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(11) | EP 3 162 727 A2 |
| (12) | EUROPEAN PATENT APPLICATION |
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| (54) | CLOSURE DEVICE FOR COUPLING CONTAINERS |
| (57) A closure for a first (101) and a second (102) container comprises a male element
(103) and a female element (104). Said male element (103) comprises means for closing
said first container (101) and means for coupling with the female element (104). The
female element (104) comprises means for closing said second container (102) and means
for coupling with the male element (103). The male and female element each comprise
means for establishing a fluid communication between the first and the second container.
The closure (105) has a longitudinal axis (X), and the male element (103) and the
female element (104), when coupled to each other, can be rotated with respect to each
other about said longitudinal axis (X). The closure can be used for devices for processing
biological samples comprised in the containers.
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[0002] In the field of pathological analysis, protocols provide that a sample collected from a patient or a biopsy is treated as soon as possible with appropriate substances, called fixatives, before being sent to the laboratory responsible for testing to be subjected to the further processing steps.
[0003] For this purpose, standard procedures are provided for handling the samples, needed to avoid alterations or contamination of the sample itself, on one hand, and indispensable for protecting the operator from continuous exposure to toxic substances, on the other.
[0004] Among such substances, for example, formaldehyde, is a fixative liquid which is very widely and commonly used in everyday laboratory practice, for which the toxic effects are known.
[0005] Precisely for this reason, standards (such as the recent European Regulation 605/2014) oblige the adoption of laboratory instrumentation which excludes any exposure of the operator to toxic substances.
[0006] Devices for processing biological samples which allow to limit the contact with harmful elements for health are known in commerce.
[0007] For example, some of them provide that the sample is placed within a container closed with a cap; the fixative liquid instead is contained and preserved in a specific housing in the cap of the container, and such a housing is closed by a separation membrane.
[0008] The breakage of the membrane, obtained by actuation of a perforation system, thus allows the flow of fixative liquid towards the sample.
[0009] While minimizing exposure to the toxic substance, such a container is not free from drawbacks.
[0010] Firstly, such a container consists of two elements, container and cap, which must necessarily be used in association, because they are designed to cooperate functionally with each other.
[0011] Other limits are that the mechanical portion comprising the actuator is in fact an element subject to breakage or faults which can either prevent or limit its use.
[0012] Furthermore, the breakage mechanism of the membrane is cumbersome in itself and reduces the volume available for the fixative liquid.
[0013] Finally, a similar container is less intuitive to use and is considerably costly, precisely because of its greater construction complexity.
[0014] The technical problem underlying the present invention is thus to make a device available to anatomic pathology laboratory operators for processing, in particular for the fixation of, a biological sample which is simple and intuitive to use, practical, not very cumbersome and low-cost.
[0015] Furthermore, the described device does not comprise partitions (septum) or separation membranes, does not comprise breakage mechanisms of partitions or separation membranes.
[0016] Such a problem is solved by a device for processing biological samples comprising the closure defined in the appended main claim and, for its particular aspects, in the dependent claims, the definitions of which form an integral part of the present invention.
[0017] Further features and advantages of the closure and of the device for processing biological samples of the present invention will be apparent from the following description of a preferred example of embodiment, given by way of a non-limiting example, with reference to the accompanying figures, in which:
figure 1 shows a device provided with the closure of the invention;
figure 2 shows a cross section of the fitting between the two elements of the closure;
figures 3 and 4 show the perspective view of the female element and the male element;
figure 5 shows the closure of the invention according to an embodiment of the invention in the open configuration, A: perspective view, B: cross section, C: section taken along line B-B, D: section taken along line A-A;
figure 6 shows the closure of the invention according to an embodiment of the invention in the closed configuration, A: perspective view, B: cross section, C: section taken along line B-B, D: section taken along line A-A;
figure 7 is a cutaway view of the closure according to an alternative embodiment of the invention.
[0018] With reference to the accompanying figures, a device according to the present invention is indicated as a whole by reference numeral 100.
[0019] The device 100 comprises a first container 101 and a second container 102 upside down over the top 101.
[0020] Each of the two containers 101,102 is closed by a cap element 103,104; the two cap elements 103,104 jointly form the closure 105 of the present invention.
[0021] In particular, the closure 105 comprises a male (cap) element 103 and a female (cap) element 104, connected to each other so as to allow the reciprocal rotation of one with respect to the other about the longitudinal axis X, as shown by the arrows in figure 1 and as detailed in the description below.
[0022] As mentioned above, the male element 103 is substantially shaped as a bottle cap and comprises a portion for closing the first container 101, means for the passage of a fluid from the container 101 to the other container 102, and vice versa, and a coupling portion with the female element 104.
[0023] The container 105 may be closed by means of an appropriate threading system 106, but other equivalent systems are also possible.
