WO2015052607A1 - Flocked swab for collecting and transferring samples of biological material and method for producing the same - Google Patents

Flocked swab for collecting and transferring samples of biological material and method for producing the same Download PDF

Info

Publication number
WO2015052607A1
WO2015052607A1 PCT/IB2014/064592 IB2014064592W WO2015052607A1 WO 2015052607 A1 WO2015052607 A1 WO 2015052607A1 IB 2014064592 W IB2014064592 W IB 2014064592W WO 2015052607 A1 WO2015052607 A1 WO 2015052607A1
Authority
WO
WIPO (PCT)
Prior art keywords
support body
reliefs
end portion
swab
base surface
Prior art date
Application number
PCT/IB2014/064592
Other languages
French (fr)
Inventor
Daniele Triva
Original Assignee
Copan Italia S.P.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Copan Italia S.P.A. filed Critical Copan Italia S.P.A.
Publication of WO2015052607A1 publication Critical patent/WO2015052607A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N2001/028—Sampling from a surface, swabbing, vaporising

Definitions

  • the present invention relates to a flocked swab for collecting and transfer of biological samples.
  • the invention further relates to a process for realizing the flocked swab.
  • the invention is applicable for example for collecting and transferring biological sample, during environmental collecting of various types or for collections made directly from the human body and in particular human orifices, so as to enable conservation, transport and/or subsequent analysis of these samples.
  • a further possible application is for collections from crime scenes.
  • the invention is advantageously applicable for oral collections.
  • the prior art comprises the use of various types of collecting and transfer devices for analytes such as organic or biological substances, for example to be subsequently subjected to laboratory examinations of analytic or diagnostic type.
  • traditional-type swabs are known constituted by a rod and an end, at which end there is a collecting element, for example constituted by a cotton fibre wound about the rod or by a sponge or the like, for defining a collecting portion adapted for absorbing internally thereof the sample to be collected.
  • a further type of swab is known from international patent document WO2004086979, which describes flocked swabs comprising an elongate support body and a plurality of flocked fibres arranged at an end of the support body for defining a collecting portion for the analytes or biological samples.
  • the types of swabs described above exhibit elongate rods which are in general made of plastic materials.
  • the known swabs exhibit at least the drawback of not being completely satisfactory in attaining the two requirements described above.
  • the main aim of the present invention is to obviate one or more of the problems encountered in the prior art. Further aims of the present invention are to provide a flocked swab for collecting and transferring biological samples which:
  • a further aim of the present invention is to provide a process for realising a flocked swab for collecting and transferring biological samples which is simple and economical to manufacture.
  • the invention can further relate to a flocked swab for collecting and transfer of biological sample in which an end portion of a support body exhibits a second part that covers a first part provided with a plurality of reliefs not covered by the second part, and wherein the end portion is covered by a flocked layer defined by a plurality of fibres attached and arranged on the end portion of the support body by flocking, so as to cover the second part and the reliefs.
  • the invention can further relate to a swab in which:
  • the first part extends at the gripping portion and the end portion
  • the connecting portion is interposed between the end portion and the gripping portion;
  • the first component is a polystyrene for general use
  • the second component is a high-impact polystyrene or anti-impact polystyrene
  • the first base surface is at least partially curved and/or at least partially straight;
  • one or more reliefs exhibit a same height and/or the height differs between one or more reliefs
  • the reliefs are present at the end portion of the first part in any number;
  • the reliefs are arranged in any geometrical arrangement at the end portion of the first part
  • the reliefs are characterised by any shape at the end portion of the first part
  • the second part exhibits a maximum thickness that is greater than the height of the reliefs
  • the second part develops at least partially internally of the first part
  • the first part exhibits one or more openings and/or one or more holes and/or one or more recesses at the end portion;
  • the second part exhibits one or more protuberances and/or one or more reliefs
  • one or more protuberances and/or one or more reliefs of the second part cross the first part at one or more openings and/or one or more holes and/or one or more recesses of the first part;
  • one or more protuberances and/or one or more reliefs of the second part exhibit a substantially cylindrical or hemispherical conformation
  • the second part exhibits one or more openings and/or one or more holes
  • the first part exhibits one or more protuberances and/or one or more reliefs crossing the second part at the openings and/or the holes of the second part;
  • one or more protuberances and/or one or more reliefs of the second part are arranged perimetrally with respect to one or more openings of the second part;
  • the openings of the second part exhibit a substantially elongate conformation
  • the swab comprises at least a layer of adhesive material or vinyl adhesive or glue arranged externally at least with respect to the end portion for enabling adhesion of the plurality of fibres on the end portion;
  • the invention further relates to a process for realizing a flocked swab according to any one of the appended claims, comprising at least a step of:
  • figure 1 is a perspective view of a first part of the support body of a swab according to an embodiment of the present invention
  • figure 2 is a lateral view of the first part of the support body of figure 1;
  • figure 3 is a view from below of the first part of the support body of figure 1;
  • figure 4 is a transversal section of the first part of the support body of figure 1, made along section plane XI-XI shown in figure 2;
  • figure 5 is a lateral view of an end of the first part of the support body of figure
  • figure 6 is a larger-scale view from above of the end of the first part of the support body of figure 5;
  • figure 7 is a lateral view of the end of the first part of the support body of figure
  • figure 7a is a detail of a relief of figure 7;
  • figure 8 is a section of the end of the first part of the support body of figure 6 made along section plane VIII-VIII, shown in figure 6;
  • figure 9 is an axonometric view from above of an end of the first part of the support body according to an embodiment of the present invention.
  • figure 10 is an axonometric view from below of the end of the first part of the support body of figure 9;
  • figure 11 is a perspective view of a swab according to an embodiment of the present invention.
  • figure 12 is a detail of the end portion of the swab of figure 11;
  • figure 13 is a lateral view of the swab of figure 11;
  • figure 14 is a section of the end portion of the support body made along section plane XIV-XIV shown in figure 13;
  • figure 15 is a view from above of the support body of figure 13;
  • figure 16 is a section of the end portion of the support body made along section plane XVI-XVI shown in figure 15;
  • figure 16a is a detail of a relief of figure 16
  • figure 17 is a section of the end portion of a swab according to an embodiment of the present invention in which the end portion is flocked.
  • 1 denotes in its entirety a flocked swab for collecting and transfer of biological samples.
  • a swab 1 according to an embodiment of the present invention is for example illustrated in figure 11, where the flocked fibres are not however shown.
  • the flocked swab 1 comprises a support body 2 which can exhibit an elongate and/or substantially rod-shaped conformation.
  • the support body 2 can be a small rod, which can extend prevalently along a longitudinal development direction.
  • the support body 2 can exhibit any section, which can vary in shape and/or dimensions along the longitudinal extension of the support body 2.
  • the support body 2 is provided with an end portion 2a defining a collecting portion 3 for the biological sample and a gripping portion 2b, at which the support body 2 can be manually grippable by an operator or connectable to a further gripping element such as a cap for test tubes or another suitable device.
  • the end portion 2a of the support body 2 can be tapered along the longitudinal extension of the support body 2, as illustrated in figure 16.
  • the gripping portion 2b is connected to the end portion 2a by means of a connecting portion 2c, which is interposed between the gripping portion 2b and the end portion 2a.
  • the support body 2 can be provided with a plurality of reinforcing ribs 4 at least at a gripping portion 2b; the ribs 4 can extend longitudinally along the support body 2, in particular along a substantially parallel direction to the longitudinal development direction of the support body 2.
  • the support body 2 can be composed of a first and a second part 5, 6.
  • the first part 5 can exhibit an elongate conformation and can develop prevalently along a longitudinal development direction that is substantially parallel to, in particular coinciding with, the longitudinal development direction of the support body 2.
  • the first part 5 extends at the gripping portion 2b, the connecting portion 2c and the end portion 2a; in other terms, the first part 5 can develop substantially along the whole length of the support body 2.
