WO2018078516A1

WO2018078516A1 - Container for collection and preservation of biopsy samples

Info

Publication number: WO2018078516A1
Application number: PCT/IB2017/056580
Authority: WO
Inventors: Daniele Tartaro; Maurizio Maletti
Original assignee: Traces S.R.L.
Priority date: 2016-10-25
Filing date: 2017-10-24
Publication date: 2018-05-03
Also published as: IT201600107394A1

Abstract

The container (10) comprises: a body (12) arranged to contain the biopsy sample (C), wherein the body (12) comprises a lateral wall (15) and a bottom wall (16), the lateral wall (15) including a mouth (18) provided with a first thread (20); a cap (14) arranged to be screwed to the body (12) to close the latter tightly, wherein the cap (14) comprises a receptacle (24) containing a preserving solution (S), a second thread (32) arranged to engage said first thread (20), and a tearable membrane (26) that seals off the receptacle (24) at its bottom; and a puncturing member (42) arranged to tear the membrane (26) to allow the preserving solution (S) to flow from the receptacle (24) to the body (12), the puncturing member (42) being received inside the body (12) and configured to be urged against the membrane (26), until the latter is torn, as a result of the cap (14) being screwed to the body (12) beyond a predetermined limit. The puncturing member (42) is arranged coaxially with the cap (14) and comprises a pointed portion (46) having a plurality of grooves (48) which radially open towards the bottom wall (16) from a vertex (V) of the pointed portion (46), so as to separate a number of conical sectors (54, 55) from each other, and a disc- shaped portion (50) which is arranged below the pointed portion (46) and has a diameter larger than the diameter at the base of the pointed portion (46), wherein a pair of diametrically opposed conical sectors (54) of the pointed portion (46) have a greater height than the remaining conical sectors (55).

Description

Container for collection and preservation of biopsy samples

The present invention relates to a container for collection and preservation of biopsy samples.

As is known, biopsy is a medical examination consisting in taking a portion or fragment of tissue from a living organism to allow analysis of that portion or fragment of tissue (for example by means of a microscope or by means of microbiological techniques or molecular biology techniques) for diagnostic purposes. Once it has been taken from the patient, the tissue sample is collected in a container and then a preserving agent, typically formalin (formaldehyde in water solution), is put into the container to ensure preservation of the biopsy sample contained inside the container. The container, with the biopsy sample immersed in formalin, can then be closed and sent to a laboratory to be analysed. Formalin, as well as other preserving agents, is a substance which is toxic by inhalation, in particular a carcinogenic substance. Although the operation of introducing formalin into the container is performed under an extractor hood, this operation is however hazardous for the health of the operators assigned to collect the biopsy samples. There is therefore a need to prevent the operator from coming into direct contact with formalin or, in any case, from being exposed to the vapours of the formalin used as preserving agent for preservation of biopsy samples.

In order to satisfy this need, specific containers for collection and preservation of biopsy samples have been conceived, as is known for example from International patent application WO 2016/079611 in the Applicant's name, which discloses a container having the features set forth in the preamble of the appended independent claim 1. According to the solution proposed by this document, the container comprises a body arranged to contain the biopsy sample to be preserved and a cap arranged to engage by screwing the body to close the latter tightly, wherein the cap comprises a receptacle which contains a preserving solution (e.g. formalin) and is sealed by a membrane, and a puncturing member that, as a result of the screwing of the cap, moves vertically, urging against the membrane to tear it and thereby allow the preserving solution contained in the receptacle to flow out of the receptacle and fill the body of the container to submerge the biopsy sample. Such a known container offers a high level of safety, as it eliminates the risk that the operator is exposed to the preserving solution.

It is an object of the present invention to provide a container for the collection and preservation of biopsy samples that, the safety level being unchanged, is simpler to produce and at the same time less expensive to manufacture than the prior art discussed above.

This and other objects are fully achieved according to the invention by virtue of a container for the collection and preservation of biopsy samples having the features set forth in the enclosed independent claim 1.

Further advantageous features of the invention are specified in the dependent claims, the subject-matter of which is to be intended as forming an integral and integrating part of the following description.

