IL38343A - Contraceptive device - Google Patents

Description

Contraceptive device ROBSR2 C-ΑΰΤ) 0*36427 The present invention relates to an intra-uterine contraceptive device to be placed without pain both in the uterine cavity and the neck of the uterus.

The positioning by a doctor of a contraceptive device for intra-uterine use has regained favour and is more extensive, after the recent controversy concernin the taking of oral contraceptives.

In the field of intra-uterine devices, the use of rings and "coiled", "looped" or "arcuate" devices is recommended in particular for reducing the rate of pregnancy. Now, in certain cases, the heretofore known devices proved to be defective either in that the woman became pregnant unwillingly, the organism could not tolerate said devices, or finally in that said devices were expelled in view of the contractions and peristaltic muscular phenomena produced and of the degree of contraction of the opening of the neck of the uterus.

In order to obviate the above-mentioned disadvantages, a novel device is proposed which acts both on the wall of the uterine cavity and the cervical wall, the part of said device which acts at the level of the uterine cavity not being flat as in the prior art.

The device according to the invention, which comprises a pair of supple, curved stems located in the same plane, the upper ends of which are folded back, in opposite directions, and a supple stem folded back on itself forming a loop, the assembly of said stems being intended to be disposed inside the uterine cavity, is characterised in that said pair of stems, the loop and a second pair of stems similar to the first pair, but ^ angularly shifted with respect thereto, are housed, by means ©f their lower ends, inside a hollow cylindrical tube intended to be placed inside the neck of the uterus, which tube is widened at its upper end and is provided with one or more windows on its side wall, the pairs of stems and the loop being in planes parallel to the axis of said tube, and in that the loo is provided at its summit with an excrescence which is substantially perpendicular to the plane of said loop.

Attention is drawn the specification of U.S.

Patent No. 3,507,274, which relates to an intra-uterine contraceptive device which differs from the device of the present invention among other things in that it has only one pair of stems, no stem folded back so as to form a loop and no windows.

The assembl constituted by the loop and the two pairs of stems in the device according to the invention is intended to occupy the greate part of the space of the uterine cavity, These stems are preformed in such a manner tha they are deformabl© rectilinearly by the application of a force, in order to enable t e doctor to place and remove the device according to the invention.

B the combination of the loop and th two pairs of stems, a device is produced, the part of which that is intended to act at the level of the uterine cavity, is i the form of a fleur de Lys.

The tubular c linde is intended to permit the menstrual flow of blood* The widened form of the end where the ste s are assembled is placed at the level of the uterine isthmus. This widening is preferably oval or elliptic in section, so that the isthmic region is not obturated, but favours the flow towards the neck. The hollow tube is also preferably oval or elliptic in order to ensure said flow.

In the side wall of the tubular cylinder there are arranged at least two windows, and preferably three, depend- ing on the dimensions of the intra-uterine devices, as wil_ , be seen later. It is an object of these windows and the shape of the section of the hollow tube to avoid excess pressures inside said tube which would favour the ejection of the device, since the loop and the pairs of stems forming the "lily" would penetrate into the cylindrical tube and would no longer ensure its holding in the neck.

The tubular cylinder disposed in the cervical region creates a zone of diffusion of acidity at the level of the cervical glair, rendering it spermifugal. It is known that the spermatozoa flee from acidity, particularly that of the vagina, and rise in the neck where they meet an alkaline medium. Due to the presence of a hollow cylindrical tube provided with two or three windows, held in the neok, the cervical glair becomes acid and remains impassable to the spermatozoa.

According to a characteristic of the invention, the hollow tube is provided with an acid cream or jelly, with a pH of about 4.5 - 5 introduced through the base of the tube, in order to encourage the diffusion of acidity at the level of the cervical glair. The most suitable spermicidal jellies and creams that may be used are those which comply with the control criteria of the International Planned Parenthood Federation. By way of non-limiting example, mention may be made of a speciality based on nonylalkyl-phenoxyethanol and of lauryl and sodium sulphate, commercialised b Laboratoires Labaz under the name of Dogynol, the pH of which being 5. The acid cream is generally introduced through the lower aperture of the cylindrical tube and the acidity must be checked every 4 or 6 months in order to determine the moment of replacement. This check can be effected by means of a pH indicator paper.

