CONTAINMENT SYSTEM

Abstract

A containment system comprises a container (2) and a lid (7) which can be removably secured to the container (2) to close an opening (5) thereof; the lid (7) comprises a chamber (12) delimited at least in part by a bottom wall (11) of the lid (7) and the containment system comprises a piston (19) inserted into said chamber (12) and movable therealong between a first position remote from the bottom wall (11) and a second position close to said bottom wall (11) and pneumatic sealing means (23, 24, 25, 26) between the piston (19) and the lid (7);the piston (19), in the first position, delimits, with the cover (7) and with the pneumatic sealing means (23, 24, 25, 26), a reservoir (21) in the chamber (12) and comprises a perforation member (20) of a frangible portion (13) provided in the bottom wall (11) of the cover (7) to break the frangible portion (13) when the piston passes from the first position to the second position so that a solution (S1) present in the reservoir (21) is injected into the container (2) when the piston (19) passes from the first position to the second position. [Fig. 3];

Description

Title of the invention: CONTAINMENT SYSTEM

[0001] The present invention relates to a containment system, and in particular a containment system for organic matter intended for biopsy.

[0002] As is known, to perform a biopsy, a sample of organic matter (biopsy sample) is taken from the patient and transferred to an analysis center where it is examined.

[0003] Containment systems are known for transporting biopsy samples in which the samples are immersed in a preservative / fixative solution, for example formalin.

[0004] Fixative solutions are known to have carcinogenic characteristics and are therefore potentially harmful to the health of those who take biopsy samples and handle these substances to preserve them.

[0005] Containment systems have therefore been developed to attempt to address this problem, the containment systems provided making it possible to minimize, ideally eliminate, any possible interaction of the operator with the fixative (carcinogenic) solution during storage of the biopsy sample for transfer.

[0006] Document WO2021105743 illustrates a container, of large dimensions, comprising a main body provided with a lower chamber filled with the fixing solution and an upper chamber. The container comprises a descender provided with a bottom wall connected to the main body in order to isolate the lower chamber from the upper chamber. The descender comprises a tubular body having a first end coupled to the bottom wall and a second end, opposite the first end, so as to define a containment volume, open at the top, intended to receive the sample. The container comprises a flexible connection system which connects the bottom wall to the main body and a cover or cap reversibly coupled to the main body.

[0007] As the connection system yields, the descender descends into the lower chamber, immersing the sample in the fixing solution.

[0008] Document US20090104692 also illustrates a container for storing a biological sample for molecular and / or histological diagnostic tests.

[0009] The container comprises a frangible membrane which separates the interior of the container into a first chamber and a second chamber isolated from the fluids of each other.

[0010] The fixing solution is contained in one of the chambers, for example the second, and the sample to be handled or treated, before being fixed, in the other.

[0011] At the appropriate time, the membrane separating the first and second chambers can be ruptured to bring the tissue sample into fluid contact with the carcinogenic solution inside the second chamber.

[0012] In general, known containers have a containment zone for the fixative solution isolated from the rest of the container by a fluid-tight membrane. The biopsy sample is placed in the volume of the container free of carcinogenic solution and, when the container is closed, the membrane ruptures, so that the fixative solution floods the entire volume of the container and therefore also the biopsy sample.

[0013] In known solutions, the sample is immersed in the fixing solution by gravity. It is therefore not guaranteed that the sample is completely immersed in the fixing solution nor that the latter is completely transferred into the chamber where the sample is placed.

[0014] There is therefore a need in the sector for a containment system for organic material intended for biopsy which is safe for the operator and reliable.

[0015] In this context, it is desired to propose a containment system capable of overcoming at least some of the aforementioned drawbacks of the known technique and of satisfying the aforementioned need.

[0016] In particular, the aim of the present invention is to provide a containment system which is safe for the operator and which prevents the possibility of the sample remaining outside the fixing solution, i.e. which ensures that all the fixing solution is transferred into the chamber where the sample is located.

[0017] This object is achieved by a containment system comprising the technical characteristics set out in one or more of the appended claims. The dependent claims correspond to possible alternative embodiments of the invention.

[0018] According to one aspect, the present invention relates to a containment system intended in particular for biopsy samples.

