DD291243A5 - INTRAUTERINE RECOMMENDED HANDLING DEVICE - Google Patents

Abstract

The present invention relates to an intrauterine antiangiogenic device consisting of an active body (2) of a metallic substance having anti-inflammatory activity, a tracer element (1) for holding the active body (2) in an intrauterine environment. The essence of this invention is that the active body (2) consists of at least two metals forming a plurality of galvanic cells in the intrauterine environment. Fig. 1 {memory preventive device; active body; Traegerelement; Metal mixtures; galvanic cells; intrauterine environment}

Description

Field of application of the invention

The invention relates to an intrauterine contraceptive device consisting of an active body made of a metallic substance having contraceptive activity and a support member made of a biologically inactive substance for supporting the active body in an intrauterine environment, wherein the support member is generally made of a plastic and provided with an indicator thread.

Characteristic of the known state of the art

For many years, the contraceptive effectiveness of some intrauterine devices has been known. They have been used since the late sixties, after the corresponding plastics had been developed and studied. Since then, the intrauterine devices have been applicable in a wide variety of different shapes, configurations and materials.

The process of developing intrauterine contraceptive devices can be divided into three sections. The first of these periods is characterized by the use of appropriate plastics (see, for example, US Patent No. 3,937,217) which are completed in the second section by a steroid-releasing substance. The third period is characterized by the introduction of copper to make the active body. The copper-based intrauterine devices consist of a support member made generally in T-form of plastic material (eg, polyethylene), an active body in the form of a copper wire in contact with the support member, and also an indicator thread which is attached to the support element. The active body is mostly a coil-shaped element and the indicator thread is a flexible line made of plastic (e.g., polyamide).

The contraceptive efficacy of the known intrauterine devices with a copper wire is far greater than that of devices made without the active substance. This finding is based on various systematic investigations. One of them is reported by I. Batär in Orvosi Hetilap (Hungarian medical weekly, 2237,129,1988, in Hungarian). It compared the efficacy, better known as inefficiency, of intrauterine devices with a copper wire (type Multiload Cu 250) and the devices made without any active substance (so called Szontngh device, made in Hungary). The quantitative data were determined by calculating the so-called cumulative net termination rates introduced by C. Tietze and S. Lewit (Stud, in Farn. Plann., 35, 4, 1973) and accepted in international practice Based on the number of women who become pregnant by one hundred women with the intrauterine device over a period of one year. The corresponding data is 2.2 for Multiload Cu 250 device and 3.9 for Szontagh device, i. h., the first of the devices offers far more contraceptive safety than the second. In the article by I. Batar no analysis of the advantages of the technical features of the intrauterine devices is given.

In the above article, the clinical observations that continued over a period of about ten years were also reported. The intrauterine contraceptive devices, which have an active body made of a copper wire, were used by 1446 women and a value of 6.9 was determined for the so-called cumulative pregnancy rate. Since 88 pregnancies occurred during the observation period, the inefficacy was high at 6.1%. Other data in the literature (e.g., referred to in Population Reports, Vol. X, 4, B103 to B135, 1985, Baltimore, USA) have similar inefficiencies. The studies carried out in some Latin American countries yielded the following characteristic data: the pregnancy rate was 5% boi women using intrauterine devices with copper, 8% in women using oral contraceptives, 18% in those using mechanical contraceptives ( Condoms) and 40% in women who did not use contraceptives. In 1987, the proposal of S. G. Kaali, gynecology specialist at the Women's Medical Pavilion (Dobbs Ferry, New York, USA) was known to inactivate the spermatozoa in the uterus by a weak electric shock. Kaaü's contraceptive has not yet been tested in the human body; in any case, no such data was available at the time of filing the present patent application; it consists of metal electrodes arranged in the uterus and a battery connected to the electrodes.

The studies have consistently provided evidence that the contraceptive efficacy of the known intrauterine devices made with a copper wire as the active body is 94-95% and that is a relatively low value, assuming 100% for full safety must go out. An improvement in effectiveness or effectiveness is therefore highly desirable.

