Patent Application
20220258153
The present invention refers to a container assembly for biological samples, which permits to collect, preserve and transport a biological sample, such as e.g. a tissue sample.
Histopathological analysis protocols require that the tissue samples obtained from patients must be treated quickly using a fixative liquid or other suitable fluid as a preservative agent, prior to sending the sample to the laboratory where it is processed.
The formaldehyde is the most commonly fixative liquid used, and its toxic effects to humans or other lifeforms are well known.
Currently, the clinician is exposed to formaldehyde when he/she introduces the sample (biopsy) into the container assembly with formaldehyde.
Nowadays, after taking the sample, the hospital staff, opens the container assembly containing the formaldehyde, places the sample inside, closes the container assembly and send it to the pathology laboratory.
Considerable risks of spilling and inhalation of formaldehyde exist in this procedure, which constitutes a danger to the health of the user.
Consequently, one aim of the present invention is to provide an improved container assembly for biological samples that is suitable to protect the healthcare professional from direct contact with the fixative liquid and that allows for a relatively safe collection, preservation and transport of biological samples in a fixative liquid.
The invention is defined in the appended claims.
According to an aspect of the invention, there is provided a container assembly for handling a biological sample, comprising:
This provides the advantage of allowing to preserve and safely transport the biological sample(s) collected for histopathological analysis. Furthermore, the presence of the self-sealing dispensing valve is an easy to use and simple to manufacture valve configured to switch between a fluid seal and fluid conduit and prevent spillages and potential inhalation of the conservation or fixative fluid (e.g. formaldehyde) by the staff handling the container assembly. As a result, the fixative liquid can be safely transferred between the first and second receptacles, wherein the sample, when present in the first receptacle, is contained in the first receptacle.
Advantageously, said barrier member may further comprise a protrusion extending from a surface facing said first receptacle and that is adapted to receive and position the biological sample when placing the biological sample onto said at least one barrier member.
Preferably, said protrusion may have a sharp-edged substantially triangular cross-section.
This provides the advantage of allowing a more efficient placement of the sample into one of the receptacles. For example, transferring a renal or cerebral tissues biopsy specimens into a container assembly with preservation fluid is normally done with a spatula, however, the handling of such a tissue is difficult due to its slippery texture. The protrusion is configured to aid the user and allow for a more efficient transfer of the tissue from the spatula onto the barrier member. In particular, the sharp uppermost edge allows a more controlled scraping off of the biopsy sample from the spatula, as well as, prevent undesired movement of the sample when placed onto the barrier member before sealing the container assembly.
Advantageously, said first receptacle and said second receptacle may at least partially be made of a resiliently deformable material. Preferably, said resiliently deformable material may be a polymer. Even more preferably, said polymer may be any one of polyethylene terephthalate, high-density polyethylene and polyvinyl chloride.
The resiliently deformable material allows the user to change the volume and fluid pressure inside any one of the receptacles creating a pressure difference between the two receptacles and moving the preservation fluid from one receptacle into the other. Here, the applied pressure is sufficient to squeeze the receptacle, open the valve and thus promote the flow of the fluid between the receptacles.
Advantageously, any one of said first and said second receptacles may be made from a transparent material. This provides the advantage of allowing visual inspection of the state of the biological sample when inside the receptacle. Further, the transparent receptacles allow the user to estimate the level of preservation fluid in any one of the receptacles during sampling, transporting and storing the sample(s).
Advantageously, said coupling member may comprise a threaded inner surface adapted to mountably engage with a corresponding threaded outer surface of said first and second receptacle. This provides the advantage of an effortless separation of the receptacles from the coupling member, thus, removing the need to use hinged or clamped connection, which requires axial alignment to provide a sealed closure.
Advantageously, said coupling member may further comprise an internal housing configured to retainingly receive said at least one self-sealing dispensing valve. This provides the advantage that the valve can be easily replaced if damaged or lost. The components of the container assembly may also be made of the autoclavable materials, thus further allowing reusing the assembly.
Advantageously, the at least one self-sealing dispensing valve may comprise a resilient membrane having at least one substantially central slit adapted to open at a predetermined fluid pressure. Preferably, said membrane may comprise at least three slits radially arranged, so as to form three resilient flaps adapted to open at a predetermined fluid pressure. Even more preferably, said at least one self-sealing dispensing valve may be made from a resilient silicone material.
The use of inert material prevents reaction with the preservation fluid and/or with the biological sample. Furthermore, the valve allows for a controlled bidirectional flow between the two receptacles providing a secure, leak resistant seal.
Advantageously, said barrier member may be a grid having a predetermined grid spacing. The size and spacing of the grid is configured to allow for retaining the biological sample within the receptacle filled with the preservation fluid and prevent the sample transfer between the receptacles.
Advantageously, said protrusion may be located adjacent to said grid.
Embodiment(s) of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:
The described example embodiment relates to a container assembly having receptacles and a coupling member of a specific shape and design. However, the invention is not restricted to the described shapes and designs but may also use any other suitable shape/design of the receptacles, coupling and valve.
