Device for Collecting, Transferring, and Storing Samples of a Biological and/or Chemical Material
20210053049 ยท 2021-02-25
Inventors
Cpc classification
B01L3/5055
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/069
PERFORMING OPERATIONS; TRANSPORTING
B01L3/5023
PERFORMING OPERATIONS; TRANSPORTING
B01L2200/141
PERFORMING OPERATIONS; TRANSPORTING
International classification
B01L3/00
PERFORMING OPERATIONS; TRANSPORTING
A61B10/00
HUMAN NECESSITIES
Abstract
A device for collecting, transferring, and storing samples of a biological and/or chemical material, wherein the device comprises: a support body, developing along a main longitudinal direction between a first end and a second end opposite to each other and connected by an intermediate portion elongate in the main longitudinal direction, a collection portion engaging the first end and configured to collect a quantity of a sample of a biological and/or chemical material, the collection portion being defined at least by a first coating layer realized on the first end and made from an elastically deformable material and by a second coating layer consisting of a layer of flocked fibers, the second coating layer being realized through a fiber flocking process on the first coating layer and being configured to absorb a quantity of liquid including at least one sample of a biological and/or chemical material.
Claims
1. A device for collecting, transferring, and storing samples of a biological and/or chemical material, wherein the device comprises: a support body, developing along a main longitudinal direction between a first end and a second end opposite to each other and connected by an intermediate portion elongate in the main longitudinal direction, a collection portion engaging the first end and configured to collect a quantity of a sample of a biological and/or chemical material, the collection portion being defined at least by one first coating layer realized on the first end and made from a deformable material, preferably an elastically deformable material, and by one second coating layer consisting of a layer of flocked fibers, the second coating layer being realized through a fiber flocking process onto the first coating layer and being configured to absorb a quantity of liquid including at least one sample of a biological and/or chemical material.
2. A device according to claim 1, wherein the first end has a widened shape transversally to the main longitudinal direction with respect to the intermediate portion, and is provided at least with one front face and one rear face opposed to each other, the collection portion engaging at least the front face of the first end and the first coating layer and the second coating layer being present at least on one part of the front face of the first end.
3. A device according to claim 1, wherein the first end has a widened shape transversally to the main longitudinal direction with respect to the intermediate portion and is provided at least with one front face and one rear face, opposed to each other, wherein the collection portion is exclusively defined on the front face of the first end and is not present on the rear face.
4. A device according to claims 1, wherein the front face and/or the flocked portion and/or the rear face feature a substantially flat shape.
5. A device according to claim from 1, wherein the front face and/or the flocked portion and/or the rear face feature a shape defined by a curved surface or by a curved and convex surface.
6. A device according to claim 1, wherein the collection portion is configured to collect or absorb a quantity ranging from 5 to 1000 microliters, or from 10 microliters to 500 microliters, or from 50 to 250 microliters of a sample, or wherein the second coating layer is configured to collect or absorb a quantity ranging from 5 to 1000 microliters, or from 10 microliters to 500 microliters, or from 50 to 250 microliters of a sample.
7. A device according to claim 1, wherein the first coating layer covers the front face of the first end only partially, and/or wherein the first coating layer covers the rear face of the first end only partially, and/or wherein the first coating layer covers the first end only partially, and/or wherein the second coating layer covers the first coating layer only partially.
8. A device according to claim 1, wherein the thickness of the first coating layer is less than 6 mm, or less than 5 mm, or less than 4 mm, or less than 3 mm and/or greater than 0.5 mm, or greater than 1 mm, or greater than 2 mm.
9. A device according to claim 1, wherein the thickness of the second coating layer is less than 3 mm, or less than 2 mm, or less than 1 mm and/or greater than 0.3 mm, or greater than 0.45 mm, or greater than 0.6 mm.
10. A device according to claim 1, wherein the first layer is made from a liquid-impermeable and/or hydrophobic material and/or wherein the first layer is liquid-impermeable and/or wherein the first coating layer is made from an elastomeric material.