Another disadvantage of the known intrauterine devices is that the copper material of the active body slowly dissolves and consequently the active body shatters during its presence in the human body. As a result, the fragmented copper wire can damage the tissue and has a shortened life. In order to avoid the consequences of this disadvantage, it has been proposed in US Pat. No. 4,335,126 to make the active body from a copper wire having a core of a nobler metal than copper. Under the name NOVA T the company Schering AG (Germany) presents an intrauterine contraceptive device of this kind, in which the core of the copper wire consists of silver. In this way, the required smoothness of the surface of the intrauterine device is maintained for a longer time than is the case with pure copper wires.

It is believed that the contraceptive effect of intrauterine devices containing copper is due to the copper. The dissolution process of copper, d. that is, the rate at which copper ions are generated by the device is uneven, so that the known devices do not have a stabilized influence on the physiological processes that take place in the human body (ie, the enzyme processes, glycogen metabolism, absorption of estrogens, the activity of the uterine muscles, the changes in the composition of fluids, etc.), influence on the mechanism of contraception, the planting of the fertilized ice.

Object of the invention

The aim of the invention is to preserve the original form of the intrauterine device throughout the period of use and to ensure a uniform release of the ions with contraceptive effect.

Explanation of the essence of the invention

The invention has for its object to provide an improved intrauterine contraceptive device with high contraceptive effect of at least 99% based on a metallic substance.

The invention is based on the recognition that the active body of the intrauterine device should be made of a suitable metal composition containing at least two metals which together form a galvanic cell in the intrauterine environment.

Based on the above finding, there has been provided an intrauterine contraceptive device which consists of an active body composed of a metallic substance having contraceptive activity and a support member composed of a biologically inactive substance to immobilize the active body in an intrauterine environment, according to the invention the active body consists of a metallic substance including at least two metals forming a plurality of localized galvanic cells in the intrauterine environment. The active body is advantageously at least partially made of an alloy of at least two metals.

The plurality of galvanic cells advantageously consists of a copper-gold or a copper-zinc-silver alloy.

Of course, other alloys may be used, and it is particularly desirable to make the active body of copper and at least one metal of higher positive electrical charge when copper the anode of the galvanic cell and the other metal, for. As gold or silver whose cathode form. Some other metal compositions are nickel and gold, copper, silver and zinc, silver and cadmium, silver and palladium.

The basic features of the intrauterine device of the invention are that the active body includes a plurality of small, in most cases microscopic, galvanic cells, from which the ions of the anode, generally copper ions, with greater concentration than from the intrauterine devices of the known constructions can be removed.

The active body of the intrauterine contraceptive device proposed by the invention may preferably be made in the form of a coil consisting of a mixture of several metals (e.g., copper is completed by zinc and silver), the mixture, if required, may also be an alloy. In this way, several metals may be present in ionic form and in controlled amounts, thereby progressively increasing the potential difference between the electrodes of the galvanic cells and increasing the efficacy of the contraceptive activity possibly based on inactivation of the spermatozoon.

Another preferred Ausführurigsbeispiel the active body has a tubular shape, wherein one or more tubular elements are used. For several tubular elements, they can be divided into annular elements.

embodiment

Further advantages and features of the intrauterine contraceptive device according to the invention are shown in more detail with reference to the accompanying drawings, which illustrate by way of example some preferred embodiments. In the drawings shows

1 shows a schematic representation of a proposed contraceptive device with a coil-shaped,

Fig. 2: a schematic representation of an intrauterine contraceptive device with a tubular,

Figure 3 is a schematic representation of an intrauterine contraceptive device having an active body in the form of two tubular and three ring-shaped elements.

As is apparent from Figures 1,2 and 3, the proposed intrauterine, contraceptive device according to the invention consists of a carrier element 1 made of plastic, an active body 2 with the required activity, the z. B. is exerted by inactivation of the spermatozoa in an intrauterine environment, and an indicator thread 3, which is connected to the Trägereiement 1 (Figures 1,2 and 3).

The support element 1 is generally made of a suitable plastic, which usually has no physiological activity in the intrauterine environment. However, the feature that the support member 1 is biologically inactive is not a feature resulting from the contraceptive action of the active body 2, and if necessary, the support member 1 may be completed by other substances of corresponding activity. The support element 1 is generally a T-shaped element with two arms that can be inserted into the uterus of a woman and should carry the active body 2.

The support element 1 generally consists of two shanks 10,11, which are connected together in a loop 14 which carries the indicator thread 3, and continues in corresponding arms 12 and 13 (Fig. 1).

