Instrument for the Insertion of a Bioactive Frameless or Framed Intrauterine Device or Intrauterine System Through a Hysteroscope

Abstract

The invention relates to a hysteroscopic technique and specific instrument, applicator or device inserter, to insert a frameless, anchored device for intrauterine and intratubal delivery of bioactive substances for long-acting contraception and gynecological treatment. This is realized by the invention of a specially designed inserter allowing the passage through the narrow working channel of a specially designed hysteroscope for the precise insertion of an anchoring means, a non-biodegradable or biodegradable anchoring knot, or a hook, under direct vision in the fundal wall of the uterus, and to which a biological active component is attached which consists of a copper, copper-silver or another metallic ion-releasing agent, or a drug-eluting system for the release of a hormone or hormone-antagonist or other substance, active in the uterus as well as in the oviducts, and which can be hand-fixed to the hysteroscope by means of a thumbpiece fixed to the inserter tube to allow safe and controlled insertion.

Claims

1.-14. (canceled)

15. A disposable IUD/IUS inserter, for use in conjunction with a hysteroscope, or blindly, comprising an inner part which is comprised of a flexible metal inner tube, between 1 and 2 mm in diameter, said tube having a front end portion comprising a stylet, said stylet being less than 1 mm in diameter, and said stylet being provided with a stylet tip; said applicator is further provided with: a handle at a rear end of said inner tube; a handle unlocking mechanism for positioning of an IUD or IUS; a release mechanism for releasing of a tail of the IUD/IUS; and an outer tube sized to allow passage through a hysteroscope working channel, said handle unlocking mechanism being connected to said outer tube.

16. The inserter according to claim 15, configured for insertion in the uterus by hysteroscopy, or blindly, allowing passage through the working channel of a specially designed hysteroscope which has a diameter between 1 and 2 mm.

17. The inserter according to claim 15, wherein the outer tube comprises a transparent, flexible plastic tube, allowing visibility of the IUD/IUS through the wall of the outer tube, having a diameter thereby facilitating passage through the narrow working channel of a thin hysteroscope, and which is 1 to 2 cm shorter than the inner tube to control the depth of insertion of an anchor of the IUD/IUS in the wall of the uterus under direct vision or blindly.

18. The inserter according to claim 15, further comprising a cylindrical element at a front end of the handle and which fits snugly into said outer tube to minimize leakage of fluid or air from the uterine cavity to prevent deflation of the uterus, and which has an opening to allow the passage of the tail of the IUD/IUS.

19. The inserter according to claim 17, wherein the plastic tube is provided with a thumbpiece securely fixed onto the tube to allow positioning of the applicator in the working channel of a specially designed hysteroscope in a pre-insertion position prior to inserting the anchor in the wall of the uterus under direct vision.

20. The inserter according to claim 15, further comprising a stylet tip for the placement of an anchor, using a hysteroscopic or blind insertion technique, as described, to insert the anchor in the wall of the uterus, suspending an active substance.

21. The inserter according to claim 20, wherein the stylet tip has a J-, t-, l-, u-, v- or inverted t-shape.

22. The inserter according to claim 15, whose length is from 10 cm to 75 cm.

23. The inserter according to claim 15, of which the handle and/or outer tube is color coded to aid in the prevention of inadvertent use of the device in the wrong size scope.

24. An intrauterine system comprising an IUD comprising two fibrous components, one for extending from the top of the uterus into the cervical canal, the other for extending in both fallopian tubes, both of them of limited dimensions, between 1 and 2 mm, the inserter of claim 19, wherein the IUD is extended through the inserter and is configured to be active in the uterus as well as in the oviducts and releasing ions from metallic micro or nanoparticles embedded in the fiber which can be co-axial or monolythic, or a fiber which is covered by electrospun material, one or both loaded with metallic micro or nanoparticles to release ions in the uterine cavity and in the Fallopian tubes.

25. The system according to claim 24, of which the tubal extensions are provided with small deformations or hooks to retain them in place, limited in size, between 1 and 2 mm.

26. The system according to claim 24, of which the metallic micro and or nanoparticles consist of copper and/or silver.

Description

DESCRIPTION OF THE DRAWINGS

[0036] These and other features of the insertion instrument with double release mechanism, one to unlock the handle, the other to release the tail of the IUD/IUS, will be more readily understood when referring to the description as well as the accompanying drawings which represent, merely by way of non-limitative examples, several embodiments of the invention, and in which:

[0037] FIG. 1 is an applicator or a device-inserter consisting of an inner part and an outer tube. Both components are specifically designed for use in conjunction with a hysteroscope of limited dimensions or for blind insertion.

[0038] FIG. 2 is a side view of the handle showing the thread release mechanism and the mechanism to unlock the handle.

[0039] FIG. 3 is another view from above of the handle with release mechanism of the tail of the IUD/IUS at the end of the handle and release mechanism to release the handle which links it with the insertion tube.