According to another characteristic of the '· invention, each of £he stems of the pairs of stems is integral with a side part of the loop. In this case, the loop and said pair of stems are preferably located in the same plane, which is parallel to the axis of the hollow tube .

The excrescence provided at the summit of the loop may be spherical or preferably cylindrical. When said excrescence is a cylinder, the face of the upper section of said cylinder is provided with a groove so as to render the contraceptive device more supple.

When, inside the uterine cavity, tensions are exerted on the excrescence of a loop integral with a pair of stems, the assembly does not return into the hollow tube; on the contrary, said pair of stems prevents the expulsion since the stems abut more strongly on the walls of the uterine cavity. fleur de Lys Such a device, due to its lily shape, avoids having to fix the hollow tube to the edge of the neck of the uterus "by one or more stitches, However, in order to render the device according to the invention more integral with the woman's internal organs, there may be provided a fixing means integral with the hollow tube on which possible stitches will be made.

This fixing means may, according to a particular embodiment of the invention, be a tongue -shaped member provided at the lower end of the hollow tube, in the form of an arc, and intended to cover the edge of the uterine neck as far as the stitch. According to another embodiment, this fixing means may be a pastille or excrescence provided on the outer wall of the hollow tube at the lower end thereof, the stitches then being effected if necessary on the inner edge of the opening of the neck. This latter mode of fixation has two advantages: for the doctor, it is much more practical to make the stitches at the level of the inner edge of the opening of the neck than to make them on the outer edge of said opening, on the one hand, and, on the other hand, such a mode of fixation enables the dimensions of the fixing means to "be reduced.

The material used for making the device accord-ing to the invention is generally a synthetic macromole-cular substance chosen in particular from polyamides, polyesters, polyfluoroalkylenes and polyolefins which do not irritate the tissues and have a high resistance to the attack of the enzymes of the tissues. If desired, 20o by volume of barium sulphate may be incorporated in the macro-molecular substance, in order to render it opaque to X-rays.

For example, the stems and the tube may be made of polypropylene.

The stems and the loop are introduced into the uterine cavity ¾ means of a pusher made of flexible plastics material, particular polystyrene, provided with a flat part at its upper end in order to facilitate the positioning, as it is necessary for the stems and the loop fleur de Lys in the form of a i-i-i-y to be suitably adapted to the size of the uterine cavity in order to ensure a sure contraceptive effect.

The invention will be more readily understood upon reading the following description, with reference to the accompanying drawings, in which: Fig. 1 shows a contraceptive device.

Fig. 2 is a section along II-II of the device of Fig. 1.

Fig. 3 shows a device similar to that of Fig. 1.

The contraceptive device according to Fig. 1 is composed of a hollow cylinder 1 of oval or elliptic section provided with windows 2 of 1 mm "by 0.37 mm (3/8) and with a widened sleeve 3 with a height of 3 ∞m and upper diameter of 3 nam. Four curved stems 4 leave this sleeve, the free end 5 of each of which is folded "back on itself and is provided with a spherical excrescence and a stem curved back on itself forming a loop 6, the loop having at its summit a substantially ellipsoidal excrescence. 7. A fixing tongue 8, in the form of an arc, connected to the contraceptive device, preferably along the lower third of the hollow tube, is fixed to the outer edge of the neck at a point 9 of the periphery of the neck.

The fixing at 9 is effected by passing the tongue 8 into the neck by means of a needle; 2 to 3 knots are generally necessary.

The curved stems 4 are cylindrical and have a diameter of 0.5 mm, the loop 6 is also cylindrical with a diameter of 0,5 to 0.75 mm, the excrescence 7 is 2 mm high and 4 mm long.

