Method and apparatus for treating incontinence

• US 7,384,390 B2
• Filed: 12/02/2004
• Issued: 06/10/2008
• Est. Priority Date: 08/04/1999
• Status: Expired due to Fees

• Current Assignee: University of Melbourne
• Original Assignee: University of Melbourne
• Inventors: Barnett, Robert W., O'Connell, Helen E., Furness, John B., Hirst, George D.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/002,606
• Publication Number:
  US 20050119710A1
• Time in Patent Office: 1,286 Days
• Field of Search: 600 29- 32, 607 40- 41
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2002/0894 Muscles non-implantable A61F2002/5066
• 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, 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 a surgically implanted innervated smooth muscle sphincter, and a second predetermined signal adapted to allow said sphincter to relax, so as to control the flow of a bodily substance therethrough, 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.

20. A sphincter stimulator according to claim 1 wherein the second predetermined signal is the absence of a stimulation.

21. A system for use in treating inadequate sphincter function in a person, the system including:

a portion of innervated smooth muscle tissue configured to define a sphincter and adapted to be implanted so as to control the flow of a bodily substance therethrough;

an implanted sphincter stimulator arranged so as to allow electrical stimuli to be applied to the sphincter; and

a non-implanted controller in communication with the sphincter stimulator for selectively triggering the generation of predetermined electrical stimulation signals to respectively contract the sphincter or allow the sphincter to relax.

22. A system according to claim 21 wherein the sphincter stimulator includes a stimulus generation 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.

23. A system according to claim 21 wherein the controller includes:

transmitter;

means for generating a predetermined control signal at the transmitter;

a power source; and

actuation means for selectively generating the control signal such that on receipt of the signal, the sphincter stimulator provides the stimulation signal at its output in order to contract the sphincter or allow it to relax.

24. A method of using an implantable sphincter stimulator for treating inadequate sphincter function, the method including the steps of disposing a smooth muscle sphincter so as to control the flow of a bodily substance therethrough, providing an implanted stimulator unit connected to electrodes, arranging the electrodes so that the electrodes are adapted to stimulate the neural structures of said sphincter, and providing a predetermined stimulation signal at the sphincter stimulator output to either contract the sphincter or allow it to relax in response to a control signal provided from an externally disposed controller.

25. A method of treating inadequate sphincter function including the steps of:

disposing an implanted innervated smooth muscle sphincter so as to control the flow of a bodily substance therethrough;

locating a plurality of electrodes in predetermined locations in the sphincter in electrically connecting the electrodes with an implanted sphincter stimulator; and

selectively actuating the sphincter stimulator to provide a predetermined stimulation signal to either contract the body passage or allow it to relax in response to a remotely generated control signal.

26. A method according to claim 25 wherein the sphincter stimulator includes 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.

27. A method of surgically implanting a sphincter stimulator system for treating inadequate sphincter function including the steps of:

implanting a smooth muscle sphincter so as to control the flow of a bodily substance therethrough;

implanting a stimulator proximal to the sphincter; and

implanting a plurality of electrodes into the sphincter at predetermined locations and electrically connecting the stimulator therewith.

28. A method according to claim 27 wherein the system includes:

a portion of innervated smooth muscle tissue configured to define a sphincter and implanted so as to control the flow of a bodily substance therethrough;

an implanted sphincter stimulator arranged so as to allow electrical stimuli to be applied to the sphincter; and

a non-implanted controller in communication with the sphincter stimulator for selectively triggering the generation of predetermined electrical stimulation signals to respectively contract the sphincter or allow the sphincter to relax.