[0040] FIG. 4 is yet another view from above of the handle with release mechanism of the tail of the IUD/IUS situated on top of the handle and release mechanism to release the handle which links it with the insertion tube.

[0041] FIG. 5 is a view of the release mechanism to lock/unlock the handle which connects the handle with the insertion tube and which is provided with a narrow part at the back end of the connecting piece to minimize leakage of water from the uterus during the procedure.

[0042] FIG. 6 is a view from below of the handle which shows the unlocked release mechanism at the end of the handle and in front, a tiny cylindrical element, fixed on the stylet which is molded in the handle, and which fits snugly in the inserter tube to minimize leakage of water flow from the uterus, and which is provided with an opening to allow the passage of the tail of the IUD/IUS.

[0043] FIG. 7 is a polymeric drug delivery system, fixed to the top of the uterus, specially designed for insertion through a hysteroscope and which is loaded with metallic micro or nanoparticles for release of copper or silver ions in the uterine cavity.

[0044] FIG. 8 is another polymeric drug delivery system, fixed to the top of the uterus, loaded with metallic micro or nanoparticles, specially designed for insertion through a hysteroscope and which has two extensions for insertion and fixation in the fallopian tubes.

[0045] FIG. 9a and FIG. 9b are representations of the very small tip of the stylet to allow assembly with an IUD or IUS for insertion through a hysteroscope and fixation at the top of the uterus.

DETAILED DESCRIPTION

[0046] Referring to FIG. 1, the hysteroscopic applicator or device inserter consists of an inner part 1, an outer protecting tube 2, a handle 3 and a release clip 4 to release the tail of the IUD/IUS. The handle 3 is connected with the insertion tube 2 by a release mechanism 5 provided with a connection ring 6, attached to the inserter tube 2, to release the tail of the IUD/IUS. A thumbpiece 7 is also fixed on the outer tube 2 to secure the applicator to the hysteroscope prior to inserting the IUD/IUS in the wall of the uterus.

[0047] FIG. 2 and FIG. 3 illustrate a preferred modes of realization of the invention in which a handle 1 with release mechanism 2 in locked mode is shown and which is connected with an insertion tube 3 by a release mechanism 4 connected on the one hand with a handle 1 and an insertion tube 3.

[0048] FIG. 4 illustrates another preferred modes of realization of the invention in which a handle 1 with slot 2 for fixation of the tail of the IUD/IUS is shown and a release mechanism 4 in locked mode which is connected with an insertion tube 3.

[0049] FIG. 5 is a view of the release mechanism 1, to lock/unlock the handle, which connects the handle with the insertion tube and which is provided with a narrow part 2 at the end of the connecting piece to minimize leakage of water from the uterus during the procedure.

[0050] FIG. 6 is a view from below of the handle 1 which shows the unlocked release mechanism 2 at the end of the handle and in front, a tiny cylindrical element 3, fixed on the stylet 4 which is molded in the handle, and which fits snugly in the inserter tube 5 to minimize leakage of water flow from the uterus, and which is provided with an opening 6 on top to allow the passage of the tail of the IUD/IUS.

[0051] FIG. 7 illustrates a preferred modes of realization of the invention in which a thin IUS 1 is illustrated, consisting of a polymeric drug delivery system, loaded with metallic micro or nanoparticles, inserted through the working channel of a hysteroscope 2 and of which the anchor is inserted in the fundus of the uterus with a thin hysteroscope inserter, in accordance with the invention. The thin fibrous delivery system, attached to the anchoring suture with a metal clip 3, is active in the uterus as well as in the cervix. This device is a multipurpose fiber extending in the cervix for both contraception and infection prevention. It has no rigid plastic body, making it a completely flexible unit.

[0052] FIG. 8 is another illustration of one of the preferred modes of realization of the invention in which a thin IUS 1 is illustrated, consisting of a polymeric drug delivery system, loaded with metallic micro or nanoparticles, inserted through the working channel of an office hysteroscope 2 and of which the anchor 3 is inserted in the fundus of the uterus with a thin hysteroscope inserter, in accordance with the invention. The device consists of a thin fibrous delivery system, attached to the anchoring suture with a metal clip 4, which is active in the uterus and cervix. This device is a multipurpose fiber extending in the cervix for both contraception and infection prevention. In addition, a similar multipurpose fiber 5 and 5 is also fixed in metal clip 4. Both tubal extensions are inserted in the tubes with a specially designed forceps and kept in place by anchoring means 6 and 6. The multipurpose IUS, with cervical and tubal extensions, has no rigid plastic body, making it a completely flexible unit to prevent traumatic lesions to the uterus.

[0053] FIG. 9a and FIG. 9b show one mode of realization of the J-shape of the upper extremity of the inserter of which FIG. 8a is a side-view depicting the tip 1 and shoulder 2 of the inserter; and FIG. 8b a front view equally depicting the tip 1 and shoulder 2 of the inserter.

[0054] 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.