Medical device to relieve the effects of genitourinary prolapse in women

Abstract

The present invention relates to the medical field and aims to alleviate the effects of genitourinary prolapse in women. This device, inserted into a deformed vagina in cases of prolapse, comprises two parts: - a proximal, tube-shaped part (9) that is rigid and has a diameter substantially equal to that of the lower part of the vagina, for positioning within it; - a distal part (10) extending from the axis of the proximal part (9), formed of elongated, disjointed elements—or stays—made of a material that deforms reversibly under pressure, fixed at one end to the proximal part (9), with their other ends free. This distal part is intended to be positioned in the mid-portion of the vagina. These stays are pre-shaped to spread apart in a corolla-like fashion, their free ends defining a circular contour to reposition the organs in their anatomical positions.

Description

Title of the invention: Medical device for relieving the effects of genitourinary prolapse in women.

[0001] The present invention relates to the medical field and specifically concerns a medical device for relieving the effects of genitourinary prolapse in women following dysfunction of the muscles and ligaments of the pelvic floor.

[0002] The organs present in the female pelvis are held in place by a set of muscles and ligaments that make up the pelvic floor. This acts as a hammock on which the bladder, uterus and rectum rest. We speak of prolapse, an anomaly commonly called "organ descent", when these organs are no longer supported by the pelvic floor and fall to varying degrees into the space normally occupied by the vagina, or even beyond the vulva if the prolapse is exteriorized.

[0003] There are four grades of prolapse, grade 4 being the complete exteriorization of an organ. The present invention concerns stages 1 to 3. Prolapse can affect the bladder (cystocele), the uterus (hysterocele) and the rectum (rectocele) in isolation or in combination. Prolapse is responsible for various symptoms. This can include perineal heaviness, a "ball" exteriorizing at the vulva, urinary, sexual or digestive signs.

[0004] The worsening of prolapse to the point of exteriorization of an organ can expose to the risk of urinary retention (blockage of bladder emptying), dilation of the kidneys with renal failure, ulceration of the vagina and cervix. Therapeutic abstention can be proposed in the case of a minimal, asymptomatic or uncomplicated form. However, there is no spontaneous improvement of the prolapse. Surgery is proposed if the symptoms become bothersome, affecting the quality of life, or in the event of complications. The risk of a woman being operated on for prolapse or "organ prolapse" during her lifetime is 11 to 19% depending on the study. The cumulative incidence of surgery reaches 15% beyond the age of 70.

[0005] Another solution is to provide a device placed in the vagina to contain the prolapse. Such a device is often used when intervention is not desirable quickly or is not possible. It can be worn temporarily or permanently.

[0006] Devices known to relieve the effects of prolapse, called "pessaries", are placed in the vagina to support the pelvic organs (bladder, rectum and uterus). These pessaries come in various shapes and sizes, including "ring" pessaries, "cube" pessaries and "donut" pessaries. Their function is to raise and then hold in place the or organs descended into the vagina by pressure on a substantial area of ​​the vaginal wall. The known pessaries, by their shapes and sizes, are more or less well adapted to the prolapses observed. The most used are ring pessaries and cube pessaries.

[0007] Due to their necessary rigidity to ensure they stay in place as well as possible, pessaries can cause pain and vaginal lesions, particularly when they are not well adapted (shape and size). In addition, they are not always easy for the patient to position correctly. Indeed, their positioning can be tricky and they present a risk of ineffectiveness in the event of malposition or too deep a position. Finally, the counter pressure exerted by the pelvic organs on them tends to evacuate them from their functional position. These devices can, however, provide relief and in many cases avoid surgical intervention, which is not always possible for various reasons, particularly if the patient lives in regions far from any medical and / or surgical center.

[0008] The aim of the present invention is to propose a solution for alleviating the effects generated by a prolapse by correctly repositioning the organs of the small pelvis by means of a medical device placed in the vagina like known pessaries, but which makes it possible to avoid the disadvantages of these devices.

