IE50843B1 - Contraceptive device designed to be placed inside the uterine cavity - Google Patents

Abstract

1. Contraceptive device designed to be placed inside the uterine cavity, of the type comprising an axial stem (1) and a tri-dimensional holding part (2) made of a supple and elastic material, said holding part being secured to one end (1a) of the stem (1) and extending transversaly to the axis (1b) of the stem (1) so as to be supported on the lateral uterine walls, said holding part (2) comprising two closed lopps (3, 4) each one of which is secured by way of elastic fastening means to the end (1a) of the stem (1) and being axially symmetrical with respect to the axis of the stem, said loops extending the stem (1) in divergent manner, characterized in that the loops have no symmetry with respect to a plane, but on the contrary are offset laterally in opposite directions one with respect to the other and also with respect to the axis of the stem, as a result of which the said holding part is adaptable in its two transverse dimensions (a and b) to the dimensions of the uterine cavity, the adjustment of the transverse dimensions (a) of the device to fit the uterine dimensions being made by a partial oberlapping of the loops in the manner of scissors blades.

Description

The present invention relates to a i. uilroceptjve device designed to be placed inside the uterine cavity and comprising : an axial stem and a three-dimensional holding part, made of a supple and elastic material said holding pari being secured to one end of the stem.

U.S.-A-4 054 131 h.ns already disclosed an intrauterine contraceptive device which comprises a central stem surmounted by a transverse how curving in towards the stem. The two ends of said bow are extended by short arms, which can be placed outside the plane common to both the bow and the stem, although this is not a requirement. The two arms, which it is admitted, could perforate the uterine tissue, are provided with fin-like portions designed Io eliminate that risk. It has however been proved that all risks of bleeding on the uterine wall is not altogether remoted.

Other deviceshave also been proposed, but they do not entirely correspond to the type of divice concerned with in the present invention. for example, the device described in b’.S.-A-3 4 33 369 has no axial stem, but instead a trapezoidal body, its trapezoidal sdiape holding it ii. position inside the uterine cavity. Moreover, even Ihough certain embodiments of such devices use a two-looped holding part, the loops are symmetrical, planes .mil of constanl width, which means that they are III.able to U.lapt to any different conformations of u ei· ι ii·· i ant n s.

FR-A-2 165 714 shows a device of a completely different and complicated d'-sign which comprises a plane loop, therefore not a tridiminsi Uial one, different folded-up stems, and a discshaped asperity.

I'he object of the piesenL invention is to produce a deviie of Lho aforesaid type, which can be endured by any woman receiving it, which is easy to produce and which shows none of the disadvantages of the already known devices.

Accordingly, the invention provides a contraceptive device designed to be placed inside the uterine cavity, comprising an axial stem and a three-dimensional holding part made of a supple and elastic material, said holding part being secured to one end of the stem and extending transversely to the axis of the stem so as to be supported on the lateral uterine walls, said holding part comprising two closed loops each one of which is secured by way of elastic fastening means to the end of the stem and being axially symmetrical with respect to the axis of the stem, said loops extending the stem in divergent manner, the loops having no symmetry with respect to a plane, but on the contrary being offset laterally in opposite directions one with respect to the other and also with respect to the axis of the stem, as a result of which said holding part is adaptable in its two transverse dimensions to the dimensions of the uterine cavity, the adjustment of the transverse dimensions of the device to fit the uterine dimensions being made of a partial overlapping of the loops in the manner of scissors blades.

On account of its application in the transverse dimension of the uterine cavity, where the walls are less innervated, the device according to the invention offers relatively few risks of rejection.

Preferably, each loop of the holding part is substantially triangular in shape, narrowing down in the direction departing from the axis of the stem.

Preferably, the stem and the holding part are molded in one piece from a supple and elastic plastics material, belonging for example to the polyethylene family.

Further preferably, the length of the stem is such that when the device has been placed into the uterine cavity, said stem is entirely contained inside said cavity.

Preferably, an active product is 5U843 incorporated in the stem.

Advantageously, the stem is hollow and closed, contains an active product and the wall thereof is dun enough to allow the active product to diffuse out.

Also preferably, the stem is made of plastics cellular-type material.

It is true that the documents GB-A-2 010 676 and U.S.-A-3 993 072 respectively disclose a porous ,,..11 and a cellular wall permitting the use of an active product m a contraceptive device, but said documents do not propose a device sucli as described in the present >. veiitiaii with a special structure which allows it to be secured efficiently inside the uterine cavity.

The invention will be more readily tmdersiood mi reading the following description with reference to the accompanying drawings, in which : - figure 1 is an elevational view of a device according to a first embodiment of the invention; Jl) - Figure 2 is a side elevation of Figure 1? - Figure 5 is a view from beneath of - Figure 4 is a cross-sectional view of 3D . uterine cavity fitted with the device of Figure 1.

The illustrated contraceptive device 1 1' igs. J and 21 comprises an axial stem 1 and a holding part 2, made from an elastic and supple material. Said holding part 2 is secured to one end la of the stein 1.

The holding part 2 is constituted by two loops 3 and 4 each one secured in one spot 3a, 4a I the end lu of the stem 1. Said holding part 2 is three-dimensional, and extends transversely to the axis ll· ot tiio stem 1 so as to rest against those areas of the uterine- wall j adjacent to the Fallopian tubes 6 (Fig 4).

The loops 3 and 4 extend from the axis tlj 35 of the sLem 1 m substantially opposite directions; - 5 moreover, said loops 3 and !l are substantially plane and their planes 3.b, 4b , are entirely separate.

