EP3370871A1 - Container for collection and preservation of biopsy samples - Google Patents

Container for collection and preservation of biopsy samples

Info

Publication number
EP3370871A1
EP3370871A1 EP16812851.0A EP16812851A EP3370871A1 EP 3370871 A1 EP3370871 A1 EP 3370871A1 EP 16812851 A EP16812851 A EP 16812851A EP 3370871 A1 EP3370871 A1 EP 3370871A1
Authority
EP
European Patent Office
Prior art keywords
cap
piercing member
container
thread
receptacle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16812851.0A
Other languages
German (de)
French (fr)
Inventor
Daniele Tartaro
Maurizio Maletti
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Traces Srl
Original Assignee
Traces Srl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Traces Srl filed Critical Traces Srl
Publication of EP3370871A1 publication Critical patent/EP3370871A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/047—Additional chamber, reservoir
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/049—Valves integrated in closure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Definitions

  • the present invention relates in general to a container for collection and preservation of biopsy samples.
  • a biopsy is a medical test which consists in removing a portion or fragment of tissue from a living organism to allow analysis of this tissue portion or fragment (for example under a microscope or using microbiological or molecular biology techniques) for diagnostic purposes.
  • a preserving agent typically formalin (formaldehyde in aqueous solution)
  • formalin formaldehyde in aqueous solution
  • the container, with the biopsy sample immersed in the formalin, may then be closed and sent to a laboratory for analysis.
  • Formalin, as well as other preserving agents is a substance which is toxic when inhaled, in particular a cancerogenous substance.
  • the container comprises a body designed to contain the biopsy sample to be preserved and a cap designed to engage, by means of screwing, with the body so as to close it in a sealed manner, the cap comprising a receptacle which contains a preserving solution (for example formalin) and being sealed by a membrane, and a piercing member which, as a result of screwing of the cap, is displaced vertically, pressing against the membrane so as to tear it and thus allow the preserving solution contained inside the receptacle to come out of the receptacle and fill the container body so that the biopsy sample is immersed in it.
  • a preserving solution for example formalin
  • a container having the features specified in the preamble of the accompanying independent claim 1 is known from WO 2007/068094.
  • This known container comprises at least one piercing member arranged inside the chamber of the container body intended to contain the biological sample.
  • the piercing member extends for example from the bottom wall of the chamber.
  • the piercing member is spaced from the axis of the chamber and has a cutting edge which extends substantially along a circumferential arc with its centre on the axis of the chamber.
  • the piercing member engages with the membrane which seals the receptacle containing the preserving solution, complete tearing of the membrane occurs such that the preserving solution contained inside the receptacle is able to flow out towards the chamber.
  • the biological sample contained inside the chamber may enter into the receptacle and remain trapped, for example, in a hid- den position behind a piece of the torn membrane.
  • a further object of the present invention is to provide a container for collection and preservation of biopsy samples which is able to guarantee a high level of safety for the operator.
  • Yet another object of the present invention is to provide a container for collection and preservation of biopsy samples which is simple and non- expensive to manufacture.
  • the invention is based on the idea of providing a container in which the piercing member is housed inside the body, coaxially with the cap, and comprises a tip portion, with a generally conical shape, having a plurality of grooves which widen out radially from the vertex of the cone towards the base of the cone, and a disc-shaped portion which is ar- ranged underneath the tip portion and has a diameter greater than the diameter of the base of the tip portion.
  • the receptacle moves towards the bottom wall of the body, and therefore towards the piercing member, until the membrane, pressing against the piercing member, is torn and therefore the preserving solution is allowed to flow out of the receptacle in order for the biopsy sample arranged inside the body to be immersed in the preserving solution.
  • the membrane is only partially torn by the piercing member, in particular in a central portion thereof.
  • the torn portion of the membrane is partially occupied by the tip portion of the piercing member and moreover the disc-shaped portion of the piercing member is close to the torn portion of the membrane, on the side facing towards the container body.
  • the preserving solution is allowed to flow out of the receptacle towards the body, but the biopsy sample is prevented from passing from the body to the receptacle after the preserving solution has flowed out.
  • the container is provided with a safety ring arranged between the cap and the body so as to prevent the cap from being screwed onto the body until the membrane is torn by the piercing member.
  • the membrane may be torn by the piercing member as a result of screwing of the cap onto the container body only if the safety ring has been removed beforehand.
  • this represents a further guarantee for the safety of the op- erator.
