ES2604529B2 - Intrauterine device insertion system in uterus of difficult canalization - Google Patents

Abstract

Medical device for access to the uterine interior and safe canalization of the cervical canal for the introduction of intrauterine devices (IUDs), consisting of a semi-rigid guide (1) with blunt tip to which cylindrical pieces with bevelled tip are successively coupled (and successively) 3.1, 3.2, 3.3). Said cylindrical pieces can be subsequently removed together with the semi-rigid guide, leaving in position only the upper caliber cylindrical part (3.3), which thus forms a working channel through which the uterine interior can be accessed and introduced by it IUD

Description

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DESCRIPTION

INTRAUTERINE DEVICE INSERTION SYSTEM IN DIFFICULT CHANNELS

TECHNICAL SECTOR

The present invention relates to a medical system for use on patients, with the purpose of guiding the insertion of intrauterine devices for medicinal and / or contraceptive use in patients in whom, due to the physical characteristics of their uterus, this is difficult or impossible, as well as the canalization of uterus for other diagnostic and therapeutic purposes.

BACKGROUND OF THE INVENTION

There are numerous models of intrauterine devices (IUDs) for medicinal and / or contraceptive use on the market, differing in forms, materials used for their manufacture, systems by which they generate their medicinal and / or contraceptive efficacy, and in physical mechanisms which are used for insertion into the uterine cavity. In all cases, its placement involves the channeling of the uterine cervix and access to the interior of the uterine cavity in a safe way.

The uterine cervix contains a channel that in natural conditions is continuously collapsed and exerts different degrees of resistance to the introduction of materials inside according to the individual. Sometimes, it may be impossible to introduce an intrauterine device due to the resistance generated by this body tissue, and this duct needs to be dilated by mechanical means. This can be achieved by using various dilators already existing in the market, of different sizes and materials.

The use of mechanical dilators requires their successive introduction into the cervical canal until the uterine cavity is reached, and subsequently removed to insert the introducer into the uterus through the widened canal. This manipulation generates pain, and it cannot be guaranteed that the dilation from very fine calibers to the necessary caliber is not producing an inappropriate tunneling of the cervical tissue (commonly called "false via"), which does not lead to the inside of the uterus but rather generates a

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trauma to the tissue thereof and can lead to serious consequences if it is not detected, including ultimately the loss of said uterus.

These inadequate tunneling ("false pathways") are more frequent when manipulating uterine necks of women who have undergone surgery on that organ, or who have abnormal cervical channels for various reasons. In these cases, it may be impossible to access the inside of the uterus to the placement of an IUD, or to perform other diagnostic or therapeutic procedures.

EXPLANATION OF THE INVENTION

The present invention has the dual purpose of achieving safe access to the interior of the uterus through the cervical canal, and of generating a secure artificial channel through which an IUD of any model can be introduced to its proper position (or other material for perform diagnostic or therapeutic procedures through said channel).

To this end, the invention consists of a solid semi-rigid glutton with a rounded tip and with characteristics that confer ecorefringence (capacity to be detected by ultrasound), to which successive semi-rigid pieces can be coupled externally and coaxially slid thereon. plastic material and beveled or rounded tip, so that the internal caliber of each major piece fits perfectly to the external caliber of the minor piece, and so on! successively.

Once the desired caliber (defined by the internal caliber of the last piece introduced) has been achieved, all the smaller caliber parts can be removed together from the inside of the latter, in such a way that a working channel of known caliber is generated through the which can slide the introducer of an IUD (or other equipment such as a biopsy cannula). All the pieces have external marking at intervals of 1 cm, and the thicker pieces have a progressively shorter overall length than the ones of smaller thickness. The pieces are marked in such a way that it can be known at what time a piece has come in its path to the tip of the immediately smaller piece.

The plastic material of the semi-rigid pieces must have sufficient consistency to keep its light open without containing the rest of the smaller pieces inside, but adequate flexibility to adapt to the curved shape that the cervical canal usually takes towards the uterine cavity.

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The invention described in this way is a novelty in the access system to the interior of the uterine cavity and can be used as follows: the small caliber guide is advanced through the cervical canal until there is evidence that It has located inside the uterine cavity. This can be defined by ultrasound or by introducing said guide through the working channel of a diagnostic hysteroscope (in this case, once this point is reached, the hysteroscope is removed leaving the guide in place).

At this point, the rear end of the guide is inserted into the channel of the first semi-rigid piece (the smaller one) and, without displacing the guide, the piece is pushed until it reaches the mark that indicates that its tip is at the same level as the tip of the guide. The process is repeated by coupling and pushing pieces of progressively larger caliber through the preceding set of pieces, up to their predefined marks. At the moment in which the desired caliber is reached, the outer part is held firmly and pulled from those of smaller calipers (facilitated by the fact that they have a longer length and fit in stepwise) so that a artificial canal that can be used in the same way as if it were the cervical canal to introduce an IUD.

This system uses the guide as a guarantee that the uterine interior will be accessed and that inadequate tunneling will not occur in the uterine tissue, and it will allow generating a secure access mode that can be coupled to multiple already existing introducer systems but ineffective in difficult cases.

The described system will be conveniently sterilized and bagged in a container that protects it from contamination until it will be used.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the features of the invention, according to a preferred example of practical realization thereof, an set of figures in the description is accompanied as an integral part of said description. where the following has been represented by way of illustration and not limitation:

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Figure 1 shows a schematic view of the semi-rigid glutton in position within a uterus, in accordance with the present invention

Figure 2 shows a schematic view of the coaxial passage of the first cylindrical part, according to a possible realization of the device according to the present invention.

Figure 3 shows a schematic view with the assembly in position of a possible embodiment of the device according to the present invention.

Figure 4 shows a schematic view with the largest caliber piece in position, once the set of lower caliber parts has been removed, according to a possible embodiment of the device according to the present invention.

Figure 5 shows a schematic view of the piece of greater caliber in position, according to a possible embodiment of the device according to the present invention, with an intrauterine device introducer (IUDs), not object of the present invention, passing through the same to reach the uterine cavity.

Below is a list of the different elements represented in the figures that make up the invention:

1 semi-rigid gluttony

2 uterus

3.1 Lower caliber cylindrical part

3.2 Medium caliber cylindrical part

3.3 Upper caliber cylindrical part

4 Intrauterine device introducer (IUDs)

5 Intrauterine device (IUD)

PREFERRED EMBODIMENT

In view of the aforementioned figures, and in accordance with the numbering adopted, an example of preferred embodiment and operation of the device can be observed therein, which comprises the parts and elements that are indicated and described in detail below. Thus, as seen in Figures 1 to 5, a possible preferred embodiment of the device or system for canalization of the uterus (2) and subsequent passage through an IUD introducer (4, 5), essentially comprises the following elements:

• A semi-rigid glutton (1) with small blunt blunt tip, marked externally centimeter by centimeter and with a differentiated mark equal to the length of the cylinder

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smaller caliber, counting from its tip, so that the point at which said cylinder (3.1) reaches its proper position is known.

• A series of attachable cylindrical parts (3.1, 3.2, 3.3) successively coaxial to the semi-rigid guide and progressively to each lower caliber cylindrical part through its outer part.

In this preferred embodiment, as shown in the figures, the caliber of the first cylindrical part (3.1) is such that it slides effortlessly over the semi-rigid guide (1) until it reaches its position, and the successive cylindrical parts (3.2, 3.3 ) they slide coaxially 10 over the outer surface of the lower caliber piece, dilating the cervical canal and accessing the inside of the uterus (2).

The cylindrical pieces will have a shorter length as their caliber is successively larger, and will be marked in such a way that it is known when the piece being introduced 15 has reached its position (the place where the bevelled tip of the larger caliber piece overlaps to that of the immediately lower caliber). In this way, all the lower caliber parts (3.1, 3.2) can be easily removed and the upper caliber (3.3), which is the function of the working channel for the introduction of IUDs (4, 5) ).

Claims (7)

5 10 fifteen twenty 25 30 35 ES 2 604 529 A1 1. Medical device for access to the uterine interior and safe canalization of the cervical canal for the introduction of intrauterine devices (IUDs) and other related uses, characterized in that it comprises: • A semi-rigid glutton with blunt tip. • A series of cylinders successively coupled in a coaxial way to the semi-rigid glutton and progressively to each cylinder of lower caliber on its external part. 2. Medical device according to claim 1, characterized in that the semi-rigid glutton is made of one or more materials that allow its ecorefingency, that is, it is possible to detect its position by means of a medical ultrasound imaging device. 3. Medical device according to claim 1 characterized in that the semi-rigid glutton has visible marks with intervals of 1 cm from the blunt tip, and because it has a differentiated mark equal to the length of the first cylinder, from the blunt tip. 4. Medical device according to claim 1 characterized in that the cylinders that are coaxially coupled to the glutton are made of semi-rigid material and have a bevelled and rounded end. 5. Medical device according to claim 1 characterized in that said cylinders have external and internal diameters such that the smaller caliber has its internal diameter such that it allows the external coupling to the semi-rigid glutton, and the successive ones in size have an internal diameter such that allow external coupling coaxially to the preceding cylinders, successively. 6. Medical device according to claim 1 characterized in that said cylinders have a smaller length as their caliber is greater, and have a visible mark such that it is possible to know when the tip of a cylinder has reached its correct position on the previous lower caliber cylinder. 7. Medical device according to claim 1 characterized in that the larger caliber cylinder has an internal diameter sufficient to advance an intrauterine device introducer inside.