Use of electrical stimulation of the lower esophageal sphincter to modulate lower esophageal sphincter pressure

• US 8,160,709 B2
• Filed: 05/14/2007
• Issued: 04/17/2012
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Soffer, Edy E., Conklin, Jeffrey
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US12/300,614
• Publication Number:
  US 20090132001A1
• Time in Patent Office: 1,800 Days
• Field of Search: 607/2, 607/40, 607/41, 607/115, 607/116, 607/124, 607/133
• 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 pressure of a lower esophageal sphincter (LES) in a subject in need thereof, comprising:

providing an electrical signal; and

delivering the electrical signal to a portion of a region encompassing said LES, wherein said region comprises the LES, 3 cm above the LES and 3 cm below the LES, to stimulate the LES and to increase the LES pressure, wherein said electrical signal is adapted to cause said LES pressure increase to be maintained for a period of at least twenty minutes after stimulation ceases.

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

providing an electrical signal; and

delivering the electrical signal to a portion of a region encompassing the LES, wherein said region comprises the LES, 3 cm above the LES and 3 cm below the LES, to stimulate the LES and to increase the LES pressure, wherein said electrical signal is adapted to cause said LES pressure increase to be maintained for a period of at least twenty minutes after stimulation ceases.

11. The method of claim 10, 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.

12. The method of claim 11, wherein the stimulation device comprises:

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

an electrical signal generator.

13. The method of claim 12, wherein at least a portion of the one or more electrodes is placed in contact with the LES.

14. The method of claim 12, wherein at least a portion of the one or more electrodes is placed in contact with a proximate region to the LES.

15. The method of claim 12, wherein the one or more electrode(s) are positioned along a longitudinal axis of the LES.

16. The method of claim 10, wherein electrical signal comprises low frequency electrical pulses to increase the LES pressure.

17. The method of claim 16, wherein the frequency of the low frequency electrical pulses is about 6 pulses per minute.

18. The method of claim 16, 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.

19. The method of claim 10, 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.

20. A computer readable medium having computer executable instructions for applying an electrical signal to stimulate the lower esophageal sphincter (LES) to modulate pressure of the LES 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, wherein said electrical signal is adapted to cause said LES pressure increase to be maintained for a period of at least twenty minutes after stimulation ceases; and

electrodes adapted to be implanted in a portion of a region encompassing the LES, wherein said region comprises the LES, 3 cm above the LES and 3 cm below the LES.

21. The computer readable medium of claim 20, 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.