ADJUSTABLE TENSION RING FOR AMELIORATION OF URINARY INCONTINENCE IN FEMALES

• US 20110065980A1
• Filed: 06/11/2008
• Published: 03/17/2011
• Est. Priority Date: 06/11/2007
• Status: Active Grant

• Current Assignee: Contipi IP LLC
• Original Assignee: ConTipi Ltd.
• Inventors: Bauder, Idan, Ziv, Elan, Bar-Or, Jonathan, Perle, Amir
• Granted Patent: US 9,198,748 B2
• Time in Patent Office: Days
• US Class Current: 600/31
• CPC Class Codes: A61F 2/0027 inflatable
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/007 O-rings
• CPC Class Codes: A61F 2250/009 for single use, e.g. having means for preventing re-use

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.

Claims

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; and

(b) a stabilizing projection, extending substantially in a plane other than that of said stiffenable ring said stabilizing projection having a size, shape, stiffness and position configured to stabilize said stiffenable ring within the vagina.

2. The apparatus according to claim 1, wherein said stiffenable 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 tensioning extension adapted to extend outside of the body, said tensioning extension adapted for selectively increasing and decreasing a rigidity of said ring after insertion thereof.

5. The apparatus according to claim 4, wherein said apparatus includes a stiffening control.

6. The apparatus according to claim 5, wherein said stiffening control is adapted to lock in a plurality of positions.

7. The apparatus according to claim 5, wherein said stiffening control is adapted for one handed use.

8. The apparatus according to claim 4 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.

9. The apparatus according to claim 8, wherein said material comprises a liquid.

10. The apparatus according to claim 8, wherein said material comprises a gas.

11. The apparatus according to claim 8, 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.

12. The apparatus according to claim 8, wherein the transfer element comprises a constricting element axially translatable along said reservoir.

13. The apparatus according to claim 4, wherein said tensioning element comprises a pull wire adapted to one or both of unfold and tension said ring.

14. The apparatus according to claim 4, 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.

15. The apparatus according to claim 4, wherein said tensioning extension comprises a static state and a second state which is biased to change back to said static state.

16. The apparatus according to claim 4, wherein said tensioning extension comprises a plurality of at least 3 different stable states corresponding to different stiffness states of said ring.

17. The apparatus according to claim 4, comprising at least one transverse support element engaging said ring.

18. The apparatus according to claim 4, comprising at least one cone shaped skirt covering apart of said device.

19. The apparatus according claim 1, wherein said stabilizing extension includes a cone shaped section.

20. The apparatus according to claim 1, wherein said stabilizing extension comprises an axial stabilizing rod.

21-52. -52. (canceled)

53. A method for ameliorating incontinence, the method comprising:

(a) intra-vaginally inserting a non-space filling ring with adjustable stiffness to contact a vaginal wall;

(b) stabilizing said ring in said vagina using at least one axial extension extending substantially in a plane other than that of the ring;

(c) selectively increasing and decreasing a pressure applied by said stiffenable ring to the vaginal wall.

54. The method according to claim 53, wherein said inserting comprises inserting in an orientation independent manner.

55. The method according to claim 53, wherein said ring applies pressure to a urethra.

56. The method according to claim 53, comprising:

introducing fluid into a lumen of tubing forming said stiffenable ring as a means of achieving said increasing.

57. The method according to claim 56, comprising:

transferring fluid from additional tubing into said lumen of tubing forming said stiffenable ring as a means of introducing said fluid.

58. The method according to claim 53, wherein stabilizing comprises anchoring said stiffenable ring to resist translational motion within the vagina.

59. The method according to claim 58, wherein said translational motion comprises axial motion.

60. The method according to claim 53, wherein stabilizing comprises anchoring said stiffenable ring to resist tipping of said ring within the vagina.

61. The method according to claim 53 wherein said increasing is performed substantially immediately after intravaginal insertion of said stiffenable ring.

62. The method according to claim 53 wherein said increasing is performed in response to an anticipated urge.

63. The method according to any of claim 53, wherein said increasing is performed in response to an actual urge.

64. The method according to claim 53, wherein said decreasing is performed after an urge passes.

65. The method according to claim 53, wherein said decreasing is performed substantially immediately prior to removal of said stiffenable ring.

66. The method according to claim 53, comprising providing prolapse amelioration using said ring, said axial extension or both.

67. The method according to claim 53, wherein said stiffness is adjusted in discrete increments.

68. A method of regulating a degree of incontinence control, the method comprising:

(a) providing an intra-vaginal ring having a stabilizing projection, said intra-vaginal ring configured to apply a selected degree of pressure to an organ through a vaginal wall;

(b) varying said pressure responsive to a need for incontinence control.