Intra-Vaginal Devices and Methods for Treating Fecal Incontinence
Devices and methods for intra-vaginal bowel control.
1 . An intravaginal device for the control of passage of stool in an adult human female user, the device comprising an occluding portion and a stabilizing portion supporting the occluding portion, the device being sized and configured to maintain position and stability in the user's vagina during repeated extensions of the occluding portion in an extension direction to contact the user's rectovaginal septum proximal to the perineal body to at least partially occlude the rectum.
2 . The intravaginal device of claim 1 wherein the device is sized and configured to maintain position and stability in the user's vagina through engagement of internal vaginal anatomy during repeated extensions of the occluding portion.
3 . The intravaginal device of claim 1 wherein the occluding portion has a lateral span less than a lateral span of the stabilizing body.
4 . The intravaginal device of claim 1 wherein the occluding portion has a lateral width of 20-60 mm.
5 . The intravaginal device of claim 1 wherein a lateral span of the stabilizing portion proximate to the occluding portion is less than a lateral span of the stabilizing portion not proximate to the occluding portion.
6 . The intravaginal device of claim 1 wherein the occluding portion is disposed in a posterior region of the stabilizing portion.
7 . The intravaginal device of claim 1 wherein the thickness in the extension direction of the stabilizing portion is less than the length in the extension direction of the occluding portion when the occluding portion is fully extended.
8 . The intravaginal device of claim 7 wherein the thickness in the extension direction of the stabilizing portion region proximate to the occluding portion is less than the length in the extension direction of the occluding portion when the occluding portion is fully extended.
9 . The intravaginal device of claim 1 wherein the thickness of the stabilizing portion in the extension direction is less than the width of the stabilizing portion in a direction perpendicular to the extension direction.
10 . The intravaginal device of claim 1 wherein the anterior side of the stabilizing portion is planar.
11 . The intravaginal device of claim 1 wherein the stabilizing portion comprises a structural perimeter surrounding a substantially open space.
12 . The intravaginal device of claim 10 further comprising a support structure in the open space adapted and configured to support the occluding portion.
13 . The intravaginal device of claim 1 further comprising a cushioning member adapted to reduce trauma to the user's vaginal tissue.
14 . The intravaginal device of claim 13 wherein the cushioning member is disposed proximally on the device so as to be in the proximity of the cervix or vaginal cuff when the device is inserted into the user's vagina.
15 . The intravaginal device of claim 13 wherein the cushioning member is disposed opposite to the occluding portion.
16 . The intravaginal device of claim 13 wherein the cushioning member comprises a part of the device that is more flexible than a part of the stabilizing portion.
17 . The intravaginal device of claim 13 wherein the cushioning member comprises an outer layer of a material disposed over an inner gel or gel-like material.
18 . The intravaginal device of claim 13 wherein the cushioning member comprises a part of the device that has a greater contact surface area than a part of the stabilizing portion.
19 . The intravaginal device of claim 1 wherein the occluding portion is inflatable and has an inner material that is less permeable to air than an outer material of the occluding portion.
20 . The intravaginal device of claim 1 further comprising a fluid inflation device adapted to inflate the occluding portion, the fluid inflation device comprising a valve adapted to limit the force applied to the rectovaginal septum.