, 12 and 13, when the weakened part of the membrane 15 or the folding partition is folded due to the effect caused by screwing the stopper 1 into the body of the container 30, the membrane gradually bends in the direction indicated by the arrow P corresponding to one of the portions of that part of the joint with the shoulder 15s. As the insertion of the rod 40 progresses, the membrane transitions from a configuration substantially orthogonal to the axis X, through a configuration inclined with respect to the axis X, to a configuration substantially parallel to the axis X and trapped between the lateral surface of the opening and the rod 40 itself. Therefore, the presence of the shoulder 15s makes it impossible for the membrane 15 or the folding partition to be folded inside the container 30 after its breakage, even if the part near the shoulder 15s is completely broken as a result of bending. In a preferred non-limiting embodiment, the membrane 15 or the folding partition optionally has a weakened part located opposite to the joint part with the shoulder 15s.

[0196] The second body 1b is schematically shown in FIGS. 3 (lateral view) and 4 (cross-sectional view along line A-A of FIG. 3). The second body 1b acts as a piston and, during use, contributes to pressurizing the volume of the reservoir 20 that holds the substance inside the recess itself, and forces leakage through the opening following the breakage of the membrane 15 or, if present, the auxiliary membrane 19.

[0197] The second body 1b comprises an upper part 25, a lower part 28 axially opposite the upper part 25, and an intermediate element 2 or a sealing element placed longitudinally between these two. The upper part 25 has a substantially cylindrical shape with at least partially a first characteristic diameter and, corresponding to its intermediate part, has a first upper shoulder 2s with a second characteristic diameter larger than the first characteristic diameter, and has a linear translation limiting element 2. In Figure 4, the two characteristic diameters are indicated by 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 comprises a linear translation limiting and sealing element, in particular a linear translation limiting element along the axis X.

[0198] In the embodiment represented in the accompanying drawings, the upper part 25 of the second body 1b comprises a plurality of ribs identified by reference numeral 3 that radially deviate from the upper part mentioned above. These ribs can be seen, for example, in Figure 3 and, as can be observed in this figure, although not limited thereto, they are preferably arranged so as to be oriented substantially parallel to the axis X for one of these directions of maximum extension. The set of ribs 3 at the point of maximum radial extension delimits a perimeter circumscribed by a circle having a diameter larger than the aforementioned first characteristic diameter d1. The purpose of these ribs 3 is to optimize the alignment of the second body 1b with respect to the first body 1a with respect to the axis X and / or to reduce, and ideally avoid, the possibility that the second body vibrates with respect to the axis X of the stopper and arranges the second body itself such that one of its axes is inclined with respect to the axis of the first body 1a. In this way, the sealing of the intermediate element or the sealing element is optimized even when an unintended force acts in a direction significantly inclined with respect to the axis X itself on the second body 1b. The radially outermost part of the ribs 3 is substantially in contact with the inner surface of the lateral wall of the first body 1a.

[0199] The wall starting from the shoulder defines a substantially V-shaped annular notch 2i, which is delimited downward by a partition wall 2g that rejoins the cylindrical or slightly truncated conical lower part 28 of the second body 1b and forms an acute angle therewith. When observing the second body 1b in cross-section along a plane parallel to the axis X from the front, the partition wall 2g consequently slopes downward, i.e., towards the bottom of the reservoir 20 that encloses a channel enabling access to the membrane 15. In particular, when observing the partition wall 2g along a section on a plane parallel to the longitudinal axis X, this wall is oriented in an inverted V with its apex facing upward. The applicant has observed that the downward slope enables sealing when the pressure increases within the reservoir 20. In fact, when the pressure rises, the force exerted by the pressure tends to "open" the partition wall 2g, but the partition wall 2g is laterally limited by the lateral walls. For this reason, the frictional force increases as the pressure within the reservoir 20 rises. Thus, the partition wall realizes a structure capable of increasing the pressure resistance and / or the opposing force against the inner surface of the lateral wall of the first body 1a in accordance with the increase in pressure within the reservoir.

[0200] The applicant observes that the maximum diameter of the lower part 28 of the second body 1b is significantly smaller than the diameter specified by the lateral wall of the lower part 20' of the upper cavity 1c of the first body 1a. The light (annular) existing between the two elements allows the leakage of substances beyond the undercut 17 in the shape of a swallowtail.

[0201] The partition wall 2g extends radially from the cylindrical part of the second body 1b such that its radially outermost part has a third characteristic diameter d3 that is larger than the second characteristic diameter d2. This third characteristic diameter d3 is only slightly larger than the second characteristic diameter and is relatively large on a scale that is accommodated between 1% and 2%.

[0202] The partition wall 2g extending over the entire circumference of the corresponding part of the second body 1b can be bent towards the lower cylindrical part of the second body 1b in such a way that it has a relative elastic flexibility allowing it to bend itself in means enabling the introduction of the second body into at least the first body 1a. In particular, the flexibility of the partition wall 2g is such that, by the bending described above, the third characteristic diameter d3, which is substantially defined thereby in the stationary state, can be temporarily reduced, for example by 10% - 20%, preferably 15%, without breaking, and then return substantially to the same third diameter d3 by elastic release. Advantageously, at least this partition wall 2g is made of a suitable plastic material. However, the embodiments of the stopper described here are such that all second bodies 1b are integrally made of plastic material, for example for molding. As in the case of the first body 1a, the second body 1b is also preferably made of a plastic material resistant to acids and / or corrosive substances, in particular capable of being housed inside the reservoir 20, and is preferably, but not limited to, a biocompatible material, i.e. a material of such a nature as not to release substances when in contact with biological samples.

[0203] The partition wall 2g acts as a scraper capable of effecting a seal of liquids and powders or granular substances even during a linear translational movement along the axis X carried out during the movement of the second body 1b under pressure. In this way, the containment of the reservoir 20 suitable for containing the substance S mentioned above is effected without using a deformable sealing ring or O-ring, which simplifies the realization of the stopper object of the present disclosure, reduces the number of separable components and contributes in particular to optimizing the production economy on a large scale.

[0204] Therefore, the reservoir 20 capable of containing substances is a cylindrical annular part defined between the outer surface of the lateral wall of the second body 1b below the partition wall 2g and the inner surface of the upper part 1r of the lateral wall of the first body 1a, (upper) partition wall 2g, (Through the annular light existing between the lower portion 28 of the second body 1b and the lateral wall of the lower portion 20' of the upper cavity 1c of the first body 1a), the outer surface of the lower portion 28 of the second body 1b and the inner surface of the lateral wall delimiting the lower portion 20' of the above-mentioned upper cavity 1c of the first body 1a, The second wall 13s, The opening and the corresponding membrane 15 or the folding partition Is defined between.

[0205] In other words, the reservoir 20 has a complex shape including an annular leakage portion that identifies the upper and lower regions substantially joined to each other, and the leakage portion is given by a dimensional difference, for example, a part of the second body 1b (especially the lower portion) when introduced into the upper cavity 1c of the first body 1a and the inner surface of a part of the lateral wall of the first body 1a. The difference in diameter between.

[0206] The radially outermost portion of the partition wall 2g can have a shape with a substantially sharp edge as in the case of FIG. 4a or a rounded contour as in the case of FIG. 4b. The applicant has found that the rounded contour contributes to improving the airtightness of the partition wall 2g on the inner surface of the lateral wall of the first body 1a, reducing scratches on the first body 1a, and improving the ease of installation after installing the second body 1b in the first body 1a. The rounded contour also reduces the risk of plastic deformation of the edge of the partition wall 2g that could otherwise occur during installation. Such a roundness can be in the shape of a circular sector or in the shape of other defined curves without angular points.

[0207] Unlike the partition wall 2g, the ring identified by the first upper shoulder 2s is not flexible and is preferably configured to maintain the centering of the second body 1b within the cavity of the first body 1a.

[0208] As can be clearly seen in FIG. 4, the lower part of the second body 1b has a bell-shaped recess 5 provided by the inner surface of the lateral wall of the lower part. The bell-shaped recess 5 is inclined with respect to the axis X, whereby the mouth of the bell, which corresponds to the lower end portion of the second body 1b, has a larger diameter, clearly the maximum, and the head portion of the bell is recessed and has a diameter smaller than the maximum diameter mentioned above.

[0209] The applicant has conceived the shape of the bell 5 in a particular way, which bell coincides with the shape in which the reservoir 20 is present within its lower part, and in particular has the shape given by the second wall 13s (in particular, its inner surface) and the opening defined thereby. In this way, when the second body 1b is introduced inside the first body 1a with respect to the maximum part and the above-mentioned axial minimum extension configuration is determined, the lower annular outer periphery 4f defined by the mouth of the bell 5 is inclined at the apex of the notch defined by the second wall 13s within the reservoir 20. For careful measurement and design clearances, in this configuration, the surface of the bell defined by the inner surface of the wall is at least partially, preferably substantially completely, inclined on the inner surface of the second wall 13s of the first body 1a, and at the same time, the partition wall 2g is also substantially inclined within the undercut 17. This state is shown in FIGS. 15 and 16. In this way, during the step of axial pressing of the stopper, there is a squeezing action of the substance contained in the reservoir 20, whereby the amount of substance remaining in the stopper 1 when the stopper 1 is in the axial minimum extension configuration can be minimized as much as possible, ideally reduced to 0.

[0210] Corresponding to the head of the bell 5, a housing 6 is obtained that includes a part of the end of the rod 40 during use and is particularly suitable for holding this by means of opposed introduction. For this purpose, a plurality of restraint ribs 7 are provided on the inner surface of the housing 6, and these restraint ribs are each arranged along a direction parallel to the direction specified by the axis X, preferably not limited thereto, and terminate towards the center of the housing 6 itself specified by the axis X. In this way, when the second body 1b is pushed into the first body 1a to a sufficient extent, the upper end portion of the rod 40 is introduced into the housing 6 and remains held. As a result, when the operator removes the stopper 1 from the container 30, the operator also holds the rod 40 together with the stopper itself, and the stopper acts as a handle for the rod 40 at this point, thereby suitably reducing the risk of contamination between the rod and the operator and conveniently preventing the operator from contaminating themselves with a part of the biological sample present on the rod and / or residues of substances.

[0211] The attached figures, particularly FIGS. 8, 10, 14, and 15, show specific embodiments of a container 30 that is basically a tube for the collection and / or storage and / or analysis of biological samples. This container is preferably made of a plastic material, such as, but not limited to, PP or PET or other plastic materials, and is preferably designed not to release substances into the biological sample when contained therein. In particular, this can be a plastic test tube, optionally transparent, for example, but not limited to, equal to 12 mm × 80 mm. This shape should not be understood as a limitation. In the illustrated embodiment, the container 30 has a generally cylindrical body that is open corresponding to a single end (upper end) where the thread 34 is correspondingly present.