The active body 2 of the proposed intrauterine device is generally designed in the form of a coil 4 which is wound around the two shafts 10 and 11 of the support element 1 (Figure 1). The coil 4 may also be a double spiral made of wire by known mechanical technologies. The simple coil 4 or the double spiral,

d. That is, a coil wound from another coil made of a wire provides a high effective surface area.

Another possibility of forming the active body 2 is shown in Fig. 2, wherein the active body 2 of a

Tube 5 is made, which encloses the two shafts 10 and 11 of the loop 14 to the beginning of the arms 12 and 13. The tube 5 can be prepared by forming a rohrförmos element from a metal sheet and this is closed, z. B. by welding the metal sheet along the lines of the connecting edges of the sheets together. Another preferred possibility is shown in Fig. 3, in which an active body 2 is divided into several parts, the shafts 10 and 11 are partially enclosed by tubular elements 7, and between them a ring 6 is arranged. Further rings 8 are located at the free ends of the respective arms 12 and 13. This solution is particularly advantageous when the active body 2 consists of sheet and wire-like elements mk oin inhomogenized surface layer, which includes at least two metals, soft microscopic or small galvanic Form cells as required by the invention. The composition consisting of two or more metals is also a requirement for the coil 4 and the tube 5, which are made in their total volume or at least on the outer surface of at least two metals. In general, the active body 2 consists of copper and at least one other metal with higher Eiektropositivität, z. Gold or silver. These metals can entweu.v form a mixture or alloy. A third and further metal can also be used, and in this way creates a series of galvanic cells of different voltage. Other preferred choices for the preparation of the active body 2 are given in the examples below, but they should not be limited to the examples.

In the intrauterine environment, the proposed contraceptive device forms a plurality of galvanic cells with electrodes in the active body 2. The electrolyte is the biological fluid of the uterus. When the active body is made of a given first metal, e.g. Copper, and an edited metal, z. If, for example, gold is prepared, the rules of electrochemical corrosion indicate that the anodes are located at the "islands" formed by the first metal, ie, the copper, and the cathodes are at the locations where The dissolution process leads to the removal of the first metal from the active body 2, and the cathodes remain virtually unchanged in their original place, their fragmentation can not be observed Concentration of the ions of the first metal, ie, the copper ions, higher than in the vicinity of the known intrauterine devices.

Through the use of a mixture or alloy containing at least two metals, the process of release of the ions which ensure the contraceptive activity of the proposed device is controlled, the cathodes or cathode islands ensure the preservation of the original shape of the active body 2, and the problems associated with the fragmentation of the active body 2 leading to a rough, fragmented outer surface in the known devices can be avoided. The composition of the mixture or alloy of the active body 2 can be selected in a wide range including several orders of magnitude. The proposed intrauterine contraceptive devices act in the following manner: The small or microscopic galvanic cells formed by the component metals of the active body 2 can not only release the required active ions in the intrauterine environment, but also generate an electric field. As a result, the contraceptive activity, which is believed to be due to chemical effects, is intensified intensely by the electric field. It is known that the spermatozoon has an electrical charge, and this leads to its migration to the cathodes and anodes of the galvanic cells, corresponding to the respective electrical charge. As a result, the inactivation process of the spermatozoon has a higher efficiency than in the known devices. Another advantage of the proposed intrauterine contraceptive devices resides in the fact that during the excitement accompanying sexual intercourse, when the temperature of the human body rises above normal levels, the intensity of the release of ions in the galvanic cells increases results in a higher activity of the proposed intrauterine contraceptive device just when that is particularly needed.

Below are some examples.

example 1

The active body 2 of the intrauterine device proposed by the invention is a coil 4 (Fig. 1) consisting of 85 parts of copper and 15 parts of gold. The coil 4 is wound from a wire and encloses the support member 1, which consists of polyethylene. The carrier element 1 is connected to a polyamide thread 3.

Example 2

The active body 2 of the intrauterine device proposed by the invention is a coil 4 (Fig. 1) made of an alloy including 30 parts of zinc and 70 parts of copper. The coil 4 is wound from a wire and encloses the support member 1, which consists of polyethylene. The Trägerelament 1 is connected to a polyamide thread.

