WO1988009647A1

WO1988009647A1 - Process for rendering women reversibly infertile by quasi-sterilization, and contraceptive means according to this process

Info

Publication number: WO1988009647A1
Application number: PCT/AT1988/000042
Authority: WO
Inventors: Axel Lengerke
Original assignee: Carinthia Textilindustriegesellschaft M.B.H.
Priority date: 1987-06-03
Filing date: 1988-06-03
Publication date: 1988-12-15
Also published as: DE3718557A1

Abstract

In a process for rendering women reversibly infertile by quasi-sterilization, each ovary (3) is screened from the fringed (5) funnel-shaped end (4) of the Fallopian tube by implantation of a filter (6) of pore size between 0,2 and 110 mum which prevents a ripe egg from entering the Fallopian tube (2) after its release and ejection from the follicle. Various executions of the filter (6) are described and illustrated.

Description

Process for the reversible infertility of women by quasi-sterilization and contraceptive means according to this process

The invention relates to a method for reversibly rendering women sterile by quasi-sterilization. The invention also relates, however, to a contraceptive agent using this method.

Various means and methods for contraception in women are already known. For example, the use of so-called cervical or portio caps, which are made from tissue-friendly plastic, is part of the prior art. These cervical or portio caps are put over the outer cervix by the doctor after each menstrual period and removed by the doctor a few days after ovulation or only shortly before the next menstrual period begins. The constantly repeated medical interventions are particularly disadvantageous.

However, it is also known to use the so-called vaginal pessaries, which consist of a cap with a ring-shaped, somewhat stiff, but elastic edge, the latter providing the seal against the vaginal walls. should act (DE-OS 28 18 3). These vaginal pessaries are inserted into the vagina before intercourse and then removed again. A disadvantage of this contraceptive, however, is that vaginal infections are often caused.

Finally, so-called intrauterine devices in the form of rings or spirals made of tissue-friendly plastic are also known, which are inserted into the uterus by the doctor. Bleeding, pain and inflammation are often disadvantages.

All of these mechanical contraceptive methods also have the disadvantage that they cannot reliably prevent pregnancy. (Pearl Index: intrauterine devices 0.3, barrier methods 39).

So far, sterilization has proven to be the only safe method of contraception. Either the sections of both fallopian tubes near the uterus are surgically removed and the stumps are prevented, or the fallopian tubes are electrically scabbed through a laparoscope. The disadvantage of sterilization, however, is that it can only be reversed with a great deal of microsurgical operation, but only a success rate of 30% is achieved.

The object of the invention is to show a possibility which, while maintaining the full functionality of the ovaries, reliably prevents the egg which has been thrown out from falling into the egg (oviduct) during a follicular jump (ovulation). The aim is therefore a quasi-sterilization which - if desired - can be reversed at any time with the same effort. - 3 -

The invention is based on the consideration that after each follicle jump the funnel-shaped fallopian tube end provided with fimbriae - chemotactically stimulated by the released egg - tries to capture this egg, to some extent by an egg catching mechanism, and then this egg into the fallopian tube, where it can be fertilized by a male sperm (sperm).

The aim of the invention is now to prevent the end of the fallopian tube from catching an egg which has become free after the follicle jump.

This problem is solved in procedural terms according to the characterizing part of claim 1 in that each ovary (ovary) is shielded against the funnel-shaped fallopian tube end provided with fimbriae by implanting a filter, the through openings of which have a size between 0.2 and 110 / im.

D _a _eτ diameter of a released during Follikelsprung egg is about 120 Lisa, it can not pass through the filter and therefore not terende from the funnel örmigen Eilei¬ are collected. The use of a filter is important because there is a requirement to allow constant fluid exchange between the ovary and the abdominal cavity. However, through openings of the filter are sufficient for this, the lower limit of which is 0.2 cm.

Another important procedural feature exists after

Claim 2 in that a filter in the form of a flexible covering is used, which is put over the ovary and closed.

It can be particularly recommended if according to claim 3, a covering with an elastically expandable or variable in diameter its opening via a tether opening for the ovary is used, which is applied sealingly to the vascular supply band (mesovarium) of the ovary.