In short, the invention is based on the idea of providing a container of the type identified above, comprising a puncturing member that, instead of being included in the cap as in the above described prior art, is accommodated inside the body, namely coaxially with the axis of the body and of the cap, and comprises a pointed portion having a plurality of grooves that radially open towards the bottom wall from a vertex of the pointed portion so as to separate a number of conical sectors from each other, and a disc- shaped portion, which is arranged below the pointed portion and has a diameter larger than the diameter at the base of the pointed portion, wherein a pair of diametrically opposed conical sectors of the pointed portion have a greater height than the remaining conical sectors.

By virtue of such a configuration the container is simpler and cheaper to manufacture than the prior art. Moreover, the special shape of the pointed portion of the puncturing member allows to tear the membrane just as much as needed to allow a quick outflow of the preserving solution from the receptacle towards the body of the container, avoiding at the same time the risk that the biopsy sample moves from the body to the receptacle. Preferably, the container is provided with a safety ring interposed between the cap and the body to prevent the cap from being screwed to the body to such an extent as to cause the tearing of the membrane by the puncturing member. The membrane can thus be torn by the puncturing member after the cap has been screwed to the body of the container only if the safety ring has been previously removed. This clearly represents a further guarantee for the safety of the operator.

Preferably, the container comprises at least one sealing ring that is interposed between the cap and the body of the container and is arranged to guarantee the tightness of the container when the preserving solution flows out of the receptacle to fill the body. This avoids the risk for the operator to come into contact with the preserving solution and the vapours emitted by the latter, once the preserving solution has flown out of the receptacle and filled the body of the container. Preferably, the cap has an external thread and the mouth of the body of the container has an internal thread arranged to engage the external thread of the cap so as to allow the cap to be screwed to the body of the container. In this case, the cap preferably comprises an annular flange acting as an end-of-travel member when the cap is screwed to the body of the container. The screwing of the cap to the body of the container is stopped at a point such that the receptacle is not immersed in the preserving solution once the latter has flown out of the receptacle into the body of the container and the latter is kept in a standing position. Furthermore, the flange allows to seal the cap to the body of the container when the biopsy sample is inside the container. In case a safety ring is provided for, it will then be preferably arranged between the annular flange of the cap and a top edge of the mouth of the body of the container.

Preferably, the container comprises supporting means fixed to the body to support the puncturing member. According to an embodiment, these supporting means are made in one piece with the body, which allows to minimize the number of pieces of the container.

According to an embodiment, the supporting means comprise a rod that extends coaxially with the body and is fixed to the bottom wall, in which case the puncturing member is mounted at the free end of the rod. Making the supporting element as a rod is advantageous as it allows to support the puncturing member taking up as little space as possible inside the body of the container. Such an embodiment is particularly recommended for containers having a small capacity, e.g. 20 ml, intended to contain biopsy samples of small sizes.

According to a further embodiment, the supporting means comprise at least one radial projection projecting radially inwards from the lateral wall of the body. This further embodiment is particularly recommended for containers with a bigger capacity, e.g. 60 ml, intended to contain biopsy samples of bigger sizes.

Preferably, the lateral wall of the body of the container includes a lower portion with an essentially frustoconical shape and an upper portion with an essentially cylindrical shape which forms the mouth of the body of the container and has a diameter larger than the diameter of the bottom wall. This shape is advantageous when the container is not kept in a standing position, but laid on a plane. In fact, by virtue of such a shape of the lateral wall of the body, the longitudinal axis of the container is tilted with respect to the plane, so that backflow of the preserving solution, and hence of the biopsy sample along with it, from the body to the receptacle is prevented. Further features and advantages of the present invention will become apparent from the following detailed description, given purely by way of non-limiting example with reference to the appended drawings, where:

Figures 1 and 2 are a perspective view and an axial section view, respectively, of a container for collection and preservation of biopsy samples according to an embodiment of the present invention, in the initial condition of delivery;

Figures 3 and 4 are a perspective view and an axial section view, respectively, of the container of Figures 1 and 2, in the final condition of use;

Figure 5 is a perspective view, on an enlarged scale, of the puncturing member of the container of Figures 1 and 2;

Figure 6 is a plan view of the puncturing member of Figure 5;

Figures 7 and 8 are axial section views that show a container for collection and preservation of biopsy sample according to a further embodiment of the present invention, in the initial condition of delivery and in the final condition of use, respectively; and

Figures 9 and 10 are a front view and a plan view, respectively, of the puncturing member of the container of Figures 7 and 8. With reference first to Figures 1 to 4, a container for collection and preservation of biopsy sample according to an embodiment of the present invention is generally indicated with 10. The container 10 basically comprises a body 12 arranged to contain a biopsy sample to be preserved (schematically shown in Figures 1 and 3, where it is indicated with C) and a cap 14 arranged to engage, by screwing, the body 12 to seal it tightly.

