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
• • 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
  • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
• • 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
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B2010/0216—Sampling brushes

Definitions

• the present invention relates to the technical field of devices for taking a biological sample - human or animal - by brushing or scraping a body surface (mouth, nose, throat, etc.) with a swab.
• the present invention is not limited to nasopharyngeal sampling, and can be used for the sampling of other types of biological samples such as amniotic fluid, aqueous humor , bile, blood, breast secretion, cerebrospinal fluid, interstitial fluid, mucus, plasma, pleural fluid, saliva, synovial fluid, urine etc.
• Devices for taking a biological sample are used in many fields which require the collection and analysis of biological material such as the field of medical analyses, or even bacteriological analyses, for example in the agro-food, cosmetics, environmental and pharmaceutical.
• a sampling device comprising: - a nasal swab,
• the swab is used to collect the biological sample to be analyzed. Once the biological sample has been collected, the swab is placed in the sterile container containing the reactive liquid, then the container is closed with the cap. The collection device is then sent to an analysis laboratory, where an operator unpacks it and uses the reagent liquid to screen for the presence of the pathogen.
• the operator When unpacking the sampling device, the operator extracts the swab. This extraction step can be performed using grasping forceps, which must be sterilized after each use. Such a procedure is unsuitable for laboratories carrying out hundreds (or even thousands) of analyzes each day.
• the swab comprises: a rod, a sampling tip at one end of the rod, and a cap at the end of the rod opposite the sampling tip.
• the cost of such a sampling device is too high.
• Sampling devices including a container, a swab and a swab capture cap are also known.
• the capture cap is designed to attach one end of the swab rod to the cap.
• the capture plug comprises deformable fins between which the end of the rod opposite the sampling tip is intended to be force-fitted to removably secure the capture plug and the swab. Even if such a sampling device makes it possible to dispense with the use of pliers to extract the swab from the container when unpacking the sampling device, the thinness of the deformable fins can induce unexpected separation of the capture cap and of the swab during the extraction operation. Since the capture cap is single-use, it is very difficult for the operator to reattach the capture cap to the swab. The use of gripping pliers then becomes necessary, which is not satisfactory.
• An object of the present invention is to propose a solution (in particular a cap and a collection device including such a cap) making it possible to remedy at least one of the aforementioned drawbacks.
• the invention proposes a cap for a device for collecting a biological sample, the device comprising a recovery container including an upper opening, as well as a swab for collecting the sample, the cap comprising:
• the internal element comprises at least first and second complementary clamping members each extending parallel to the longitudinal axis and each including a respective free end, and in that the cover is deformable, the application of a pinching force on the cap inducing the movement of the free ends of the first and second clamping members towards each other, so that:
• Preferred but non-limiting aspects of the cap according to the invention are the following:
• the internal element may comprise a longitudinal through slot, said slot dividing the internal element into two portions forming the first and second complementary clamping members;
• the internal element can be of cylindrical shape, the longitudinal axis forming an axis of symmetry of the internal element, said internal element comprising: o a concave frustoconical base opposite the cover, o a blind channel extending along the longitudinal axis between the concave frustoconical base and the cover;
• the cap may further comprise an annular flange at the periphery of the lid, said flange projecting perpendicular to the plane of the lid, and being arranged so as to extend around the upper opening when the cap is positioned on the container, the flange forming a means of manipulation of the cap adapted for the application of the pinching force;
• the collar may comprise at least two slats separated from each other, each slat having the shape of a portion of a cylinder;
• the collar may comprise: o an internal face intended to face the container, and o an external face opposite the internal face, the external face including a pattern to increase its surface roughness;
• the internal element may comprise a thread between its end connected to the cover and its free end, said thread being intended to cooperate with a corresponding thread provided on the container.
• the invention also relates to a device for taking a biological sample, the device comprising:
• a recovery container defining an internal volume, the container including at least one side wall, a bottom and an upper opening,
• a collection swab including a rod and a sampling tip at one of the ends of the rod, at least a portion of the rod being intended to be positioned in the internal volume of the container after collection of the sample, remarkable in that it further comprises a cap as described above, said cap being adapted to be positioned on the container to cap the upper opening.