11. A device according to claim 1, wherein the first coating layer is made from a liquid-absorbing material and/or a spongy material and/or wherein the first layer is liquid-absorbing and features an additional absorbing capability with respect to an absorbing capability of the second coating layer and/or wherein the first coating layer is made from an elastomeric material.
12. A device according to claim 1, wherein the first coating layer consists of a plurality of separate sub-portions and/or is provided with a plurality of pre-indented sub-portions and/or is provided with indentations realized in such a way as to define a plurality of at least partially separate sub-portions, so as to facilitate the detachment of at least one individual sub-portion of the first coating layer, and of a corresponding sub-portion of the second layer, from the first end at a time following sample collection.
13. A device according to claim 1, wherein the first coating layer is made from one or more of the following materials: synthetic sponge, expanded resin, expanded polyethylene, EVA, LDPE, expanded polyurethane, polyether, polyester, Stratocell, Antistatic, foam Plastazote, rubber mousse, latex, Dryfeel.
14. A kit for collecting, transferring, and storing samples of a biological and/or chemical material, wherein the kit comprises at least: a housing body having at least one housing seat for a storage element for samples of a biological material, in particular a paper for storing samples of a biological material or another medium for storing samples of a biological material, the housing seat being configured to make it possible to removably house the storage element for samples of a biological material, the housing body being configured to keep at least one storage portion of the storage element accessible for the deposition of a sample of a biological material whenever the storage element is housed in the housing seat; an operating portion movable at least between a first closing position where it is arranged close to the housing seat and at least one opening position where it is arranged in a position spaced away from the housing seat; and at least one engagement element configured to engage a device to the operating portion according to claim 1.
15. A method for realizing a device for collecting, transferring, and storing samples of a biological and/or chemical material according to claim 1, wherein the method comprises at least the following steps: realizing the support body, including at least the first end, the second end, and the intermediate portion; realizing the collection portion on the first end of the support body, through the realization and attachment of the first coating layer to the first end and through the implementation of the second coating layer by flocking a layer of fibers onto the first coating layer.
Description
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[0021] With reference to the figures, the numeral 20 identifies a device for collecting, transferring, and storing samples of a biological and/or chemical material as a whole. In this context, by biological material we also mean a microbiological material. Also, by biological and/or chemical material we also mean in fact any types of analyte, such as, indicatively but not exhaustively, microorganisms, antibodies/antigens, substances developing an antimicrobic action, nucleotides, antibiotics, hormones, sequences of DNA, enzymes, organic materials, biological materials or materials of biologic origin, enrichment supplements or selective supplements for culture media, and the like, as well as any types of chemical substances. Consequently, such definition comprises samples of different natures intended for a subsequent analysis in the clinical, chemical, biological, microbiological, environmental, genetic, forensic fields and the like. Also, in this text the terms deformable material and elastically deformable material, which a first coating layer of a collection portion of the device 20 is made from, shall be construed as a material that is capable of deforming to an appreciable extent following a stress manually applied by a user to the collection device 20 to make the collection portion of the collection device 20 and here to a storage medium, such as a storage paper, or another medium used to store samples of a biological and/or chemical material commonly used in this sector. The storage paper can be made from cellulose, or from another material suitable for this purpose. More specifically, the elastically deformable material which the first coating layer is made from shall be capable of deforming upon getting in contact with such storage medium to increment the adhesion and the surface of exchange between the collection portion, and in particular of the first and second coating layer, and the support surface of the storage medium put in contact with such layers. Also, by this term elastically deformable material we mean a material having a greater deformability with respect to the material that the support body 21 of the collection device 20 and its first end are made from. Finally let's point out that in this context the wording device for