Method for stimulating pelvic floor muscles for regulating pelvic viscera

• US 4,739,764 A
• Filed: 04/22/1986
• Issued: 04/26/1988
• Est. Priority Date: 05/18/1984
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Schmidt, Richard, Lue, Tom, Tanagho, Emil A., Gleason, Curtis A.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/855,085
• Time in Patent Office: 735 Days
• Field of Search: 128/419 E, 128/419 R, 128/423 R, 128/783, 128/788, 128/794, 128/799
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Applicant'"'"'s U.S. patent application Ser. No. 611,836, now U.S. Pat. No. 4,607,639, describes a method for controlling the function of a bladder, including identification of selected nerve bundles controlling the separate functions of the bladder and its external sphincter and the application of pulse trains to one or more electrodes positioned on the nerve bundles to control the functions of the bladder and external sphincter. The methods taught herein utilize similar method steps for modulating symptoms resulting from a loss of coordination between the normally synchronized functions of a bladder and bowel and their associated sphincters. The methods are also used for treating incontinence by increasing sphincter tonus. The use of similar method steps for controlling evacuation of the bowel is also disclosed.

Claims

1. A method for modulating symptoms resulting from a loss of coordination between the normally synchronized functions of organs and for treatment of incontinence by increasing sphincter tonus either by direct stimulation of a sphincter muscle or by modulating reflex control mechanisms so that more effective sphincter tonus results, said organs including a bladder, a rectum and associated sphincters, in an anatomical system of a selected human, said system including S2 and S3 and S4 sacral segments of a spinal cord and a sacral nerve originating at each of said sacral segments, said sacral nerves forming a pelvic nerve when they leave the sacral canal, connected to said bladder to control contractions of a detrusor muscle thereof, and somatic components that subdivide into (1) a superior somatic nerve and (2) a pudendal nerve, including (a) an inferior somatic nerve connected to muscles controlling the external sphincter of said bladder, (b) an anal branch connected to an anal sphincter for said rectum, and (c) a dorsal nerve connected to a penis, the nerve bundle connected to said sphincters being controllable at a lower level of electrical stimulation than that required to control the functions of said bladder and rectum,

said method comprising the steps of

identifying the anatomical location and functional characteristics of selected nerve bundles controlling the separate function of at least one organ of said organs,

positioning electrode means on said nerve bundles for electrically stimulating said nerve bundles while simultaneously isolating adjacent nerve bundles therefrom, and

applying pulse trains sequentially to said electrode means to separately control the function of at least said one organ.

2. The method of claim 1 positioning step comprises positioning at least two separate electrodes each on a separate nerve bundle and said applying step comprises applying coordinated and synchronized pulse trains sequentially or simultaneously to said electrode means to simultaneously and/or separately control the function of at least one of said organs.

3. The method of claim 2 wherein said positioning step comprises positioning a separate electrode on each of at least two separate nerve bundles, selected from the sacral nerve nerves originating at said sacral segments, said pudendal nerve, said superior somatic nerve, said inferior somatic nerve and said anal branch, for modulating symptoms resulting from a loss of coordination between the normally synchronized functions of said organs.

4. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve and said pudendal nerve.

5. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve and said superior somatic nerve.

6. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve and said inferior somatic nerve.

7. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve and said anal branch.

8. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve, said pudendal nerve and said superior somatic nerve.

9. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve, said superior somatic nerve, and said inferior somatic nerve.

10. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 sacral nerve, said superior somatic nerve, and said anal branch.

11. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve and said pudendal nerve.

12. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve and said superior somatic nerve.

13. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve and said inferior somatic nerve.

14. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve and said anal branch.

15. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve, said pudendal nerve and said superior somatic nerve.

16. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve, said superior somatic nerve and said inferior somatic nerve.

17. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S3 sacral nerve, said superior somatic nerve and said anal branch.

18. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves, and said pudendal nerve.

19. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves and said superior somatic nerve.

20. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves and said inferior somatic nerve.

21. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves and said anal branch.

22. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves, said pudendal nerve, and said superior somatic nerve.

23. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves and said superior somatic nerve.

24. The method of claim 3 wherein said positioning step comprises positioning an electrode on each of said S2 and S3 sacral nerves, said superior somatic nerve and said inferior somatic nerve.

25. The method of claim 3 wherein said positioning step comprises positioning said electrodes unilaterally on said separate nerve bundles.

26. The method of claim 3 wherein said positioning step comprises positioning said electrodes bilaterally on said separate nerve bundles.

27. The method of claim 1 wherein said positioning step comprises positioning at least one separate electrode on at least one nerve bundle selected from said pudendal nerve, said superior somatic nerve, said inferior somatic nerve and said anal branch and said applying step comprises treating incontinence by increasing sphincter tonus either by direct stimulation of the sphincter muscle or by modulating reflex control mechanisms so that more effective sphincter tone results.

28. The method of claim 27 wherein said positioning step comprises positioning an electrode on said pudendal nerve.

29. The method of claim 27 wherein said positioning step comprises positioning an electrode on said superior somatic nerve.

30. The method of claim 27 wherein said positioning step comprises positioning an electrode on said inferior somatic nerve.

31. The method of claim 27 wherein said positioning step comprises positioning an electrode on said anal branch.

32. The method of claim 27 wherein said positioning step comprises positioning an electrode on each of said pudendal nerve and said superior somatic nerve.

33. The method of claim 27 wherein said positioning step comprises positioning an electrode on each of said superior somatic nerve and said inferior somatic nerve.

34. The method of claim 27 wherein said positioning step comprises positioning an electrode on each of said superior somatic nerve and said anal branch.

35. A method for simultaneously controlling the coordinated and synchronized functions of a bowel and associated sphincter in an anatomical system of a selected human, said system including S2, S3 and S4 sacral segments of a spinal cord and a sacral nerve originating at each of said sacral segments and each of said sacral nerves including a dorsal root and a ventral root in a sacral canal, said sacral nerves forming a pelvic nerve when they leave the sacral canal connected to said bladder to control contractions of a detrusor muscle thereof, a superior somatic nerve and a pudendal nerve including an inferior somatic nerve connected to muscles controlling the external sphincter of said bladder, and an anal branch connected to an urethral said method comprising the steps of

identifying the anatomical location and functional characteristics of those nerve bundles controlling the separate functions of said bowel and sphincter,

separating motor, sensory and autonomic and somatic nerve fibers controlling the separate functions of the bowel and associated sphincter from other nerve fibers,

positioning electrode means on selected ones of said nerve bundles for electrically stimulating such fibers while simultaneously isolating adjacent nerve fibers therefrom, and

applying coordinated and synchronized pulse trains sequentially or simultaneously to said electrode means to simultaneously and/or separately control the functions of said bowel and sphincter.