  • the present invention also relates to a container for collection and preservation of biopsy samples, comprising:
  • a body suitable for containing the biopsy sample comprising a lateral wall and a bottom wall, the lateral wall including a mouth provided with a first thread; a cap arranged to be screwed to the body so as to close it in a sealed manner, wherein the cap comprises a receptacle containing a preservation solution, a second thread arranged to engage with the first thread, and a tearable membrane which seals the receptacle at the bottom;
  • a piercing member arranged to tear the membrane so as to allow the preserving so- lution to flow out of the receptacle towards the body, the piercing member being housed inside the body and being configured to press against the membrane until the latter is torn, as a result of the cap being screwed to the body beyond a predetermined limit;
  • a safety ring arranged between the cap and the body so as to prevent the cap from being screwed to the body beyond this predetermined limit.
  • the container comprises at least one sealing ring which is arranged between the cap and the container body and is designed to ensure sealed closure of the container when the preserving solution flows out of the receptacle and fills the body. This prevents the risk that the operator come into contact with the preserving solution and with the vapours emit- ted by it, once the preserving solution has flowed out of the receptacle and filled the container body.
  • the cap has an external thread and the mouth of the container body has an internal thread arranged to engage with the external thread of the cap in order to allow screw- ing of the cap to the container body.
  • the cap preferably comprises an annular flange acting as an end-of-travel member when the cap is screwed to the container body. Screwing of the cap to the container body is stopped at a point such that the receptacle does not remain immersed in the preserving solution once the latter has flowed out of the receptacle into the container body, with the container body being kept in the upright position.
  • the flange allows the cap to be sealingly connected to the container body when the biopsy sample is placed inside the container.
  • the ring will therefore be arranged preferably between the annular flange of the cap and a top edge of the mouth of the container body.
  • the container comprises supporting means which are fixed to the body to sup- port the piercing member.
  • these supporting means are made as one piece with the body, thereby allowing the number of parts of the container to be reduced to a minimum.
  • the supporting means comprise a rod which extends coaxi- ally with the body and is fixed to the bottom wall, in which case the piercing member is mounted on the free end of the rod.
  • the configuration of the support element as a rod is particularly advantageous since it allows the piercing member to be supported and takes the smallest possible amount of space inside the container body.
  • This embodiment is particularly suitable for containers with a small capacity, e.g. 20 ml, intended to contain small- size biopsy samples.
  • the supporting means comprise at least one radial projection projecting radially inwards from the lateral wall of the body.
  • This embodiment is particularly suitable for containers with a larger capacity, e.g. 60 ml, intended to contain large-size biopsy samples.
  • the lateral wall of the container body includes a bottom portion with an essentially frustoconical shape and a top portion with an essentially cylindrical shape, defining the mouth of the container body and having a diameter greater than that of the bottom wall.
  • This configuration is advantageous when the container is not kept in an upright position, but is placed lying with its lateral wall on a plane.
  • the longitudinal axis of the container is inclined relative to that plane, so that the return flow of the preserving solution, and of the biopsy sample therewith, from the body to the receptacle is prevented.
  • Figures 1 and 2 show 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 supply condition;
  • Figures 3 and 4 show a perspective view and an axial section view, respectively, of the container of Figures 1 and 2, in the final use condition;
  • Figures 5 and 6 are perspective views, from different angles, showing the piercing member of the container of Figures 1 and 2 on an enlarged scale;
  • Figures 7 and 8 are axial section views showing, in the initial supply condition and in the final use condition, respectively, a container for collection and preservation of biopsy samples according to a further embodiment of the present invention.
  • Figures 9 and 10 show a front view and a plan view, respectively, of the piercing member of the container of Figures 7 and 8.
  • a container for collection and preservation of biopsy samples is generally indicated 10.
  • the container 10 basically comprises a body 12 suitable for containing a biopsy sample to be preserved (schematically shown in Figure 3, where it is indicated C) and a cap 14 ar- ranged to engage with the body 12 by means of screwing so as to close the body in a sealed manner.
  • the body 12 comprises a lateral wall 15 closed at the bottom by a bottom wall 16 on which the biopsy sample C is placed.
  • the lateral wall 15 includes a bottom portion 17 with an es- sentially frustoconical shape and a top portion, or mouth, 18, with an essentially cylindrical shape, having preferably a diameter greater than that of the bottom wall 16.
  • the mouth 18 is provided with an internal thread 20.
  • the cap 14 comprises a receptacle 24 containing a preserving solution S (for example formalin).
  • the receptacle 24 is suitably sized to contain the desired volume of preserving so- lution and, preferably, to also have a free volume equal to at least 30% of the volume of preserving solution.
  • the receptacle 24 is sealed at the bottom by a tearable membrane 26, which is for example made of aluminium or polymer material.
  • the membrane 26 is attached, for example by means of gluing, to an annular bottom edge 28 of the receptacle 24.
