Containment device for biological samples

Abstract

A containment device (10) for biological samples, which comprises: - a first vessel (11) for depositing a biological sample, - a lid (12) adapted to engage the first vessel (11), - a sealed chamber (13), adapted to contain a preservative substance, placed between the lid (12) and the first vessel (11), the sealed chamber (13) being defined by a second vessel (14) which is at least partially inserted in the first vessel (11) with a first opening (15), for filling, directed toward the lid (12), and closed by the lid (12) onto the first vessel (11). The device (10) comprises reversible means (16) for creating a passage between the sealed chamber (13) and the first vessel (11) for the preservative substance.

Description

[0001] CONTAINMENT DEVICE FOR BIOLOGICAL SAMPLES

[0002] The present invention relates to a containment device for biological samples.

[0003] Nowadays, after a surgical operation, and / or in order to conduct tests that involve the removal of tissue, any tissue samples removed may need to be sent to a laboratory for analysis.

[0004] Usually in this step, the use is made of containers in which the biological sample is immersed in formaldehyde solutions (formalin), the use of which presents risks.

[0005] Formaldehyde is, in fact, a substance that is recognized as being carcinogenic.

[0006] This has highlighted the problem of safety for analyst technicians, given the current impossibility of substituting formaldehyde with another, less dangerous preservative.

[0007] Today containers are known and available on the market for samples of biological tissue that, although they use formaldehyde, set out to keep it isolated from contact with the technicians.

[0008] For example, a device is known described in EP3222551A1 filed by this same applicant, which describes a containment device for biological samples, which comprises:

[0009] - a first vessel for depositing a biological sample,

[0010] - a lid adapted to close the first vessel,

[0011] - a hermetically-sealed chamber, adapted to contain a preservative, which is arranged between the lid and the first vessel, and is defined by a second vessel inserted in the first vessel with the filling opening directed toward the lid, and closed by said lid onto the first vessel,

[0012] - means for creating a passage between the hermetically-sealed chamber and the first vessel for the descent of the preservative from the chamber to the first vessel, such means comprising:

[0013] - a region with a pre-fracture which is defined on the second vessel, - a corresponding presser which extends from the lid and is capable of reaching the region with the pre-fracture.

[0014] In particular, the first vessel and the lid are mutually engaged with coupling means which define:

[0015] - either a first configuration of use, in which the first vessel is closed and the second vessel is intact,

[0016] - or a second configuration of use, in which the lid is closed and is displaced toward the inside of the first vessel, and the presser breaks the region with pre-fracture of the second vessel, placing the two vessels in communication and allowing the preservative contained in the second vessel to enter the first vessel containing the biological sample.

[0017] These known techniques, although much appreciated on the market, are not always capable of meeting the requirements of operators.

[0018] In fact, conventional containment devices for biological samples have an irreversible operation, since, once the bottom of the second vessel is broken and placed in communication with the first vessel, it is no longer possible to restore the physical separation between the two vessels.

[0019] Owing to this, the situation can arise where, once turned upside down, the preservative tends to return to the starting vessel, since the physical separation between the two vessels is no longer there; and this is a situation that absolutely must be avoided for the operators.

[0020] The aim of the present invention is to provide a containment device for biological samples which is capable of improving the known art in one or more of the above-mentioned aspects.

[0021] Within this aim, an object of the invention is to provide a containment device for biological samples that allows a reversible operation.

[0022] Another object of the invention is to provide a containment device for biological samples that makes it possible to restore the physical separation between the vessel containing the biological sample and the vessel containing, at least initially, a preservative substance. A further object of the present invention is out to overcome the drawbacks of the background art in a manner that is alternative to any existing solutions.

[0023] Another object of the invention is to provide a containment device for biological samples that is highly reliable, easy to implement and of low cost.

[0024] This aim and these and other objects which will become more apparent hereinafter are achieved by a containment device for biological samples, which comprises:

[0025] - a first vessel for depositing a biological sample,

[0026] - a lid adapted to engage said first vessel,

[0027] - a sealed chamber, adapted to contain a preservative substance, placed between said lid and said first vessel, said chamber being defined by a second vessel which is at least partially inserted in said first vessel with a first opening, for filling, directed toward said lid, and closed by said lid onto said first vessel, said device being characterized in that it comprises reversible means for creating a passage between said sealed chamber and said first vessel for said preservative substance.

