The present invention provides a cervical sample collection device and a method of sample collection thereof. More specifically, the device contains a solution which can be plunged into the cervix and then re-collected and provided to laboratory or hospital for analysis.

BACKGROUND OF THE INVENTION

The collection and analysis of cellular samples for the detection of precancerous and cancerous lesions are vital steps in the prevention, diagnosis and treatment of cervical, and other diseases. A Pap Test is performed as a risk assessment and is a basic screening procedure. The Pap test is performed by collecting a smear of the cervix which is usually performed by opening the vagina via a speculum and then a scraper or brush is used to gently collect the cells. These cells are then examined under a microscope to see any anomalies among them.

At present this is the most effective method for adequate sampling, which is basically a two-step process using two instruments, the extended-tip spatula or speculum and an endocervical brush. The endocervical brush is a nylon brush and there are a lot of drawbacks in using it for sampling.

All the brushed devices available do not have means to precisely control the depth of sampling. This provides a severe challenge as patients may get hurt and lead to internal bleeding. The situation gets more complicated in case of pregnant ladies wherein the location of the transformation zone may descend, and practitioners are reluctant to sample deeply and may choose to abandon the endocervical brush altogether, also in cases where genital warts are present on the inner side of vagina, the brush based sample collection methods might not be possible.

Another disadvantage is, ease of transfer of the collected samples from the endocervical brush to the slides as it is not easy to dislodge the cells within the bristles as this may result in losing valuable diagnostic material and increasing the risk of false diagnosis.
Further, there are always chances of contamination while transferring the diagnostic material from endocervical brush to a glass slide.

Another major drawback is, chance that the brush may completely miss the transformation zone that leads to inaccurate sampling and hence multiple testing must be done causing unnecessary discomfort, bleeding and unjustified medical expenses.

Further, the samples collected need to be rinsed in the fixative solution otherwise the cervical mucus tends to air-dry and manual action alone of removal from bristles may be enough to dry the sample cervix tissue.

The closest prior art available in the public domain limits its solution in providing scrapers that are shaft mounted to control the depth of scraping and a liquid medium to store the cells so that they don’t dry.

In US20120157878A1, provides a device that allows women to collect and preserve cervical cell samples to be later tested in a clinical analysis laboratory. It includes a cylindrical body, housing a shaft that axially pushes and retracts a cell collector. The penetration necessary for the insertion device is self-induced by the woman, and therefore has morphological characteristics that are adaptable to the anatomical shape of the vagina. The shaft slides inside the device to position the cell collector on the surface of the cervix. Once the sample is taken, the shaft is retracted, and the cell collector collapses as a consequence of the sliding inside the device, and positioning itself inside the handle, which may contain a liquid medium for cellular containment;

WO2016114644A1, the invention provides a device for the self-sampling of epithelial cells, intended to provide a tool that can supply cells that can be used in subsequent analyses, preferably in analyses focused on the detection of cervical cancer or the human papillomavirus. The device comprises a cylindrical structure having two main sections, namely a gripping handle and an insertion tube, with a central rod extending through the cylindrical structure and comprising a retraction and push mechanism, allowing a sample to be taken from a patient quickly and effectively; and

WO2019064124A1 provides a device (10) for collecting a sample from a uterus (14). The device includes a core (24) defining a core outer surface (28) and a distal brush section (30) provided with brush bristles (32) extending from the core outer surface (28). A sheath (26) receives at least part of the core (24) thereinto and defines axially opposed sheath proximal and distal ends (34 and 36). The core (24) and sheath (26) are movable relative to each other between a device retracted configuration and a device expanded configuration, wherein, in the device retracted configuration, the brush bristles (32) are compressively contained within the sheath (26) in a brush bristle compressed configuration, and, in the device expanded configuration, the brush bristles (32) are outside the sheath (26), distally to the sheath distal end (36), in a brush bristle expanded configuration wherein the brush bristles (32) span a larger volume than in brush bristle compressed configuration. Also, a kit including the device and methods of using the device.

