WO2019216766A1 - Closable container for receiving biological material, and a method for receiving biological material in the container - Google Patents

Closable container for receiving biological material, and a method for receiving biological material in the container Download PDF

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Publication number
WO2019216766A1
WO2019216766A1 PCT/NL2019/050276 NL2019050276W WO2019216766A1 WO 2019216766 A1 WO2019216766 A1 WO 2019216766A1 NL 2019050276 W NL2019050276 W NL 2019050276W WO 2019216766 A1 WO2019216766 A1 WO 2019216766A1
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WO
WIPO (PCT)
Prior art keywords
container
cover
receiving spaces
biological material
preserving liquid
Prior art date
Application number
PCT/NL2019/050276
Other languages
French (fr)
Inventor
Lieuwe Hendrik FABER
Cindy JANSZEN
Original Assignee
7Care B.V.
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 7Care B.V. filed Critical 7Care B.V.
Publication of WO2019216766A1 publication Critical patent/WO2019216766A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B10/0096Casings for storing test samples

Definitions

  • the invention relates to a closable container for receiving biological material, and a method for receiving biological material in the closable container.
  • colorectal cancer An increasing number of men and women over a certain age are nowadays regularly invited to participate in a population screening program, for instance to screen for the presence of colorectal cancer.
  • colorectal cancer can for instance be prevented or be detected and treated at an early stage. If colorectal cancer is discovered early, the chances of recovery are greater and the treatment is less severe.
  • a population screening program does not only involve taking tissue biopsies, but a sufficient number of healthcare providers also has to be trained for the follow-up examination. If the screening produces a favourable outcome, there is no reason for further examination at the hospital, and the person in question need not do anything. If any abnormalities are however detected, for instance blood in the faeces, a follow-up examination is necessary. Such a follow-up examination comprises in many cases a colonoscopy.
  • a colonoscopy is an exploratory examination of the large intestine. It allows an internist or gastroenterologist to view the inside of a rectum, large intestine and the distal part of the small intestine.
  • the examination is generally performed using an exploratory instrument: the endoscope.
  • An endoscope generally comprises a flexible tube provided at an outer end with a small light source and a camera. The light source ensures that the physician can see the inside of the intestine properly.
  • the camera is connected to a screen which allows the physician to watch the examination.
  • Abnormalities in the large intestine can be detected by means of colonoscopy and, if desired, the physician can also perform small procedures immediately.
  • Tissue samples/biopsy samples are usually also taken from the intestinal tissue or from the tissue of another organ. These have to be received in a container for further testing.
  • a biopsy is typically performed in order to test a piece of tissue for abnormalities.
  • a colorectal polyp can for instance be benign or malignant.
  • a biopsy can be performed with a so-called biopsy punch.
  • each biopsy sample or polyp taken with a biopsy punch or other tool is received separately in a transparent container.
  • Each container is provided here with a preserving liquid such as for instance formaldehyde. The filled containers are then sent to a pathology or histology department for further diagnosis.
  • Biopsies taken from different areas can easily be switched around. Because several containers, all filled with formaldehyde, are used per patient, a lot of formaldehyde is used. An additional harmful effect is the exposure to formaldehyde, which is categorized as carcinogenic.
  • a container may additionally come into contact with organic solvents such as, in addition to formaldehyde, for instance xylene, acetone, ethyl alcohol, isopropyl alcohol and other related substances. Under the conditions applied the above stated chemicals can erase or make partially illegible the data on the containers. This is of course also undesirable.
  • organic solvents such as, in addition to formaldehyde, for instance xylene, acetone, ethyl alcohol, isopropyl alcohol and other related substances.
  • the invention provides for this purpose a closable container for receiving biological material, comprising a number of mutually separated receiving spaces with open wall part along which a biological material can be inserted, a cover which is provided with coupling means for coupling to the container, wherein the cover covers the open wall parts of the receiving spaces, and wherein wall parts of the receiving spaces and of the cover are permeable to a preserving liquid and impermeable to the biological material.
  • the cover is preferably rotatable relative to the container during use in order to clear the open wall part of receiving spaces, or can be made rotatable relative to the container, for instance by breaking a wall part.
  • Side wall parts of the container are preferably fixedly connected to other wall parts of the container, such as a bottom part.
  • the container according to the invention collects in one single container a number of biopsy samples, which are each received in a receiving space. Each biopsy sample is thus separated from another biopsy sample, but a number of biopsy samples originating from the same patient are situated in the same container. This prevents errors and danger of confusion, and if desired the information related to a patient can furthermore be arranged only on the container and need not be provided per biopsy sample on each receiving space.
  • the cover of the container covers the open wall parts of the receiving spaces, which are all closed after coupling of cover and container.
  • a biopsy sample or other piece of tissue cannot be removed from a receiving space in the coupled situation.
  • Wall pails of the receiving spaces are further permeable to preserving liquid, for instance provided with recesses, through which liquids and gases from outside the container can easily come into contact with biopsy samples received in the receiving spaces, wherein the liquids or gases can also easily leave the receiving spaces again.
  • the recesses can be arranged in the form of a grating.
  • Access of treatment liquids and gases can be important for enabling temporary storage of the biopsy samples, but also in the case of sample pretreatment of a biopsy sample, wherein the container is immersed in diverse liquid chemicals, for instance to fixate the cells of a biopsy sample or other piece of tissue for microscopic examination. It will be apparent that the container is preferably manufactured from a suitable chemically-resistant material so as to be able to withstand such treatments.
  • tissue or biological material is understood to mean organic material, isolated from for instance humans, animals or plants. This tissue or biological material can for instance be intended for histological or pathological examination.
  • biological material also includes bodily material, for instance mucus, discharge, cervical smears, but also veterinary material.
  • the biological material can in principle be taken from any part of a body, such as for instance from the lungs, liver, intestine, stomach and so on.
  • a further advantage of the container relates to the ability to handle a number of biopsy samples with one single operation.