[0028] Further characteristics and advantages of the invention will become better apparent from the detailed description that follows of a preferred, but not exclusive, embodiment of the containment device for biological samples according to the invention, which is illustrated for the purposes of nonlimiting example in the accompanying drawings wherein:

[0029] - Figure 1 is a perspective overall view of a containment device for biological samples, according to the invention;

[0030] - Figure 2 is a cross-sectional view of the device of Figure 1;

[0031] - Figure 3 is an exploded view of the device in Figure 1 ;

[0032] - Figures 4a and 4b are each a perspective view of a first component of the device of Figure 1;

[0033] - Figure 5 is a perspective view of a second component of the device of Figure 1.

[0034] With reference to the figures, a device for containing biological samples, according to the invention, is generally designated by the reference numeral 10.

[0035] The device 10 comprises:

[0036] - a first vessel 11 for depositing a biological sample, not shown in the figures,

[0037] - a lid 12 adapted to engage the first vessel 11,

[0038] - a sealed chamber 13, adapted to contain a preservative substance (not shown in the figures), arranged between the lid 12 and the first vessel 11.

[0039] This sealed chamber 13 is defined by a second vessel 14, at least partially inserted in the first vessel 11, with a first opening 15, for filling, directed toward the lid 12.

[0040] The sealed chamber 13 is closed by the lid 12 onto the first vessel 11.

[0041] The first vessel 11 is made of plastic material, such as for example polypropylene (PP).

[0042] The lid 12 is made of plastic material, such as for example low- density polyethylene (LDPE).

[0043] The second vessel 14 is made of plastic material, such as for example high-density polyethylene (HDPE).

[0044] One of the peculiarities of the invention consists in that the device 10 comprises reversible means 16 for creating a passage between the sealed chamber 13 and the first vessel 11, for the preservative substance.

[0045] In the present description, the expression “reversible means for creating a passage” means that after creating the passage it is possible to restore the physical separation between the inside of the hermetically-sealed chamber and the inside of the first vessel, in so doing closing the passage completely.

[0046] In particular, the second vessel 14 has a body with a substantially beaker-like extension with:

[0047] - the first opening 15, for filling, at a first end,

[0048] - a second opening 17 in the bottom 18 of the beaker and directed toward the first vessel 11, for the passage of the preservative substance from the chamber 13 to the first vessel 11.

[0049] Advantageously, the reversible means 16 comprise:

[0050] - a plug 19,

[0051] - means 20 for the elastic return of the plug 19.

[0052] The plug 19 is made of plastic material, such as for example polypropylene (PP).

[0053] This plug 19 is provided with a tray-like element 21, which is crossed entirely by a cross-shaped element 22, in a single piece with the latter component.

[0054] The cross-shaped element 22 is defined by four partitions 23a, 23b, 23c, 23d, which are arranged to provide a cross-shaped cross-section, and has:

[0055] - a first portion 24, at least partially within the tray-like element 21,

[0056] - a second portion 25 extending from the bottom 26 of the tray-like element 21 and directed toward the first vessel 11.

[0057] The four partitions 23a, 23b, 23c and 23d define a corresponding number of sectors 27 of the tray-like element 21.

[0058] This tray-like element 21 has at least one through hole 28, in its bottom 26, in order to allow the passage of the preservative substance through the plug 19, toward the chamber 13.

[0059] In the example shown in the figures, the tray-like element 21 has a through hole 28 in its bottom 26, in each sector 27.

[0060] Advantageously, the second portion 25 of the cross-shaped element 22 is arranged at the sealed chamber 13.

[0061] The tray-like element 21 has a filling opening 29 directed toward the lid 12. The tray-like element 21 of the plug 19 is fully inserted inside the second vessel 14 and has an outside diameter that is substantially comparable to, and slightly smaller than, the inside diameter of the second vessel 14.

[0062] The second portion 25 of the cross-shaped element 22 has, at its free end, a substantially flat part 30, which lies on a plane of arrangement that is perpendicular to the axis of extension of the cross-shaped element 22.

[0063] This flat part 30 is adapted to interact with, and completely close, the second opening 17 of the second vessel 14.