Therefore, none of the cited prior art provides a device that does not scrape the cervix for tissue collection. Hence, there is a technological gap wherein the convention method of sample collection from cervix is dangerous and inadequate. The present invention takes account of all the drawbacks and provides a cervical sample collection device and a method of sample collection thereof.

OBJECT(S) OF THE INVENTION

The main object of the present invention is to provide a sampling device that obviates the painful process of using a scraping brush by providing a device that introduces sample stabilizing solution into the cervix for washing and collecting the cervical tissue and re-collect the sample loaded exocervical liquid for examination.

Yet another object of the invention is to provide a re-usable and do it yourself device.

Yet another object of the invention is to formulate a sample stabilizing solution which helps in stabilizing DNA and RNA of cervical cells and prevent drying.

SUMMARY OF THE INVENTION

Accordingly, the present invention takes into account the limitation and the drawbacks of the prior art and provides a plunger-based sampling device that stores a liquid, the plunger on being pressed empties the liquid into the cervix via extrusion plunger action and the liquid can then be re-collected in the sampling device via intrusion plunger action. The liquid flushes the cervix without causing any unwanted discomfort and collects cells for sampling. Further, the liquid flushes more surface area as compared to a swab or brush bristle, which enhances the chance of collecting sample from the localized infected area.
In an embodiment of the present invention provides a cervical sample collection device (100) is shown comprises of a hollow barrel (102), a plunger (104) mounted on a coil spring (110), a distended hollow center storing sample stabilizing solution (112), and a stopper (106) at the anterior end. The plunger (104) stays at its expanded position or normal position due force exerted by coil spring (110) inside the barrel (102). The sample stabilizing solution (112) is stored at the bottom of the barrel (102) and a stopper (106) is provided to avoid leakage. The anterior end (114) of the barrel (102) is designed for easy insertion into the vaginal cavity and for positioning the cervical sample collection device (100) to obtain sample cervical cells. While the anterior end of the barrel (114) is inserted into the cervix, the user is required to hold the plunger (104) to maintain a compressed position or away from the normal position counteracting the force exerted by coil spring (110). The compressed position or away from the normal position of the plunger (104) pushes sample stabilizing solution (112) into the cervix. Once the user releases the hold, the plunger (104) attains the original expanded position or normal position, which draws all the liquid in and hence facilitates exocervical sample collection. However, one skilled in the art will realize, however, that the barrel (102) can have other cross-sectional geometries and still function as intended.

In another embodiment of the present invention, the method of sampling the cervix comprises steps of removing the stopper (106) from the anterior end (114); inserting the sampling device into the cervix pushing the plunger (104) and emptying the sample stabilizing solution (112); holding the plunger for prescribed duration to stop the plunger moving back to its initial position; and releasing the plunger allowing the sample loaded exocervical liquid cervix liquid to fill the sampling device. This liquid can be further provided to the laboratories for analysis such as LBC, PAP, HPV DNA, HPV Genotyping, Neisseria, Gonorrhoea, Chlamydia, Bacterial Vaginosis, Trichomonas etc.

In yet another embodiment of the present invention, the invention provides a sample stabilizing solution comprising 50-120g of NaCl, 1-10g of KCl, 5-20g of Na2HPO4 and 0.5-5g of KH2PO4, and optionally EDTA, BSA, or trehalose in 500-2000ml of distilled water; having a pH of 7 ± 1.

In yet another embodiment of the present invention, the invention provides a method of preparing sample stabilizing solution, comprising steps of dissolving 80g of NaCl, 2g of KCl, 14.4g of Na2HPO4 and 2.4g of KH2PO4 in 800ml of distilled water; adjusting pH to 7.4 with HCl; and making up the final volume to 1000ml.

In another embodiment of the present invention, the invention provides a method of preparing sample stabilizing solution, comprising steps of dissolving 80g of NaCl, 2g of KCl, 14.4g of Na2HPO4 and 2.4g of KH2PO4 in 800ml of distilled water; adjusting pH to 7.4 with HCl; and making up the final volume to 1000ml, wherein sample loaded exocervical liquid showed stability of DNA for up to 2 months at room temperature and other cells for up to 5 days at room temperature.