[0009] According to the invention, the medical device for relieving the effects of genitourinary prolapse in women, intended to be introduced into the vagina, a vagina which in its lower part at rest and without constraint has the shape of a tube in the suburethral zone which widens in its middle part, and which under the effect of prolapse has a volume deformed by the pressures exerted on its wall, is characterized in that it comprises two parts

[0010] a) A proximal part in the form of a tube (9) which cannot be deformed under the pressure of soft organs, having an axis (YY) and a diameter substantially equal to that of the vagina in its lower part without constraint, intended to be positioned in the lower part of the vagina,

[0011] b) A distal part (10) extending the proximal part (9) along its axis (YY), formed from elongated elements. These preformed disjointed elongated elements are steel wires covered with biocompatible flexible material.They are made of a material which can be deformed under pressure in a reversible manner, these elements having first ends inserted and fixed in the proximal part (9), and second free ends, this distal part being intended to be positioned in the middle part of the vagina, and in that the disjointed elements of the distal part (10) are preformed to deviate from the axis (YY) from the proximal part and form a corolla, their second free ends delimiting a circular contour of diameter substantially greater than the diameter of the middle part of the vagina without constraint, in order, when the device is put in place, to rest on the middle of the vagina and repo- . locate the organs in their anatomical positions.

[0012] According to one embodiment, the device according to the invention is characterized in that the proximal part (9) comprises a hollow cylindrical core made of a material that is non-deformable under pressure and light, externally covered with a layer of flexible biocompatible material and internally filled with the same material, and in which the first ends of the elongated elements of the distal part (10) are regularly distributed and fixed.

[0013] Also, the device according to the invention is insertable into an applicator tube (60) when it is not in use and during the initial phase of its application, the preformed elongated elements of the distal part (10) being tightened by elastic deformation around the axis (YY) of the device in the extension of the proximal part (9) when it is stored in the applicator, then returning to their preformed state when the applicator is removed.

[0014] This device allows both to reposition and then to maintain the soft organs of the small pelvis in their anatomical positions. The device can be placed and removed without difficulty, according to the needs of the patient and by herself. Also, due to its construction and operation, the device according to the invention remains in place and cannot be evacuated spontaneously. Finally, it limits vaginal pain and lesions and is naturally adapted to prolapses (simple or combined) of the bladder and rectum.

[0015] Other characteristics and advantages of the invention will emerge on reading the detailed description which follows, given with reference to the appended figures:

[0016] [Fig.l] schematically represents, in section, 4 views of the female pelvis with the different pelvic organs, in normal position on 1a, displaced due to prolapse on 1b, with an applicator of the device on 1b, and finally replaced with a medical device according to the invention inserted into the vagina on 1d.

[0017] [Fig.2] isolates two opposing whales manufactured together in a first embodiment.

[0018] [Fig. 3] shows a side view of all the ribs in the deployed position of this embodiment of the device.

[0019] [Fig.4] shows a bottom view of all the whales inserted into the tube of the proximal part.

[0020] [Fig.5] shows the same embodiment in side view, with all the elements assembled.

[0021] [Fig.6] shows an example of an applicator.

[0022] [Fig.7] represents a second embodiment of the medical device according to the invention.

[0023] As indicated above, [Fig.l] schematically represents in section 4 views of the small female pelvis with the various pelvic organs, namely the bladder 1 ending in the urethra 2, the rectum 3, the uterus 4 and the vagina 5:

[0024] - shows the different organs in their “normal” anatomical positions;

[0025] - 1b represents a combined prolapse of the bladder 1, cystocele 6, and of the rectum 2, rectocele 7, where these deformed organs put pressure on the walls of the vagina. The arrows show the direction of the pressures which are thus exerted on the vaginal wall and have led to the narrowing of the vagina 5;

[0026] - on the, a cylindrical applicator 8 has been placed at the entrance of the vagina. It contains a pusher and the device according to the invention before it is pushed into the vagina. At this stage the organs are still putting pressure on the vagina.