  • the container in which a plurality of biopsy samples are received can indeed be handled in simple manner and for instance be placed in another outer container. This likewise saves time, both when the biopsy samples are being taken and during processing of the biopsy samples in the laboratory.
  • the container according to the invention is environmentally friendly in the sense that it can reduce the quantity of plastic used in the industry and can also provide for a reduction of the quantity of preserving liquid which is used, such as for instance the suspect formaldehyde, currently classified as Group 1 : Carcinogenic to humans.
  • a container is for this purpose provided, the cover of which is provided with handling means for handling the coupled container and cover.
  • a practical embodiment provides a container, wherein the container is cylindrical and the receiving spaces are arranged adjacently of each other in a peripheral direction of the container, separated by radially running side wall parts.
  • the radially running side wall parts are preferably fixedly connected to other wall parts of the container.
  • the receiving spaces can extend over the whole periphery of the container. It is also possible for the receiving spaces to extend over only a part of the periphery, preferably through a peripheral angle of more than 180°, and more preferably lying between 180° and 340°, still more preferably between 180° and 320°, and most preferably between 180° and 300°.
  • the receiving spaces are preferably arranged adjacently of each other.
  • the portion of the container which comprises no receiving spaces can likewise comprise an open wall part, which is preferably closed by a wall part of the cover after coupling of cover and container. If desired, this wall part can be breakable or removable. It is also possible to embody the cover such that an open wall part of the portion of the container which comprises no receiving spaces is not closed after coupling of cover and container.
  • the cover comprises for this purpose an open wall part which, in the situation in which the cover is coupled to the container, is aligned with the open wall part of the portion of the container which comprises no receiving spaces.
  • Yet another embodiment relates to a container wherein the receiving spaces are removable from the container.
  • Yet another embodiment relates to a container, wherein this container comprises a central passage opening for the coupling means of the cover, which opening is closed off liquid- tightly from the receiving spaces.
  • the section of the central passage opening is for instance circular, although this is not essential.
  • the central passage opening can extend from an upper plane of the container into a lower plane of the container, although this is not essential either.
  • a suitable embodiment of the container comprises coupling means in the form of resilient tongues which can be arranged in the passage opening and which are able to spring out under a lower edge of the passage opening.
  • the cover is hereby coupled to the container, at least in a vertical direction. Rotation of the cover round a vertical axis is possible if desired, wherein some friction may be experienced from wall parts of the cover and the container moving over each other.
  • An embodiment which promotes simple handling of the container comprises a container wherein the handling means comprise an engaging part protruding from a plane of the cover. The cover and a container coupled thereto can then be taken up together by a person by gripping the engaging part between two fingers.
  • the invented container is embodied such that wall parts of the receiving spaces and of the cover are permeable to a preserving liquid and impermeable to the biological material.
  • An embodiment suitable in this context relates to a container wherein the wall parts which are permeable to the preserving liquid and impermeable to the biological material comprise perforations.
  • the perforations extend over the wall thickness of the relevant wall parts and allow passage of preserving liquid. The perforations are however small enough to stop a biopsy sample or other tissue sample.
  • an improved embodiment relates to a container wherein the wall parts of the receiving spaces which are permeable to the preserving liquid and impermeable to the biological material comprise bottom wall parts of the receiving spaces.
  • an embodiment of the cover has a guide wall part which is receivable in the container for the purpose of guiding the cover during arranging thereof on the container.
  • the container is provided with an accommodating space, separated from the receiving spaces, for the guide wall part of the cover.
  • the container further comprises an outer container in which the container is received, wherein the outer container comprises an outer container cover whereby the container can be retained in the outer container, and wherein the outer container contains a preserving liquid for the biological material.
  • This embodiment has the additional advantage that the container - and the receiving spaces - need not comprise preserving liquid. The biopsy samples which were taken and are situated in the receiving spaces all come into contact with the preserving liquid substantially simultaneously when the container is coupled to the outer container. Because only the outer container is filled with preserving liquid, the quantity of preserving liquid is kept limited.
  • a container wherein the outer container cover contains the preserving liquid, and the preserving liquid is released into the receiving spaces from the outer container cover during closing and/or by operating an operating member.
  • This embodiment has the additional advantage that a person handling the container and/or the outer container generally cannot come into contact with the preserving liquid, for instance with the formaldehyde which entails health risks.
  • the container prefferably be formed substantially from a plastic material.
  • Plastic material can be readily embodied in diverse forms and can be obtained with the desired physical and chemical properties. It is advantageous if the whole container is formed substantially from the plastic material. The entire container can thus be manufactured integrally, which makes the container easy to produce by means of known techniques for the processing of plastics, such as for instance injection moulding.
  • the plastic material is chosen from the group formed by: polyacetal, polyamide, polycarbonate, polyester, polypropylene, polyurethane, polystyrene and acrylonitrile butadiene styrene, polyphenylene sulphide, polyethylene terephthalate, polybutylene terephthalate and polyoxymethylene.
  • polyacetal polyamide, polycarbonate, polyester, polypropylene, polyurethane, polystyrene and acrylonitrile butadiene styrene, polyphenylene sulphide, polyethylene terephthalate, polybutylene terephthalate and polyoxymethylene.
  • a plastic material such as polyacetal is particularly suitable.
  • Poly acetal has a good chemical resistance compared to a wide range of common chemicals.
  • objects manufactured from poly acetal have good mechanical properties.
  • the container is at least partially provided with information.
  • This information can be arranged in any known manner, for instance by writing with a means suitable for this purpose, by means of stickers or by marking with for instance a laser.
  • a possible information surface can be embodied so that it can be coupled releasably to the container, the cover and/or the receiving spaces. Arranging data on the information surface can then take place independently of the rest of the container so that a more flexible manner of working is possible.
  • For a releasably coupling connection of the information surface to the container, the cover and/or the receiving spaces it is possible to envisage diverse systems, such as snap systems or slide systems, with which rapid and simple coupling and uncoupling is possible. If desired, the coupling can be provided with a locking. Uncoupling is hereby made more difficult, this reducing the risk of undesired uncoupling of an information surface.
