Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-03-13
2003-04-08
Pelham, Joseph (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S106000, C604S027000
Reexamination Certificate
active
06544226
ABSTRACT:
FIELD OF THE INVENTION
In a general sense, the invention is directed to systems and methods for treating interior tissue regions of the body. More specifically, the invention is directed to systems and methods for treating dysfunction in body sphincters and adjoining tissue, e.g., in and around the lower esophageal sphincter and cardia of the stomach.
BACKGROUND OF THE INVENTION
As
FIG. 1
shows, the esophagus
10
is a muscular tube that carries food from the mouth into the stomach
12
. The muscles in the walls of the esophagus
10
contract in a wavelike manner, moving the food down to the stomach
12
. The interior wall of the esophagus includes glands that secrete mucus, to aid in the movement of food by providing lubrication. The human esophagus is about twenty-five centimeters long.
The stomach
12
, located in the upper left hand side of the abdomen, lays between the esophagus
10
and the small intestine
14
. In people and most animals, the stomach
12
is a simple baglike organ. A human being's stomach is shaped much like a J.
The average adult stomach can hold a little over one quart (0.95 liter). The stomach
12
serves as a storage place for food. Food in the stomach
12
is discharged slowly into the intestines
14
. The stomach
12
also helps digest food.
The upper end of the stomach connects with the esophagus
10
at the cardiac notch
16
, at the top of the J-shape. The muscular ring called the lower esophageal sphincter
18
surrounds the opening between the esophagus
10
and the stomach
12
. The funnel-shaped region of the stomach
12
immediately adjacent to the sphincter
18
is called the cardia
20
. The cardia
20
comprises smooth muscle. It is not a sphincter.
The lower esophageal sphincter
18
relaxes, or opens, to allow swallowed food to enter the stomach
12
. The lower esophageal sphincter
18
, however, is normally closed, to keep the stomach
12
contents from flowing back into the esophagus
10
.
Another sphincter, called the pyloric sphincter
22
, surrounds the duodenal opening of the stomach
12
. The pyloric sphincter
22
keeps non-liquid food material in the stomach
12
until it is processed into a more flowable, liquid form. The time that the stomach
12
retains food varies. Usually, the stomach
12
empties in three to five hours.
In a person suffering from gastrointestinal reflux disease (GERD), the lower esophageal sphincter
18
is subject to spontaneous relaxation. The sphincter
18
opens independent of the normal swallowing function. Acidic stomach contents surge upward into the esophagus
10
, causing pain, discomfort, and damage the mucosal wall of the esophagus
10
.
The stomach
12
distends to accommodate various food volumes. Over time, stomach distention can stretch the cardia
20
or otherwise cause loss of compliance in the cardia
20
. Loss of compliance in the cardia
20
can also pull the lower esophageal sphincter
18
open when the stomach
12
is distended, even absent sphincter muscle relaxation. The same undesired results occur: acidic stomach contents can surge upward into the esophagus
10
. Unlike the stomach, the esophagus has no natural protection against stomach acids. When the stomach contents make contact with the esophagus, heartburn or other disease symptoms, including damage to the esophagus, can occur.
Complications of GERD include esophageal erosion, esophageal ulcer, and esophageal stricture; replacement of normal esophageal epithelium with abnormal (Barrett's) epithelium; and pulmonary aspiration.
SUMMARY OF THE INVENTION
One aspect of the invention provides systems and methods for treating a targeted tissue region with a tissue heating element. The tissue heating element is incorporated in a carrier. The carrier is intended, in use, to be temporarily mounted to an exterior of an independent catheter body, such as an endoscope. The catheter body is deployed, with the carrier mounted on it, into the targeted tissue region. The tissue heating element is operated, e.g., to form one or more tissue lesions, after which the catheter body is retrieved from the targeted tissue region. The carrier can then be removed from the catheter body, allowing the catheter body to be subsequently used for another purpose.
In one embodiment, the systems and methods can be used to treat tissue regions along the gastrointestinal track, e.g., in and around the lower esophageal sphincter, to treat GERD and related dysfunctions.
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Gaiser John
Utley David S.
West Scott
Curon Medical, Inc.
Patel Vinod D
Pelham Joseph
Ryan Kromholz & Manion
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