BRIEF DESCRIPTION OF THE DRAWING(S)
The object of the invention may be understood in more details and more particularly description of the invention briefly summarized above by reference to certain embodiments thereof which are illustrated in the appended drawings, which drawings form a part of this specification. It is to be noted, however, that the appended drawings illustrate preferred embodiments of the invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective equivalent embodiments.
Figure 1 shows side view of cervical sample collection device according to the embodiments of the present invention;
Figure 2 shows cross-sectional view of cervical sample collection device according to the main embodiments of the present invention;
Figure 3 shows prospective view of a cervical sample collection device according to the embodiments of the present invention;
Figure 4 elucidates the process of sampling wherein sample stabilizing solution (112) is plunged into cervix by continuously pressing the plunger (104); and
Figure 5 elucidates the process of sampling wherein the stabilizing solution (112) is plunged back in thereby collecting the sample.

DETAILED DESCRIPTION OF THE INVENTION
The present invention now will be described hereinafter with reference to the detailed description, in which some, but not all embodiments of the invention are indicated. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. The present invention is described fully herein with non-limiting embodiments and exemplary experimentation.
The present invention relates to a cervical sample collection device which permits obtainment of cervical cell samples and a method for using the device. In particular, the present invention permits patient to self-sample to obtain cervical cells. The invention allows the user to collect the sample at their own convenience without undue discomfort and pain. Further, the exocervical sample collection device facilitates the collection of cervical cell samples in such a way as to minimize or even eliminate contamination of the sample with other materials.
In an embodiment of the present invention provides a plunger-based sampling device (100) comprising a hollow barrel open at the anterior and the posterior end, a plunger (104) mounted on a spring (102) inserted from the posterior/distal end, a distended hollow center storing sample stabilizing solution, and a stopper (106) at the anterior end of the plunger (114).
In another embodiment of the present invention, the method of collecting cervical cells, comprising providing cervical self-sampling collection device (100), comprising a hollow barrel (102), distended to accommodate sample stabilizing solution (112), the hollow barrel (102) defining a slidably positioned plunger (104) inserted via posterior end, mounted on a coil spring (110), a stopper (106) at the anterior end of the plunger (114); removing the stopper (106) from the anterior end of the plunger (114); inserting the anterior end of the plunger (114) into the vaginal canal without contacting the cervix; continuously pressing the plunger (104) to extend the coil spring (110) and pushing the sample stabilizing solution (112) into cervix; releasing the plunger (104) creating a negative pressure for the sample stabilizing solution (112) released in the cervix to be re-absorbed; and withdrawing the cervical self-sampling collection device (100).
The cervical self-sampling collection device (100) has preferred volume of the sample stabilizing solution (112) in the range of 1ml to 30ml and the minimum and maximum volume re-absorbed is in the range of 1ml to 10ml. The preferred length of the hollow barrel (102) is in the range of 5cm to 30cm and diameter 0.5cm to 5cm.
Referring now to Figure 1, a cervical sample collection device (100) is shown comprising of a hollow barrel (102), a plunger (104) mounted on a coil spring (110, a distended hollow center storing sample stabilizing solution (112), and a stopper (106) at the anterior end. The plunger (104) stays at its expanded position or normal position due force exerted by coil spring (110) inside the barrel (102). The plunger (104) has an elastomeric insert (108) at its one end that is inserted into the barrel (102). The sample stabilizing solution (112) is at the bottom of the barrel (102) and a stopper (106) is provided to avoid leakage. The sample stabilizing solution (112) has mixture of chemicals which helps in stabilizing DNA and RNA of cervical cells for a long duration of time.
In Figure 2, sectional view of cervical sample collection device 100 is shown. The cervical sample collection device (100) is shown comprises of a hollow barrel (102) open at the anterior and the posterior/distal end, a plunger (104) mounted on a coil spring (110) inserted from the posterior end, a distended hollow center storing sample stabilizing solution (112), and a stopper (106) at the anterior end. The assembly of barrel (102) and plunger (104) is concentric or co-axial for smooth operation of cervical sample collection device (100).
In Figure 3, shows prospective view of an exocervical sample collection device according to the embodiments of the present invention, as illustrated, the hollow barrel (102) of cervical sample collection device (100) is substantially circular in cross-section. It has been found that a substantially circular cross-section provides for the most efficient use of the interior volume of the barrel (102). The anterior end of the barrel/plunger (112) is designed for easy insertion into the vaginal cavity and in positioning the cervical sample collection device (100) to obtain a sample of cervical cells. While the anterior end of the barrel (102) is inserted, the user is required to hold the plunger (104) to maintain a compressed position or away from the normal position counteracting the force exerted by coil spring (110). Once the user releases the hold, the plunger (104) attains the original expanded position or normal position, which sucks all the liquid and hence facilitates exocervical sample collection. However, one skilled in the art will realize, however, that the barrel (102) can have other cross-sectional geometries and still function as intended.
Figure 4 elucidates the process of sampling wherein sample stabilizing solution (112) is plunged into cervix by continuously pressing the plunger (104). The cervical self-sampling collection device (100) is shaped to conform to the uterine cavity for easy insertion, collecting a biological sample from a patient having a vagina (202) leading to a uterus (204) having a uterine wall (206) delimiting a uterine cavity (208) through a cervix (210) having a cervical canal (212). The cervical self-sampling collection device (100) is inserted in the vagina (202), prior to actual insertion of part thereof in the uterine cavity (208).
Figure 5 elucidates the process of sampling wherein the stabilizing solution (112) is plunged back in thereby collecting the sample. As shown in Figure 4 continuously pressing the plunger (104) to extend the coil spring (110) and pushing the sample stabilizing solution (112) into cervix and once the plunger (104) is released the liquid released in the cervix is re-absorbed due to negative pressure created due to movement of the plunger to its original extended position.
While the invention has been disclosed in its preferred forms, it will be apparent to those skilled in the art that many modifications, additions, and deletions can be made therein without departing from the spirit and scope of the invention and its equivalents as set forth in the following claims.