  • the first part 5 can be characterised by any section at the gripping portion 2b; in particular the section of the first part 5 at the gripping portion 2b can be characterised by an at least partially curved profile, as illustrated in figure 5 and figure 7.
  • the first part 5 can exhibit a same shape as the section along the longitudinal development of the gripping portion 2b, but the shape can vary in dimensions; the dimensions of the section can in particular increase proceeding from the gripping portion 2b towards the connecting portion 2c.
  • the first part 5 can be characterised by a marked reduction of section, such as for example a marked tapering, able to reduce the dimensions and the size of the first part at the end portion 2a.
  • marked reduction of section and/or marked tapering of the first part 5 is meant a considerable reduction in the dimensions of the section of the first part 5 at the connecting portion 2c.
  • the marked reduction of section of the first part 5 at the connecting portion 2c is for example illustrated in figure 5 and figure 7.
  • the dimensions of the section characterising the first part 5 can vary in the following way along the development of the support body 2; the dimensions can increase from the gripping portion 2b towards the connecting portion 2c, then to reduce at the connecting portion 2c.
  • the first part 5 preferably exhibits one or more reliefs 7 at the end portion 2a.
  • the first base surface 10 can be at least partly flat, in particular flat in portions, and can be characterised by the presence of portions and/or tracts which are substantially flat and are intervalled by one or more reliefs 7 which function as elements which interrupt the planarity of the first base surface 10.
  • the reliefs 7 can emerge distancingly from the first base surface 10 by a height H; the height H can be defined transversally and/or perpendicularly to the first base surface 10 of the first part 5.
  • the height H can assume a maximum value at the maximum distance of the geometrical profile of each relief 7 from the first base surface.
  • the height H of the reliefs 7 can vary along a substantially different direction to the prevalent development direction of the first base surface 10; in particular, the maximum height H of each relief 7 can differ with respect to the maximum height H of the other reliefs 7.
  • the reliefs 7 can be characterised by an at least partly curved conformation, in particular substantially hemispherical.
  • the reliefs 7 can constitute substantially hemispherical protuberances emerging from the first base surface 10 of the first part 5 at the end portion 2a.
  • the first part 5 can further exhibit a bar 13 developing emergingly from the first base surface 10, which can substantially extend over a whole width of the first part 5 at the end portion 2a, as illustrated for example in figure 6; the bar 13 can contribute to increasing the rigidity of the end portion 2a.
  • the bar 13 can be made in a single piece with the first part 5 and/or can exhibit a relief 7; this relief 7 can emerge in height with respect to the bar 13, as illustrated in figure 5.
  • the first part 5 exhibits a geometrical profile at least partly straight and/or at least partly curved, as illustrated in figure 16.
  • the geometrical profile of the first part 5 preferably exhibits straight portions alternated with curved portions.
  • the first part 5 can be at least partly in contact with the second part 6, in particular at least at the connecting portion 2c and the end portion 2a of the support body 2.
  • the second part 6 it develops at the connecting portion 2c and the end portion 2a.
  • the second part 6 develops at least partly externally of the first part 5, in particular at the end portion 2a; in other terms, the second part 6 can at least partly cover the first part 5 at the connecting portion 2c and/or at the end portion 2a.
  • the second part 6 preferably exhibits one or more openings and/or one or more holes and/or one or more recesses at the end portion 2a; the openings and/or holes and/or recesses can function as housing seatings of the reliefs 7 of the first part 5.
  • the first part 5 can develop at least partly internally of the second part 6, in particular at one or more openings and/or one or more holes and/or one or more recesses of the second part 6.
  • the second part 6 is preferably complementarily-shaped with respect to the geometrical profile of the first part 5; for example, at the reliefs 7 of the first part 5, the second part 6 an exhibit one or more openings and/or one or more holes and/or one or more recesses.
  • the second part 6 can be characterised by a thickness S at the end portion 2a.
  • the thickness S can be defined as the distance between the first base surface 10 of the first part 5 and the external surface 12 of the second part 6 and can vary along the extension of the second part 6.
  • the thickness S can preferably vary between a minimum thickness S and a maximum thickness S; the minimum thickness S can be at least 50% or 30% or 10% of the maximum thickness S.
  • the thickness S can be absent at the reliefs 7, as the reliefs 7 can at least partly project from the external surface 12 of the second part 6.
  • the thickness S can be substantially of the same order of size as the height H; in particular, the height H of the reliefs can be at least 50% of the thickness S and/or 75% of the thickness S and/or substantially the same as the maximum thickness S.
  • the reliefs 7 In relation to the positioning of the reliefs 7, they can be substantially flush with the external surface 12 of the second part 6 at the end portion 2a; in other terms, the reliefs 7 do not project from the external surface 12 of the second part 6, nor are they recessed below it, as illustrated in figure 16.
  • the reliefs 7 emerge from the external surface 12 of the second part 6 at the end portion 2a; in particular, the reliefs 7 can emerge by a fraction H' of the height H, as illustrated in figure 16a.
  • the fraction H' of the height H of the reliefs 7 can be not greater than 1 mm and/or not greater than 0.2 mm and/or not greater than 0.1 mm and/or at least 0.03 mm.
  • the reliefs 7 can be at least partly uncovered at the external surface 12 of the second part 6; in other terms, the height H of the reliefs can be smaller than the thickness S of the second part.
  • the second part 6 can exhibit a maximum thickness S that is greater than the height H; the maximum thickness S can preferably be greater than the height H by at least 0.03 mm.
  • the second part 6 can laterally surmount the reliefs 7, leaving however at least an uncovered portion at the top of the reliefs 7.
  • the first part 5 of the support body 2 can exhibit a first and a second base surface 10, 11, which are reciprocally opposite.
  • the reliefs 7, with reference to the geometry of the first part 5, can develop at the first and/or at the second base surface 10, 11; in particular, as illustrated in figure 5 and figure 7, the reliefs 7 can develop both at the first base surface 10 and the second base surface 1 1.
  • the reliefs 7 can be positioned and/or arranged with respect to the second base surface 11 and/or to the external surface 12 of the second part 6 similarly to what was previously described in relation to the geometry and arrangement of the reliefs 7 with respect to the first base surface 10 and the external surface 12 of the second part 6.
  • the second part 6 can at least partly develop internally of the first part 5.
  • the first part 5 can exhibit one or more openings and/or one or more holes and/or one or more recesses at the end portion 2a.
  • the second part 6 can exhibit one or more protuberances and/or one or more reliefs; in particular one or more reliefs and/or one or more protuberances of the second part 6 of the support body 2 develop at least partly internally of the first part 5 at one or more openings and/or one or more holes and/or one or more recesses of the first part 5.
  • the reliefs and/or the protuberances of the second part 6 can preferably cross the first part 5 at the end portion 2a.
  • the swab 1 can comprise a layer of adhesive material 9 or vinyl adhesive or glue, which can be arranged externally at least of the end portion 2a in order to enable adhesion of a plurality of fibres 8 on the end portion 2a.
  • the layer of adhesive material 9 or vinyl adhesive or glue can further be arranged externally at least of the connecting portion 2c and/or the end portion 2a, as illustrated in figure 17.
  • the relief portions 7 emerging from the external surface 12 of the second part 6 and/or the portions of the reliefs 7 substantially flush with the external surface 12 of the second part 6 and/or the portions of the reliefs 7 at least partially uncovered at the external surface 12 of the second part 6 can be in contact with the layer of adhesive material 9 or vinyl adhesive or glue.
  • the collecting portion 3 can develop at an end portion of the swab 1, which collecting portion 3 can be constituted by a plurality of fibres 8.
  • the colleting portion 3 is of a flocked type and can be made by flocking of a plurality of fibres 8 on the end portion 2a of the support body 2 able to define a flocked layer on the end portion 2a.
  • the flocked fibres 8 on the end portion 2a can be made of a hydrophilic or non-hydrophilic material, but the collecting portion 3 is in any case hydrophilic by capillary effect thanks to the characteristics of the fibres 8 and the distribution of the fibres 5 on the support body 2.