According to claim 4, the covering can be brought to the ovary by a laparoscope and placed over the latter and the supply band while temporarily widening the through opening. After the passage opening has been released, it is narrowed by the elastic restoring force or by tightening a retaining band so that the covering is held securely on the ovary and on the vascular supply band. The ligament tension or elastic constriction should, however, only be relatively small so that the blood supply to the ovary is not impaired.

According to claim 5, the covering can be fed through the laparoscope by means of expanding pliers and expanded in the area of the ovary to accommodate it. When the spreader is moved back from their working position to the rest position, then it outputs the envelope-free, so that it surrounds the ovary, wherein an optional holding is tightened ribbon or the envelope is held in place with a ELA stischen in ^• opening portion provided band.

Of course, the expanding pliers must be designed in such a way that they can move freely together with the folded or rolled covering through the working channel of the laparoscope, which generally has a diameter of about 5 mm.

The contraceptive agent according to the invention by the method described above is according to claim 6 characterized by a casing made of implantable material, which is provided at least in a partial area of its jacket with filter openings in the size between 0.2 and 110 Am and has an insertion opening for the ovary and the vascular supply band.

The insertion opening of the casing can have an elastically expandable edge (claim 7).

According to a preferred embodiment according to claim 8, the covering consists at least partially of a filter film with a mesh size between 0.2 and 110 m. Such filter foils are known per se and have hitherto usually been used as bacterial filters.

According to claim 9, the filter film can consist of a polyester fabric, the weaving threads of which are fixed against each other at the crossing points, so that the specified mesh width remains constant under all circumstances.

According to a possible embodiment according to claim 10, the envelope is designed as a sack or pouch, which is provided at its opening with a tether or an elastic closure - and, in the open state, can be placed over the ovary and the vascular supply band. The volume of the covering should correspond approximately to 2 to 3 times the volume of an ovary carrying a follicle ready for jumping. Apart from the fact that this measure avoids a narrow constriction of the ovary, this dimensioning of the covering also ensures the full exchange of fluids with the abdominal wall.

According to a possible embodiment, the covering according to claim 11 consists at least in part of a flexible injection molded part. You can also use the wrapper in one

Blowing or drawing process from a suitable, possibly cut film or filter material. To one of these variants is the envelope of claim 12 made from a film tube which is closed at one end by an injection-molded end piece and bears at the other end a likewise injection-molded tip _"in which the passage opening is provided.

A further possibility according to claim 13 is that the sheathing does not have filter openings in its entire wall, but instead consists of a flexible, preformed, elastically deformable part, which consists of

Filter films has closed windows. The filter foils of the windows can be welded, injected or cast in or glued in.

According to the invention, an optimal possibility for contraception is created by bringing about a quasi-sterilization. The implanted filter body can remain in the abdominal cavity without problems as long as no pregnancy is desired. The quasi-sterilization can be reversed at any time by a slight surgical intervention, practically in the same way that was used to bring about the quasi-sterilization, namely with the aid of a laparoscope.

The invention is explained in more detail below with the aid of a drawing. Show it

1 shows a schematically simplified sectional illustration of a woman's uterus with only one ovary and the associated fallopian tube in its natural state, the funnel-shaped open end of the associated Fallopian tubes, Fig. 3 also in a schematic simplified representation of the means for bringing about and ensuring one

Quasi-sterilization, Fig. 4 in a schematic simplified representation another

Means for producing quasi-sterilization in the

Section and Fig. 5 shows another embodiment of this means in

View.

According to FIGS. 1 and A of the drawing, the fallopian tubes 2 are connected to the uterus 1 of a woman on both sides, which lead to the ovary 3 and face it with the funnel-shaped widened fallopian tube end 4. The fallopian tube end 4 is provided with the so-called fimbria 5.

The ovary 3 is connected to the pelvic wall via the vascular supply band 10. Another, only inconsistently present vascular supply band 11, which leads to the uterus 1, has essentially only position-stabilizing meaning. After an egg formed on the surface of the ovary 3 has become free after the follicle jump, the funnel-shaped fallopian tube end provided with the fimbria 5 tries to capture this egg. For this purpose, the end of the fallopian tube 4 is attracted by the egg to a certain extent by chemotactic means. The egg caught by the egg trapping mechanism then enters the fallopian tube 2, where it can be fertilized by a male sperm cell (sperm).

