Adjustable tension ring for amelioration of urinary incontinence in females

Abstract

An apparatus for amelioration of incontinence in a female subject. The apparatus comprises a stiffenable ring adapted for intra-vaginal insertion and a stabilizing extension, projecting axially from said stiffenable ring, said stabilizing extension having a size and position configured to stabilize said stiffenable ring within the vagina.

What is claimed is: 
     
         1 . An apparatus for amelioration of urinary incontinence in a female subject, the apparatus comprising:
 (a) a ring with adjustable stiffness, adapted for intra-vaginal insertion;   (b) a stabilizing projection comprising an anchor configured to extend in one direction axially towards a cervix of the female subject and away from said ring, said anchor sized for one or more of reducing translational motion, reducing tipping of the ring and/or reducing ring rotation, with respect to a vaginal wall by extending away from the ring, said stabilizing projection having a size, shape, stiffness and position configured to stabilize said stiffenable ring within the vagina; and,   (c) a tensioning extension adapted to extend outside of a body of the female subject and located on an opposite side of the ring from the stabilizing projection, said tensioning extension adapted for selectively increasing and decreasing a rigidity of said ring after insertion thereof.   
     
     
         2 . The apparatus according to  claim 1 , wherein said ring is adapted to switch from a first geometric configuration outside the body to a second configuration after intra vaginal insertion. 
     
     
         3 . The apparatus according to  claim 2 , wherein said switch from said first configuration to said second configuration is performed mechanically. 
     
     
         4 . The apparatus according to  claim 1 , wherein said apparatus includes a stiffening control. 
     
     
         5 . The apparatus according to  claim 4 , wherein said stiffening control is adapted to lock in a plurality of positions. 
     
     
         6 . The apparatus according to  claim 4 , wherein said stiffening control is adapted for one handed use. 
     
     
         7 . The apparatus according to  claim 1 , wherein said ring comprises an inner lumen in fluid communication with said tensioning extension and wherein said tensioning extension comprises:
 (i) a reservoir of material; and   (ii) a transfer element adapted to move at least a portion of the material into said inner lumen of said stiffenable ring.   
     
     
         8 . The apparatus according to  claim 7 , wherein said material comprises a liquid. 
     
     
         9 . The apparatus according to  claim 7 , wherein said material comprises a gas. 
     
     
         10 . The apparatus according to  claim 7 , wherein said reservoir of material comprises an additional length of tubing defining a lumen in fluid communication with said inner lumen of said tubing of said ring. 
     
     
         11 . The apparatus according to  claim 7 , wherein the transfer element comprises a constricting element axially translatable along said reservoir. 
     
     
         12 . The apparatus according to  claim 1 , wherein said tensioning element comprises a pull wire adapted to one or both of unfold and tension said ring. 
     
     
         13 . The apparatus according to  claim 1 , comprising at least one arm supporting said ring and at least one tension element that retracts said ring while said arm supports said ring, thereby changing a stiffness in said ring. 
     
     
         14 . The apparatus according to  claim 1 , wherein said tensioning extension comprises a static state and a second state which is biased to change back to said static state. 
     
     
         15 . The apparatus according to  claim 1 , wherein said tensioning extension comprises a plurality of at least 3 different stable states corresponding to different stiffness states of said ring. 
     
     
         16 . The apparatus according to  claim 1 , comprising at least one transverse support element engaging said ring. 
     
     
         17 . The apparatus according to  claim 1 , comprising at least one cone shaped skirt covering a part of said device. 
     
     
         18 . The apparatus according  claim 1 , wherein said stabilizing extension includes a cone shaped section. 
     
     
         19 . The apparatus according to  claim 1 , wherein said stabilizing extension comprises an axial stabilizing rod. 
     
     
         20 . A method for ameliorating incontinence, the method comprising:
 (a) intra-vaginally inserting in a vagina a ring with adjustable stiffness to contact a vaginal wall;   (b) stabilizing said ring in said vagina using at least one axial projection comprising an anchor configured to extend in one direction axially towards a cervix, the cervix located at the end of the vagina opposite the vaginal introitus, and away from said ring, said anchor sized for one or more of reducing translational motion, reducing tipping of the ring and/or reducing ring rotation, with respect to a vaginal wall by extending away from the ring;   (c) selectively increasing and decreasing a pressure applied by said stiffenable ring to the vaginal wall using a tensioning extension located on an opposite side of the ring from the stabilizing projection and extending outside of the vagina in which the ring is inserted.   
     
     
         21 . The method according to  claim 20 , wherein said inserting comprises inserting in an orientation independent manner. 
     
     
         22 . The method according to  claim 20 , wherein said ring applies pressure to a urethra. 
     
     
         23 . The method according to  claim 20 , comprising:
 introducing fluid into a lumen of tubing forming said ring as a means of achieving said increasing.   
     
     
         24 . The method according to  claim 23 , comprising:
 transferring fluid from additional tubing into said lumen of tubing forming said ring as a means of introducing said fluid.   
     
     
         25 . The method according to  claim 20 , wherein stabilizing comprises anchoring said ring to resist translational motion within the vagina. 
     
     
         26 . The method according to  claim 25 , wherein said translational motion comprises axial motion. 
     
     
         27 . The method according to  claim 20 , wherein stabilizing comprises anchoring said ring to resist tipping of said ring within the vagina. 
     
     
         28 . The method according to  claim 20 , wherein said increasing is performed substantially immediately after intravaginal insertion of said ring. 
     
     
         29 . The method according to  claim 20  wherein said increasing is performed in response to an anticipated urge. 
     
     
         30 . The method according to  claim 20 , wherein said increasing is performed in response to an actual urge. 
     
     
         31 . The method according to  claim 20 , wherein said decreasing is performed after an urge passes. 
     
     
         32 . The method according to  claim 20 , wherein said decreasing is performed substantially immediately prior to removal of said ring. 
     
     
         33 . The method according to  claim 20 , comprising providing prolapse amelioration using said ring, said axial projection or both. 
     
     
         34 . The method according to  claim 20 , wherein said stiffness is adjusted in discrete increments. 
     
     
         35 . A method of regulating a degree of incontinence control, the method comprising:
 (a) providing an intra-vaginal ring having a stabilizing projection comprising an anchor configured to extend axially in one direction towards a cervix of a vagina in which the ring is inserted and away from said ring, said anchor sized for one or more of reducing translational motion, reducing tipping of the ring and/or reducing ring rotation, with respect to a vaginal wall by extending away from the ring, said intra-vaginal ring configured to apply a selected degree of pressure to an organ through the vaginal wall;   (b) varying said pressure responsive to a need for incontinence control using a tensioning extension located on an opposite side of the ring from the stabilizing projection and extending outside of the vagina in which the ring is inserted.