Method and apparatus for treatment of the gastrointestinal tract

• US 7,738,961 B2
• Filed: 10/09/2006
• Issued: 06/15/2010
• Est. Priority Date: 10/09/2006
• Status: Expired due to Fees

• Current Assignee: Paras Holdings LLC, Triad Support Systems, Inc.
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US11/539,645
• Publication Number:
  US 20080086179A1
• Time in Patent Office: 1,345 Days
• Field of Search: 607/40
• 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 an upper esophageal sphincter or esophagus to modify activity of said upper esophageal sphincter or esophagus in order to treat gastrointestinal conditions of a patient, the method comprising the steps of:

arranging at least two stimulating electrodes within a portion of said upper esophageal sphincter or esophagus, wherein said at least two stimulating electrodes are in different locations within said portion of said upper esophageal sphincter or esophagus; and

triggering electrical stimuli from the stimulating electrodes when said patient enters a feed phase and wherein said stimuli causes said portion of said upper esophageal sphincter or esophagus to contract and wherein the electrodes are stimulated in a pattern that slows passage of a food bolus through the upper esophageal sphincter or esophagus.

2. The method of claim 1, further comprising the step of arranging a plurality of stimulating electrodes within or adjacent a lower esophageal sphincter wherein stimuli from the plurality of stimulating electrodes stimulate the lower esophageal sphincter.

3. A method of electrically stimulating an upper esophageal sphincter or esophagus of a patient, the method comprising the steps of:

arranging at least two stimulating electrodes within different portions of said upper esophageal sphincter or esophagus;

providing electrical energy to the stimulating electrodes to thereby cause at least one of said portion of the upper esophageal sphincter and an esophagus to be stimulated;

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

modulating the stimulating electrodes in response to the change detected in the gastrointestinal tract, wherein said change is indicative of said patient entering into a feed phase, to modify operation of the portion of the upper esophageal sphincter or esophagus, wherein the electrodes are stimulated in a pattern that slows passage of a food bolus through the upper esophageal sphincter or esophagus.

4. The method of claim 3 wherein electrical stimuli from the stimulating electrodes are applied to nerves supplying the upper esophageal sphincter or esophagus.

5. The method of claim 3 wherein the one or more 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.

6. 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.

7. The method of claim 3, further comprising a plurality of stimulating electrodes within or adjacent a lower esophageal sphincter wherein stimuli from the stimulating electrodes stimulate the lower esophageal sphincter.

8. A device for electrical stimulation of one or more structures in the gastrointestinal tract of a patient and for use in the treatment of gastrointestinal conditions, 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 different portions of at least one of an upper esophageal sphincter or an esophagus or in contact with nerves innervating the upper esophageal sphincter or the esophagus; and

one or more sensing electrodes for monitoring physiological parameters; and

a microprocessor programmed to vary activity of the stimulating electrodes in response to change detected in the gastrointestinal tract, wherein said change is indicative of said patient entering into a feed phase, to thereby modify operation of the upper esophageal sphincter or the esophagus, wherein the microprocessor is further programmed to stimulate the stimulating electrodes in a pattern that slows passage of a food bolus through the upper esophageal sphincter or esophagus.

9. The device of claim 8 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.

10. The device of claim 8 wherein the pulse generator is wirelessly connected to the electrode sets.

11. The device of claim 8 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.

12. The device of claim 8 wherein the sensing electrodes are adapted to be 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.

13. The device of claim 8 wherein the gastrointestinal condition is obesity.

14. The device of claim 8, further comprising a plurality of stimulating electrode sets connected to the pulse generator wherein the electrode sets are adapted to be positioned within a lower esophagus esophageal sphincter or in contact with nerves innervating the lower esophageal sphincter.