[0212] The Applicant observes that, substantially corresponding to the rupture of the membrane 15, the screw-mating screw connection, optionally but preferably present, together with the sealing ring 10k, ensures a watertight connection between the container 30 and the stopper 1, thereby preventing the exit of dust, liquid, and gas from the container and the stopper. For this purpose, the screw and mating screw described here are preferably of the double-screw type. This allows for a high feed rate along the axis X and reduces the weakening of the resistance section of the lateral wall that might otherwise be possible by using a single screw.

[0213] The Applicant observes that the screw-mating screw connection can be such that the screw 34 extends from the body of the container 30 or provides a recess realized on the body of the container 30. In particular, in the embodiment described so far and represented in the attached figures, the screw 34 is present on the outer surface of the lateral wall of the container 30 (the container can thus be said to have a male screw) and extends radially from such an outer surface. This configuration is not to be understood as limiting. The reason is, although not to be understood as limiting, that in further embodiments, the screw of the container 30 can be arranged on the inner surface of the lateral wall of the container 30. When the screw is present on the inner surface of the lateral wall of the container 30 and thus the container 30 has an inner screw, there can be a solution where the screw extends radially inwards, in particular up to the center of the container 30, or is realized through a recess on the inner surface of the lateral wall of the container 30. Consistently, when the screw is made on the inner surface of the lateral wall of the container 30, the mating screw 10 present on the object of the stopper 1 of the present disclosure can be realized either on the outer surface of the stopper 1 itself or alternatively on the annular wall 13v.

[0214] The opposite end (lower end) of the container 30 is marked by a V-shaped bottom 32. In particular, the lateral walls taper progressively towards the center of the body of the container 30 about the aforementioned axis X in the attached figures. The bottom 32 is configured to effect the centering of the rod 40 and / or the swab 42 for the collection of biological samples along the axis X. Thus, the V-shape of the bottom 32 cooperates with the guiding portions 13s, 13v, in particular the second wall 13s, to contribute to the centering of the rod 40 along the axis X. Optionally, but not limited thereto, the V formed by the bottom 32 has no apex and the shape assumed by the bottom 32 is a truncated V-shape. In this case, the wall delimiting the bottom has a central section arranged in a plane orthogonal to the plane of the axis X. A culture medium can be deposited on the bottom of the container 30 during use.

[0215] One or more support legs 31 for realizing the support skirt can be present at the lower end of the container 30 to keep the container 30 in an upright position. The support legs 31 can be integral with the body of the container 30, for example in a molding process, and can also be integral with the bottom 32 so as to join seamlessly with each other. Further, the support legs 31 can be realized from a ring joint with the lateral walls of the container 30.

[0216] The body of the stopper 1 is preferably realized in a plastic material resistant to acids and / or corrosive substances and / or in a biocompatible plastic material so as not to release substances when in contact with biological samples. In certain embodiments, the plastic material in which the stopper is realized is opaque, and thus the substance S cannot be seen from outside the stopper itself. By hiding the substance S and preventing it from freely moving within the container 30, the risk that a particular subject, including children who may have access to the stopper 1 described herein, will swallow or otherwise come into contact with the substance S is reduced. The use of an opaque stopper is also effective when the substance S contained in the reservoir 20 is photosensitive. The reason is that in this way, even if the stopper object of the present disclosure has to be left in the exposed area for a long time, the risk of decomposition of the substance S itself is reduced.

[0217] So far, the release stopper 1 having a screw for coupling with the container 30 has been described, but this particular technical feature is not limiting. In fact, in embodiments not shown in the accompanying drawings, the removable coupling can be realized by a clip suitable for engaging an undercut present on the container 30 and placed on the stopper 1, or vice versa, by a clip suitable for engaging an undercut present on the outer surface of the stopper 1 and placed on the container 30. Here, the clip can be configured to cause significant pressurization of the stopper 1 against the container 30 during closing, resulting in a reduction in the axial extension along the axis X of the assembly formed by the stopper 1 and the container 30, and it has been observed that this pressurization or reduction in axial extension thereby indirectly enables the piercing of the membrane 15.

[0218] During the attachment of the stopper 1, the operator, or a machine, first performs the following steps.

[0219] Placing the substance within the first body 1a of the stopper 1 such that the substance is deposited within the reservoir 20 delimited by the membrane 15 or the foldable partition. A subsequent step of at least partially disposing the second body (1b) within the first body (1a), whereby a reservoir (20) within a closed volume and containment of a substance are effected, isolated from the external environment.

[0220] The Applicant observes that at least the two steps described above can be realized by a machine for assembling the stopper (1). In this way, a large number of stoppers (1) can be attached in a very short time. The assembly of the stopper described herein can alternatively be carried out by an operator performing subsequent operations, or alternatively by a specific operator of the manufacturing company of the stopper (1).

[0221] In particular, the placement of the substance (S) within the first body (1a) can be by injection of a fluid, a gelatinous material or a solid material within the first body (1a), whereby this fluid or solid material is first deposited on a membrane or a folding partition and then fills part of the portion above a cavity defined within the first body (1a). Also, the placement of the substance (S) within the first body (1a) can include the introduction of two main substances that can react to form a gas or vapor, the gas or vapor being capturable within the reservoir (20) by a seal effected by the second body (1b). When the injection is effected by the aforementioned machine, this injection can be carried out taking into account a predetermined injection time (where the flow of the fluid or solid material from the machine to the stopper (1) is known) or the difference in weight of the fluid or solid material within the reservoir of the aforementioned machine, for having a predetermined constant transfer of the substance. In a particular embodiment, the machine can comprise a gripper element for holding the first body (1a) in a predetermined position and other elements for introducing at least partially the second body (1b) within the first body (1a) as described above.

