CONTAINER FOR SELECTIVE TRANSFER OF SAMPLES OF BIOLOGICAL MATERIAL
20220176379 · 2022-06-09
Inventors
Cpc classification
Y10T436/25
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
B01L3/5021
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0609
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/046
PERFORMING OPERATIONS; TRANSPORTING
B01L2400/0688
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A container for selective transport of samples of biological material or of biological origin suitable for containing at least a fluid or liquid and/or for containing at least a portion of a collecting device, the container having a selective passage portion configured to prevent exit of a fluid or liquid from the container, through the passage portion, at least in at least an operating sealed condition defined at least by a rest state of the container or by a first value of mechanical shaking of the container and/or by a first value of relative centrifugal force to which the container is subjected, and configured selectively to enable exit of the fluid or liquid from the container, across the passage portion, at least in an operating passage condition, defined at least by a corresponding second state of mechanical shaking of the container and/or wherein the container is subjected to a corresponding second relative centrifugal force.
Claims
1. A container for selective transport of samples of biological material or of biological origin comprising a body having at least a compartment suitable for containing at least a fluid or liquid and/or for containing at least a portion of a collecting device for biological samples, the body comprising at least an access opening to the compartment and at least a containing wall integral to the body and provided with at least a selective passage portion integral to the body, wherein the selective passage portion is configured such as to prevent exit of a fluid or liquid from the container, through the passage portion at least in an operating sealed condition in which the container is in a rest state or is subjected to a first value of mechanical shaking and/or is subjected to a first value of relative centrifugal force for a first predetermined time interval, and wherein the selective passage portion is further configured such as selectively to enable exit of the fluid or liquid from the container, across the passage portion, at least in an operating passage condition, in which the container is subjected to a corresponding second state of mechanical shaking and/or is subjected to a corresponding second relative centrifugal force, for a second predetermined time interval.
2. The container of claim 1, wherein the selective passage portion is configured such as to prevent exit of the fluid or liquid from the container at a plurality of the sealed operating conditions, applied for a first predetermined time interval of shaking and in which the container is subjected to a plurality of respective first values of mechanical shaking which plurality of values is lower than a predetermined state of mechanical shaking of the container and/or in which the container is subjected to a plurality of respective first values of relative centrifugal force which first values are lower than a relative predetermined value of centrifugal force and/or wherein the portion of selective passage is configured such as to selectively enable outlet of the fluid or liquid from the container through the passage portion, at a plurality of the operating passage conditions, applied for a second predetermined time interval of shaking and in which the container is subjected to a plurality of second respective values of mechanical shaking that are greater than the predetermined state of mechanical shaking and/or in which the container is subjected to a plurality of respective second relative values of centrifugal force greater than the relative predetermined value of centrifugal force.
3. The container of claim 1, wherein the selective passage portion is configured such as to prevent exit of the fluid or liquid from the container through the selective passage portion at least in a sealed operating condition in which the container is subjected to a relative centrifugal acceleration or relative centrifugal force (RCF) that is lower than 500×g, or lower than 1000×g, or lower than 2000×g, or lower than 3000×g, or lower than 4000×g, or lower than 5000×g, for a first predetermined time interval of shaking and/or in which the selective passage portion is configured such as to selectively enable exit of the fluid or liquid from the container through the selective passage portion in an operative passage condition in which the container is subjected to a relative centrifugal acceleration or relative centrifugal force (RCF) of at least 500×g, or at least 1000×g, or at least 2500×g, or at least 5000×g, or at least 7500×g, or at least 10000×g for a second predetermined time interval of shaking.
4. The container of claim 1, wherein the selective passage portion is provided with at least a passage opening or a plurality of passage openings, each opening being so dimensioned as to prevent passage of the liquid or fluid in the operative sealed condition and in order to enable passage of the liquid or fluid in the operating passage condition and/or each opening having at least a transversal opening dimension of less than about 0.2 mm, or than about 0.1 mm, or than about 0.05 mm, or than about 0.02 mm or than about 0.01 mm, or wherein each passage opening exhibits both transversal dimensions with opening of less than about 0.2 mm, or than about 0.1 mm, or than about 0.05 mm, or than about 0.02 mm or than about 0.01 mm, or wherein each passage opening is a hole with a diameter of less than about 0.2 mm, or than about 0.1 mm, or than about 0.05 mm, or than about 0.02 mm or than about 0.01 mm.
