Device and implantation system for electrical stimulation of biological systems
First Claim
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1. A method for treating esophageal dysfunction and preventing a hiatal hernia in a patient, comprising:
- providing a device comprising at least one electrode operably connected to a pulse generator, and an energy source, said device adapted to apply electrical stimulation to a target tissue, wherein the at least one electrode is positioned on a first end of the device and the pulse generator is positioned on a second end of the device;
implanting said device within a gastrointestinal tract of the patient, wherein the first end of the device is implanted in a portion of esophageal tissue of the patient and said at least one electrode is positioned to be in electrical communication with a lower esophageal sphincter of the patient, wherein the second end of the device is implanted in an abdomen of the patient, and wherein said device is implanted such that a slack in a range of 1 cm to 10 cm exists between said first end and said second end; and
operating said device to cause electrical stimulation to be applied to the patient'"'"'s lower esophageal sphincter muscle to modulate function of said lower esophageal sphincter muscle, wherein said operation is not dependent upon, influenced by, modified by, lengthened by, or shortened by a physiological state of a patient.
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Abstract
The present specification discloses devices and methodologies for the treatment of achalasia. Individuals with achalasia are 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.
308 Citations
15 Claims
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1. A method for treating esophageal dysfunction and preventing a hiatal hernia in a patient, comprising:
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providing a device comprising at least one electrode operably connected to a pulse generator, and an energy source, said device adapted to apply electrical stimulation to a target tissue, wherein the at least one electrode is positioned on a first end of the device and the pulse generator is positioned on a second end of the device; implanting said device within a gastrointestinal tract of the patient, wherein the first end of the device is implanted in a portion of esophageal tissue of the patient and said at least one electrode is positioned to be in electrical communication with a lower esophageal sphincter of the patient, wherein the second end of the device is implanted in an abdomen of the patient, and wherein said device is implanted such that a slack in a range of 1 cm to 10 cm exists between said first end and said second end; and operating said device to cause electrical stimulation to be applied to the patient'"'"'s lower esophageal sphincter muscle to modulate function of said lower esophageal sphincter muscle, wherein said operation is not dependent upon, influenced by, modified by, lengthened by, or shortened by a physiological state of a patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A system for treating esophageal dysfunction in a patient, comprising:
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a pulse generator in electrical communication with, and physically attached to, at least one electrode, wherein said pulse generator is positioned on a first end of a strap and is configured to be implanted within the patient'"'"'s abdomen, wherein said at least one electrode is positioned on a second end of said strap and is configured to be implanted in esophagus tissue of the patient, wherein, upon implantation, said at least one electrode and said pulse generator are separated by a slack in a range of 1 cm to 10 cm, and wherein said pulse generator with said at least one electrode provide electrical stimulation to the proximate, mid, or distal esophagus or LES to effectuate a decrease in LES tone and pressure and/or an increase in esophageal peristalsis; a controller module wired or wirelessly connected to said pulse generator, said controller module capable of receiving, storing and transmitting programmatic instructions directed toward the operation of said pulse generator; and an energy storage component, wherein said energy storage component is integrated with said pulse generator or with said controller and is configured to be independently implanted within the patient or secured outside the patient against the patient'"'"'s skin, wherein said operation is not dependent upon, influenced by, modified by, lengthened by, or shortened by a physiological state of the patient. - View Dependent Claims (15)
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Specification