[0019] The containment system comprises a container having a bottom, a side wall extending from the bottom and an opening defined by the side wall on the side opposite the bottom.

[0020] The containment system includes a lid that can be removably secured to the side wall of the container to close the opening.

[0021] The lid comprises a bottom wall, provided to at least partially close the opening of the container, and a chamber, or compartment, delimited at least partially by the bottom wall.

[0022] Preferably, the containment system, in particular the cover, comprises a single chamber.

[0023] The containment system comprises a piston, preferably a single piston, inserted into the chamber of the cover and movable along it between a first position distant from the bottom wall and a second position close to the bottom wall in a direction of advance.

[0024] Preferably, the piston is hollow.

[0025] The containment system comprises pneumatic sealing means between the piston and the cover. The piston, in the remote position, delimits, with the cover and with the pneumatic sealing means, a reservoir in the chamber of the cover itself.

[0026] The bottom wall comprises a frangible portion and the piston comprises a member for perforating the frangible portion so as to break the frangible portion when the piston moves from the distant position to the close position.

[0027] Advantageously, a solution possibly present in the reservoir is injected into the container by the sealed pushing action of the piston when the latter passes from the distant position to the close position.

[0028] Preferably, the piston in the position close to the bottom wall is in contact with the bottom wall itself. Advantageously, in this way, the bottom wall defines a stop for the piston.

[0029] Preferably, the piston has an end portion, from which said perforation member extends, shaped like said bottom wall. In this way, advantageously, when the piston is moved from the remote position to the close position, the space that can be occupied by a solution present in the reservoir is minimized.

[0030] Preferably, the bottom wall of the cover has a concavity oriented towards the piston. Advantageously, in this way, a solution present in the reservoir is caused to be deposited on the bottom of the cavity.

[0031] Preferably, the frangible portion is located in a base of the concavity so as to facilitate the injection of a solution from the reservoir to the container.

[0032] Preferably, the piston has an annular groove on its outer lateral surface and the pneumatic sealing means comprise an O-ring, for example made of rubber, inserted in the annular groove.

[0033] Preferably, the piston has a second annular groove on its outer lateral surface and the pneumatic sealing means comprise a second O-ring, for example made of rubber, inserted in the second annular groove.

[0034] Preferably, the containment system comprises a system for locking the piston in the position remote from the bottom wall of the cover and in the position close to the bottom wall of the cover. In this way, advantageously, the stroke of the piston can be adjusted between the remote position and the close position.

[0035] Preferably, the locking system comprises a tooth, for example annular, in the cover projecting towards the chamber and a first and a second groove in the piston.

[0036] Preferably, the tooth is secured in the first groove when the piston is in the position away from the bottom wall of the cover. Preferably, the tooth is secured in the second groove when the piston is in the position close to the bottom wall of the cover.

[0037] Preferably, the lid and the container can be removably secured by means of a threaded coupling so that opening and closing the container is particularly simple.

[0038] Preferably, the perforation member has a length equal to a height of the reservoir measured in the direction of advance of the piston so that the frangible portion breaks as soon as the piston is actuated.

[0039] Preferably, the perforation member is in contact with the frangible portion when the piston is in the position remote from the bottom wall of the cover.

[0040] Preferably, the perforating member has a cross section so as to be able to tear the frangible portion and not to obstruct the passage of a solution from the reservoir to the container.

[0041] Preferably, the containment system includes a buffer solution in the container so that a sample introduced into the container remains hydrated.

[0042] Preferably, the containment system comprises a solution in the tank, preferably a carcinogenic solution, for example formalin, which advantageously remains isolated.

[0043] Preferably, the buffer solution and the solution in the reservoir, once mixed, form a fixative solution which can preserve the sample at least until the relevant examinations.

[0044] Preferably, the chamber extends at least partially inside the container when the lid is secured with the container so as to contain the total height of the containment system.

[0045] In practice, an inert buffer solution is placed in the container, while formalin (carcinogenic) is placed in the reservoir of the cap. The reservoir is hermetically sealed so that the formalin does not come into contact with the operators. Only after inserting the biopsy into the inert buffer solution and closing the cap can the formalin be injected inside the container to obtain the fixative solution.

[0046] In this way, any contact of the operator with the formalin is excluded.