5. The container of claim 1, wherein the selective passage portion is provided with at least a weakened portion or a plurality of weakened portions, each weakened portion being closed or substantially closed at least in one of the sealed operating conditions and/or before the container is brought into one of the operating passage conditions for the second predetermined time interval, and being suitable for opening in at least one of the operating passage conditions by realising a passage opening suitable for enabling passage of the liquid or fluid through the selective passage portion and/or being destined to open in at least one of the operating passage conditions, realising a passage opening having a diameter or at least a transversal opening dimension, or both the transversal opening dimensions, of less than about 1 mm, or about 0.5 mm, or about 0.1 mm, or about 0.05 mm, or about 0.02 mm or about 0.01 mm and/or wherein the weakened portions are realised by discontinuities in the thickness of the body or by predetermined reductions of thickness realised on the body in the selective passage portion, and/or wherein the body exhibits, at the weakened portions, a thickness of less than about 0.5 mm and/or 0.2 mm and/or 0.1 mm, and/or 0.05 mm and/or 0.02 mm and/or 0.01 mm.
6. The container of claim 1, wherein the selective passage portion is provided with at least an elastically deformable portion or a plurality of elastically deformable portions, each elastically deformable portion being substantially closed at least in one of the sealed operating conditions and/or before the container is brought into one of the operating passage conditions for the predetermined time, and being destined to open by elastic deformation in one of the operating passage conditions by realising at least a passage opening, and/or wherein it is destined to open by elastic deformation at least in one of the operating passage conditions by realising at least a passage opening exhibiting a diameter or at least a transversal opening dimension, or both transversal opening dimensions, of less than about 2 mm, or about 1 mm, or about 0.5 mm, or about 0.1 mm, or about 0.05 mm, or about 0.02 mm or about 0.01 mm.
7. The container of claim 1, wherein the selective passage portion comprises a number of passage openings or of weakened portions ranging from 1 a 30.
8. A kit for selective transfer of samples of biological material or material of biological origin, comprising a laboratory test-tube selectively closable by a lid and further comprising a container according to claim 1 and selectively insertable and closable in the test-tube by the lid, wherein the body of the container further comprises a rest portion profiled such as to cooperate with a corresponding support portion of the test tube such as to maintain the container in the test tube in a predetermined position, raised and distanced from the bottom of the test tube and/or wherein the container is configured such as to be removably insertable in a laboratory test tube and selectively closable in the test tube such as to enable transfer into the test tube of a fluid or liquid contained in the container by mechanical shaking of the test tube in one of the operative passage conditions for the second predetermined time interval.
9. A method for using a container constructed according to claim 1 for selective transfer of samples or biological material or materials of biological origin to a test tube in which the container is inserted, the method comprising: mechanically shaking the test tube greater than a predetermined mechanical shaking and/or applying a relative centrifugal force that is greater than a predetermined relative centrifugal force on the test tube.
10. A process for selective transfer of samples of biological material or material of biological origin comprising steps of: inserting a container (1) according to claim 1 in a laboratory test tube (10); closing the container (1) in the test tube (10); and mechanically shaking the test tube (10) containing the container (1) to a level that is greater than a predetermined mechanical shaking, or subjecting the test tube (10) to a relative centrifugal force that is greater than a predetermined relative centrifugal force, for the second predetermined time interval, such as to cause passage of at least a part of the fluid or liquid from the container (1) to the test tube (10) through the selective passage portion (6).
11. The container of claim 5, wherein the number of weakened portions ranges from 1 to 30.
Description
[0023] There now follows, by way of non-limiting example, a detailed description of some preferred embodiments of a container according to the invention, in which:
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031] The figures illustrate, by way of non-limiting example, an embodiment of the invention configured for transferring samples of biological material or material of biological origin, but the invention can also be applicable for different uses to the illustrated ones. In the present description, by biological material or material of biological origin, various materials are intended, both biological and of biological origin, among which also samples of tissues from living beings, for example cells comprising DNA.
[0032] With reference to the accompanying figures, 1 denotes in its entirety a container for selective transfer of samples of biological material or material of biological origin comprising a body 2 having at least a compartment 3 suitable for containing at least a fluid or liquid and/or for containing at least a portion 16a of a collecting device 16 for biological samples. The container 1 can be for example a basket for selective transfer of samples of biological material or material of biological origin. The body 2 comprises at least an access opening 4 to the chamber 3 and at least a containing wall 5 provided with at least a selective passage portion 6.