[0222] When this successive step is carried out, in particular by the introduction of the second body within the first body, when the volume of the reservoir (20) is properly defined and insulated, the stopper is ready for operative use.

[0223] In the use via the elements of sampling and storage of biological material, the operator first collects the biological material of interest and deposits it inside the container, taking care to place the elements of sampling and storage of biological material such that the swab 42 is placed at the bottom of the container itself. If there is a culture medium inside the container 30, the swab 42 can be advantageously placed in contact with the culture medium itself.

[0224] In a subsequent step of the coupling, the stopper 1 is coupled to the container 30 and the elements for collection and storage of biological material, and after completion of the coupling, the container 30 has a closed, limited volume corresponding to one of the openings of the container, by virtue of the presence of the stopper 1. As a result of the coupling of the stopper 1 with the container 30 due to interference with the rod 40 housed inside the container 30 in particular, and by axial pressurization between the stopper 1 and the container 30, a perforation of a membrane or a folding partition is effected such that the inside of the container 30 communicates directly with the reservoir 20. It should be noted that the sealing action exerted by the partition wall 2g following the perforation of the membrane 15 does not allow the overall release of the substance S inside the container 30: leakage can exist even without a pressure action towards the axial minimum extension configuration, but in practice, it is necessary to continue applying pressure to the second body 1b to complete the release.

[0225] According to certain embodiments of the elements for the collection and storage of biological materials, in particular, in relation to the longitudinal extension of the rod 40 compared to the longitudinal extension of the container 30 into which the collection element is introduced, the perforation of the membrane 15 or the folding partition is carried out either before the contact between the screw 34 and the mating screw 10 or downstream of such contact. Thus, in the first case, the step of coupling first involves perforating, opening or breaking the membrane 15 or the folding partition, followed by relative sliding between the rod 40 and the stopper 1, in particular relative sliding between the rod 40 and the first body 1a of the stopper 1, and then the coupling between the screw 34 and the mating screw 10 is carried out, and thus the direct engagement between the stopper 1 and the container 30 is carried out, and then the stopper 1 can actually be screwed onto the container 30 to finally enclose the rod 40. Thus, there is an engagement (and thus a direct coupling) of the stopper 1 onto the container 30 only after perforating, opening or breaking the membrane 15 or the folding partition. The Applicant points out that, in particular, due to the perforation, opening or breaking of the membrane 15 or the folding partition, there is at least partial, optionally complete separation of the membrane 15 or the folding partition from the first body 1a in which the closing element is an integral part (at least before perforation, opening or breaking).

[0226] In the second case, the step of perforating or opening the membrane 15 or the folding partition results from the engagement between the screw 34 and the mating screw 10. In this case, the removable coupling in particular involves gradually screwing the stopper in the first body 1a of the stopper 1 onto the container 30, and the perforation of the membrane 15 or the folding partition is caused by gradually screwing the stopper 1 onto the container 30.

[0227] To release the substance S inside the volume part of the container 30, the operator operates the second body by exercising the action of pressure after or simultaneously with the axial pressurization of the stopper 1 that performs the gradual introduction of the second body 1b inside the first body 1a. By the gradual introduction of the second body 1b inside the first body 1a with axial sliding along the axis X, a corresponding gradual decrease in the volume part of the reservoir 20 and a gradual distribution of the substance inside the container 30 are performed, and this introduction ends when the axial minimum extension configuration is reached. In this configuration, the reservoir 20 is substantially empty and all of the substance S is substantially inside the container 30.

[0228] By means of a progressive axial pressing of the stopper 1, sliding of the partition wall 2g (or at least a part thereof, or the radially outermost or end portion) on the inner surface of the side wall of the first body 1a in a direction substantially specified by the longitudinal axis X of the stopper is carried out. The sliding determines the sliding friction between the radially outermost or end portion of the partition wall 2g and the aforementioned inner surface, and due to this friction and also due to the low roughness of the inner surface, a seal of the liquid and / or gas and / or powder material is carried out so as to allow the substance S to leak only from the open channel, for example by breaking the membrane 15 or the folding partition wall. Therefore, there is elastic deformation in at least a part of the partition wall 2g, and subsequently, the radially outer portion of the partition wall 2g exerts a force caused by the axial pressing itself, which is oriented in a direction substantially orthogonal to the inner surface of the lateral wall of the first body 1a and to the advancing direction of the second body 1b within the first body 1a, or equivalently, a force oriented in a direction substantially orthogonal to the longitudinal axis X of the stopper. It is observed that there is no sealing ring of rubbery or silicone material to maintain the seal towards the external environment, i.e., to delimit the volume portion of the reservoir 20. Preferably, since the entire body of the stopper 1 is made of a single plastic material, the absence of silicone material and / or rubber components makes it possible to reduce the risk of interaction and / or incompatibility with the substances contained within the reservoir 20. Thereby, the comparison for possible interactions has to be made only between the substance S and the specific type of plastic material used, which makes the stopper 1 described herein flexible for use with various types of substances. Furthermore, the absence of components such as a sealing ring made of silicone material or similar elements reduces the risk of cracking and makes it possible to maintain long-term storage. The absence of a sealing ring made of silicone material or similar elements also helps to keep down the manufacturing cost of the stopper described herein.

