Systems and methods for electrically stimulating the lower esophageal sphincter to treat gastroesophageal reflux disease

• US 8,538,534 B2
• Filed: 03/13/2012
• Issued: 09/17/2013
• 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:
  US13/419,255
• Publication Number:
  US 20120232610A1
• Time in Patent Office: 553 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 specification describes methods and devices using electrical 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 treating gastroesophageal reflux disease (GERD) in a subject in need thereof, comprising:

providing an electrical signal; and

delivering the electrical signal to a portion of a region encompassing a lower esophageal sphincter (LES) of said patient, 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 after stimulation ceases.

2. The method of treating GERD of claim 1 wherein said period is at least twenty minutes.

3. The method of treating GERD of claim 1, wherein delivering the electrical signal comprises using a stimulation device configured to generate and deliver the electrical signal to the portion of the region encompassing said LES.

4. The method of treating GERD of claim 3, wherein the stimulation device comprises:

one or more electrodes adapted for placement in contact with the portion of the region encompassing said LES.

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

6. The method of treating GERD of claim 4, wherein at least a portion of the one or more electrodes is positioned above the LES.

7. The method of treating GERD of claim 4, wherein at least a portion of the one or more electrodes is positioned below the LES.

8. The method of treating GERD of claim 4, wherein at least a portion of the one or more electrodes is positioned along a longitudinal axis of the LES.

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

10. The method of treating GERD of claim 1, wherein the electrical signal comprises a pulse duration of about 10 milliseconds to about 500 milliseconds and a pulse amplitude of about 5 mAmp to about 10 mAmp.

11. A computer readable medium having computer executable instructions for applying an electrical signal to stimulate the lower esophageal sphincter (LES) to treat a condition or disease condition, comprising:

instructions to generate and deliver an electrical signal, wherein said electrical signal is adapted to cause said LES pressure increase to be maintained for a period 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.

12. The computer readable medium of claim 11 wherein said period is at least twenty minutes.

13. The computer readable medium of claim 11, wherein the 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.

14. The computer readable medium of claim 11, wherein delivering the electrical signal comprises using a stimulation device configured to generate and deliver the electrical signals to the portion of the region encompassing the LES.

15. The computer readable medium of claim 11, wherein at least a portion of the one or more electrodes is placed in contact with the LES.

16. The computer readable medium of claim 11, wherein at least a portion of the one or more electrodes is placed above the LES.

17. The computer readable medium of claim 11, wherein at least a portion of the one or more electrodes is placed below the LES.

18. The computer readable medium of claim 11, wherein the one or more electrode(s) are positioned along a longitudinal axis of the LES.

19. The computer readable medium of claim 11, 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, or combinations thereof.

20. The computer readable medium of claim 11, wherein the electrical signal comprises low frequency electrical pulses to increase the LES pressure.