[0024] The male element 103 comprises a truncated-cone-shaped portion 107 open towards the bottom, a side wall 108 and an upper base 109.
[0025] The side wall 108 protrudes beyond the upper base 109 and originates an inwardly jutting edge 110, which defines a ring seat 111.
[0029] The female element 104 is also substantially shaped as a bottle cap and comprises a portion for closing the second container 102, means for the passage of a fluid to the other container 101 and vice versa, and a coupling portion with the male element 103.
[0030] According to an aspect of the invention, the second container 102 may be closed by means of an appropriate threading system 114 or with equivalent systems.
[0031] The female element 104 comprises a truncated-cone-shaped central portion 115 open at the bottom, a side wall 116 and an upper base 117, which mutually originate a circumferential edge 118.
[0032] The side wall 116 is not continuous and near the upper base 117 has a "C"-shaped recess 119, which forms a ring seat 120 having a step 121, a side wall 122 and an upper wall 123.
[0034] According to an aspect of the invention, the number of through holes present in the two elements 103, 104 is the same.
[0036] Indeed, the male element 103 is upside down and rests on the other element 104 so that the two truncated-cone-shaped elements 107,115 match, and then pressed so as to fit the jutting edge 110 inside the housing 120.
[0038] According to the present invention, the fitting allows the rotation of one element 103 with respect to the other 104 about the axis X.
[0039] In particular, such a rotation allows two configurations: either open (OPEN=O), in which the holes of the male element and of the female element respectively match allowing the passage of fluid from one container 101 to the other 102, or closed (CLOSED=C), in which the holes 113,124 are completely misaligned.
[0040] Identifying the configuration of the device 100 of the present invention may be advantageously facilitated by affixing appropriate indicator means 125 clearly visible on the closure 105, as shown in figure 1, for example.
[0041] The passage from one configuration to the other may be obtained by rotating one container 101 with respect to the other 102 about the axis X.
[0042] According to a second embodiment, the coupling between the two elements 103,104 of the closure 105 may be obtained either alternatively or additionally to the fitting system described above, also by means of an appropriate connection pin 126 with a sealing O-ring (not shown in figure).
[0043] In this regard, for example, a pin central to the two bases 109,117 may be provided with a sealing O-ring.
[0044] According to an alternative embodiment of the present invention, the described closure 105 further comprises elements 220 to seal the holes 113 of the male element 103.
[0045] According to a preferred aspect of the invention, such elements 220 are comprised in the female element 104.
[0046] More in detail, as shown in figure 7, the base of the female element 117 comprises seats 221 for housing said elements 220.
[0047] According to a preferred aspect, said elements 220 are made of elastic and deformable material.
[0048] Even more preferably, said elements 220 are represented by elastic and deformable material balls.
[0051] According to a preferred aspect of the invention, the number of the elements 220 for sealing the holes 113 corresponds to the number of holes.
[0052] As shown in figure 7, two balls of silicon material may be provided, each of which intended to close one of the two holes 113.
[0053] The use of the device 100 of the present invention provides that one of the two containers 101,102 is already pre-filled by the manufacturer with fixative liquid, e.g. formaldehyde, and then immediately closed by means of the closure 105 of the present invention already arranged in the closed (CLOSED=C) configuration.
[0054] Subsequently, the container 101 with the closure 105 is turned over by the operator onto the container 102, in which the sample to be processed 127 is placed.
[0056] At this point, the operator rotates the elements 103,104 of the closure 105 in opposite direction about the axis X until the holes 113,124 match in the open configuration towards the opening configuration.
[0058] Afterwards, the closure 105 is placed in the closed configuration to prevent the fixative liquid and the sample (if small in size) from coming accidentally again in the container 101.
[0059] After a sufficient time, the device 100 may be turned upside down so that after having reopened the closing system 105, the fixative liquid is collected completely in the first container 101; finally, the closure 105 is placed in closed configuration again.
[0061] The method described above is made even simpler by affixing wordings such as "OPEN" or O" to indicate the open configuration and "CLOSED" or "C" to indicate the closed configuration.
[0062] In the embodiment of the closure according to the invention comprising further elements 220 for sealing the holes 113, such elements 220 are in the position which matches the position of said holes 113 in the "CLOSED" configuration.
[0063] Thanks to the use of the device and the closure of the present invention biological samples may be processed in different manners.
[0064] For example, loose fresh samples inserted in the container can be processed, or samples can be processed in appropriate "cassettes" for inclusion or biopsies or samples attached to appropriate supports can be processed.
[0065] According to an aspect of the invention, the biological samples may be biopsies taken by means of appropriate instruments and samples attached to appropriate support elements such as, for example, the Endokit device (a patent of Bio-Optica Milano S.p.A.).
[0066] Figure 7 shows details of a preferred constructive example of the closure of the invention comprising two balls 220 made of silicon material which close and seal the holes of the male element 113.