The body 12 comprises a lateral wall 15 which is closed at the bottom by a bottom wall 16 on which the biopsy sample C is placed. The lateral wall 15 includes a lower portion 17, preferably having an essentially frustoconical shape, and an upper portion, or mouth, 18, of essentially cylindrical shape, preferably having a diameter larger than that of the bottom wall 16. In the embodiment shown in the drawings, the mouth 18 is provided with an internal thread 20.

The cap 14 comprises a receptacle 24 in which a preserving solution S (e.g. formalin) is contained. The receptacle 24 is conveniently sized to contain the desired volume of preserving solution and, preferably, also to have a free volume equal at least to 30% of the volume of the preserving solution. The receptacle 24 is sealed at the bottom by a tearable membrane 26 that is made, for example, of aluminium or polymeric material. The membrane 26 is fixed, for example by gluing, to an annular bottom edge 28 of the receptacle 24.

According to the embodiment illustrated in the drawings, the cap 14 comprises a lower portion 30 provided with an external thread 32, arranged to engage with the thread 20 of the mouth 18 of the body 12 to allow the cap 14 to be screwed to the body 12. The receptacle 24 further comprises an upper portion 36 that is provided with gripping means 38 (formed, for example, by radial projections) to increase the grip for the operator and thus make the operation of screwing of the cap 14 to the body 12 easier. An annular flange 40 is provided between the lower portion 30 and the upper portion 36 of the cap 14 and is arranged to act as an end-of-travel member when the cap 14 is screwed to the body 12. The container 10 further comprises a puncturing member 42 arranged to tear the membrane 26 of the receptacle 24 as a result of the cap 14 being screwed to the body 12 beyond a predetermined limit. The puncturing member 42 is accommodated inside the body 12, preferably in a fixed position with respect to the body 12, and is arranged coaxially with the cap 14, that is with its axis aligned with the axis of the cap 14 (i.e. the axis about which the cap 14 is rotated when it is screwed to the body 12). The direction of the axis of the puncturing member 42, as well as of the axis of the cap 14, is indicated x in the drawings. The axis x also coincides with the axis of the body 12.

Preferably, the puncturing member 42 is mounted on a supporting member 44 fixed to the body 12. In the embodiment of Figures 1 to 4, the supporting member 44 is made as a rod that extends along the axis x and is fixed to the bottom wall 16 (preferably made in one piece with the bottom wall 16), and the puncturing member 42 is placed on the top of this rod. With reference also to Figures 5 and 6, the puncturing member 42 comprises, first of all, a pointed portion 46 having a plurality of grooves 48 that radially open downwards, i.e. towards the bottom wall 16, from a vertex V of the pointed portion. The puncturing member 42 further comprises a disc-shaped portion 50 placed below the pointed portion 46 and preferably having a diameter larger than the diameter at the base of the pointed portion 46. The disc-shaped portion 50 has a recess 52 in which the top end of the rod 44 is engaged. According to a further embodiment of the present invention, the puncturing member 42, or at least a portion thereof (for example the pointed portion 46 and/or the disc- shaped lower portion 50), may be made in one piece with the rod 44. The grooves 48 separate a plurality of conical sectors 54, 55 (in the proposed embodiment, four conical sectors) from each other, which conical sectors are axially symmetric two by two with respect to the axis of the pointed portion 46 (that coincides with the above mentioned axis x). Advantageously, two of the conical sectors, namely those indicated with 54, have a greater height than the remaining conical sectors 55.

