On April 28, 2015 , the USPTO issued U.S. Patent Number 9020597 to EndoStim, Inc., which was successfully prosecuted by Novel IP.
The '597 patent is directed towards the present specification which discloses devices and methodologies for the treatment of GERD. Individuals with GERD may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow, have improved energy storage requirements, enable improved LES function while concurrently delivering additional health benefits, and enable improved LES function post stimulation termination.
Independent Claim 1 describes "A system for treating a patient with gastroesophageal reflux disease, comprising: at least one electrode positioned within 3 cm above and 3 cm below the patient's lower esophageal sphincter (LES); a waveform generator operably coupled to said at least one electrode; a controller configured to electrically stimulate the LES to increase a pressure of the LES from a first level to a second level or improve a function of the LES, wherein said controller controls the waveform generator to repeatedly: a) generate and apply an electrical pulse train to the LES through the at least one electrode for a stimulation period, and b) terminate the electrical pulse train for a rest period, wherein said electrical pulse train comprises a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude a range of 2 to 15 mAmp, and a duty cycle ranging from 1 to 100%, wherein values for each of said pulse width, pulse amplitude, and pulse frequency are selected such that said increase in pressure or improvement in function of the patient's LES occurs at least five minutes after initiating an application of said electrical pulse train and maintains for at least 20 minutes after said electrical pulse train terminates".