Device and Implantation System for Electrical Stimulation of Biological Systems

Abstract

The present specification discloses devices and methodologies for the treatment of transient lower esophageal sphincter relaxations (tLESRs). Individuals with tLESRs 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 and have improved energy storage requirements.

1 . An electrical stimulation device adapted to treat gastroesophageal reflux disease (GERD) in a patient, comprising:
 a pulse generator;   at least one electrode in electrical communication with the pulse generator, wherein said at least one electrode is adapted to be implanted such that said at least one electrode is configured to contact a region comprising a lower esophageal sphincter (LES) of the patient, wherein the region comprises of tissue within a distance of 3 cm from the LES;   an energy storage component; and   a non-transitory memory for storing programmatic code which, when executed by a processor, causes said pulse generator to generate a pulse stream, said pulse stream being defined by a plurality of parameters, in accordance with a preset period,   wherein said plurality of parameters comprise a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, a duty cycle ranging from 1 to 100%, and a pulse frequency and wherein said plurality of parameters is defined such that electrical stimulation provided by said pulse stream to said region causes a reduction in at least one of a frequency of occurrence or an intensity of GERD symptoms in said patient, said reduction occurring only after 5 minutes of electrical stimulation.   
     
     
         2 . The electrical stimulation device of  claim 1 , wherein said electrical stimulation provided to said region is preset in time and not triggered by a sensed physiological state of said patient. 
     
     
         3 . The electrical stimulation device of  claim 1 , further comprising an accelerometer wherein said electrical stimulation device includes a pre-programmed stimulation mode adapted to automatically stimulate the patient's LES during time periods in which the patient is in a supine position, as determined by said accelerometer. 
     
     
         4 . The electrical stimulation device of  claim 3 , wherein said supine position is defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level of inclination is programmable and has a range of 50 to 80 degrees. 
     
     
         5 . The electrical stimulation device of  claim 3 , wherein said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time is programmable and has a range of 1 minute to 60 minutes. 
     
     
         6 . The electrical stimulation device of  claim 3 , wherein said automatic stimulation occurs after a minimum percentage of data points occur within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent. 
     
     
         7 . The electrical stimulation device of  claim 1 , wherein said pulse frequency has a range of 1-100 Hz or 1-59 cpm. 
     
     
         8 . The electrical stimulation device of  claim 1 , further comprising a second electrode adapted to be implanted within the lower esophageal sphincter (LES), an esophageal body, an upper esophageal sphincter (UES), a gastro-esophageal junction (GEJ), a stomach, or a gastrointestinal (GI) tract of said patient. 
     
     
         9 . A method of treating a patient with gastroesophageal reflux disease (GERD) using the electrical stimulation device of  claim 1 , comprising:
 implanting the at least one electrode within said region;   implanting the pulse generator, the non-transitory memory, and energy storage component into the patient; and   programming said electrical stimulation device, wherein said programming comprises defining a pulse width in a range of 30 μsec to 5 msec, a pulse amplitude in a range of 2 to 15 mAmp, an on period in a range of 1 second to 23 hours, 59 minutes, and 59 seconds, an off period in a range of 1 second to 23 hours, 59 minutes, and 59 seconds, a duty cycle ranging from 1 to 100%, and a pulse frequency.   
     
     
         10 . The method of  claim 9 , further comprising implanting at least one second electrode within the lower esophageal sphincter (LES), an esophageal body, an upper esophageal sphincter (UES), a gastro-esophageal junction (GEJ), a stomach, or a gastrointestinal (GI) tract of said patient. 
     
     
         11 . An electrical stimulation device configured to treat gastroesophageal reflux disease (GERD) in a patient, comprising:
 a pulse generator;   at least one electrode in electrical communication with the pulse generator, wherein said at least one electrode is adapted to be implanted such that said at least one electrode is configured to contact a region comprising a lower esophageal sphincter (LES) of the patient, wherein the region comprises of tissue within a distance of 3 cm from the LES;   an energy storage component; and   a non-transitory memory for storing programmatic code which, when executed by a processor, causes said pulse generator to generate a pulse stream, said pulse stream being defined by a plurality of parameters, in accordance with a preset period   wherein said plurality of parameters comprise a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, a duty cycle ranging from 1 to 100%, and a pulse frequency and wherein said plurality of parameters is defined such that electrical stimulation provided by said pulse stream to said region causes a reduction in at least one of a frequency of occurrence or an intensity of GERD symptoms while not inhibiting swallowing in said patient during an application of said electrical stimulation.   
     
     
         12 . The electrical stimulation device of  claim 11 , wherein said electrical stimulation provided to said region is preset in time and not triggered by a sensed physiological state of said patient. 
     
     
         13 . The electrical stimulation device of  claim 11 , further comprising an accelerometer wherein said system includes a pre-programmed stimulation mode adapted to automatically stimulate the patient's LES during time periods in which the patient is in a supine position, as determined by said accelerometer. 
     
     
         14 . The electrical stimulation device of  claim 13 , wherein said supine position is defined by a level of inclination relative to a vertical baseline, wherein 0 degrees is a vertical position, and wherein said level of inclination is programmable and has a range of 50 to 80 degrees. 
     
     
         15 . The electrical stimulation device of  claim 13 , wherein said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time is programmable and has a range of 1 minute to 60 minutes. 
     
     
         16 . The electrical stimulation device of  claim 13 , wherein said automatic stimulation occurs after a minimum percentage of data points occur within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent. 
     
     
         17 . The electrical stimulation device of  claim 11 , wherein said pulse frequency has a range of 1-100 Hz or 1-59 cpm. 
     
     
         18 . The electrical stimulation device of  claim 11 , further comprising a second electrode adapted to be implanted within the lower esophageal sphincter (LES), an esophageal body, an upper esophageal sphincter (UES), a gastro-esophageal junction (GEJ), a stomach, or a gastrointestinal (GI) tract of said patient. 
     
     
         19 . A method of treating a patient with gastroesophageal reflux disease (GERD) using the electrical stimulation device of  claim 11 , comprising:
 implanting the at least one electrode within said region;   implanting the pulse generator, the non-transitory memory, and energy storage component into the patient; and   programming said electrical stimulation device, wherein said programming comprises defining a pulse width in a range of 30 μsec to 5 msec, a pulse amplitude in a range of 2 to 15 mAmp, an on period in a range of 1 second to 23 hours, 59 minutes, and 59 seconds, an off period in a range of 1 second to 23 hours, 59 minutes, and 59 seconds, a duty cycle ranging from 1 to 100%, and a pulse frequency.   
     
     
         20 . The method of  claim 19 , further comprising implanting at least one second electrode within the lower esophageal sphincter (LES), an esophageal body, an upper esophageal sphincter (UES), a gastro-esophageal junction (GEJ), a stomach, or a gastrointestinal (GI) tract of said patient. 
     
     
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