Certain terminology may be used in the following description for convenience only and is not limiting. The words ‘right’, ‘left’, ‘lower’, ‘upper’, ‘front’, ‘rear’, ‘upward’, ‘down’ and ‘downward’, ‘top’ and ‘bottom’ designate directions in the drawings to which reference is made and are with respect to the described component when assembled and mounted. The words ‘inner’, ‘inwardly’ and ‘outer’, ‘outwardly’ refer to directions toward and away from, respectively, a designated centreline or a geometric centre of an element being described (e.g. central axis), the particular meaning being readily apparent from the context of the description.
Further, relative positional terms, such as, ‘distal’, ‘proximal’, ‘lateral’ and ‘medial’ are understood in their normal meaning and in relation to a specific element being described. In particular, these terms designate directions in relation to the tool or user end, e.g. proximal is in a direction towards the installation tool or user, wherein distal refers to the direction away from the installation tool or user.
Further, as used herein, the terms ‘connected’, ‘attached’, ‘coupled’, ‘mounted’ are intended to include direct connections between two members without any other members interposed therebetween, as well as, indirect connections between members in which one or more other members are interposed therebetween. The terminology includes the words specifically mentioned above, derivatives thereof, and words of similar import.
Further, unless otherwise specified, the use of ordinal adjectives, such as, ‘first’, ‘second’, ‘third’ etc. merely indicate that different instances of like objects are being referred to and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking or in any other manner.
Referring now to
A coupling member 6 is operably coupleable between the first and second receptacle 1, 2 so as to fluidly sealingly connect the two receptacles 1, 2 and provide a fluid passage between the first and second receptacle 1, 2. A self-sealing dispensing valve 4 is provided within the fluid passage of the coupling member 6 allowing selective bi-directional fluid flow between the first and second receptacle 1, 2.
The side wall 41 may further comprise at least two elongated side protrusions 44 to also provide for better positioning and retention of the valve 4 inside the housing 5. A resilient membrane 45 of the valve 4 is provided with three radially arranged slits 46 forming flaps 47. At a predetermined fluid pressure, the flaps 47 open and the fixative liquid passes through the valve 4.
However, it is understood by the person skilled in the art that any suitable number of slits and flaps may be used to provide a bidirectional valve that is actuatable at a predetermined fluid pressure. It is understood that the slits are formed by cutting through the membrane 45 without removing any material therefrom.
When in a closed position, the flaps 47 abut closely to one another, preventing leakage of the liquid therethrough. In order to open the valve 4, a suitable pressure is applied to the resilient walls of one of the receptacles 1, 2 increasing the internal fluid pressure and forcing the liquid through the valve 4 by pushing the flaps 47 outwardly into the direction of the other receptacle 1, 2.
When the pressure is released, the resilient flaps 47 of the membrane 45 move back to a flat closed position, thus preventing fluid to pass through. The valve 4 may be made of a resilient inert material, such as silicone, though, any other suitable resilient thermoplastic polymers can be used.
The coupling member 6 of the example embodiment comprises an internal thread 10 adapted to lockingly engage with a corresponding threaded neck 7, 8 of a respective receptacle 1, 2.
Furthermore, as shown in
The barrier member or grid 9 may have a pre-determined mesh size chosen in such a way that the biopsy specimen (e.g. taken from a patient) cannot pass through the openings of the grid 9. Preferably, the mesh size is between 100 and 1000 microns, as this size is sufficient to retain most biological samples received for tissue processing. However, any other suitable mesh size may be used.
The barrier member 9 of the coupling member 6 may comprise a protrusion 11 (see
Furthermore, as shown in
The operation of the container assembly according to the present invention is as follows:
Before its use, the fixative liquid 3 is placed in the second receptacle 2 of the container assembly (see
When placing a biological sample into the first receptacle 1, the first receptacle 1 is unscrewed from the coupling member 6 and the biological sample is placed onto the grid 9 (see
Once the biological sample is placed on the grid 9 (see
In order to remove the biological sample from the container assembly, the above-mentioned operation is simply reversed, i.e. first the fixative liquid 3 is transferred from the first receptacle 1 into the second receptacle 2 by lightly pressing the walls of receptacle 1. Once the liquid is fully moved into the second receptacle 2, the first receptacle 1 can be unscrewed from the coupling member 6 to access the sample.
Typically, the biological sample will be located on the grid 9 (see
As a result, the biological sample can be transported immersed within the fixative liquid for its conservation, while the user is protected from getting into contact with the fixative liquid 3, in particular, when placing the sample into one of the receptacles 1, 2 of the container assembly, and when removing the sample from one of the receptacles 1, 2 of the container assembly.
Even though reference has been made to a specific embodiment of the invention, it is obvious for a person skilled in the art that the container assembly for biological samples described herein is susceptible to numerous variations and modifications, and that all of the details mentioned can be substituted for other technically equivalent ones without departing from the scope of protection defined by the attached claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19382610.4 | Jul 2019 | EU | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/042463 | 7/17/2020 | WO |