  • a container according to the invention wherein a biological material is inserted into the mutually separated receiving spaces via the open wall parts, and wherein the cover provided with coupling means is coupled with the coupling means to the container, wherein the cover covers the open wall parts of the receiving spaces.
  • the invention provides further embodiments of the method wherein the coupled assembly of container and cover is taken up by handling means provided on the cover; wherein the container and the cover are coupled by inserting resilient tongues into a central passage opening which is closed off liquid-tightly from the receiving spaces and having them spring out under a lower edge of the passage opening; and wherein the cover is arranged on the container under the guidance of a guide wall part receivable in the container.
  • Particularly advantageous embodiments of the method further comprise of receiving the container coupled to the cover in an outer container and retaining the container in the outer container with an outer container cover, wherein the outer container contains preserving liquid for the biological material; and a method wherein the outer container cover contains the preserving liquid, and the preserving liquid is released into the receiving spaces from the outer container cover during closing and/or by operating an operating member.
  • Figure 1 is a schematic perspective view of a container for receiving biological material in open situation according to an embodiment of the invention
  • Figure 2 is a schematic perspective view of a cover of the container according to an embodiment of the invention.
  • Figure 3 is a schematic perspective view of a method step according to an embodiment of the invention.
  • Figure 4 is a schematic perspective view of a container for receiving biological material in closed situation according to an embodiment of the invention.
  • Figure 5 is a schematic perspective view of another method step according to an embodiment of the invention.
  • Figure 6 is a schematic perspective top view of a container for receiving biological material, coupled to a cover, according to an embodiment of the invention
  • Figure 7 is a schematic perspective bottom view of the container, coupled to a cover, shown in figure 6;
  • Figure 8 is a schematic perspective view of yet another method step according to an embodiment of the invention.
  • Figure 9 is a schematic perspective view of a container for receiving biological material, received in an outer container, according to an embodiment of the invention.
  • Figure 10 is a schematic perspective view of a cover of the container according to another embodiment of the invention.
  • a closable container 1 for receiving biopsy samples is shown.
  • the closable container 1 comprises an assembly 2 of five mutually separated receiving spaces 3.
  • Receiving space 3 each have an open wall part, in the shown embodiment an open upper side 4 along which a biopsy sample (not shown) can be inserted into receiving space 3.
  • Container 1 is cylindrical and receiving spaces 3 are arranged adjacently of each other in a peripheral direction 6 of container 1 , wherein a receiving space 3 is separated from an adjacent receiving space 3 by a radially running side wall part 7, wherein the receiving spaces are removable from the container.
  • Assembly 2 is preferably manufactured integrally, for instance by means of injection moulding.
  • Receiving spaces 3 can be removable from container 1 each individually or, preferably, as assembly 2.
  • closable container 1 is temporarily received in a support means which is embodied according to figure 1 as a second container 5.
  • a protruding upper edge 8 of container 1 supports here on an upper edge of second container 5.
  • Containers 1 and 5 and assembly 2 are made from a suitable, preferably transparent, plastic.
  • Container 1 is closable by means of a cover 9, shown in figure 2.
  • Cover 9 has a size such that this cover 9 covers the open wall parts 4 of all receiving spaces 3.
  • Cover 9 is further provided with coupling means for coupling to container 1.
  • the coupling means comprise two resilient tongues 11 extending in the direction of a bottom 10 of container 1. Tongues 11 can be arranged in a passage opening 12 of container 1, wherein they can spring out under a lower edge l 2a of passage opening 12 in order to couple container 1 and cover 9.
  • Cylindrical passage opening 12 is received centrally in container 1 and extends in the direction of bottom 10. Central passage opening 12 is moreover closed off liquid-tightly from receiving spaces 3 by means of closed side walls.
  • Resilient tongues 11 are provided at a lower outer end with protruding wall parts 1 la with which they extend under lower edge 12a in the coupled situation.
  • wall parts of receiving spaces 3 and of cover 9 are permeable to a preserving liquid and impermeable to the biopsy sample. This is achieved by providing wall parts of the cover which are permeable to the preserving liquid and impermeable to the biopsy sample with perforations 13. Bottom wall parts of receiving spaces 3 are provided in similar manner with perforations 14. The perforations (13, 14) extend over the whole wall thickness of the cover and the bottom wall parts, so that a liquid can flow in and out freely.
  • Cover 9 further comprises handling means 15 for handling the coupled container 1 and cover 9.
  • handling means 15 comprise an engaging part which protrudes from a plane of cover 9 and can be engaged with the fingers of a hand.
  • cover 9 comprises on a periphery thereof a guide wall part 16 receivable in container 1.
  • Wall part 16 takes the form of a cylindrical strip, a longitudinal axis of which extends in the direction of a longitudinal axis of the cylindrical passage opening 12.
  • guide wall part 16 is received for the purpose of guiding cover 9 in an insertion space 17 received for this purpose in the container.
  • Wall surfaces of guide wall part 16 and insertion space 17 are here correspondingly formed so that they can be moved along each other, possibly with some friction.
  • Guide wall part 16 functions as twist lock for simultaneously closing the receiving spaces 3.
  • Guide wall part 16 can be broken off in order to enable rotation of cover 9 relative to container 1 about a vertical axis.
  • a container 1 which further comprises an outer container 18.
  • Closable container 1, particularly assembly 2 of receiving spaces 3, is here received in outer container 18.
  • An upper opening 19 of the outer container for this purpose has clearance such that the closed container 1 can be carried through upper opening 19 until protruding upper edge 8 of the coupled cover 9 finds support on an upper edge 20 of outer container 18.
  • Outer container 18 is further provided on an upper side with screw thread 21 with which an outer container cover 22 can be coupled.
  • This cover 22 is for this purpose provided on an inner side with a depending collar part 23 provided with a corresponding screw thread, not visible in the figure.
  • container 1 is situated, provided with cover 9, in outer container 18.