  • the collecting portion 3 can exhibit a continuous layer of fibres 8 made of a substantially adsorbent material, or preferably not adsorbent in relation to the sample, but in any case comprising a plurality of capillary interstices in which a predetermined quantity of the sample can be retained by soaking, and can be efficiently released therefrom quantitatively at the chosen moment, for example by rubbing the collecting portion 3 on an appropriate release surface or by dilution of the sample in an appropriate dilutant, or by centrifuging the sample in an appropriate device.
  • the depositing by electrostatic flocking is done in such a way as to produce, on the pertinent end of the flocked swab 1, a substantially continuous layer - that is theoretically substantially homogeneous - of a plurality of fibres 8 with a substantially ordered deposition that is substantially perpendicular at all points to the end portion 2a of the support body 2.
  • Each fibre 8 can be substantially parallel to the adjacent fibres 8, at least on the theoretical deposition level of the fibres 8.
  • the fibres 8 can be arranged on the support body 2 in a substantially ordered way and so as to form a substantially continuous layer on the collecting portion 3 and are further advantageously arranged on the collecting portion 3 in such a way as to define a plurality of capillary interstices able to adsorb the sample by capillarity action.
  • the flocked collecting portion 3 can be configured and dimensioned so as to collect a suitable quantity of sample, or to collect a quantity of sample comprised for example between 5 and 1000 microlitres, between 10 and 500 microlitres, or between 20 and 200 microlitres, or between 40 and 160 microlitres.
  • the fibres 8 can exhibit a titre comprised between 1 and 7 dtex or between 1.5 and 5 dtex, or between 1.7 e 3.3 dtex, and/or a length comprised between 0.2mm and 3 mm or between 0.6mm and 2mm.
  • the fibres 8 can be arranged by flocking on the collecting portion 3 of the support body 2 with a surface density for example comprised between 50 and 500 fibres per mm 2 or between 100 and 200 fibres per mm 2 of surface of the end portion 2a of the support body 2.
  • the layer of fibres can be characterised by an absorption capacity for example of 0.5 ⁇ per mm 2 , or at least 0.6 ⁇ per mm 2 , or at least 0.7 ⁇ per mm 2 , or at least 0.75 ⁇ per mm 2 of surface of the support body 2.
  • the fibres 8 can be made of a material that is substantially not hydrophilic or adsorbent towards the sample and/or in a material selected from among: polyamide (PA or nylon), rayon, polyester, carbon fibre, alginate, natural fibre, or a mixture of these materials.
  • the fibres 8 are preferably made of nylon.
  • the support body 2 can be bendable without breaking at least up to reaching a degree of curvature of 5 mm, or 4mm or 3mm or 2mm or 1 mm.
  • the support body 2 can be bendable without breaking for at least 10 cycles, or 20 cycles, or 50 cycles, or 100 cycles or 200 cycles of bending to 90° in opposite directions at an ambient temperature of about 25°C.
  • the flocked swab 1 and/or the support body 2 can exhibit a longitudinal extension comprised between 50mm and 250mm or between 100mm e 200mm or between 140mm and 180mm and/or a thickness of the end portion and/or the connecting portion 2c in a perpendicular section to the longitudinal development direction of the support body 2, comprised between 0.8mm and 6mm or between 1mm and 5mm or between 2mm and 4mm.
  • the collecting portion 3 can exhibit a longitudinal extension comprised between 3mm and 40mm or between 8mm and 30mm or between 10mm and 20mm and/or a thickness, comprising the fibres 8, comprised between 2 and 7 mm or between 4 and 6mm.
  • the collecting portion 3 can exhibit any shape adapted to the type of sample to be collected or the collecting seating, for example rounded or with one or more sharp edges.
  • the support body 2 is preferably realised by means of co-moulding or bi-material injection moulding; this production process of the support body 2 can be composed of two steps.
  • the first part 5 of the support body is realised with the first material by injection moulding and in another step the second part 6 of the support body 2 is realised using the second material by injection moulding.
  • the step preceding the realising of the second part 6 is preferably carried out after the step in which the injection moulding of the first part 5 is carried out.
  • the support body 2 is constituted by a single piece, in which substantially the first and the second part 5, 6 can be identified, which first and second part 5, 6 are respectively made of the first and the second material.
  • the first part 5 can be realised in a first material and the second part can be realised in a second material.
  • the first and the second material can be of the polymer type; the first material is preferably polystyrene-based and/or is a polystyrene and the second material is an elastomer.
  • the first material can be constituted by a mixture of two or more components; the first material is preferably composed of a first and a second component.
  • the first component can be a polystyrene for general use (GPPS - General purpose polystyrene); the second component can be a polystyrene such as HIPS (High impact polystyrene).
  • the weight percentage of the first component can be at least 50% of the weight of the whole mixture, while the weight percentage of the second component can be constituted by the difference between the 100% corresponding to the total weight of the mixture and the weight percentage of the first component; the weight percentage of the second component of the second component is therefore lower than or equal to 50% of the weight of the mixture.
  • the first component can preferably be present in the mixture constituting the first material in a weight percentage comprised between 60% and 80%, in particular around 70%, and the second component, consequently, can be present in the mixture in a weight percentage comprised between 20% and 40%, in particular around 30%.
  • the first part can be made up of the first component of 2.1 g (70% of the weight of the mixture) and by the second component of 0.9 g (30% of the weight of the mixture).
  • the mixture constituting the first material can be homogeneous or heterogeneous.
  • the elastomer can preferably exhibit an elongation at break comprised between 500%) and 1000%), in particular around 750% (values calculated with a test velocity of 500 mm/min) and/or a breaking load comprised between 8 and 12 MPa, in particular between 9 and 11 MPa, preferably about 9.8 MPa (values calculated with a test velocity of 500 mm/min).
  • the elastomer can exhibit a tear strength comprised between 15 and 40 kN/m, in particular between 20 and 30 kN/m, preferably about 26 kN/m.
  • the elastomer can exhibit a Shore A hardness comprised between 30 and 70, in particular between 40 and 60, preferably about 50 (values calculated with a load application time of 3 seconds).
  • the end portion 2a of the support body 2 can be provided with at least a weakened part (not shown in the figures), or a break point, enabling facilitating a selective breakage of the swab 1 at the end portion 2a and a separation of at least a part of the flocked collecting portion 3 from at least another part of the flocked collecting portion 3 and from the gripping portion 2b.
  • the flocked swab 1 can be realised by means of a plurality of different support bodies 2, each provided with a collecting portion 3 having a different conformation or shape and specifically configured for collecting a sample in a specific location, or for collecting a specific quantity of sample.
  • the flocked swab 1 can further comprise a container for transport of the sample having an internal containing seating and an access opening.
  • the container not illustrated as of known type, can be a test tube for transport of samples of biological materials or biological origin.
  • the flocked swab 1 can further comprise a closing cap removably mountable on the access opening for selectively closing the container.
  • the container and/or the closing cap can be made of a plastic material, for example polystyrol or polystyrene and/or of a suitable material for use with the specific sample to be collected, or in general adapted for use with biological materials of biological origin.
  • the container and/or the closing cap and/or the support body 2 can be sterilised.
  • the flocked swab 1 can further comprise a sealed pack (not illustrated in the figures as of known type) in which the support body 2 and/or the container and the closing cap can be housed before use for collecting a sample.
  • the support body 2, the pack, the container and the cap can be sterile.
  • the invention further relates to a process for realising a flocked swab 1 of the above-described type.
  • the process can comprise for example the following steps:
  • the step including realising the support body 2 by injection co-moulding or injection bi-material co-moulding can in turn comprise steps of:
  • the step including the realisation of the second part 6 is preferably carried out following the step in which the injection moulding of the first part 5 is performed.
  • the process can further comprise the step of realising on the support body 2 at least a first weakened part at the flocked collecting portion 3 by injection moulding of the support body 2 or by means of a material removal working of the support body 2.
  • the present invention enables obtaining one or more of the following advantages.
  • the invention enables realising a process and a flocked swab produced in accordance with the process, able to obviate the problems encountered in the prior art.
  • the invention further enables increasing the efficiency, the safety and reliability of the collecting processes of the biological samples.
  • the swabs of the invention further exhibit a high degree of ease of use as well as high qualities of reliability and safety of use.
  • the invention is simple to actuate and not excessively expensive.