In the initial condition of delivery of the container 10, as shown in Figures 1 and 2, the membrane 26 is at a given distance from the vertex of the pointed portion 46 of the puncturing member 42. Furthermore, in the initial condition of delivery the container 10 is provided with a safety ring 56 interposed between the cap 14 and the mouth 18 of the body 12, for example placed around the lower portion 30 of the cap 14 so as to be axially interposed between the flange 40 of the cap 14 and the top edge of the mouth 18 of the body 12. By virtue of the presence of the safety ring 56, the cap 14 cannot be screwed further with respect to the initial condition of delivery, in which the flange 40 abuts against the safety ring 56 and the latter abuts in turn against the top edge of the mouth 18. The container 10 is configured in such a way that in the initial condition of delivery the vertex V of the pointed portion 46 of the puncturing member 42 is at a given distance from the membrane 26. Since in such a condition, as explained above, the cap 14 cannot be screwed further to the body 12, the puncturing member 42 remains at a distance from the membrane 26. There is therefore no risk for the operator, while handling the container 10, to cause the tearing of the membrane 26 and thus the early outflow of the preserving solution. On the other hand, once the safety ring 56 has been removed, the cap 14 can be further screwed to the body 12 with respect to the initial condition of delivery shown in Figures 1 and 2. In this way, the membrane 26 is shifted together with the cap 14 towards the bottom wall 16 of the body 12 and is torn by the contact with the pointed portion 46 of the puncturing member 42. Figures 3 and 4 show, indeed, the container 10 in the final condition of use, in which the operator, after having introduced the biopsy sample C into the body 12 and removed the safety ring 56, has screwed the cap 14 to the body 12 completely, until the flange 40 of the cap 14 comes into abutment against the top edge of the mouth 18 of the body 12. Once the membrane 26 is torn, the preserving solution is free to flow, by gravity, out of the receptacle 24, passing through the grooves 48 of the pointed portion 46 of the puncturing member 42, and fall in the underlying body 12. By virtue of the special shape of the pointed portion 46 of the puncturing member 42, as described above, the pointed portion 46 is able to tear the membrane 26 enough to ensure a quick outflow of the preserving solution from the receptacle 24 towards the body 12 of the container, preventing at the same time the biopsy sample C from passing from the body 12 to the receptacle 24. In order to guarantee tightness of the container 10, when the preserving solution has flown out of the receptacle 24 and fills the body 12, the cap 14 is advantageously provided with a sealing ring 58 placed around the lower portion 30 above the external thread 32.

The embodiment of the container 10 described above with reference to Figures 1 to 6 is particularly recommended for small capacity containers (e.g. containers with a capacity of 20 ml) to be used to contain biopsy samples of a small sizes.

A further embodiment of the present invention is shown in Figures 7 to 10, in which parts and elements identical or corresponding to those of Figures 1 to 6 have been indicated with the same reference numbers. The structure and operation of the container according to this further embodiment are essentially similar to those of the embodiment described above with reference to Figures 1 to 6. Therefore, the explanations provided above in connection with the first embodiment apply generally to this further embodiment. This further embodiment differs from the previous one in that, instead of a rod extending coaxially with the body of the container from the bottom wall of the latter, at least one radial projection 60 projecting radially inwards from the lateral wall 15 of the body 12, in particular from the lower portion 17 of the lateral wall 15, is used as the supporting means to support the puncturing member 42 inside the body 12. In the example shown in Figures 7 and 8 a single radial projection 60 is provided, that extends along the whole internal circumference of the lateral wall 15. Alternatively, a plurality of radial projections 60 may be provided for, in particular three or more radial projections.

According to this further embodiment, the puncturing member 42 further comprises a mounting portion 62, that is placed below the disc-shaped portion 50 and is suitably shaped to be mounted resting on the radial projection(s) 60. For example, as can be seen in particular in Figure 9, the mounting portion 62 may comprise a plurality of spokes 64 that extend radially outwards and are preferably angularly equally spaced apart one from each other. Preferably, there are four spokes 64, but there might be a different number of spokes, for example only two or three. In the example shown in Figures 7 to 10 the spokes 64 rest directly at their free ends on the radial projection 60. It is also possible, however, that the spokes are connected to an annular support member arranged to be mounted resting on the radial projection 60, in which case it is sufficient to provide three radial projections, 120 degrees apart from each other, instead of a single radial projection that extends along the whole internal circumference of the lateral wall 15. This further embodiment is particularly recommended for containers of larger capacity (e.g. containers with a capacity of 60 ml), to be used to contain biopsy samples of larger sizes.

