![]() container assembly and method of preserving a tissue sample
专利摘要:
CONTAINER ASSEMBLY AND METHOD OF STORING A TISSUE SAMPLE This is a container assembly (500) comprising a container (1) for storing a tissue sample (45) and a cover (2) adapted to engage the container (1). The cover (2) comprises: a top member (321) comprising a receptacle (211), a seal (22) to seal said receptacle (211), a puncture member (323) to break said seal (22 ) by displacing the puncture limb (323). The container assembly (500) has a first and a second position, in which, in the first position, the container (1) is isolated from the receptacle (211) and, in the second position, fluid communication is provided between the receptacle (211 ) and the container (1). The container assembly (500) comprises a separator (31) positioned between the seal (22) and the bottom (13) of the container (1), and the separator (31) is provided with at least one opening adapted to provide a passage fluid between the receptacle (211) and the container (1). 公开号:BR112013031779B1 申请号:R112013031779-5 申请日:2011-11-11 公开日:2020-11-03 发明作者:Ole Jakobsen;Christoffer Bay;Jacob Ilskov 申请人:Biopsafe ApS; IPC主号:
专利说明:
The present invention relates to a container assembly, more specifically to a container assembly comprising: a container for storing a tissue sample, said container comprising a bottom, a cover adapted to engage said container, said cover comprising: a top member comprising a receptacle, said receptacle being adapted to contain a preserving agent, a seal to seal said receptacle, a puncture member to break said seal through displacement of said puncture member, where the container assembly has a first and a second position, in which, in the first position, the container is isolated from the receptacle, and in the second position fluid communication is provided between the receptacle and the container. The invention further relates to a method of preserving a tissue sample. Container assemblies for releasing an agent into a container at a desired time are well known and come in many shapes and sizes, both within industry and within consumer goods. In hospitals and clinics, containers or Petri dishes are used to collect and store tissue samples, so that after a tissue sample has been taken from a patient, the tissue sample is placed in a container, and a conservation, often formalin, is subsequently filled into the recipient before the container is closed and sent to a laboratory for analysis. Here, the container is normally opened in a flow chamber as formalin and other preservatives are toxic for inhalation. The problem with this is that, at the hospital, employees who collect the tissue sample need to handle it with a preservative daily when filling the container. Typically, a formalin dispenser station or a container-mountable dispenser is temporarily used. After the formalin has been dispensed into the container, the lid is fitted to the container. Handling of a preservative can therefore result in spillage and inhalation. Inhalation and other exposures are a health hazard 10 and the handling of formalin and other preservatives should be carried out with great care. Document No. W02004 / 000678 describes different modes of mixing flasks, in particular the embodiment shown in Figures 6A to B shows a mixing flask 15 where a rigid rod is pressed through a supplementary container and the diluent is introduced into the container. US No. 5,152,965 describes a container assembly comprising a reagent bottle and a container adapted to engage an adapter assembly positioned between the two. The reagent bottle contains a reagent to be mixed with a reagent diluent in the container. The adapter assembly comprises a coupler and a hollow plunger. The reagent bottle is interlockable with the coupler in a first position and is capable of advancing to a second position in relation to the adapter assembly so that the hollow plunger displaces the sealing of the reagent bottle allowing the reagent to flow through hollow plunger to mix with the diluent in the container. Advancing the coupler results in increased pressure in the container, which is undesirable as the increased pressure can result in the contents spilling into the container when the adapter assembly is removed from the container. Document No. W02008 / 040812 describes a receptacle configured to receive a volume of preservative, and a lid containing the preservative and which is adapted to be coupled to a tissue storage container. The preservative is introduced into the lid via a one-way valve. The cover additionally comprises a membrane with several holes. A plastic disc containing an equivalent amount of holes is placed between the receptacle and the membrane on the cover. When the holes are aligned, for example, by turning the cap, the preservative flows into the receptacle. This requires that the container assembly be oriented so that the cover is facing upwards, thereby allowing the preservative to flow into the gravity-assisted container. The purpose of the present invention is to provide a container assembly where the risk of spillage and evaporation is reduced considerably and the risk of the sample being trapped in the cover is eliminated. In a first aspect, this is achieved by providing a container assembly comprising a separator positioned between the seal and the bottom of the container, and the separator is provided with at least one opening adapted to provide a passage of fluid between the receptacle and the container. By positioning the separator between the receptacle and the bottom of the container, it is ensured that the tissue sample is not attached to the top member or the puncture medium and, at the same time, that the seal does not interfere with the tissue sample. . The tissue sample will be positioned normally at the bottom of the container. According to a preferred embodiment, the container assembly additionally comprises a space between the separator and the seal, the separator being provided with a conduit adapted to provide a passage of fluid between the space and the container. This makes it possible for the air in the container to travel upwards and thus makes it easier for the preserving agent to enter the container through the separator. The conduit may have a hole positioned above the level of the preservative after the seal has