In order to achieve quasi-sterilization, it is important to counteract the entry of an egg released after the follicle jump into the funnel-shaped fallopian tube end 4 and thus also its further transport into the fallopian tube 2. For this purpose, each ovary 3 is shielded from the end of the oviduct 4 by a filter 6, as shown in FIG. 2 of the drawing. This filter may be made ^'from a tested implantation polyester fabric having a mesh size ώn 0.2 to 110. In order to form the filter 6, preference is given to a polyester fabric, the individual weaving threads of which are fixed against one another at the crossing points, so that it is ensured that the specified mesh size is retained at all points and under all circumstances.

According to a possible embodiment according to FIG. 3, a bag or pouch 7 made of filter film is used as the filter 6.

This sachet or pouch 7 can be made from a flat filter film 6. First of all, a blank is made from it and then, after appropriate folding, it is connected at the edge by the application of weld seams in such a way that the sachet or pouch 7 with the opening 8 on there is an end.

In the edge region of the opening 8, the sachet or bag 7 should have a circumferential elastic band which is attached in such a way that, in the relaxed state, it automatically brings the opening 8 to a dimension which corresponds to only a fraction of its normal opening width.

It is also important that the sachet or sachet 7 is made from the filter film 6 in such a size that its volume is dimensioned much larger than the volume of an ovary occupied by a mature egg 3. The volume of the sachet or sachet 7 should be the same Correspond to two to three times the volume of an ovary 3. The shielding of the ovary 3 against the funnel-shaped fallopian tube end 4 of the associated fallopian tube 2 is brought about by a surgical intervention using a laparoscope through the abdominal wall. With the help of the laparoscope or one through it. When the spreading forceps are movable through the working channel, the pouch 7 can be brought up to the ovary 3 in the folded state. The spreading pliers are then released and the opening 8 of the bag or pouch 7 is brought to its greatest possible width against the restoring effect of the elastic band 9.

Now the sachet or pouch 7 is pushed with the help of the spreading pliers from its opening 8 in the area of the funnel-shaped fallopian tube end 4 over the ovary 3 until it reaches the area of the vascular supply band 10, 11 (mesovarium) with its elastic band 9 .

If the spreading pliers are then closed, they come free from the opening 8 of the sachet or pouch 7, whereby the elastic band 9 running on the edge thereof can also relax. In this way, a closure of the sachet or sachet 7 is brought about to some extent by sealingly engaging the vascular supply band 10, 11 in the area of the elastic band.

From FIG. 2 of the drawing it can be seen that the sack or bag 7, which is placed around the ovary 3 and consists of filter foil 6, shields the ovary 3 against the funnel-shaped fallopian tube end 4 provided with the fimbriae 5 and thereby permanently reliably prevents a mature egg released by the follicular jump reaches the end of the ovary 4 and thus the ovary 2.

It is also worth mentioning that this is a closure for the Band 8 acting opening 8 of the sachet or sachet 7 should ensure a certain minimum size of the opening 8, so that the blood supply to the ovary 3 enclosed by the sachet or sachet 7 is ensured without impairments under all circumstances.

The sack or bag 7 made of filter film 6, which effects the quasi-sterilization, can remain at the belly height for as long as no pregnancy is desired. On the other hand, the quasi-sterilization can be reversed at any time if this is desired or is even necessary. A slight surgical intervention using the laparascope not only allows the sack or pouch 7 to be removed from the ovary 3, but also completely removed from the abdominal cavity.

The sachet or pouch 7 can also be preformed into the use form by blowing or deep-drawing a suitable filter film. However, it is also possible to produce the filter 6 in whole or in part by injection molding, blowing, deep-drawing and other known production methods for elastically deformable thin-walled hollow bodies. If the entire filter is manufactured by injection molding or deep drawing from the same material (usually a body-compatible silicone rubber or another plastic), the filter through-openings can be used immediately or subsequently, e.g. B. by punching, making sure that the specified dimensions are not exceeded. For the desired liquid or moisture exchange, it is sufficient if the filter passage openings are only made in some areas. It is also possible to manufacture the filter in a blow molding process.

