Systems and methods for the treatment of bladder dysfunctions using neuromodulation

Abstract

Systems and Methods treat bladder dysfunctions using neuromodulation stimulation. Bladder emptying through stimulation of urethral afferents, and continence through stimulation of the dorsal genital nerve, is provided with one or more implanted pulse generators and one or more leads. A simple surgical procedure preserves all existing functions. A stimulating catheter is provided to be used as a clinical screening tool. The stimulating catheter is used to measure bladder pressures and stimulate the urethra at the same time.

1 .- 48 . (canceled) 
     
     
         49 . A method of providing bladder function comprising:
 providing a first lead including one or more stimulation electrodes,   providing a second lead including one or more stimulation electrodes,   positioning the first lead on, in, or near a dorsal genital nerve,   positioning the second lead on in, or near urethral afferents,   applying a stimulation pulse to the first lead and to the second lead to provide bladder function.   
     
     
         50 . A method according to  claim 49 :
 wherein positioning the first lead comprises:
 inserting the first lead midline or near midline over the pubic symphysis aiming toward the clitoris in females or base of penis in males, and 
   advancing the first lead to reach the dorsal genital nerve between the pubic symphysis and the clitoris in females or the base of the penis in males.   
     
     
         51 . A method according to  claim 49 :
 wherein positioning the second lead comprises:
 inserting the second lead through the skin of the perineum, 
 advancing the second lead to a target depth necessary for positioning along the urethra. 
   
     
     
         52 . A method of improving bladder function comprising:
 providing a first elongated lead comprising one or more stimulation electrodes sized and configured to be implanted in a tissue region at or near a target A,   providing a second elongated lead comprising one or more stimulation electrodes sized and configured to be implanted in a tissue region at or near a target B,   providing a pulse generator to convey one or more electrical stimulation waveforms to the first lead to stimulate the target A and to the second lead to stimulate the target B,   implanting the first lead in the tissue region at or near the target A,   implanting the second lead in the tissue region at or near the target B,   coupling the first lead and the second lead to the pulse generator,   operating the pulse generator to convey one or more electrical stimulation waveforms to the first lead to stimulate the target A, the stimulation waveforms conveyed to the stimulation electrodes affecting afferent stimulation of target A,   operating the pulse generator to convey one or more electrical stimulation waveforms to the second lead to stimulate the target B, the stimulation waveforms conveyed to the stimulation electrodes affecting afferent stimulation of target B, and the afferent stimulation activating central nervous system circuitry that coordinates and/or produces efferent activity in target A and/or efferent activity in target B to produce and/or further continence and/or bladder emptying.   
     
     
         53 . A method of improving bladder function comprising:
 providing an elongated lead comprising one or more stimulation electrodes sized and configured to be implanted in a tissue region at or near a target A and/or a target B,   providing a pulse generator to convey one or more electrical stimulation waveforms to the elongated lead to stimulate the target A and/or the target B,   implanting the elongated lead in the tissue region at or near the target A and/or the target B,   coupling the elongated lead to the pulse generator,   operating the pulse generator to convey one or more electrical stimulation waveforms to the elongated lead to stimulate the target A and/or the target B, the stimulation waveforms conveyed to the stimulation electrodes affecting afferent stimulation of target A and/or target B, the afferent stimulation activating central nervous system circuitry that coordinates and/or produces efferent activity in target A and/or efferent activity in target B to produce and/or further continence and/or bladder emptying.   
     
     
         54 . A method according to  claim 53 :
 wherein the afferent stimulation activating central nervous system circuitry that coordinates and/or produces efferent activity in target A and/or efferent activity in target B and/or the pelvic nerve (s) and/or hypogastric nerve (s) to produce and/or further continence and/or bladder emptying.   
     
     
         55 . A method according to  claim 53 :
 wherein implanting the elongated lead comprises:   inserting the lead midline or near midline over the pubic symphysis aiming toward the clitoris in females or base of penis in males, and   advancing the lead to reach the target A and/or target B between the pubic symphysis and the clitoris in females or the base of the penis in males.   
     
     
         56 . A method according to  claim 53 :
 wherein implanting the elongated lead comprises:
 inserting the elongated lead through the skin of the perineum, and advancing the lead to a target depth necessary to reach the target A and/or target B along the urethra. 
   
     
     
         57 . A method according to  claim 53 :
 wherein implanting the elongated lead comprises:
 inserting the lead about 2 cm lateral and about 2 cm caudal to the midpoint of a line defined between the posterior superior iliac spine and the ischical tuberosity, and 
 advancing the lead to a target depth necessary to reach the target A and/or the target B. 
   
     
     
         58 . A method of restoring bladder function comprising:
 implanting a first lead adapted for dorsal genital nerve stimulation,   implanting a second lead adapted for urethral afferent stimulation,   coupling the first lead to a pulse generator,   coupling the second lead to the pulse generator,   operating the pulse generator in a continence mode to allow the bladder to fill, and   after the bladder has filled to a level, operating the pulse generator in a micturition mode to empty some or all of the contents of the bladder.   
     
     
         59 . A system for restoring bladder function comprising:
 a first lead adapted for dorsal genital nerve stimulation,   a second lead adapted for urethral afferent stimulation,   a pulse generator adapted to couple to the first lead and the second lead to provide electrical stimulation to the dorsal genital nerve and the urethral afferents, the pulse generator including a continence mode to allow the bladder to fill, and the pulse generator including a micturition mode to empty some or all of the contents of the bladder after the bladder has filled to a level.