  • the cap 14 comprises a bottom portion 30 provided with an external thread 32 arranged to engage with the thread 20 of the mouth 18 of the body 12 so as to allow the cap 14 to be screwed to the body 12.
  • the receptacle 24 further comprises a top portion 36 which is provided with gripping means 38 (formed for example by radial projections) for increasing the grip of the operator and therefore facilitating the operation of screwing the cap 14 to the body 12.
  • gripping means 38 formed for example by radial projections
  • the container 10 further comprises a piercing member 42 arranged to pierce 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 piercing member 42 is housed inside the body 12, preferably in a fixed position relative to the body 12, and is arranged coaxially with the cap 14, i.e. with its axis aligned with the axis of the cap 14 (the axis about which the cap 14 is rotated when being screwing to the body 12).
  • the direction of the axis of the piercing member 42, as well as that of the axis of the cap 14, is indicated x in the Figures.
  • the piercing member 42 is mounted on a supporting element 44 fixed to the body 12.
  • the supporting element 44 is formed as a rod which extends along the axis x and is fixed to the bottom wall 16 thereof (being preferably made as one piece with the bottom wall 16) and the piercing member 42 is posi- tioned at the top of this rod.
  • the piercing member 42 comprises a tip portion 46 having a conical shape with a plurality of grooves 48 which widen out radially from the vertex towards the base of the cone.
  • the piercing member 42 further comprises a discshaped portion 54 positioned underneath the tip portion 46 and having preferably a diame- ter greater than the diameter of the base of the tip 46.
  • the piercing member 42 further comprises a bottom mounting portion 50, for example made as one piece with the tip portion 46.
  • the bottom mounting portion 50 has a cavity 52 in which the top end of the rod 44 engages.
  • the piercing member 42, or at least a portion thereof may be made as one piece with the rod 44.
  • the mem- brane 26 is at a certain distance from the vertex of the tip portion 46 of the piercing member 42.
  • the container 10 is provided with a safety ring 56 arranged between the cap 14 and the mouth 18 of the body 12, for example around the bottom 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. Owing to the presence of the safety ring 56, the cap 14 may not be further screwed starting from the initial supply condition, where the flange 40 presses against the safety ring 56 and the latter in turn bears against the top edge of the mouth 18.
  • the container 10 is configured so that in the initial supply condition the vertex of the tip portion 46 of the piercing member 42 is located at a certain distance from the membrane 26. Since in this condition, as explained above, the cap 14 may not be further screwed to the body 12, the piercing member 42 remains at a distance from the membrane 26. There is therefore no risk that the operator, while handling the container 10, may cause tearing of the membrane 26 and therefore early outflow of the preserving solution.
  • FIGS 3 and 4 show the container 10 in the final use condition, where the op- erator, after introducing the biopsy sample into the body 12 and after removing the safety ring 56, has completely screwed the cap 14 to the body 12 until the flange 40 of the cap 14 abuts against the top edge of the mouth 18 of the body 12.
  • the preserving solution is free to flow out of the receptacle 24, by gravity, passing through the grooves 48 in the tip portion 46 of the piercing member 42, and flow down into the underlying body 12.
  • the longitudinal axis of the container 10 (coinciding with the aforementioned axis x) is inclined relative to that plane owing to the particular shape of the lateral wall 15, so that the return flow of the preserving solution, and of the biopsy sample C therewith, from the body 12 to the receptacle 24 is prevented.
  • the cap 14 is advantageously provided with a sealing ring 58 arranged around the bottom portion 30 above the external thread 32.
  • the embodiment of the container 10 described above with reference to Figures 1 to 6 is suitable in particular for containers with a small capacity (e.g. 20 ml containers) intended to be used for containing small-size biopsy samples.
  • FIG. 7 to 10 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 given the same reference numbers.
  • the structure and operation of the container according to this further embodiment are substantially similar to those of the embodiment described above with reference to Figures 1 to 6. In general, therefore, the description provided above in connection with the first embodiment is also applicable to this further embodiment.
  • This further embodiment differs from the first embodiment in that at least one radial pro- jection 60 projecting radially inwards from the lateral wall 15 of the body 12, in particular from the bottom portion 17 of the lateral wall 15, is used as supporting means for supporting the piercing member 42 inside the body 12, instead of a rod extending coaxially with the body of the container from the bottom wall thereof.
  • a single radial projection 60 which extends along the entire inner circumference of the lateral wall 15, is provided.
  • several radial projections 60 in particular three or more radial projections, may be provided.
  • the bottom mounting portion 50 of the piercing member 42 is suitably formed to be mounted resting on the radial projection(s) 60.
  • the bottom mounting portion 50 may comprise a plurality of radial arms 50a which extend radially outwards and are preferably equally spaced angularly from each other.