been broken. In this way, the air in the container below the separator bypasses the preservative, making it easier for the preservative to enter the container below the separator. The cover may constitute a cover. Instead of having to remove the cover after releasing the contents in the receptacle, the cover can remain in the container and act as a lid, making it easy to transport. The cover may comprise a membrane that has a substantially convex shape in the first position and a substantially concave shape in the second position. This membrane preferably covers the puncture limb. The different shapes of the membrane in the first and second positions make it possible for employees to observe from above if the seal has been broken. The cover is preferably adapted to be hermetically sealed to the container. This contributes to reducing the risk of spillage. The cover may comprise a protective cover to cover the membrane. Thus, it is ensured that the membrane and, thus, the puncture member are not accidentally pressed and the seal is not broken when it is not intended to do so. The container assembly may comprise a tracking device, so that the tissue sample can be traced from where it was taken to the laboratory. The container assembly can also comprise a temperature tracker, so that it is possible to observe whether the fabric has been subjected to heat or cold, which can affect the tissue sample and, consequently, the results of a test. The puncture member can be provided with at least one opening, to provide a passage between the space and the container. This facilitates the flow of the preservative into the container. The preservative can flow around the puncture limb as well. The separator may comprise a bottom and engaging means for engaging with the corresponding engaging means of the cover, so that the bottom of the separator is prevented from coming into contact with the bottom of the container. Therefore, the tissue sample does not have the risk of being pressed or crushed when in the container and when the cover is removed for insertion or removal of the tissue sample, the separator remains connected to the cover and does not interfere with the handling of the tissue sample. The engagement means can be, for example, threads or a snap closure. An outer diameter of the separator can be substantially equal to an inner diameter of the container, so that the separator and the container fit substantially and little fluid can deviate from the separator. The seal can be selected from a group consisting of a film, a foil, a membrane and a polymer. These are all materials that are suitable for drilling or cutting or, in a way, penetrating, so that the preservative can escape. A portion of the container assembly may comprise a transparent portion for viewing the interior of the container. This allows the user of the container assembly to visually inspect the sample to see if proper preservation has been carried out or if the preservative has been released from the receptacle into the container. The assembly can be fitted with an indicator to indicate whether the seal has been broken. This can be seen as an indicator of whether the contents of the receptacle have been compromised, if the seal has been damaged, contaminants may enter the receptacle, or if the contents of the receptacle have been released and thereby alert the user. If the content has been released, the user knows that the container should not be opened without taking different safety measures, such as opening the container in a flow chamber. The separator is preferably a contrast color, such as blue, to a color of the fabric. This makes it easier to observe the tissue sample if it gets stuck in the separator during transport, for example, to the laboratory. The puncture member can be provided with at least two projections to break the seal, so that more holes are created in the seal and the preservative can more easily leave the receptacle and enter the container. By providing the puncture member with teeth, the seal can be broken or punctured in several places, facilitating the flow of preservative into the container. The cover can be adapted to be locked to the container. This ensures that there can be no tampering with the tissue samples. According to another embodiment, the container assembly may comprise a container for storing a tissue sample, a cover adapted to engage the container, wherein the cover comprises: a top member comprising a receptacle, wherein the receptacle is adapted to contain a preservative, a seal to seal said receptacle, a puncture or puncture member to break said seal in which the seal is broken by displacing the puncture or puncture member, a volume where the volume is defined inside the outer walls of the container assembly, where a puncture or puncture member is provided with latching means adapted to engage the corresponding latching means provided on the top member, so that the position of the puncture or puncture member adjustable regardless of the orientation of the container assembly, the container assembly has a first and a second position, where, in the first position, the container is separate from the receptacle, and in the second position fluid communication is provided between the receptacle and the container, where the volume in the first position is the same as the volume in the second position. By not changing the volume of the container assembly, the pressure inside the container remains the same and, thus, the risk of spillage when opened is reduced considerably. The puncture or puncture member can be adapted to support the seal after the seal has been broken. By allowing the puncture or puncture member to withstand the seal, the risk of parts of the seal sliding into the container after the seal has been broken and mixed with the content here, is reduced. The cover may additionally comprise a ring member adapted to engage said container. This ensures that the cover is connectable to the container. The seal can be broken from outside the receptacle. By not having to mount any puncture or puncture means inside the receptacle, the risk of spillage during the assembly of the cover is reduced and the risk of any contaminants entering the receptacle is reduced, and the service life of the assembly is increased. The puncture or puncture member and receptacle