Abstract
A disposable IUD/IUS inserter is for use in conjunction with a hysteroscope, or blindly, including an inner part which has a flexible metal inner tube, between 1 and 2 mm in diameter. The inner tube has a front end portion including a stylet, the stylet being less than 1 mm in diameter, and the stylet being provided with a stylet tip. The IUD/IUS inserter is further provided with a handle at a rear end of the 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, the handle unlocking mechanism being connected to the outer tube.
Claims
1. A disposable IUD/IUS inserter, for use in conjunction with a hysteroscope comprising an inner part comprising a stylet having a stylet tip for inserting an anchoring portion of an IUD/IUS into a fundal wall of a uterus; said inserter is further provided with: a handle connected to a rear end of said stylet; a tail release mechanism extending from a rear end of the handle, the tail release mechanism comprising a rounded portion extending about the rear end of the handle and a flat plate extending away at a decline from the rear end of the handle and the rounded portion, the tail release mechanism being configured to release a tail of the IUD/IUS; an outer tube covering the stylet and sized to allow passage through a hysteroscope working channel, and a handle unlocking mechanism releasably connected to said outer tube and comprising a connecting ring partially surrounding the outer tube, the connecting ring has a narrow part at a back end of the connecting ring to reduce release of water from the uterus through the outer tube during insertion, the handle unlocking mechanism further comprising a flat plate rearward of the connecting ring and extending at an incline in the opposite direction of the declining flat plate of the tail release mechanism.
2. The inserter according to claim 1, wherein the outer tube comprises a transparent, flexible plastic tube, allowing visibility of the IUD/IUS through a wall of the outer tube, having a diameter thereby facilitating passage through the hysteroscope working channel, and is 1 to 2 cm shorter than the stylet to control a depth of insertion of an anchor of the IUD/IUS in the wall of the uterus under direct vision.
3. The inserter according to claim 2, wherein the outer tube is provided with a thumbpiece securely fixed onto the outer tube to secure the inserter in the hysteroscope working channel in a pre-insertion position prior to inserting the anchor in the wall of the uterus under direct vision.
4. An intrauterine system comprising an IUD comprising two fibrous components, one fibrous component for extending from a top of a uterus into a cervical canal, the other fibrous component for extending in both fallopian tubes, both having a dimension between 1 and 2 mm, the intrauterine system further comprising the inserter of claim 3, wherein the IUD is extended through the inserter and is configured to be active in the uterus as well as in the oviducts and is further configured to release ions from metallic micro or nanoparticles embedded in the fiber of one or both of the fibrous components into the uterine cavity and fallopian tubes, wherein the fiber can be co-axial or monolithic, or covered by electrospun material.
5. The system according to claim 4, wherein the two fibrous components are provided with small deformations or hooks to retain them in place.
6. The system according to claim 4, wherein the metallic micro or nanoparticles consist of copper and/or silver.
7. The inserter according to claim 1, wherein the inserter is configured to pass through the hysteroscope working channel having a diameter between 1 and 2 mm.
8. The inserter according to claim 1, further comprising a cylindrical element adjacent a front end of the handle which fits snugly into said outer tube to minimize leakage of fluid or air through the outer tube from the uterine cavity to prevent deflation of the uterus, wherein an opening is provided on an outer surface of the cylindrical element to allow passage of the tail of the IUD/IUS between the cylindrical element and an inner surface of the outer tube.
9. The inserter according to claim 1, wherein the stylet tip has a J-, t-, l-, u-, v- or inverted t-shape.
10. The inserter according to claim 1, wherein a length of the inserter is from 10 cm to 75 cm.
11. The inserter according to claim 1, wherein the tail release mechanism is a release clip extending outwardly from the handle.
12. The inserter according to claim 1, wherein the handle unlocking mechanism is separate from the handle.
Description
DESCRIPTION OF THE DRAWINGS
(1) 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:
(2) 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.
(3) FIG. 2 is a side view of the handle showing the thread release mechanism and the mechanism to unlock the handle.
(4) 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.
(5) 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.
(6) 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 (FIG. 5A) at the back end of the connecting piece to minimize leakage of water from the uterus during the procedure.