[0027] - on Id, after pushing the device from the applicator 8 and withdrawing the latter, a device according to the invention was placed in the vagina. It comprises two parts connected to each other, one tubular 9, positioned at the entrance of the vagina, and the other, which extends the first, composed of threads deployed in a corolla which press on the middle part of the vagina. The upper part of the vagina is not touched by the device whose total length is of the order of 7 to 9 cm so that it is adapted to the anatomy of the small pelvis of women.

[0028] a) The tubular part, (9), called the proximal part because it is close to the entrance of the vagina, coated with medical silicone, is non-deformable under pressure from the soft organs, extends over at least a third of the length of the suburethral zone. It has a length of approximately 2 cm, and a diameter slightly smaller than the diameter of the entrance zone of the vagina at rest, approximately 1.5 cm. This tubular part is positioned in the suburethral zone and pushes the bladder 1: the urethra 2 thus returns to its normal position and the entrance of the vagina returns to its normal shape at rest as on the. It also comprises a non-absorbable thread (17) fixed to the proximal part (9), to facilitate removal of the device.

[0029] b) The other part, (10), called the distal part because it is distant from the entrance of the vagina, is formed from solid and flexible threads covered with medical silicone, called whales in the following, their characteristics bringing them closer to those of umbrella whales. The first ends of the whales are joined and fixed inside the tubular part (9), and the upper ends are free. In the waiting position in the applicator, the flexible whales are compressed. Once removed from the applicator, these flexible whales spread out in a corolla and exert on the vaginal wall counter pressures shown by arrows 11 and 12 which compensate for the pressures exerted due to the prolapse represented by arrows 6 and 7 respectively of 1b.The deployed whales rest on the middle part of the vagina, which is then subjected to well-distributed locoregional pressure at the level of the anterior, posterior and lateral walls, thus pushing the bladder 1 upwards and the rectum 3 downwards. This device is not . intended to penetrate beyond the middle zone of the vagina. The device has a total length of between 7 and 9 cm, the proximal part (9) having a length of the order of 2 cm, the free ends of the preformed elements of the distal part (10) being distributed over a circle with a diameter of between 4 and 6 cm.

[0030] Thus, with this device, the proximal part (9), intended to be located in the suburethral part of the vagina and to exert moderate pressure on the urethra, makes it possible to reduce the risk of stress urinary incontinence. Also, this device in its distal part (10) exerting constant pressure, causes a moderate anatomical deformation of the middle part of the vagina, much less significant than the pessaries which have a larger contact surface with the wall of the vagina and can cause discomfort, or even pain. In addition, the contact of the whales covered with medical silicone is extremely localized, on small areas of the vaginal wall and these areas are not always the same during successive positionings.Also, due to the applicator and the shape of the device, positioning is easier compared to that of pre-existing devices since this device fits the shape of the lower and middle parts of the vagina in its anatomical form. The device according to the invention is effective thanks to this mechanical action of the corolla whales which exert a harmonious distribution of pressure. Finally, it does not cause difficulty in urination or defecation.

[0031] According to a first preferred embodiment of the device, the distal part (10) is formed from eight whales manufactured in pairs, the core of which is a steel wire.

[0032] [Fig. 2] shows a pair of ribs of the device before assembly. The steel wire has a suitable hardness and is preformed to form a small central base (13), with axis XX and a width (approximately 1 cm) less than the diameter of the tubular part (9). This base is extended by two preformed branches symmetrical with respect to the axis YY of the device, itself perpendicular to the axis XX of their base (13). The ribs are first parallel to the axis YY of the device over a low zone (14) of approximately 1 cm, then separated by an angle of the order of thirty degrees with respect to this axis in a middle zone (15) of approximately 3 cm, and finally brought back parallel to the axis YY in a terminal zone (16), so that the spacing between the two ribs in the terminal part (16) is of the order of 5 cm. Except at their base, the whales are covered with a layer of medical silicone.

