Method and apparatus for treating incontinence

• US 20050119710A1
• Filed: 12/02/2004
• Published: 06/02/2005
• Est. Priority Date: 08/04/1999
• Status: Active Grant

• Current Assignee: University of Melbourne
• Original Assignee: University of Melbourne
• Inventors: Barnett, Robert W., O'Connell, Helen E., Furness, John B., Hirst, George D.
• Granted Patent: US 7,384,390 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2002/0894 Muscles
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

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.

Claims

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.