Fig. 3 shows a : referred contraceptive device, which differs somewhat 'from that of Fig. 1 in that one of the stems 4 of eac pair of stems is integral with a side part of the loop 6, said stems and said loop being located in the same plane parallel to the axis of the hollow tube. The cylindrical excrescence 7 has a groove on the face opposite the face of contact of said excrescence with the loop. The arcuate fixing tongue of Fig. 1 is advantageously replaced here by a pastille or excrescence 8 provided at the lower end of the hollow tube and intended for making stitches on the inner edge of the opening of the uterine neck.

In general, the largest internal diametrical dimension of the cylindrical tube 1 may vary between 2 and 2.5 mm and the largest outer diametrical dimension between 3.3 and 4 mm. The length of the tube and the height of the stems-loop assembly intended to occupy the intra-uterine cavity depend upon the clinical examination made by the doctor.

In fact, it is known from KNOGH' s studies published in 1967 that intra-uterine devices (abbreviated to I.U.D. ), adaptable according to the measurements, give better results than the standard, non-adaptable devices, as will be seen in Table I hereinafter.

TABLE I Standard I.U.D. Adaptable I.U.D. 356 cases 707 cases Pain and bleeding 18$ 2.

Expulsions 11 0.1$ Pregnancies 6$ 0 $ The perfect occupation of the uterine cavity ensures the contraceptive effect by triggering an early pre-decidual cytological maturation. Consequently, in order "fleur de Lys" to obtain the desired prevention, the height of the -"Ιϋ " to be placed in the uterine cavity will depend on the measurements of the woman and will be between 15. and 25mm (transfundal measurement).

Furthermore, in order to complete the prevention and the tolerance at the level of the uterine cavity, sizes, or rathermore lengths, of tube 1 should be used which differ according to the measurements of the woman. The cylindrical tube preferably has a length of between 22 and 47 mm.

The tubes intended to be lodged in the cervical part will preferably be supplied with the following four lengths: 22mm, 32mm, 37mm and 47mm. For the first two lengths, a Charriere gauge 10 (or French gauge 10) with an inner end diameter of 2 mm and outer end diameter of 3.3 mm. For the last two lengths, a Charriere gauge 12 (or "French gauge 12") will be used with an inner end diameter of 2.5 mm and outer end diameter of 4 mm.

The extreme width of the device according to the invention, inside the uterine cavity, varies between 16 and 26 mm.

Claims (6)

1. Contraceptive device to be placed both, in the uterine cavity and in the neck of the uterus and comprising a pair of supple, curved stems located in the same plane and the upper ends of which are folded back in opposite directions and a supple stem folded back on itself, forming a loop, wherein said pair of stems, the loop and a second pair of stems similar to the first pair but angularly shifted with respect thereto, are housed, by means of their lower ends, inside a hollow cylindrical tube, in-tended to be place inside the neck of the uterus, which tube is provided with a widening at its upper end and with one or more windows on its side wall, the pairs of stems and the loop being in planes parallel to the axis of said tube, and the loop is provided at its summit with an excrescence substantially perpendicular to said loop.

2. Device as claimed in Claim 1, wherein each of the stems of a pair of stems is integral with a side part of the loop, the loop and the stems to which it is connected being located in a plane parallel to the axis of the hollow tuhe .

3. Device as claimed in Claim 1, wherein the excrescence provided at the summit of the loop is cylindrical and provided on its upper face with a diametrical groove.

4. Device as claimed in Claim 1, wherein the hollow tube is provided with a spermicidal cream or jelly with a pH of between 4. and 5.

5. Device as claimed in Claim 1, wherein the hollow tube is provided with a fixing means at its lower part which - 9 - is to be stitched near the opening of the uterine neck.

6. Device as claimed in Claim 5, wherein the fixing means is a pastille or excrescence intended to enable the stitches to be made on the inner edge of the opening of the uterine neck. - 10 -