Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
2000-02-18
2002-07-30
Gibson, Roy D. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C607S105000, C607S113000
Reexamination Certificate
active
06427089
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to an apparatus and method for the treatment of the stomach. More specifically, the invention relates to an apparatus and method to reduce the distensibility and/or volume of the stomach to treat obesity and other eating disorder related conditions.
2. Description of Related Art
Currently, a large segment of the American population suffers from eating disorders which can cause obesity, bulimia and anorexia leading to a number of disease states both physical and psychological. Since the advent of processed foods with designer taste addition, obesity has become prevalent in every geographic area of the United States. The snack food slogan, “you cannot eat just one” has become a reality. Modification of excessive dietary intake is a multibillion-dollar industry.
There are many severe health consequences of obesity including heart disease, stroke and diabetes all of which can result in death, morbidity and/or significant quality of life issues. Related health conditions include gastroesophageal reflux (GERD) which is caused from regurgitation of gastric contents into the esophagus is aggravated by excessive food intake typical of compulsive eating and other eating disorders associated with the obese patient. 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. 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.
Current medical management has not been able to successfully intervene to significantly reduce the incidence of obesity within the U.S. For example, pharmacological modification with diet suppressants has been associated with significant metabolic side effects. Various attempts to reduce the volume of the stomach through surgical intervention or indwelling devices have had limited effectiveness with significant drawbacks. For example, in the morbidly obese, surgical intervention with gastric stapling, gastric banding and ileo-jejunal bypass has been abandoned because of the severe short-term surgical complications and the long-term side effects of surgically induced malabsorption and/or the potential for gastric obstruction. Other attempts to reduce the volume of the stomach through the use of indwelling gastric balloons have had only limited effectiveness in combatting the dietary rages of these patients. Such devices are prone to failure due to the extremely corrosive /acidic environment of the stomach. Once placed, they can not be readily modified or adjusted to meet the changing eating patterns and dietary needs of the patient. Also, they fail to address the significant problem of injurious contact with the gastric mucosa that can result from leaving an inflated bag in the stomach for an extended period of time. Moreover, these devices and approaches present the potentially fatal risks of gastric obstruction and infection from the indwelling device. Finally, due to combination of one or more of gastric wall contact, gastric obstruction and bacterial infection, such devices present a significant risk of causing gastric ulcers.
The present therapies for GERD include pharmacological, surgical and minimally invasive treatment. Despite marginal success, all have clinical limitations and none adequately treat the disease or address the patient's need to reduce ingested food. 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 drugs may provide short-term relief, they do not address the underlying cause of LES dysfunction. They also present the disadvantage of adverse side affects as well as requiring the patient to remain on long term drug therapy which is often cost prohibitive. Surgically 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. A 10-year study reported the morbidity rate for this procedure to be 17% and mortality 1%. This rate of complication drives up both the medical cost and convalescence period for the procedure and excludes significant portions of certain patient populations (e.g., the elderly and immuno-compromised).
Efforts to perform Nissen fundoplication and related sphincteroplasty procedures by less invasive techniques have resulted in the development of laparoscopic Nissen fundoplication and related laparoscopic procedures. Other attempts to perform fundoplication involve fastening of the invaginated gastroesophageal junction to the fundus of the stomach 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 the LES and the risk of leaks developing at the newly created gastroesophageal junction. Other noninvasive procedures for tightening the LES still do not solve the fundamental problem of reducing the patient's ability to overeat and cause an overproduction of stomach acid which results in acid reflux. It is predicted that such a reduction can ameliorate gastroesophageal reflux without direct modification of the sphincter and the resulting complications.
In order to more fully appreciate the issue involved in the treatment of obesity and the diagnosis and treatment of obesity-related conditions a description of the anatomy of the stomach and adjoining structures will now be presented. Referring to
FIGS. 1A and 1B
, the anatomy of the stomach can be divided into different segments on the basis of the mucosal cell types in relation to external anatomical boundaries. The cardiac segment is immediately subjacent to the gastroesophageal junction and is a transition zone of the esophageal squamous epithelium into the gastric mucosa. The fundus is the portion of the stomach that extends above the gastroesophageal junction. The body or corpus of the stomach extends from the fundus to the incisura angularis on the lesser curvature of the stomach. The majority of parietal acid forming cells are present in this segment. The fundus and the corpus function as the main reservoir of ingested food. The antrum extends from the lower border of the corpus to the pyloric sphincter. The majority of gastrin producing or G-cells are present in the antral mucosa. The main blood supply is variable but typically courses from the celiac axis into the gastric and gastroepiploic arcades. Nutrient vessels to the stomach coarse from the vascular arcades of the greater and lesser curvatures. These vessels penetrate the gastric wall in a perpendicular fashion and arborize horizontally in
Davis Paul
Gibson Roy D.
Heller Ehrman White & McAuliffe
LandOfFree
Stomach treatment apparatus and method does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Stomach treatment apparatus and method, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Stomach treatment apparatus and method will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2853104