As it is clear from the description provided above, the present invention allows the collection and preservation of biopsy samples avoiding the risk that the operator comes into contact with the preserving solution and with the vapours and volatile substances emitted by the preserving solution. Furthermore, the container according to the invention has a simple structure, with a small number of parts, and can thus be manufactured at low cost. Additionally, the special arrangement and shape of the puncturing member allows a quick outflow of the preserving solution from the receptacle towards the body of the container, and at the same time prevents the biopsy sample from getting into the receptacle once the membrane that seals the receptacle has been torn by the puncturing member.

Naturally, the principle of the invention remaining unchanged, the embodiments and the constructional details may vary widely from those described and illustrated purely by way of non-limiting example, without thereby departing from the scope of the invention as defined in the appended claims.

Claims

1. Container (10) for collection and preservation of biopsy samples (C), comprising: a body (12) arranged to contain the biopsy sample (C), wherein the body (12) comprises a lateral wall (15) and a bottom wall (16), the lateral wall (15) including a mouth (18) provided with a first thread (20);

a cap (14) arranged to be screwed to the body (12) to close the latter tightly, wherein the cap (14) comprises a receptacle (24) containing a preserving solution (S), a second thread (32) arranged to engage said first thread (20), and a tearable membrane (26) that seals off the receptacle (24) at its bottom; and

a puncturing member (42) arranged to tear the membrane (26) to allow the preserving solution (S) to flow from the receptacle (24) to the body (12), the puncturing member (42) being accommodated inside the body (12) and configured to be urged against the membrane (26) until the latter is torn, as a result of the cap (14) being screwed to the body (12) beyond a predetermined limit;

characterized in that the puncturing member (42) is arranged coaxially with the cap (14) and comprises a pointed portion (46) having a plurality of grooves (48) which radially open towards the bottom wall (16) from a vertex (V) of the pointed portion (46) so as to separate a number of conical sectors (54, 55) from each other, and a disc-shaped portion (50), which is arranged below the pointed portion (46) and has a diameter larger than the diameter at the base of the pointed portion (46), wherein a pair of diametrically opposed conical sectors (54) of the pointed portion (46) have a greater height than the remaining conical sectors (55).

2. Container according to claim 1, further comprising supporting means (44; 60) fixed to the body (12) to support the puncturing member (42).

3. Container according to claim 2, wherein said supporting means (44; 60) comprise a rod (44) extending upwards from the bottom wall (16) of the body (12), and wherein the puncturing member (42) is mounted at the free end of the rod (44).

4. Container according to claim 2, wherein said supporting means (44; 60) comprise at least one radial projection (60) projecting radially inwards from the lateral wall (15) of the body (12), and wherein the puncturing member (42) comprises a lower mounting portion (62, 64) arranged to be mounted resting on said at least one radial projection (60).

5. Container according to any of claims 2 to 4, wherein said supporting means (44; 60) are made in one piece with the body (12).

6. Container according to any of the preceding claims, further comprising a safety ring (56) interposed between the body (12) and the cap (14) to prevent the cap (14) from being screwed to the body (12) beyond said predetermined limit.

7. Container according to any of the preceding claims, wherein said first thread (20) is an external thread and said second thread (32) is an internal thread.

8. Container according to claim 6 and claim 7, wherein the cap (14) comprises an annular flange (40) acting as an end-of-travel member when the cap (14) is screwed to the body (12), and wherein the safety ring (56) is axially interposed between the annular flange (40) of the cap (14) and an upper edge of the mouth (18) of the body (12).

9. Container according to claim 7 or claim 8, further comprising a sealing ring (58) mounted around the cap (14) above said second thread (32).

10. Container according to any of the preceding claims, wherein the lateral wall (15) includes a lower portion (17) with an essentially frustoconical shape and an upper portion, defining said mouth (18), with an essentially cylindrical shape, the diameter of the upper portion being larger than that of the bottom wall (16).