[0033] [Fig. 3] shows in more detail and in side view the set of ribs (10), in the deployed position. This set is formed of the four pairs of ribs whose coplanar bases (13) are crossed in a star shape in their middles. An extraction wire (17) is attached to this crosspiece. The lower zones (14) of the ribs are perpendicular to the plane of the bases (13), and are distributed regularly according to a cylinder for their insertion into the solid tube (9), shown next to the set of front ribs joining of the two parts. This tube is for example formed of polypropylene covered with medical silicone. The material chosen must be solid, non-deformable under pressure from soft organs and light enough so that gravity is insensitive, especially in a standing position. The internal diameter of this tube is just greater than the diameter of the envelope of the lower parts of the whales thus joined to form the proximal part of the device. In a preferred embodiment, the whales are covered in their terminal part (16) intended to press on the vaginal wall with a second layer of medical silicone (shown only on one of the whales in this figure). Also, the flexible whales are preformed between their lower (14) and middle (15) parts to be inclined relative to the direction of their base (13) and thus facilitate their insertion by bending into an applicator tube, as described below.

[0034] [Fig. 4] shows a bottom view of the set of ribs thus assembled in the tube (10) where they are embedded in medical silicone which fills the tube. The bases (13) of the four pairs of ribs are shown in dotted lines and the ribs in their middle (15) and terminal (16) zones are inclined relative to their respective bases, as indicated above to facilitate their folding into the applicator before use, then their deployment when an applicator tube is removed.

[0035] [Fig. 5] shows a side view of the entire device, fully assembled after joining the two parts. As indicated above, the device thus formed therefore comprises the proximal part, (9), non-deformable under pressure, formed of the tube and its container and the distal part (10) flexible and reversibly deformable under pressure, formed by the whales in their medial (15) and terminal (16) zones, the assembly being intended to match the anatomical shape of the lower and medial parts of the vagina at rest, without pressure stress, the terminal parts of the whales resting on the anterior, posterior and lateral walls of the medial part of the vagina. In this figure all the terminal parts of the whales have been covered with a second layer of medical silicone.

[0036] As indicated above, to relieve the effects of prolapse, the device is introduced longitudinally into the vagina and is positioned naturally to create counter-pressures in its distal part (10) which oppose the pressures generated by the prolapse and reposition the soft organs. The open contour defined by the free ends of the whales avoids any trauma on the deep part of the vagina and on the cervix. Finally, the inflections between the median zones (15) and the terminal zones (16) of the whales mean that the device, once in place, cannot slide spontaneously in the axis of the vagina, in particular in the standing position.

[0037] [Fig. 6] shows an embodiment of a suitable applicator (60) into which the medical device described above is inserted before and for its application. It comprises a hollow cylinder (61) into which the device according to the invention is inserted along its YY axis, the internal diameter of which is barely greater than the external diameter of the tube (9). The tube (9) is pushed into the hollow cylinder with the assembly of flexible ribs which fold as the push progresses and are therefore compressed into the waiting position in this cylinder. For placement, the applicator further comprises a pusher (62). After introduction of the cylinder containing the device into the vagina, a pusher sliding in the hollow cylinder allows the device to be placed. The applicator consisting of the hollow cylinder and the pusher can then be removed.

[0038] The invention is not limited to the first embodiment precisely described and the industrialization of the device according to the invention may lead to choices different from those made for this first embodiment.

[0039] In particular, the first embodiment shows a distal part formed of 8 wire stays: for a larger support area the number of elements can be greater than 8. In addition, the elements of the distal part (10), called stays in the detailed description above, can be something other than round section steel wires covered with medical silicone, provided that the material chosen gives them strength, flexibility and that they can be preformed. But these elongated elements, of a length of the order of the height of the middle part of the vagina, are always intended to exert only localized contacts distributed homogeneously on the vaginal walls.In all cases, the elements of the distal part are coated with a layer of flexible material compatible with human tissues and thick enough, at least in their upper part, (like the double layer described in the embodiment described in detail) to avoid any risk of injury.