[0033] As can be seen in
[0034] The selective passage portion 6 is configured such as to prevent exit of the fluid or liquid from the container 1, through the passage portion 6, at least in at least a sealed operative condition characterised at least by a state of repose of the container 1 or by a first value of mechanical shaking of the container 1 and/or by a first value of relative centrifugal force to which the container 1 is subjected. The selective passage portion 6 can be configured such as to prevent exit of the fluid or liquid from the container 1 at a plurality of these sealed operative conditions, characterised at least by a plurality of respective first mechanical shaking values of the container 1 that are less than a predetermined stage of mechanical shaking of the container 1, and/or characterised at least by a plurality of respective first values of centrifugal force that are less than a predetermined relative centrifugal force, the sealed operating conditions being applied for a predetermined first time interval. For example, the selective passage portion 6 can be configured such as to prevent exit of the fluid or liquid from the container 1 through the selective passage portion 6 at least in a sealed operative configuration in which the container 1 is subjected to a relative centrifugal acceleration or a relative centrifugal force (RCF) that is less than 500×g, less than 1000×g, or less than 2000×g, or less than 3000×g, or less than 4000×g, or less than 5000×g, for a predetermined first shaking time interval.
[0035] The above-indicated relative centrifugal forces can correspond for example for some common laboratory centrifuges, to an angular velocity of less than 500 rpm (revolutions per minute), or less than 1000 rpm, or less than 2500 rpm, or less than 4000 rpm or less than 5000 rpm. The selective passage portion 6 is further configured such as selectively to enable exit of the fluid or liquid from the container 1, through the passage portion 6, at least in an operative passage condition, characterised at least by a corresponding second state of mechanical shaking of the container 1 and/or in which the container 1 is subjected to a corresponding second relative centrifugal force. The selective passage portion 6 can be configured such as to selectively enable exit of the fluid or liquid from the container 1, through the passage portion 6, in a plurality of the operative passage conditions, characterised at least by a plurality of second respective values of mechanical shaking of the container 1 that are greater than the predetermined state of mechanical shaking of the container 1 and/or characterised at least by a plurality of respective second values of centrifugal force superior to the value of relative centrifugal force greater than the predetermined value of relative centrifugal force, applied for a second predetermined time interval.
[0036] For example the selective passage portion 6 can be configured such as to selectively enable exit of the fluid or liquid from the container 1 through the selective passage portion 6 in an operative passage condition in which the container 1 is subjected to a relative centrifugal acceleration or relative central force (ROE) of at least 500×g, or at least 1000×g, or at least 2500×g, or at least 5000×g, or at least 7500×g, or at least 10000×g for a second predetermined interval of shaking time. The above-cited relative centrifugal forces can correspond, for example, for some centrifuges, at an angular velocity of at least 5000 rpm, or 6000 rpm, or 7000 rpm or 8000 rpm or 10000 rpm. These values can be valid for example for a centrifuge having a rotor radius in the order of 5 cm. The selective passage portion 6 can be configured such as to enable the passage of at least 80%, or at least 85%, or at least 90% or at least 95% of the fluid or liquid contained in the compartment 3 when the container 1 is subjected to one of the operative passage conditions for a second time interval of shaking of at least 20 seconds, or at least 40 seconds, or at least 1 minute, or at least 2 minutes.
[0037] The duration of the first time interval, in which there is no passage of fluid or liquid through the selective passage portion 6, also in conditions of mechanical shaking or the container 1, depends on the entity of the mechanical shaking itself. According to the values of mechanical shaking, it can be for example less than 5 minutes, or less than 2 minutes, or less than 1 minute, or less than 30 minutes, or less than 10 minutes. Also the duration of the second time interval, at which the passage of fluid or liquid through the selective passage portion 6 depends on the entity of the mechanical shaking, and can be for example of at least 10 seconds, or at least 20 seconds, or at least 40 seconds, or at least 1 minute, or at least 2 minutes, or at least 5 minutes, according to the relative centrifugal force RCF applied.
