Treatment of pelvic organ prolapse

Abstract

The present invention relates to the diagnosis and treatment of pelvic floor prolapse. The diagnosis and treatment may involve the use of a multiple sensor-enabled device for vaginal insertion capable of providing real-time data regarding the pa -tient’s physiology, the position and movement of the urethra, and the muscular strength of the patient’s vagina and pelvic floor. The methods and devices of the invention may also be useful to addressing other medical issues, including urinary incontinence, sexual health, and fecal incontinence, as well as facilitate patient home wellness activities.

1 . An intravaginal device comprising a plurality of sensors mounted on a flexible printed circuit board (PCB) attached to or incorporated within the device, wherein the device is configured to:
 a) provide real-time data selected from position, movement, pressure, and flow of the vagina and/or urethra; and   b) transmit the real-time data wirelessly to a graphical user interface; 
 wherein the position data relates to at least one of the position of the vagina and the position of an anatomical organ of interest relative to an anatomical or external reference point. 
   
     
     
         2 . The intravaginal device of  claim 1 , wherein the sensors are accelerometers. 
     
     
         3 . The intravaginal device of  claim 1 , wherein the sensors are positioned along a length of the device. 
     
     
         4 . The intravaginal device of  claim 1 , wherein the real-time data is position or movement data. 
     
     
         5 . The intravaginal device of  claim 1 , wherein the device comprises a pressure sensor. 
     
     
         6 . The intravaginal device of  claim 5 , wherein the data is pressure data. 
     
     
         7 . The intravaginal device of  claim 1 , wherein at least one of the plurality of the sensors comprises at least one of a gyroscope, an inductive noncontact position sensor, a string potentiometer, a linear variable differential transformer, a potentiometer, a capacitive transducer, an Eddy-current sensor, a Hall effect sensor, an optical proximity sensor, a piezo-electric transducer, and a photodiode array. 
     
     
         8 . The intravaginal device of  claim 1 , wherein the position and movement data comprises at least one of: magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound, and video data. 
     
     
         9 . The intravaginal device of  claim 1 , wherein at least one of the plurality of sensors comprises at least one of a force collector, a piezo-resistive sensor, a capacitive sensor, an electromagnetic sensor, a piezo-electric sensor, an optical sensor, a potentiometric sensor, a resonant sensor, a thermal sensor, an ionization sensor; an ultrasonic sensor, a density sensor, a resistive sensor, a surface acoustic wave sensor, a capacitive sensor, an infrared sensor, an optical imaging sensor, a dispersive signal technology sensor, and an acoustic pulse recognition sensor. 
     
     
         10 . The intravaginal device of  claim 1 , wherein the device is inflatable. 
     
     
         11 . The intravaginal device of  claim 10 , wherein the device comprises a plurality of inflatable compartments. 
     
     
         12 . The intravaginal device of  claim 1 , wherein at least one of the plurality of sensors has multiple measurement and reporting capabilities. 
     
     
         13 . A method for treating a female subject with a pelvic floor disorder comprising the steps of:
 (a) inserting into the subject’s vagina the device of  claim 1 ;   (b) displaying on a graphical user interface a visual representation of the subject’s vagina corresponding to a position of the device that is generated by the sensors prior to performance of a pelvic floor exercise, and recording the position that is prior to the performance;   (c) displaying on the graphical user interface a visual representation of the subject’s vagina corresponding to a position of the device that is generated by the sensors during the performance of the pelvic floor exercise by the subject, and recording the position that is during the performance;   (d) repeating steps (b) and (c) one or more times; and   (e) generating pelvic floor position information based on the recorded positions of the subject’s vagina during steps (b) and (c) and using the pelvic floor position information to guide the subject via the visual representation during at least one step (c) so as to activate pelvic floor muscles that strengthen the pelvic floor or to limit activation of pelvic floor muscles that harm the pelvic floor, thereby treating the pelvic floor disorder.   
     
     
         14 . The method of  claim 13 , wherein steps (b) and (c) occur in real-time. 
     
     
         15 . The method of  claim 13 , wherein the device transmits the positions of the subject’s vagina during steps (b) and (c) wirelessly to the graphical user interface. 
     
     
         16 . The method of  claim 13 , wherein the graphical user interface is a display screen of a computer or smart phone. 
     
     
         17 . The method of  claim 13 , wherein steps (b) and (c) are repeated five or six times daily and/or wherein steps (b) and (c) are performed every four to six weeks. 
     
     
         18 . The method of  claim 13 , wherein the method strengthens the pelvic floor muscles of the subject. 
     
     
         19 . The method of  claim 13 , wherein the pelvic floor exercise comprises a Kegel maneuver or a Valsalva maneuver. 
     
     
         20 . The method of  claim 13 , wherein the pelvic floor disorder is pelvic floor weakness or pelvic organ prolapse (POP).