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.

Description

CROSS-REFERENCE[0001]The present application is a continuation of U.S. patent application Ser. No. 14 / 201,766, entitled “Device and Implantation System for Electrical Stimulation of Biological Systems” and filed on Mar. 7, 2014, which is a continuation-in-part of U.S. patent application Ser. No. 14 / 175,927, of the same title and filed on Feb. 7, 2014, which is a continuation-in-part application of U.S. patent application Ser. No. 13 / 661,483, entitled “Methods and Systems for Treating the Gastrointestinal Tract” and filed on Oct. 26, 2012, which is a continuation of U.S. patent application Ser. No. 12 / 775,436, entitled “Method and Apparatus for Treatment of the Gastrointestinal Tract” and filed on May 6, 2010, which is a continuation of U.S. patent application Ser. No. 11 / 539,645, of the same title, filed on Oct. 9, 2006, and issued on Jun. 15, 2010 as U.S. Pat. No. 7,738,961.[0002]U.S. patent application Ser. No. 14 / 201,766 is also a continuation-in-part application of U.S. patent a...

AI Technical Summary

Benefits of technology

The invention relates to a system for increasing pressure in a patient's lower esophageal sphincter (LES) to treat a condition called gastroesophageal reflux disease (GERD). The system includes electrodes that are placed on the LES and a controller that generates an electrical pulse train to the LES. This increases pressure during a rest period after the stimulation period, to reduce symptoms of GERD. The system is designed to avoid inducing dysphagia (difficulty swallowing) in the patient and to allow the patient to swallow while being stimulated. The controller ensures that the electrical stimulation does not inhibit the patient's esophageal motility.

Problems solved by technology

However, the LES fails to completely return to baseline pressure and, instead, relaxes again, thereby causing an episode of acid reflux.

For failed peristalsis, the LES relaxes in the absence of an expected bolus, again resulting in an episode of acid reflux.

While the typical acid load in a gastro-esophageal reflux disease (GERD) patient is greater than in a tLESR patient, tLESR is a common problem and expensive to manage in both primary and secondary care settings.

The acid and bile damages the esophageal mucosa resulting in heartburn, ulcers, bleeding, and scarring, and long term complications such as Barrett's esophagus (pre-cancerous esophageal lining) and adeno-cancer of the esophagus.

However, daily use of PPIs or H2RAs is not universally effective in the relief of tLESR symptoms or as maintenance therapy.

Additionally, not all patients are comfortable with the concept of having to take daily or intermittent medication for the rest of their lives and many are interested in nonpharmacological options for managing their reflux disease.

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