[0229] Thus, the end portion 41 is introduced at least partially inside the first body 1a and in particular causes the retention of the membrane 15 or the folding partition inside the first body 1a by capturing the membrane 15 itself between the lateral surface of the substance discharge channel and the shoulder 15s arranged substantially corresponding to said discharge channel.

[0230] The connection between the stopper 1 and the container 30 is such that the introduction of the end portion 41 inside the first body 1a and inside the reservoir 20 is sufficient to ensure the engagement inside the housing 6 obtained at the end of the bell 5. Thus, substantially close to the axially minimum extension configuration, the end portion 41 enters for introduction by opposition inside the housing 6 and remains held there by the action of the rib 7.

[0231] Preferably, corresponding to the axially minimum extension configuration, the second body 1b thus takes a blocking position with respect to the first body 1a and, as a result of such axial extension of the stopper 1, becomes inoperable. In other words, the blocking position is determined by the engagement of the stop ring 28s of the second body 1b corresponding to the annular recess of the invention corresponding to the inner surface of the lateral wall of the first body 1a. Thus, a state of double and / or simultaneous locking of the end portion 41 of the rod 40 and of the second body 1b with respect to the first body 1a occurs.

[0232] The Applicant notes that when a reagent substance is introduced into the body of the container 30, the release of the substance S from the reservoir 20 into the container 30 may cause a chemical reaction. As a result, by separating the two chemical reagents from each other using the stopper 1 described herein, since the stopper 1 is firmly screwed into the body of the container 30, it is noted that the operator can start the chemical reaction completely safely only when desired.

[0233] The Applicant has observed that the characteristic perforating function of the rod 40 on the membrane 15 or the folding partition when a swab for collecting biological and / or microbiological materials as described herein is introduced into the container 30 through a perforation or opening element, is applicable not only to the stopper 1 marked by the presence of the second body 1b as described above, but also to the stoppers according to the embodiments described hereinafter, which stopper is a first body 1a configured to be directly coupled to the container 30 and comprising a coupling element 10, the coupling element being suitable for enabling the removable fixation of the stopper 1 corresponding to the opening of the container 30, defining a first mounting configuration of the stopper on the container, where preferably the stopper closes the container 30, the first body 1a, and a closing element (in particular a membrane 15 or a folding partition) forming at least a part of the wall of the reservoir 20 and facing the inside of the container 30 in the mounting configuration, the closing element (in particular a membrane 15 or a folding partition) being selectively Open configured to be possible and / or breakable by the action of a perforation or opening element 40, 41, 42 housed inside the container, different from the stopper 1, defining at least a second opening configuration of the stopper, and comprising a closing element (in particular a membrane 15 or a folding partition).

[0234] In particular, the method of perforating the membrane 15 or the folding partition via the rod 40 mentioned above can also be applied here to a stopper provided with a closing indicator 10k, which closing indicator 10k is suitable for engaging or corresponding to a mating closing indicator 30k arranged on the container 30 and determines the closed configuration of the container 30.

[0235] In this way, the method is Introducing perforating or opening elements 40, 41, 42 into the interior of container 30 through an opening in the container itself, said opening being suitable for accommodating discharge stopper 1 such that said perforating or opening elements 40, 41, 42 are removable from container 30 and / or are at least partially movable inside container 30; including arranging discharge stopper 1 substantially corresponding to the opening of container 30.

[0236] Subsequent to the arranging step, a closing element (in particular membrane 15 or folding partition) is opened and / or damaged and / or destroyed by the perforating or opening elements 40, 41, 42, enabling at least partial discharge of a predetermined amount of substance S accommodated inside reservoir S inside container 30 by the exertion of force between discharge stopper 1 and container 30.

[0237] In a non-limiting embodiment, rod 40 may be provided with a body that is at least partially hollow and configured to enable passage of substance S from reservoir 20 to swab 42, in particular to enable passage of substance S from reservoir 20 to a position substantially corresponding to or proximate swab 42. In this way, the substance, in particular a fluid, passes between cavity 41i inside rod 40 and the outer surface of rod 40.

[0238] Accordingly, one embodiment of an element for collecting biological and / or microbiological material comprises a rod 40 having a cavity 41i with a substantially axial extension communicating with at least one first opening, in particular a first transfer duct 40k, preferably a first set of transfer ducts 40k, and at least a second opening, in particular a second transfer duct 40f, preferably a second set of transfer ducts 40f.

[0239] Thus, in certain embodiments, the cavity 41i extends at least between a first height (or equivalently, a first portion of the rod 40) where the first transfer duct 40k is present, or the first set of transfer ducts 40k if present, and a second height (or a second portion of the rod 40) where the second transfer duct is present, or the second set of transfer ducts 40f if present. In the embodiment shown in the accompanying figures, the first height or the first portion substantially corresponds to the end portion of the rod 40 identified by reference numeral 41, which is substantially opposite to the portion of the rod 40 where the swab 42 correspondingly exists.

[0240] The first transfer duct 40k, or the first set of transfer ducts 40k if present, is preferably arranged substantially corresponding to the first end portion of the rod 40. In particular, when the rod 40 is introduced into the reservoir 20, the first transfer duct 40k, or the first set of transfer ducts 40k if present, is arranged at a height such that it allows the passage of the substance S within the cavity 41i.