• the diameter of the blind channel can be less than or equal to the diameter of the rod of the swab.
• FIG. 1 is a schematic representation of a biological sample collection kit
• FIG. 2 is a schematic representation in perspective of a first embodiment of the cap
• FIG. 3 is a top view of the first cap embodiment
• FIG. 4 is a sectional view of the first cap embodiment
• FIG. 5 is a schematic representation in perspective of a second embodiment of the cap
• - Figure 6 is a top view of the second cap embodiment
• - Figure 7 is a sectional view of the second cap embodiment
• FIG. 8 is a schematic representation in perspective of a third embodiment of the cap
• FIG. 9 is a top view of the third cap embodiment
• FIG. 10 is a sectional view of the third cap embodiment
• FIG. 11 is a schematic representation in perspective of a fourth embodiment of the cap
• FIG. 12 is a top view of the fourth cap embodiment
• FIG. 13 is a sectional view of the fourth cap embodiment.
• Such a cap can be integrated into a kit - hereinafter referred to as "device” - for taking a biological sample.
• such a sampling device conventionally comprises:
• the container 1 can be cylindrical in shape. It comprises one (or more) side wall(s) 11, a bottom 12 at one of the ends of the side wall 11, and an upper opening 13 for inserting the swab 2.
• This container 1 constitutes a housing for transporting the swab 2 once the biological sample has been taken. More specifically, the container 1 is used for transporting the swab between the sampling area and the medical analysis laboratory allowing the processing of the biological sample taken.
• the container also contains one (or more) reactive fluid(s) in which the swab is immersed. It is (are) this reactive fluid(s) which is (are) analyzed to detect the presence of a pathogenic agent. Since such a container is known to those skilled in the art, it will not be described in more detail below.
• Swab 2 is used to collect the biological sample. It comprises a rod 21 of variable length, and a sampling tip 22 at one end of the rod 21.
• the sampling tip 22 is intended to be brought into contact with a sampling zone of a patient (sinus, mouth nose, auditory canal, etc.) to collect the biological sample, for example by brushing or scraping.
• the sampling tip can be made of different materials (cotton, plastic, etc.) and have different shapes depending on the intended application. Since such a swab is known to those skilled in the art, it will not be described in more detail below.
• the cap 3 makes it possible to close the container 1 once the swab 2 has been introduced into the container 1 via the upper opening 13.
• the cap 3 comprises a lid 31 intended to cover the upper opening 13 of the container 1.
• the cap 3 comprises also an internal element 32 intended to be inserted into the container 1 via the upper opening 13.
• the internal element 32 comprises at least two clamping members 312, 322 spaced apart by a distance d. These clamping members 321, 322 define a space for receiving the end 23 of the rod 21 opposite the sampling tip 22.
• the distance d between the clamping members 312, 322 can be substantially equal to or less than the rod end diameter 23 21 opposite to the sampling tip 22.
• the cap 3 may also include a thread (not shown) intended to cooperate with a complementary thread 14 of the container 1 in order to removably fix the cap 3 on the container 1.
• the cap 3 may include an annular collar 33 adapted to extend around the container 1 when the cap 3 is positioned on the upper opening 13. This collar may advantageously include a pattern on its outer face to facilitate the gripping of the cap by the 'operator.
• the cap 3 of which different variants will now be described, makes it possible to dispense with the use of grippers to extract the swab from the container during the analysis of the sample by an operator.
• the first and second embodiments described below also provide a function of pinching the end 23 opposite the sampling tip 22. This makes it possible to guarantee reproducible attachment of the swab 2 on the cap 3. Indeed, the pinching function makes it possible to compensate for any deformation of the clamping members 321, 322, so that the cap 3 can be reused several times, unlike the caps of the prior art which are for single use.
• FIG. 2 to 4 there is illustrated a first embodiment of the cap according to the invention.
• Cap 3 includes:
• the cover 31 is substantially cylindrical, and of axis of symmetry A-A'.
• the cover 31 comprises diametrically opposed concave notches 311, said concave notches 311 extending longitudinally along the axis A-A'. These concave notches 311 define gripping zones for the thumb and index finger of an operator.
• the internal element 32 is also substantially cylindrical and has an axis of symmetry A-A'.
• the internal element 32 comprises a blind channel 325 extending along the longitudinal axis A-A' between its free end and the cover 31.
• This blind channel 325 is intended to receive the end 23 opposite the end piece. sampling 22.
• the diameter of the blind channel 325 is substantially equal to or less than the diameter of the rod 21 .
• the base 324 of the internal element 32 opposite the cover 31 is of concave frustoconical shape. This makes it easier to insert the end 23 of the rod 21 into the blind channel 325.
• the internal element 32 comprises a longitudinal through slot 323 passing through the axis A-A'.
• This through slot 323 makes it possible to define first and second complementary clamping members 321, 322 each extending parallel to the longitudinal axis A-A'.
