Autonomic nerve stimulation to treat a gastrointestinal disorder

• US 7,856,273 B2
• Filed: 07/28/2005
• Issued: 12/21/2010
• Est. Priority Date: 07/28/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven E., Parnis, Steven M., Guzman, Albert W., Buras, William R.
• Primary Examiner(s): Bertram; Eric D.
• Assistant Examiner(s): Layno; Carl H
• Application Number:
  US11/191,846
• Publication Number:
  US 20070027492A1
• Time in Patent Office: 1,972 Days
• Field of Search: 607/2, 607/40, 607/45, 607/118, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence

Abstract

A method and apparatus for stimulating a portion of a vagus nerve of a patient to treat a gastrointestinal disorder is provided. At least one electrode is coupled to at least one portion of a vagus nerve of the patient. The portion of the a vagus nerve may include an esophageal plexus, a myenteric plexus of aurbach, a submucous plexus of the meissner, a principal nerve of the lesser curvature of the stomach, and a gastric branch of said vagus nerve. An electrical signal is applied to the portion of the vagus nerve using the electrode to treat the gastrointestinal disorder.

Claims

1. A method of treating a patient having a gastrointestinal disorder, comprising:

receiving, by an implantable medical device (IMD), external input from a patient, the external input pertaining to a subjective observation by the patient of a symptom of a gastrointestinal disorder affecting the patient;

receiving, by the IMD, internal input from a sensor in the patient, the internal input pertaining to at least one symptom from the group consisting of;

an acid production factor;

a muscle spasm relating to the diaphragm;

a diaphragm measurement;

spasms related to the esophagus; and

spasms related to the stomach region;

in response to receiving the internal and external inputs, automatically determining whether or not electrical stimulation treatment is appropriate;

in response to a determination that electrical stimulation treatment is appropriate, automatically determining, based on data relating to the gastrointestinal disorder, signal characteristics suitable to reduce at least one disorder effect from the group consisting of;

acid production;

a muscle spasm relating to the diaphragm;

a spasm related to an esophagus region; and

a spasm related to the stomach region;

after determining the signal characteristics suitable to reduce at least one disorder effect, generating an electrical signal according to the determined signal characteristics; and

applying the electrical signal to a vagus nerve of the patient via at least one electrode directly coupled to at least one portion of the vagus nerve, the portion selected from the group consisting of;

a myenteric plexus of Auerbach;

a submucous plexus of the Meissner;

a principal nerve of the lesser curvature of the stomach; and

a gastric branch of said vagus nerve.

2. The method of claim 1, wherein said gastrointestinal disorder comprises at least one of a motility disorder, a gastric disorder, an acid secretion disorder, chronic nausea, and an eating disorder from the group consisting of a motility disorder, an anorexia nervosa, a bulimia nervosa, a compulsive overeating disorder, and a binge overeating disorder.

3. The method of claim 1, wherein different electrodes are directly coupled to at least two different portions of the vagus nerve;

and

further comprising automatically determining which portion of the vagus nerve to stimulate, in response to the determination that electrical stimulation treatment is appropriate.

4. The method of claim 3, wherein the operation of automatically determining which portion of the vagus nerve to stimulate comprises:

automatically selecting from among different electrodes connected to different portions of the vagus nerve, based on the based on data relating to the gastrointestinal disorder, the different portions available for selection comprising at least two portions from the group consisting of;

the myenteric plexus of Auerbach;

the submucous plexus of the Meissner;

the principal nerve of the lesser curvature of the stomach; and

the gastric branch of the vagus nerve.

5. The method of claim 1, further comprising generating a physiological response to said electrical signal that is selected from the group consisting of an afferent action potential, an efferent action potential, an afferent hyperpolarization, a sub-threshold depolarization, and an efferent hyperpolarization.

6. The method of claim 5, wherein applying the electrical signal comprises generating an efferent action potential in combination with an afferent action potential.

7. The method of claim 1 wherein the IMD is operable to define the electrical signal by at least one parameter selected from the group consisting of a current magnitude, a pulse frequency, a pulse width, an on-time, and an off-time, wherein said at least one parameter is selected to treat the gastrointestinal disorder.