can be adapted to fit substantially. This means that they are shaped so that they themselves leave minimal space for anything that is positioned between the two, except for the broken seal, when the puncture or puncture member was moved to its terminal position. The terminal position is defined as a position where the puncture or puncture member cannot be moved further from its initial position. This reduces the risk of any preservative flowing from the container back into the receptacle behind the puncture or puncture member, thereby separating the tissue sample from the preservative. At least a part of the space in the receptacle can form part of the space in the container, when the cover is mounted on the container and the seal has been broken. This means that the puncture or puncture member is moved so that, when the seal has been broken, the puncture or puncture member acts as a new separator between the receptacle and the container and at least part of the space in the receptacle now forms part of the container where the tissue sample can be present. The puncture or puncture member can only be able to advance when the cover is mounted on the container. This ensures that the seal is not accidentally broken, and the preservative can leak. The puncture or puncture member can only be able to advance when the top member is pushed down simultaneously while being rotated. This ensures that even when the top member is mounted on the container, the seal is not accidentally broken. The cover may comprise a resistant means to exhort the puncture or puncture member away from the receptacle. This makes it possible to open the cover 5 by simultaneously rotating and pushing the cover. In addition, this contributes to ensuring that the seal does not rest on the puncture or puncture member and thereby increasing the risk of unintentional tearing of the seal. The receptacle may comprise a hole and a bottom, wherein the receptacle may be tapered towards the bottom. By making the receptacle tapered, a faster release of the preservative is achieved and it is not possible that the entire preservative will not be released into the container when the seal is broken. The receptacle 15 can also be straight or cylindrical. According to a second aspect, a method of preserving a tissue sample comprises the steps of: providing a container, filled with a preservative and sealed by a seal, a puncture member and a separator, placing a sample of fabric in said container, engaging said cover with the container thereby positioning said separator between the seal and the bottom of the container, displacing the puncture member by means of which said seal is broken and the preservative is permitted entering the container through the separator. The puncture limb is preferably displaced by pressing on the puncture limb. A different method of providing a container assembly for containing a tissue sample may be provided, comprising the steps of: providing a container, providing a cover that includes a top member with a receptacle and the puncture or puncture member, filling said receptacle with a preservative, sealing said receptacle with a seal, placing a tissue sample in said container, engaging said cover with the container, moving the puncture or puncture member by engaging the engagement means of the member puncture or puncture with the means of engagement on the top member of the cover, through which the seal is broken and the preservative is introduced into the container. Any attributes of the first aspect can be incorporated into the second aspect and vice versa. In the following, the invention will be described in more detail with reference to the drawings in which: Figure 1 shows a perspective view of the container assembly in a first embodiment, Figure 2 shows an exploded view of the container assembly shown in Figure 1, Figure 3 shows the detailed view of a cross-section of the coverage in the first modality, Figure 4 shows a cross section of the container assembly in a first position in the first mode, Figure 5 shows a cross-section of a first embodiment of the container assembly in a first position with the lid slightly pushed down, Figure 6 shows a cross-section of a first embodiment of the container assembly in a second position where the seal has been broken, and Figure 7 shows a view corresponding to Figure 3 of the container assembly in a second embodiment, Figure 8 shows a perspective view of the container assembly in a third embodiment, Figure 9 shows a cross section of the container assembly in a first position in the third embodiment, Figure 10 shows a cross section of the container assembly in a second position in the third embodiment, Figure 11 shows a cross section of the container assembly in the third embodiment, Figure 12 shows a perspective view of assembling the container in a shelter mode, Figure 13 shows a cross section of the container assembly in a first position in the fourth embodiment. Figure 14 shows a cross section of the container assembly in a first position in a fifth embodiment. Figure 15 shows a cross section of the container assembly in a second position in a fifth embodiment. Figure 16 shows a cross section of the container assembly in a first position in a sixth embodiment. Figure 17 shows a cross section of the container assembly in a second position in a sixth embodiment. Figure 18 shows an exploded view of the container assembly in a sixth embodiment as well as the container assembly 20 in an assembled state. Figure 19 shows an exploded view of the container assembly in a seventh embodiment as well as the container assembly in a perspective view in an assembled state. Figure 20 shows the container assembly in a state assembled in a seventh embodiment. Figure 21 shows a cross section of the container assembly in a first position in a seventh embodiment. Similar numerical references refer to similar attributes throughout the drawings. Figure 1 shows a container assembly generally designated 100 and comprising a container 1 for containing a tissue sample and a cover 2 in an assembled state. In the embodiment shown, the cover 2 comprises a ring member 26, which has grooves for a firmer grip, and a top member 21. The ring member 26 can be provided with a rubber surface or simply with a soft surface around it. instead. The top member 21 is provided with