Electrical Stimulation System for the Treatment of Gastrointestinal Disorders

A method for implanting a stimulation system in a gastrointestinal tract of a patient, the stimulation system comprising one or more electrodes and a stimulator module comprising a pulse generator and a power source, wherein the stimulator module is in electrical communication with the one or more electrodes through one or more leads, the method comprising:

• endoscopically identifying a site on a gastric wall of the patient in order to determine a target location for placing the one or more electrodes;
• percutaneously placing the one or more electrodes at the identified site on the gastric wall;
• forming a subcutaneous pocket in the patient;
• placing a first portion of the stimulator module in an abdominal cavity of the patient's body;
• and
• placing a second portion of the stimulator module, comprising the power source, in the subcutaneous pocket;
• connecting one of the one or more leads to the stimulator module, wherein the one of the one or more leads is connected to the one or more electrodes;
• connecting a lead of the stimulator module to the power source module;
• and
• activating the stimulator module to generate a plurality of electrical pulses, wherein the electrical pulses have a frequency in a range of 1 Hz to 300 Hz, a pulse amplitude in a range of 0.5 mA to 30 mA, a pulse width in a range of around 30 μsec to 5 msec, and a session duration in a range of 1 minute to 1 day.

A method for implanting a stimulation system in a gastrointestinal tract of a patient, the stimulation system comprising at least two electrodes and a stimulator module comprising a pulse generator and a power source, wherein the stimulator module is in electrical communication with the at least two electrodes through one or more leads, the method comprising:

• identifying a site on a gastric wall of the gastrointestinal tract of the patient using endoscopic visualization in order to determine a target location for placing the at least two electrodes, wherein the site is located no more than 10 cm from a pylorus of the patient;
• percutaneously placing the at least two electrodes at the identified site on the gastric wall, wherein the at least two electrodes are placed substantially parallel to each other with a spacing of approximately 1 cm between the at least two electrodes;
• forming a subcutaneous pocket in the patient, wherein the subcutaneous pocket is external to the gastric wall;
• placing the stimulator module in the subcutaneous pocket of the patient's body;
• connecting one of the one or more leads to the stimulator module located in the subcutaneous pocket, wherein the one of the one or more leads is connected to the at least two electrodes;
• and
• activating the stimulator module to generate a plurality of electrical pulses, wherein the electrical pulses have a frequency in a range of 1 Hz to 300 Hz, a pulse amplitude in a range of 0.5 mA to 30 mA, a pulse width in a range of around 30 μsec to 5 msec, and a session duration in a range of 1 minute to 1 day.