8. The method of claim 1, wherein the operation of receiving internal input from the sensor comprises detecting at least one disorder from the group consisting of a motility disorder, a gastric disorder, an acid secretions disorder, a chronic nausea disorder, an anorexia nervosa disorder, a bulimia nervosa disorder, a compulsive overeating disorder, and a binge overeating disorder.

9. The method of claim 1, wherein applying the electrical signal comprises applying said signal during a first treatment period, and said method further comprises applying a second electrical signal to the vagus nerve using said at least one electrode during a second treatment period to treat the gastrointestinal disorder.

10. The method of claim 9, wherein said first treatment period comprises a period ranging from one hour to six months, and wherein said second treatment period comprises a period ranging from one month to 10 years.

11. The method of claim 1, wherein applying the electrical signal comprises performing an electrical stimulation, and the method further comprising performing said electrical stimulation in combination with at least one of a magnetic stimulation, a chemical stimulation, and a biological stimulation.

12. The method of claim 1, wherein the at least one electrode is coupled to a portion of the vagus nerve from the group consisting of a principal nerve of the lesser curvature of the stomach and a gastric branch of the vagus nerve.

13. An apparatus comprising:

an implantable medical device (IMD) configured to perform operations comprising;

receiving external input from a patient, the external input pertaining to a subjective observation by the patient of a symptom of a gastrointestinal disorder affecting the patient;

receiving internal input from a sensor in the patient, the internal input pertaining to at least one symptom from the group consisting of;

an acid production factor;

a muscle spasm relating to the diaphragm;

a diaphragm measurement;

spasms related to the esophagus; and

spasms related to the stomach region;

in response to receiving the internal and external inputs, automatically determining whether or not electrical stimulation treatment is appropriate;

in response to a determination that electrical stimulation treatment is appropriate, automatically determining, based on data relating to the gastrointestinal disorder, signal characteristics suitable to reduce at least one disorder effect from the group consisting of;

acid production;

a muscle spasm relating to the diaphragm;

a spasm related to an esophagus region; and

a spasm related to the stomach region;

after determining the signal characteristics suitable to reduce at least one disorder effect, generating an electrical signal according to the determined signal characteristics for application to a vagus nerve of the patient via at least one electrode directly coupled to at least one portion of the vagus nerve, the portion selected from the group consisting of;

a myenteric plexus of Auerbach;

a submucous plexus of the Meissner;

a principal nerve of the lesser curvature of the stomach; and

a gastric branch of said vagus nerve.

14. The apparatus of claim 13, wherein the at least one electrode is selected from the group consisting of a spiral electrode and a paddle electrode.

15. An apparatus according to claim 13, wherein the gastrointestinal disorder comprises at least one of a motility disorder, a gastric disorder, an acid secretion disorder, chronic nausea, and an eating disorder from the group consisting of a motility disorder, an anorexia nervosa, a bulimia nervosa, a compulsive overeating disorder, and a binge overeating disorder.

16. An apparatus according to claim 13, wherein the IMD comprises a programmable electrical signal generator operable to generate the electrical signal and apply the electrical signal to the at least one electrode.

17. An apparatus according to claim 16, wherein the IMD is operable to generate the electrical signal according to at least one parameter suitable to treat the gastrointestinal disorder, the at least one parameter selected from the group consisting of a current magnitude, a pulse frequency, a pulse width, an on-time, and an off-time.

18. An apparatus according to claim 13, wherein the IMD comprises at least one electrode suitable for directly coupling to a nerve.

19. An apparatus according to claim 13, wherein the IMD is operable to automatically select between different electrodes coupled to different portion of the vagus nerve for application of the electrical signal, in response to the determination that electrical stimulation treatment is appropriate.

20. An apparatus according to claim 13, wherein the IMD is operable to generate a physiological response to said electrical signal that is selected from the group consisting of an afferent action potential, an efferent action potential, an afferent hyperpolarization, a sub-threshold depolarization, and an efferent hyperpolarization.

21. An apparatus according to claim 13, wherein the IMD is operable to generate an efferent action potential in combination with an afferent action potential.