USE OF ELECTRICAL STIMULATION OF THE LOWER ESOPHAGEAL SPHINCTER TO MODULATE LOWER ESOPHAGEAL SPHINCTER PRESSURE

• US 20090132001A1
• Filed: 05/14/2007
• Published: 05/21/2009
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Conklin, Jeffrey, Soffer, Edy E.
• Granted Patent: US 8,160,709 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The present invention describes methods and devices using low frequency electrical stimulation or neural high frequency stimulation to modulate lower esophageal sphincter (LES) pressure. The electrical stimulation may be delivered to the LES via one or more electrodes that is placed in contact with the LES tissue. The methods and devices are useful to treat a number of conditions or disease conditions, including for example, gastroesophageal reflux disease (GERD).

Claims

1. A method of modulating lower esophageal sphincter (LES) pressure in a subject in need thereof, comprising:

providing an electrical signal; and

delivering the electrical signal to a LES or a proximate region to the LES to stimulate the LES.

2. The method of claim 1, wherein delivering the electrical signal comprises using a stimulation device configured to generate and deliver the electrical signal to the LES or the proximate region to the LES.

3. The method of claim 2, wherein the stimulation device comprises:

one or more electrodes adapted for placement in contact with the LES or the proximate region to the LES tissue; and

an electrical signal generator.

4. The method of claim 3, wherein at least a portion of the one or more electrodes is positioned on the LES.

5. The method of claim 3, wherein at least a portion of the one or more electrodes is positioned on the proximate region to the LES.

6. The method of claim 3, wherein the one or more electrode(s) are positioned along a longitudinal axis of the LES.

7. The method of claim 1, wherein electrical signal comprises low frequency electrical pulses to increase the LES pressure.

8. The method of claim 7, wherein the frequency of the low frequency electrical pulses is about 6 pulses per minute.

9. The method of claim 7, wherein the electrical signal further comprises a pulse duration of about 10 milliseconds to about 500 milliseconds and a pulse amplitude of about 5 mAmp to about 10 mAmp.

10. The method of claim 1, wherein the electrical signal comprises high frequency electrical pulses to decrease the LES pressure.

11. The method of claim 10, wherein the electrical signal further comprises a train duration of about 2 milliseconds to about 300 microseconds.

12. The method of claim 10, wherein the frequency of the high frequency electrical pulses is a frequency of about 50 Hz and the electrical signal further comprises a train duration of about 6 seconds, a pulse duration of about 20 milliseconds, a pulse amplitude of about 10 volts and a pulse interval of about 60 seconds.

13. A method of treating a condition or disease condition related to or caused by abnormal lower esophageal sphincter (LES) pressure in a subject in need thereof, comprising:

providing an electrical signal; and

delivering the electrical signal to the LES or a proximate region to the LES to stimulate the LES.

14. The method of claim 13, wherein delivering the electrical signal comprises using a stimulation device configured to generate and deliver the electrical signal to the LES or the proximate region to the LES.

15. The method of claim 14, wherein the stimulation device comprises:

one or more electrodes adapted for placement on the LES; and

an electrical signal generator.

16. The method of claim 15, wherein at least a portion of the one or more electrodes is placed in contact with the LES.

17. The method of claim 15, wherein at least a portion of the one or more electrodes is placed in contact with a proximate region to the LES.

18. The method of claim 15, wherein the one or more electrode(s) are positioned along a longitudinal axis of the LES.

19. The method of claim 13, wherein electrical signal comprises low frequency electrical pulses to increase the LES pressure.

20. The method of claim 19, wherein the frequency of the low frequency electrical pulses is about 6 pulses per minute.

21. The method of claim 19, wherein the electrical signal further comprises a pulse duration of about 10 milliseconds to about 500 milliseconds and a pulse amplitude of about 5 mAmp to about 10 mAmp.

22. The method of claim 13, wherein the electrical signal comprises high frequency electrical pulses to decrease the LES pressure.

23. The method of claim 22, wherein the electrical signal further comprises a train duration of about 2 milliseconds to about 300 microseconds.

