Device for intrauterine use

Surgery – Female reproductory tract shields – supports – or birth...

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128832, 128839, A61F 606, A61F 614

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active

056261489

DESCRIPTION:

BRIEF SUMMARY
The object of the present invention is a device for intrauterine use comprising means for attaching the device to the interior wall of the uterus, as well as an active agent releasing member connected to the said attachment means.
Various devices for intrauterine application are widely used for contraceptive purposes. Contraceptives, i.a. releasing copper ions and generally of T-shape, so called spiral-IUDs, one variant of which is also hormone releasing, have today gained extensive use. These contraceptives are fitted by means of an insertion tube into the uterus, wherein they more or less adapt to the interior space of the uterus. Although the preventive effect of these contraceptives generally speaking is good, they have some disadvantages. One such disadvantage is the mechanical strain of the T-hook on the walls of the uterus, which may lead to the breaking of the wall structure, or even to the hook growing into the wall.
Also contraceptive devices have been proposed in the literature which are attached to the wall of the uterus, usually its back wall. In this case the contraceptive need not be hook-shaped and there is no risk of the contraceptive discharging from the uterus. One such solution is disclosed in the U.S. Pat. No. 4,708,134, which comprises successive hollow tubular bodies, especially of copper, attached to a thread, which tubular construction can be attached to the inner wall of the uterus by means of a hook or a knot connected with the thread. Another device to be attached with a hook to the wall of the uterus is known from the EP-patent specification A 0100924, according to which a string of copper beads, either in the form of a single strand or a loop, is attached to a hook. This device is fitted in its place with a special, relatively large insertion device, which, when turned, makes the upper end of the hook correspondingly turn and attach to the wall of the uterus. Both devices are complicated to their construction and the latter especially to its way of insertion, which substantially decreases their application possibilities.
From the WO-publication WO90/05507 a device for attachment to the uterus wall is known, wherein the active agent releasing member is of polymer fibres in the form of individual fibre strands or fibre loops. Although the detailed structure of the fibres has not been described in the said publication, it is evident that they are formed of a polymer permeable to active agent, e.g. steroids, into the matrix of which the active agent is distributed and wherefrom it diffuses out. Such matrix-active agent systems do, however, exhibit some disadvantages, especially as regards the release profile of the active agent. The release rate of the active agent is dependant on both the concentration of the active agent in the matrix, as well as on the surface area of the matrix body. When the matrix is degraded due to the conditions within the uterus and the release of active agent, the permeability of the active agent and thus the release rate increases. As this process cannot be controlled, the release of active agent will be uneven and thus unreliable.
According to the invention a device has now been developed which eliminates the afore mentioned disadvantages and which allows for a reliable and controlled release of active agent into the uterus. Thus the device according to the invention is characterized in that the active agent releasing member is in the form of a closed container enclosing the active agent, at least a part of the walls of the container being permeable to the active agent.
The device according to the invention is advantageously in the form of a cylinder or a capsule, wherein the walls of the cylinder or capsule are permeable to the active agent. A material suitable for the walls or wall parts is a silicone polymer. A suitable container for the purpose of the invention is obtained by cutting tubular pieces of a suitable length from a thin silicone tube, closing one end thereof by gluing, for example using a silicone glue, filling the tube with the desired

REFERENCES:
patent: 3396819 (1968-08-01), Zaffaroni et al.
patent: 3954103 (1976-05-01), Garcia-Roel
patent: 4708134 (1987-11-01), Wildemeersch
patent: 5303717 (1994-04-01), Wildemeersch
International Publication WO 91/00714 published 24 Jan. 1991.

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