  • the outer container cover 22 comprises a reservoir containing a quantity of preserving liquid, for instance formaldehyde, for biopsy samples.
  • Outer container cover 22 is further provided with an operating member 24 in the form of a push button. When operating member 24 is pushed, the quantity of preserving liquid enclosed in the reservoir is released from outer container cover 22 into receiving spaces 3 of container 1.
  • the preserving liquid can reach the biopsy samples situated in receiving spaces 3 in simple manner through the perforations (13, 14) received in cover 9 and assembly 2. It is also possible for the preserving liquid, for instance formaldehyde, to be situated in a container other than outer container cover 22. It is thus possible to contain the preserving liquid in outer container 18.
  • Container 1, cover 9, receiving spaces 3, second container 5 and/or outer container 18 can each be at least partially provided with information for identifying the biopsy samples which were taken.
  • cover 9 comprises in addition to the components already shown in figure 2 an additional wall part 16A.
  • wall part 16A takes the fonn of a cylindrical strip, a longitudinal axis of which extends in the direction of a longitudinal axis of cylindrical passage opening 12 during coupling of cover 9 and container 1.
  • Wall part 16A is intended to cover identification stickers or codes arranged on a side wall of container 1 when cover 9 is rotated relative to container 1, thus reducing the chance of errors due to for instance switching. It is indeed the case that, when biological material is taken, identification stickers, for instance barcodes, are printed out and arranged on the peripheral wall of container 1.
  • a number of biopsy samples is inserted into the mutually separate receiving spaces 3 via the open wall parts 4, wherein container 1 is not closed by cover 9, and the container is received in a second container 5 for support (figure 1 ).
  • Cover 9 is then coupled using resilient tongues 1 1 to container 1 , and particularly to assembly 2 of the receiving spaces 3 which are provided with a biopsy sample. This is done by bringing cover 9 with guide wall part 16 into alignment with insertion space 17 of container 1 and then moving cover 9 downward into container 1 as according to the arrow 30 shown in figure 3.
  • the coupled situation between cover 9 and container 1 which is shown in figure 4 is achieved by inserting cover 9 into container 1 to such an extent that resilient tongues 11 spring out to a position under lower edge l2a. In this coupled situation cover 9 covers the open wall parts 4 of receiving spaces 3 so that they are closed off to the biopsy samples present in receiving spaces 3.
  • FIG. 1 The coupled container 1 and cover 9 are then gripped by engaging part 15 and removed from second container 5 in the direction of arrow 31, as shown in figure 5.
  • Figures 6 and 7 show the container 1 which has been removed from container 5 and is closed with cover 9 to at least the biopsy samples present in receiving spaces 3.
  • the closed container 1 is carried into an outer container 18 through an upper plane 19 as according to arrow 32.
  • outer container 18 is not filled, but it is also possible for it to be filled beforehand with a preserving liquid such as formaldehyde.
  • Outer container 18 has one internal space in which closed container 1 can be received, wherein engaging part 15 can eventually protrude partially above the plane in which an upper edge 20 of outer container 18 lies.
  • an outer container cover 22 is screwed onto the outer container 18 provided with the closed container 1. Pressing the operating member 24 incorporated in cover 22 releases a quantity of preserving liquid, for instance formaldehyde, in safe manner.
  • the quantity of preserving liquid can here be adapted to the requirement.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

Described is a container for receiving biological material. The container comprises a number of mutually separated receiving spaces with open wall part along which a biological material can be inserted. A cover is provided with coupling means for coupling to the container, wherein the cover covers the open wall parts of the receiving spaces. Wall parts of the receiving spaces and of the cover are permeable to a preserving liquid and impermeable to the biological material. Also described is a method for receiving biological material in a container, wherein use is made of an outer container containing preserving liquid for the biological material.

Description

CLOSABLE CONTAINER FOR RECEIVING BIOLOGICAL MATERIAL, AND A METHOD FOR RECEIVING BIOLOGICAL MATERIAL IN THE CONTAINER
TECHNICAL FIELD OF THE INVENTION
The invention relates to a closable container for receiving biological material, and a method for receiving biological material in the closable container.
BACKGROUND OF THE INVENTION
An increasing number of men and women over a certain age are nowadays regularly invited to participate in a population screening program, for instance to screen for the presence of colorectal cancer. With the screening program, colorectal cancer can for instance be prevented or be detected and treated at an early stage. If colorectal cancer is discovered early, the chances of recovery are greater and the treatment is less severe.
Such population screening is done on a large scale, and it is thus important for the organization thereof to be planned and executed as efficiently as possible. A population screening program does not only involve taking tissue biopsies, but a sufficient number of healthcare providers also has to be trained for the follow-up examination. If the screening produces a favourable outcome, there is no reason for further examination at the hospital, and the person in question need not do anything. If any abnormalities are however detected, for instance blood in the faeces, a follow-up examination is necessary. Such a follow-up examination comprises in many cases a colonoscopy.
A colonoscopy is an exploratory examination of the large intestine. It allows an internist or gastroenterologist to view the inside of a rectum, large intestine and the distal part of the small intestine. The examination is generally performed using an exploratory instrument: the endoscope. An endoscope generally comprises a flexible tube provided at an outer end with a small light source and a camera. The light source ensures that the physician can see the inside of the intestine properly. The camera is connected to a screen which allows the physician to watch the examination. Abnormalities in the large intestine can be detected by means of colonoscopy and, if desired, the physician can also perform small procedures immediately. Tissue samples/biopsy samples are usually also taken from the intestinal tissue or from the tissue of another organ. These have to be received in a container for further testing.
A biopsy is typically performed in order to test a piece of tissue for abnormalities. A colorectal polyp can for instance be benign or malignant. A biopsy can be performed with a so-called biopsy punch. According to the prior art, each biopsy sample or polyp taken with a biopsy punch or other tool is received separately in a transparent container. Each container is provided here with a preserving liquid such as for instance formaldehyde. The filled containers are then sent to a pathology or histology department for further diagnosis.
