Sphincter treatment apparatus

Abstract

An apparatus treats tissue at or near a sphincter. The apparatus has an elongated member having at least one lumen including an inflation lumen, and a basket assembly including a first and a second arm. An inflatable member is coupled to the inflation lumen and has a deployed and a non-deployed state. In the deployed state, the inflatable member expands the basket assembly into contact with tissue. At least one of the first and second arms of the basket assembly has a fluid lumen having an aperture for conveying a fluid from the basket assembly. A source of fluid is coupled to the fluid lumen for conveyance of fluid through the aperture. The fluid can be, e.g., an electrolytic solution, and / or an anti-infection agent, and / or an echogenic media, and / or a steroid, and / or an anesthetic, and / or a medicament, and / or a tissue cooling agent. The source can be a drug delivery device.

Description

RELATED APPLICATIONS [0001] This application is a divisional of co-pending U.S. application Ser. No. 10 / 728,684, filed Dec. 5, 2003, which is a divisional of U.S. application Ser. No. 09 / 776,140, filed Feb. 2, 2001 (now U.S. Pat. No. 6,673,070), which is a continuation of U.S. application Ser. No. 09 / 235,060, filed Jan. 20, 1999 (now U.S. Pat. No. 6,254,598), which is a continuation-in-part of U.S. patent application Ser. No. 09 / 026,316, filed Feb. 19, 1998 (now U.S. Pat. No. 6,056,744).FIELD OF THE INVENTION [0002] This invention relates generally to an apparatus for the treatment of sphincters, and more specifically to an apparatus that treats 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 resu...

AI Technical Summary

Benefits of technology

"The invention is a device for treating tissue near a sphincter. It includes an elongated member with a lumen and a basket assembly with two arms. The basket assembly is attached to the elongated member and has a deployed and non-deployed configuration. An inflatable member is positioned inside the basket assembly and can expand it to its deployed configuration. The device also has two energy delivery devices that can be advanced from the arms to a treatment site. The inflatable member can be inflated with a fluid, such as an electrolytic solution, an anti-infection agent, or a medicament, to dilate the tissue near the sphincter. The technical effects of this invention include improved treatment of tissue near a sphincter with minimally invasive techniques and the ability to dilate the tissue without the need for a surgery."

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.

Such signals may cause a higher than normal frequency of relaxations of the LES allowing acidic stomach contents to be repeatedly ejected into the esophagus and cause the complications described above.

However, there is no current device or associated medical procedure available for the electrical mapping and treatment of aberrant electrical sites in the LBS and stomach as a means for treating GERD.

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 the 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.

Images