  • the radial arms 50a are four in number, but they might also be different in number, for example only two or three. In the ex- ample shown in Figures 7 to 10, the radial arms 50a rest directly with their free ends on the radial projection 60.
  • the radial arms prefferably be connected to an annular support element suitable configured to be mounted resting on the radial projection 60; in this case, it is sufficient to provide three radial projections located at 120° with respect to each other, instead of a single radial projection which extends along the entire inner circumference of the lateral wall 15.
  • This further embodiment is particularly suitable for containers with a larger capacity (e.g. 60 ml containers), intended to be used for containing large-size biopsy samples.
  • a larger capacity e.g. 60 ml containers
  • the present invention allows biopsy samples to be collected and preserved without the risk for the operator to come into contact with the preserving solution and with the vapours and volatile substances emitted by the preserving solution.
  • the container according to the invention has a simple structure, with a small number of parts, and may therefore be manufactured at a low cost.
  • the biopsy sample is prevented from entering into the receptacle, once the membrane which seals the recepta- cle has been torn by the piercing member.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

The container (10) comprises: a body (12) suitable for containing 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) so as to close it in a sealed manner, wherein the cap (14) comprises a receptacle (24) containing a preserving solution (S), a second thread (32) arranged to engage with said first thread (20), and a tearable membrane (26) which seals the receptacle (24) at the bottom; and a piercing member (42) arranged to tear the membrane (26) so as to allow the preserving solution (S) to flow out of the receptacle (24) towards the body (12), the piercing member (42) being housed inside the body (12) and being designed to be pressed 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 piercing member (42) is arranged coaxially with the cap (14) and comprises a tip portion (46) having a conical shape with a plurality of grooves (48) which widen out radially from the vertex towards the base of the cone, and a disc-shaped portion (54) which is arranged underneath the tip portion (46) and has a diameter greater than the diameter of the base of the tip portion (46).

Description

Container for collection and preservation of biopsy samples
The present invention relates in general to a container for collection and preservation of biopsy samples.
As is known, a biopsy is a medical test which consists in removing a portion or fragment of tissue from a living organism to allow analysis of this tissue portion or fragment (for example under a microscope or using microbiological or molecular biology techniques) for diagnostic purposes. Once removed from the patient, the tissue sample is collected inside a container and then a preserving agent, typically formalin (formaldehyde in aqueous solution), is introduced into the container in order to ensure preservation of the biopsy sample. The container, with the biopsy sample immersed in the formalin, may then be closed and sent to a laboratory for analysis. Formalin, as well as other preserving agents, is a substance which is toxic when inhaled, in particular a cancerogenous substance. Even if the operation of introducing the formalin into the container is performed under an extractor hood, this operation nevertheless is potentially dangerous for the health of the operators responsible for collecting the biopsy samples. There is therefore the need to prevent the operator from coming directly into contact with the formalin or from being exposed to the vapours of the formalin used as a preserving agent for preserving biopsy samples.
In order to satisfy this requirement, special containers for collecting and preserving biopsy samples have been devised, as is known for example from document WO2016/079611 in the name of the Applicant. According to this prior art document, the container comprises a body designed to contain the biopsy sample to be preserved and a cap designed to engage, by means of screwing, with the body so as to close it in a sealed manner, the cap comprising a receptacle which contains a preserving solution (for example formalin) and being sealed by a membrane, and a piercing member which, as a result of screwing of the cap, is displaced vertically, pressing against the membrane so as to tear it and thus allow the preserving solution contained inside the receptacle to come out of the receptacle and fill the container body so that the biopsy sample is immersed in it. This known container offers a high degree of safety since it eliminates the risk of the operator being exposed to the pre- serving solution.
A container having the features specified in the preamble of the accompanying independent claim 1 is known from WO 2007/068094. This known container comprises at least one piercing member arranged inside the chamber of the container body intended to contain the biological sample. The piercing member extends for example from the bottom wall of the chamber. Moreover, the piercing member is spaced from the axis of the chamber and has a cutting edge which extends substantially along a circumferential arc with its centre on the axis of the chamber. When, upon screwing of the cap onto the body of the container, the piercing member engages with the membrane which seals the receptacle containing the preserving solution, complete tearing of the membrane occurs such that the preserving solution contained inside the receptacle is able to flow out towards the chamber. However, owing to the fact that the membrane is completely torn, the biological sample contained inside the chamber may enter into the receptacle and remain trapped, for example, in a hid- den position behind a piece of the torn membrane.