In a gastroenterology department the currently known method is labour-intensive and prone to errors because biopsies have to be secured in low light and under pressure.
Biopsies taken from different areas can easily be switched around. Because several containers, all filled with formaldehyde, are used per patient, a lot of formaldehyde is used. An additional harmful effect is the exposure to formaldehyde, which is categorized as carcinogenic.
It is moreover not unusual for multiple biopsies to be taken per patient (as many as 15 and more), which results in the use of a plurality of different containers filled with
formaldehyde. Reaching the diagnosis is thus also labour-intensive.
Because large quantities of biopsy samples and tissue samples are generally examined and analysed in laboratories, it is necessary to be able to trace such biopsies back to the different sources from which they originate in reliable manner. For this purpose the containers in which the tissue or biopsy samples are situated are provided with data, from which the origin of the tissue biopsy sample can be traced. The known method requires repeated arranging of information, which creates a danger of switching.
A container may additionally come into contact with organic solvents such as, in addition to formaldehyde, for instance xylene, acetone, ethyl alcohol, isopropyl alcohol and other related substances. Under the conditions applied the above stated chemicals can erase or make partially illegible the data on the containers. This is of course also undesirable. SUMMARY OF THE INVENTION
It is an object of the present invention to prevent or at least partially obviate the above stated prior art drawbacks.
The invention provides for this purpose a closable container for receiving biological material, comprising a number of mutually separated receiving spaces with open wall part along which a biological material can be inserted, a cover which is provided with coupling means for coupling to the container, wherein the cover covers the open wall parts of the receiving spaces, and wherein wall parts of the receiving spaces and of the cover are permeable to a preserving liquid and impermeable to the biological material. The cover is preferably rotatable relative to the container during use in order to clear the open wall part of receiving spaces, or can be made rotatable relative to the container, for instance by breaking a wall part. Side wall parts of the container are preferably fixedly connected to other wall parts of the container, such as a bottom part.
The container according to the invention collects in one single container a number of biopsy samples, which are each received in a receiving space. Each biopsy sample is thus separated from another biopsy sample, but a number of biopsy samples originating from the same patient are situated in the same container. This prevents errors and danger of confusion, and if desired the information related to a patient can furthermore be arranged only on the container and need not be provided per biopsy sample on each receiving space.
The cover of the container covers the open wall parts of the receiving spaces, which are all closed after coupling of cover and container. A biopsy sample or other piece of tissue cannot be removed from a receiving space in the coupled situation. Wall pails of the receiving spaces are further permeable to preserving liquid, for instance provided with recesses, through which liquids and gases from outside the container can easily come into contact with biopsy samples received in the receiving spaces, wherein the liquids or gases can also easily leave the receiving spaces again. The recesses can be arranged in the form of a grating. Access of treatment liquids and gases can be important for enabling temporary storage of the biopsy samples, but also in the case of sample pretreatment of a biopsy sample, wherein the container is immersed in diverse liquid chemicals, for instance to fixate the cells of a biopsy sample or other piece of tissue for microscopic examination. It will be apparent that the container is preferably manufactured from a suitable chemically-resistant material so as to be able to withstand such treatments.
In the context of the present application tissue or biological material is understood to mean organic material, isolated from for instance humans, animals or plants. This tissue or biological material can for instance be intended for histological or pathological examination. The term biological material also includes bodily material, for instance mucus, discharge, cervical smears, but also veterinary material. The biological material can in principle be taken from any part of a body, such as for instance from the lungs, liver, intestine, stomach and so on.
A further advantage of the container relates to the ability to handle a number of biopsy samples with one single operation. The container in which a plurality of biopsy samples are received can indeed be handled in simple manner and for instance be placed in another outer container. This likewise saves time, both when the biopsy samples are being taken and during processing of the biopsy samples in the laboratory.
The container according to the invention is environmentally friendly in the sense that it can reduce the quantity of plastic used in the industry and can also provide for a reduction of the quantity of preserving liquid which is used, such as for instance the suspect formaldehyde, currently classified as Group 1 : Carcinogenic to humans.
In an embodiment of the invention a container is for this purpose provided, the cover of which is provided with handling means for handling the coupled container and cover.
A practical embodiment provides a container, wherein the container is cylindrical and the receiving spaces are arranged adjacently of each other in a peripheral direction of the container, separated by radially running side wall parts. The radially running side wall parts are preferably fixedly connected to other wall parts of the container. The receiving spaces can extend over the whole periphery of the container. It is also possible for the receiving spaces to extend over only a part of the periphery, preferably through a peripheral angle of more than 180°, and more preferably lying between 180° and 340°, still more preferably between 180° and 320°, and most preferably between 180° and 300°. In these embodiments the receiving spaces are preferably arranged adjacently of each other. When the receiving spaces extend through a peripheral angle of 180°, half of the periphery is not taken up by receiving spaces. When the receiving spaces extend for instance through a peripheral angle of 300°, one sixth of the periphery is not taken up by receiving spaces. These embodiments are extra advantageous in combination with a cover which closes the open wall parts of the receiving spaces after coupling of cover and container. The portion of the container which comprises no receiving spaces can likewise comprise an open wall part, which is preferably closed by a wall part of the cover after coupling of cover and container. If desired, this wall part can be breakable or removable. It is also possible to embody the cover such that an open wall part of the portion of the container which comprises no receiving spaces is not closed after coupling of cover and container. The cover comprises for this purpose an open wall part which, in the situation in which the cover is coupled to the container, is aligned with the open wall part of the portion of the container which comprises no receiving spaces. This has the advantage that a receiving space can be made accessible by a single rotation of the cover, wherein said open wall part of the cover is aligned with an open wall part of the relevant receiving space.
Yet another embodiment relates to a container wherein the receiving spaces are removable from the container.
