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1. WO2018130946 - CONTAINER FOR COLLECTION AND PRESERVATION OF BIOPSY SAMPLES

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[ EN ]

Container for collection and preservation of biopsy samples

BACKGROUND OF THE INVENTION

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

As is known, biopsy is a medical examination that consists in taking a portion or fragment of tissue from a living organism to allow the analysis of this portion or fragment of tissue (e.g. by means of a microscope or by means of microbiology 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 aqueous solution), is introduced into the container to ensure preservation of the biopsy sample. The container with the biopsy sample immersed in formalin can therefore be closed and sent to a laboratory to be analysed. Formalin, as well as other preserving agents, is a toxic substance by inhalation, in particular a carcinogenic substance. Even if the operation of introducing the formalin into the container is carried out under a suction hood, this operation puts 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 formalin used as preserving agent for preservation of biopsy samples.

To meet this need, special containers have been designed for collection and preservation of biopsy samples.

A container for collection and preservation of biopsy samples is known for example from WO2012/171529. According to this known solution, the container comprises a body arranged to contain the biopsy sample to be preserved and a cap arranged to engage the body by screwing to seal the latter, wherein the cap comprises a receptacle, which contains a preserving solution (e.g. formalin) and is sealed by a membrane, and a puncturing member arranged to be urged against the membrane to tear it and thus allow the preserving solution contained in the receptacle to flow out of the receptacle and fill the body of the container to flood the biopsy sample. This known container is particularly complex and is therefore also particularly expensive to manufacture.

A container for collection and preservation of biopsy samples is also known from WO2016/131859. According to this known solution , the container comprises a lower body portion arranged to contain the biopsy sample to be preserved, an upper body portion containing the preserving solution, a valve arranged to allow the preserving solution to flow from the upper body portion to the lower body portion and a control member through which the operator is able to control the displacement of the valve from a closed position, in which it seals the upper body portion, thus preventing the preserving solution from flowing from the upper body portion to the lower body portion, to an open position, in which it allows the preserving the solution to flow from the upper body portion to the lower body portion. According to this known solution, the control member extends parallel to the longitudinal axis of the container, hence through the upper body portion. Accordingly, the control member is at least partly immersed in the preserving solution contained in the upper body portion. Therefore, appropriate measures are necessary to prevent the operator from coming into contact with the preserving solution when he is acting on the control member.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a container for collection and preservation of biopsy samples that is both simple and inexpensive to manufacture, but that at the same time ensures a high degree of safety for the operator, and that also is particularly suitable for use with small and medium biopsy samples, in particular of sizes of a few millimetres or even less than one millimetre.

This and other objects are fully achieved according to the invention thanks to a container for collection and preservation of biopsy samples having the characteristics defined in the annexed independent claim 1.

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

In summary, the invention is based on the idea of providing a container comprising

a cup-shaped lower body open at its top,

a cup- shaped upper body open at its bottom, and

an intermediate body interposed between the lower body and the upper body, wherein the lower body is detachably connected to the intermediate body to enclose together with the intermediate body a lower chamber intended to receive the biopsy sample to be preserved,

wherein the upper body is connected to the intermediate body and encloses with the intermediate body an upper chamber containing a given quantity of preserving solution, wherein the intermediate body includes at least one transverse wall which separates the lower chamber from the upper chamber and has at least one first through hole through which the lower chamber is able to be put in fluid communication with the upper chamber, wherein the container further comprises flow control means carried by the intermediate body for controlling the flow through said at least one first through hole, said flow control means being movable relative to the intermediate body between a first position, in which they sealingly close said at least one first through hole, thus preventing the preserving solu-tion from flowing from the upper chamber to the lower chamber, and a second position, in which they open said at least one first through hole, thus allowing the preserving solution to flow from the upper chamber to the chamber lower, and

wherein the container further comprises manually-operated control means which are associated to said flow control means to allow an operator to control the displacement of said flow control means between said first and second positions, and which project laterally from the intermediate body.

Since the container has a reduced number of components and since these components can be easily produced by moulding from plastic material or by other similar process, the con-tainer according to the invention is extremely simple and inexpensive to manufacture.