It is an object of the present invention to provide a container for collection and preservation of biopsy samples which is not affected by the aforementioned drawbacks of the prior art. In particular, it is an object of the present invention to provide a container for collec- tion and preservation of biopsy samples which, upon breakage of the membrane which seals the receptacle of the cap, allows the preserving solution to flow out of the receptacle of the cap towards the chamber of the body, but at the same time prevents the sample from entering into the receptacle. A further object of the present invention is to provide a container for collection and preservation of biopsy samples which is able to guarantee a high level of safety for the operator. Yet another object of the present invention is to provide a container for collection and preservation of biopsy samples which is simple and non- expensive to manufacture.
These and other objects are fully achieved according to the invention by a container for collection and preservation of biopsy samples having the features set forth in the accompanying independent claim 1. Further advantageous features of the invention are specified in the dependent claims, the contents of which are to be understood as forming an integral and complementary part of the description below.
In brief, the invention is based on the idea of providing a container in which the piercing member is housed inside the body, coaxially with the cap, and comprises a tip portion, with a generally conical shape, having a plurality of grooves which widen out radially from the vertex of the cone towards the base of the cone, and a disc-shaped portion which is ar- ranged underneath the tip portion and has a diameter greater than the diameter of the base of the tip portion. When the cap is screwed onto the body the receptacle moves towards the bottom wall of the body, and therefore towards the piercing member, until the membrane, pressing against the piercing member, is torn and therefore the preserving solution is allowed to flow out of the receptacle in order for the biopsy sample arranged inside the body to be immersed in the preserving solution. Owing to the particular arrangement and shape of the piercing member, the membrane is only partially torn by the piercing member, in particular in a central portion thereof. The torn portion of the membrane is partially occupied by the tip portion of the piercing member and moreover the disc-shaped portion of the piercing member is close to the torn portion of the membrane, on the side facing towards the container body. In this way, the preserving solution is allowed to flow out of the receptacle towards the body, but the biopsy sample is prevented from passing from the body to the receptacle after the preserving solution has flowed out. There is therefore no need to provide a separating element between the membrane and the bottom of the container body in order to prevent the biopsy sample from passing from the body to the receptacle after the membrane has been torn.
Preferably, the container is provided with a safety ring arranged between the cap and the body so as to prevent the cap from being screwed onto the body until the membrane is torn by the piercing member. In this way, the membrane may be torn by the piercing member as a result of screwing of the cap onto the container body only if the safety ring has been removed beforehand. Naturally, this represents a further guarantee for the safety of the op- erator.
The presence of a safety ring arranged between the cap and the body in order to prevent screwing of the cap onto the body beyond a predetermined limit does not depend on a spe- cific position and/or configuration of the piercing member. The present invention, therefore, also relates to a container for collection and preservation of biopsy samples, comprising:
a body suitable for containing the biopsy sample, wherein the body comprises a lateral wall and a bottom wall, the lateral wall including a mouth provided with a first thread; a cap arranged to be screwed to the body so as to close it in a sealed manner, wherein the cap comprises a receptacle containing a preservation solution, a second thread arranged to engage with the first thread, and a tearable membrane which seals the receptacle at the bottom;
a piercing member arranged to tear the membrane so as to allow the preserving so- lution to flow out of the receptacle towards the body, the piercing member being housed inside the body and being configured to press against the membrane until the latter is torn, as a result of the cap being screwed to the body beyond a predetermined limit; and
a safety ring arranged between the cap and the body so as to prevent the cap from being screwed to the body beyond this predetermined limit.
Preferably, the container comprises at least one sealing ring which is arranged between the cap and the container body and is designed to ensure sealed closure of the container when the preserving solution flows out of the receptacle and fills the body. This prevents the risk that the operator come into contact with the preserving solution and with the vapours emit- ted by it, once the preserving solution has flowed out of the receptacle and filled the container body.
Preferably, the cap has an external thread and the mouth of the container body has an internal thread arranged to engage with the external thread of the cap in order to allow screw- ing of the cap to the container body. In this case, the cap preferably comprises an annular flange acting as an end-of-travel member when the cap is screwed to the container body. Screwing of the cap to the container body is stopped at a point such that the receptacle does not remain immersed in the preserving solution once the latter has flowed out of the receptacle into the container body, with the container body being kept in the upright position. Moreover, the flange allows the cap to be sealingly connected to the container body when the biopsy sample is placed inside the container. In case a safety ring is provided, the ring will therefore be arranged preferably between the annular flange of the cap and a top edge of the mouth of the container body.
Preferably, the container comprises supporting means which are fixed to the body to sup- port the piercing member. According to an embodiment, these supporting means are made as one piece with the body, thereby allowing the number of parts of the container to be reduced to a minimum.