[0241] In the embodiment shown in FIG. 18, the first set of transfer ducts 40k extends radially around the lateral surface area of the rod 40, and the second set of transfer ducts 40f extends radially around the lateral surface area of the rod 40. This embodiment enables, for example, but not limited thereto, the uniform dispersion of the substance onto the swab 42 through the second set of transfer ducts 40f, provides a uniform immersion, and reduces the risk of the sectors of the swab 42 not being properly immersed in the substance.

[0242] In particular, the second set of transfer ducts 40f allows the substance contained in the reservoir 20 to flow in substantial contact with the swab 42 at a slightly higher height. Preferably, in the embodiment shown in FIG. 19, the swab 42 is a flocked swab and is arranged around a part of the rod 40 that does not have the cavity 41i and is introduced into the rod 40.

[0243] Alternatively, in the embodiment shown in FIG. 19, the first transfer duct 40k is an axial opening realized at the end of the rod 40, in particular a coaxial head opening having a cavity 41i. FIG. 19 shows a solution with a single second transfer duct 40f, but this solution can be combined with the presence of a second transfer duct or a plurality of transfer ducts in any of the embodiments described above.

[0244] In a further embodiment shown in FIG. 20, the second transfer duct 40f, or if present the second set of transfer ducts 40f, is arranged at the height where the swap 42 is present. Thus, the second transfer duct 40f, or the second set of transfer ducts 40f, is covered by and / or surrounded by the swap 42. Thus, in this embodiment, it is possible to perform the transfer from the reservoir and the direct immersion of the swap 42 by the more radially inner part. The embodiments described here can be combined with the first transfer duct 40k or the first set of transfer ducts 40k according to any of the embodiments described here.

[0245] If the first and / or second set of transfer ducts 40k, 40f are present, a plurality of transfer ducts belonging to the same set can be arranged at the same or different heights. In particular, the plurality of transfer ducts can be axially aligned and arranged along the direction of the maximum extension of the inner cavity 41i (or, equivalently, the body of the rod).

[0246] In the embodiments described herein, the hollow rod can be coupled to a discharge stopper provided with first and second bodies movable relative to each other, in particular to a discharge stopper such as an object of the present disclosure, or the hollow rod can be coupled to a conventional discharge stopper provided with a reservoir and a breakable partition or membrane for discharging the substance contained therein, such as those briefly described above.

[0247] The present invention is not limited to the embodiments shown in the figures. For this reason, when reference signs follow the features recited in the claims, it is understood that these reference signs are included only for the purpose of enhancing the clarity of the claims and in no way constitute a limitation of the claims themselves.

[0248] Finally, it is obvious that additional, corrective, or variant features that are obvious to those skilled in the art can be applied to the purposes of the present disclosure without exceeding the scope of protection provided by the appended claims.

Claims

1. A discharge stopper (1) suitable and / or intended to be removably coupled to a container (30) and configured to contain a substance (S) and selectively discharge it into said container (30), said stopper (1) being A first body (1a) configured to be directly coupled to said container (30) and comprising a coupling element (10), said coupling element (10) being suitable to enable a removable fastening of said stopper (1) corresponding to an opening of said container (30), defining a first mounting configuration of said stopper onto said container, in which first mounting configuration said stopper closes said container, a first body (1a), and A second body (1b) coupled to and movable relative to said first body (1a) and defining, together with said first body (1a), at least one reservoir (20) configured to contain said substance (S), said reservoir (20) being isolated from the external environment in at least a first closed configuration of said stopper, a second body (1b), and A closing element (15) forming at least part of the wall of said reservoir (20) and facing the inside of said container (30) in said mounting configuration, said closing element (15) being configured to be selectively openable and / or destructible by the action of a perforating or opening element (40, 41, 42) housed inside said container (30) different from said stopper (1), defining at least a second open configuration of said stopper, a closing element (15) and comprising said second body (1b) comprising a cavity (6) configured to enable a removable engagement of a terminal portion of said perforating or opening element (40, 41, 42) by opposed introduction, said stopper being configured to enable said opposed introduction only when in an open configuration, a discharge stopper (1).

2. The second body (1b) is axially translatable relative to the first body along a predetermined axis (X) of the stopper (1), and / or at least a lower portion of the second body (1b) is movably received inside the first body (1a) to define the reservoir (20), and / or the reservoir (20) is confined between the first body (1a) and the second body (1b), the stopper according to claim 1.

3. Comprising a tapered portion or element (14) arranged in the first body (1a) and suitable for directing and / or driving at least a part of the piercing elements (40, 41, 42) towards the closing element (15), the tapered portion (14) being arranged at a position longitudinally outside and / or facing the closing element (15), and / or the tapered portion or element (14) being integral with the first body (1a), substantially funnel-shaped, and configured to be accessible from inside the container (30), and / or the closing element (15) being different from the stopper (1), and different from the container, and / or configured to be selectively openable and / or destructible by the action of a piercing or opening element (40, 41, 42) removably accommodated inside the container, defining at least the second open configuration of the stopper, the stopper according to claim 2.

4. The cavity (6) is configured to enable the removable engagement of the terminal portion of the piercing or opening element (40, 41, 42) only when the introduction by opposition is in the open configuration and close to or corresponding to the axially minimum extension configuration, the stopper according to any one of claims 1 to 3.

5. Suitable and / or intended to be removably coupled to the head portion of the container (30), and / or the first body (1a) is configured and intended to be removably coupled to the head portion of the container (30), the stopper according to any one of claims 1 to 4.

