Surgery – Instruments – Electrical application
Reexamination Certificate
2002-02-27
2003-07-08
Peffley, Michael (Department: 3739)
Surgery
Instruments
Electrical application
C607S101000
Reexamination Certificate
active
06589238
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to an apparatus and method for the treatment of sphincters, and more specifically to an apparatus and method that treat esophageal sphincters.
2. Description of Related Art
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 D O; Johnston B T:
Gastroesophageal Reflux Disease: Current Strategies For Patient Management
. Arch Fam Med, 5(4):221-7; (1996 April)).
Acute symptoms of GERD include heartburn, pulmonary disorders and chest pain. 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. Severe esophageal ulcerations occur in 20-30% of patients over age 65. Moreover, GERD causes adenocarcinoma, or cancer of the esophagus, which is increasing in incidence faster than any other cancer (Reynolds J C:
Influence Of Pathophysiology, Severity, And Cost On The Medical Management Of Gastroesophageal Reflux Disease
. Am J Health Syst Pharm, 53(22 Suppl 3):S5-12 (Nov. 15, 1996)).
Current drug therapy for GERD includes histamine receptor blockers which reduce stomach acid secretion and other drugs which may completely block stomach acid. However, while pharmacologic agents may provide short term relief, they do not address the underlying cause of LES dysfunction.
Invasive procedures requiring percutaneous introduction of instrumentation into the abdomen exist for the surgical correction of GERD. One such procedure, Nissen fundoplication, involves constructing a new “valve” to support the LES by wrapping the gastric fundus around the lower esophagus. 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. In fact, a recent 10 year, 344 patient study reported the morbidity rate for this procedure to be 17% and mortality 1% (Urschel, J D:
Complications Of Antireflux Surgery
, Am J Surg 166(1): 68-70; (1993 July)). This rate of complication drives up both medical cost and convalescence period for the procedure and may exclude portions of certain patient populations (e.g., the elderly and immuno-compromised).
Efforts to perform Nissen fundoplication by less invasive techniques have resulted in the development of laparoscopic Nissen fundoplication. Laparoscopic Nissen fundoplication, reported by Dallemagne et al.
Surgical Laparoscopy and Endoscopy
, Vol. 1, No. 3, (1991), pp. 138-43 and by Hindler et al.
Surgical Laparoscopy and Endoscopy
, Vol.2, No. 3, (1992), pp. 265-272, involves essentially the same steps as Nissen fundoplication with the exception that surgical manipulation is performed through a plurality of surgical cannula introduced using trocars inserted at various positions in the abdomen.
Another attempt to perform fundoplication by a less invasive technique is reported in U.S. Pat. No. 5,088,979. In this procedure, an invagination device containing a plurality of needles is inserted transorally into the esophagus with the needles in a retracted position. The needles are extended to engage the esophagus and fold the attached esophagus beyond the gastroesophageal junction. A remotely operated stapling device, introduced percutaneously through an operating channel in the stomach wall, is actuated to fasten the invaginated gastroesophageal junction to the surrounding involuted stomach wall.
Yet another attempt to perform fundoplication by a less invasive technique is reported in U.S. Pat. No. 5,676,674. In this procedure, invagination is done by a jaw-like device and fastening of the invaginated gastroesophageal junction to the fundus of the stomach is done via a transoral approach using a remotely operated fastening device, eliminating the need for an abdominal incision. 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.
There is a need in the art for a less invasive GERD treatment apparatus that does not require major surgical intervention or require the introduction of foreign materials into the body. Yet another need exists for a method of treating GERD that does not involve the medical risks of leakage and infection developing at an artificially created gastroesophageal junction. Yet another need exists for an apparatus that treats GERD with minimum trauma to the LES.
SUMMARY OF THE INVENTION
Accordingly, an object of the invention is to provide an apparatus and method for the treatment of GERD.
Another object of the invention is to provide an apparatus and method to treat GERD using minimally invasive surgical methods such as non-percutaneously.
Yet another object of the invention is to provide an apparatus and method to treat the esophageal sphincters using minimally invasive surgical methods.
Another object of the invention is to provide an apparatus and method to tighten the LES.
A further other object of the invention is to provide an apparatus and method to reduce the frequency of spontaneous relaxation and opening of the LES.
Yet another object of the invention is to provide an apparatus and method to reduce the frequency and severity of gastroesophageal reflux events.
These and other objects of the invention are provided in an apparatus that includes a first expandable member that is expandable by an expansion medium. The first expandable member includes an exterior and a plurality of apertures. The expansion medium is released from the first expandable member when a sufficient pressure is applied to the expansion medium housed in an interior of the first expandable member. A second expandable member is positioned at least partially adjacent to the first expandable member. The second expandable member is configured to receive at least a portion of the expansion medium from the interior of the first expandable member. An electromagnetic energy delivery device is coupled to one of the first or second expandable members and is configured to be coupled to a power source. The first and second expandable members are sized to be expanded sufficiently to open a sphincter.
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pat
Edwards Stuart D
Utley David S
Curon Medical, Inc.
Peffley Michael
Ryan Kromholz & Manion S.C.
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