According to an embodiment, the supporting means comprise a rod which extends coaxi- ally with the body and is fixed to the bottom wall, in which case the piercing member is mounted on the free end of the rod. The configuration of the support element as a rod is particularly advantageous since it allows the piercing member to be supported and takes the smallest possible amount of space inside the container body. This embodiment is particularly suitable for containers with a small capacity, e.g. 20 ml, intended to contain small- size biopsy samples.
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 embodiment is particularly suitable for containers with a larger capacity, e.g. 60 ml, intended to contain large-size biopsy samples.
Preferably, the lateral wall of the container body includes a bottom portion with an essentially frustoconical shape and a top portion with an essentially cylindrical shape, defining the mouth of the container body and having a diameter greater than that of the bottom wall. This configuration is advantageous when the container is not kept in an upright position, but is placed lying with its lateral wall on a plane. In fact, owing to this particular shape of the lateral wall of the body, the longitudinal axis of the container is inclined relative to that plane, so that the return flow of the preserving solution, and of the biopsy sample therewith, from the body to the receptacle is prevented. Further features and advantages of the present invention will result more clearly from the following detailed description, provided purely by way of a non-limiting example with reference to the attached drawings, where:
Figures 1 and 2 show 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 supply condition;
Figures 3 and 4 show a perspective view and an axial section view, respectively, of the container of Figures 1 and 2, in the final use condition;
Figures 5 and 6 are perspective views, from different angles, showing the piercing member of the container of Figures 1 and 2 on an enlarged scale;
Figures 7 and 8 are axial section views showing, in the initial supply condition and in the final use condition, respectively, a container for collection and preservation of biopsy samples according to a further embodiment of the present invention; and
Figures 9 and 10 show a front view and a plan view, respectively, of the piercing 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 samples according to an embodiment of the present invention is generally indicated 10. The container 10 basically comprises a body 12 suitable for containing a biopsy sample to be preserved (schematically shown in Figure 3, where it is indicated C) and a cap 14 ar- ranged to engage with the body 12 by means of screwing so as to close the body in a sealed manner.
The body 12 comprises a lateral wall 15 closed at the bottom by a bottom wall 16 on which the biopsy sample C is placed. The lateral wall 15 includes a bottom portion 17 with an es- sentially frustoconical shape and a top portion, or mouth, 18, with an essentially cylindrical shape, having preferably a diameter greater than that of the bottom wall 16. The mouth 18 is provided with an internal thread 20.
The cap 14 comprises a receptacle 24 containing a preserving solution S (for example formalin). The receptacle 24 is suitably sized to contain the desired volume of preserving so- lution and, preferably, to also have a free volume equal to at least 30% of the volume of preserving solution. The receptacle 24 is sealed at the bottom by a tearable membrane 26, which is for example made of aluminium or polymer material. The membrane 26 is attached, for example by means of gluing, to an annular bottom edge 28 of the receptacle 24. The cap 14 comprises a bottom portion 30 provided with an external thread 32 arranged to engage with the thread 20 of the mouth 18 of the body 12 so as to allow the cap 14 to be screwed to the body 12. The receptacle 24 further comprises a top portion 36 which is provided with gripping means 38 (formed for example by radial projections) for increasing the grip of the operator and therefore facilitating the operation of screwing the cap 14 to the body 12. An annular flange 40 designed to act as an end-of-travel member when the cap 14 is screwed to the body 12 is provided between the bottom portion 30 and the top portion 36 of the cap 14.
The container 10 further comprises a piercing member 42 arranged to pierce 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 piercing member 42 is housed inside the body 12, preferably in a fixed position relative to the body 12, and is arranged coaxially with the cap 14, i.e. with its axis aligned with the axis of the cap 14 (the axis about which the cap 14 is rotated when being screwing to the body 12). The direction of the axis of the piercing member 42, as well as that of the axis of the cap 14, is indicated x in the Figures.
Preferably, the piercing member 42 is mounted on a supporting element 44 fixed to the body 12. In the embodiment shown in Figures 1-4, the supporting element 44 is formed as a rod which extends along the axis x and is fixed to the bottom wall 16 thereof (being preferably made as one piece with the bottom wall 16) and the piercing member 42 is posi- tioned at the top of this rod. With reference also to Figures 5 and 6, the piercing member 42 comprises a tip portion 46 having a conical shape with a plurality of grooves 48 which widen out radially from the vertex towards the base of the cone. The piercing member 42 further comprises a discshaped portion 54 positioned underneath the tip portion 46 and having preferably a diame- ter greater than the diameter of the base of the tip 46. Preferably, the piercing member 42 further comprises a bottom mounting portion 50, for example made as one piece with the tip portion 46. The bottom mounting portion 50 has a cavity 52 in which the top end of the rod 44 engages. According to a further embodiment of the present invention, the piercing member 42, or at least a portion thereof (for example the tip portion 46 and/or the bottom mounting portion 50), may be made as one piece with the rod 44.
