WO2008012393A1

WO2008012393A1 - Medical kit and set of instruments for performing a home test for the detection of precursor lesions of cervical cancer

Info

Publication number: WO2008012393A1
Application number: PCT/ES2007/070134
Authority: WO
Inventors: Maximino REY LÁZARO; Arturo Gil Bretones
Original assignee: Rey Lazaro Maximino; Arturo Gil Bretones
Priority date: 2006-07-28
Filing date: 2007-07-17
Publication date: 2008-01-31
Also published as: ES2296527B1; ES2296527A1; BRPI0713816A2

Abstract

The invention relates to an instrumental and medical kit for performing a home test for the detection of precursor lesions of cervical cancer. The invention can be used to collect cells from the vagina and to store same in a liquid medium for subsequent analysis. The kit consists of a case (1) which is provided with a first container (7) for tightly housing a bottle of methanol (2) and a second container (8) for tightly housing a set of medical instruments. The instruments consist of a brush (3) which is fitted with a semispherical head (5) having a set of bristles mounted thereto, said bristles being introduced into the cervix in order to impregnate cells which are subsequently introduced into the bottle of methanol (2) for analysis.

Description

MEDICAL AND INSTRUMENTAL KIT FOR THE REALIZATION OF A

AUTOTEST FOR DETECTION OF PRECURSOR INJURIES OF

CERVICAL CANCER

D E S C R I P C I Ó N

OBJECT OF THE INVENTION

The field of application of the present invention is that of preventive medicine, and more specifically that of the industry dedicated to the manufacture of therapeutic, preventive devices, elements and devices.

The present invention relates to a medical kit and the instruments used for the realization of a self-test of cervical cancer precursor lesions.

The object of the invention consists in the development of means for facilitating the autonomous realization, for example, at home and privately, of a self-test for detecting precursor lesions of cervical cancer. , which allows easy and simple collection of cells from the vagina and their storage in a liquid medium for subsequent cytological laboratory study.

BACKGROUND OF THE INVENTION

Cervical cytology has proven to be an effective method to reduce cervical cancer mortality because it allows detecting the precursor lesions thereof. It is noteworthy that it is the third cancer in frequency in developed countries, after breast and colon, and the second in less developed countries.

As is currently known, the cytology applied to screening methods consists of a low-cost test, but also of low sensitivity (51-59% is reached in the best series), has a large number of false negatives, or what is the same, very low ability to detect cancer when it exists.

The problems of the current method are low sensitivity and difficult access to it for the general population due to the inconvenience that this test should be performed in a medical center and by a specialist.

In a review carried out in the New England specialized medical journal, specifically in the November 2005 edition, the fact that there is approximately 40% of the female population that does not attend early cancer detection campaigns is described, claiming as causes Ia need to make an appointment and mainly modesty.

Cervical cancer has an incidence in developed countries of between 4 and 8 cases per 100,000 women, while in less developed countries it reaches between 16 and 20 cases per 100,000 women.

Given this health problem, early detection campaigns were proposed to reduce the mortality caused by this type of cancer, detecting and treating precursor lesions.

Currently, the test performed by the gynecologist consists of the direct vision of the cervix and the collection with a swab and a spatula of a sample of the endocervix and another sample of the extocervix respectively, rubbing them then against a glass holder to visualize next in a microscope using the so-called pap smear.

This method has been very useful to reduce mortality, taking into account the cost-effectiveness. The only problem with this test is its low sensitivity, of the order of 51-59%, which means that it has many false negatives.

To correct this defect, we worked with new techniques, such as the so-called liquid cytology that increased this sensitivity.

Another crucial discovery was the finding of the causal association in 99.9% of cancers, of the human papillomavirus or HPV; although the detection of the virus as a screening method is not acceptable, due to the high prevalence of this virus in women between 20 and 30 years.

The cytology in liquid medium has been a great improvement, since although the gynecologist takes the Ia, the extension of the sample is performed in a container with a liquid medium, getting the sample to be of better quality, thus decreasing the amount Remarkable false negatives, as well as the HPV test, which, as already mentioned, is the causative agent in 99.9% of cancers.

It should be noted that work has been done to a greater or lesser extent, by many specialists, to seek progress in science in the last century in the field of cervical cancer.

The pioneering work of Schauta and Wethein on surgical treatment was followed by the contributions of Hinselman and Papanicolau, which laid the foundations for secondary cancer prevention, through Ia detection, diagnosis and treatment of pre-invasive or micro-invasive lesions.

However, despite screening programs, advanced stage neck cancers are still being diagnosed.