Abstract

A flocked swab (1) for collecting and transfer of samples of biological material, wherein the swab (1) comprises at least: a support body (2) and a flocked layer defined by a plurality of fibres (8) constituting a flocked collecting portion (3) able to absorb a quantity of a sample of biological material, the support body (2) having an elongate conformation and exhibiting at least an end portion (2a) and at least a gripping portion (2b), the support body (2) comprising a first part (5) and a second part (6) and being made in a single piece by co-moulding of the first part (5), in a first polymer material, and the second part (6), in a second polymer material.

Description

FLOCKED SWAB FOR COLLECTING AND TRANSFERRING SAMPLES OF BIOLOGICAL MATERIAL AND METHOD FOR PRODUCING THE SAME.
The present invention relates to a flocked swab for collecting and transfer of biological samples. The invention further relates to a process for realizing the flocked swab. The invention is applicable for example for collecting and transferring biological sample, during environmental collecting of various types or for collections made directly from the human body and in particular human orifices, so as to enable conservation, transport and/or subsequent analysis of these samples. A further possible application is for collections from crime scenes. The invention is advantageously applicable for oral collections.
The prior art comprises the use of various types of collecting and transfer devices for analytes such as organic or biological substances, for example to be subsequently subjected to laboratory examinations of analytic or diagnostic type. For example, traditional-type swabs are known constituted by a rod and an end, at which end there is a collecting element, for example constituted by a cotton fibre wound about the rod or by a sponge or the like, for defining a collecting portion adapted for absorbing internally thereof the sample to be collected.
A further type of swab is known from international patent document WO2004086979, which describes flocked swabs comprising an elongate support body and a plurality of flocked fibres arranged at an end of the support body for defining a collecting portion for the analytes or biological samples. The types of swabs described above exhibit elongate rods which are in general made of plastic materials.
In the case of flocked swabs destined for use in collecting samples directly from human orifices, for example from the mouth, on the one hand there is the need not to make the user uncomfortable during use of the swab, while maintaining the collecting portion sufficiently soft for this aim, and on the other hand the need to succeed in efficiently collecting the biological sample, which is more difficult in cases where the collecting portions are excessively soft.
The known swabs exhibit at least the drawback of not being completely satisfactory in attaining the two requirements described above.
The main aim of the present invention is to obviate one or more of the problems encountered in the prior art. Further aims of the present invention are to provide a flocked swab for collecting and transferring biological samples which:
- facilitates and simplifies the collecting of a biological sample; and/or
- increases the efficiency, safety and reliability of the biological sample collecting process; and/or
- increases the reliability and safety of use for the user at the moment of use of the swab; and/or
- exhibits a high degree of ease of use for the user or the patient;
- guarantees a high degree of flexibility of use.
A further aim of the present invention is to provide a process for realising a flocked swab for collecting and transferring biological samples which is simple and economical to manufacture.
These aims and others besides, which will emerge more clearly from the following description, are substantially attained by a process for realizing a flocked swab and a flocked swab according to what is expressed in one or more of the accompanying claims, taken alone or in combination with one another or with any one of the aspects set down in the following.
In some further aspects of the invention, each of which can be taken alone or in combination with any one of the claims or the other aspects indicated in the following, the invention can further relate to a flocked swab for collecting and transfer of biological sample in which an end portion of a support body exhibits a second part that covers a first part provided with a plurality of reliefs not covered by the second part, and wherein the end portion is covered by a flocked layer defined by a plurality of fibres attached and arranged on the end portion of the support body by flocking, so as to cover the second part and the reliefs. In further aspects of the invention, each of which can be taken alone or in combination with any one of the claims or the other aspects indicated in the following, the invention can further relate to a swab in which:
- the first part extends at the gripping portion and the end portion;
- the second part develops at the end portion;
- the connecting portion is interposed between the end portion and the gripping portion;
- the first component is a polystyrene for general use;
- the second component is a high-impact polystyrene or anti-impact polystyrene;
- the first base surface is at least partially curved and/or at least partially straight;
- the first base surface is flat in portions;
- the reliefs emerge at portions of interruption of the planarity of the first base surface;
- one or more reliefs exhibit a same height and/or the height differs between one or more reliefs;
- the reliefs are present at the end portion of the first part in any number;
- the reliefs are arranged in any geometrical arrangement at the end portion of the first part;
- the reliefs are characterised by any shape at the end portion of the first part;
- the second part at the end portion is complementarily-shaped with respect to the geometrical profile of the first part;
- the second part exhibits a maximum thickness that is greater than the height of the reliefs;
- the second part develops at least partially internally of the first part;
- the first part exhibits one or more openings and/or one or more holes and/or one or more recesses at the end portion;
- the second part exhibits one or more protuberances and/or one or more reliefs;
- one or more protuberances and/or one or more reliefs of the second part cross the first part at one or more openings and/or one or more holes and/or one or more recesses of the first part;
- one or more protuberances and/or one or more reliefs of the second part exhibit a substantially cylindrical or hemispherical conformation;
- the second part exhibits one or more openings and/or one or more holes;
- the first part exhibits one or more protuberances and/or one or more reliefs crossing the second part at the openings and/or the holes of the second part;
- one or more protuberances and/or one or more reliefs of the first part crossing the second part at the openings and/or the holes of the second part project from the external surface of the end portion;
- one or more protuberances and/or one or more reliefs of the second part are arranged perimetrally with respect to one or more openings of the second part;
- the openings of the second part exhibit a substantially elongate conformation;
- the swab comprises at least a layer of adhesive material or vinyl adhesive or glue arranged externally at least with respect to the end portion for enabling adhesion of the plurality of fibres on the end portion;
- one or more portions at least partially uncovered of the reliefs are in contact with a layer of adhesive material or vinyl adhesive or glue.
In a further aspect thereof, taken alone or in combination with any further aspect set down in the following or with any claim, the invention further relates to a process for realizing a flocked swab according to any one of the appended claims, comprising at least a step of:
- realising the support body in a single piece by means of co-moulding of the first part, made of a first polymer material, and the second part, made of a second polymer material; and/or
- applying a layer of adhesive material or vinyl adhesive or glue at least at an external surface of the second part; and/or
- applying a layer of adhesive material or vinyl adhesive or glue also to the reliefs of the first part; and/or - drying the layer of adhesive material or vinyl adhesive or glue in a suitable oven of a conventional type so as to polymerise the glue at least partially; and/or
- applying by flocking the plurality of fibres on the end portion, in order to obtain at least a flocked collecting portion; and/or
- realising at least a weakened part on the support body at the flocked collecting portion.
A detailed description will now be made, by way of non-limiting example, of one or more preferred embodiments of the invention, in which:
figure 1 is a perspective view of a first part of the support body of a swab according to an embodiment of the present invention;
figure 2 is a lateral view of the first part of the support body of figure 1;
figure 3 is a view from below of the first part of the support body of figure 1; figure 4 is a transversal section of the first part of the support body of figure 1, made along section plane XI-XI shown in figure 2;
figure 5 is a lateral view of an end of the first part of the support body of figure
2;
figure 6 is a larger-scale view from above of the end of the first part of the support body of figure 5;
figure 7 is a lateral view of the end of the first part of the support body of figure
6, tilted with respect to figure 5;
figure 7a is a detail of a relief of figure 7;
figure 8 is a section of the end of the first part of the support body of figure 6 made along section plane VIII-VIII, shown in figure 6;
figure 9 is an axonometric view from above of an end of the first part of the support body according to an embodiment of the present invention;
figure 10 is an axonometric view from below of the end of the first part of the support body of figure 9;
figure 11 is a perspective view of a swab according to an embodiment of the present invention;
figure 12 is a detail of the end portion of the swab of figure 11; figure 13 is a lateral view of the swab of figure 11;
figure 14 is a section of the end portion of the support body made along section plane XIV-XIV shown in figure 13;
figure 15 is a view from above of the support body of figure 13;
figure 16 is a section of the end portion of the support body made along section plane XVI-XVI shown in figure 15;
figure 16a is a detail of a relief of figure 16;
figure 17 is a section of the end portion of a swab according to an embodiment of the present invention in which the end portion is flocked.
With reference to the accompanying figures, 1 denotes in its entirety a flocked swab for collecting and transfer of biological samples.
A swab 1 according to an embodiment of the present invention is for example illustrated in figure 11, where the flocked fibres are not however shown. The flocked swab 1 comprises a support body 2 which can exhibit an elongate and/or substantially rod-shaped conformation. In detail, as illustrated in the accompanying figures, the support body 2 can be a small rod, which can extend prevalently along a longitudinal development direction. The support body 2 can exhibit any section, which can vary in shape and/or dimensions along the longitudinal extension of the support body 2.