projection (s) 214 to make it easier to access the top member 21, when the top member 21 is to be rotated. The cover is a lid, making the container assembly easy to transport. In the modality shown, the container assembly is in a mounted state of, at most, 35 mm thick or deep or long on one side of it, which makes it possible to send it in a correspondence. The container assembly can also have a maximum of 20 mm on one side of it, 25 mm on one side of it or 50 mm on one side of it. The container assembly can be larger on one side of it, or even smaller on one side of it. The receptacle in this modality is adapted to contain 10 ml of preservative, such as formalin. The receptacle may be able to contain a different amount of preservative, such as less than 15 ml, less than 20 ml, less than 25 ml, less than 50 ml, less than 100 ml or less than 10 ml of preservative or more than 100 ml of preservative. Container 1 is at least capable of containing the corresponding amount of preservative as well as a tissue sample. A tissue sample can receive up to 1 cm3, but they tend to be smaller, up to 1 mm3. The tissue sample may be able to be covered by the preservative regardless of the orientation of the assembly. Figure 2 shows the different parts of the container assembly 100 in a first embodiment. In addition to the top member 21, the cover comprises a seal 22 in the form of a foil. The seal can also be a film, a membrane, a polymer, a composite material or glass. The top member 21 is made of a polymer material, but it can be made of other materials such as glass. In the embodiment shown, the cover 2 further comprises a packaging 24 in the form of an O-ring seal to seal the connection between the ring member 26 and the top member 21. Other sealing means can be used. Between a puncture or puncture member 23 and the top member 21 are the resistant medium 25 in the form of a spring positioned to urge the puncture or punch member 23 away from the seal 22. In other embodiments, the resistant medium 25 can be made of another resistant material such as rubber or it can be in the form of flexible rods positioned around the circumference of the puncture or punch member 23 or inside the top member 21 along the circumference of the receptacle 211. The rods can be made of a polymer or a metal. The resistant means 25 can be integrated with the top member 21 or with the puncture or puncture member 23. In this embodiment, the puncture or puncture member 23 in the form of a puncture or plunger is provided with openings 2 32 in an area of the puncture or puncture member 23 that is adapted to enter receptacle 211. Openings 232 contribute to facilitate a fluid communication between the receptacle and the container 1. The puncture or puncture member 23 may also, or alternatively, be provided with openings along the flange 233, which is not intended to enter receptacle 211. The puncture or puncture member 23 it is hollow, but it can be solid and have a larger opening or several smaller openings to facilitate fluid communication between receptacle 211 and container 1. Making the puncture or puncture member 23 solid and making it the same fits in shape with receptacle 211 or only providing the puncture or punch member 23 with the opening (s) along the flange 233, receptacle 211 is almost filled by the puncture or punch member 23 or ac the connection between receptacle 21 and container 1 is sealed when the puncture or puncture member 23 has reached its terminal position. This prevents the preservative from being separated from the tissue sample. Only a minimal or none of the preservative can flow back into receptacle 211 and into a space that is not reachable for the tissue sample, since the tissue sample may be larger than the openings provided. Finally, the container assembly 100 comprises the container 1 adapted to engage the ring member 26. The engagement between the two can be done through threads or through a pressure cover, by pressing a resistant circumferential flange on the member of ring 26 on a flange or other projections in container 1 or vice versa. The ring member 26 is used, in this embodiment, to hold the container 1 and the top member 21 together and it helps to control how far the top member 21 can be pushed down. The container 1 and / or the cover 2 can be provided with a transparent part to look inside the container 1 to see if a tissue sample is in the container 1 or if the seal 22 has been broken and the preservative is in the container 1 Container 1 and cover 2 can be fitted with a locking mechanism to prevent tampering with the tissue sample on the way from the hospital to the laboratory. The locking mechanism can be of a type that can only be opened by laboratory personnel or the same can be an indicator that shows whether assembly 100 has been opened. Figure 3 shows a closed framing view of a roofing modality 2 in an assembled state. As shown in detail in that Figure, the top member 21 is provided with the receptacle 211 inside the top member 21 in the embodiment shown. The top member 21 is additionally provided with engagement means in the form of indentations 213. These are adapted to engage the projections 261 provided on the ring member 26. The engagement between the two holds the top member 21 in position as well as providing a safety margin of how far down the top member 21 can be pushed. If such movement limiting means were not present, it may be possible to accidentally press the top member 21 and break the seal 22. Additionally, the ring member 26 is provided with the projection (s) 262 that maintain (maintain) the puncture or puncture member 23 in place. In the embodiment shown, the puncture or puncture member 23 is provided with threads 231 which are adapted to engage threads 212 inside the top member 21. These ensure that the puncture or puncture member 23 cannot be merely pushed from from below, so that seal 22 breaks unintentionally. When it is desired to break the seal 22, the top member 21 is advanced so that the seal 22 breaks. In this embodiment, the top member 21 must be rotated at the same time as the top member 21 is being pushed from the top simultaneously with the puncture or punch member 23 which is pushed from the bottom. The puncture or puncture member 23 is being pushed from below by the container 1. Before breaking the seal 22, the cover 2 