Yet another embodiment relates to a container, wherein this container comprises a central passage opening for the coupling means of the cover, which opening is closed off liquid- tightly from the receiving spaces. The section of the central passage opening is for instance circular, although this is not essential. The central passage opening can extend from an upper plane of the container into a lower plane of the container, although this is not essential either. A suitable embodiment of the container comprises coupling means in the form of resilient tongues which can be arranged in the passage opening and which are able to spring out under a lower edge of the passage opening. The cover is hereby coupled to the container, at least in a vertical direction. Rotation of the cover round a vertical axis is possible if desired, wherein some friction may be experienced from wall parts of the cover and the container moving over each other.
An embodiment which promotes simple handling of the container comprises a container wherein the handling means comprise an engaging part protruding from a plane of the cover. The cover and a container coupled thereto can then be taken up together by a person by gripping the engaging part between two fingers.
The invented container is embodied such that wall parts of the receiving spaces and of the cover are permeable to a preserving liquid and impermeable to the biological material. An embodiment suitable in this context relates to a container wherein the wall parts which are permeable to the preserving liquid and impermeable to the biological material comprise perforations. The perforations extend over the wall thickness of the relevant wall parts and allow passage of preserving liquid. The perforations are however small enough to stop a biopsy sample or other tissue sample.
Although ever wall part can in principle be permeable to the preserving liquid, an improved embodiment relates to a container wherein the wall parts of the receiving spaces which are permeable to the preserving liquid and impermeable to the biological material comprise bottom wall parts of the receiving spaces.
In order to facilitate arranging of the cover on the container in a desired position an embodiment of the cover has a guide wall part which is receivable in the container for the purpose of guiding the cover during arranging thereof on the container. In this embodiment the container is provided with an accommodating space, separated from the receiving spaces, for the guide wall part of the cover.
The advantages of the invention become particularly manifest in an embodiment in which the container further comprises an outer container in which the container is received, wherein the outer container comprises an outer container cover whereby the container can be retained in the outer container, and wherein the outer container contains a preserving liquid for the biological material. This embodiment has the additional advantage that the container - and the receiving spaces - need not comprise preserving liquid. The biopsy samples which were taken and are situated in the receiving spaces all come into contact with the preserving liquid substantially simultaneously when the container is coupled to the outer container. Because only the outer container is filled with preserving liquid, the quantity of preserving liquid is kept limited.
In an advantageous embodiment of the invention a container is proposed wherein the outer container cover contains the preserving liquid, and the preserving liquid is released into the receiving spaces from the outer container cover during closing and/or by operating an operating member. This embodiment has the additional advantage that a person handling the container and/or the outer container generally cannot come into contact with the preserving liquid, for instance with the formaldehyde which entails health risks.
It is preferred for the container to be formed substantially from a plastic material. Plastic material can be readily embodied in diverse forms and can be obtained with the desired physical and chemical properties. It is advantageous if the whole container is formed substantially from the plastic material. The entire container can thus be manufactured integrally, which makes the container easy to produce by means of known techniques for the processing of plastics, such as for instance injection moulding.
In a particular preferred embodiment the plastic material is chosen from the group formed by: polyacetal, polyamide, polycarbonate, polyester, polypropylene, polyurethane, polystyrene and acrylonitrile butadiene styrene, polyphenylene sulphide, polyethylene terephthalate, polybutylene terephthalate and polyoxymethylene. Such plastics are generally available in readily processable variants. A plastic material such as polyacetal is particularly suitable. Poly acetal has a good chemical resistance compared to a wide range of common chemicals. In addition, objects manufactured from poly acetal have good mechanical properties. In a further improved embodiment the container is at least partially provided with information. This information can be arranged in any known manner, for instance by writing with a means suitable for this purpose, by means of stickers or by marking with for instance a laser. A possible information surface can be embodied so that it can be coupled releasably to the container, the cover and/or the receiving spaces. Arranging data on the information surface can then take place independently of the rest of the container so that a more flexible manner of working is possible. For a releasably coupling connection of the information surface to the container, the cover and/or the receiving spaces it is possible to envisage diverse systems, such as snap systems or slide systems, with which rapid and simple coupling and uncoupling is possible. If desired, the coupling can be provided with a locking. Uncoupling is hereby made more difficult, this reducing the risk of undesired uncoupling of an information surface.
In another aspect of the invention it also provides a method for receiving biological material in a container. In a suitable method a container according to the invention is provided, wherein a biological material is inserted into the mutually separated receiving spaces via the open wall parts, and wherein the cover provided with coupling means is coupled with the coupling means to the container, wherein the cover covers the open wall parts of the receiving spaces. Such a method makes it possible to store biological material and other tissue samples in a rapid, efficient, reliable and safe manner for further diagnosis.
The invention provides further embodiments of the method wherein the coupled assembly of container and cover is taken up by handling means provided on the cover; wherein the container and the cover are coupled by inserting resilient tongues into a central passage opening which is closed off liquid-tightly from the receiving spaces and having them spring out under a lower edge of the passage opening; and wherein the cover is arranged on the container under the guidance of a guide wall part receivable in the container.
Particularly advantageous embodiments of the method further comprise of receiving the container coupled to the cover in an outer container and retaining the container in the outer container with an outer container cover, wherein the outer container contains preserving liquid for the biological material; and a method wherein the outer container cover contains the preserving liquid, and the preserving liquid is released into the receiving spaces from the outer container cover during closing and/or by operating an operating member.
The embodiments of the invention described in this patent application can be combined in any possible combination of these embodiments, and each embodiment can individually form the subject-matter of a divisional patent application.