In the initial supply condition of the container 10, as shown in Figures 1 and 2, the mem- brane 26 is at a certain distance from the vertex of the tip portion 46 of the piercing member 42. Moreover, in the initial supply condition the container 10 is provided with a safety ring 56 arranged between the cap 14 and the mouth 18 of the body 12, for example around the bottom 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. Owing to the presence of the safety ring 56, the cap 14 may not be further screwed starting from the initial supply condition, where the flange 40 presses against the safety ring 56 and the latter in turn bears against the top edge of the mouth 18. The container 10 is configured so that in the initial supply condition the vertex of the tip portion 46 of the piercing member 42 is located at a certain distance from the membrane 26. Since in this condition, as explained above, the cap 14 may not be further screwed to the body 12, the piercing member 42 remains at a distance from the membrane 26. There is therefore no risk that the operator, while handling the container 10, may cause tearing of the membrane 26 and therefore early outflow of the preserving solution.
However, once the safety ring 56 has been removed the cap 14 may be further screwed to the body 12 with respect to the initial supply condition shown in Figures 1 and 2. In this way, the membrane 26 is displaced together with the cap 14 towards the bottom 16 of the body 12 and is torn when it comes into contact with the tip portion 46 of the piercing member 54. Figures 3 and 4 show the container 10 in the final use condition, where the op- erator, after introducing the biopsy sample into the body 12 and after removing the safety ring 56, has completely screwed the cap 14 to the body 12 until the flange 40 of the cap 14 abuts against the top edge of the mouth 18 of the body 12. Once the membrane 26 has been torn, the preserving solution is free to flow out of the receptacle 24, by gravity, passing through the grooves 48 in the tip portion 46 of the piercing member 42, and flow down into the underlying body 12. In this condition, even in case where the container 10 is not kept in an upright position, but is placed lying with its lateral wall 15 on a plane, the longitudinal axis of the container 10 (coinciding with the aforementioned axis x) is inclined relative to that plane owing to the particular shape of the lateral wall 15, so that the return flow of the preserving solution, and of the biopsy sample C therewith, from the body 12 to the receptacle 24 is prevented.
In order to ensure sealed closure of the container 10 when the preserving solution flows out of the receptacle 24 and fills the body 12, the cap 14 is advantageously provided with a sealing ring 58 arranged around the bottom portion 30 above the external thread 32. The embodiment of the container 10 described above with reference to Figures 1 to 6 is suitable in particular for containers with a small capacity (e.g. 20 ml containers) intended to be used for containing small-size biopsy samples.
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 given the same reference numbers. The structure and operation of the container according to this further embodiment are substantially similar to those of the embodiment described above with reference to Figures 1 to 6. In general, therefore, the description provided above in connection with the first embodiment is also applicable to this further embodiment.
This further embodiment differs from the first embodiment in that at least one radial pro- jection 60 projecting radially inwards from the lateral wall 15 of the body 12, in particular from the bottom portion 17 of the lateral wall 15, is used as supporting means for supporting the piercing member 42 inside the body 12, instead of a rod extending coaxially with the body of the container from the bottom wall thereof. In the example shown in Figures 7 and 8 a single radial projection 60, which extends along the entire inner circumference of the lateral wall 15, is provided. Alternatively, several radial projections 60, in particular three or more radial projections, may be provided.
According to this further embodiment, the bottom mounting portion 50 of the piercing member 42 is suitably formed to be mounted resting on the radial projection(s) 60. For example, as can be seen in particular in Figure 9, the bottom mounting portion 50 may comprise a plurality of radial arms 50a which extend radially outwards and are preferably equally spaced angularly from each other. Preferably, the radial arms 50a are four in number, but they might also be different in number, for example only two or three. In the ex- ample shown in Figures 7 to 10, the radial arms 50a rest directly with their free ends on the radial projection 60. It is also conceivable, however, for the radial arms to be connected to an annular support element suitable configured to be mounted resting on the radial projection 60; in this case, it is sufficient to provide three radial projections located at 120° with respect to each other, instead of a single radial projection which extends along the entire inner circumference of the lateral wall 15.
This further embodiment is particularly suitable for containers with a larger capacity (e.g. 60 ml containers), intended to be used for containing large-size biopsy samples. As is clear from the above description, the present invention allows biopsy samples to be collected and preserved without the risk for the operator to come into contact with the preserving solution and with the vapours and volatile substances emitted by the preserving solution. Moreover, the container according to the invention has a simple structure, with a small number of parts, and may therefore be manufactured at a low cost. Moreover, owing to the particular arrangement and configuration of the piercing member, the biopsy sample is prevented from entering into the receptacle, once the membrane which seals the recepta- cle has been torn by the piercing member.