[0047] In this way, the fixing solution is obtained by mixing the buffer solution and the carcinogenic preservative solution.

[0048] Other characteristics and advantages of the aforementioned aspect will appear more clearly on reading the indicative, and therefore non-limiting, description of a preferred but non-exclusive embodiment of a containment system for organic matter intended for biopsy.

[0049] This description will be set out below with reference to the attached drawings, provided solely for information purposes and, consequently, non-limiting, in which: [Fig.l] illustrates a containment system in accordance with the description in a schematic perspective view; [Fig.2] illustrates the containment system of [Fig.l] in an exploded perspective schematic view; [Fig.3] illustrates the containment system of [Fig.l] in a first operational configuration in a schematic sectional view; [Fig.4] illustrates the containment system of [Fig.l] in a second operational configuration in a schematic sectional view; [Fig.5] illustrates a containment system according to the description in a schematic perspective view and in a first operational configuration; [Fig.6] illustrates the containment system of [Fig.5] in a schematic sectional view and in a first operational configuration.

[0050] With reference to the attached figures, the number 1 indicates a containment system preferably intended to contain and preserve a sample S of organic matter intended for biopsy.

[0051] The containment system 1 has an axis A and is symmetrical with respect to this axis A.

[0052] The containment system 1 is preferably intended for the safe transport of biopsy samples with a diameter of less than 0.3 mm.

[0053] The containment system 1 comprises a container 2 which has a bottom 3, a side wall 4, extending from the bottom 3, and an opening 5 delimited by the side wall 4 on the side opposite the bottom 3.

[0054] With reference to [Fig.6], it can be observed that the container 2 comprises a pin 31 extending from the bottom 3 towards the opening 5. The pin 31 is eccentric relative to the axis A of the containment system 1.

[0055] Advantageously, the pin 31 can have a function of breaking up the sample S to be analyzed.

[0056] The side wall 4 is cylindrical with an axis corresponding to the axis A of the containment system 1.

[0057] The container 2 has an internal volume V2 preferably of 20 ml.

[0058] The container 2 comprises a thread 6 on the side wall 4, preferably on a outer surface 4a of the side wall 4.

[0059] The thread 6 is provided essentially at the level of the opening 5.

[0060] The containment system 1 comprises a cover or plug 7 which can be secured with the container 2 to close the opening 5.

[0061] Preferably, the cover 7 has an axis corresponding to the axis A of the containment system 1 (when the cover 7 is secured with the container 2).

[0062] The cover 7 comprises a side wall 8 which has, on its inner surface 8a, a thread 9.

[0063] The thread 9 is intended to engage with the thread 6 of the container 2 and to define a removable coupling between the container 2 and the cover 7.

[0064] In the embodiment illustrated by way of example, the cover 7 has, on an outer surface 8b of the side wall 8, a knurling 10 to facilitate the application of the cover 7 to the container 2 or its removal therefrom.

[0065] The cover 7 comprises a bottom wall 11, intended to at least partially close the opening 5 of the container 2.

[0066] The cover 7 comprises a chamber, or compartment, 12 delimited, at least in part, by the bottom wall IL

[0067] In the preferred embodiment illustrated, the cover 7 comprises only one chamber 12.

[0068] By observing for example figures 3 and 4, the chamber 12 is delimited lower by the bottom wall 11 and is located on the side opposite the container 2 with respect to the bottom wall 11.

[0069] In the illustrated example, it is observed that the chamber 12, when the cover 7 is coupled to the container 2, is at least partially inserted inside the container 2.

[0070] In alternative embodiments not illustrated, the chamber 12 may be completely external to the container 2 when the cover 7 is applied to the container 2.

[0071] The bottom wall 11 comprises a frangible portion 13, for example a membrane.

[0072] In the illustrated preferred embodiment, the bottom wall has a truncated-conical shape and the frangible portion 13 at least partially defines its smaller base.

[0073] In the preferred embodiment illustrated, the cover 7 has a hole 14, for example circular, in the bottom wall 11 and the frangible portion 13 closes this hole 14.

[0074] In the example illustrated, a wall 15, preferably cylindrical, extends from the bottom wall 11 to delimit the chamber 12.