BRIEF DESCRIPTION OF THE FIGURES
The invention will now be further elucidated on the basis of several non-limitative embodiments. In the figures:
Figure 1 is a schematic perspective view of a container for receiving biological material in open situation according to an embodiment of the invention;
Figure 2 is a schematic perspective view of a cover of the container according to an embodiment of the invention;
Figure 3 is a schematic perspective view of a method step according to an embodiment of the invention;
Figure 4 is a schematic perspective view of a container for receiving biological material in closed situation according to an embodiment of the invention;
Figure 5 is a schematic perspective view of another method step according to an embodiment of the invention;
Figure 6 is a schematic perspective top view of a container for receiving biological material, coupled to a cover, according to an embodiment of the invention;
Figure 7 is a schematic perspective bottom view of the container, coupled to a cover, shown in figure 6;
Figure 8 is a schematic perspective view of yet another method step according to an embodiment of the invention;
Figure 9 is a schematic perspective view of a container for receiving biological material, received in an outer container, according to an embodiment of the invention; and finally Figure 10 is a schematic perspective view of a cover of the container according to another embodiment of the invention. DESCRIPTION OF EXEMPLARY EMBODIMENTS
Referring to figure 1, a closable container 1 for receiving biopsy samples is shown. The closable container 1 comprises an assembly 2 of five mutually separated receiving spaces 3. Receiving space 3 each have an open wall part, in the shown embodiment an open upper side 4 along which a biopsy sample (not shown) can be inserted into receiving space 3. Container 1 is cylindrical and receiving spaces 3 are arranged adjacently of each other in a peripheral direction 6 of container 1 , wherein a receiving space 3 is separated from an adjacent receiving space 3 by a radially running side wall part 7, wherein the receiving spaces are removable from the container. Assembly 2 is preferably manufactured integrally, for instance by means of injection moulding. Receiving spaces 3 can be removable from container 1 each individually or, preferably, as assembly 2.
In the shown embodiment closable container 1 is temporarily received in a support means which is embodied according to figure 1 as a second container 5. A protruding upper edge 8 of container 1 supports here on an upper edge of second container 5. Containers 1 and 5 and assembly 2 are made from a suitable, preferably transparent, plastic.
Container 1 is closable by means of a cover 9, shown in figure 2. Cover 9 has a size such that this cover 9 covers the open wall parts 4 of all receiving spaces 3. Cover 9 is further provided with coupling means for coupling to container 1. The coupling means comprise two resilient tongues 11 extending in the direction of a bottom 10 of container 1. Tongues 11 can be arranged in a passage opening 12 of container 1, wherein they can spring out under a lower edge l 2a of passage opening 12 in order to couple container 1 and cover 9. Cylindrical passage opening 12 is received centrally in container 1 and extends in the direction of bottom 10. Central passage opening 12 is moreover closed off liquid-tightly from receiving spaces 3 by means of closed side walls. Resilient tongues 11 are provided at a lower outer end with protruding wall parts 1 la with which they extend under lower edge 12a in the coupled situation.
As shown clearly in figures 6 and 7, wall parts of receiving spaces 3 and of cover 9 are permeable to a preserving liquid and impermeable to the biopsy sample. This is achieved by providing wall parts of the cover which are permeable to the preserving liquid and impermeable to the biopsy sample with perforations 13. Bottom wall parts of receiving spaces 3 are provided in similar manner with perforations 14. The perforations (13, 14) extend over the whole wall thickness of the cover and the bottom wall parts, so that a liquid can flow in and out freely.
Cover 9 further comprises handling means 15 for handling the coupled container 1 and cover 9. In the shown embodiment handling means 15 comprise an engaging part which protrudes from a plane of cover 9 and can be engaged with the fingers of a hand.
In order to facilitate placing of cover 9 on container 1 in correct manner cover 9 comprises on a periphery thereof a guide wall part 16 receivable in container 1. Wall part 16 takes the form of a cylindrical strip, a longitudinal axis of which extends in the direction of a longitudinal axis of the cylindrical passage opening 12. During arranging of cover 9 on container 1 guide wall part 16 is received for the purpose of guiding cover 9 in an insertion space 17 received for this purpose in the container. Wall surfaces of guide wall part 16 and insertion space 17 are here correspondingly formed so that they can be moved along each other, possibly with some friction. Guide wall part 16 functions as twist lock for simultaneously closing the receiving spaces 3. Guide wall part 16 can be broken off in order to enable rotation of cover 9 relative to container 1 about a vertical axis.
Referring to figures 8 and 9, a container 1 is shown which further comprises an outer container 18. Closable container 1, particularly assembly 2 of receiving spaces 3, is here received in outer container 18. An upper opening 19 of the outer container for this purpose has clearance such that the closed container 1 can be carried through upper opening 19 until protruding upper edge 8 of the coupled cover 9 finds support on an upper edge 20 of outer container 18.
Outer container 18 is further provided on an upper side with screw thread 21 with which an outer container cover 22 can be coupled. This cover 22 is for this purpose provided on an inner side with a depending collar part 23 provided with a corresponding screw thread, not visible in the figure. After arranging and closing of cover 22, container 1 is situated, provided with cover 9, in outer container 18. In the embodiment shown in figure 9 the outer container cover 22 comprises a reservoir containing a quantity of preserving liquid, for instance formaldehyde, for biopsy samples. Outer container cover 22 is further provided with an operating member 24 in the form of a push button. When operating member 24 is pushed, the quantity of preserving liquid enclosed in the reservoir is released from outer container cover 22 into receiving spaces 3 of container 1. The preserving liquid can reach the biopsy samples situated in receiving spaces 3 in simple manner through the perforations (13, 14) received in cover 9 and assembly 2. It is also possible for the preserving liquid, for instance formaldehyde, to be situated in a container other than outer container cover 22. It is thus possible to contain the preserving liquid in outer container 18.
Container 1, cover 9, receiving spaces 3, second container 5 and/or outer container 18 can each be at least partially provided with information for identifying the biopsy samples which were taken.
Referring to figure 10, another embodiment of cover 9 comprises in addition to the components already shown in figure 2 an additional wall part 16A. Just as guide wall part 16, wall part 16A takes the fonn of a cylindrical strip, a longitudinal axis of which extends in the direction of a longitudinal axis of cylindrical passage opening 12 during coupling of cover 9 and container 1. Wall part 16A is intended to cover identification stickers or codes arranged on a side wall of container 1 when cover 9 is rotated relative to container 1, thus reducing the chance of errors due to for instance switching. It is indeed the case that, when biological material is taken, identification stickers, for instance barcodes, are printed out and arranged on the peripheral wall of container 1.
