Intraurethral device and method

Abstract

A device and method for treating female urinary incontinence is provided. A device in accordance with the invention includes a sheath having a distal portion, a proximal portion, and a lumen extending therebetween. A distal member is elastically hinged to the distal portion of the sheath. A flow control valve unit is disposed within a lumen of the sheath. The distal member may be urged into axial alignment with the sheath, and the device may be inserted into a female urethra. Once the device is inserted sufficiently distally into the female urethra, the distal member will return to a position which is not in axial alignment with the sheath.

1 . (canceled)  
   
   
       2 . An intraurethral device, comprising: 
 a sheath having a distal portion, a proximal portion, and a lumen therethrough;    a urinary flow control valve disposed within the lumen of said sheath;    a distal member having a distal portion and a proximal portion, the proximal portion of the distal member being hingedly connected to the distal portion of the sheath; and    an insertion tool for axially aligning the lumen of the distal member with the lumen of the sheath.    
   
   
       3 . The intraurethral device of  claim 2  wherein the distal member is biased to extend radially away from the sheath.  
   
   
       4 . The intraurethral device of  claim 2 , wherein the distal member defines a lumen.  
   
   
       5 . The intraurethral device of  claim 4  wherein the insertion tool axially aligns the lumen of the distal member with the lumen of the sheath.  
   
   
       6 . The intraurethral device of  claim 2 , wherein the distal portion of said distal member is generally conical in shape.  
   
   
       7 . The intraurethral device of  claim 2 , wherein the outer diameter of said distal member is substantially equal to the outer diameter of said sheath.  
   
   
       8 . The intraurethral device of  claim 2 , further comprising a linking member for hingedly connecting the proximal portion of the distal member to the distal portion of the sheath.  
   
   
       9 . The intraurethral device of  claim 2 , further comprising a proximal retainer disposed on the proximal portion of the sheath.  
   
   
       10 . The intraurethral device of  claim 9 , wherein the proximal retainer includes a proximal lock.  
   
   
       11 . The intraurethral device of  claim 10 , wherein said proximal lock includes a plurality of recesses or cavities adapted to receive a flanged portion of said urinary flow control valve.  
   
   
       12 . An intraurethral device, comprising: 
 a sheath having a distal portion, a proximal portion, and a lumen therethrough;    a urinary flow control valve disposed within the lumen of said sheath;    a distal member having a distal portion and a proximal portion, the proximal portion of the distal member being operatively connected to the distal portion of the sheath; and    wherein said distal member is actuatable between a first, outwardly extended position and a second, longitudinally extended position.    
   
   
       13 . The intraurethral device of  claim 12 , wherein a longitudinal axis of the distal member is disposed at an angle relative to a longitudinal axis of the sheath.  
   
   
       14 . The intraurethral device of  claim 13 , wherein the distal member defines a lumen.  
   
   
       15 . The intraurethral device of  claim 14 , further comprising an insertion tool for axially aligning the lumen of the distal member with the lumen of the sheath.  
   
   
       16 . The intraurethral device of  claim 12 , wherein the distal portion of said distal member is generally conical in shape.  
   
   
       17 . The intraurethral device of  claim 12 , wherein the outer diameter of said distal member is substantially equal to the outer diameter of said sheath.  
   
   
       18 . The intraurethral device of  claim 12 , further comprising a linking member for hingedly connecting the proximal portion of the distal member to the distal portion of the sheath.  
   
   
       19 . The intraurethral device of  claim 12 , further comprising a proximal retainer disposed on the proximal portion of the sheath.  
   
   
       20 . The intraurethral device of  claim 19 , wherein the proximal retainer includes a proximal lock.  
   
   
       21 . The intraurethral device of  claim 19 , wherein said proximal lock includes a plurality of recesses or cavities adapted to receive a flanged portion of said urinary flow control valve.