Intra-Vaginal Device For Fecal Incontinence

Abstract

An intra-vaginal device for the control of stool passage, including a body mechanism for securing the device around the area of the pubic notch and in the area of the posterior fornix, the body mechanism including a force applying mechanism for reversibly applying a force to a posterior portion of the vagina to occlude the rectum. A method of controlling the passage of stool in a patient, by inserting an intra-vaginal device into the patient's vagina such that an anterior end rests around the pubic notch and a posterior end rests in the posterior fornix, exerting a force towards the posterior side of the vagina, moving an anterior wall of the patient's rectum towards the posterior wall of the rectum with the force applying portion, impeding the passage of stool, and removing the force, allowing stool to pass.

1 - 180 . (canceled) 
     
     
         181 . An intravaginal device for the control of stool passage of a female user, the device comprising:
 an intravaginal stabilizing body having a proximal portion and a distal portion, the proximal portion being configured to be positioned in a superior portion of a vaginal cavity of the user; and   an expandable member having a dome-shaped portion, a center of the dome-shaped portion being positioned along the proximal portion of the stabilizing body, the expandable member having an expanded state and a retracted state,   wherein the stabilizing body is sized and configured to fit entirely within a vaginal cavity of the user with a longitudinal extent of the stabilizing body extending substantially along a length of the vaginal cavity to hold the expandable member in contact with the user's recto-vaginal septum to control the passage of stool through a rectum of the user.   
     
     
         182 . The device of  claim 181 , wherein the stabilizing body extends in a longitudinal direction and in a lateral direction that is substantially perpendicular to the longitudinal direction, and the stabilizing body has a laterally narrower portion and a laterally wider portion along a length of the stabilizing body. 
     
     
         183 . The intravaginal device of  claim 182 , wherein the center of the dome-shaped portion of the expandable member is positioned along the laterally narrower portion of the stabilizing body. 
     
     
         184 . The device of  claim 183 , wherein the expandable member is not positioned along the laterally wider portion of the stabilizing body. 
     
     
         185 . The device of  claim 183 , wherein the proximal portion of the stabilizing body comprises the laterally narrower portion, and the distal portion of the stabilizing body comprises the laterally wider portion. 
     
     
         186 . The device of  claim 183 , wherein a greatest lateral extent of the expandable member is supported by the laterally narrower portion of the stabilizing body. 
     
     
         187 . The device of  claim 183 , wherein substantially an entire length of the expandable member is positioned along the laterally narrower portion of the stabilizing body. 
     
     
         188 . The device of  claim 181 , wherein the expandable member has a width of 1-6 cm and a length of 1-6 cm. 
     
     
         189 . The device of  claim 188 , wherein the expandable member has a width of 3-4 cm and a length of 2-5 cm. 
     
     
         190 . The device of  claim 181 , wherein the device is adapted to prevent rotation about an axis extending from a proximal to a distal end of the device during the expanded and retracted states. 
     
     
         191 . The device of  claim 181 , wherein the stabilizing body has a lateral span that is narrower in proximity to the expandable member than in a region not in proximity to the expandable member. 
     
     
         192 . The device of  claim 181 , wherein the stabilizing body is substantially planar. 
     
     
         193 . The device of  claim 192 , wherein the expandable member extends out of the plane of the stabilizing body. 
     
     
         194 . The device of  claim 181 , wherein the expandable member comprises a supportive member adapted to prevent deflection of the expandable member. 
     
     
         195 . The device of  claim 181 , wherein the device is configured to support the expandable member against the recto-vaginal septum above a perineal body of the user in the expanded and retracted states. 
     
     
         196 . The device of  claim 181 , wherein the expandable member is foldable into the stabilizing body. 
     
     
         197 . The device of  claim 181 , wherein the expandable member includes a spring adapted to expand the expandable member. 
     
     
         198 . The device of  claim 181 , wherein the expandable member includes an electromagnetic system. 
     
     
         199 . The device of  claim 181 , wherein the expandable member is selectively controllable by a user to transition between the expanded state and the retracted state. 
     
     
         200 . The device of  claim 181 , wherein the device is sized and configured such that tension in the vaginal wall in the superior portion of the vagina is less than tension in the vaginal wall in an inferior portion of the vaginal cavity when the device is disposed in the vaginal cavity and the expandable member is in the retracted state. 
     
     
         201 . The device of  claim 181 , wherein the stabilizing body is in the form of one or more wire forms enclosed in tubing. 
     
     
         202 . The device of  claim 201 , wherein the stabilizing body further comprises one or more springs. 
     
     
         203 . The device of  claim 181 , wherein the stabilizing body includes a first wire form that extends along a first side of the stabilizing body, a second wire form that extends along a second side of the stabilizing body, and a spring that connects an end of the first wire form to an end of the second wire form. 
     
     
         204 . The device of  claim 203 , wherein the spring is configured to allow the stabilizing body to be folded along a length of the device. 
     
     
         205 . The device of  claim 181 , wherein the expandable member comprises a balloon. 
     
     
         206 . The device of  claim 181 , wherein the device is sized and configured to fit entirely within the vaginal cavity of the user. 
     
     
         207 . The device of  claim 181 , further comprising a cushioning portion secured to the stabilizing body, opposite the expandable member. 
     
     
         208 . A method of controlling passage of stool in a patient, the method comprising:
 inserting a first end portion of an intra-vaginal device into a vagina of the patient, the intra-vaginal device comprising an expandable member supported by a stabilizing body, the first end portion of the intra-vaginal device comprising the expandable member;   further inserting the intra-vaginal device into the vagina of the patient until the entire stabilizing body is positioned in the vagina of the patient; and   expanding the expandable member of the intra-vaginal device against a vaginal septum of the patient to control the passage of stool through a rectum of the patient.   
     
     
         209 . The method of  claim 208 , comprising inserting the intra-vaginal device into the vagina of the patient until the first end portion of the intra-vaginal device is positioned in a proximal end region of the vagina and a second end portion of the intra-vaginal device is positioned in a distal end region of the vagina. 
     
     
         210 . The method of  claim 208 , further comprising contracting the expandable member while the intra-vaginal device remains disposed in the vagina of the patient to allow stool to pass through the rectum of the patient. 
     
     
         211 . The method of  claim 208 , wherein expanding the expandable member of the intra-vaginal device against the vaginal septum of the patient occludes the rectum. 
     
     
         212 . The method of  claim 208 , wherein expanding the expandable member comprises inflating the expandable member. 
     
     
         213 . The method of  claim 212 , wherein the expandable member is inflated using a pumping mechanism disposed outside the vagina of the patient while the intra-vaginal device is positioned in the vagina of the patient. 
     
     
         214 . The method of  claim 208 , wherein inserting the intra-vaginal device into the vagina of the patient comprises narrowing sides of the intra-vaginal device. 
     
     
         215 . The method of  claim 214 , wherein narrowing the sides of the intra-vaginal device comprises folding the intra-vaginal device about a longitudinal axis of the intra-vaginal device. 
     
     
         216 . The method of  claim 214 , further comprising returning the sides of the intra-vaginal device to an open position after inserting the intra-vaginal device into the patient of the vagina.