Because of the exact manufacturability of the .openings, or mesh size not to do without the use of a filter film, it is also possible to produce only parts of the wall of the filter 6 from a corresponding film, but the other parts from a molded or cast material.

A favorable manufacturing option for the filter is obtained if the filter is manufactured from a filter hose. In the simplest case, one end of the hose can be closed by contracting and welding, and the other can be provided with the elastic collar 9 according to FIG. 3 or a tightenable retaining band.

4 shows an embodiment in which a filter hose 12 is provided with a sprayed-on, thin-walled cap 13 at one end which, as a molded end piece, brings about the end, whereas an end piece 14 is molded onto the other end of the filter hose 12 contains an expandable opening 16, optionally provided with an edge bead 15.

5, the filter 6 is formed by a balloon-shaped, thin-walled, collapsible body 17, in the jacket of which window openings 19 are provided which are closed by filter inserts 18, the material of the body 17 closely adjoining the edges of the filters. Here, too, there is an expandable opening 21 provided with an edge bead 20.

Claims

Patent claims

1. A method for reversibly rendering women sterile by quasi-sterilization, characterized in that each ovary (3) is shielded against the funnel-shaped fallopian tube end provided with fimbriae (5) by implanting a filter (6), the passage openings of which have a size between 0.2 and 110 μm.

2. The method according to claim 1, characterized in that a filter (6) in the form of a flexible covering (7, 12 to 14, 17) is used, which is placed over the ovary (3) and closed.

3. The method according to claim 1 or 2, characterized gekenn¬ characterized in that a sheath (7, 12 to 1, 17) with an elastically expandable passage opening (8) for the Eier¬ stick (3) is used, which seals the vessel supply ¬ supply band (10, 11) of the ovary (3) is applied.

4. The method according to any one of claims 1 to 3, characterized in that the covering (7, 12 to 14, 17) brought to the ovary (3) by a laparoscope and with temporal widening of the through opening (8, 16, 21st ) over this and the supply band (10, 11).

5. The method according to any one of claims 1 to 4, characterized in that the covering (7, 12 to 14, 17) by means of spreading forceps through the laparoscope and expanded in the Be¬ area of the ovary (3) for its inclusion.

6. Means for contraception by the method according to one or more of claims 1 to 5, gekennzeich¬ net by a covering made of implantable material (7, 12 to 14, 17), the filter openings in at least in a partial area of the size between 0.2 and 110 μm. is provided and has an insertion opening (8, 16, 21) for the ovary (3) and the vascular supply band (10, 11).

7. Means according to claim 6, characterized in that the Einführungsöf opening (8) of the sheath has an elastically expandable edge (9, 15, 20).

8. Means according to claim 6 or 7, characterized in that the covering (7, 12 to 14, 17) at least for

Part consists of a filter film (7, 12, 18) with a mesh size between 0.2 and 110 microns.

9. A composition according to claim 8, characterized in that the filter film (7, 12, 18) consists of a polyester fabric, the weaving threads of which are fixed against one another at the crossing points.

10. Means ^* according to one of claims 6 to 9, character- ized in that the envelope (6) is designed as a small bag or bag (7) which at its opening (8) with a retaining band (9) or see an elastic closure and, in the open state, can be slipped over the ovary (3) and the vascular supply band (10, 11).

11. Means according to one of claims 6 to 10, characterized by the fact that the covering (12 to 14, 17) consists at least in part of a flexible injection molded part.

12. A composition according to claim 11, characterized in that the covering consists of a film tube (12) which is closed at one end by an injection-molded end piece (13) and at the other end carries an injection-molded end piece (14) in which the lead-through opening (16) is provided.

13. Means according to one of claims 6 to 11, characterized ge indicates that the sheath (6) consists of a flexible, pre-formed elastically deformable part (17) having windows (19) closed by filter foils (18).