[0064] The second vessel 14 has a tubular portion 31 at the second opening 17, which extends from it toward the first vessel 11.

[0065] The flat part 30 is a stopper made of hard plastic material, for example polypropylene (PP), with an overmolding of soft plastic material on the outside, such as for example thermoplastic rubber (SEBS), which determines the seal on the inner rim of the tubular portion 31.

[0066] The flat part 30:

[0067] - is accommodated within the tubular portion 31, in the closed configuration of the second opening 17,

[0068] - protrudes from the tubular portion 31 in the direction of the first vessel 11, in the open configuration of the second opening 17.

[0069] The tubular portion 31 has a lamina 32 arranged transversely along the diameter of the tubular portion 31.

[0070] The lamina 32 is coupled to the tubular portion 31 :

[0071] - by way of a hinge 33, at a first end thereof,

[0072] - by way of a pre-fracture 34 at a second end thereof, diametrically opposite to the previous end.

[0073] The substantially flat part 30 is provided with a partition / raised portion 35 which is adapted to interact with, and abut against, the lamina 32.

[0074] The aim of the lamina 32 is to indicate the first use of the device 10.

[0075] In fact, with the first use of the device 10, the plug 19 is lowered / performs a translational motion in order to create the passage from the sealed chamber 13 to the first vessel 11 and, owing to such translation, the partition 35 of the flat part 30 irreversibly breaks the pre-fracture 34 of the lamina 32, lowering it and leaving it at least partially lowered.

[0076] In this manner the operator, by looking inside the first vessel 11, which is at least partially transparent, is capable of detecting the status of integrity or otherwise of the lamina 32, thus deducing any prior use of the device.

[0077] The means 20 for elastic return are constituted by a helical spring which surrounds the second portion 25 of the cross-shaped element 22 and is interposed between the bottom 26 of the tray-like element 21 and the bottom 18 of the second vessel 14.

[0078] This spring is made of acetal resin (POM).

[0079] The first portion 24 of the cross-shaped element 22 has a free end 36 with a narrow cross-section, in contact with and internally interacting with the lid 12, and in particular the top 37 of the lid 12.

[0080] The lid 12 is made of flexible plastic material, at least at the region of interaction with the free end 36 of the first portion 24, i.e. in the region of the top 37.

[0081] The top 37 of the lid 12 effectively acts as a button which, if pressed, pushes on the free end 36 of the cross-shaped element 22, in so doing determining an axial translational movement of the plug 19, toward the first vessel 11, so creating a passage between the sealed chamber 13 and the first vessel 11.

[0082] When the device 10 is closed, the lid 12, which contains the second vessel 14 which is provided internally with the reversible means 16, is screwed onto the first vessel 11.

[0083] The use of the device 10 according to the invention is the following.

[0084] Once the biological sample is taken from the patient, this is inserted in the first vessel 11. Then the lid 12 is screwed onto the first vessel 11.

[0085] The lid 12 contains inside it the second vessel 14, which defines the sealed chamber 13 and which in turn contains the reversible means 16.

[0086] Inside the chamber 13 there is a preservative substance, such as for example formalin, which is previously loaded into the sectors 27.

[0087] Once the lid 12 is screwed onto the first vessel 11, the operator presses the top 37 of the lid 12, thus pushing the plug 19 toward the first vessel 11.

[0088] As a result of this translation, the flat part 30 protrudes from the tubular portion 31 of the second vessel 14, so freeing at least partially the second opening 17 and opening the passage for the descent of the preservative substance in the first vessel 11 onto the biological sample.

[0089] Once the pressure is removed from the top 37 of the lid 12, by virtue of the elastic return of the spring 20, the plug 19 returns to the original position and the flat part 30 returns to completely close the second opening 17 and the tubular portion 31 of the second vessel 14.

[0090] During the first use, it is also necessary to break the lamina 32, as previously explained.

[0091] In practice it has been found that the invention fully achieves the intended aim and objects by providing a containment device for biological samples that allows a reversible operation.

[0092] With the invention a containment device for biological samples has been provided that makes it possible to restore the physical separation between the vessel containing the biological sample and the vessel containing, at least initially, a preservative substance.

[0093] The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims. Moreover, all the details may be substituted by other, technically equivalent elements.