collecting, transferring, and storing samples of a biological and/or chemical material does not include those devices, typically disposable but even re-usable after washing, which are solely configured and intended for cleaning portions of a user's mouth, and not specifically to collect samples for analytical purposes, for instance for laboratory, forensic and/or medical applications, consequently this definition does not include, for instance, toothpicks and devices for tongue, tooth, and gum cleaning. The device 20 for collecting, transferring, and storing samples of a biological and/or chemical material comprises at least one support body 21, developing along a main longitudinal direction 22 from a first end 23 to a second end 24 opposite to each other and interconnected by an intermediate portion 25 featuring an elongate shape in the main longitudinal direction 22. The support body 21 is preferably made from a substantially rigid or partially flexible material and, for instance, from a plastic material. The support body 21 might be for instance made from a plastic polymer or co-polyester or polystyrene or nylon/polyamide or another material suitable for this purpose. The device 20 also comprise at least one collection portion 26 engaging the first end 23 and configured to collect a quantity of a sample of a biological and/or chemical material. The collection portion 26 is configured to collect or absorb a quantity ranging from 5 to 1000 microliters of a sample. Preferably this quantity ranges from 10 microliters to 500 microliters, and even more preferably from 50 to 250 microliters of a sample. The collection portion 26 is defined at least by one first coating layer 26a made from an elastically deformable material realized on the first end 23 and by at least one second coating layer 26b consisting of a layer of flocked fibers, the second coating layer 26b being realized through a fiber flocking process on the first coating layer 26a and being configured to absorb a quantity of liquid comprising at least one sample of a biological and/or chemical material. The collection portion 26 is configured to collect or absorb a substantially known quantity of a sample, and in particular the fibers are arranged on the first coating layer 26a so as to define a plurality of capillary interstices suitable for absorbing the sample by capillarity. Preferably is a first layer of adhesive material arranged between the first coating layer 26a and the first end 23 to attach the first coating layer 26a at least to the front face of the first end 23. Alternatively, a step might be provided of heating the material of the first end 23 and/or of the first coating layer 26a so as to make such materials capable of stably adhering to each other even after their cooling down. Preferably is a second layer of adhesive material provided between the first coating layer 26a and the second coating layer 26b, to make it possible for the flocked fibers to adhere to the first coating layer 26a, during the flocking process. The adhesive material might be, for instance, a vinylic adhesive or an adhesive of another type suitable for this purpose. In this case too, as an alternative, there might be provided a step of heating the material of the first coating layer 26a so as to make such material suitable for determining the adhesion of the fibers in a stable manner even after their cool down. The second coating layer 26b formed of a flocking layer can be realized for instance according to the teachings of the already mentioned patent EP1608268B1 or patent applications WO2014/049460 and WO2014/207598, on behalf of this Applicant, and whose content concerning the type of the fibers used and the arrangement and characteristics of the layer of flocking fibers is incorporated in the present text for reference. Specifically, the fibers are arranged by the flocking process on the first coating layer 26a in a substantially orderly manner. Preferably are the fibers arranged on the first coating layer 26a so as to form a substantially continuous layer. The fibers preferably feature a count ranging from 1 to 10 dtex, or from 2 to 7 dtex, or from 3 to 5 dtex. The fibers preferably feature a length ranging from 0.2 mm to 3 mm, or from 0.4 mm to 2 mm, or from 0.6 mm to 1.5 mm. The fibers can be made, for instance, from a polyamide (PA or nylon) and/or rayon and/or polyester and/or carbon fiber and/or alginate and/or natural fiber and/or cotton and/or a mix of such materials. The collection portion 26 can feature, for instance, a surface density of fibers on the first coating layer 26a ranging from 50 to 1,000 fibers per mm.sup.2 or from 100 to 500 fibers per mm.sup.2. The first end 23 preferably features a shape, transversally to the main longitudinal direction 22 widened, with respect to the intermediate portion 25, and is provided at least with one front face 23a and one rear face 23b, reciprocally facing each other. Preferably the front face 23a and/or the flocked portion and/or the rear face 23b feature a substantially flat configuration. Alternatively, the front face 23a and/or the flocked portion and/or the rear face 23b might feature a configuration defined by