(7) 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(FIG. 6A), 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.
(8) 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.
(9) 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.
(10) 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
(11) Referring to FIG. 1, the hysteroscopic applicator or device inserter consists of an inner part 1, an outer protecting (insertion) 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 insertion 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 in a hysteroscope (not shown) in a pre-insertion position prior to inserting the IUD/IUS in the wall of the uterus under direct vision. The inner part 1 may be a flexible inner tube, and may be produced from metal. The outer insertion tube 2 may be a transparent plastic tube and may be flexible, allowing visibility of the IUD/IUS through the wall of the outer tube, and having a diameter thereby facilitating passage through the hysteroscope working channel. The inserter may be 10 cm to 75 cm long, and when used with a hysteroscope, the hysteroscope may be 1 to 2 cm shorter than the stylet to control a depth of insertion of an anchor of the IUD/IUS in the wall of the uterus under direct vision. The inserter is configured to pass through the hysteroscope working channel having a diameter between 1 and 2 mm. The handle 3 and/or the outer tube 2 may be color coded to aid in preventing inadvertent use of the inserter in the wrong hysteroscope.
(12) FIG. 2 and FIG. 3 illustrate a preferred mode of realization of the invention in which the handle 3 with release clip 4 in locked mode is shown and which is connected with insertion tube 2 by release mechanism 5 connected on the one hand with a handle 3 and an insertion tube 2.
(13) FIG. 4 illustrates another preferred mode of realization of the invention in which a handle 10 with slot 12 for fixation of the tail of the IUD/IUS is shown and release mechanism 5 in locked mode which is connected with insertion tube 2.
(14) FIG. 5 is a view of the release mechanism 5, to lock/unlock the handle, which connects the handle with the insertion tube and which is provided with a narrow part 6′ (FIG. 5A) at the end of the connecting piece 6 to minimize leakage of water from the uterus during the procedure.
(15) FIG. 6 is a view from below of the handle 3 which shows the unlocked release mechanism 4 at the end of the handle and in front, a tiny cylindrical element 14 (FIG. 6A) fixed on the stylet 16 which is molded in the handle, and which fits snugly in the insertion tube 2 to minimize leakage of fluid or air (such as water) flow from the uterus, and which is provided with an opening 18 on top to allow the passage of the tail of the IUD/IUS.
(16) FIG. 7 illustrates a preferred mode of realization of the invention in which a thin IUS 20 is illustrated, consisting of a polymeric drug delivery system, loaded with metallic micro or nanoparticles, inserted through the working channel of a hysteroscope 22 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 24, 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.
(17) FIG. 8 is another illustration of one of the preferred modes of realization of the invention in which a thin IUS 30 is illustrated, consisting of a polymeric drug delivery system, loaded with metallic micro or nanoparticles, inserted through the working channel of an office hysteroscope 32 and of which the anchor 34 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 36, 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 fibers 38 and 40 is also fixed in metal clip 36. Both tubal extensions are inserted in the tubes with a specially designed forceps and kept in place by anchoring means 42 and 44. 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.
(18) FIG. 9A and FIG. 9B show one mode of realization of a J-shape of the upper extremity of the inserter of which FIG. 9A is a side-view depicting the tip and shoulder 52 of the inserter; and FIG. 9B a front view equally depicting the tip 50 and shoulder 52 of the inserter. Other tip shapes are contemplated including t-, l-, u-, v-, or inverted t-shape. The invention further contemplates an intrauterine system comprising an IUD comprising two fibrous components, one fibrous component for extending from a top of a uterus into a cervical canal, the other fibrous component for extending in both fallopian tubes, both having a dimension between 1 and 2 mm, the intrauterine system further comprising the inserter, wherein the IUD is extended through the inserter and is configured to be active in the uterus as well as in the oviducts and is further configured to release ions from metallic micro or nanoparticles embedded in the fiber of one or both of the fibrous components into the uterine cavity and fallopian tubes, wherein the fiber can be co-axial or monolithic, or covered by electrospun material. The two fibrous components are provided with small deformations or hooks to retain them in place, and the metallic micro or nanoparticles consist of copper and/or silver.
(19) 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.