The support body 2 is provided with an end portion 2a defining a collecting portion 3 for the biological sample and a gripping portion 2b, at which the support body 2 can be manually grippable by an operator or connectable to a further gripping element such as a cap for test tubes or another suitable device. The end portion 2a of the support body 2 can be tapered along the longitudinal extension of the support body 2, as illustrated in figure 16. The gripping portion 2b is connected to the end portion 2a by means of a connecting portion 2c, which is interposed between the gripping portion 2b and the end portion 2a. The support body 2 can be provided with a plurality of reinforcing ribs 4 at least at a gripping portion 2b; the ribs 4 can extend longitudinally along the support body 2, in particular along a substantially parallel direction to the longitudinal development direction of the support body 2. The support body 2 can be composed of a first and a second part 5, 6.
The first part 5 can exhibit an elongate conformation and can develop prevalently along a longitudinal development direction that is substantially parallel to, in particular coinciding with, the longitudinal development direction of the support body 2. The first part 5 extends at the gripping portion 2b, the connecting portion 2c and the end portion 2a; in other terms, the first part 5 can develop substantially along the whole length of the support body 2. The first part 5 can be characterised by any section at the gripping portion 2b; in particular the section of the first part 5 at the gripping portion 2b can be characterised by an at least partially curved profile, as illustrated in figure 5 and figure 7. The first part 5 can exhibit a same shape as the section along the longitudinal development of the gripping portion 2b, but the shape can vary in dimensions; the dimensions of the section can in particular increase proceeding from the gripping portion 2b towards the connecting portion 2c. At the connecting portion 2c, the first part 5 can be characterised by a marked reduction of section, such as for example a marked tapering, able to reduce the dimensions and the size of the first part at the end portion 2a. By marked reduction of section and/or marked tapering of the first part 5 is meant a considerable reduction in the dimensions of the section of the first part 5 at the connecting portion 2c. The marked reduction of section of the first part 5 at the connecting portion 2c is for example illustrated in figure 5 and figure 7.
In other terms, the dimensions of the section characterising the first part 5 can vary in the following way along the development of the support body 2; the dimensions can increase from the gripping portion 2b towards the connecting portion 2c, then to reduce at the connecting portion 2c.
The first part 5 preferably exhibits one or more reliefs 7 at the end portion 2a. With reference to the geometrical profile of the first part 5, at the end portion 2a it exhibits a first base surface 10 developing along a prevalent development direction. The first base surface 10 can be at least partly flat, in particular flat in portions, and can be characterised by the presence of portions and/or tracts which are substantially flat and are intervalled by one or more reliefs 7 which function as elements which interrupt the planarity of the first base surface 10. The reliefs 7 can emerge distancingly from the first base surface 10 by a height H; the height H can be defined transversally and/or perpendicularly to the first base surface 10 of the first part 5. In particular the height H can assume a maximum value at the maximum distance of the geometrical profile of each relief 7 from the first base surface. The height H of the reliefs 7 can vary along a substantially different direction to the prevalent development direction of the first base surface 10; in particular, the maximum height H of each relief 7 can differ with respect to the maximum height H of the other reliefs 7. With reference to the geometry of the reliefs 7, the reliefs 7 can be characterised by an at least partly curved conformation, in particular substantially hemispherical. In other terms, as illustrated for example in figures 5, 6, 7, 8, 9 and 10, the reliefs 7 can constitute substantially hemispherical protuberances emerging from the first base surface 10 of the first part 5 at the end portion 2a.
The first part 5 can further exhibit a bar 13 developing emergingly from the first base surface 10, which can substantially extend over a whole width of the first part 5 at the end portion 2a, as illustrated for example in figure 6; the bar 13 can contribute to increasing the rigidity of the end portion 2a. The bar 13 can be made in a single piece with the first part 5 and/or can exhibit a relief 7; this relief 7 can emerge in height with respect to the bar 13, as illustrated in figure 5. At the end portion 2a, the first part 5 exhibits a geometrical profile at least partly straight and/or at least partly curved, as illustrated in figure 16. At the end portion 2a, the geometrical profile of the first part 5 preferably exhibits straight portions alternated with curved portions.
The first part 5 can be at least partly in contact with the second part 6, in particular at least at the connecting portion 2c and the end portion 2a of the support body 2.
As for the second part 6, it develops at the connecting portion 2c and the end portion 2a. The second part 6 develops at least partly externally of the first part 5, in particular at the end portion 2a; in other terms, the second part 6 can at least partly cover the first part 5 at the connecting portion 2c and/or at the end portion 2a. The second part 6 preferably exhibits one or more openings and/or one or more holes and/or one or more recesses at the end portion 2a; the openings and/or holes and/or recesses can function as housing seatings of the reliefs 7 of the first part 5. In other words, at the end portion 2a the first part 5 can develop at least partly internally of the second part 6, in particular at one or more openings and/or one or more holes and/or one or more recesses of the second part 6.
At the end portion 2a, the second part 6 is preferably complementarily-shaped with respect to the geometrical profile of the first part 5; for example, at the reliefs 7 of the first part 5, the second part 6 an exhibit one or more openings and/or one or more holes and/or one or more recesses.
The second part 6 can be characterised by a thickness S at the end portion 2a. The thickness S can be defined as the distance between the first base surface 10 of the first part 5 and the external surface 12 of the second part 6 and can vary along the extension of the second part 6. The thickness S can preferably vary between a minimum thickness S and a maximum thickness S; the minimum thickness S can be at least 50% or 30% or 10% of the maximum thickness S. Alternatively the thickness S can be absent at the reliefs 7, as the reliefs 7 can at least partly project from the external surface 12 of the second part 6.
The thickness S can be substantially of the same order of size as the height H; in particular, the height H of the reliefs can be at least 50% of the thickness S and/or 75% of the thickness S and/or substantially the same as the maximum thickness S.
In relation to the positioning of the reliefs 7, they can be substantially flush with the external surface 12 of the second part 6 at the end portion 2a; in other terms, the reliefs 7 do not project from the external surface 12 of the second part 6, nor are they recessed below it, as illustrated in figure 16.
In a variant, the reliefs 7 emerge from the external surface 12 of the second part 6 at the end portion 2a; in particular, the reliefs 7 can emerge by a fraction H' of the height H, as illustrated in figure 16a. The fraction H' of the height H of the reliefs 7 can be not greater than 1 mm and/or not greater than 0.2 mm and/or not greater than 0.1 mm and/or at least 0.03 mm.
In a further variant, the reliefs 7 can be at least partly uncovered at the external surface 12 of the second part 6; in other terms, the height H of the reliefs can be smaller than the thickness S of the second part. In particular, the second part 6 can exhibit a maximum thickness S that is greater than the height H; the maximum thickness S can preferably be greater than the height H by at least 0.03 mm. In other terms, the second part 6 can laterally surmount the reliefs 7, leaving however at least an uncovered portion at the top of the reliefs 7.
Returning to the characteristics of the swab 1, which can be common to all the variants of the preferred embodiment of the invention, at the end portion 2a the first part 5 of the support body 2 can exhibit a first and a second base surface 10, 11, which are reciprocally opposite. The reliefs 7, with reference to the geometry of the first part 5, can develop at the first and/or at the second base surface 10, 11; in particular, as illustrated in figure 5 and figure 7, the reliefs 7 can develop both at the first base surface 10 and the second base surface 1 1. From the geometrical and structural point of view, the reliefs 7 can be positioned and/or arranged with respect to the second base surface 11 and/or to the external surface 12 of the second part 6 similarly to what was previously described in relation to the geometry and arrangement of the reliefs 7 with respect to the first base surface 10 and the external surface 12 of the second part 6.
In a further embodiment of the present invention (not shown in the figures), at the end portion 2a of the support body 2 the second part 6 can at least partly develop internally of the first part 5. In particular, the first part 5 can exhibit one or more openings and/or one or more holes and/or one or more recesses at the end portion 2a. As regards the second part 6, it can exhibit one or more protuberances and/or one or more reliefs; in particular one or more reliefs and/or one or more protuberances of the second part 6 of the support body 2 develop at least partly internally of the first part 5 at one or more openings and/or one or more holes and/or one or more recesses of the first part 5. The reliefs and/or the protuberances of the second part 6 can preferably cross the first part 5 at the end portion 2a.
Returning to the characteristics of the swab 1 which can be common to all the variants of the various embodiments of the present invention, the swab 1 can comprise a layer of adhesive material 9 or vinyl adhesive or glue, which can be arranged externally at least of the end portion 2a in order to enable adhesion of a plurality of fibres 8 on the end portion 2a. The layer of adhesive material 9 or vinyl adhesive or glue can further be arranged externally at least of the connecting portion 2c and/or the end portion 2a, as illustrated in figure 17. In particular, the relief portions 7 emerging from the external surface 12 of the second part 6 and/or the portions of the reliefs 7 substantially flush with the external surface 12 of the second part 6 and/or the portions of the reliefs 7 at least partially uncovered at the external surface 12 of the second part 6 can be in contact with the layer of adhesive material 9 or vinyl adhesive or glue.