Moreover, since the manually-operated control means project laterally from the intermedi- ate body, said control means are not immersed, even in part, in the preserving solution, and therefore the container is safer to handle for the operator than the containers of the prior art, with no need for further specific measures and therefore with no increase in cost. The presence of the flow control means in the intermediate body of the container also helps to guarantee a high level of safety for the operator, since it ensures the hermetic closing of the upper chamber and the lower chamber, thus eliminating the risk that the operator comes in direct contact with the preserving solution or is exposed to the vapours generated by the preserving solution. A further advantage of the container according to the invention is that the container can be filled, before use, with different amounts of preserving solution to be used for storing biopsy samples of different sizes.

According to an embodiment, the flow control means comprise a plunger-like member housed in a second through hole which extends into the intermediate body passing through the first through hole. The plunger- like member has a first portion configured to seal the first through hole and a second portion adjacent to the first one, configured to allow the fluid to flow through the first through hole. The plunger-like member is slidable in the second through hole between a first position, in which the first portion of the plunger-like member is placed at the first through hole and thus sealingly closes said hole, and a second position, in which the second portion of the plunger-like member is placed at the first through hole and thus allows fluid flow through said hole. In order to allow the preserving solution to flow from the upper chamber to the lower chamber through the first through hole, the operator has therefore only to move the plunger-like member axially in the second through hole. When the plunger-like member is placed in the first position it projects radially outwards from the intermediate body of the container. In this way, in order to move the plunger-like member from the first position to the second position, and therefore allow the preserving solution to flow from the upper chamber to the lower chamber, and vice versa to move the plunger-like member from the second position to the first position, and therefore stop the flow of the preserving solution from the upper chamber to the lower chamber, the operator simply has to urge the plunger-like member radially inwards by act-ing on one end or the other of this member projecting from the intermediate body. In this case, therefore, the two opposite ends of the plunger-like member act as manually-operated control means by which the operator is able to control the flow control means.

According to a further embodiment, the flow control means comprise a rotary member which is rotatably arranged in a second through hole extending along a diameter of the intermediate body and is provided with at least one ball-shaped closure part configured to seal a respective pair of first through holes longitudinally aligned with each other, wherein one of said first holes is provided in an upper transverse wall of the intermediate body arranged above the second through hole, and therefore facing the upper chamber of the container, while the other of said first holes is provided in a lower transverse wall of the intermediate body arranged below the second through hole, and therefore facing the lower chamber of the container. The rotary member is rotatable between a first position, in which the at least one ball-shaped closure part of the rotary member seals the respective pair of first through holes, and a second position, in which a through hole of the at least one ball-shaped closure part of the rotary member is aligned with the holes of the respective pair of first through holes, thus allowing the preserving solution to flow from the upper chamber to the lower chamber. In this case, the manually-operated control means by which the operator is able to control the flow control means, i.e. to rotate the rotary member in one direction or the other between the first and second positions, are preferably formed by a control knob which is rigidly connected to one end of the rotary member projecting from the second through hole .

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the present invention will become more apparent from the following detailed description, which is given purely by way of non-limiting example with reference to the annexed drawings, wherein:

Figures 1 and 2 are perspective views of a container for collection and preservation of biopsy samples according to an embodiment of the present invention, with the flow control means in the closed position and in the open position, respectively;

Figure 3 shows the container of Figures 1 and 2 in a disassembled condition;

Figures 4 and 5 are views from above of the intermediate body of the container of Figures 1 and 2, with the flow control means in the closed position and in the open position, respectively;

Figure 6 shows the plunger-like member acting as a flow control means of the con-

tainer of Figures 1 and 2;

Figures 7 and 8 are a perspective view and an exploded view, respectively, of a container for collection and preservation of biopsy samples according to a further embodiment of the present invention; and

Figures 9 and 10 are axial section views of the container of Figures 7 and 8, with the flow control means in the closed position and in the open position, respectively.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference first to Figures 1 to 3, a container for collection and preservation of biopsy samples according to an embodiment of the present invention is generally indicated with 10.

The container 10 basically comprises a lower body 12, an upper body 14 and an intermedi-ate body 16 A longitudinal axis of the container 10 is indicated with z and, in the position in which the container is shown in Figures 1 and 2, is oriented vertically. Each one of the lower body 12, upper body 14 and intermediate body 16 preferably has an axisymmetric configuration with respect to the longitudinal axis z.