6. When the closing element (15) is arranged in the first body (1a) and / or is integral with the first body (1a) and / or at least when the stopper is in the first closed configuration, the closing element is integral with the first body (1a), and / or the closing element (15) is a waterproof element configured and designed to hold solids, liquids and / or gases, the stopper according to any one of claims 1 to 5.

7. The closing element is a membrane (15) or a folding partition, and / or the closing element is configured to withstand the pressure induced on the reservoir (20) by the axial pressing of the second body (1b) against the first body (1a) manually induced by an operator, the closing element comprising a weakened portion suitable to break first by the mechanical confrontation induced by the piercing or opening element (40, 41, 42), and / or in the open configuration, the substance is at least partially released into the container (30), and / or when the stopper is coupled to the container (30), by keeping the isolation of the entire volume defined by the assembly of the container (30) and the reservoir (20) from the external environment, and / or by causing a limited release of the substance through the opening defined by the breakage of the closing element (15), configured to release the substance into the container (30) when in the open configuration. The stopper according to any one of claims 1 to 6.

8. comprising a holding element of the closing element configured to prevent the release and / or fall of the closing element (15) within the container (30), the holding element being configured to hold the closing element (15) inside the first body (1a), the holding element comprising a shoulder (15s) against which or over which the closing element (15) abuts or folds when the holding element is opposed to the piercing or opening element (40, 41, 42). The shoulder part (15s) is disposed substantially corresponding to the channel between the reservoir (20) and the closing element. The stopper according to any one of claims 1 to 7.

9. In the opening operation configuration, the closing element (15) is held by the shoulder part (15s) and captured between the channel and a part of the perforating or opening element (40, 41, 42) disposed in the channel. The stopper according to claim 8, wherein the closing element (15) is configured to break without releasing fragments or parts.

10. The second main body (1b) is movable relative to the first main body (1a), and its axial movement defines at least an axial maximum extension configuration of the stopper (1) along the longitudinal axis (X) and an axial minimum extension configuration of the stopper (1) along the longitudinal axis (X). The first closing configuration includes the axial maximum extension configuration, and the second opening configuration includes the axial minimum extension configuration. The second opening configuration occurs corresponding to an intermediate longitudinal extension between the longitudinal extension corresponding to the maximum extension configuration and the longitudinal extension corresponding to the longitudinal minimum extension configuration. The stopper according to any one of claims 1 to 9.

11. The first main body (1a) includes an upper cavity (1c) laterally defined by lateral walls separated from each other by the presence of the closing element (15) and a lower cavity. The second main body (1b) is configured to be installed corresponding to the upper cavity (1c) of the first main body (1a). The stopper according to any one of claims 1 to 10.

12. The second body (1b) comprises an intermediate section with a sealing and linear translation limiting element (2), the sealing and linear translation limiting element sealing the volume of the reservoir (20) and configured to limit the stroke of the second body (1b) relative to the first body (1a) between the linear maximum extension configuration and the linear minimum extension configuration of the stopper, The second body (1b) comprises an upper part (25) and a lower part (28) with the intermediate section interposed longitudinally therebetween, The diameter substantially defined by the radially outermost 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), The sealing element (2) comprises a shoulder (2s) configured to engage, at a first upper height, with a retaining part (23) protruding from the inner surface of the lateral wall of the first body (1a) during use, the engagement between the retaining part (23) and the shoulder (2s) being such that the second body (1b) cannot be completely withdrawn from the first body (1a) when the second body (1b) is pre-inserted, and / or the sealing element (2) comprises a partition wall (2g) configured to perform the sealing and containment of the volume of the reservoir (20), the partition wall having a structure such that it also limits the translation of the second body (1b) relative to the first body (1a) in the axial minimum extension configuration, The stopper according to claim 11.

13. The first body (1a) comprises an annular recess arranged at an intermediate height between the minimum height and the maximum height defined by the first body (1a) and / or at a height substantially corresponding to the height at which the closing element (15) is located, the annular recess being configured to accelerate the cooling of the first body (1a), the stopper according to any one of claims 1 to 12.

14. The first main body (1a) is provided with a pressure relief element (29) configured to allow a predetermined amount of air to be discharged when the second main body (1b) is introduced into the first main body (1a). The pressure relief element (29) is configured to allow a predetermined amount of air to be discharged when the second main body (1b) is introduced into the first main body (1a) in a non-operative mounting configuration of the second main body (1b) into the first main body (1a) without affecting the airtightness of the reservoir (20) itself when at least reaching the maximum axial extension configuration. The pressure relief element (29) comprises notches arranged corresponding to the head portion of the inner surface of the lateral wall of the first main body (1a) and / or arranged corresponding to the head portion of the upper cavity (1c). The stopper according to claim 13 when dependent on claim 12 or claim 12.

15. The second main body (1b) is configured to be coupled to the bottom of the reservoir (20) and has a recess (5) having a shape substantially following the shape defined by the bottom of the reservoir (20). The recess (5) opens into the cavity (6), and the cavity (6) has a plurality of restraining ribs (7) of the perforating or opening element (40, 41, 42). The stopper according to any one of claims 1 to 14.

16. The stopper according to claim 2, wherein the reservoir (20) is confined at least between the lateral wall of the first main body (1a) and the lower portion (28) of the second main body (1b).

17. The stopper according to claim 7, wherein a weakened portion is provided in the membrane or the folding partition wall.