[0094] In practice the materials employed, provided they are compatible with the specific use, and the contingent dimensions and shapes, may be any according to requirements and to the state of the art.

[0095] The disclosures in Italian Patent Application No. 102023000001155 from which this application claims priority are incorporated herein by refer - ence.

[0096] Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly, such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

CLAIMS1. A containment device (10) for biological samples, which comprises:- a first vessel (11) for depositing a biological sample,- a lid (12) adapted to engage said first vessel (11),- a sealed chamber (13), adapted to contain a preservative substance, placed between said lid (12) and said first vessel (11), said sealed chamber (13) being defined by a second vessel (14) which is at least partially inserted in said first vessel (11) with a first opening (15), for filling, directed toward said lid (12), and closed by said lid (12) onto said first vessel (11), said device (10) being characterized in that it comprises reversible means (16) for creating a passage between said sealed chamber (13) and said first vessel (11) for said preservative substance.

2. The device (10) according to claim 1, characterized in that said second vessel (14) has a body with a substantially beaker-like extension with:- said first opening (15), for filling, at a first end,- a second opening (17) in the bottom (18) of said beaker and directed toward said first vessel (11), for the passage of said preservative substance from said sealed chamber (13) to said first vessel (11).

3. The device (10) according to one or more of the preceding claims, characterized in that said reversible means (16) comprise:- a plug (19),- means (20) for the elastic return of said plug (19).

4. The device (10) according to one or more of the preceding claims, characterized in that said plug (19) has a tray-like element (21), which is crossed entirely by a cross-shaped element (22), said cross-shaped element (22) being defined by four partitions (23a, 23b, 23c, 23d) which are arranged to provide a cross-like cross-section, and having:- a first portion (24), at least partially within said tray-like element- a second portion (25) extending from the bottom (26) of said traylike element (21) and directed toward said first vessel (11).

5. The device (10) according to one or more of the preceding claims, characterized in that said tray-like element (21) has at least one through hole (28) in its bottom (26).

6. The device (10) according to one or more of the preceding claims, characterized in that said tray-like element (21) has a filling opening (29) directed toward said lid (12), said tray-like element (21) being entirely inserted inside said second vessel (14) and having an outside diameter substantially comparable to, and slightly smaller than, the inside diameter of said second vessel (14).

7. The device (10) according to one or more of the preceding claims, characterized in that said second portion (25) of said cross-shaped element (22) is arranged at said sealed chamber (13), said second portion (25) having, at its free end, a substantially flat part (30) which lies on a plane of arrangement that is perpendicular to the axis of extension of said crossshaped element (22), said substantially flat part (30) being adapted to interact with and completely close said second opening (17) of said second vessel (14).

8. The device (10) according to one or more of the preceding claims, characterized in that said second vessel (14) is provided with a tubular portion (31) at said second opening (17) which extends from it toward said first vessel (11), said substantially flat part (30) being a hard plastic stopper, with an overmolding of soft plastic material on the outside, said flat part (30):- being accommodated within said portion (31), in the closed configuration of said second opening (17),- protruding from said portion (31) in the direction of said first vessel (11), in the open configuration of said second opening (17).

9. The device (10) according to one or more of the preceding claims, characterized in that said tubular portion (31) is provided with a lamina (32) arranged transversely along the diameter of said tubular portion (31), said lamina (32) being coupled to said tubular portion (31):- by way of a hinge (33), at a first end thereof,- by way of a pre-fracture (34) at a second end thereof, diametrically opposite to the previous end.

10. The device (10) according to one or more of the preceding claims, characterized in that said substantially flat part (30) is provided with a partition / raised portion (35) adapted to interact with, and abut against, said lamina (32).

11. The device (10) according to one or more of the preceding claims, characterized in that said means (20) for elastic return are constituted by a helical spring which surrounds said second portion (25) of said cross-shaped element (22) and is interposed between said bottom (26) of said tray-like element (21) and said bottom (18) of said second vessel (14).

12. The device (10) according to one or more of the preceding claims, characterized in that said first portion (24) of said cross-shaped element (22) has a free end (36) with a narrow cross-section, in contact with and internally interacting with said lid (12), said lid (12) being made of flexible plastic material, at least at the region of interaction with said free end (36) of said first portion (24).

Images