METHOD AND APPARATUS FOR TREATMENT OF THE GASTROINTESTINAL TRACT

• US 20080086179A1
• Filed: 10/09/2006
• Published: 04/10/2008
• Est. Priority Date: 10/09/2006
• Status: Active Grant

• Current Assignee: Paras Holdings LLC, Triad Support Systems, Inc.
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K
• Granted Patent: US 7,738,961 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

A method and device for electrically stimulating one or more structures in the gastrointestinal tract as described. The one or more structures are preferably selected from the upper esophageal sphincter, the esophagus and gastric fundus. The method may involve the step of arranging a plurality of stimulating electrodes adjacent one or more structures which may further include the lower esophageal sphincter, the stomach, the pyloric sphincter, the small intestine, the colon and the vagus. The method and device may further include sensing electrodes to detect change in one or more physiological parameters in the gastrointestinal tract and modulate the stimulating electrodes in response to the change. The device comprises a pulse generator, a power source, a plurality of stimulating electrode set, one or more sensing electrodes and means for varying activity of the stimulating electrodes in response to change detected in the gastrointestinal tract. The method and device may be used to treat obesity and/or GERD.

Claims

1. A method of electrically stimulating one or more structures in the gastrointestinal tract to modify activity of the one or more structures to treat conditions such as obesity and GERD, the method comprising the steps of:

arranging a plurality of stimulating electrodes within or adjacent a portion of the gastrointestinal tract, wherein;

electrical stimuli from the stimulating electrodes causes the one or more structures to contract and wherein the one or more structures are selected from the upper esophageal sphincter, the esophagus and the gastric fundus.

2. The method of claim 1, further including the step of arranging a plurality of stimulating electrodes within or adjacent one or more structures selected from the lower esophageal sphincter, the stomach, the pyloric sphincter, the small intestine the colon and the vagus, wherein stimuli from the stimulating electrodes stimulate the respective structure

3. A method of electrically stimulating one or more structures in the gastrointestinal tract, the method comprising the steps of:

arranging a plurality of stimulating electrodes within a portion of the gastrointestinal tract;

providing electrical energy to the stimulating electrodes to thereby cause the structure to be stimulated;

arranging one or more sensing electrodes to detect change in one or more physiological parameters in the gastrointestinal tract; and

modulating the stimulating electrodes in response to the change detected in the gastrointestinal tract to modify operation of the one or more structures.

4. The method of claim 3 wherein the one or more structures are selected from the upper esophageal sphincter, the esophagus, the lower esophageal sphincter, the gastric fundus and the vagus.

5. The method of claim 4 wherein the one or more structures further include the stomach and/or the pyloric sphincter.

6. The method of claim 3 wherein electrical stimuli from the stimulating electrodes are applied to nerves supplying the one or more structures.

7. The method of claim 3 wherein the sensing electrodes detect change in the one or more physiological parameters selected from esophageal peristalsis, esophageal pH, esophageal impedence, esophageal pressure, esophageal electrical activity, gastric peristalsis, gastric electrical activity, gastric chemical activity, gastric hormonal activity, gastric temperature, gastric pressure, gastric impedence and gastric pH, blood chemical and/or hormonal activity, vagal or other gastrointestinal neural activity and salivary chemical activity.

8. The method of claim 3 wherein the one or more sensing electrodes are positioned in or adjacent one or more of the esophagus, the stomach, the small intestine, vagus or other nerves supplying the gastrointestinal tract and the vascular system.

9. A device for electrical stimulation of one or more structures in the gastrointestinal tract and for use in the treatment of conditions such as obesity or GERD, the device comprising:

a pulse generator providing electrical stimulation;

a power source for powering the pulse generator;

a plurality of stimulating electrode sets connected to the pulse generator wherein the electrode sets are adapted to be positioned within or adjacent the one or more structures or in contact with nerves innervating the one or more structures; and

one or more sensing electrodes for monitoring physiological parameters; and

means for varying activity of the stimulating electrodes in response to change detected in the gastrointestinal tract to thereby modify operation of the one or more structures.

10. The device of claim 9 further comprising a microprocessor for controlling operation of the device and wherein the microprocessor is the means for varying activity of the stimulating electrodes.

11. The device of claim 9 wherein the one or more structures are selected from the upper esophageal sphincter, the esophagus, lower esophageal sphincter and the gastric fundus.

12. The device of claim 11 wherein the one or more structures further includes the stomach, the pyloric sphincter, the small intestine, the colon and the vagus.

13. The device of claim 9 wherein the electrical stimulation has a shape which is square, rectangular, sinusoidal or saw-tooth and wherein the electrical stimulation has a frequency in the range of 1 Hz-1 MHz.

14. The device of claim 9 wherein the pulse generator is wirelessly connected to the electrode sets.

15. The device of claim 9 wherein the sensing electrodes sense one or more of change in gastrointestinal, muscle tone, peristaltic activity, esophageal peristalsis, esophageal pH, esophageal pressure, esophageal impedence, esophageal electrical activity, gastric peristalsis, gastric electrical activity, gastric chemical activity, gastric hormonal activity, gastric temperature, gastric impedence, gastric pH, blood chemical and hormonal activity, vagal or other gastrointestinal neural activity and salivary chemical activity.

16. The device of claim 9 wherein the sensing electrodes are positioned in or adjacent one or more of the esophagus, the stomach, the small intestine, the colon, the vagus or other gastrointestinal nerves and the vascular system.

17. The device of claim 9 when used to treat obesity and/or GERD.