[0075] The wall 15 of the chamber 12 corresponds, in its upper part, to the side wall 8 of the cover 7.

[0076] In the example illustrated, the side wall 8 of the cover is presented as formed by two cylindrical surfaces of different radii superimposed and connected by an annular crown 16.

[0077] The chamber 12 is open and has an opening 17 for access to the interior delimited by the side wall 8, 15.

[0078] The bottom wall 11 has a concavity oriented towards the mouth 17.

[0079] The cover 7 comprises a tooth 18 projecting towards the inside of the chamber 12 visible in particular in figures 3 and 4.

[0080] Tooth 18 is annular in the illustrated example but may have another shape in other embodiments not illustrated.

[0081] The tooth 18 is preferably provided essentially at the level of the mouth 17.

[0082] The containment system comprises a piston 19 inserted or insertable into the chamber 12 of the cover 7. In the embodiment illustrated by way of example, the piston 19 is hollow and has an open cavity 19b.

[0083] In the embodiment of Figures 5 and 6, the containment system 1 comprises a plug 30 inserted into the cavity 19b.

[0084] The containment system comprises a single piston 19.

[0085] Preferably, the container 2, the cover 7 and the piston 19 constitute the entire structure of the containment system and are preferably made of plastic.

[0086] Advantageously, the containment system is in practice made up of only three structural parts.

[0087] The piston 19 is movable along the chamber 12 between a position distant from the bottom wall 11, illustrated for example in [Fig.3], and a position close to the bottom wall 11, illustrated for example in [Fig.4].

[0088] The piston 19 is movable along the axis A of the confinement system 1 in a direction of advance.

[0089] The concavity of the bottom wall 11 of the cover 7 is oriented towards the piston 19.

[0090] The piston 19 comprises a perforation member 20 for breaking the frangible portion 13 of the cover 7 when the piston moves from the far position to the close position.

[0091] In the illustrated example, the perforation member 20 has a cross-section; however, in alternative embodiments, it can have a section of any shape.

[0092] With reference to the embodiment of Figures 5 and 6, described by limiting itself to the parts which differentiate it from the embodiment of [Fig.l], it is observed that the perforation member 20 is essentially cylindrical and has an end portion 20a, intended to break the frangible portion 13, which develops transversely to the axis A so as to have an elliptical shape.

[0093] In this way, the perforation member is particularly sharp and its shape facilitates the breaking of the frangible portion 13.

[0094] The containment system 1 comprises pneumatic sealing means, between the piston 19 and the cover 7, which delimit, with the cover 7 and the piston 19, a reservoir 21 in the chamber 12.

[0095] In this way, a preservative solution SI present in the reservoir 21, for example formaldehyde, is injected into the container 2 when the piston 19 moves from the distant position to the close position.

[0096] In the preferred embodiment illustrated, the piston 19 has an end portion 22 oriented towards the bottom wall 11 of the cover of truncated-conical shape and having an axis corresponding to the axis A.

[0097] The perforation member 20 preferably extends from the smaller base of the end portion 22.

[0098] The end portion 22 is preferably shaped like the bottom wall 11 of the cover 7 so as to fit the latter when the piston 19 is in the close position.

[0099] Advantageously, the profiles of the chamber in the stopper and the piston, which mate with the same shape, prevent biopsies and frustules from entering the chamber of the stopper once the piston is lowered, thus avoiding any possibility of them remaining dry, in particular, for example, in the event of transport or handling of the containment system.

[0100] The perforation member 20 has a length essentially equal to a height of the reservoir 21 measured along the axis A of the containment system; in alternative embodiments, the perforation member 20 may have a length less than a height of the reservoir 21 measured along the axis A of the containment system.

[0101] As illustrated in [Fig. 3], the perforation member 20 is in contact with the frangible portion 13 when the piston 19 is in the position remote from the bottom wall 11 of the cover 7; in alternative embodiments, the perforation member 20 may be spaced from the frangible portion 13 when the piston 19 is in the position remote from the bottom wall 11 of the cover 7.

[0102] As illustrated in [Fig.4], the piston 19, in the position close to the bottom wall 11, is practically in contact with the bottom wall 11 itself; in alternative embodiments not illustrated, the piston 19 in the position close to the bottom wall 11 may be moved away from the bottom wall 11 itself.