Example 3

The active body 2 of the intrauterine device proposed by the invention is a coil 4 (Fig. 1) made of an alloy including 40 parts of palladium and 70 parts of silver. The coil 4 is wound from a wire and encloses the support member 1, which consists of polyethylene. The carrier element 1 is connected to a polyamide thread.

Example 4

The active body 2 of the intrauterine device proposed by the invention is a coil 4 (Fig. 1) made of an alloy including 18 parts nickel and 82 parts gold. The coil 4 is wound from a wire and encloses the support member 1, which consists of polyethylene. The support element 1 is connected to a polyamide thread 3.

Belspiel5

The active body 2 is a tube 5 (Fig. 2) made of an alloy made of 40 parts of copper, 25 parts of silver and 35 parts of zinc. The pipe 5 is made by welding a metal sheet. The carrier element 1, which consists of plastic, is connected to a polyamide thread 3.

Examples

The active body 2 is made of a copper wire and a copper sheet having a surface layer including gold mixed with copper. The wires are in the form of rings β and 8, the sheet is closed to form tubular elements 7 (Figure 3). The Trägerolement 1, which consists of plastic, is connected to a thread 3, which consists of a flexible plastic.

Example 7

The active body 2 consists of a wire and a sheet made of an alloy consisting of 90 parts of silver and 10 parts of cadmium. The wires are in the form of rings 6 and 8, the sheet is closed and forms tubular elements 7 (Figure 3). The support element 1, which consists of plastic, is connected to a thread 3, which consists of a flexible plastic.

The intrauterine contraceptive devices of the invention were studied under physiological conditions. According to the observations, the effective life span is more than 20 years and the contraceptive efficacy is at least 99%. The device can be applied in the same way as the known devices.

Claims (14)

An intrauterine contraceptive device comprising an active body of a metallic substance having contraceptive activity and a support member for holding the active body in an intrauterine environment, characterized in that the active body (2) consists of at least two metals containing a plurality form galvanic cells in this intrauterine environment. 2. Contraceptive device according to claim 1, characterized in that the active body (2) consists at least partially of an alloy, which is formed from at least two metals. A contraceptive device according to claim 1 or 2, characterized in that the active body (2) consists of a mixture and / or an alloy including at least one metal consisting of zinc, copper, nickel, silver and cadmium Group is selected, and at least one metal that is nobler than the Metali selected from this group. A contraceptive device according to claim 3, characterized in that said nobler metal is selected from the group consisting of silver, gold and cadmium. 5. Contraceptive device according to claim 3 or 4, characterized in that the mixture and / or the alloy contain zinc. 6. Contraceptive device according to claim 1 to 5, characterized in that the active body (2) consists of a coil (4) which is wound around the carrier element (1). A contraceptive device according to claims 1 to 6, characterized in that the active body (2) is at least partially in the form of a tubular element (5, 7) arranged along the shafts (10, 11) of the support element (D). 8. Contraceptive device according to claim 7, characterized in that the active body (2) consists of at least two tubular elements (7) which surround the carrier element (1). 9. Contraceptive device according to claim 8, characterized in that the active body (2) consists of two tubular elements (6) and three rings (6,8), wherein a ring on the shafts (10,11) is arranged and two are on the arms (12,13) of the support element (1). A contraceptive device according to claim 1, characterized in that the active body (2) is made of a metallic element selected from a metal selected from the group consisting of zinc, copper, cadmium, nickel and silver and at least one Metal having a higher electropositivity than that of the metal selected from the group, said metals forming a mixture and / or an alloy, wherein said mixture and / or said alloy constitute a plurality of galvanic cells in the intrauterine environment. A contraceptive device according to claim 10, characterized in that said metallic element consists of at least one metal selected from the group consisting of silver, palladium and gold. Contraceptive device according to claim 10 or 11, characterized in that the metal selected from the group is copper and the metallic element is made with another metal of lower electropositivity than that of copper, this further metal being in particular zinc. Contraceptive device according to claims 10 to 12, characterized in that the active body (2) is shaped so as to form a coil (4) and / or at least one tubular element (5, 7). 14. Contraceptive device according to claim 13, characterized in that this active body (2) includes at least one ring (6,8) which surrounds this carrier element. For this 1 page drawings