[0001] The present invention relates to a closure according to the preamble of claim 1,
and to a device for processing biological samples comprising two containers connected
to each other by means of said closure.
[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] JP 4 543122 discloses a closure according to the preamble of claim 1, suitable for connecting
two containers and comprising means to establish a fluid communication between them.
[0015] 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.
[0016] Furthermore, the described device does not comprise partitions (septum) or separation
membranes, does not comprise breakage mechanisms of partitions or separation membranes.
[0017] 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.
[0018] 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.
[0019] With reference to the accompanying figures, a device according to the present invention
is indicated as a whole by reference numeral 100.
[0020] The device 100 comprises a first container 101 and a second container 102 upside
down over the top 101.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] The container 105 may be closed by means of an appropriate threading system 106,
but other equivalent systems are also possible.
[0025] The male element 103 comprises a truncated-cone-shaped portion 107 open towards the
bottom, a side wall 108 and an upper base 109.
[0026] The side wall 108 protrudes beyond the upper base 109 and originates an inwardly
jutting edge 110, which defines a ring seat 111.
[0027] According to a preferred aspect, said edge 110 comprises a rounded inner profile
112.
[0028] In the upper base 109 there are present at least two through holes 113.
[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.
[0033] Two or more through holes 124 are obtained in the upper base 117.
[0034] According to an aspect of the invention, the number of through holes present in the
two elements 103, 104 is the same.
[0035] The two elements 103,104 are coupled by fitting to obtain the closure 105 of the
invention.
[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 ring seat 120.
[0037] Advantageously, the fitting is promoted by the rounded profile 112.
[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 is 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 the present invention, the described closure 105 further comprises elements
220 to seal the holes 113 of the male element 103.
[0045] According to 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.
[0049] Such deformable material is, for example, represented by an elastic polymer.
[0050] In an embodiment, such balls are made of silicon material.
[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.
[0055] The second container 102 is thus closed.
[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.
[0057] In this manner, the fixing liquid can flow towards the sample by inclining the device.
[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.
[0060] The sample 127 may thus be extracted and subjected to the further processing steps.
[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.
[0078] For example, plastic materials which are approved and authorized for the specific
use may be used. Colors and shapes may vary according to particular needs or preferences
without departing from the main function described above.
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
male element (103) further comprising 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), said female element (104) comprising means for closing
said second container (102) and means for coupling with the male element (103), said
female element (104) further comprising 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),
whereby the male element (103) can be pressed so as to fit the jutting edge (110)
inside the ring seat (120), thereby forming the coupling means, said male element
(103) and female element (104) each comprising means for establishing a fluid communication
between said first container (101) and said second container (102) represented by
through holes (113,124), 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),
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, and wherein said closure
further comprises elements (220) for closing and sealing the through holes of the
male element (113), said elements (220) being housed in corresponding seats (221)
of the female element (104).
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 do not comprise elements for breaking partitions and/or membranes.
4. A closure (105) according to the claim 1, wherein said inwardly jutting edge (110)
comprises a rounded inner profile (112).
5. A closure (105) according to the preceding claim, comprising indicator elements (125)
of the open or closed configuration of the closure.
6. 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.
7. A closure (105) according to the claim 1, wherein said elements (220) are made of
deformable material.
8. A device (100) for processing biological samples (127) 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 7.
1. Verschluss (105) für einen ersten (101) und einen zweiten (102) Behälter, der ein
männliches Element (103) und ein weibliches Element (104) aufweist, wobei das männliche
Element (103) Mittel zum Verschließen des ersten Behälters (101) und Mittel zur Kupplung
mit dem weiblichen Element (104) aufweist, wobei das männliche Element (103) ferner
einen am Boden offenen kegelstumpfförmigen Abschnitt (107), eine Seitenwand (108)
und eine obere Basis (109) aufweist, wobei die Seitenwand (108) über die obere Basis
(109) hinaus vorsteht, von der ein einwärts vorstehender Rand (110) ausgeht, der einen
Ringsitz (111) definiert, wobei das weibliche Element (104) Mittel zum Verschließen
des zweiten Behälters (102) und Mittel zur Kupplung mit dem männlichen Element (103)
aufweist, wobei das weibliche Element (104) ferner einen am Boden offenen kegelstumpfförmigen
Abschnitt (115), eine Seitenwand (116) und eine obere Basis (117) aufweist, von denen
gegenseitig ein Rand (118) ausgeht, wobei die Seitenwand (116) eine "C"-förmige Vertiefung
(119) aufweist, die einen Ringsitz (120) erzeugt, der eine Stufe (121), eine Seitenwand
(122) und eine obere Wand (123) aufweist, wodurch das männliche Element (103) gepresst
werden kann, damit der vorstehende Rand (110) innerhalb des Ringsitzes (120) sitzt,
um hierdurch die Kupplungsmittel zu bilden,
wobei das männliche Element (103) und das weibliche Element (104) jeweils Mittel zum
Herstellen einer Fluidverbindung zwischen dem ersten Behälter (101) und dem zweiten
Behälter (102) aufweisen, die durch Durchgangslöcher (113, 124) dargestellt sind,
wobei der Verschluss (105) eine Längsachse (X) aufweist und dadurch gekennzeichnet ist, dass das männliche Element (103) und das weibliche Element (104) miteinander gekoppelt
sind und relativ zueinander um die Längsachse (X) herum gedreht werden können,
wobei die Mittel zur Fluidverbindung zwei oder mehr Durchgangslöcher (113) in der
oberen Basis des männlichen Elements (109) und zwei oder mehr Durchgangslöcher (124)
in der Basis des weiblichen Elements (117) aufweisen, wobei die Löcher des weiblichen
Elements (124) ausgelegt sind, um in jeweils einer offenen oder einer geschlossenen
Konfiguration des Verschlusses zu den Löchern des männlichen Elements (113) zu passen
oder nicht zu passen, und wobei der Verschluss ferner Elemente (220) aufweist, um
die Durchgangslöcher des männlichen Elements (113) zu verschließen und abzudichten,
wobei die Elemente (220) in entsprechenden Sitzen (221) des weiblichen Elements (104)
aufgenommen sind.