Naturally, the principle of the invention remaining unchanged, the embodiments and constructional details may be greatly varied with respect to those described and illustrated here purely by way of a non-limiting example, without thereby departing from the scope of the invention as defined in the accompanying claims.

Claims

1. Container (10) for collection and preservation of biopsy samples (C), comprising: a body (12) suitable for containing 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) so as to close it in a sealed manner, wherein the cap (14) comprises a receptacle (24) containing a preserving solution (S), a second thread (32) arranged to engage with said first thread (20), and a tearable mem- brane (26) which seals the receptacle (24) at the bottom; and
a piercing member (42) arranged to tear the membrane (26) so as to allow the preserving solution (S) to flow out of the receptacle (24) towards the body (12), the piercing member (42) being housed inside the body (12) and being designed to be pressed 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 piercing member (42) is arranged coaxially with the cap (14) and comprises a tip portion (46) having a conical shape with a plurality of grooves (48) which widen out radially from the vertex towards the base of the cone, and a disc-shaped portion (54) which is arranged underneath the tip portion (46) and has a diameter greater than the diameter of the base of the tip portion (46).
2. Container according to claim 1, further comprising supporting means (44; 60) which are fixed to the body (12) to support the piercing member (42).
3. Container according to claim 2, wherein said supporting means (44; 60) comprise a rod (44) which extends upwards from the bottom wall (16) of the body (12), and wherein the piercing member (42) is mounted at the free end of the rod (44).
4. Container according to claim 2, wherein the 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 piercing member (42) comprises a bottom mounting portion (50, 50a) arranged to be mounted resting on said at least one radial projection (60).
5. Container according to any one of claims 2 to 4, wherein said supporting means (44; 60) are made as one piece with the body (12).
6. Container according to any one of the preceding claims, further comprising a safety ring (56) arranged between the body (12) and the cap (14) so as to prevent the cap (14) from being screwed to the body (12) beyond said predetermined limit.
7. Container according to any one 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) arranged to act as an end-of-travel member when the cap (14) is screwed to the body (12), and wherein the safety ring (56) is axially arranged between the annular flange (40) of the cap (14) and a top edge of the mouth (18) of the body (12).
9. Container according to claim 7 or claim 8, further comprising a sealing ring (58 arranged around the cap (14) above said second thread (32).
10. Container according to any one of the preceding claims, wherein the lateral wall (15) includes a bottom portion (17) with an essentially frustoconical shape and a top portion, defining said mouth (18), with an essentially cylindrical shape, the diameter of the top portion being greater than that of the bottom wall (16).
EP16812851.0A 2015-11-06 2016-11-03 Container for collection and preservation of biopsy samples Withdrawn EP3370871A1 (en)

Applications Claiming Priority (2)

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ITUB2015A005037A ITUB20155037A1 (en) 2015-11-06 2015-11-06 Container for the collection and storage of biopsy samples.
PCT/IB2016/056600 WO2017077467A1 (en) 2015-11-06 2016-11-03 Container for collection and preservation of biopsy samples

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EP3370871A1 true EP3370871A1 (en) 2018-09-12

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RU176704U1 (en) * 2017-09-21 2018-01-25 Егор Евгеньевич Круглов CONTAINER FOR TRANSPORTATION IN ISOTHERMAL CONDITIONS AND HOMOGENIZATION OF BIOPSI MATERIAL FOR MICROBIOLOGICAL STUDIES
EP3660160A1 (en) * 2018-11-28 2020-06-03 GTZ Microlab Detect, S.L. Portable device and method for detecting microorganisms or metabolites in a sample
KR102263967B1 (en) * 2019-04-25 2021-06-14 프리시젼바이오 주식회사 Liquid Supplying Device
KR102263972B1 (en) * 2019-04-25 2021-06-14 프리시젼바이오 주식회사 Driving Method of Liquid Supplying Device
CN110841732A (en) * 2019-11-23 2020-02-28 江苏徐海环境监测有限公司 Environmental monitoring sample storage tube
CN214585470U (en) * 2020-06-19 2021-11-02 上海快灵生物科技有限公司 Biochemical test paper tube

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IT8315212V0 (en) * 1983-07-08 1983-07-08 Mira Lanza Spa CONTAINER EQUIPPED FOR THE ETHERPORARY PREPARATION OF DILUTED LIQUID DETERGENTS STARTING FROM SINGLE-DOSE CONCENTRATED DETERGENT CONTAINERS
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