a curved surface. Preferably is such curve convex. The front face 23a and the rear face 23b can be substantially equal to each other and/or symmetrical. The thickness of the first end 23, as measured between the first face and the second face and/or in a direction perpendicular to the first face and/or to the second face, can range from 0.5 mm to 5 mm, or from 0.7 to 4 mm, or from 1 to 2.5 mm. The surface of the front face 23a and/or of the rear face 23b can range from 20 mm.sup.2 to 1250 mm.sup.2, or from 80 mm.sup.2 to 700 mm.sup.2, or from 120 mm.sup.2 to 400 mm.sup.2. The width 30 of the front face 23a and/or of the rear face 23b, in a direction perpendicular to the main longitudinal direction 22, can range from 5 mm to 40 mm, or from 10 mm to 30 mm, or from 12 mm to 22 mm. Such length coincides with the diameter of such faces, should the latter feature a circular shape, as illustrated. The collection portion 26 can have a length 31 ranging from 5 mm to 40 mm, or from 10 mm to 30 mm, or from 15 mm to 25 mm, or from 12 mm to 20 mm. The collection portion 26 is engaged at least to the front face 23a of the first end 23 and the first coating layer 26a and the second coating layer 26b are present at least on a portion of the front face 23a of the first end 23. In the preferred embodiment, the collection portion 26 is uniquely defined on the front face 23a of the first end 23 and is absent on the rear face 23b, as illustrated in the attached figures. In a variant not shown here, the collection portion 26 can also be defined on the rear face 23b of the first end 23. In one embodiment, the first layer 26a is made from a liquid-impermeable and/or hydrophobic material. In one embodiment, the first layer 26a is liquid-impermeable. In one alternative embodiment, the first coating layer 26a can be made from a liquid-absorbing and/or spongy material. In particular, the first layer 26a can be a liquid-absorbing one and have an additional absorbing capability with respect to an absorbing capability of the second coating layer 26b. The first coating layer 26a can, for instance, be made from an elastomeric material. The absorbing capability of the collection portion 26 can be fully defined by the second layer coating layer 26b alone, for instance in the case the first coating layer 26a is liquid-impermeable. The second coating layer 26b can be configured to collect or absorb a quantity ranging from 5 to 1000 microliters, or from 10 microliters to 500 microliters, or from 50 to 250 microliters of a sample. In a preferred embodiment, as illustrated in the figures, the first coating layer 26a covers the first end 23 only partially, and in particular it covers the front face 23a only of the first end 23. Alternatively, the first coating layer 26a can fully cover the front face 23a of the first end 23, or in other alternatives it can fully covers the rear face 23b too or the complete first end 23. In the embodiment here illustrated, the second coating layer 26b fully covers the first coating layer 26a, both in correspondence with one front face 23a thereof, and in correspondence with a lateral surface perpendicular to the front face 23a.
[0022] In a variant, not illustrated here, the second coating layer 26b can cover the first coating layer 26a only partially. In the variant wherein the first coating layer 26a is also present on the rear face 23b of the first end 23, the first coating layer 26a can cover the rear face of the first end 23 only partially. The thickness 32 of the first coating layer 26a is preferably less than 6 mm, or less than 5 mm, or less than 4 mm, or less than 3 mm. The thickness 32 of the first coating layer 26a is preferably greater than 0.5 mm, or greater than 1 mm, or greater than 2 mm. The thickness 33 of the second coating layer 26b is preferably less than 3 mm, or less than 2 mm, or less than 1.5 mm. The thickness 33 of the second coating layer 26b is preferably less than 0.2 mm, or greater than 0.4 mm, or greater than 0.6 mm. In an alternative embodiment, not illustrated here, the first coating layer 26a can be formed of a plurality of separate sub-portions and/or be provided with a plurality of pre-indented sub-portions. For instance, the first coating layer 26a can be provided with indentations cut in such a way as to define a plurality of at least partially separate sub-portions, so as to make the detachment of at least one single sub-portion of the first coating layer 26a, and of the corresponding sub-portion of the second layer 26b, from the first end 23 easier at a time following sample collection. The support body 21 is preferably provided, for instance in correspondence with the intermediate portion 25, with a coupling portion 27. In particular, the collection device 20 can be a buccal collecting swab or a buccal or lingual one. In the present text, by buccal we mean a collection of a biological sample that is made in a patient's mouth, and consequently also comprises a lingual collection or the like. In any case, the concepts herein might find applications, in one or more of its aspects, for collections of types different from buccal collection, for instance for collections in other cavities of