[0103] In the example illustrated, the piston 19 has a first annular groove 23 and an O-ring 24 inserted in the annular groove 23 to provide sealing between the piston 19 and the cover 7.

[0104] The piston 19 has a second annular groove 25, distant from the first annular groove 23 along the axis A, and an O-ring 26 inserted in the annular groove 23 to provide sealing between the piston 19 and the cover 7.

[0105] Advantageously, the presence of the O-rings 24, 26 ensures the sealing of the reservoir 21, which is particularly important in the case where the solution SI is carcinogenic or otherwise harmful to the operator.

[0106] In alternative embodiments not shown, the piston 19 may be equipped with a single O-ring or more than two O-rings.

[0107] The annular groove 23 and / or the annular groove 25 are provided on an outer lateral surface 19a of the piston 19.

[0108] The outer lateral surface 19a has two grooves 27, 28, preferably also annular, intended to be secured with the tooth 18 of the cover 7. The grooves 27, 28 define, with the tooth 18, a system for locking the piston 19 respectively in the position distant from the bottom wall 11 of the cover 7 and in the position close to the bottom wall 11 of the cover 7.

[0109] With reference to Figures 5 and 6, it can be observed that the groove 28 is discreet and identifiable at the level of projections 32 which project from the external lateral surface 19a of the piston 19.

[0110] Advantageously, in this way, the blocking of the piston 19 in stable configurations is ensured by the particular shape of the confinement system without requiring any intervention on the part of the operator.

[0111] In particular, the tooth 18 secured in the groove 28 prevents the reopening of the chamber 12.

[0112] To actuate the piston 19, pressure from the operator is sufficient to overcome the resistance of the tooth 18 embedded in the groove 27.

[0113] The distance between the grooves 27 and 28, measured along the axis A, identifies the stroke of the piston 19 between the position far from the bottom wall 11 of the cover 7 and the position close to the bottom wall 11 of the cover 7.

[0114] In a preferred embodiment, the containment system comprises a solution S2, for example an inert buffer solution, in the container 2.

[0115] In a preferred embodiment, the containment system comprises the SI solution in the reservoir 21.

[0116] Preferably, solution S1 and solution S2, once mixed, form a fixing solution for preserving sample S.

[0117] With reference to Figures 5 and 6, it can be seen that the side wall 4 of the container 2 has a ring 29 which projects externally and which defines a stop for the lid 7 when it is screwed onto the container 2 itself.

[0118] The ring 29 prevents the lid 7 from being screwed too tightly onto the container, i.e. it adjusts the closing force applicable to the lid 7, thus making it easier for the operator to open the container.

[0119] In use, from a configuration of the type illustrated in [Fig. 1], the containment system 1 can be used by opening the container 2.

[0120] The cover 7 is unscrewed and removed while the solution SI, which may be a carcinogenic and dangerous solution, for example formaldehyde, remains contained in the cover 7 itself.

[0121] The sample S is introduced into the container 2 and immersed in the solution S2, if present, which maintains its hydration.

[0122] Once the sample has been introduced into the container 2, the cover 7 can be closed by screwing it back onto the container 2.

[0123] Once the container 2 is closed, the piston 19 can be actuated by moving it from the distant position to the close position.

[0124] By pushing the piston 19, the groove 27 disengages from the tooth 18 and the piston 19 slides downwards, observing [Fig.3], until the groove 28 engages with the tooth 18.

[0125] In this way, the perforation member 20 tears the frangible portion 13 and the solution SI is injected, thanks in particular to the presence of the O-rings 24, 26, into the container 2 through the hole 14.

[0126] Solution SI and solution S2 form the fixing solution once mixed and the sample can be sent for further analysis.

[0127] The containment system 1 ensures the fixation of the sample and the safety of the operator, who does not come into contact with the solution in the reservoir 21 under any circumstances.

[0128] The solution does not precipitate in the container but is injected into it, affecting the entire sample and filling the interior volume of the container.

[0129] The injection ensures the complete transfer of the preservative solution into the inert buffer solution.