[0038] The permeability of the selective passage portion 6 can further increase on increasing the temperature, also in relation to the material the container 1 is made of, and therefore corresponding to an increase in temperature there can be a reduction of the relative centrifugal force necessary to cause the fluid or liquid passage through the selective passage portion 6. The above-cited values relate to a container 2 at ambient temperature. The mechanical shaking of the container 1 and/or the test tubes can be for example done by means of a common laboratory centrifuge. The centrifuge is not illustrated as it is of known type. Centrifuges are widely used instruments in scientific laboratories, for example such as to separate particles in solution, by means of application of an artificial centrifugal force obtained with a high-speed rotating system. The sedimentation force artificially developed by the centrifuge is commonly called Relative Centrifugal Force, although it would be more properly known as acceleration, and is indicated by a number representing a multiple of the force, or rather acceleration, of the Earth's gravity, denoted by “×g”. Centrifuges are distinguished on the basis of the maximum RCF that can be reached, which essentially depends on the angular rotation velocity reached by the rotor of the centrifuge, i.e. the distance between the centre of rotation and the position in which the test tube containing the substance to be centrifuged is at. The relation between the RCF, the rotations per minute developed by the centrifuge and the radius of the rotor (r) is described by the following equation:
RCF(g)=(rpm/1000).sup.2*11,18*r
[0039] The following is an example of a conversion table from which it is possible to deduce, for each rotor and rapidly and directly, the conversion between rpm and RCF.
TABLE-US-00001 Conversion Table Conversion Table Speed Rotor Radius (from center of rotor to sample) in centimeters (RPM) 4 5 6 7 8 9 10 11 12 13 14 15 1000 4 56 67 7
89 101 112 123 134 145 157 168 1500 101 126 151 17
201 22
252 277 302 327 352 377 2000 179 224 2
8 313 358 402 447 492 537 591
26
71 2500 280 349 419 489 559 629
99 7
9 839 90
76 104
3000 402 50
804 704 805 9
100
1107 1207 1308 1409 150
3500 548 885 822
59 10
1233 1370 1507 1
43 1780 1917 2054 4000 716 894 1073 1252 1431 1
10 1789 19
2147 2325 2
04 2
3 4500
1132 1358 1585 1
11 203
2264 24
2717 2943 3170 33
5000 1118 13
1677 1957 22
251
2795 3075 3354 3
34 3913 41
5500 1353 1691 2029 2387 270
3044 3
82 3720 405
4
97 4735 5073 6000 1810 201
2415 2817 3220 3622 4025 4427 4830 5232 5
35
037 6500 1889 2362 2834 330
3779 4251 4724 519
5
8 6141
613 7085 7000 2191 2739 3287 3835 43
3 4930 5478 602
574 7122 7669 8217 7500 2516 3144 3773 4402 50
5
0
289 691
7547 8175 8804 9433 8000 2862 3578 4293 500
5724 6440 7155 7871
9302 10017 10733 8500 3231 4
39 4847
654 64
2 7270
07
888
10501 11309 12118 9000 3
22 4528 5433
339 7245 8150
05
961 10867 11773 1267
13584 9500 4036 5045 6054 7063 8072 90
1 100
0 11099 12108 13117 1412
15135 10000 4472 5
0
708 782
8
44 10082 11180 122
13418 14534 1565
1
770 10500 4930 516
7398 862
8
1 110
1232
13
14791 15024 1725
18489 11000 5411 6764 8117 94
9 10822 12175 1352
14881 16233 17586 18
9 202
2 11500 5914 7393
871 10350 1182
13307 1478
162
4 17743 1
221 20700 22178 12000 6440 8050 9
0 11269 12879 144
1
0
9 1770
19319 20
29 22539 2414
13000 7558 9447 11337 1322
15115 17005 1
4 20784 22673 24
2 28452 28341 13500 8150 101
8 1222
142
1
300 1833
2037
2241
24451 2648
28528 30563 14000 8765 1095
13148 15339 17530 19722 21
13 24104
295 28487 30678 328
indicates data missing or illegible when filed
[0040] As illustrated in
[0041] The selective passage portion 6 can be provided with at least a passage opening 14 or a plurality of passage openings, each passage opening being so dimensioned as to prevent the passage of liquid or fluid in the operative sealed condition and in order to enable passage of the liquid or fluid in the operative passage condition. Each opening can exhibit at least a transversal opening dimension which is lower than about 0.2 mm, or about 0.1 mm, or about 0.05 mm, or about 0.02 mm or about 0.01 mm. “Transversal opening dimension” means one of the measured opening dimensions in a plane that is parallel to the containing wall 5 in which the selective passage portion 6 is defined, and thus in a plane that is perpendicular to the development direction of the opening through the thickness of the containing wall 5. As illustrated in
[0042] In an alternative form, not illustrated, each passage opening 14 can be realised by means of a hole with a diameter that is smaller than about 0.2 mm, or about 0.1 mm, or about 0.05 mm, or about 0.02 mm or about 0.01 mm. The dimension of the passage opening 14 is determined such that the surface tension, and therefore the internal cohesion forces, of the liquid or fluid contained in the container 1 are sufficient to maintain the liquid or fluid in the container 1, not allowing passage of the liquid or fluid through the passage openings 14 in the repose conditions or up to application of a determined relative centrifugal force.
