BODILY SAMPLE COLLECTION DEVICE

Abstract

A device for the collection of a bodily sample from an anatomical cavity, the device includes an impermeable sheath arranged and configured to receive a user's finger, the sheath comprising a distal end and a proximal end; an absorbent body positioned at the distal end of the sheath; and a hermetically closable pad positioned at the proximal end of the sheath.

Claims

1. A device for the collection of a bodily sample from an anatomical cavity, the device comprising: an impermeable sheath arranged and configured to receive a user's finger, said sheath comprising a distal end and a proximal end; an absorbent body positioned at the distal end of the sheath; and a hermetically closable pad positioned at the proximal end of the sheath.

2. The device according to claim 1, wherein the pad comprises a first surface facing, in use, the cavity, said first surface comprising an adhesive layer.

3. The device according to claim 1, wherein the pad comprises a line of weakness about which the pad can be folded.

4. The device according to claim 2, wherein the adhesive is a pressure-sensitive adhesive.

5. The device according to claim 2, wherein the adhesive is a reseal adhesive.

6. The device according to claim 2, wherein the adhesive layer is covered by a removable film.

7. The device according to claim 6, wherein the surface of the removable film facing, is use, the cavity, comprises an absorbent layer.

8. The device according to claim 2, wherein the pad comprises a second surface facing, in use, away from the cavity, said second surface comprising an impermeable layer.

9. The device according to claim 1, wherein the absorbent body comprises an absorbent layer.

10. The device according to claim 1, further comprising a removal string coupled to the distal end of the sheath.

11. The use for collecting a bodily sample from an anatomical cavity, of a device according to claim 1.

12. The use according to claim 11, wherein the anatomical cavity in the vaginal cavity, the rectal cavity or the buccal cavity.

13. A method for collecting a bodily sample from an anatomical cavity comprising the steps of collecting a sample from said anatomical cavity using a device according to claim 1 and hermetically closing the proximal end of the sheath.

Description

[0032] The invention will be further described with reference to the drawings and figures, in which

[0033] FIG. 1 is a schematic representation of a device according to the present invention in its insertion and collection configuration;

[0034] FIG. 2 is a schematic representation of the device of FIG. 1, being pulled out from the patient's cavity after collection of the sample;

[0035] FIG. 3 is a schematic representation of the device of FIG. 1 in its withdrawn configuration;

[0036] FIG. 4 is a schematic representation of the device of FIG. 1, with the cover being removed from the pad; and

[0037] FIG. 5 is a schematic representation of the device of FIG. 1, in its closed configuration.

[0038] Referring to FIG. 1, there is illustrated a device 1 for the collection of a bodily sample from an anatomical cavity, the device 1 comprising an impermeable sheath 2 arranged and configured to receive a user's finger (not shown), said sheath 2 comprising a distal end D and a proximal end P; an absorbent body 3 positioned at the distal end D of the sheath 1; and a hermetically closable pad 4 positioned at the proximal end P of the sheath 2.

[0039] The sheath 2 is substantially tubular. The sheath 2 comprises or consists of a material which is flexible at least in the radial direction so as to allow the user to insert a finger therein. The sheath 2 comprises a fluid impermeable material to prevent bodily fluids from soiling the user's finger.

[0040] The sheath 2 is preferably closed at its distal end to prevent bodily fluids absorbed by the absorbent body 3 from soiling or being contaminated by the user's finger. At its proximal end, the sheath 2 is opened to allow the user to insert his or her finger into the sheath 2. The opening at the proximal end of the sheath 2 substantially corresponds in dimensions and shape to an opening through the pad 4.

[0041] The pad 4 has a first surface 4a facing, in use, the patient's anatomical cavity and a second surface 4b which in use, faces away from the anatomical cavity. The first surface 4a comprises a layer of adhesive, which is preferably a pressure-sensitive adhesive. The layer of adhesive is covered by a removable film 5.

[0042] The second surface 4b of the pad 4 preferably comprises an impermeable layer. In a preferred embodiment, the sheath 2 extends through the aperture of the pad 4 and along the second surface 4b of the pad 4 to form an impermeable layer.

[0043] The pad 4 preferably comprises a line of weakness 7 about which the pad can be folded to hermetically close the sheath 2.

[0044] With reference to FIG. 4, the removable film 5 has a first surface 5a facing, in use, the patient's anatomical cavity and a second surface 5b which faces the layer of adhesive on the first surface 4a of the pad 4.

[0045] The dimensions and shape of the removable film 5 correspond to the dimensions and shape of the pad 4, but may comprise a tab (not shown) to facilitate the peeling away of the film 5 from the pad 4. The film 5 comprises an opening which substantially corresponds in dimensions and shape to the opening of the pad 4 and the sheath 2.

[0046] The first surface 5a of the film 5 may comprise an absorbent layer to absorb any fluid leaking from the anatomical cavity. The film 5 may comprise an impermeable layer, for example on its second surface 5b, to prevent contamination of the sample by the adhesive or of the adhesive by the sample.

[0047] An absorbent body 3 is secured to the distal end or tip of the sheath 2. In the device 1 shown in the figures, an absorbent sheet is secured to the distal end of the sheath 2, by bonding, gluing, sealing, sewing, welding or any other suitable securing method.

[0048] A string or cord 6 is coupled to the distal end of the sheath 2 to assist with the removal of the device 1 from the anatomical cavity.

[0049] In use, the device 1 is preferably packaged with the absorbent body 3 positioned inside the sheath 2 (see configuration of FIG. 3) so as to avoid any contamination before use. The user (i.e. the person collecting the sample) positions his or her finger at the distal end of the sheath 2, pushes the absorbent body 3 through the aperture 8 of the pad 4, and in the process, inserts his or her finger in the sheath 2. The absorbent body 3 is now exposed (see FIG. 1) and the device 1 is ready for insertion into the anatomical cavity of the patient.

[0050] The user inserts the sheathed finger through the anatomical orifice and into the anatomical cavity, for example, the vaginal cavity. Once the absorbent body 3 is at the target area, it can absorb any surrounding bodily fluid, or the user can contact the absorbent body 3 against the vaginal walls by bending his or her finger.

[0051] Once the sample has been collected, the absorbent body 3 is removed by pulling on the string 6. The sheath 2 reversed itself and the absorbent body 3 is now back inside the sheath 2 (see FIG. 3).

[0052] With reference to FIG. 4, the film 5 is peeled off the pad 4, thereby revealing the adhesive layer on the first surface 4a of the pad 4. The pad 4 is folded along the line of weakness 7 so that the adhesive layer contacts itself and pressure is applied on the second surface 4b of the pad 4 so as hermetically close the sheath 2. The sample is now contained within the sheath 2, which is hermetically closed and can be placed in a bag or enveloped for sending to the laboratory.

[0053] The technician can open the pad 4, insert his or her finger in the same manner so as to expose the sample. The sample can be removed by any suitable method. For example, the technician can directly place the sheathed finger in a suitable medium to extract, dilute or dissolve the sample from the absorbent body 3. If multiple analysis are to be carried out, the technician may remove an aliquot and reseal the sheath 2 for future extractions.

[0054] Thus, from the above description, it can be seen that the present invention provides a device and a method for the safe, sterile and hygienic collection of a sample from a patient's anatomical cavity. The device according to the present invention does not comprise any rigid or sharp parts, which could injure or hurt the patient so that the collection process is painless. The device is easier to manipulate than conventional swab stick so that it allows patients to opt of self-collection. The risk of contamination is minimised as there is no contact with the absorbent body by the user. The sample collection process also minimises the risk of soiling the user's or patient's fingers.