[0040] Furthermore, in the first embodiment detailed above, the eight whales were manufactured and then assembled in pairs and their lower parts (14) are distributed regularly around the YY axis of the device to occupy a cylinder inserted in the tube 9 where they are embedded in medical silicone: this construction, which makes it possible to guarantee that once deployed the support zones of the whales are regularly spaced on the vaginal walls, is however not the only one which makes it possible to obtain the same result. In particular, the whales can be independent and the fixing of their lower parts in the tube 9 of the proximal part can be carried out in a different way, for example by positioning by means of regularly distributed grooves, formed on the internal surface of the tube of the proximal part.

[0041] [Fig.7] shows a second embodiment in which the distal part, 10, is formed from 6 reversibly deformable lamellae under pressure, preformed in a suitable plastic material and covered with biocompatible flexible material in their upper part. Their lower parts are inserted into the tube of the proximal part 9 where they are embedded in a biocompatible flexible material, of the type medical silicone. These strips, when brought closer to the axis of the device to fit into an applicator, form a cylinder substantially in the continuity of the tube and they unfold into a corolla, because they are preformed, when the device is applied.

[0042] The first embodiment comprises wire elements with which the support area on the vaginal wall is minimized: this second embodiment may be more suitable for countering the effects of a significant prolapse, the contact surfaces with the vaginal walls being a little larger while remaining separate and applied to different areas during successive applications.

[0043] Also, the tubular core covered with medical silicone of the proximal part 9 can be formed from a material other than polypropylene provided that it is non-deformable under pressure from soft organs and light enough so that gravity does not prevent the device from remaining in place after it has been positioned in the vagina, in particular in the standing position.

[0044] Finally, an average size of total length 8 cm for example can be universal enough to cover many needs. But it is also possible to provide a range of sizes to adapt to all needs.

Claims

Claims

1. Medical device for relieving the effects of genitourinary prolapse in women, intended to be introduced into the vagina which in its lower part at rest and without constraint has the shape of a tube in the suburethral zone which widens in its middle part, and which under the effect of prolapse has a volume deformed by the pressures exerted on its wall, characterized in that it comprises two parts: a) A proximal part in the form of a tube (9) which cannot be deformed under the pressure of soft organs, having an axis (YY) and a diameter substantially equal to that of the vagina in its lower part without constraint, intended to be positioned in the lower part of the vagina, b) A distal part (10) extending the proximal part (9) along its axis (YY), formed from separate elongated elements made of a material which can be deformed under pressure in a reversible manner, these elements having first ends inserted and fixed in the proximal part (9),and second free ends, this distal part being intended to be positioned in the middle part of the vagina, and in that the disjointed elements of the distal part (10) are preformed to deviate from the axis (YY) from the proximal part and form a corolla, their second free ends delimiting a circular contour of diameter substantially greater than the diameter of the middle part of the vagina without constraint, in order, when the device is put in place, to rest on the middle of the vagina and reposition the organs in their anatomical positions.,

2. Device according to claim 1, characterized in that the proximal part (9) comprises a hollow cylindrical core made of a material which is non-deformable under pressure and light, externally covered with a layer of flexible biocompatible material and internally filled with the same material, and in which the first ends of the elongated elements of the distal part (10) are regularly distributed and fixed.

3. Device according to one of claims 1 and 2, characterized in that the preformed disjointed elongated elements are steel wires covered with biocompatible flexible material.

4. Device according to claim 1, characterized in that the proximal part (9) extends over at least a third of the length of the suburethral zone.

5. Device according to claim 1, characterized in that the device has a total length of between 7 and 9 cm, the proximal part (9) having a length of the order of 2 cm, the free ends of the preformed elements of the distal part (10) being distributed over a circle with a diameter of between 4 and 6 cm.

6. Device according to claim 1, characterized in that the device is insertable into an applicator tube (6) when it is not in use and during the initial phase of its application, the preformed elongated elements of the distal part (10) being tightened by elastic deformation around the axis (YY) of the device in the extension of the proximal part (9) when it is stored in the applicator, then returning to their preformed state when the applicator is removed.

7. Device according to one of claims 1 to 4, characterized in that it further comprises a non-absorbable thread (17) fixed to the proximal part (9), to facilitate removal of the device.

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