System and methods for electrical stimulation of biological systems
First Claim
1. A system for increasing a length of a high pressure zone of a lower esophageal sphincter (LES) of a patient, the high pressure zone having a maximum pressure, said system comprising:
- at least one electrically stimulating electrode configured to be implanted proximate said LES;
a waveform generator coupled to said at least one electrode; and
,a controller configured to electrically stimulate an area proximate said LES, wherein said controller controls the waveform generator to repeatedly generate and apply an electrical pulse train through the at least one electrically stimulating electrode and wherein said electrical pulse train comprises a pulse width having a range of 30 μ
sec to 5 msec and a pulse amplitude having a range of 2 to 15 mAmp, wherein values for each of said pulse width and pulse amplitude are selected such that the length of said high pressure zone is increased above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient and said maximum pressure is not increased.
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Accused Products
Abstract
Systems and methods for the treatment of gastroesophageal reflux disease (GERD) include at least one electrically stimulating electrode coupled to a pulse generator. Individuals with GERD are treated by implanting a stimulation device within and/or proximate the patient'"'"'s lower esophageal sphincter, gastric fundus, or other nearby gastrointestinal structures and applying electrical stimulation to the patient'"'"'s lower esophageal sphincter and/or fundus, in accordance with certain predefined protocols. Electrical stimulation provided by the disclosed systems results in an increase in the length of the high pressure zone of the LES and/or modulation of the receptive relaxation response of the fundus to decrease gastric pressure, creating a longer barrier to the reflux of gastric contents or increasing functional lower esophageal pressure respectively, thereby treating GERD.
308 Citations
16 Claims
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1. A system for increasing a length of a high pressure zone of a lower esophageal sphincter (LES) of a patient, the high pressure zone having a maximum pressure, said system comprising:
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at least one electrically stimulating electrode configured to be implanted proximate said LES; a waveform generator coupled to said at least one electrode; and
,a controller configured to electrically stimulate an area proximate said LES, wherein said controller controls the waveform generator to repeatedly generate and apply an electrical pulse train through the at least one electrically stimulating electrode and wherein said electrical pulse train comprises a pulse width having a range of 30 μ
sec to 5 msec and a pulse amplitude having a range of 2 to 15 mAmp, wherein values for each of said pulse width and pulse amplitude are selected such that the length of said high pressure zone is increased above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient and said maximum pressure is not increased. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A system for increasing a length of a high pressure zone of a lower esophageal sphincter (LES) of a patient, the high pressure zone having a maximum pressure, said system comprising:
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at least one electrically stimulating electrode configured to be positioned proximate said LES; a waveform generator coupled to said at least one electrode; a controller configured to electrically stimulate an area proximate said LES to increase the length of said high pressure zone above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient, wherein said controller controls the waveform generator to repeatedly generate and apply an electrical pulse train through the at least one electrically stimulating electrode, wherein said electrical pulse train comprises a pulse width having a range of 30 μ
sec to 5 msec and a pulse amplitude having a range of 2 to 15 mAmp, and wherein values for each of said pulse width and pulse amplitude are selected such that prior to stimulation, an average pressure within said high pressure zone is greater than a first pressure, the maximum pressure is equal to a second pressure, and a baseline length is equal to a first length and, after stimulation, an average pressure within said high pressure zone is greater than the first pressure, the maximum pressure is equal the second pressure, and a length of the high pressure zone is at least 10% greater than said baseline length. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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Specification