and the container 1 are preferably hermetically coupled. In the embodiment shown, receptacle 211 is tapered so that the orifice of receptacle 516 is wider than the bottom 215. The receptacle may have other shapes such as cylindrical, pyramid-shaped polygon or other shapes. Correspondingly, the puncture or puncture member can have the same shape. In all modalities, the receptacle on the cover can be filled with a preservative in the place where the cover is being manufactured or at least before the cover is delivered to the user. The receptacle can be filled with a preservative through the hole, which is subsequently sealed by the seal. From the modality in Figure 4, it can be seen how the puncture or puncture member 23 rests on the edge of the container 1 and, by fitting the cover 2 on the container 1, the puncture or puncture member 23 is lightly pressed up. This ensures that the puncture or puncture member 23 has the ability to advance only when the cover 2 is mounted on the container 1. The engaging means 231 and 212 do not yet have the ability to engage if the top member 23 is rotated. In this modality, the top member 21 must be pressed down as well. This assurance that the top member 21 must be pressed downward also to break the seal 22 can be left out. Instead of advancing the engagement of the engagement means on the top member 212 with the engagement means on the puncture or on the puncture member 231, by turning the top member 21, it may be possible to have a sudden release of the preservative, in that the seal 22 is broken by pressing the top member 21 down without turning the top member 21. In that case, the indentation 213 extends upwards and does not interrupt the projection 261 until after the seal 22 has been broken. Between the ring member 26 and the container 1 additional packaging (not shown) can be provided for additional sealing between the two. The broken line surrounds the volume 110 which does not change 5 during the breaking of the seal 22. The volume 110 is defined by the interior of the outer walls of the container assembly 100. This is the inner wall of the top member 21, of the ring member 23 and container 1. Where the parts overlap, it is the innermost parts that define the volume. In Figure 5, the top member 21 was pressed downward as can be seen in the engagement between the projection 261 and the indentation 213. The puncture or puncture member 23 is ready to engage the top member 21. By rotating the top member 180 to 360 degrees, the puncture or puncture member is forced through the seal and the seal is broken. The seal 22 is broken from below, which means that the puncture or puncture member 23 is outside the receptacle 211 before the seal 22 is broken. The top member can be rotated more or less to break seal 22 and reach its terminal position 20. Figure 6 shows the puncture or puncture member 23 in the terminal position. The top part of the puncture or the puncture member 23 above the flange 233 fits exactly into the receptacle 211. The top part of the puncture or the puncture member 25 can be smaller or larger than the receptacle 211. After the seal has been broken, it is positioned between the top member 21 and the puncture or puncture member 23, and the seal 22 is prevented from entering container 1. The puncture or puncture member 23 supports the seal 22 after the seal 22 has been broken. The seal 22 may also be of a type that, upon puncture, the seal removes the sides, leaving nothing but a ring of sealing material along the edge of the hole in receptacle 216. The space that is left when the member of puncture or puncture 23 has reached its terminal position is preferably less than 1/20 of the space in the receptacle of orifice 216 to the bottom 215 or the distance from the bottom of the receptacle 215 to the puncture or puncture member 23 is less than 1 mm. Figures 1 to 6 show different positions or states that the container assembly can have. In Figures 1 to 3, a container, a cover is provided, including a top member with a receptacle and the puncture or puncture member. In Figure 3 the receptacle is filled with a preservative and the receptacle is sealed. In Figure 4 a tissue sample (not shown) is placed in the possibly empty container and the cover is brought in to engage with the container. In Figure 5, the top member is pressed down and in Figure 6 the puncture or puncture member is displaced by engaging the puncture member or puncture member with engagement means on the top member. The seal is consequently broken or punctured and the preservative is allowed to enter the container. Figure 7 shows a container assembly in a second embodiment. The second modality works as described for the first modality and the attributes with the same reference number are the same. The difference here is that the container 10 extends to the puncture or puncture member 23. The puncture or puncture member 23 thus has the option of resting on the projection 262 in the container or on the edge of the container. So that it is either the projection 262 that presses the puncture or puncture member 23 upward, that is, the edge of the container. By causing the container to extend to the puncture or puncture member, the personal hole of the container assembly is best protected from spillage since the wall above the level of preservative in the container is higher. Figures 8 to 11 show a third embodiment of the invention. Referring to Figure 8, the assembly comprises a container 1 and a cover 2, the cover 2 which 5 comprises a protective cover 27 and a top member 21. The purpose of the protective cover 27 is to ensure that the membrane (see Figures 9 and 10) is not pressed unintentionally. The protective cover 27 can be articulated or removable. The top member 21 is provided with projections 29 10 for an easy grip and is removed from the container 1 when rotating. The diameter 0 of this modality is 33 mm, but it can be smaller or larger. The height H is 47 mm, but it can be smaller or larger. The receptacle 211 can be taller so that more preservative can be contained. The receptacle 211 and the container 1 should preferably have the capacity to contain about 20 ml preservative, respectively. In Figure 9 the assembly is in the first position and in Figure 10 in the second position. The cross-section in Figures 9 to 10 is made along line AA as