Intra-uterine insertion device

Abstract

An inserter having a proximal and distal end, is for inserting and positioning an intra-uterine device (IUD), which is attached to a withdrawal string. The inserter includes a plunger having a central longitudinal axis, which is configured for slidable mounting of a hollow protective tube. The distal end of the plunger is configured for dismountable connection with the IUD. The protective tube is configured to slidably cover the IUD. The inserter has a handle attached to the proximal end of the plunger, and has a longitudinal member that forms part of the handle, which extends in the distal direction with respect to the plunger. The longitudinal member contains a friction contact surface.

What is claimed is: 
     
         1 . An inserter, having a proximal and distal end, for inserting and positioning an intra-uterine device (IUD) which is attached to a withdrawal string, said inserter comprising:
 a) a plunger, having a central longitudinal axis, configured for slidable mounting of a hollow protective tube, the distal end of the plunger being configured for dismountable connection with the RID, which protective tube is configured to slidable cover the   b) a handle attached to the proximal end of the plunger; and   c) a longitudinal member that forms part of the handle, which extends in the distal direction with respect to the plunger, which longitudinal member contains a friction contact surface,   wherein   the longitudinal member is in essentially fixed relation to the plunger, and is configured to receive a force in an essentially radial direction relative to the central longitudinal axis of the plunger,   the longitudinal member comprises a longitudinal guiding rail and the protective tube comprises at the proximal end a cuff which slidably engages with the longitudinal guiding rail, allowing the protective tube to slide relative to the longitudinal member,   the cuff can frictionally engage against the friction contact surface,   the frictional engagement of the cuff against the friction contact surface is manually actuatable and increases resistance to sliding of the protective tube relative to the plunger.   
     
     
         2 . The inserter according to  claim 1 , wherein the longitudinal guiding rail has a T-shaped profile and the cuff has reciprocating slot through which the longitudinal guiding rail can slide. 
     
     
         3 . An inserter, having a proximal and distal end, for inserting and positioning an intra-uterine device (IUD) which is attached to a withdrawal string, said inserter comprising:
 a) a plunger, having a central longitudinal axis, configured for slidable mounting of a hollow protective tube, the distal end of the plunger being configured for dismountable connection with the IUD, which protective tube is configured to slidably cover the IUD;   b) a handle attached to the proximal end of the plunger; and   c) a longitudinal member that forms part of the handle, which extends in the distal direction with respect to the plunger, which longitudinal member contains a friction contact surface,   wherein   the longitudinal member is in essentially fixed relation to the plunger, and is configured to receive a force in an essentially radial direction relative to the central longitudinal axis of the plunger,   the longitudinal member comprises a longitudinal guiding slot and the protective tube comprises at the proximal end a cuff, the cuff comprising a T-shaped protrusion which slidably engages in the longitudinal guiding slot, allowing the protective tube to slide relative to the longitudinal member,   the cuff can frictionally engage against the friction contact surface,   the frictional engagement of the cuff against the friction contact surface is manually actuatable and increases resistance to sliding of the protective tube relative to the plunger.   
     
     
         4 . The inserter according to  claim 1 , wherein the plunger is disposed with a longitudinal groove for receiving the withdrawal string. 
     
     
         5 . The inserter according to  claim 1 , wherein the plunger terminates in a distal tip configured to dismountably couple to the proximal end of the central rod of the IUD. 
     
     
         6 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD) . 
     
     
         7 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD), wherein the protective tube further comprises a flange, optionally slidable, on the surface of the protective tube, configured to abut with the entrance of the cervix to prohibit further insertion of the protective tube into the uterine cavity. 
     
     
         8 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD),
 wherein   the IUD is a T-shaped IUD comprising a pair of wings each having a rounded wing tip, wings fixed to a central rod, said IUD positioned at the distal end of the plunger;   the protective tube is attached in fixed relation to a first discrete contact element and the plunger is attached in fixed relation to a second discrete contact element, the first and second discrete contact elements being in slidable relation to each other and configured such that they frictionally engage together so increasing the resistance to sliding of the protective tube relative to the plunger selectively at a first discrete position which corresponds to a position of the protective tube where it covers at least part of the wings of the IUD when the central rod of the IUD is engaged with the distal end of the plunger.   
     
     
         9 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (VD),
 wherein   the IUD is a T-shaped IUD comprising a pair of wings each having a rounded wing tip, which wings are fixed to a central rod, said IUD positioned at the distal end of the plunger ; and   the protective tube is attached in fixed relation to a third discrete contact element and the plunger is attached in fixed relation to a fourth discrete contact element, the third and fourth discrete contact elements being in slidable relation to each other and configured such that they engage together so increasing the resistance to sliding of the protective tube relative to the plunger selectively at a second discrete position which corresponds to a location of the protective tube where it covers at least part of the IUD central rod, and the wings are unfolded when the central rod of the :IUD is engaged with the distal end of the plunger.   
     
     
         10 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (VD),
 wherein   the IUD is a T-shaped IUD comprising a pair of wings each having a rounded wing tip, which wings are fixed to a central rod, said IUD positioned at the distal end of the plunger; and   the protective tube is attached in fixed relation to a first discrete contact element and the plunger is attached in fixed relation to a second discrete contact element, the first and second discrete contact elements being in slidable relation to each other and configured such that they frictionally engage together so increasing the resistance to sliding of the protective tube relative to the plunger selectively at a first discrete position which corresponds to a position of the protective tube where it covers at least part of the wings of the IUD when the central rod of the IUD is engaged with the distal end of the plunger, and   the protective tube is attached in fixed relation to a third discrete contact element and the plunger is attached in fixed relation to a fourth discrete contact element, the third and fourth discrete contact elements being in slidable relation to each other and configured such that they engage together so increasing the resistance to sliding of the protective tube relative to the plunger selectively at a second discrete position which corresponds to a location of the protective tube where it covers at least part of the IUD central rod, and the wings are unfolded when the central rod of the VD is engaged with the distal end of the plunger, wherein the first and third discrete contact elements are one and the same.   
     