Claims

Claims

1. Containment system comprising - a container (2) having a bottom (3), a side wall (4) extending from the bottom and an opening (5) delimited by the side wall (4) on the side opposite the bottom (3); - a cover (7) removably secured to the container (2) to close said opening (5), said cover (7) comprising a bottom wall (11), designed to at least partially close said opening (5), and a chamber (12) delimited at least partly by said bottom wall (11), said containment system comprising - a piston (19) inserted into said chamber (12) and movable therealong between a first position distant from said bottom wall (11) and a second position close to said bottom wall (11);- pneumatic sealing means (23, 24, 25, 26) between said piston (19) and said cover (7), said piston (19), in the first position, delimiting with the cover (7) and the pneumatic sealing means (23, 24, 25, 26) a reservoir (21) in said chamber (12), said bottom wall (11) comprising a frangible portion (13) and said piston (19) comprising a perforation member (20) of said frangible portion (13) to break the frangible portion (13) when the piston passes from the first position to the second position so that a solution (SI) present in the reservoir (21) is injected into the container (2) when the piston (19) passes from the first position to the second position.;

2. Containment system according to claim 1, wherein said piston (19) in the second position is in contact with the bottom wall (11).

3. Containment system according to claim 1 or 2, wherein said bottom wall (11) has a concavity oriented towards said piston (19).

4. A containment system according to claim 3, wherein said frangible portion (13) is located in a base of said concavity.

5. A containment system according to any preceding claim, wherein said piston (19) has a first annular groove (23) on its outer lateral surface (19a) and said pneumatic sealing means comprise a first O-ring (24) inserted into said first annular groove (23).

6. A containment system according to claim 5, wherein said piston (19) has a second annular groove (25) on said outer side surface (19a) and said pneumatic sealing means comprises a second O-ring (26) inserted into said second annular groove (25).

7. Containment system according to any one of the preceding claims, wherein said piston (19) has an end portion (22), from which said perforation member (20) extends, shaped like said bottom wall (11) so as to fit said bottom wall (11) when the piston (19) is in said second close position.

8. Containment system according to any one of the preceding claims, comprising a locking system (18, 27, 28) of the piston (19) in the first position and in the second position.

9. A containment system according to claim 8, wherein said locking system (18, 27, 28) comprises a tooth (18) in the cover (7) projecting towards said chamber (12) and a first and a second groove (27, 28) in said piston (19), said tooth (18) being secured in the first groove (27) when the piston is in the first position and being secured in the second groove (28) when the piston (19) is in the second position.

10. A containment system according to any preceding claim, wherein the lid (7) and the container (2) are removably securable by means of a threaded coupling (6, 9).

11. A containment system according to any preceding claim, wherein said piercing member (20) has a length equal to a height of the reservoir (21) measured along an axis (A) of the containment system.

12. A containment system according to any preceding claim, wherein said piercing member (20) is in contact with said frangible portion (13) when the piston (19) is in the first position.

13. A containment system according to any preceding claim, wherein said piercing member (20) has a cross section.

14. A containment system according to any preceding claim, comprising said solution (SI) in said reservoir (21).

15. A containment system according to any preceding claim, comprising a buffer solution (S2) in said container.

16. Containment system according to claims 14 and 15, wherein the buffer solution (S2) and the solution (SI) mixed together form a fixative solution.

17. A containment system according to any preceding claim, wherein the solution (SI) is a preservative solution.

18. A containment system according to any preceding claim, wherein said chamber extends at least partially within the container when the lid is secured with the container.

19. A containment system according to any preceding claim, wherein said perforating member (20) is substantially cylindrical and has an end portion (20a) which extends transversely relative to an axis (A) of the containment system so as to have an elliptical shape.

20. A containment system according to any preceding claim, wherein said cover (7) comprises a single chamber (12) defined by said chamber (12).

21. A containment system according to any preceding claim, comprising a single piston (19) defined by said piston (19).

22. A containment system according to any preceding claim, wherein said container (2) comprises a side wall (4) having a ring (29) which projects outwardly from said side wall (4) and which defines a stop for said cover (7) when said cover (7) is secured with said container (2).

23. A containment system according to any preceding claim, wherein said container (2) comprises a pin (31) extending from said bottom (3) towards said opening (5), said pin (31) being eccentric with respect to an axis (A) of the containment system.

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