CLAIMS:CLAIMS

We Claim:

1. A cervical self-sampling collection device (100), comprising:
a hollow barrel (102) with open ends;
a slidable plunger (104) accommodated through distal/posterior end limited by the circumference of anterior end;
a removable stopper (106) at the anterior end of the plunger (104);
wherein,
the hollow barrel (102), is distended to accommodate sample stabilizing solution (112);
the plunger (104) is mounted on a coil spring (110) for maintaining an original extended position of the coil spring (110) thereby maintaining the plunger (104) above the sample stabilizing solution (112); and
the plunger (104) is pressed to compress the coil spring (110) and push the liquid into cervix and once the plunger (104) is released the liquid released in the cervix is re-absorbed due to negative pressure created due to movement of the plunger to its original extended position.
2. The cervical self-sampling collection device (100), wherein the anterior end of the plunger (114) conforms to a shape of at least part of the uterine cavity so that sample stabilizing solution (112) makes contact to the uterine wall on pressing the plunger (104).

3. The cervical self-sampling collection device (100), wherein the sample stabilizing solution comprises 50-120g of NaCl, 1-10g of KCl, 5-20g of Na2HPO4 and 0.5-5g of KH2PO4, and optionally EDTA, BSA, or trehalose in 500-2000ml of distilled water; having a pH of 7 ± 1.

4. The cervical self-sampling collection device (100), wherein the sample loaded exocervical liquid showed stability of DNA up to 2 months at room temperature and other cells for up to 5 days at room temperature.

5. A method of collecting cervical cells via cervical self-sampling collection device (100), comprising steps of:

removing the stopper (106) from the anterior end of the plunger (114) cervical from the self-sampling collection device (100);

inserting the anterior end of the plunger (114) into the vaginal canal without contacting the cervix;
continuously pressing the plunger (104) to extend the coil spring (110) and pushing the sample stabilizing solution (112) into cervix;
releasing the plunger (104) creating a negative pressure for the sample stabilizing solution (112) released in the cervix to be re-absorbed; and
withdrawing the cervical self-sampling collection device (100).
6. The method of collecting cervical cells, wherein the time of releasing the plunger (104) for re-absorption is in between 1-5 minutes.