Gastrointestinal electrical stimulation device and method for treating gastrointestinal disorders

• US 8,417,342 B1
• Filed: 10/23/2008
• Issued: 04/09/2013
• Est. Priority Date: 07/03/2007
• Status: Active Grant

• Current Assignee: University of Mississippi Medical Center (University of Mississippi)
• Original Assignee: University of Mississippi Medical Center (University of Mississippi)
• Inventors: Abell, Thomas
• Primary Examiner(s): Bertram, Eric D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US12/256,789
• Time in Patent Office: 1,629 Days
• Field of Search: None
• US Class Current: 607/40
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A device and method is provided for treating treat gastrointestinal disorders using electrical stimulation. In one advantageous form, the method uses mucosal EGG (mEGG) to analyze a patient'"'"'s natural gastric electrical activity. The mEGG can be measured anywhere in the gastrointestinal tract. From the mEGG, one can determine whether a patient is a good candidate for gastrointestinal electrical stimulation. For example, analysis of the frequency, amplitude and a ratio of frequency to amplitude can be used to determine who should receive gastrointestinal electrical stimulation, and at what the various stimulation parameters should be. The present method can be used to treat various disorders relating to gastrointestinal electrical activity. Ideally, the gastric electrical stimulation is delivered at a desired frequency and amplitude to effectuate normalization of gastric electrical current/activity, thereby treating disorders associated with gastric electrical activity. Advantageously, gastrointestinal electrical stimulation is effectuated by endoscopically delivering the electrostimulating device.

Claims

1. A method for treating disorders relating to abnormal gastrointestinal electrical activity in a patient, said method comprising:

determining frequency and amplitude of natural gastrointestinal electrical activity in the patient;

calculating a frequency to amplitude ratio from the determined frequency and amplitude; and

administering electrical stimulation to the gastrointestinal tract of the patient based on the calculated frequency to amplitude ratio, using an endoscopically insertable neural modulation device, to thereby normalize the gastric electrical activity in the patient.

2. The method of claim 1, wherein the administering electrical stimulation comprises applying electrical current having a frequency in the range of 10-100 Hz.

3. The method of claim 1, wherein the administering electrical stimulation comprises applying electrical current in the range of 5 to 20 mAmps and 5 to 10 volts.

4. The method of claim 1, wherein the administering electrical stimulation comprises applying electrical current having a frequency of burst in a range of 5 to 50 burst per minute.

5. The method of claim 1, wherein the administering electrical stimulation comprises applying electrical stimulation to a patient having a natural frequency to amplitude ratio generally in the range of 1 to 100 cycles per minute/millivolts.

6. The method for treating disorders of claim 1, further comprising inserting an electrode into the mucosa of the gastrointestinal tract of the patient for use when determining frequency and amplitude of natural gastrointestinal electrical activity in the patient and for administering electrical stimulation to the gastrointestinal tract of the patient.

7. A method for treating gastrointestinal disorders relating to abnormal gastrointestinal electrical activity in a patient, said method comprising:

determining frequency and amplitude of natural gastric electrical activity in the patient using an electrode inserted into the mucosa of the patient;

calculating a frequency to amplitude ratio from the determined frequency and amplitude; and

administering electrical stimulation to the gastrointestinal tract of the patient based on the calculated frequency to amplitude ratio, using an endoscopically insertable neural modulation device operatively associated with the electrode, to thereby treat the gastrointestinal disorders.

8. The method of claim 7, wherein the gastrointestinal disorders are selected from the group consisting of gastrointestinal disorders, including gastroparesis, dyspepsia, gastro-esophageal reflux and nausea/vomiting of any etiology, along with disorders such as hyperemesis gravidarum of pregnancy, acute and chronic pancreatitis and other pancreato-biliary disorders, including biliary dyskinesia;

nausea/vomiting of chemotherapy and/or related to other cancer therapies;

rapid and other disordered gastric emptying;

metabolic disorders including diabetes;

bacterial overgrowth and small bowel dysmotility;

constipation, diarrhea and pelvic floor disorders;

autonomic disorders;

post-transplantation disorders;

other post-surgical disorders; and

nutritional disorders related to inability to maintain adequate weight. Also included are classic eating disorders, such as anorexia nervosa or bulimia nervosa.