2. Verschluss (105) nach dem vorhergehenden Anspruch, wobei die Mittel zum Verschließen
des ersten Behälters (101) und/oder des zweiten Behälters (102) ein Gewinde (106,
114) aufweisen.
3. Verschluss (105) nach einem der vorhergehenden Ansprüche, wobei die Mittel zur Fluidverbindung
keine Elemente zum Durchbrechen von Unterteilungen und/oder Membranen aufweisen.
4. Verschluss (105) nach Anspruch 1, wobei der einwärts vorstehende Rand (110) ein abgerundetes
Innenprofil (112) aufweist.
5. Verschluss (105) nach dem vorhergehenden Anspruch, der Indikatorelemente (125) der
offenen oder geschlossenen Konfiguration des Verschlusses aufweist.
6. Verschluss (105) nach einem der vorhergehenden Ansprüche, wobei die Kupplungsmittel
zwischen dem männlichen Element und dem weiblichen Element einen Verbindungsstift
(126) gegebenenfalls mit einer O-Ringdichtung aufweisen.
7. Verschluss (105) nach Anspruch 1, wobei die Elemente (220) aus verformbarem Material
hergestellt sind.
8. Vorrichtung (100) zur Bearbeitung von biologischen Proben (127), die zwei Behälter
(101, 102) aufweist, die mittels des Verschlusses (105) nach einem der vorhergehenden
Ansprüche 1 bis 7 miteinander verbunden sind.
1. Fermeture (105) pour un premier (101) et un second (102) contenant comprenant un élément
mâle (103) et un élément femelle (104), ledit élément mâle (103) comprenant des moyens
pour fermer ledit premier contenant (101) et des moyens de couplage avec l'élément
femelle (104), ledit élément mâle (103) comprenant en outre une portion de forme tronconique
(107) ouverte au niveau du fond, une paroi latérale (108) et une base supérieure (109),
dans laquelle ladite paroi latérale (108) fait saillie au-delà de la base supérieure
(109) donnant lieu à un bord proéminent vers l'intérieur (110) qui définit un siège
annulaire (111), ledit élément femelle (104) comprenant des moyens pour fermer ledit
second contenant (102) et des moyens de couplage avec l'élément mâle (103), ledit
élément femelle (104) comprenant en outre une portion de forme tronconique (115) ouverte
au niveau du fond, une paroi latérale (116) et une base supérieure (117), qui donnent
lieu mutuellement à un bord (118), dans laquelle ladite paroi latérale (116) a un
évidement en forme de « C » (119), qui crée un siège annulaire (120) ayant un décrochement
(121), une paroi latérale (122) et une paroi supérieure (123), moyennant quoi l'élément
mâle (103) peut être appuyé de sorte à faire rentrer le bord proéminent (110) à l'intérieur
du siège annulaire (120), pour ainsi former les moyens de couplage,
lesdits élément mâle (103) et élément femelle (104) comprenant chacun des moyens pour
établir une communication fluidique entre ledit premier contenant (101) et ledit second
contenant (102) représentés par des trous traversants (113, 124), ladite fermeture
(105) ayant un axe longitudinal (X) et étant caractérisée en ce que ledit élément mâle (103) et ledit élément femelle (104) sont couplés l'un à l'autre
et peuvent tourner l'un par rapport à l'autre autour dudit axe longitudinal (X),
dans laquelle lesdits moyens de communication fluidique comprennent deux trous traversants
(113) ou plus dans la base supérieure de l'élément mâle (109) et deux trous traversants
(124) ou plus dans la base de l'élément femelle (117), lesdits trous de l'élément
femelle (124) étant capables de concorder ou de ne pas concorder avec lesdits trous
dans l'élément mâle (113) dans une configuration ouverte ou fermée de ladite fermeture,
respectivement, et dans laquelle ladite fermeture comprend en outre des éléments (220)
pour fermer et étanchéifier les trous traversants de l'élément mâle (113), lesdits
éléments (220) étant logés dans des sièges (221) correspondants de l'élément femelle
(104).
2. Fermeture (105) selon la revendication précédente, dans laquelle les moyens pour fermer
ledit premier contenant (101) et/ou ledit second contenant (102) comprennent un filetage
(106, 114).
3. Fermeture (105) selon l'une quelconque des revendications précédentes, dans laquelle
lesdits moyens de communication fluidique ne comprennent pas d'éléments pour rompre
des cloisons et/ou des membranes.
4. Fermeture (105) selon la revendication 1, dans laquelle ledit bord proéminent vers
l'intérieur (110) comprend un profil interne arrondi (112).
5. Fermeture (105) selon la revendication précédente, comprenant des éléments indicateurs
(125) de la configuration ouverte ou fermée de la fermeture.
6. Fermeture (105) selon l'une quelconque des revendications précédentes, dans laquelle
lesdits moyens de couplage entre l'élément mâle et l'élément femelle comprennent une
goupille de raccordement (126) éventuellement avec un joint torique d'étanchéité.
7. Fermeture (105) selon la revendication 1, dans laquelle lesdits éléments (220) sont
formés d'un matériau déformable.
8. Dispositif (100) pour traiter des échantillons biologiques (127) comprenant deux contenants
(101, 102) raccordés l'un à l'autre au moyen de la fermeture (105) selon l'une quelconque
des revendications 1 à 7 précédentes.