     
         11 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD),
 wherein   the IUD is a T-shaped IUD comprising a pair of wings each having a rounded wing tip, which wings fixed to a central rod, said IUD positioned at the distal end of the plunger;   the protective tube is attached in fixed relation to a fifth discrete contact element and the plunger is attached in fixed relation a sixth discrete contact element, the fifth discrete contact element and sixth discrete contact element being in slidable relation to each other and configured such that they engage, so stopping the sliding of the protective tube relative to the plunger selectively at a third discrete position which corresponds to a location of protective tube where IUD central rod is uncovered when the central rod of the IUD is engaged with the distal end of the plunger.   
     
     
         12 . The inserter according to  claim 1 , further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD),
 wherein   the IUD is a T-shaped :RID comprising a pair of wings each having a rounded wing tip, which wings are fixed to a central rod, said IUD positioned at the distal end of the plunger ; and   the protective tube is attached in fixed relation to a first discrete contact element and the plunger is attached in fixed relation to a second discrete contact element, the first and second discrete contact elements being in slidable relation to each other and configured such that they frictionally engage together so increasing the resistance to sliding of the protective tube relative to the plunger selectively at a first discrete position which corresponds to a position of the protective tube where it covers at least part of the wings of the IUD when the central rod of the IUD is engaged with the distal end of the plunger, and   the protective tube is attached in fixed relation to a third discrete contact element and the plunger is attached in fixed relation to a fourth discrete contact element, the third and fourth discrete contact elements being in slidable relation to each other and configured such that they engage together so increasing the resistance to sliding of the protective tube relative to the plunger selectively at a second discrete position which corresponds to a location of the protective tube where it covers at least part of the IUD central rod, and the wings are unfolded when the central rod of the IUD is engaged with the distal end of the plunger,   the protective tube is attached in fixed relation to a fifth discrete contact element and the plunger is attached in fixed relation a sixth discrete contact element, the fifth discrete contact element and sixth discrete contact element being in slidable relation to each other and configured such that they engage, so stopping the sliding of the protective tube relative to the plunger selectively at a third discrete position which corresponds to a location of protective tube where IUD central rod is uncovered when the central rod of the IUD is engaged with the distal end of the plunger,   wherein the first, third and fifth discrete contact elements are one and the same.   
     
     
         13 . An inserter assembly, comprising:
 an inserter according to  claim 1  or  3 , wherein the plunger is disposed with a longitudinal groove for receiving the withdrawal string and which further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD), and   a T-shaped intra-uterine device (IUD) comprising a pair of wings each having a rounded wing tip, which wings fixed to a central rod, said IUD positioned at the distal end of the plunger, wherein the IUD further comprises a withdrawal string attached at one end, preferably to the rod, wherein the withdrawal string passes along the longitudinal groove for receiving the withdrawal string.   
     
     
         14 . A method for priming for insertion into the cervical canal an inserter assembly comprising:
 an inserter according to  claim 1  or  3 , wherein the plunger is disposed with a longitudinal groove for receiving the withdrawal string and which further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD), and   a T-shaped intra-uterine device (IUD) comprising a pair of wings each having a rounded wing tip, which wings fixed to a central rod, said IUD positioned at the distal end of the plunger, wherein the IUD further comprises a withdrawal string attached at one end, preferably to the rod, wherein the withdrawal string passes along the longitudinal groove for receiving the withdrawal string,   wherein the IUD is positioned with the wings outside the protective tube, the method comprising:
 a) keeping the withdrawal string relaxed; 
 b) advancing partially the protective tube distally over the plunger until the protective tube is positioned such that the wing tips of the IUD would partially protrude from the protective tube but are touching when the central rod of the IUD is engaged with the distal end of the plunger; 
 c) activating frictional engagement of the friction contact surface against the protective tube so as to fix the position of the protective tube relative to the plunger; 
 d) providing tension to the withdrawal string, wherein the IUD enters inside the central lumen of the protective tube until the wings of the IUD are covered by the protective tube and the wing tips of the IUD partially protrude (preferably are half out) from the protective tube but are touching, and the proximal end of the IUD is engaged with the distal end of the plunger; and 
 e) thereby priming the inserter assembly. 
   
     
     
         15 . A method for priming for insertion into the cervical canal an inserter assembly comprising:
 an inserter according to  claim 1  or  3 , wherein the plunger is disposed with a longitudinal groove for receiving the withdrawal string and which further comprising the protective tube having a central lumen through which the plunger is disposed, wherein the distal end of the protective tube is configured for receiving the intra-uterine device (IUD), and   a T-shaped intra-uterine device (IUD) comprising a pair of wings each having a rounded wing tip, which wings fixed to a central rod, said IUD positioned at the distal end of the plunger, wherein the IUD further comprises a withdrawal string attached at one end, preferably to the rod, wherein the withdrawal string passes along the longitudinal groove for receiving the withdrawal string,   wherein the IUD is positioned with the wings outside the protective tube, the method comprising:
 a) placing the withdrawal string under tension so that the proximal end of the IUD is engaged with the distal end of the plunger; 
 b) partially advancing the protective tube distally over the plunger until the wings of the RID are covered by the protective tube and the wing tips of the IUD partially protrude from the protective tube but are touching; and 
 c) thereby priming the inserter assembly.