shown in Figure 8, and Figure 11 is a cross-section along line BB shown also in Figure 8. Container 1 is adapted to receive a sample of fabric 45 and the cover comprises a top member 321. A separator 31 is provided between the seal 22 and the bottom 13 of the container. In this way, in assembled state with the cover attached to the container 1, the container 1 is separated into two spaces, a first 11 and a second 12 space. Although spaces 11, 12 are separated, this does not necessarily mean that the separator 31 and the container 1 are sealed tightly with fluid. The fluid can be prevented from bypassing the separator 31. The fluid can also bypass the separator 31 instead of traveling through the separator 31. The circumference of the container 1 is substantially the same size as the outer circumference of the separator 31, but the internal circumference of the container 1 may be slightly larger than the outer circumference of the separator 31. Referring to Figures 9 to 10, the top member 321 is provided with latching means 324, such as threads, for latching with container 1. Container 1 is also provided with latching means 325, here in the form of threads for engagement with corresponding threads on the top member 321. The engagement between the top member 321 and the container 1 can alternatively be achieved by means of a snap closure. Additionally, the top member 321 is provided with engagement means 326 for engagement with the puncture member 323. The engagement means 326 is in the form of four slits in a hollow cylindrical shape which is adapted to receive the puncture member 323. The cylindrical shape can be solid and / or the number of slots can be varied. Instead, the engagement means can be provided in the form of a locking latch. In addition, the top member 321 can be provided with engagement means 327 for engagement with the engagement means 328 provided on the inner side of the separator 31. Thereby, the separator 31 remains attached to the cover 2 when the cover 2 is removed from the container 1, for example, to take a tissue sample. The engagement means 327, 328 can be in the form of threads or a snap closure. On top of the top member 321, the membrane 28 is positioned. In Figure 9, it has a substantially convex shape and in Figure 10 it has a substantially concave shape. When the pressure is removed from the membrane 28, the membrane 28 will maintain its concave shape. This allows people to see from above whether the conservation agent has been released. Since container 1 is preferably transparent, it can also be seen by container 1 if the preservative has been released. The membrane 28 can be a spring membrane that automatically bursts to its first position. The puncture member 323 is activated by pressing the membrane 28. In this way, the puncture member 323 is moved along the longitudinal geometric axis of the assembly and the seal 22, which separates receptacle 211 from container 1, is broken or broken . In the embodiment shown, the puncture member 323 is provided with teeth 329 to pierce the seal 22. The puncture member 323 is made of a polymer material, but can be made of metal or other suitable materials. An additional drilling element 330 to break seal 22 is provided, but may be dispensable. The seal 22 can be a metal foil, a film or a polymeric membrane. The separator 31 is adapted to be hung from the cover 2. At the bottom 13 of the separator 31, a grid is provided. The separator 31 must be able to let the preservative through, while ensuring that seal 22 does not enter container 1 and ensuring that tissue sample 45 does not migrate to receptacle 211 during transport. Referring to Figure 11, the openings 291 in the grid in the separator 31 are square, each approximately 1 mm in cross-sectional size, but can be smaller or larger, circular or in the shape of a polygon. The grid is permeable to a liquid with a surface tension similar to that of water. Another type of permeable membrane can be used as well. The separator 31 can be provided with openings elsewhere, such as in the walls of the separator 31. The separator 31 is not a container for the tissue sample such as a cassette, but the container 1 in two deep spaces of the container 1 is adapted to receive tissue sample 45. The first space 11 can also be positioned on the cover 2. Referring to Figures 9 to 11, the separator 31 is additionally provided with a duct 30 with an orifice or 5 air inlet at the bottom of the separator 31 and an air orifice or outlet positioned at a distance from the air inlet. The air outlet is positioned so that when the seal 22 has been broken and the preservative has left the receptacle 211, the preservative cannot pass through the grid due to the small size of the openings and the surface tension of the agent, without, for example, shaking the assembly. The permeability of the grid can be increased by means of the duct 30 which allows air in the container 1 to bypass the preserving agent through the duct 30 and thereby allows the preserving agent to pass through the openings 291 in the grid. The orifice or air inlet is therefore positioned so that it is above the level of the preservative when the seal 22 has been broken. Two ducts 30 are provided in this modality, however one of 20 more than two ducts 30 and other duct formats can be provided. The separator 31 or at least the grid is blue or another contrasting color in relation to a tissue sample. This makes it easy to see a sample of fabric in the case where it grips the separator 31. The separator can be 25 different colors. The space 12 for the tissue sample 45 is positioned under the separator 31. The assembly can be fitted with a tracking device such as an RFID (radio frequency identification) label, so that the sample can be traced from collection to test in a laboratory 30. Sample 45 does not need to be covered by the preservative at all times, as the fumes in container 1 will generally be sufficient to store sample 45. Figures 12 and 13 show a fourth embodiment of the invention in the form of container assembly 400. Figure 13 shows a cross section of the assembly along line AA as shown in Figure 12. All the attributes and functions present in the third embodiment are also present in the fourth modality in which the same reference numbers indicate similar attributes. The difference between the third