PEDIATRIC VAGINAL PROBE FOR COLLECTION OF SAMPLES OFCELLSObject of the invention:The present invention relates to a medical device, which is used in gynecological inspection for the collection of samples from cells of the vagina, in which the pediatric vaginal probe has the particularity that it can be used to obtain samples from the vagina or area External genitalia of girls between 0 and 9 years old, having the anatomical measures and characteristics necessary to avoid damaging the patient during the procedure.
Background of the invention:When it is necessary to obtain a vaginal sample from a pediatric patient to identify if she was a victim of sexual abuse or has an infection, it is difficult to carry out the procedure due to genital anatomy and physiology. During the prepubertal stage, the patient lacks fatty tissue in the labia majora, has small lower lips, thin hymen, thin skin, delicate and sensitive; all this makes it difficult to introduce existing probes for adult patients.
The length of the anterior vaginal wall in a prepubertal is approximately 8 cm, the posterior wall is 9-10 cm, the uterine length is 4 cm, so it should be considered that the pediatric vaginal probe measures less than these measurements, respectively. In addition, for the vaginal probe to pass through the vaginal orifice and the hymen, it is necessary that the diameter of the vaginal probe be equal to or less than 5 mm.
Currently during these studies a test tube is used that is inserted through the vaginal cavity to obtain a sample of vaginal fluids, which can cause pain and discomfort in the patient, causing the girl to refuse to have the inspection performed; Another risk is to hurt the patient by breaking the hymen or irritating the area.
Currently there is a patent US 60 / 673,410, which is a device used to obtain samples of the vaginal cavity of adult women in which a probe is inserted into the cavity and rotated to obtain a cellular sample. This device is of general use and is not focused on prepubertal patients, since the measurements of the probe are not the most suitable to be inserted in the vaginal cavity of girls. Another US patent 09 / 499,296 is related to measuring the pH of the vaginal fluid using a pH indicator test strip, but it also makes it difficult to use this device in the vaginal cavity of pediatric patients.
BRIEF DESCRIPTION OF THE DRAWINGSFigure 1 shows an external perspective view of the main body having a cylindrical configuration, with a main body being shown in its base in which a suction and extraction device can be coupled.
Figure 2. It shows a perspective view of the inside of the piece, showing a piece similar to the previous one subdivided into two compartments, a space to the hollow center in the middle of two solid spaces.
Figure 3. Shows a perspective view of the distal part of the piece, where the shape of the preferred oval termination is shown.
Figure 4. Shows a perspective view of the proximal part of the piece, where a special space is shown where a main body will be inserted in which a suction and extraction device can be coupled with a lubricating fluid, such as a syringe with the Saline solution.
Figure 5. Shows a perspective view of a vaginal examination with a pediatric vaginal probe inserted into the vaginal cavity to obtain a cellular sample of the tissue.
Detailed description of the invention:The present invention provides a pediatric vaginal probe for collection of vaginal cell samples. This probe comprises a main body that has inside it an internal channel, a distal end and a proximal end; at the proximal end a reservoir is fixedly fixed to seal it, said reservoir has a liquid dispensing mechanism; and at the termination of the distal end presents an exit or re-entry hole.
The main body has an internal channel that consists of a channel that runs through it longitudinally through which a liquid flows from one end to the other by the action of a positive or negative pressure. The main body is manufactured from a flexible and soft material, preferably plastic, such as PVC or silicone.
The ends are cylindrical and straight. Particularly the distal end decreases gradually defining a preferably conical and rounded termination, without affecting the diameter of the internal channel. On the outside it presents a visual indicator, which allows to identify how much distance from this end has been introduced.
For its part, the proximal end is fixedly fixed to a reservoir to seal it. Optionally the articulation is through a threaded termination that allows it to articulate and disarticulate. The reservoir is complemented by the dispensing mechanism, which, depending on the pressure exerted, dispenses or sucks a liquid to make it flow from the reservoir towards the distal end, or from the distal end towards the reservoir. Said reservoir in its exterior presents a volume scale, to measure the amount of liquid contained and dispensed.
The reservoir and the dispensing mechanism are the same piece, or separate pieces that are coupled together, and in this latter condition optionally they are a syringe, and it is the dispensing mechanism that controls the entrance and exit of liquid from the reservoir, by means of positive pressure. or negative; as well as the speed of the flow supplied and return of the liquid to the reservoir. Preferably, when a positive pressure is exerted, a liquid is supplied from the reservoir, and when a negative pressure is exerted by the dispensing mechanism, the liquid is sucked to re-enter it into the reservoir.
In Figure 1, an external perspective view of the main body (1) is shown, where the proximal end is seen, and the distal end Particularly the pediatric vaginal probe described herein is designed to facilitate the collection of vaginal cells in pediatric patients, since it is designed with necessary measures of cylindrical configuration, 14 cm in length, 2 mm in diameter at its distal end (3) and 5 mm in the rest of the piece, in such a way that it can be used in prepubertal patients, which it has an extremely proximal compartment (2) in which a syringe can be fitted (see figure 4) to inject a saline solution of 5 ce, which passes through its internal channel (4), reaches the end opening distal (3), which will be inside the vaginal cavity, to irrigate it and to exert negative pressure, suck the same solution and get a vaginal sample of the same amount to be later analyzed , without the risk of it being trapped by the vaginal walls at the moment when the piston is retracted, due to its consistency.
This pediatric vaginal probe is constructed of semi-flexible and biocompatible material that does not cause allergy in patients, such as silicone, and is prone to be sterilized.
With this solution it is possible to obtain a cellular sample of the genital area of the patient without causing pain, in a fast and efficient way, in such a way that the procedure is of short duration. In addition, its design is practical and during the procedure there is a reduction in the risk of making mistakes during the procedure.
The materials, shape, size and arrangement of the piece will be susceptible to variation as long as it does not involve an alteration of the essential characteristics of the invention, which are claimed below: