OA20200A - Intrauterine expander device. - Google Patents

Abstract

The invention consists of an expansion catheter for intrauterine placement, featuring anatomical characteristics adaptable to the different morphologies of the uterine organ in its internal cavities, and which efficiently enables the dilatation and separation of the internal walls of the cavity subsequent to their reduction in the surgical process of endometrial scraping in the different surgical techniques of the procedure, in order to serve as a separator and isolator in the prevention of intrauterine adhesions, facilitating drainage both internally through the device and perimetrally. The device, containing an expansion device in a collapsed state, is placed in the uterus by means of an insertion device with the aid of a pusher, which is discarded together with the insertion device once the unit is in place.

Description

INTRAUTERINE EXPANDER DEVICE

DESCRIPTION

OBJECT OF THE INVENTION

The présent invention relates to an expander cathéter for intrauterine placement with anatomical features adaptable to the different morphologies presented by the uterine organ in its inner cavities and which efficiently allows for expansion and séparation of the inner walls of the uterine cavity in order to fulfil a dual purpose: on one hand to separate the uterine walls in order to prevent intrauterine adhesions, i.e. avoiding the coaptation thereof, and on the other hand to allow compression ofthe uterine walls, acting as a hemostatic factor.

BACKGROUND OF THE INVENTION

The uterine cavity is what is defined in medicine as a virtual cavity. This means that the uterine walls, in the absence of artificial séparation between them, are in intimate contact. This coaptation of the uterine wall may lead to adhesion formation or scarring that occurs between the opposite faces in cases where an alteration or internai injury occurs, such as in the case of intrauterine surgery.

There are various methods that hâve been used over the years aimed at reducing the rate of formation of these adhesions. Among the different methods, physical or barrier methods are the most used and effective, as evidenced by the comparative studies of Lin (Lin, X., Wei, M., Li, T. C., Huang, Q., Huang, D., Zhou, F., & Zhang, S. (2013). A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prévention of adhesion reformation following hystéroscopie surgery for Asherman syndrome: a cohort study. European Journal of Obstetrics & Gynecology and Reproductive Biology, 170 (2), 512-516. doi: 10.1016/ j.ejogrb.2013.07.018), which observed that the rate of adhesion when an intrauterine cathéter was used was lower than when an IUD or antiadherential gel was used.

These types of cathéters are embodied in a kind of inflatable body that involves a sériés of extracorporeal outer tubes through which, once implanted, the device itself can inflate, defining a single central drainage channel.

The problem with this type of device is its design (badly adapted to the uterine anatomy), the difficulty of placement and the poor drainage of accumulated bleeding inside the cavity.

The invention also relates to the method of Patent WO2016074647, wherein an inflatable balloon species is provided for separating the uterine walls, and balloons for fixing to the cervix, with two push valves, also having the same problems of the difficulty in the placement and the poor drain ofthe bleeding accumulated inside the cavity, by providing only an internai drain.

In parallel, in US pat No. 4552557A, there is also provided an inflatable balloon species, also with an inner drain, in which a single internai inflation chamber is involved in the form of a triangle, with the same limitations from the point of view of problems relating to the difficulty in placement and the poor drain of the bleeding accumulated inside the cavity, by providing only an internai drain.

The invention also relates to these problems in addition to the fact that these devices do not provide A guidance system for the introduction of the cathéter with fixation to the uterine and posterior base with latéral drainage to the cervix.

DESCRIPTION OF THE INVENTION

The intrauterine expander device that is proposed solves the problems of transvaginal placement and internai positioning, and also avoids the patients discomfort due to over inflation of the walls, presenting substantial improvements in its many drainage channels for removal of additional pressure caused by liquid accumulation and the obstruction of the main drainage channel, in addition to not having extracorporeal outer tubes.

To that end and more specifically, based on the conceptual structure of the type of devices described above, the device of the invention présents the particularity that it is embodied from an inflatable main body, which has a configuration in the form of an inverted spear tip with a blunt tip in its central area, coinciding with a central drainage channel with a drain through a central tube, with the particularity that said body is formed from several superimposed individual inflation chambers, which détermine two flexible latéral flaps with rounded edges which are initially folded occupying a minimum volume within an insertion device, of tubular and open configuration, like a sheath. Thus, it substantially facilitâtes implanting the device and its passage through the cervix, securing the depth of the end sites in the introduction of the insertion device, and which can be easily removed coaxially from the device once arranged in the work area by means of an internai pusher which is also discarded together with the insertion device which can be easily deployed by sélective inflation of its chambers, for which the same are associated to small inflation tubes passing internally to the main drainage tube, having a length greater than the latter, so that at their lower extremity they adopt a spiral configuration allowing their retraction once the device is adapted to the physiognomy of the patient, and which are intracavitary, not external, to improve the discomfort of wearing them hanging on the outside, thus avoiding possible sources of infection and limitation ofthe patients activity, said tubes concluding in the corresponding non-return valves.

Thus, the main inflatable body présents an ergonomie configuration with variables adapting to the different morphologies of the organ, defining, when inflated, a contour section curved both in its two major faces and its two minor faces, which détermine in its support on the uterine wall a plurality of additional drainage conduits to the central drainage channel.

More specifically, in the main body a double centre and latéral inflation quadruple chamber to create more drainage channels is involved; apart from the unified central channel, thus covering ail angles of liquid removal by intra-mural sécrétion and thus avoiding over pressures and épithélial tissue adhesions.

In turn, said main body ends lower down in a triple balloon for attaching to the cervix, with discontinuous latéral attachment rings and drainage canalisation to prevent its dislodgement and possible withdrawals during the phases of muscle contraction.

