US-20260124068-A1 - INSERTER

US20260124068A1US 20260124068 A1US20260124068 A1US 20260124068A1US-20260124068-A1

Abstract

The present invention relates to an inserter for an intrauterine system comprising a handle ( 3 ), and an insertion tube ( 6 ) having a first end and a second end, and being arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube ( 6 ) comprises at least one frame slot for receiving a frame of the intrauterine system. The invention also relates to a kit comprising an inserter according to the present invention and an intrauterine system, wherein the intrauterine system ( 1 ) comprises a therapeutic component ( 1 b ) and a continuous, closed frame ( 1 a ), the therapeutic component ( 1 b ) being connected to the frame ( 1 a ) at least one point, and therapeutic component ( 1 b ) of the intrauterine system ( 1 ) is at least mainly arranged inside the first end of the insertion tube ( 6 ) and the frame ( 1 a ) of the intrauterine system ( 1 ) is at least mainly arranged outside the first end of the insertion tube ( 6 ).

Inventors

Heikki Lyytikäinen
Ilkka Jutila
Ulla Calvo Alonso
Harri Jukarainen
Taina Träder
Andrew MacLeod
Michael Noble
David Whitaker

Assignees

BAYER OY

Dates

Publication Date: 20260507
Application Date: 20260105
Priority Date: 20080917

Claims (2)

1 . An inserter for an intrauterine system comprising a handle ( 3 ), and an insertion tube ( 6 ) having a first end and a second end, being arranged in connection with the handle, and the first end of the insertion tube ( 6 ) comprising at least one frame slot for receiving a frame of the intrauterine system, characterised in that the handle ( 3 ) has a longitudinal opening ( 8 ) at its first end, said opening ( 8 ) having a longitudinal axis parallel to the longitudinal axis of the inserter, a first end ( 8 a ) and a second end ( 8 b ), and further comprising a moveable slider ( 5 ) arranged in said longitudinal opening ( 8 ) and having a first end ( 5 a ) and a second end ( 5 b ), a plunger ( 2 ) attached to the handle ( 3 ), the second end of the insertion tube being attached to the slider ( 5 ).
2 - 12 . (canceled)

Description

The present invention relates to an inserter for positioning an intrauterine device or an intrauterine system in the uterus as well as to a kit comprising an intrauterine system and an inserter. BACKGROUND OF THE INVENTION Various types of inserters have been developed for the positioning of mechanical and copper wire-containing intrauterine devices (IUDs) as well as of intrauterine systems having a drug containing cylinder (IUSs). In the following, IUD and IUS can be used interchangeably and when one is mentioned, it is to be understood that either of them can be used. Most common inserters are constructed for introducing the device into the uterus in a contracted state. These inserters usually comprise an insertion tube having a relatively narrow diameter and a rounded, blunt end which will pass through the cervical canal easily and will not damage or injure the fundus upon contact therewith, and a plunger inside the insertion tube. Prior to insertion the device, whether an IUD or an IUS, is usually retracted into the insertion tube either by means of string(s) attached to the device and intended for the removal of the device from the uterus, or by pushing the device into the insertion tube by a plunger with inserters having a special window to adapt the device in the expanded shape (see for example GB 1 403 393). Then the insertion tube with the device therein is introduced through the cervical canal into the uterus. When the device is correctly positioned, it is released either by pushing the plunger towards the uterus or by holding the plunger steady and by retracting the insertion tube outwards. Once expulsed from the insertion tube within the uterine cavity, the device is supposed to resume its original expanded shape. Simple rod-shaped inserters have been suggested for inserting relatively small or sufficiently flexible intrauterine devices in their original, expanded shape by using a push-in technique. With these inserters the correct positioning and a secure attachment of an IUS or IUD on the inserter as well as proper handling of the removal strings may be difficult. The European patent application EP 1 691 740 relates to an inserter, with which the correct positioning and directional stiffness of the device in the inserter prior to and during insertion can be ensured, for instance, by shaping the forward end of the plunger such that the IUS assumes a specified constant configuration when drawn into the insertion tube. The IUS will thus not be twisted during insertion. European patent EP 798 999 relates to an inserter, which allows the correct positioning of an IUS also in those cases in which the elongate member of a T-shaped device contains active material, which involves a diameter larger than that of an elongate member of a copper-wire IUD. The inserter comprises a plunger, a handle attached to the plunger, a string for the removal of the IUS, a cleft on the end of the handle to lock the string(s) in such a way that the IUS remains immobile in relation to the plunger, and an insertion tube around the plunger. The IUS is drawn into the insertion tube by pushing the tube over the device or by pulling on the removal threads whereafter the threads are manually locked in the cleft. The relative movement of the plunger and the protective tube is restricted by a stop member or stop members to ascertain that the correct configuration of the IUS is achieved. The stop members ensure that the front edge of the insertion tube is stopped in a configuration in which the hemispherical tips of the T-wings remain partly uncovered by the insertion tube but the wings nevertheless remain pressed against each other. This inserter overcomes many of the problems encountered with the conventional inserters, but the string(s) still need to be manually handled and locked. Furthermore, document WO 2007/075086 shows an applicator for inserting an IUD, wherein the end of the applicator has two recesses for receiving the flexible arms of the IUD, and for fixing them during insertion. Document NL 8601570 shows an IUD comprising a rod which one end is secured to a ring of resilient material. The IUD, when inserted, is positioned on an insertion tube such that the rod is inside the tube and the ring outside of it. The inserters described in these documents overcome many of the problems encountered with the conventional inserters, but the string(s) still need to be handled and manually locked. Further, the inserters are designed primarily for the insertion of the conventional devices which are to be inserted in a compressed configuration. Therefore there is still need for an improved kit comprising an intrauterine system and an inserter. OBJECT AND SUMMARY OF THE INVENTION An object of the invention is to provide a simple, easy to use inserter and kit comprising an intrauterine system and an inserter for the positioning of an intrauterine system in the uterus by solving at least partially at least some of the problems mention