Method and apparatus for monitoring implantable device for urinary continence

Abstract

One or more sensors are incorporated onto one or more of an implantable device and a surgical tool used for placement and/or adjustment of the implantable device. The implantable device includes an adjustable membrane element for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence. In various embodiments, the one or more sensors can be configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, or a shape of the body lumen.

What is claimed is: 
     
         1 . An implantable device configured to be implanted within body tissue adjacent to a body lumen for controllable coaptation of the body lumen, the implantable device comprising:
 an adjustable membrane element including a continuous wall having an inner surface defining a chamber;   an elongate conduit including:
 a conduit peripheral surface connected to and sealed to the adjustable membrane element; 
 a conduit rear end; 
 a conduit front end; and 
 a conduit lumen extending longitudinally in the conduit from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the adjustable membrane element by a flowable material introduced through the first opening; and 
   one or more sensors incorporated into at least one of the adjustable membrane element or the elongate conduit and configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body lumen.   
     
     
         2 . The implantable device of  claim 1 , wherein the one or more sensors comprise at least one ultrasonic sensor. 
     
     
         3 . The implantable device of  claim 2 , further comprising an additional conduit lumen extending longitudinally in the conduit, the additional conduit lumen having an inlet configured to receive a portion of a push rod. 
     
     
         4 . The implantable device of  claim 3 , wherein the additional conduit lumen comprises an outlet configured to allow a portion of the push rod to exit. 
     
     
         5 . The implantable device of  claim 2 , further comprising a rear port connected to the elongate conduit at the conduit rear end, the rear port including a cavity and an elastic septum configured to seal the cavity, the cavity configured to contain the flowable material and being in fluid communication with the conduit lumen. 
     
     
         6 . The implantable device of  claim 2 , wherein the at least one ultrasonic sensor is affixed onto the adjustable membrane element. 
     
     
         7 . The implantable device of  claim 6 , wherein the at least one ultrasonic sensor is on a midline of the adjustable membrane element that is perpendicular to the elongate conduit. 
     
     
         8 . The implantable device of  claim 6 , wherein the at least one ultrasonic sensor is adjacent a connection between the adjustable membrane element and the elongate conduit. 
     
     
         9 . The implantable device of  claim 2 , wherein the at least one ultrasonic sensor is affixed onto the inner surface of the continuous wall of the adjustable membrane element. 
     
     
         10 . The implantable device of  claim 2 , wherein the at least one ultrasonic sensor is incorporated into the elongate conduit. 
     
     
         11 . The implantable device of  claim 10 , wherein the at least one ultrasonic sensor is at or adjacent the conduit front end. 
     
     
         12 . The implantable device of  claim 11 , wherein the at least one ultrasonic sensor is adjacent a connection between the adjustable membrane element and the elongate conduit. 
     
     
         13 . The implantable device of  claim 1 , wherein the one or more sensors comprise at least one optical sensor. 
     
     
         14 . An implantable device configured to be implanted within body tissue adjacent to a body lumen for controllable coaptation of the body lumen, the implantable device comprising:
 an adjustable membrane element including a continuous wall having an inner surface defining a chamber;   an elongate conduit including:
 a conduit peripheral surface connected to and sealed to the adjustable membrane element; 
 a conduit rear end; 
 a conduit front end; and 
 a conduit lumen extending longitudinally in the conduit from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the adjustable membrane element by a flowable material introduced through the first opening; and 
   multiple sensors incorporated into at least one of the adjustable membrane element or the elongate conduit and configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body lumen.   
     
     
         15 . The implantable device of  claim 14 , wherein the multiple sensors comprise at least one of an ultrasonic sensor or an optical sensor. 
     
     
         16 . The implantable device of  claim 15 , wherein the multiple sensors further comprise at least one of a pressure sensor or a strain gauge. 
     
     
         17 . An implantable device kit for controllable coaptation of a body lumen in tissue of a living body, the implantable device kit comprising:
 an implantable device configured to control the coaptation of the body lumen, the implantable device including:
 an adjustable membrane element including a continuous wall having an inner surface defining a chamber; 
 an elongate conduit including:
 a conduit peripheral surface connected to and sealed to the adjustable membrane element; 
 a conduit rear end; 
 a conduit front end; 
 a first conduit lumen extending longitudinally in the conduit from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the adjustable membrane element by a flowable material introduced through the first opening; and 
 a second conduit lumen extending longitudinally in the conduit from an inlet on the conduit and an end at or near the conduit front end; 
 
   a sensor probe including a probe front end configured to enter the inlet of the second conduit lumen and reach the end of the second conduit lumen through the second conduit lumen; and   multiple sensors incorporated into the implantable device and the sensor probe and configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body lumen.   
     
     
         18 . The implantable device kit of  claim 17 , wherein the multiple sensors comprise at least one of an ultrasonic sensor or an optical sensor incorporated into at least one of the adjustable membrane element or the elongate conduit of the implantable device. 
     
     
         19 . The implantable device kit of  claim 17 , wherein the multiple sensors comprise at least one of an ultrasonic sensor or an optical sensor incorporated into the probe front end. 
     
     
         20 . The implantable device kit of  claim 17 , wherein the multiple sensors comprise at least one of an ultrasonic sensor or an optical sensor and at least one of a pressure sensor or a strain gauge.