Apparatus to treat esophageal sphincters

Abstract

A sphincter treatment apparatus has an introducer means including a distal portion means. An expandable device means includes a plurality of arm means. Each arm means of the plurality has a distal section means and a proximal section means. Each of distal sections means of the arm means are coupled and each of the proximal sections means of the arm means are coupled to the introducer means distal portion means. The expandable device means is configured to at least partially dilate a sphincter in a deployed state. An energy delivery device means is introduceable from the introducer means into a selected site of the sphincter. The energy delivery device means is configured to deliver sufficient energy to reduce a frequency of relaxation of the sphincter.

Description

RELATED APPLICATIONS [0001] This application is a divisional of application Ser. No. 10 / 838,292, which is a divisional of application Ser. No. 09 / 971,085, filed Oct. 4, 2001 (now U.S. Pat. No. 6,749,607), which is a continuation of application Ser. No. 09 / 036,092, filed Mar. 6, 1998, now abandoned.FIELD OF THE INVENTION [0002] This invention relates generally to an apparatus to treat sphincters, and more particularly to an apparatus to treat esophageal sphincters. DESCRIPTION OF RELATED ART [0003] Gastroesophageal reflux disease (GERD) is a common gastroesophageal disorder in which the stomach contents are ejected into the lower esophagus due to a dysfunction of the lower esophageal sphincter (LES). These contents are highly acidic and potentially injurious to the esophagus resulting in a number of possible complications of varying medical severity. The reported incidence of GERD in the U.S. is as high as 10% of the population (Castell DO; Johnston BT: Gastroesophageal Reflux Diseas...

AI Technical Summary

Benefits of technology

[0013] Accordingly, an object of the present invention is to provide an apparatus that reduces a frequency of sphincter relaxation.

[0014] Another object of the invention is to provide an apparatus to create controlled cell necrosis in a sphincter tissue underlying a sphincter mucosal layer. Yet another object of the invention is to provide an apparatus to create controlled cell necrosis in a sphincter and minimize injury to a mucosal layer of the sphincter.

[0015] A further object of the invention is to provide an apparatus to controllably produce a lesion in a sphincter without creating a permanent impairment of the sphincter's ability to achieve a physiologically normal state of closure.

[0016] Still another object of the invention is to provide an apparatus to create a tightening of a sphincter without permanently damaging anatomical structures near the sphincter.

[0017] Another object of the invention is to provide an apparatus to create controlled cell necrosis in a lower esophageal sphincter to reduce a frequency of reflux of stomach contents into an esophagus.

[0019] In another embodiment, an expandable device means is coupled to an introducer distal portion means. The expandable device means includes a first arm means with a proximal and distal section means and a second arm means with proximal and distal section means. The first and second arm distal portion means are coupled. The expandable device means is configured to at least partially dilate a sphincter in a deployed state. An energy delivery device means is coupled to the expandable device means. The energy delivery device means is configured to deliver sufficient energy to reduce a frequency of relaxation of the sphincter while minimizing cell necrosis of a mucosal layer of the sphincter.

Problems solved by technology

These contents are highly acidic and potentially injurious to the esophagus resulting in a number of possible complications of varying medical severity.

On a chronic basis, GERD subjects the esophagus to ulcer formation, or esophagitis and may result in more severe complications including esophageal obstruction, significant blood loss and perforation of the esophagus.

However, while pharmacologic agents may provide short term relief, they do not address the underlying cause of LES dysfunction.

Although the operation has a high rate of success, it is an open abdominal procedure with the usual risks of abdominal surgery including: postoperative infection, herniation at the operative site, internal hemorrhage and perforation of the esophagus or of the cardia.

This rate of complication drives up both the medical cost and convalescence period for the procedure and may exclude portions of certain patient populations (e.g., the elderly and immuno-compromised).

However, this procedure is still traumatic to the LES and presents the postoperative risks of gastroesophageal leaks, infection and foreign body reaction, the latter two sequela resulting when foreign materials such as surgical staples are implanted in the body.

While the methods reported above are less invasive than an open Nissen fundoplication, some still involve making an incision into the abdomen and hence the increased morbidity and mortality risks and convalescence period associated with abdominal surgery.

Others incur the increased risk of infection associated with placing foreign materials into the body.

All involve trauma to LES and the risk of leaks developing at the newly created gastroesophageal junction.

Besides the LES, there are other sphincters in the body which if not functionally properly can cause disease states or otherwise adversely affect the lifestyle of the patient.

Reduced muscle tone or otherwise aberrant relaxation of sphincters can result in a laxity of tightness disease states including, but not limited to, urinary incontinence.

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