Systems and methods for incontinence control

Abstract

A system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a surface configured to occlude the urethral meatus, a first adhesive layer disposed on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus, and a second adhesive layer disposed over the first adhesive layer and configured to provide a sealing engagement between the body and the urethral meatus, wherein the second adhesive layer is removable from the first adhesive layer.

1 . A system for managing female incontinence comprising:
 a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a surface configured to occlude the urethral meatus;   a first adhesive layer disposed on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus; and   a second adhesive layer disposed over the first adhesive layer and configured to provide a sealing engagement between the body and the urethral meatus, wherein the second adhesive layer is removable from the first adhesive layer.   
     
     
         2 . The system of  claim 1 , wherein the second adhesive layer is removable from the first adhesive layer without detaching the first adhesive layer from the body. 
     
     
         3 - 35 . (canceled) 
     
     
         36 . The system of  claim 2 , wherein the second adhesive layer has a peel force in relation to the first adhesive layer and normal separation force in relation to the first adhesive layer, and wherein the peel force is less than the normal separation force. 
     
     
         37 - 102 . (canceled) 
     
     
         103 . The system of  claim 1 , wherein the first adhesive layer comprises a first adhesive surface, and wherein the second adhesive layer comprises a second adhesive surface and a release liner, the release liner having a first side configured to carry the second adhesive surface and a second side removably attached to the first adhesive surface of the first adhesive layer. 
     
     
         104 - 107 . (canceled) 
     
     
         108 . The system of  claim 103 , wherein the release liner is biodegradable. 
     
     
         109 . The system of  claim 1 , wherein at least one of the first adhesive layer and second adhesive layer comprises a gel. 
     
     
         110 . The system of  claim 109 , wherein the at least one of the first adhesive layer and second adhesive layer comprises a hydrogel. 
     
     
         111 . (canceled) 
     
     
         112 . The system of  claim 1 , further comprising:
 a removal feature coupled to the second adhesive layer, and configured to be engaged by a user for removal of the second adhesive layer from the first adhesive layer without detaching the first adhesive layer from the body.   
     
     
         113 . The system of  claim 112 , wherein the removal feature comprises a tab. 
     
     
         114 . (canceled) 
     
     
         115 . The system of  claim 1 , further comprising:
 a third adhesive layer disposed over the second adhesive layer and configured to provide a sealing engagement between the body and the urethral meatus, wherein the third adhesive layer is removable from the second adhesive layer.   
     
     
         116 . The system of  claim 115 , further comprising:
 a fourth adhesive layer disposed over the third adhesive layer and configured to provide a sealing engagement between the body and the urethral meatus, wherein the fourth adhesive layer is removable from the third adhesive layer.   
     
     
         117 . The system of  claim 116 , wherein the first adhesive layer comprises a first adhesive surface, the second adhesive layer comprises a second adhesive surface and a first release liner, the first release liner having a first side configured to carry the second adhesive surface and a second side removably attached to the first adhesive surface of the first adhesive layer, and wherein the third adhesive layer comprises a third adhesive surface and a second release liner, the second release liner having a first side configured to carry the third adhesive surface and a second side removably attached to the second adhesive surface of the second adhesive layer, and wherein the fourth adhesive layer comprises a fourth adhesive surface and a third release liner, the third release liner having a first side configured to carry the fourth adhesive surface and a second side removably attached to the third adhesive surface of the third adhesive layer. 
     
     
         118 . The system of  claim 1 , further comprising:
 an anti-bacterial coating.   
     
     
         119 . The system of  claim 1 , wherein the body has a longitudinal axis, a first end, and a second end, and wherein the body comprises a thinner-walled portion and a thicker walled portion, the thicker walled portion generally located at or adjacent the first end. 
     
     
         120 . The system of  claim 119 , wherein the first end is configured to be oriented posteriorly when the body is in place between the labia minora and the vestibule floor. 
     
     
         121 . The system of  claim 1 , wherein a peel force to separate the second adhesive layer from the first adhesive layer is between about two lbf and about five lbf. 
     
     
         122 - 123 . (canceled) 
     
     
         124 . The system of  claim 1 , wherein the body has a longitudinal axis, a posterior end, and an anterior end, and wherein the body comprises a thinner-walled portion and a thicker walled portion, the thicker walled portion generally located at or adjacent the posterior end, and wherein the system further comprises:
 a removal feature coupled to the second adhesive layer and located adjacent the anterior end of the body, the removal feature configured to be engaged by a user for removal of the second adhesive layer from the first adhesive layer without detaching the first adhesive layer from the body.   
     
     
         125 . The system of  claim 124 , wherein the first adhesive layer comprises a first adhesive surface, and wherein the second adhesive layer comprises a second adhesive surface and a release liner, the release liner having a first side configured to carry the second adhesive surface and a second side removably attached to the first adhesive surface of the first adhesive layer. 
     
     
         126 . The system of  claim 125 , wherein the removal feature is integral with the release liner. 
     
     
         127 . The system of  claim 1 , further comprising:
 a first sheet having a first portion and a second portion, the first portion of the first sheet coupled to the body and the second portion of the first sheet extending from a dorsal side of the body, opposite a ventral side of the body containing the surface of the body, wherein the second portion of the first sheet is configured to be grasped by a user in order to apply a removal force on the body to separate the body from at least one of the urethral meatus and the vestibule floor.   
     
     
         128 . The system of  claim 127 , wherein the first portion of the first sheet is a first end of the first sheet and the second portion of the first sheet is a second end of the first sheet, and wherein the first end of the first sheet is coupled to the body at a first lateral end of the body, the system further comprising:
 a second sheet having a first end and a second end, the first end of the second sheet coupled to the body at a second lateral end of the body, opposite the first lateral end, and the second end of the second sheet extending from the dorsal side of the body, wherein the second end of the second sheet is configured to be grasped by the user in order to apply a removal force on the body to separate the body from at least one of the urethral meatus and the vestibule floor.   
     
     
         129 . The system of  claim 128 , wherein the second end of the first sheet is secured to the second end of the second sheet. 
     
     
         130 - 168 . (canceled)