the body or for collections blood samples. A detailed description of a preferred explanatory embodiment of a kit for collecting, transferring, and/or storing samples of a biological material, identified by the reference numeral 1 as a whole, is provided below. This kit comprises at least one housing body 2 having at least one housing seat 3 for a storage element 4 for samples of a biological material. The housing seat 3 is configured to make it possible to removably house the storage element 4 for samples of a biological material. The storage element 4 is preferably a chemically treated paper suitable for storing samples of a biological material, and in particular a paper comprising at least one substance capable of storing a sample of a biological material, in particular suitable for storing a buccal sample. Alternatively, the element 4 might be a different medium type suitable for this purpose. The housing seat 3 can consequently be configured to make it possible to removably house such chemically treated paper for storing biological samples, and preferably it is configured as a lateral opening of the housing body 2 into which the paper can be slidingly inserted. The housing body 2 is configured to have at least one storage portion 5 of the storage element accessible for depositing a sample of a biological material whenever the storage element is housed in the housing seat 3, for instance by way of a front opening, with respect to the mentioned lateral opening. The kit 1 also comprises an operating portion 6 movable at least between a first closing position wherein it is arranged close to the housing seat 3 and at least one opening position wherein it is arranged in a position spaced away from the housing seat 3. The kit 1 also comprises an engagement element 7 configured to selectively and removably engage a collection device 20 of the above illustrated type to the kit 1, and in particular to the housing body 2 and/or to the operating portion 6. The device 20 is selectively and removably couplable with the engagement element 7 by way of the coupling portion 27. Further characteristics of the collecting kit and further variants, equally applicable in combinations with the concepts herein, are illustrated in the already mentioned patent application WO2014/001940 (Triva), whose contents, as far as possible specific embodiments of kit are concerned, is incorporated in the present description for reference. In the embodiments illustrated in the present patent application, the engagement element 7 is configured to selectively and removably engage the collection device 20 for samples of a biological material to the operating portion 6, so that the collection device 20 is selectively portable, as a consequence of the operating portions 6 being moved, in correspondence with the housing seat 3 and of the storage portion 5 in the first closing position and/or so that the collection portion 26 is selectively portable in correspondence with the housing seat 3 and/or in contact with the storage portion 5 in the first closing position. The kit can also comprise a closure 13 suitable for selectively closing the kit 1 at least in the first closing position, shown in detail in
[0023] The concepts herein also concern a method to implement a device 20 for collecting, transferring, and storing samples of a biological and/or chemical material of the above described type. The method comprises at least the following steps: realizing the support body 21 including at least the first end 23, the second end 24, and the intermediate portion 25; realizing the collection portion 26 on the first end 23 of the support body 21, by realizing and securing the first coating layer 26a to the first end 23 and by realizing the second coating layer 26b by flocking a layer of fibers onto the first coating layer 26a. The support body 21 can be for instance realized by injection molding or extrusion. The method can also comprise a step of gluing the first coating layer 26a to the first end 23. The step of flocking the second coating layer 26b onto the first coating layer 26a can be performed either before or after applying the first coating layer 26a to the first end 23 of the support body 21. For instance, the step of flocking the second coating layer 26b onto the first coating layer 26a can be performed on a sheet of the first coating layer 26a and the sheet can subsequently be cut into portions of appropriate dimensions and subsequently applied to the first end 23 of the support body 21. Preferably are the fibers arranged on the first coating layer 26a by a flocking process in an electrostatic field, preferably in a substantially perpendicular manner to the surface of the first coating layer 26a. The fibers can be arranged on the first coating layer 26a exclusively in correspondence with the front surface of the first coating layer 26a, or even in correspondence with a lateral surface of the first coating layer 26a, perpendicular to the front surface, as illustrated in the figures. In one variant, the method can also comprise a step of indenting or dinking the first coating layer 26a to define a plurality of sub-portions of the first coating layer 26a. Such