Finally, after the triple balloon emerges the aforementioned central drainage tube, which extends to the upper edge as a complément to the different inflation channels, ie, in addition to the latéral drainage channels which are formed upon inflation of the chambers, a central conduit is added for the évacuation of internai liquids, thus defining seven drain channels, one central, two upper, two lower and two latéral channels.

The spécial configuration of the device causes it to hâve a smaller size and weight, without external tip shaped plastic forms.

Similarly, having different inflation chambers allows partial and irregular inflation for greater adaptation to intracavitary dysmorphies.

As for the main body folding mode within the sheath, it will be folded as a pivoting shaft for more efficient deployment in the cathéter adaptability to the latéral walls ofthe uterine cavity.

The morphology of the device deployed in the form of a latéral float with internai canalisation paths and the frontal inflation limiter allow greater adaptability to the intrauterine cavities, as well as a greater volume of séparation, without any inhérent discomfort in placement, to avoid possible total or partial adhesions that involve a subséquent re-intervention by the gynaecologist; discomfort added to the phases of muscle contraction of the utérus in the recovery stage.

DESCRIPTION OF THE DRAWINGS

To complété the description that is going to be made and to assist a better understanding of the invention's characteristics, according to a preferred practical embodiment thereof, accompanying as an intégral part of said description, is a set of drawings, where in an illustrative and non limiting way, the following is represented:

Figure 1 shows a top side perspective view of an intrauterine expander device made in accordance with the object of the présent invention, deployed but not fully inflated.

Figure 2 shows a detail in a different perspective from the whole ofthe previous figure

Figure 3 shows the device of Figure 1 according to another perspective.

Figure 4 shows a perspective view of the device of the preceding figures, duly inflated.

Figure 5 finally shows a sectional view of the device, introduced into an applicator sheath for the introduction of the assembly into the utérus.

PREFERRED MODE FOR CARRYING OUT THE INVENTION

In view of the aforementioned figures, it can be seen that the proposed intrauterine expander device is constituted from an inflatable main body (1), which has a configuration in the form of an inverted spear tip, with rounded edges, in which a central drainage channel (2) towards a central tube (3) is defined above, which central channel (2) has a blunt tip (4), such that said inflatable main body (1) is constituted from several individual inflation chambers, which détermine two flexible latéral flaps (5) with rounded edges that initially fold occupying a minimum volume within an inserter device (6), the one shown in Figure 5, of tubular configuration with rounded and open tip (11), like a sheath, which significantly facilitâtes the implantation of the device and its passage through the cervix.

This inserter device (6) can be easily coaxially removed from the main device by pulling it, once arranged in the work area, next to the internai pusher element (11).

In this way, the device can be easily deployed by inflating its chambers, for which they are associated with small inflation tubes (7) that pass internally to the central drainage tube (3), presenting a greater length than the latter, so that in their lower extremity, not shown in the figures, they adopt a spiral configuration, which allows their retraction once the device is adapted to the physiognomy of the patient, ending at these extremities in the corresponding non-return valves, not represented in the figures.

The main body (1) présents an inflatable and ergonomie configuration adaptable to the different morphologies of the organ, with the particularity that, when inflate, it defines a contour section curved both in its two major faces and its two minor faces, which détermine, in its support on the uterine wall, a plurality of drainage conduits or channels (8) additional to the central drainage channel.

In this sense, and as noted above, a double centre and latéral inflation quadruple chamber is involved in the main body to create a greater number of drainage channels (8).

Lower down the main body (1) a triple balloon for attaching to the cervix (9), with discontinuous latéral attachment rings and drainage canalisation to prevent its dislodgement and possible withdrawals during the phases of muscle contraction, is arranged.

From this structuring, the following structural advantages are derived:

• Device with its own inserter, which significantly facilitâtes its placement and reduces the discomfort of said operation.

• The multi-chamber configuration allows for greater expansion along the latéral edges.

· Anatomical shape that adapts to the uterine cavity.

• Wide distension capacity, which increases the séparation of the walls exerting hemostatic action by compression.

• Increased perimeter drainage capacity of accumulated sécrétions.

Claims (4)

1. Intrauterine expander device, characterised in that it is constituted from an inflatable main body (1), which has a configuration in the form of an inverted spear tip, with rounded edges, in which a central drainage channel (2) is defined above towards a central tube (3), which central channel (2) has a blunt tip (4), such that said inflatable main body (1) is constituted from several individual inflation chambers, which détermine two flexible latéral flaps (5) with rounded edges, said body having on its inflation a contour section curved both on its major faces and on its minor faces, which détermine in its support on the walls of the utérus, a plurality of drainage conduits or channels (8) additional to the central drainage channel determined by the central tube (3), it having been provided that the chambers of the inflatable main body (1) are assisted by small inflation tubes (7) that pass internally to the central drainage tube (3), with the particularity that below the main body (1) a sériés of balloons, preferably three, attached to the cervix (9) are arranged with discontinuous rings (10) to facilitate perimeter drainage.

2. Intrauterine expander device, according to claim 1, characterised in that it includes an inserter device (6) in which the main body (1), of tubular and open configuration, like a sheath, is initially inserted and folded, as an inserting element of the device through the cervix, axially removable with respect to the device once inserted with the help of an internai pushing element (11).

3. Intrauterine expander device, according to claim 1, characterised in that the inflation tubes (7) adopt a spiral configuration in correspondence with their lower extremity, giving them a rétractable character.

4. Intrauterine expander device, according to claim 1, characterised in that a double centre and latéral inflation quadruple chamber is involved in the main body.