The loops 3, 4 constituting the holding peirt 2 are each substantially triangle-shaped, narrowing down in the direction departing from the axis lt> of the stem 1. The fastening point 3 a., 4a of the loops 3, 4 is the apex of the right-angled triangle opposite the hypotenuse of said triangle.

The mean planes 3b., 41, of the loops 3, 4 are divergent from the end la of the stem 1. Said mean j,lanes 3^, 4b are symmetrical togethej· with respect to the axis Lb of the stem 1 (Figure 2) but they present no plane symmetry.

'The stem 1 and the holding part 2 are 1.3 advantageously molded in one piece in a supple plastics material, belonging preferably to the polyethylene family.

The length of the stem 1 is such that, when the device has been placed into the uterine cavity 7, said stem is entirely contained in said cavity (Fig. 4).

Advantageously, an active product is incorporated in the stem 1. For example, the stem 1 can be hollow and closed, it can contain an active product and its wall can be thin enough to allow said product to diffuse out. According to another example, the stem 1 is made of plastics cellular-type material and contains an active product filling up each cell.

Advanfcageously, the stem 1 is made from a vinyl acetate and ethylene copolymer. 'This material presents the advantage of constituting a membrane permeable to relatively large organic molecules.

'The intrauterine device described hereinabove is really three-dimensional, and it is designed and dimensioned transversely to the stem 1 so as to be constantly supported by the faces of the uterine cavity, whatever the cvclic changes of the cavity walls III or Un anatomic i! i mcnsj on» of the cavity. Its length a is such that the device rests against the opposite outermost side faces 5.

The other two dimensions b and c width and height respectively, are adapted to those of the cavity 7 in which the device is introduced.

This device is not likely to perforate the uterine wall or to press into it, due to the rounded angle shape of its loops 3, 4 to their suppleness and to ιheir great deformability.

With the two symmetrical loops 3, 4 and 1 he axial stem J composing it, this device covers the three zones where the implantations are normally made .

Due to the elasticity of the structure where the loops are joined to the central stem, the said joining point acting virtually as a hinge for the loops, the two loops 3, 4 can retract one towards the other in the direction of the length a" and thus adapt to the length of the horns of the uterus even if these are asymmetrical.

The central stem 1 ensures the stability of the .levice once placed inside the cavity 7 by preventing the pivoting movement of the two loops 3, 4 about tue middle of the device constituted by the points 3£ and 4a substantially in coincidence one with the other and with the end la. of the stem 1.

According to the example illustrated in figure 2, the stem 1 is hollow. Its wall lc is thin enough to allow the diffusion outside the stem of the complementary active products that it contains(such as for example biological, chemical, and antibiotic products) The stem 1 is an integral part of the mtrauterine device and it can be molded with the loops 3, 4 or be added thereon, if its constituent material is difI erent from that ιιΓ the loops 3, A. The material Constituting the stem 1 may be a cellular-type material impregnated with the active product.

The stein 1 may of course be solid and receive a copper or bimetallic wire, or a sleeve impregnated with the complenientary-ac ting products.

In the case illustrated in Figure 2, the end of the tubular stem 1 can be closed in by crushing, welding or any mechanical means.

The walls lc_ of said tube can be provided with orifices allowing the diffusion of the products 8 contained therein or creating a way-in from the physiological medium of the uterus to the inside of the tube 1.

The whole intrauterine device assembly can be molded from a cellular plastics material permitting its impregnation in vacuum by the aforesaid active products. Said products can also be incorporated in the plastics material at molding time.

A pulling cord not shown permitting the removal of the device is attached to the stem 1.

Due to its suppleness and to its shape, the device described hereinabove can fit inside a conventional inserting tube of small diameter and as a result can be inserted by the conventional means.

Claims (10)

1. A contraceptive device designed to be placed inside the uterine cavity, comprising an axial stem and a threedimensional holding part made of a supple and elastic

2. A device according to Claim 1, wherein each loop of the holding part has a substantially triangular shape narrowing down in the direction departing from the axis of the stem. 25

3. A device according to Claim 1 or 2, wherein the stem and the holding part are molded in one piece in a supple and elastic plastics material.

4. A device according to Claim 3, wherein the plastics material is a polyethylene. 30 5. A device according to any one of Claims 1 to 4, wherein the length of the stem is such that when the device has been placed inside the uterine cavity, said stem is entirely contained inside said cavity.

5. Thereof is thin enough to allow the active product to diffuse out. 5 material, said holding part being secured to one end of the stem and extending transversely to the axis of the stem so as to be supported on the lateral uterine wails, said holding part comprising two closed loops each one of which is secured by way of elastic fastening means to the end of the 10 stem and being axially symmetrical with respect to the axis of the stem, said loops extending the stem in divergent manner, the loops having no symmetry with respect to a plane, but on the contrary being offset laterally in opposite directions one with respect to the other and also with 15 respect to the axis of the stem, as a result of which said holding part is adaptable in its two transverse dimensions to the dimensions of the uterine cavity, the adjustment of the transverse dimensions of the device to fit the uterine dimensions being made by a partial overlapping of the loops 20 in the manner of scissors blades.

6. A device according to any one of Claims 1 to 5, wherein an active product is incorporated in the stem.

7. A device according to Claim 6, wherein the stem is hollow and closed, contains an active product and the wall

8. A device according to Claim 7, wherein the stem is made of a cellular plastics material.

9. A device according to Claim 1, substantially as

10. Hereinbefore described with reference to and as illustrated in the accompanying drawings.