DUAL ANCHORING DEVICE FOR THE SUSPENSION OF BIOACTIVE SUBSTANCES IMMEDIATELY FOLLOWING CESAREAN SECTION DELIVERY FOR CONTRACEPTION AND TREATMENT

Abstract

The invention relates to an anchoring device specifically for the retention of bioactive substances in the immediate post-Cesarean section uterus for contraception. The invention includes a dual anchoring device, preferably a permanent anchoring knot, provided with a noose, for insertion in the top of the uterus with an inserter, and which is kept in place during the involution phase of the uterus by a supplementary means of temporary fixation, to overcome the risk of IUD/IUS dislodgment from the soft uterine wall. The anchoring device includes a biodegradable suture, consolidated with the permanent anchoring knot, for its temporary fixation to the serosa of the uterus. The anchoring knot can be easily removed from the uterus at any time after its insertion in the uterine wall and fixation to the serosa due to the fast biodegrading time of the suture.

Claims

1. An anchoring device for easy and safe anchoring of an intrauterine device or intrauterine system to the top (fundus) of the post-Cesarean section uterus, said device comprising an anchoring knot, said knot comprising a body and a noose, wherein said noose allows threading of a biodegradable suture for temporary fixation of the anchoring device in the soft muscular tissue to prevent the intrauterine device or system from being expelled from the uterus.

2. The anchoring device according to claim 1 which comprises an anchoring knot threaded with a biodegradable suture, wherein the biodegradable suture is suitable to be tied to the serosa.

3. The anchoring device according to claim 1 which comprises an anchoring knot threaded with a biodegradable suture, wherein the biodegradable suture is suitable to be fixed to the serosa with a surgical metal or biodegradable clip.

4. A drug delivery compartment for insertion and anchoring to the fundus of the postpartum uterus consisting of a drug delivery body provided with an anchoring device according to claim 1 at the top of the drug delivery rod, and with a tail at the bottom for easy removal of the intrauterine device or intrauterine system from the uterine cavity.

5. The drug delivery compartment according to claim 4, for insertion and anchoring to the fundus of the postpartum uterus, wherein the intrauterine device or intrauterine system as well as the removal tail are integrated in top and the bottom of the drug delivery rod by threading a suture through a preformed curved channel in the rod and fixed in place by a thermoformed spherical thickening at the end of the suture.

6. A tube-shaped drug delivery compartment fixed on a suture thread comprising metal or plastic clips placed on the suture at least below the tube to keep the tube affixed to the anchoring thread.

7. A method for preventing the expulsion of an IUD from the post-Caesarian uterus, said method comprising the following steps: immediately post-Cesarean, inserting an IUD in the uterus of a patient with an applicator, thereby puncturing the uterus, whereby said IUD is provided with anchoring means comprised of a knot and a noose; removing the applicator from the uterus and threading the noose of the anchoring knot to the serosa with a biodegradable knot or by a metal or biodegradable clip.

Description

DESCRIPTION OF THE DRAWINGS

[0019] The invention will be better understood with reference to the description as well as the attached drawings, which show, purely by way of example, various embodiments of the invention and in which:

[0020] FIG. 1 is a frameless IUD of which the anchor consists of a knot, which is inserted though the wall of the post-partum uterus, and which has a noose through which a biodegradable suture is threaded.

[0021] FIG. 2 and FIG. 3 show the fixation of the anchoring knot to the serosa of the uterus by stitching the suture to it or by fixing it to the serosa with a metal or biodegradable clip.

[0022] FIG. 4 is a representation of a hormone-releasing system with a fixation means attached to the top of the drug delivery system and with removal tail attached to the bottom of it.

[0023] FIG. 5 and FIG. 6 is a more detailed representation of the mode of realization to attach the anchoring means and the removal tail to the drug delivery rod described in FIG. 4.

[0024] FIG. 7 is a representation of a tube-shaped drug delivery compartment to which the anchoring means and removal tail, being a suture with anchoring knot on the top of the suture, is threaded through the lumen of the drug delivery tube and of which the tube is prevented from sliding off the anchoring suture my means of a metal or plastic clips.

DESCRIPTION OF THE PREFERRED MODE OF REALIZATION

[0025] Referring to FIG. 1, showing the fundal part of the uterus 1 with IUD 2 and device anchor 3 which is inserted through the fundal wall and of which the biodegradable suture 4 is inserted through the noose of the anchoring knot 3.

[0026] FIG. 2 and FIG. 3 show a segment of the uterine fundus 1 with anchoring knot 3 and the preferred mode of realization consisting of temporarily attaching the anchoring knot to the serosa of the uterus; in FIG. 2 by tying the suture 4 to the serosa and in FIG. 3 by fixing the suture to the serosa with clip 5.

[0027] Referring now particularly to FIG. 4, an anchoring means 6 is integrated into the upper part of a drug delivery system 2 for its retention in the uterus, and is provided with a tail 7 also integrated into the drug delivery system for removal of the IUS.

[0028] FIG. 5 shows the preferred mode of realization of the attachment of the anchoring suture 4 to the drug delivery rod by spherical thermo-deformation of the end of the suture 8.

[0029] FIG. 6 shows a similar mode of realization of the attachment of the removal tail to the drug delivery by spherical thermos-deformation of the end of the tail.

[0030] FIG. 7 is a schematic representation of the fixation of a tube-shaped drug delivery system 2 by means of two metal clips 5 and 5 onto the suture which keep the system affixed to the anchoring thread.

[0031] The invention has been described and illustrated merely by way of example which is in no way restrictive. Numerous changes in its conception may be made without departing from the spirit of the invention.