[0043] Alternatively, in the solution illustrated in
[0044] In an alternative embodiment, not illustrated in the accompanying figures, the selective passage portion 6 can be provided with at least an elastically deformable portion or a plurality of elastically deformable portions, each elastically deformable portion being substantially closed at least in one of the sealed operating conditions and/or before the container 1 is brought into one of the operative passage conditions by realising at least a passage opening 14. The selective passage portion 6 can be destined to open by means of elastic deformation at least in one of the operative passage conditions, by realising a passage opening 14 exhibiting a diameter or at least a transversal opening dimension, or both the transversal opening dimensions, smaller than about 2 mm, or about 1 mm, or about 0.5 mm, or about 0.1 mm, or about 0.05 mm, or about 0.02 mm or about 0.01 mm. The selective passage portion 6 can comprise a number from 1 to 30, or from 2 to 15, or from 4 to 8, of the passage openings 14 or the weakened portion or the elastically deformable portions.
[0045] The illustrated embodiment of
[0046] The body 2 can be made of a plastic material, for example made of polypropylene or virgin polypropylene, or in any other material suitable for the aim, and can be realised by injection. The weakened portions and/or the openings can be realised on the body 2 in the same injection operation that the body 2 of the container 1 is made in, by suitable punches which enable the passage openings 14 and/or the weakened portions and/or the elastically deformable portions to be realised.
[0047] The present invention further relates to a kit for selective transfer of samples of biological material or material of biological origin, comprising a laboratory test tube 10 selectively closable by means of a lid 11 and further comprising a container 1 of the above-described type and selectively insertable and closable in the test tube 10 by means of the lid 11, as illustrated in
[0048] The invention further relates to the use of a container 1 of the above-described type for selective transfer of samples of biological material or material of biological origin from the container 1 to a test tube 10 in which the container 1 is inserted, by means of mechanical shaking of the test tube 10 greater than a predetermined mechanical shaking and/or by means of application of a relative centrifugal force that is greater than a predetermined relative centrifugal force to the test tube 10.
[0049] The invention further relates to a process for selective transfer of samples of biological material or material of biological origin, which can comprise steps of: inserting a portion 16a of a sample device 16 for biological samples, for example the collecting portion of a flocked tampon, in the container 1; inserting a lysing fluid or liquid into the container 1; subjecting the container 1 comprising the portion 16a of a collecting device 16 and the lysing fluid or liquid to heat incubation, at a predetermined temperature and for a predetermined time.
[0050] The process can further comprise the step of breaking the collecting device 16 at a weakened portion 16b thereof in order to insert only the collecting portion 16a in the container 1. The process can further comprise steps of inserting the container 1 in the laboratory test tube 10; closing the container 1 in the test tube 10 by means of the lid 11; mechanically shaking the test tube 10 containing the container 1, for example by positioning the test tube 10 in a laboratory centrifuge, at a greater level than a predetermined mechanical shaking, or subjecting the test tube 10 to a relative centrifugal force that is greater than a relative predetermined centrifugal force, for the second predetermined time interval, such as to cause passage of at least a part of the fluid or liquid from the container 1 to the test tube 10 across the selective passage portion 6.
[0051] The process can further comprise the steps of removing the container 1 from the test tube 10 after the step of mechanically shaking the test tube 10 containing the container 1. The step of mechanically shaking the test tube 10 containing the container 1, or subjecting the test tube 10 to a relative centrifugal force, can be performed at a relative angular velocity and for a time that are sufficient to cause passage of at least 80%, or at least 90% or at least 95% of the fluid or liquid from the container 1 to the 10.
[0052] The present invention enables attainment of at least one of the above-cited aims. The invention enables realising a container able to obviate one or more of the problems encountered in the prior art. Further, a container according to the invention enables significant reduction of the risks of contamination of the biological sample treated, as it eliminates a step of further handling of the portion of the collecting device. Further, the invention enables simplification of the extraction of the biological sample from the collecting device and reducing the time necessary for the performing of this operation. It is further of note that the invention enables recuperating the test tube, substantially completely, all of the biological sample initially collected by the collecting device. The invention is further simple and economical to realise and easy to use.