Method and apparatus for treating incontinence

Abstract

An improved method, system and arrangement for treatment of urinary incontinence is disclosed, in which a portion of innervated smooth muscle ( 2 ) is transplanted and disposed around the urethra to provide a urethral sphincter ( 2 ). Electrical stimulation, by an implanted stimulator ( 1 ), maintains continuous tone in the sphincter. A remote controller ( 7 ) permits the sphincter ( 2 ) to be allowed to relax, and hence permit urine to flow out of the bladder.

1 . An implantable sphincter stimulator configured for operatively providing electrical stimulation to a surgically implanted innervated smooth muscle sphincter so as to control the flow of a bodily substance therethrough, the stimulator including:
 a stimulus generating unit in electrical communication with a receiver, the stimulus generating unit operatively configured to provide a first predetermined electrical stimulation signal adapted to contract said sphincter, and a second predetermined signal adapted to allow said sphincter to relax, one of said predetermined signals being selected in response to a control signal received at the receiver from a remote controller.   
   
   
       2 . A sphincter stimulator according to  claim 1  wherein the stimulation signal is such as to provide a continuous tone in said sphincter. 
   
   
       3 . A sphincter stimulator according to  claim 2  wherein the stimulation is pulsatile. 
   
   
       4 . A sphincter stimulator according to  claim 3  wherein the stimulation signal is generally rectangular and symmetrical biphasic. 
   
   
       5 . A sphincter stimulator according to  claim 4  wherein the stimulation signal current is less than or equal to 30 mA. 
   
   
       6 . A sphincter stimulator according to  claim 3  wherein the stimulation pulse frequency is in the range of 0.025 to 2.5 Hz. 
   
   
       7 . A sphincter stimulator according to  claim 3  wherein the stimulation pulse has a width in the range of 0.05 to 0.20 milliseconds. 
   
   
       8 . A sphincter stimulator according to  claim 1  wherein the control signal is communicated by RF, microwave, optically or magnetically. 
   
   
       9 . A sphincter stimulator according to  claim 1  wherein the stimulus generating unit includes a demodulator responsive to the received signal for providing a modulated signal to a stimulus encoder which in turn provides a signal to a stimulus driver which provides the stimulation signal at selected ones of the stimulator outputs. 
   
   
       10 . A sphincter stimulator according to  claim 1  wherein after the sphincter has relaxed, the stimulator includes means to supply the first stimulation signal at a selected one of its outputs to contract the sphincter when a predetermined signal to contract the sphincter is not received by the receiver for a predetermined period. 
   
   
       11 . A sphincter stimulator according to  claim 1  including a transmitter for transmitting sphincter stimulator telemetry information indicative of one or more parameters of the stimulator for detection remotely. 
   
   
       12 . A sphincter stimulator according to  claim 11  wherein the information is transmitted by the same communications means as the control signal. 
   
   
       13 . A sphincter stimulator according to  claim 11  wherein the parameters include one or more of the stimulation signal frequency, current, width and/or shape, or received signal strength or battery status. 
   
   
       14 . A sphincter stimulator according to  claim 11  wherein the receiver is configured to accept a remotely generated sphincter stimulator calibration signal and in response, the signal processing unit selectively varies one or more of the output properties of the sphincter stimulator. 
   
   
       15 . A sphincter stimulator according to  claim 14  wherein the calibration signal is transmitted in response to received sphincter stimulator telemetry information. 
   
   
       16 . A sphincter stimulator according to  claim 1  wherein the stimulation generating unit is operatively connected to the sphincter by one or more electrical leads, each having one or more electrodes. 
   
   
       17 . A sphincter stimulator according to  claim 16  wherein the lead includes three electrodes disposed in an epimysal configuration about the sphincter. 
   
   
       18 . A sphincter stimulator according to  claim 16  wherein the lead includes three electrodes disposed in a cuff configuration about the sphincter. 
   
   
       19 . A sphincter stimulator according to  claim 16  wherein the lead includes three electrodes disposed in a tripolar configuration about the sphincter.