METHODS AND SYSTEMS FOR ACHIEVING A PHYSIOLOGICAL RESPONSE BY PUDENDAL NERVE STIMULATION AND BLOCKADE

• US 20090036945A1
• Filed: 08/01/2008
• Published: 02/05/2009
• Est. Priority Date: 08/02/2007
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Tai, Changfeng, Chancellor, Michael B.
• Granted Patent: US 8,805,510 B2
• Time in Patent Office: Days
• US Class Current: 607/39
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

Methods and apparatus are therefore provided herein for stimulating a desired physiological effect. The methods and apparatus can be used to control micturition, defecation and/or ejaculation. The methods and apparatus also can be used to control pain in the lower pelvic region, for example and without limitation, interstitial cystitis. The methods and apparatus also can be used to increase sexual sensation.

Claims

1. A method of controlling one or both of micturition and defecation in a subject, comprising:

inducing one or both of micturition and defecation in the subject by applying an electrical signal to a pudendal nerve or a branch thereof of a subject at a first point on the pudendal nerve or branch thereof, the electrical signal having an amplitude and frequency able to create a reflex that results in one or both of bladder contractions and rectal contractions; and

applying an electrical signal ipsilaterally or bilaterally to the pudendal nerve of the subject or a branch thereof distal to the first point, the electrical signal having an amplitude and frequency able to inhibit contraction of one or both of the external urethral sphincter and the anal sphincter of the subject.

2. The method of claim 1, further comprising prior to producing one or both of micturition and defecation in the subject, applying an electrical signal to a pudendal nerve or a branch thereof of the subject, the electrical signal having an amplitude and frequency able to create a reflex that inhibits one or both of bladder contractions and rectal contractions in the subject.

3. The method of claim 2, wherein the frequency of the electric signal having an amplitude and frequency able to create a reflex that inhibits one or both of bladder contractions and rectal contractions in the subject ranges from 0.5 Hz to 15 Hz.

4. The method of claim 2, in which the electrical signals are biphasic.

5. The method of claim 4, in which the electrical signals are biphasic and charge-balanced.

6. The method of claim 1, in which the frequency of the electric signal having an amplitude and frequency able to create a reflex that results in one or both of bladder contractions and rectal contractions in the subject ranges from 15 Hz to 50 Hz.

7. The method of claim 1, in which the frequency of the electric signal having an amplitude and frequency able to create a reflex able to inhibit contraction of one or both of the external urethral sphincter and the anal sphincter of the subject is greater than 4 kHz.

8. The method of claim 1, in which the electric signals are biphasic.

9. The method of claim 8, in which the electrical signals are biphasic and charge-balanced.

10. The method of claim 1, wherein an implanted microprocessor-controlled pulse generator is used to apply the electric signal to the pudendal nerve of the subject or a branch thereof.

11. The method of claim 10, wherein the pulse generator comprises at least three output channels that are independently adjustable with respect to one or more of output pulse voltage, amperage and frequency.

12. The method of claim 11, wherein the pulse generator comprises an antenna and one or more of the output pulse voltage, amperage and frequency of the electric signal produced by the output channels are controllable by an external transmitter that transmits a signal that is received by the antenna of the pulse generator and data can be transmitted from the pulse generator to an external receiver.

13. The method of claim 12, wherein the external receiver is contained in a device comprising the transmitter.

14. The method of claim 12, in which the external transmitter transmits an identification signal to the pulse generator, the pulse generator requiring an appropriate identification signal from the transmitter to control one or more of the output pulse voltage, amperage, wave shape and frequency of the electric signal produced by the output channels.

15. The method of claim 12, in which one of the pulse generator and the transmitter comprises an RFID tag and the other of the pulse generator and the transmitter comprises an RFID reader and verification of the identity of the pulse generator and transmitter by RFID is required to control one or more of the output pulse voltage, amperage, wave shape and frequency of the electric signal produced by the output channels.

16. The method of claim 12, in which signals from the transmitter are encrypted and can only be decrypted by a matching pulse generator.

17. The method of claim 12, wherein one of the pulse generator and the transmitter require identification of the other before the transmitter can control one or more of the output pulse voltage, amperage, wave shape and frequency of the electric signal produced by the output channels.

18. A method of stimulating a physiological response in a subject, comprising, stimulating a superficial branch of a pudendal nerve in a subject transdermally, intradermally or subdermally, with electrical pulses at a frequency and amplitude able to either inhibit or stimulate one or more of bladder contractions, rectum contractions, and bulbospongiosus and ischiocavernosus muscle contractions, thereby obtaining the physiological response.