[0067] In particular, the balls 220 are housed in seats 221 which are part of the base 117 of the female element and which are arranged in position corresponding to the holes of the male element 113.
[0068] From the description provided above, a person skilled in the art can appreciate how the closure and the device for processing biological samples solve the main problems related to the containers of the prior art, which were highlighted in the initial part of the present description.
[0069] Indeed, the closure and the described device are simple and intuitive to use, practical and easy to handle.
[0070] Furthermore, the simplicity of construction of the closure, which does not require the use of separation partitions or membranes or of mechanisms for breaking partitions or separation membranes, make it cost-effective and rarely subject to breakage or manufacturing faults such to compromise its use.
[0071] Furthermore, the described closure can be adapted to different types of containers, provided they are compatible.
[0072] A person skilled in the art may particularly appreciate how the device eliminates the problem of exposing the operator to toxic or potentially toxic substances and simplifies the processing operations, and more in general, the preparation operations of the samples to be analyzed.
[0073] The device according to the invention further assures that the fixative liquid may be easily and completely retrieved at the end of the operations for safe disposal (special waste).
[0074] More specifically, the closure of the invention may be adapted to any container with no particular limits.
[0075] The possibility of making the closure of the invention also with deformable material elements for sealing the holes, in particular the holes of the male element, allows to completely seal such holes, assuring that there is no leak or passage, however minimal, of fluid or vapors from one container 101 to the other 102.
[0076] The present invention may also be made in the form in which the housing seats of the elements for sealing the holes are comprised in the male element and, consequently, close and seal and the holes of the female element.
[0077] A person skilled in art may make many adaptations, changes and replacements to the embodiments of the device described above or may replace elements with others which are functionally equivalent, in order to satisfy contingent needs without however departing from the scope of protection of the appended claims.
1. A closure (105) for a first (101) and a second (102) container comprising a male element
(103) and a female element (104), said male element (103) comprising means for closing
said first container (101) and means for coupling with the female element (104), said
female element (104) comprising means for closing said second container (102) and
means for coupling with the male element (103), said male element (103) and female
element (104) each comprising means for establishing the fluid communication between
said first container (101) and said second container (102), said closure (105) having
a longitudinal axis (X) and being characterized in that said male element (103) and said female element (104) are coupled to each other and
can be rotated with respect to each other about said longitudinal axis (X).
2. A closure (105) according to the preceding claim, wherein the means for closing said
first container (101) and/or said second container (102) comprise a threading (106,114).
3. A closure (105) according to any one of the preceding claims, wherein said means for
fluid communication are through holes (113,124).
4. A closure (105) according to any one of the preceding claims, wherein said means for
fluid communication do not comprise elements for breaking partitions and/or membranes.
5. A closure (105) according to any one of the preceding claims, wherein said male element
(103) comprises a truncated-cone-shaped portion (107) open at the bottom, a side wall
(108) and an upper base (109), wherein said side wall (108) protrudes beyond the upper
base (109) originating an inwardly jutting edge (110) which defines a ring seat (111).
6. A closure (105) according to the preceding claim, wherein said inwardly jutting edge
(110) comprises a rounded inner profile (112).
7. A closure (105) according to any one of the preceding claims, wherein said female
element (104) comprises a truncated-cone-shaped portion (115) open at the bottom,
a side wall (116) and an upper base (117), which mutually originate an edge (118),
wherein said side wall (116) has a "C"-shaped recess (119), which creates a ring seat
(120) having a step (121), a side wall (122) and an upper wall (123).
8. A closure (105) according to any one of the preceding claims, wherein said means for
fluid communication comprise two or more through holes (113) in the upper base of
the male element (109) and two or more through holes (124) in the base of the female
element (117), said holes of the female element (124) being able to either match or
not match said holes in the male element (113) in an either open or closed configuration
of said closure, respectively.
9. A closure (105) according to the preceding claim, comprising indicator elements (125)
of the open or closed configuration of the closure.
10. A closure (105) according to any one of the preceding claims, wherein said coupling
means between the male element and the female element comprise a connecting pin (126)
possibly with a sealing O-ring.
11. A closure (105) according to any one of the preceding claims, further comprising elements
(220) for closing and sealing the holes of the male element (113), said elements (220)
being housed in corresponding seats (221) of the female element (104).
12. A closure (105) according to the preceding claim, wherein said elements (220) are
made of deformable material.
13. A device (100) for processing biological samples (127) comprising the closure (105)
according to each of the preceding claims.
14. A device (100) according to the preceding claim, wherein said biological samples (127)
are either free or inside suitable cassettes or attached to suitable supports.
15. A device according to claim 13 or 14, comprising two containers (101,102) connected
to each other by means of the closure (105) according to any one of the preceding
claims from 1 to 12.