• the through slot 323 extends from the free end of the internal element 32 and to a certain depth in the cover 31. This makes it possible to make the cover 31 deformable so that the application on the cover 31 of a pinching force by the operator's thumb and index finger causes the free ends of the first and second clamping members 312, 322 to move towards each other.
• the pinching force applied by the operator to the lid 31 makes it possible to maintain the first and second clamping members 312, 322 pressed against the rod 21 of the swab 2. This avoids any unexpected separation of the swab 2 and the cap 3 during the manipulation of the cap 3 by the operator, which facilitates the extraction of the swab 2 from the container 1.
• the cap 3 comprises an internal element 32 identical to that described with reference to the first embodiment. This internal element will not be described again.
• This second embodiment differs from the first embodiment in that the cover 31 comprises a substantially circular plate.
• the internal element 32 extends along the longitudinal axis A-A', perpendicular to the substantially circular plate.
• the cap 3 can be made of polypropylene or any other material known to those skilled in the art.
• the thickness of this plate can be between 0.5 and 5 millimeters. In all cases, the thickness or (and) the material constituting the cover 31 is (are) provided to allow a curved deformation of the cover 31 under the effect of a pinching force.
• Cover 31 also includes an annular flange extending parallel to the internal element.
• the annular flange is composed of two semi-cylindrical strips 311, 312 diametrically opposed. These slats 311, 312 define gripping zones for the operator's thumb and index finger.
• the arc Alpha of the curved surface of each strip 311, 312 is between 45° and 170°.
• the principle of operation of such a cap 3 is as follows: the operator positions the cap 3 on the upper opening 13 of the container 1 . He inserts the inner element 32 into the container 1, the free end of the inner element 32 comes into contact with the end 23 of the swab 2 opposite the sampling tip 22.
• the tapered base 324 facilitates the movement of the end 23 to the blind channel 325.
• the end 23 enters the blind channel 325.
• the operator then continues the insertion of the internal element 32 into the container 1, which causes the insertion of rod 21 in blind channel 325.
• the swab 2 is secured to the cap 3.
• the operator applies a pinching force on the slats 311, 312 of the collar. This pinching force is transmitted to the rod 21 via the first and second clamping members 321, 322. This makes it possible to limit any unexpected detachment of the swab during its extraction.
• the internal element 32 comprises a plurality of pins 326a-326d extending perpendicular to the cover 31.
• Each pin 326a-326d may consist of a cylinder extending parallel to the longitudinal axis A-A' .
• each pin 326a-326d may consist of a truncated cone whose axis of revolution is parallel to the axis A-A'. This facilitates the insertion of the end 23 of the rod 21 between the pins 326a-326d of the internal element 32 when closing the container 1 with the cap 3.
• the ratio of the length to the diameter of each spike may be between 5 and 20, preferably between 8 and 15.
• the distance "e" between the pins 326a-326d is substantially equal to or less than the diameter of the end 23 of the rod 21 opposite the sampling tip 22. This allows removable attachment of the swab 2 to the cap 3, in order to facilitate the manipulation of the swab 2 by an operator during the treatment of the biological sample taken.
• This embodiment differs from the third embodiment in that the cap 3 comprises a side skirt 327 extending around the pins 326a-326b of the internal element.
• the dimensions of the side skirt 327 are adapted so that the side skirt is insertable into the container.
• the cap 3 described above makes it possible to make the connection between the cap and the swab more reliable. This facilitates the extraction of the swab for the analysis of the sample taken.
• the proximal part of the cap allows it to be manipulated, while the distal part of the cap (or active end) allows the swab to be held.
• the cap according to the first two embodiments is arranged to allow the transfer of a pinching force (or "pinch” according to the English terminology) applied to the cap towards the stem of the swab to hold the swab and cap together.
• the pinching force is applied in a direction belonging to a secondary plane containing the secondary longitudinal axes of the first and second clamping members, and at a height between the cover and the free ends of the first and second clamping members, preferably at a height close to the lid.
• cap can, for other applications, be used independently of a sampling kit.
• the cap according to the invention can be used for gripping any type of object of tubular shape.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Hematology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Pathology (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Pulmonology (AREA)
• Sampling And Sample Adjustment (AREA)
• Apparatus Associated With Microorganisms And Enzymes (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=74045730

Family Applications (1)

Country Status (3)

Family Cites Families (5)

• 2020
  • 2020-10-08 FR FR2010307A patent/FR3114956B1/fr active Active
• 2021
  • 2021-10-08 EP EP21783321.9A patent/EP4225151A1/de active Pending
  • 2021-10-08 WO PCT/EP2021/077808 patent/WO2022074175A1/fr unknown

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