and the fourth modality is that the fourth modality is higher and has the capacity to contain about 20 ml of formalin or other preservative in both receptacle 211 and container 1. The duct (s) ) 30, in this modality, is not (are) longer (s) since it takes a while before the preservative passes through the separator 31 and, thus, the conduit (s) 30 will still be (will be) above the level of the preservative when seal 22 has been broken. The conduit (s) 30 can be longer, such as between 2 to 5 cm in length. Any size of container with the capacity to contain between 5 to 50 ml of preserving agent can be imagined. Figures 14 and 15 show a fifth embodiment of the invention in the form of container assembly 500. All attributes and functions present in the third and fourth embodiments are also present in the fifth embodiment in which the same reference numbers indicate similar attributes. In Figure 14, assembly 500 is in a first position and in Figure 15 the assembly is in a second position. In addition to similar attributes as those described in the third and / or fourth embodiments, the container assembly 500 additionally comprises a removable cover 528 provided with grip parts 548. The cover 528 protects the membrane 28 from pressure during transport. Figures 16 to 18 show a sixth embodiment of the invention in the form of container assembly 600. Container assembly 600 differs from others in the third embodiment in which the top member 621 is taller and has the capacity to contain more preservative agent . The puncture or puncture member 323 is also taller and has a T-shaped or cross-sectional shape 626 at the top. The projection 626 rests on a circumferential flange 627 provided on the top member 621. Thus, when the membrane 28 is pressed downwards, the projection is forced to pass the circumferential flange 627 on which it rested in its initial position. The circumferential flange 627 or the projection 626 can have resilient properties, which allow the projection 626 to pass the circumferential flange 627. The projection 626 can be tapered so that it can be pressed through the flange 627 more easily. The circumferential flange 627 can also be in the form of circumferential projections that are not connected across the entire circumference. The top member 621 can be connected to the container 1 so that the outside of the top member 621 engages with the inside of the container 1. It can be vice versa as well. The top member 621 and container 1 can be provided with threaded engagement means. Additionally, the separator 31 is provided with conduit (s) 31 in the form of segments. By extending the wall (s) of the conduit (s) through the separator 31 like a rope, the separator 31 becomes more rigid. The conduit (s) 30 does not extend above the upper edge of the separator 31, but may extend in other ways. The top member 621 extends above the highest point of the membrane 28 in a first position, thereby protecting the membrane 28 from pressure when no protective cover is provided. The highest point in this modality is the center of the membrane. The sixth modality can additionally comprise any of the attributes of the third, fourth and fifth modality. Figures 19 to 21 show a seventh embodiment of the invention. In addition to the attributes in the sixth embodiment, the container assembly 700 is additionally provided with a cover 728. The top member 721 does not extend beyond the highest point of the membrane 28 as it does in the sixth embodiment. The seventh modality can contain any of the attributes of the third, fourth, fifth and sixth modality. By "ruptured" is meant that a hole has been created in the film or seal where either the preservative can flow out or particles or contaminants outside can enter. The term "cover" as used in this document includes all the meanings that cover a hole in a container. The term "separator" is used for a member used to separate the seal from a potential tissue sample placed in the container. In some embodiments, the separator also functions as the puncture or puncture member, so that the separator and the puncture member form an element, although in other embodiments the puncture member and the separator are separate elements. The word "container" is generally used on the container or space that is adapted to contain the tissue sample. In addition, it is conceivable to make use of other container assembly configurations. The same can be of industrial size in which the container has the capacity to contain at least 1 liter or less than 5 liters, 10 liters, 100 liters, 1,000 liters or more. The container can contain a substance that must be mixed with a second substance of less than one volume. The cover or lid may have the capacity to contain the second substance, with a volume of less than 5 ml, 10 ml, 30 ml, 50 ml, 100 ml or more than 100 ml, which must be mixed with the substance in the container. The second substance can be a toxic or volatile substance in which it is important that the exact amount of substance is introduced into the container. This larger container assembly may have the same attributes as the first, second, third or fourth modality. Any attribute of these modalities can be applied independently of each other in this larger size container assembly. In general, the attributes of the modalities shown and described can be combined freely and no attributes should be seen as essential unless stated in the independent claims.
权利要求:
Claims (19) [0001] 1. CONTAINER ASSEMBLY (300) comprising - a container (1) configured to store a tissue sample (45); said container (1) comprising a bottom (13); - a cover (2) adapted to engage said container (1), said cover (2) comprising: a top member (21) comprising a receptacle (211), said receptacle (211) containing an agent conservation, - a seal (22) for sealing said receptacle (211); - a puncture member (323) configured to break said seal (22) by displacing said puncture member (323); wherein the container assembly (300) has a first and a second position, where, in the first position, the container (1) is isolated from the receptacle (211) and, in the second position, fluid communication is provided between the receptacle (211) and the container (1), and wherein the container assembly (300) is characterized by comprising a separator (31) positioned between the seal and the bottom (13) of the container (1), and the separator (31 ) is provided with at least one opening (291) adapted to provide a fluid passage between the receptacle (211) and the container (1). [0002] 2. CONTAINER ASSEMBLY (300), according to claim 1, characterized in that it additionally comprises a space (11) between the separator (31) and the seal (22), the separator (31) being provided with a conduit (30) adapted to provide a fluid passage between the space (11) and the container (1). [0003] 3. CONTAINER ASSEMBLY, according to claim 2, characterized in that the conduit (30) has an orifice positioned above the level of the preservative after the seal (22) has been broken. [0004] 4. CONTAINER ASSEMBLY (300) according to any one of claims 1 to 3, characterized in that the cover (2) constitutes a lid. [0005] 5. CONTAINER ASSEMBLY (300) according to any one of claims 1 to 4, characterized in that the cover (2) comprises a membrane (28) that has a substantially convex shape in the first position and a substantially concave shape in the second position. [0006] CONTAINER ASSEMBLY (300), according to any one of claims 1 to 5, characterized in that the cover (2) is adapted to be fluid and tightly sealed to the container (1). [0007] 7. CONTAINER ASSEMBLY (300), according to claim 5, characterized in that the cover (2) comprises a protective cover to cover the membrane (28). [0008] CONTAINER ASSEMBLY (300) according to any one of claims 1 to 7, characterized in that the container assembly (300) comprises a tracking device. [0009] CONTAINER ASSEMBLY according to any one of claims 2 to 8, characterized in that the puncture member (323) is provided with at least one opening, to provide a passage between the receptacle (211) and the space (11 ). [0010] 10. CONTAINER ASSEMBLY according to any one of claims 1 to 9, characterized in that the separator (31) comprises a bottom (311) and a coupling means (328) for coupling with the corresponding coupling means (327) of the cover (2), so that the bottom (311) of the separator (31) is prevented from coming into contact with the bottom (13) of the container (1). [0011] CONTAINER ASSEMBLY according to any one of claims 1 to 10, characterized in that an outer diameter of the separator (31) is substantially equal to an inner diameter of the container (1). [0012] CONTAINER ASSEMBLY, according to any one of claims 1 to 11, characterized in that the seal (22) is selected from the group consisting of a film, a foil, a membrane and a polymer. [0013] 13. CONTAINER ASSEMBLY according to any one of claims 1 to 12, characterized in that a part of the container assembly (300) comprises a transparent part for viewing the interior of the container (D. [0014] CONTAINER ASSEMBLY, according to any one of claims 1 to 13, characterized in that the assembly (300) is provided with an indicator to indicate whether the seal (22) has been broken. [0015] CONTAINER ASSEMBLY, according to any one of claims 1 to 14, characterized in that the separator (31) is a contrast color, such as blue, for a fabric color. [0016] 16. CONTAINER ASSEMBLY, according to any one of claims 1 to 15, characterized in that the puncture member (323) is provided with at least two projections to break the seal (22). [0017] 17. CONTAINER ASSEMBLY, according to any one of claims 1 to 16, characterized in that the puncture member (323) is provided with teeth. [0018] 18. CONTAINER ASSEMBLY, according to any one of claims 1 to 17, characterized in that the cover (2) is adapted to be locked in the container (1). [0019] 19. METHOD OF STORING A TISSUE SAMPLE (45), in a container assembly, as defined in any of claims 1 to 18, characterized by comprising the steps of: - providing the container (1), - providing the cover (2) which includes the top member (21) with the receptacle (211) filled with a preservation agent and sealed by the seal (22), the puncture member (323) and the separator (31), - place a tissue sample in said container (D, - engaging said cover (2) with the container (1), 10 thereby positioning said separator (31) between the seal (22) and the bottom (13) of the container ( 1), - move the puncture member (323) by means of which said seal (22) is broken and the preservative is allowed to enter the container (1) through the separator 15 (31)
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同族专利:
公开号 | 公开日 HRP20160862T8|2016-10-21| MX339841B|2016-06-13| AR086918A1|2014-01-29| RU2013156531A|2015-07-20| CN103635147B|2016-04-06| MX2013014716A|2014-08-18| ES2583057T5|2020-02-19| AU2011370782A1|2013-12-12| EP2720617B2|2019-06-12| CA2837607C|2018-07-24| US9726585B2|2017-08-08| EP3061401A2|2016-08-31| JP2014517315A|2014-07-17| ES2583057T3|2016-09-16| PL2720617T5|2020-02-28| RU2604125C2|2016-12-10| BR112013031779A2|2017-09-26| HUE029752T2|2017-05-29| NZ618155A|2015-07-31| ES2751303T3|2020-03-31| PT2720617T|2016-07-27| PE20141796A1|2014-12-12| WO2012171529A1|2012-12-20| HRP20160862T1|2016-09-23| SI2720617T1|2016-10-28| JP5936088B2|2016-06-15| HRP20160862T4|2019-10-18| EP3061401A3|2016-09-21| CA2837607A1|2012-12-20| DK2720617T4|2019-09-02| AU2011370782B2|2016-05-12| EP2720617A1|2014-04-23| EP3653132A1|2020-05-20| US20150037830A1|2015-02-05| RS54918B1|2016-10-31| US20170231604A1|2017-08-17| LT2720617T|2016-10-10| EP3061401B1|2019-08-21| WO2012171529A8|2014-02-20| CN103635147A|2014-03-12| US10376247B2|2019-08-13| DK2720617T3|2016-07-25| PL2720617T3|2016-11-30| CL2013003388A1|2014-06-27| BR112013031779A8|2019-01-02| EP2720617B1|2016-04-27| CO6930343A2|2014-04-28| DK3061401T3|2019-11-25| RS54918B2|2019-11-29|
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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law| 2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure| 2020-01-28| B25D| Requested change of name of applicant approved|Owner name: BIOPSAFE APS (DK) | 2020-02-11| B25G| Requested change of headquarter approved|Owner name: BIOPSAFE APS (DK) | 2020-05-19| B09A| Decision: intention to grant| 2020-11-03| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 11/11/2011, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
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申请号 | 申请日 | 专利标题 DKPA201170297|2011-06-14| DKPA201170297|2011-06-14| PCT/DK2011/050434|WO2012171529A1|2011-06-14|2011-11-11|Container assembly and associated method| 相关专利
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