The discovery of the papillomavirus association and its confirmation in the etiology by Zur Handerson has meant a great change in the diagnostic strategy.

Given the above, it follows that the best way to prevent the type of cancer that concerns here would be that all women of risk age could regularly undergo gynecological controls, and since this situation is far from the reality should be approached this possibility to a greater number of women worldwide, regardless of their geographical or economic situation.

DESCRIPTION OF THE INVENTION

The medical kit for the realization of self-test for the detection of precursor lesions of cervical cancer proposed by the present invention allows a gynecological control to be practically and effectively procured to a considerably larger number of women, which is reached by other traditional methods.

The medical kit basically comprises a box provided with a first receptacle that houses a bottle and a second receptacle that houses a medical instrument consisting of a brush used by the woman for its introduction by its distal end at the bottom of the vagina for Ia collection of cells that will be used for cytological study and detection of human papillomavirus DNA.

After the removal of the brush from the vagina, its distal end is introduced inside the bottle in which a methanol solution is found, the cell collection being deposited inside.

The bottle is then sent to a reference laboratory where the sample will be read (said reading being advantageously carried out with the cytology system in liquid medium, which is much more effective than conventional cytology), the user receiving the result, from which you must perform or not further controls or visits to specialists to undergo treatment depending on the results obtained.

Thus, the invention has significant advantages, both for women in particular and for the health system in general, since with this system it can be achieved, on the one hand that a greater number of women undergo regular cytological control, as it results a comfortable and economical method, which also does not take time for the user to go to the consultation thus saving the possible loss of work hours that could lead to, and on the other hand avoids the saturation of medical consultations for preventive purposes, since only Those women with some pathology will attend the consultations.

The brush comprises a head composed of a set of bristles in hemispherical arrangement located at the distal end of a displaceable and rotating piston inside an outer sheath, the outer sheath having a circular widening that allows the clamping of the brush while it is introduced The head at the bottom of the vagina for impregnation of uterine cells. DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description. where, for the purposes of illustration and not limitation, the following has been represented:

Figure 1.- Shows a plan view of the medical kit in which the elements that compose it are observed.

Figure 2.- It shows a side view of the medical kit represented in Figure 1 in which the open box is shown with two cuts in which the bottle and the brush housed in the box are observed.

Figure 3.- Shows a detailed view of the distal end of the brush.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the figures, an example of a preferred embodiment of the object of the present invention is described below.

More specifically, as seen in Figure 1, the medical kit comprises a box (1) inside which a methanol bottle (2) and a brush (3) are properly arranged to allow its correct transfer and storage, as well as its subsequent shipment, once used, to a laboratory in safe conditions,

In said figure 1, a first receptacle (7) that houses a bottle (2) and a second receptacle (8) that houses a medical instrument consisting of a brush (3) formed by a brush (3) hemispherical head (5), equipped with a set of bristles, located at the distal end of a plunger (9), as shown in Figure 3, movable and rotating inside an outer sheath (4), counting this outer cover (4) with a circular widening (6) represented in figures 1 or 2.

The procedure to be followed for the realization of the self-test with the medical kit of the invention is that the woman uses the brush (3) as a vaginal buffer. The woman introduces the brush (3) by pushing and rotating inside the cervix the plunger (9) with the head (5) located at its distal end, while holding the outer sheath (4), more specifically by its circular widening (6).

The head (5) is therefore impregnated with uterine cells that are introduced inside the bottle (2) with the methanol solution. This bottle (2) will be subsequently sent to a reference laboratory where the reading of said sample will be carried out.

Claims

1.- Medical kit for the realization of a self-test for the detection of precursor lesions of cervical cancer characterized in that it comprises a box (1) that has a first receptacle (7) that houses a methanol bottle (2), and a second receptacle (8) that houses a medical instrument fitted, in which the medical instrument consists of a brush (3) comprising: - an outer sheath (4) provided with a circular widening (6),

- a piston (9) movable and rotating inside the outer sheath (4),

- a head (5) located at the distal end of the plunger (9) that has a hemispherical shape and is equipped with a set of bristles applicable for introduction into the cervix and impregnation of cells for subsequent introduction into the methanol bottle (2).

2.- Instrumental for the realization of a self-test for detection of precursor lesions of cervical cancer characterized in that it consists of a brush (3) comprising:

- an outer sheath (4) equipped with a circular widening (6),

- a piston (9) movable and rotating inside the outer sheath (4),

- a head (5) located at the distal end of the plunger (9) which has a hemispherical shape and is equipped with a set of bristles applicable for introduction into the cervix and impregnation of cells for further analysis.