The lower body 12 has a cup-shaped configuration, open at its top, with a side wall 12a, having for example a cylindrical or frustoconical shape, and a bottom wall 12b. The lower body 12 is detachably connected, for example by threaded connection, to the intermediate body 16 so as to enclose with the latter a lower chamber 18 suitable for containing a biopsy sample (not shown) to be preserved.

The upper body 14 also has a cup-shaped configuration (arranged upside down, so as to be open at its bottom), with a side wall 14a, having for example a cylindrical or frustoconical shape, and a bottom wall 14b. The upper body 14 is connected to the intermediate body 16, for example by threaded connection, so as to enclose with the latter an upper chamber 20 that is pre-filled with a given quantity of preserving solution (for example formalin). The amount of preserving solution contained in the upper chamber 14 will be chosen according to the size of the biopsy sample that is to be stored inside the container 10. For example, this quantity may be between 10 and 60 ml.

The intermediate body 16 comprises a lateral wall 16a, preferably of a cylindrical shape, and a transverse wall 16b, which extends perpendicularly to the longitudinal axis z and separates the lower chamber 18 from the upper chamber 20 in the assembled condition of the container 10. The transverse wall 16b has a first through hole 22, through which the lower chamber 18 can be put in fluid communication with the upper chamber 20. In the proposed embodiment the first through hole 22 is placed in the centre of the transverse wall 16b and has an ovoid shape. The above-mentioned position and shape of the first through hole 22 are not however essential for the purposes of the present invention.

With reference also to Figures 4 and 5, the intermediate body 16 has a second through hole 24 (preferably having a circular cross-section) extending transversely in the transverse wall 16b of the intermediate body 16 passing through the first through hole 22. Preferably, the second through hole 24 extends along a diameter of the intermediate body 16 passing through the major axis of the first through hole 22.

A plunger- like member 26 is slidably mounted in the second through hole 24. The plungerlike member 26 is manually operable to control the flow through the first through hole 22. In particular, the plunger-like member 26 is displaceable along the second through hole 24 between a first position (shown in Figures 1 and 4), or closed position, in which it seals the first through hole 22 and thus prevents the preserving solution contained in the upper chamber 20 from flowing towards the lower chamber 18, and a second position (shown in Figures 2 and 5), or open position, in which it allows flow through the first through hole 22, thus allowing the preserving solution to flow from the upper chamber 20 to the lower chamber 18.

As can be seen in Figure 6, the plunger-like member 26 comprises a pair of axially opposed end portions 28a and 28b, namely a first end portion 28a and a second end portion 28b, and a pair of intermediate portions 30 and 32, namely a first intermediate portion 30 and a second intermediate portion 32, which are arranged adjacent to one another and are interposed between the end portions 28a and 28b.

The end portions 28a and 28b of the plunger-like member 26 project laterally from the intermediate body 16, so as to allow the operator, acting on them, to move the plunger-like member 26 along the second through hole 24 between the aforementioned first and second positions. Preferably, the end portions 28a and 28b project alternately to each other from the intermediate body 16, as shown in Figures 4 and 5, in that when the plunger-like member 26 is in the first position (Figure 4) only the end portion 28b projects laterally from the intermediate body 16, whereas when the plunger- like member 26 is in the second position (Figure 5) only the end portion 28a projects laterally from the intermediate body 16. Therefore, in order to move the plunger-like member 26 from the first position to the second po-sition the operator has to act on the end portion 28b, urging it towards the inside of the intermediate body 16, whereas in order to move the plunger- like member 26 in the opposite direction, that is from the second position to the first position, the operator has to act on the end portion 28a, urging it towards the inside of the intermediate body 16. Preferably, the end portions 28a and 28b have a circular cross-section, with a diameter equal to that of the second through hole 24.

The first intermediate portion 30 of the plunger-like member 26 is located adjacent the first end portion 28a and preferably has a cross-section of circular shape, with a diameter equal to that of the first end portion 28a. The second intermediate portion 32 of the plunger-like member 24 has a reduced cross-section with respect to the first intermediate portion 30, preferably also a cross-section of circular shape. The two intermediate portions 30 and 32 are suitably sized with respect to the first through hole 22 so that the first intermediate portion 30 seals the first through hole 22 when it is at said hole, while the second intermediate portion 32 allows the flow through the first through hole 22 when it is at said hole. There-fore, in the above-mentioned first position of the plunger-like member 26 the first intermediate portion 30 of the plunger-like member 26 is located at the first through hole 22 and the preserving solution is not allowed to flow through the first through hole 22, whereas in the above-mentioned second position of the plunger-like member 26 the second intermediate portion 32 of the plunger-like member 26 is located at the first through hole 22 and the preserving solution is allowed to flow through the first through hole 22 from the upper chamber 20 to the lower chamber 18.