step of indenting or dinking is preferably performed so as to realize indentations developing in a direction perpendicular to the surface of the first coating layer 26a intended for receiving the second coating layer 26b. The indenting or dinking step can be performed either before or after applying the first coating layer 26a to the first end 23 of the support body 21. Such step can for instance be performed by cutting the first coating layer 26a down to a depth less than the overall thickness of the first coating layer 26a, so as not to completely separate the sub-portions of the first support layer 26a, or alternatively it can be performed by cutting the first coating layer 26a all along the depth of the overall thickness of the first coating layer 26a, so as to completely separate the sub-portions of the first coating layer 26a. The indenting or dinking step can be performed before applying the second coating layer 26b onto the first coating layer 26a. This step can be performed after applying a second layer 26b of adhesive material, suitable for allowing for the adhesion of the second coating layer 26b onto the first coating layer 26a, onto the first coating layer 26a and before realizing the second coating layer 26b on the first coating layer 26a. Such step can be performed before applying a second layer 26b of adhesive material, suitable for allowing for the adhesion of the second coating layer 26b onto the first coating layer 26a, onto the first coating layer 26a and before realizing the second coating layer 26b onto the first coating layer 26a. Alternatively such step can be performed after applying the second coating layer 26b onto the first coating layer 26a. The concepts herein also concern a method for collecting, transferring, and/or storing samples of a biological material by a device 20 and/or a kit 1 of the above-mentioned type. The method can comprise for instance at least the following steps: collecting a sample of a biological material onto at least one collection portion 26 of a collecting element 20, preferably a buccal sample. If the first coating layer 26a is impermeable, the quantity of the sample is fully absorbed by the second flocked coating layer 26b, whereas in the case the first coating layer 26a is also absorbing, then an additional quantity of liquid comprising the sample can be collected therein. The method also comprises the step of subsequently and selectively coupling the collection device 20 with a housing body 2 or with a movable operating portion 6 of the kit 1, then bringing the collection portion 26 of the collection device 20 in contact with a storage portion 5 of a storage element 4 for samples of a biological material housed in a housing seat 3 of the housing body 2 to transfer a quantity of the biological material from the collection portion 26 of the collection device 20 to the storage portion 5. Thanks to the presence of the first deformable coating layer 26a, an optimum compression is made of the second flocked coating layer 26b and consequently is possible to optimize the transfer of the collected quantity of sample, even in the case the first layer 26a is impermeable and/or the sample has not been absorbed. If the first layer 26a is also an absorbing one, and consequently it absorbed an additional quantity of liquid comprising the sample, a part of such additional quantity can also be released towards the storage portion 5 thanks to the pressure exerted during transfer. This method can also comprise a step of subsequently moving the collection portion 26 away from the storage portion 5 of the storage element 4 to bring the kit 1 to a storage and/or transfer position. The method can also comprise a step of storing the sample of a biological material on the storage portion 5 for a period of time, the kit 1 being preferably configured in a storage or transfer position. The method can also comprise a step of removing one or more of the separate and/or pre-indented sub-portions from the collection portion 26, for a separate use of a part of the collected sample. The concepts herein also concern the use of a device 20 and/or a kit 1 of the above-mentioned type, for collecting, transferring, and/or storing a sample of a biological material and/or for a buccal collection, transfer, and storage of a sample of a buccal biological material. The concepts herein make it possible to achieve at least one or more of the following advantages. First of all, the concepts herein make it possible to solve one or more of the problems encountered in the known art. The concepts herein also guarantee a reliable and fully traceable storage of the collected sample. The concepts herein also provide a high reliability in any operating conditions and as much independently as possible of the modes of use by a specific professional user. The concepts herein also allow for an optimum transfer of a sample collected from a collection device to a storage paper or to another storage or analysis medium. The concepts herein are also easy to use. The concepts herein also allow to reduce the risk of contaminating the collected samples. Finally, the concepts herein are simple and economical to implement.