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.

We claim: 
     
         1 . A system for treating a gastrointestinal condition of a patient, comprising:
 a pulse generator in electrical communication with an electrode, wherein said electrode is adapted to be implanted such that said electrode is configured to be in electrical communication with 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, and wherein said pulse generator generates a pulse stream;   an energy storage component; and   a non-volatile memory for storing programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream,   wherein said pulse stream comprises a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, a pulse frequency having a range of 2 to 80 Hz, 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 swallowing of the patient is not hindered by said stimulation.   
     
     
         2 . The system of  claim 1 , wherein said electrode is adapted to be implanted such that said electrode is configured to contact said region comprising said lower esophageal sphincter (LES). 
     
     
         3 . The system of  claim 1 , wherein said pulse stream further comprises an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds and an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds. 
     
     
         4 . The system of  claim 1 , 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, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees. 
     
     
         5 . The system of  claim 4 , 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 system of  claim 5 , 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 system of  claim 1 , wherein said system does not have a sensor to determine when the patient is swallowing and does not modify said stimulation based on said swallowing. 
     
     
         8 . An implantable system for treating a gastrointestinal condition of a patient, comprising:
 a passive stimulator for receiving energy from a source;   a pulse generator in electrical communication with said passive stimulator, wherein said pulse generator is adapted to be implanted such that an electrode in electrical communication with said pulse generator is configured to be in electrical communication with a region comprising a lower esophageal sphincter (LES) of the patient, wherein the region comprises tissue within a distance of 3 cm from the LES and wherein said pulse generator generates a pulse stream, wherein said system does not include an implantable energy storage component; and   programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream,   wherein said pulse stream comprises a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, a pulse frequency having a range of 2 to 80 Hz, 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 swallowing of the patient is not hindered by said stimulation.   
     
     
         9 . The system of  claim 8 , wherein said pulse generator is adapted to be implanted such that said electrode is configured to contact said region comprising said lower esophageal sphincter (LES). 
     
     
         10 . The system of  claim 8 , wherein said pulse stream further comprises an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds and an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds. 
     
     
         11 . The system of  claim 8 , 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, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees. 
     
     
         12 . The system of  claim 11 , 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. 
     
     
         13 . The system of  claim 12 , 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. 
     
     
         14 . The system of  claim 8 , wherein said system does not have a sensor to determine when the patient is swallowing and does not modify said stimulation based on said swallowing. 
     
     
         15 . A system for treating a gastrointestinal condition of a patient, comprising:
 a pulse generator in electrical communication with at least one electrode, wherein said electrode is adapted to be implanted such that said electrode is configured to be in electrical communication with a region comprising a lower esophageal sphincter (LES) of the patient, wherein the region consists of tissue within a distance of 3 cm from the LES, wherein said pulse generator generates a pulse stream;   an energy storage component; and   programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream, wherein the programmatic code is not configured to modify the pulse stream based upon data from a sensor indicative of the patient engaging in swallowing,   wherein said pulse stream comprises a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, a pulse frequency having a range of 2 to 80 Hz, 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 swallowing of the patient is not hindered by said stimulation.   
     
     
         16 . The system of  claim 15 , wherein said electrode is adapted to be implanted such that said electrode is configured to contact said region comprising said lower esophageal sphincter (LES). 
     
     
         17 . The system of  claim 15 , wherein said pulse stream further comprises an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds and an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds. 
     
     
         18 . The system of  claim 15 , 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, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees. 
     
     
         19 . The system of  claim 18 , 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. 
     
     
         20 . The system of  claim 19 , 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. 
     
     
         21 . A system for treating a gastrointestinal condition of a patient, comprising:
 a pulse generator in electrical communication with at least one electrode, wherein said electrode is adapted to be implanted such that said electrode is configured to be in electrical communication with a region comprising a lower esophageal sphincter (LES) of the patient, wherein the region comprises tissue within a distance of 3 cm from the LES, wherein said pulse generator generates a pulse stream;   an energy storage component; and   programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream, wherein the programmatic code is not configured to modify the pulse stream based upon data from a sensor indicative of the patient engaging in swallowing,   wherein said pulse stream has a pulse width having a range of 30 μsec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, a pulse frequency having a range of 2 to 80 Hz, and a duty cycle ranging from 1 to 100%, wherein values for at least one of said pulse width, pulse amplitude, and pulse frequency are selected such that swallowing of the patient is not hindered by said stimulation.   
     
     
         22 . The system of  claim 21 , wherein said electrode is adapted to be implanted such that said electrode is configured to contact said region comprising said lower esophageal sphincter (LES). 
     
     
         23 . The system of  claim 21 , wherein said pulse stream further comprises an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds and an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds. 
     
     
         24 . The system of  claim 21 , 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, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees. 
     
     
         25 . The system of  claim 24 , 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. 
     
     
         26 . The system of  claim 25 , 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. 
     
     
         27 . The system of  claim 21 , wherein said system does not have a sensor to determine when the patient is swallowing.