In the initial supply condition of the container 10, the plunger-like member 26 is in the first position, whereby the preserving solution contained in the upper chamber 20 cannot flow towards the lower chamber 18. In this position, the second end portion 28b of the plungerlike member 26 projects from the second through hole 24. Once the biopsy sample is intro-duced into the lower chamber 18 of the container 10, in order to let the preserving solution flow from the upper chamber 20 to the lower chamber 18 so as to completely immerse the biopsy sample, the operator moves the plunger-like member 26 to the second position by urging on the second end portion 28b. In this way, the second intermediate portion 32 of the plunger-like member 26 is positioned at the first through hole 22, allowing the flow through said hole. In this position, the first end portion 28a of the plunger-like member 26 projects from the second through hole 24, from the side opposite to the second end portion 28b.

To bring the plunger-like member 26 back to the first position, in order to seal the lower chamber 18 and thus avoid that the preserving solution contained therein, possibly together with the biopsy sample, return to the upper chamber 20, the operator must simply press on the first end portion 28a.

A further embodiment of a container for collection and preservation of biopsy samples ac-cording to the present invention is shown in Figures 7 to 10, where parts and elements identical or similar to those of the container of Figures 1 to 6 have been indicated with corresponding reference numbers , increased by 100 .

This further embodiment differs from the one previously described with reference to Fig-ures 1 to 6 in the configuration of the flow control means which control the fluid communication between the lower chamber and the upper chamber, as well as in the configuration of the manually-operated control means by which the operator is able to control the movement of the flow control means between the first position and the second position.

In this case, in fact, the flow control means comprise a rotary member 126 rotatable about its axis (extending along a diameter), instead of a plunger-like member shiftable along its axis. The rotary member 126 is rotatably arranged in the second through hole 124 to rotate between the first position (Figure 9), or closed position, and the second position (Figure 10), or open position. The rotary member 126 comprises at least one ball-shaped closure part 127 having a through hole 129 whose axis extends perpendicular to the axis of the rotary member 126. In the illustrated example, the rotary member 126 comprises two ball-shaped closure parts 127, each having a respective through hole 129.

In the first position of the rotary member 126 the through holes 129 of the two ball-shaped closure parts 127 are arranged with their axes substantially perpendicular to the longitudinal axis z of the container. In this position, each of the two ball-shaped closure parts 127 seals a respective pair of first through holes 122' and 122" aligned to one another in a direction parallel to the longitudinal axis z, wherein the through hole 122' of each pair of first through holes 122' and 122" is made in an upper transverse wall 16b' of the intermediate body 16, arranged above the axis of the second through hole 124, while the through hole 122" of each pair of first through holes 122' and 122" is made in a lower transverse wall 16b" of the intermediate body 16, arranged below the axis of the second through hole 124.

On the other hand, when the rotary member 126 is in the second position the through holes 129 of the two ball-shaped closure parts 127 are aligned each with the two through holes 122' and 122" of each pair of first through holes 122' and 122", whereby the preserving so-lution is allowed to flow from the upper chamber 120 to the lower chamber 118 through, in order, the through holes 122', 129 and 122" for each of the ball-shaped closure parts 127.

A control knob 128 is rigidly connected (preferably formed in one piece) to one end of the rotary member 126 projecting from the second through hole 124, on which control knob the operator can manually act to rotate the rotary member 126 in one direction or the other between the first position and the second position defined above. Also in this case, therefore, the manually-operated control means (formed herein by the control knob 128) project laterally from the intermediate body 126.

For the rest, what has already been explained above with regard to the embodiment of Figures 1 to 6 applies to this further embodiment as well.

Thanks to the use of a container according to the present invention, the operator can insert the biopsy sample into the lower chamber without coming into contact with the preserving solution contained in the upper chamber. The container according to the invention therefore avoids the risk that the operator is exposed to the preserving solution contained in the upper chamber and to the vapours generated by the same, not only before the operation of inserting the biopsy sample into the container, but also during and after this operation.

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

For example, the container may further comprise a safety ring that seals the upper body, so as to further increase the safety level of the container.