In a method according to the invention a number of biopsy samples is inserted into the mutually separate receiving spaces 3 via the open wall parts 4, wherein container 1 is not closed by cover 9, and the container is received in a second container 5 for support (figure 1 ).
Cover 9 is then coupled using resilient tongues 1 1 to container 1 , and particularly to assembly 2 of the receiving spaces 3 which are provided with a biopsy sample. This is done by bringing cover 9 with guide wall part 16 into alignment with insertion space 17 of container 1 and then moving cover 9 downward into container 1 as according to the arrow 30 shown in figure 3. The coupled situation between cover 9 and container 1 which is shown in figure 4 is achieved by inserting cover 9 into container 1 to such an extent that resilient tongues 11 spring out to a position under lower edge l2a. In this coupled situation cover 9 covers the open wall parts 4 of receiving spaces 3 so that they are closed off to the biopsy samples present in receiving spaces 3.
The coupled container 1 and cover 9 are then gripped by engaging part 15 and removed from second container 5 in the direction of arrow 31, as shown in figure 5. Figures 6 and 7 show the container 1 which has been removed from container 5 and is closed with cover 9 to at least the biopsy samples present in receiving spaces 3.
In a further step the closed container 1 is carried into an outer container 18 through an upper plane 19 as according to arrow 32. At that moment outer container 18 is not filled, but it is also possible for it to be filled beforehand with a preserving liquid such as formaldehyde. Outer container 18 has one internal space in which closed container 1 can be received, wherein engaging part 15 can eventually protrude partially above the plane in which an upper edge 20 of outer container 18 lies.
In a subsequent step an outer container cover 22 is screwed onto the outer container 18 provided with the closed container 1. Pressing the operating member 24 incorporated in cover 22 releases a quantity of preserving liquid, for instance formaldehyde, in safe manner. The quantity of preserving liquid can here be adapted to the requirement.
It will be apparent that many variations and applications are still possible within the scope of the invention for a skilled person in the field.

Claims

1. Closable container for receiving biological material, comprising a number of mutually separated receiving spaces with open wall part along which a biological material can be inserted, a cover which is provided with coupling means for coupling to the container, wherein the cover covers the open wall parts of the receiving spaces, and wherein wall parts of the receiving spaces and of the cover are permeable to a preserving liquid and impermeable to the biological material.
2. Container according to claim 1 , wherein the cover is further provided with handling means for handling the coupled container and cover.
3. Container according to claim 1 or 2, wherein the container is cylindrical and the receiving spaces are arranged adjacently of each other in a peripheral direction of the container, separated by radially running side wall parts.
4. Container according to any one of the foregoing claims, wherein the receiving spaces are removable from the container.
5. Container according to any one of the foregoing claims, wherein the container comprises a central passage opening for the coupling means of the cover, which opening is closed off liquid-tightly from the receiving spaces.
6. Container according to claim 5, wherein the coupling means comprise resilient tongues which can be arranged in the passage opening and which are able to spring out under a lower edge of the passage opening.
7. Container according to any one of the claims 2-6, wherein the handling means comprise an engaging part protruding from a plane of the cover.
8. Container according to any one of the foregoing claims, wherein the wall parts which are permeable to the preserving liquid and impermeable to the biological material comprise perforations.
9. Container according to any one of the foregoing claims, wherein the wall parts of the receiving spaces which are permeable to the preserving liquid and impermeable to the biological material comprise bottom wall parts.
10. Container according to any one of the foregoing claims, wherein the cover has a guide wall part which is receivable in the container for the purpose of guiding the cover during arranging thereof on the container.
1 1. Container according to any one of the foregoing claims, further comprising an outer container in which the container is received, wherein the outer container comprises an outer container cover whereby the container can be retained in the outer container, and wherein the outer container contains a preserving liquid for the biological material.
12. Container according to claim 11 , wherein the outer container cover contains the preserving liquid, and the preserving liquid is released into the receiving spaces from the outer container cover during closing and/or by operating an operating member.
13. Container according to any one of the foregoing claims, formed substantially from a plastic material.
14. Container according to claim 13, wherein the plastic material is chosen from the group formed by polyacetal, polyamide, polycarbonate, polyester, polypropylene, polyurethane, polystyrene and acrylonitrile butadiene styrene, polyphenylene sulphide, polyethylene terephthalate, polybutylene terephthalate and polyox ymethylene.
15. Container according to any one of the foregoing claims, at least partially provided with information.
16. Method for receiving biological material in a container, wherein a container according to any one of the foregoing claims is provided, wherein a biological material is inserted into the mutually separated receiving spaces via the open wall parts, and wherein the cover provided with coupling means is coupled with the coupling means to the container, wherein the cover covers the open wall parts of the receiving spaces.
17. Method according to claim 16, wherein the coupled assembly of container and cover is taken up by handling means provided on the cover.
18. Method according to any one of the claims 16-17, wherein the container and the cover are coupled by inserting resilient tongues into a central passage opening which is closed off liq uid- tightl y from the receiving spaces and having them spring out under a lower edge of the passage opening
19. Method according to any one of the claims 16-18, wherein the cover is arranged on the container under the guidance of a guide wall part receivable in the container.
20. Method according to any one of the claims 16-19, further comprising of receiving the container coupled to the cover in an outer container containing preserving liquid for the biological material, and retaining the container in the outer container with an outer container cover.
21. Method according to claim 20, wherein the outer container cover contains the preserving liquid, and the preserving liquid is released into the receiving spaces from the outer container cover during closing and/or by operating an operating member.
PCT/NL2019/050276 2018-05-11 2019-05-09 Closable container for receiving biological material, and a method for receiving biological material in the container WO2019216766A1 (en)

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NL2020915A NL2020915B1 (en) 2018-05-11 2018-05-11 LOCKABLE HOLDER FOR RECORDING BIOLOGICAL MATERIAL, AND A METHOD FOR RECORDING BIOLOGICAL MATERIAL IN THE HOLDER
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