18. A container (30) for storing a biological sample, comprising a body that is openable at least corresponding to at least one of its own first parts (33), the body comprising a lateral wall of the container and a bottom wall (32) coupled to the lateral wall of the container, the container (30) being configured to accommodate, inside thereof, a microbiological sample collection device provided with a swab (42) and a rod for realizing the perforation or opening element (40, 41, 42), and being removably coupled to the stopper (1) according to any one of claims 1 to 17. After the container (30) removably connects the stopper (1) to the container (30), a terminal portion (41) of the rod of the microbiological sample collection device on the side opposite to the portion where the swab (42) is correspondingly located is such that it performs or is configured to perform a partial introduction of the perforation of the closing element (15) and the terminal portion (41) of the rod (40) within the first body (1a). The container (30) has a longitudinal extension and the shape of the bottom wall (32).

19. Comprising a bottom (32) in a substantially "V" shape, corresponding to the bottom (32), the lateral wall of the container tapers gradually towards the center of the body of the container (30), and the bottom (32) is configured to center the rod (40) and / or the swab (42) along the longitudinal axis (X) of the container (30) for collecting the biological sample. The bottom (32) cooperates with the guiding portions (13s, 13v) of the stopper (1) to contribute to the centering of the rod (40) along the longitudinal axis (X). The container according to claim 18.

20. The container (30) according to claim 18 or claim 19, and Elements (40, 41, 42) for collecting and storing a biological sample, suitable for realizing a perforation or opening element for the release stopper (1). A discharge stopper (1) suitable for removably coupling to the container (30), configured to contain a substance (S) and to discharge it into the container (30), The discharge stopper (1) is suitable and / or intended to be removably fastened to the container (30), configured to contain a substance (S) and to selectively discharge it into the container (30), the stopper (1) being, A first body (1a) configured to be directly coupled to the container (30) and comprising a coupling element (10), the coupling element being suitable to enable a removable fastening of the stopper (1) corresponding to an opening of the container (30), defining a first mounting configuration of the stopper on the container, in which the stopper closes the container, a first body (1a), A second body (1b) coupled to the first body (1a), movable, and defining with the first body (1a) at least one reservoir (20) configured to contain the substance (S), the reservoir (20) being isolated from the external environment in at least a first closed configuration of the stopper, a second body (1b), A closing element (15) forming at least a part of the wall of the reservoir (20) and facing the inside of the container (30) in the mounting configuration, the closing element (15) being selectively openable and / or destructible by the action of a piercing or opening element (40, 41, 42) housed inside the container (30) different from the stopper (1), defining at least a second open configuration of the stopper, a discharge stopper (1) comprising a closing element (15), A kit comprising, The kit, wherein the second body (1b) is provided with a cavity (6) configured to enable removable engagement of the end portion of the piercing or opening element (40, 41, 42) by opposed introduction, and the stopper is configured to enable said opposed introduction only when in the open configuration. **Claim 21** A method for dispensing a substance within a release stopper according to any one of claims 1 to 17 or within a kit according to claim 20, comprising: placing the substance within the first body (1a) of the stopper (1) such that the substance is deposited within the reservoir (20) delimited by the closure element (15); subsequently placing at least partially the second body (1b) within the first body (1a), such placement causing the reservoir (20) and the containment of the substance within a closed volume isolated from the external environment; A method as described above. **Claim 22** coupling the stopper (1) to a container (30), such coupling resulting in the container (30) being provided with a closed and defined volume by the presence of the stopper (1) corresponding to its opening; placing a piercing or opening element (40, 41, 42) inside the container (30); perforating or opening or breaking the closure element (15) such that the interior of the container (30) is placed in direct communication with the reservoir (20) by the coupling of the stopper (1) to the container (30) and / or to the piercing or opening element (40, 41, 42); A step of applying pressure to the second body (1b) of the stopper (1) after or in conjunction with axial pressurization of the stopper (1), thereby causing progressive introduction of the second body (1b) into the first body (1a), and by the progressive introduction of the second body (1b) into the first body (1a), a corresponding progressive reduction of the volume portion of the reservoir (20) and a progressive distribution of the substance into the container (30) are carried out, the step and The method according to claim 21, comprising.

23. By the perforation or opening or destruction of the closing element (15), at least partial separation of the closing element (15) from the first body (1a) is carried out, and the closing element (15) is an integral part of the first body (1a) at least before the perforation or opening or destruction. The method according to claim 22.

24. The release stopper (1) according to any one of claims 1 to 17, and Elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples, comprising a rod (40) having a substantially axial extension and a swab (42) made at one end of said rod or to which said rod (40) is firmly and / or rigidly attached, wherein said elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples are such that said rod (40) is at least partially hollow and configured to allow a substance to pass between a first part of said elements (40, 41, 42) for the storage of biological and / or microbiological samples and a second part substantially corresponding to or adjacent to said swab (42) by passing the substance between an inner cavity (41i) of said rod (40) and an outer surface of said rod (40) itself, and in this case said elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples are configured and intended to cause at least a partial leakage of a substance (S) from a reservoir of said release stopper (1) according to any one of claims 1 to 17. Kit.

25. The kit according to claim 24, wherein said elements (40, 41, 42) for the collection and storage of biological and / or microbiological samples comprise a first transfer duct (40k) and at least a second transfer duct (40f), and said first transfer duct (40k) and said second transfer duct (40f) communicate with said cavity (41i).

26. Alternatively, said second transfer duct (40f) is arranged at the height where said swab (42) is present and / or covers said swab (42) and / or is surrounded by said swab (42), or said second transfer duct (40f) is placed in a part of said rod (40) different from the part of said rod (40) where said swab (42) is present. The kit according to claim 25.

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