19. The method of claim 18, wherein the physiological response is one or more of micturition, defecation, ejaculation, orgasm, inhibition of bladder contractions, inhibition of pelvic pain of bladder, urethra, prostate, anus, or rectum, inhibition of rectal contractions, and sexual arousal.

20. The method of claim 18, wherein the electrical pulses are biphasic.

21. The method of claim 20, wherein the electrical pulses are biphasic and charge balanced.

22. The method of claim 18, wherein the electrical pulses range from 0.5 to 15 Hz.

23. The method of claim 22, wherein the physiological response is inhibition of bladder contractions, inhibition of pelvic pain of bladder, urethra, prostate, anus, or rectum, and inhibition of rectal contractions.

24. The method of claim 18, wherein the electrical pulses range from 15 to 50 Hz.

25. The method of claim 24, wherein the physiological response is micturition.

26. The method of claim 24, wherein the physiological response is defecation.

27. The method of claim 24, wherein the physiological response is ejaculation.

28. The method of claim 24, wherein the physiological response is one or both of orgasm and increased sexual response.

29. The method of claim 24, wherein the pulses are applied in two or more stimulation intervals of from 0.5 to 60 seconds with a rest period of no electrical stimulation able to cause bladder or rectal contractions between stimulation intervals.

30. The method of claim 18, wherein the pulses are applied perigenitally or perianally.

31. A system for controlling one or both of micturition and defecation in a subject, comprising:

an implantable pulse generator unit having a first output channel adapted to produce electric pulses in a first stage at a frequency ranging from 0.5 Hz to 15 Hz, and in a second stage at a frequency ranging from 15 Hz to 50 Hz, and a second output channel adapted to produce electric pulses at a frequency of at least 4 kHz during the second stage, the pulse generation unit comprising a first wireless communication system for receiving control instructions from a wireless controller; and

a wireless controller, comprising an input, a display and a second wireless communication system configured to send control instructions to the implantable pulse generator.

32. The system of claim 31, wherein the electric pulses are biphasic.

33. The system of claim 31, wherein the first wireless communication system also transmits status information for the pulse generator to the wireless controller.

34. The system of claim 31, the pulse generator unit comprising a third output channel adapted to produce electric pulses at a frequency of at least 4 kHz at the same time as the second output channel.

35. The system of claim 31, further comprising lead wires and electrodes connected to the output channels.

36. A method of stimulating a physiological response in a subject, comprising, stimulating the pudendal nerve or a branch thereof in a subject using an implanted electrode, with electrical pulses at a frequency and amplitude able to stimulate one or more of bladder contractions, rectum contractions, and bulbospongiosus and ischiocavernosus muscle contractions, thereby obtaining the physiological response.

37. The method of claim 36, wherein the physiological response is one or more of micturition, defecation, ejaculation, orgasm, inhibition of bladder contractions, inhibition of pelvic pain of bladder, urethra, prostate, anus, or rectum, inhibition of rectal contractions, and sexual arousal.

38. The method of claim 36, wherein the electrical pulses are biphasic.

39. The method of claim 36, wherein the electrical pulses are biphasic and charge balanced.

40. The method of claim 36, wherein the electrical pulses range from 0.5 to 15 Hz.

41. The method of claim 40, wherein the physiological response is inhibition of bladder contractions, inhibition of pelvic pain of bladder, urethra, prostate, anus, or rectum, and inhibition of rectal contractions.

42. The method of claim 36, wherein the electrical pulses range from 15 to 50 Hz.

43. The method of claim 42, wherein the physiological response is micturition.

44. The method of claim 42, wherein the physiological response is defecation.

45. The method of claim 42, wherein the physiological response is ejaculation.

46. The method of claim 42, wherein the physiological response is one or both of orgasm and increased sexual response.

47. The method of claim 42, wherein the pulses are applied in two or more stimulation intervals of from 0.5 to 60 seconds with a rest period of no electrical stimulation between stimulation intervals.

48. A system for controlling one or both of micturition and defecation in a subject, comprising:

a pulse generator unit having a first output channel adapted to produce electric pulses in a first stage at a frequency ranging from 0.5 Hz to 15 Hz, and in a second stage at a frequency ranging from 15 Hz to 50 Hz and a controller configured to send control instructions to the implantable pulse generator.

49. The system of claim 48, wherein the electric pulses are biphasic.

50. The system of claim 48, further comprising a lead wires and an electrode connected to the output channel.

51. The system of claim 50, wherein the pulse generator is implantable.

52. The system of claim 48, wherein the pulses in the second stage are applied in two or more stimulation intervals of from 0.5 to 60 seconds with a rest period of no electrical stimulation able to cause bladder or rectal contractions between stimulation intervals.