24. The method of claim 22, wherein frequency of the high frequency electrical pulses is about 50 Hz and the electrical signal further comprises a train duration of about 6 seconds, a pulse duration of about 20 milliseconds, a pulse amplitude of about 10 volts and a train interval of about 60 seconds.

25. The method of claim 13, wherein the condition or disease condition is selected from the group consisting of gastroesophageal reflux disease (GERD), food reflux, acid reflux, reflux esophagitis, chronic heart burn, gastroparesis, scleroderma, hypotensive lower esophageal sphincter, extraesophageal manifestations caused by reflux, achalasia, and combinations thereof.

26. A method of decreasing esophageal pressure or treating esophageal spasm or nutcracker esophagus, comprising:

providing an electrical signal comprising high frequency electrical pulses; and

delivering the electrical signal to a region of the esophagus above the LES to stimulate the esophageal muscle.

27. The method of claim 26, wherein delivering the electrical signal comprises using a stimulation device configured to generate and deliver the electrical signal to the region of the esophagus above the LES.

28. The method of claim 27, wherein the stimulation device comprises:

one or more electrodes adapted for placement on region of the esophagus above the LES; and

an electrical signal generator.

29. The method of claim 26, wherein the electrical signal further comprises a train duration of about 2 milliseconds to about 300 microseconds.

30. The method of claim 26, wherein frequency of the high frequency electrical pulses is about 50 Hz and the electrical signal further comprises a train duration of about 6 seconds, a pulse duration of about 20 milliseconds, a pulse amplitude of about 10 volts and a train interval of about 60 seconds.

31. An exogenous electrical signal adapted for delivery to a lower esophageal sphincter (LES) of a patient in need of treatment for the modulation of LES pressure or for a condition or disease condition related to or cause by abnormal LES pressure, comprising:

low frequency electrical pulses, wherein the exogenous electrical signal is adapted to increase the LES pressure or to treat a condition or disease condition related to or caused by abnormally low LES pressure.

32. The exogenous electrical signal of claim 31, wherein frequency of the electrical pulses is less than 60 pulses per minute.

33. The exogenous electrical signal of claim 31, wherein the frequency of the electrical pulses is about 6 pulses per minute.

34. The exogenous electrical signal of claim 31, comprising a frequency of 6 pulses per minute, a pulse duration of about 375 milliseconds and a pulse amplitude of about 5 mAmp.

35. The exogenous electrical signal of claim 31, wherein the electrical signal further comprises a pulse duration of about 10 milliseconds to about 500 milliseconds and a pulse amplitude of about 5 mAmp to about 10 mAmp.

36. An implantable device configured to apply the electrical signal of claim 31.

37. A computer readable medium having computer executable instructions for applying an electrical signal to stimulate the lower esophageal sphincter (LES) to modulate LES pressure in a subject in need thereof or to treat a condition or disease condition related to or caused by abnormal LES pressure in a subject in need thereof, comprising:

instructions to generate and deliver an electrical signal comprising low frequency pulses to increase the LES pressure or to treat a condition or disease condition caused by or related to abnormally low LES pressure;

or

instructions to generate and deliver an electrical signal comprising high frequency pulses to decrease the LES pressure or to treat a condition or disease condition caused by or related to abnormally high LES pressure.

38. The computer readable medium of claim 37, wherein the instructions to generate and deliver the electrical signal comprising low frequency pulses further comprise instructions to generate and deliver a pulse duration of about 10 milliseconds to about 500 milliseconds and a pulse amplitude of about 5 mAmp to about 10 mAmp.

39. The computer readable medium of claim 37, wherein the instructions to generate and deliver the electrical signal comprising high frequency pulses further comprise instructions to generate and deliver a train duration of about 2 millisecond to about 3000 microseconds.

40. The computer readable medium of claim 37, wherein the high frequency of the electrical signal is a frequency of about 50 Hz and the instructions to generate and deliver the electrical signal comprising high frequency pulses further comprise instructions to generate and deliver a train duration of about 6 seconds, a pulse duration of about 20 milliseconds, a pulse amplitude of about 10 volts and a pulse interval of about 60 seconds.