The collecting portion 3 can develop at an end portion of the swab 1, which collecting portion 3 can be constituted by a plurality of fibres 8. The colleting portion 3 is of a flocked type and can be made by flocking of a plurality of fibres 8 on the end portion 2a of the support body 2 able to define a flocked layer on the end portion 2a. The flocked fibres 8 on the end portion 2a can be made of a hydrophilic or non-hydrophilic material, but the collecting portion 3 is in any case hydrophilic by capillary effect thanks to the characteristics of the fibres 8 and the distribution of the fibres 5 on the support body 2. In other terms, the collecting portion 3 can exhibit a continuous layer of fibres 8 made of a substantially adsorbent material, or preferably not adsorbent in relation to the sample, but in any case comprising a plurality of capillary interstices in which a predetermined quantity of the sample can be retained by soaking, and can be efficiently released therefrom quantitatively at the chosen moment, for example by rubbing the collecting portion 3 on an appropriate release surface or by dilution of the sample in an appropriate dilutant, or by centrifuging the sample in an appropriate device.
The depositing by electrostatic flocking is done in such a way as to produce, on the pertinent end of the flocked swab 1, a substantially continuous layer - that is theoretically substantially homogeneous - of a plurality of fibres 8 with a substantially ordered deposition that is substantially perpendicular at all points to the end portion 2a of the support body 2. Each fibre 8 can be substantially parallel to the adjacent fibres 8, at least on the theoretical deposition level of the fibres 8. As already mentioned, the fibres 8 can be arranged on the support body 2 in a substantially ordered way and so as to form a substantially continuous layer on the collecting portion 3 and are further advantageously arranged on the collecting portion 3 in such a way as to define a plurality of capillary interstices able to adsorb the sample by capillarity action. The flocked collecting portion 3 can be configured and dimensioned so as to collect a suitable quantity of sample, or to collect a quantity of sample comprised for example between 5 and 1000 microlitres, between 10 and 500 microlitres, or between 20 and 200 microlitres, or between 40 and 160 microlitres. The fibres 8 can exhibit a titre comprised between 1 and 7 dtex or between 1.5 and 5 dtex, or between 1.7 e 3.3 dtex, and/or a length comprised between 0.2mm and 3 mm or between 0.6mm and 2mm. The fibres 8 can be arranged by flocking on the collecting portion 3 of the support body 2 with a surface density for example comprised between 50 and 500 fibres per mm2 or between 100 and 200 fibres per mm2 of surface of the end portion 2a of the support body 2. The layer of fibres can be characterised by an absorption capacity for example of 0.5 μΐ per mm2, or at least 0.6 μΐ per mm2, or at least 0.7 μΐ per mm2, or at least 0.75 μΐ per mm2 of surface of the support body 2. The fibres 8 can be made of a material that is substantially not hydrophilic or adsorbent towards the sample and/or in a material selected from among: polyamide (PA or nylon), rayon, polyester, carbon fibre, alginate, natural fibre, or a mixture of these materials. The fibres 8 are preferably made of nylon.
As regards the mechanical properties of the support body 2, it can be bendable without breaking at least up to reaching a degree of curvature of 5 mm, or 4mm or 3mm or 2mm or 1 mm. The support body 2 can be bendable without breaking for at least 10 cycles, or 20 cycles, or 50 cycles, or 100 cycles or 200 cycles of bending to 90° in opposite directions at an ambient temperature of about 25°C. From the dimensional point of view, the flocked swab 1 and/or the support body 2 can exhibit a longitudinal extension comprised between 50mm and 250mm or between 100mm e 200mm or between 140mm and 180mm and/or a thickness of the end portion and/or the connecting portion 2c in a perpendicular section to the longitudinal development direction of the support body 2, comprised between 0.8mm and 6mm or between 1mm and 5mm or between 2mm and 4mm. The collecting portion 3 can exhibit a longitudinal extension comprised between 3mm and 40mm or between 8mm and 30mm or between 10mm and 20mm and/or a thickness, comprising the fibres 8, comprised between 2 and 7 mm or between 4 and 6mm. The collecting portion 3 can exhibit any shape adapted to the type of sample to be collected or the collecting seating, for example rounded or with one or more sharp edges.
As regards the production process, the support body 2 is preferably realised by means of co-moulding or bi-material injection moulding; this production process of the support body 2 can be composed of two steps. In a step the first part 5 of the support body is realised with the first material by injection moulding and in another step the second part 6 of the support body 2 is realised using the second material by injection moulding. The step preceding the realising of the second part 6 is preferably carried out after the step in which the injection moulding of the first part 5 is carried out. On terminating the co-moulding or bi-material moulding comprising the two previously-described steps, the support body 2 is constituted by a single piece, in which substantially the first and the second part 5, 6 can be identified, which first and second part 5, 6 are respectively made of the first and the second material.
From the point of view of the materials used for realising the support body 2, the first part 5 can be realised in a first material and the second part can be realised in a second material. The first and the second material can be of the polymer type; the first material is preferably polystyrene-based and/or is a polystyrene and the second material is an elastomer.
The first material can be constituted by a mixture of two or more components; the first material is preferably composed of a first and a second component. The first component can be a polystyrene for general use (GPPS - General purpose polystyrene); the second component can be a polystyrene such as HIPS (High impact polystyrene). As regards the composition of the mixture, the weight percentage of the first component can be at least 50% of the weight of the whole mixture, while the weight percentage of the second component can be constituted by the difference between the 100% corresponding to the total weight of the mixture and the weight percentage of the first component; the weight percentage of the second component of the second component is therefore lower than or equal to 50% of the weight of the mixture. The first component can preferably be present in the mixture constituting the first material in a weight percentage comprised between 60% and 80%, in particular around 70%, and the second component, consequently, can be present in the mixture in a weight percentage comprised between 20% and 40%, in particular around 30%. For example, should the first part exhibit a total weight of 3g, it can be made up of the first component of 2.1 g (70% of the weight of the mixture) and by the second component of 0.9 g (30% of the weight of the mixture). The mixture constituting the first material can be homogeneous or heterogeneous.
The elastomer can preferably exhibit an elongation at break comprised between 500%) and 1000%), in particular around 750% (values calculated with a test velocity of 500 mm/min) and/or a breaking load comprised between 8 and 12 MPa, in particular between 9 and 11 MPa, preferably about 9.8 MPa (values calculated with a test velocity of 500 mm/min).
The elastomer can exhibit a tear strength comprised between 15 and 40 kN/m, in particular between 20 and 30 kN/m, preferably about 26 kN/m.
The elastomer can exhibit a Shore A hardness comprised between 30 and 70, in particular between 40 and 60, preferably about 50 (values calculated with a load application time of 3 seconds).
The end portion 2a of the support body 2 can be provided with at least a weakened part (not shown in the figures), or a break point, enabling facilitating a selective breakage of the swab 1 at the end portion 2a and a separation of at least a part of the flocked collecting portion 3 from at least another part of the flocked collecting portion 3 and from the gripping portion 2b.
The flocked swab 1 can be realised by means of a plurality of different support bodies 2, each provided with a collecting portion 3 having a different conformation or shape and specifically configured for collecting a sample in a specific location, or for collecting a specific quantity of sample. The flocked swab 1 can further comprise a container for transport of the sample having an internal containing seating and an access opening. The container, not illustrated as of known type, can be a test tube for transport of samples of biological materials or biological origin. The flocked swab 1 can further comprise a closing cap removably mountable on the access opening for selectively closing the container. The container and/or the closing cap can be made of a plastic material, for example polystyrol or polystyrene and/or of a suitable material for use with the specific sample to be collected, or in general adapted for use with biological materials of biological origin. The container and/or the closing cap and/or the support body 2 can be sterilised. The flocked swab 1 can further comprise a sealed pack (not illustrated in the figures as of known type) in which the support body 2 and/or the container and the closing cap can be housed before use for collecting a sample. The support body 2, the pack, the container and the cap can be sterile.
The invention further relates to a process for realising a flocked swab 1 of the above-described type. The process can comprise for example the following steps:
- realising the support body 2 by injection co-moulding or injection bi- material co-moulding;
- applying a layer of adhesive material or vinyl adhesive or glue at least at an external surface 12 of the end portion 2a;
- applying at the end portion 2a a plurality of fibres 8 so that the fibres 8 are arranged on the end portion 2a of the support body 2 by flocking, in particular internally of an electromagnetic and/or electrostatic field;
- drying the layer of adhesive material 9 or vinyl adhesive or glue in an appropriate oven of a conventional type in order to at least partly polymerise the adhesive material and vinyl adhesive or glue.
The step including realising the support body 2 by injection co-moulding or injection bi-material co-moulding can in turn comprise steps of:
- injection- moulding a first part 5 of the support body 2 in the first polymer material;
- injection- moulding a second part of the support body 2 in the second polymer material.
The step including the realisation of the second part 6 is preferably carried out following the step in which the injection moulding of the first part 5 is performed.
The process can further comprise the step of realising on the support body 2 at least a first weakened part at the flocked collecting portion 3 by injection moulding of the support body 2 or by means of a material removal working of the support body 2.
The present invention enables obtaining one or more of the following advantages. Firstly, the invention enables realising a process and a flocked swab produced in accordance with the process, able to obviate the problems encountered in the prior art. The invention further enables increasing the efficiency, the safety and reliability of the collecting processes of the biological samples. The swabs of the invention further exhibit a high degree of ease of use as well as high qualities of reliability and safety of use. Lastly, the invention is simple to actuate and not excessively expensive.

Claims

1. A flocked swab (1) for collecting and transfer of samples of biological material, wherein the swab (1) comprises at least:
- a support body (2) having an elongate conformation and having at least an end portion (2a) and at least a gripping portion (2b), the support body (2) comprising a first part (5) and a second part (6), the second part (6) at least partially covering the first part (5) at least at the end portion (2a); and
- a flocked layer defined by a plurality of fibres (8) attached and arranged on the end portion (2a) of the support body (2) by flocking, so as to at least partially cover at least the second part (6) of the support body (2), the plurality of fibres (8) constituting a flocked collecting portion (3) aimed at absorbing a quantity of a sample of biological material, the support body (2) being made in a single piece by co-moulding of the first part (5), in a first polymer material, and the second part (6), in a second polymer material.
2. The swab of claim 1, wherein the first polymer material is constituted by a mixture composed by a first component and at least a second component and/or wherein the first component and/or the second component is a polystyrene and/or wherein the second polymer material is an elastomer.
3. The swab (1) of claim 1 or 2, wherein, at the end portion (2a), the first part (5) exhibits one or more reliefs (7) developing at least partially internally of the second part (6) and/or wherein the second part (6) exhibits, at the end portion (2a), one or more openings in which the reliefs (7) are housed and/or wherein one or more of the reliefs (7) exhibits a curved conformation and/or a substantially hemispherical conformation.
4. The swab (1) of any one of the preceding claims, wherein the first part (5) at the end portion (2a) exhibits a first base surface (10), the first base surface (10) developing along a prevalent development direction of the support body (2), and wherein one or more of the reliefs (7) emerges distancingly from the first base surface (10) for a height (H), the height (H) being defined perpendicularly to the first base surface (10) and/or varying along a substantially parallel direction to the prevalent development direction of the first base surface (10).
5. The swab of claim 3 or 4, wherein the second part (6) at the position of the reliefs (7) is characterised by a thickness (S), the thickness (S) being defined as the distance between the first base surface (10) of the first part (5) and an external surface (12) of the second part (6), the thickness (S) being variable between a maximum thickness (S), at the first base surface (10), and a minimum thickness (S), at least at one of the reliefs (7), the minimum thickness (S) being less than 50% or 30% or 10% of the maximum thickness (S).
6. The swab of claims 3, 4, or 5, wherein the second part (6) is absent at least at a portion of the reliefs (7) and the reliefs (7) are at least partially not covered by the second part (6), and/or wherein the reliefs protrude at least partially from the external surface (12) of the second part (6), or wherein the height (H) of the reliefs (7) is at least 50% or 75% or substantially 100% of the maximum thickness (S) of the second part (6) and/or wherein the flocked layer, defined by a plurality of fibres (8) attached to and arranged on the end portion (2a) of the support body (2) by means of flocking, also covers the reliefs (7).
7. The swab (1) of any one of the preceding claims, wherein the first part (5) at the end portion (2a) exhibits a first and a second base surface (10; 11) reciprocally opposite, the reliefs (7) developing in reciprocally opposite directions at the opposite first and the second base surface (10; 11) and/or wherein the reliefs (7) emerge distancingly from the first and the second base surface (10; 11) for a height (H), the height (H) being defined perpendicularly to the first base surface (10) and/or to the second base surface (11).
8. The swab (1) of any one of the preceding claims, wherein the second part (6) exhibits an external surface (12) and the reliefs (7) are made substantially flush with the external surface (12) of the second part (6) and/or wherein the second part (6) exhibits an external surface (12) and the reliefs (7) emerge from the external surface (12) of the second part (6) by a fraction (Η') of the height (H) not greater than 1 mm and/or 0.2 mm and/or 0.1 mm and/or at least equal to 0.03 mm and/or wherein the second part (6) exhibits an external surface (12) and the reliefs (7) are recessed relative to the external surface (12) of the second part (6) by a fraction (Η') of the height (H) not greater than 1 mm and/or 0.2 mm and/or 0.1 mm and/or at least equal to 0.03 mm and/or wherein the second part (6) exhibits an external surface (12), one or more reliefs (7) being at least partially uncovered at the external surface (12).
9. A process for realising a flocked swab (1) for collecting and transfer of samples of biological material, the swab (1) comprising at least:
- a support body (2) having an elongate conformation and having at least an end portion (2a) and at least a gripping portion (2b), the support body (2) comprising a first part (5) and a second part (6), the second part (6) at least partially covering the first part (5) at least at the end portion (2a); and
- a flocked layer defined by a plurality of fibres (8) attached and arranged on the end portion (2a) of the support body (2) by flocking, so as to at least partially cover at least the second part (6) of the support body (2), the plurality of fibres (8) constituting a flocked collecting portion (3) aimed at absorbing a quantity of a sample of biological material, the process comprising at least steps of:
• producing the support body (2) by co-moulding in a single piece, the co- moulding comprising the steps of:
i. injection- moulding the first part (5) of the support body (2) in a first polymer material;
ii. injection- moulding the second part (6) of the support body (2) in a second polymer material, the second part (6) developing at least at the end portion (2a),
• applying a layer of adhesive material (9) or vinyl adhesive or glue at least at an external surface (12) of the second part (6);
• applying, at the end portion (2a), a plurality of fibres (8), the fibres (8) being arranged on the end portion (2a) of the support body (2) by means of flocking.
10. The process of the preceding claim, wherein the step of injection- moulding a first part (5) of the support body (2) is realized before the step of injection- moulding a second part (6) of the support body (2) and/or wherein at the end portion (2a) the first part (5) is conformed such as to define one or more reliefs (7) developing at least partially internally of the second part (6) and/or the second part (6) exhibits, at the end portion (2a), one or more openings in which the reliefs (7) are housed.
PCT/IB2014/064592 2013-10-10 2014-09-17 Flocked swab for collecting and transferring samples of biological material and method for producing the same WO2015052607A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2013A001673 2013-10-10
IT001673A ITMI20131673A1 (en) 2013-10-10 2013-10-10 FLOCKED BUFFER FOR THE COLLECTION AND TRANSFER OF SAMPLES OF BIOLOGICAL MATERIAL AND RELATIVE PRODUCTION METHOD

Publications (1)

Publication Number Publication Date
WO2015052607A1 true WO2015052607A1 (en) 2015-04-16

Family

ID=49585535

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/064592 WO2015052607A1 (en) 2013-10-10 2014-09-17 Flocked swab for collecting and transferring samples of biological material and method for producing the same

Country Status (2)

Country Link
IT (1) ITMI20131673A1 (en)
WO (1) WO2015052607A1 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017077415A1 (en) * 2015-11-03 2017-05-11 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
JP2018025546A (en) * 2016-07-29 2018-02-15 株式会社アクティス Sampling tool and sampling kit for biomaterial
CN112370085A (en) * 2020-11-13 2021-02-19 山东第一医科大学附属省立医院(山东省立医院) Nasal cavity or pharyngeal cavity microorganism sampling device
GB2594068A (en) * 2020-04-15 2021-10-20 Meiban Int Pte Ltd Moldable swab for collecting biological specimens
US11291986B2 (en) 2017-02-24 2022-04-05 Becton, Dickinson And Company Unique sample transfer device for an automated pipettor for processing a variety of clinical microbiological specimens
WO2022115427A1 (en) * 2020-11-24 2022-06-02 Sanderson Macleod, Inc. Brush or swab assembly and method of manufacturing a brush or swab
USD975271S1 (en) 2020-09-21 2023-01-10 Vectornate Korea Co., Ltd. Swab for collecting biological samples
USD982158S1 (en) 2020-09-21 2023-03-28 Vectornate Usa Inc. Swab for collecting biological samples
RU2800759C2 (en) * 2020-11-06 2023-07-27 Мюн кю ЧХОИ Sample collector for selection and transportation of samples of biological fluids and method for its manufacture

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0784949A2 (en) * 1996-01-18 1997-07-23 John Stephen Griffiths Mouth Cleaners
WO2004086979A1 (en) 2003-04-01 2004-10-14 Copan Innovation Limited Swab for collecting biological specimens
US20050065539A1 (en) * 2003-08-20 2005-03-24 Muser Andrew P. Cell scraper
US20120171712A1 (en) * 2011-01-05 2012-07-05 Copan Italia S.P.A. Process for Realising a Device for Collecting and Transferring Samples for Molecular Biology
US20130245495A1 (en) * 2010-12-24 2013-09-19 Ansheng Li Flocking swab for biological sampling quantitatively and method for making the same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0784949A2 (en) * 1996-01-18 1997-07-23 John Stephen Griffiths Mouth Cleaners
WO2004086979A1 (en) 2003-04-01 2004-10-14 Copan Innovation Limited Swab for collecting biological specimens
US20050065539A1 (en) * 2003-08-20 2005-03-24 Muser Andrew P. Cell scraper
US20130245495A1 (en) * 2010-12-24 2013-09-19 Ansheng Li Flocking swab for biological sampling quantitatively and method for making the same
US20120171712A1 (en) * 2011-01-05 2012-07-05 Copan Italia S.P.A. Process for Realising a Device for Collecting and Transferring Samples for Molecular Biology

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017077415A1 (en) * 2015-11-03 2017-05-11 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
US10864518B2 (en) 2015-11-03 2020-12-15 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
EP3834941A2 (en) 2015-11-03 2021-06-16 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
EP3834941A3 (en) * 2015-11-03 2021-08-18 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
JP2018025546A (en) * 2016-07-29 2018-02-15 株式会社アクティス Sampling tool and sampling kit for biomaterial
US11291986B2 (en) 2017-02-24 2022-04-05 Becton, Dickinson And Company Unique sample transfer device for an automated pipettor for processing a variety of clinical microbiological specimens
GB2594068A (en) * 2020-04-15 2021-10-20 Meiban Int Pte Ltd Moldable swab for collecting biological specimens
USD975271S1 (en) 2020-09-21 2023-01-10 Vectornate Korea Co., Ltd. Swab for collecting biological samples
USD982158S1 (en) 2020-09-21 2023-03-28 Vectornate Usa Inc. Swab for collecting biological samples
RU2800759C2 (en) * 2020-11-06 2023-07-27 Мюн кю ЧХОИ Sample collector for selection and transportation of samples of biological fluids and method for its manufacture
CN112370085A (en) * 2020-11-13 2021-02-19 山东第一医科大学附属省立医院(山东省立医院) Nasal cavity or pharyngeal cavity microorganism sampling device
WO2022115427A1 (en) * 2020-11-24 2022-06-02 Sanderson Macleod, Inc. Brush or swab assembly and method of manufacturing a brush or swab

Also Published As

Publication number Publication date
ITMI20131673A1 (en) 2015-04-11

Similar Documents

Publication Publication Date Title
WO2015052607A1 (en) Flocked swab for collecting and transferring samples of biological material and method for producing the same
EP3014240B1 (en) A flocked swab and a method for collection and transfer of samples of biological material
US9170177B2 (en) Device and a method for collecting and transferring samples of biological material
ITMI20110004A1 (en) PROCEDURE FOR REALIZING A DEVICE FOR THE COLLECTION AND TRANSFER OF SAMPLES FOR MOLECULAR BIOLOGY
ES2297406T3 (en) TORUNDA TO COLLECT BIOLOGICAL SAMPLES.
ES2850123T3 (en) Device for collecting, transferring and storing samples of a biological and / or chemical material
RU2011103097A (en) ABSORBABLE PRODUCT WITH UPPER LAYER WITH FIBER BUNDLES
US20130245495A1 (en) Flocking swab for biological sampling quantitatively and method for making the same
CN1775194A (en) Absorbing article
WO2012013953A2 (en) Apparatus and method for storing and reusing remnants of soap
WO2012080356A2 (en) Cosmetic mask intended to be applied on a surface of the body, associated use and method
CN101103931B (en) Device containing absorbent stuffing used for collecting clinical diagnose analyzing sample
FR2911106B1 (en) SUPPORT FOR ATTACHING A PLASTIC BODY COMPONENT TO THE STRUCTURE OF A VEHICLE, CORRESPONDING BODY ELEMENT AND USE OF THE SUPPORT.
CN105536128A (en) Applying and smearing device for administration of auxiliary semi-solid preparation and liquid preparation
WO2022190726A1 (en) Specimen sampling swab
JPH03114424A (en) Disposable cotton swab for makeup or its removal
CN217611158U (en) Disposable medical swab
CN107149951B (en) A kind of tool plug container is tied up related
KR980700928A (en) FLEXIBLE DISPENSER AND METHOD FOR DISPENSING SORBENT NON-WOVEN WEBS CONTAINING MICROFIBERS
JP2012081045A (en) Pad for wound surface, and manufacturing method of the same
RU33319U1 (en) Device for storing and applying the drug (options)
Lisnevskyi THE STRUCTURE OF SUPPORT DESIGN DECISIONS SYSTEM DURING THE DESIGNING OF GLASS UNIT
CA2264344A1 (en) Hand gliders
RU2004119140A (en) HYGIENIC WAND

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14786339

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 14786339

Country of ref document: EP

Kind code of ref document: A1