Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2002-05-17
2004-09-14
Pantuck, Bradford C (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S142000
Reexamination Certificate
active
06790214
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to a device, assembly, system, and method for treating gastroesophageal reflux disease by restoring the gastroesophageal flap valve. The present invention more particularly relates to restoring the gastroesophageal flap valve by drawing gastric tissue into a shape approximating a normal gastroesophageal flap and fixing the tissue into that shape.
BACKGROUND
Gastroesophageal reflux disease (GERD) is a chronic condition caused by the failure of the anti-reflux barrier located at the gastroesophageal junction to keep the contents of the stomach from splashing into the esophagus. The splashing is known as gastroesophageal reflux. The stomach acid is designed to digest meat, and will digest esophageal tissue when persistently splashed into the esophagus.
FIG. 1
is a front cross-sectional view of the esophageal-gastro-intestinal tract
40
from a lower portion of the esophagus
41
to the duodenum
42
. The stomach
43
is characterized by the greater curvature
44
on the anatomical left side and the lesser curvature
45
on the anatomical right side. The fundus
46
of the greater curvature
44
forms the superior portion of the stomach
43
, and traps gas and air bubbles for burping. The esophageal tract
41
enters the stomach
43
at a point below the superior portion of the fundus
46
, forming a cardiac notch
47
and an acute angle with respect to the fundus
46
known as the Angle of His
57
. The lower esophageal sphincter (LES)
48
is a discriminating sphincter able to distinguish between burping gas, liquids, and solids, and works in conjunction with the fundus
46
to burp. The gastroesophageal flap valve (GEFV)
49
includes a moveable portion and an opposing more stationary portion. The moveable portion of the GEFV
49
is an approximately 180 degree, semicircular, gastroesophageal flap
50
(alternatively referred to as a “normal moveable flap” or “moveable flap”) formed of tissue at the intersection between the esophagus
41
and the stomach
43
. The opposing more stationary portion of the GEFV
49
comprises a portion of the lesser curvature
45
of the stomach
43
adjacent to its junction with the esophagus
41
. The gastroesophageal flap
50
of the GEFV
49
principally comprises tissue adjacent to the fundus
46
portion of the stomach
43
, is about 4 to 5 cm long (
51
) at it longest portion, and the length may taper at its anterior and posterior ends. The gastroesophageal flap
50
is partially held against the lesser curvature
45
portion of the stomach
43
by the pressure differential between the stomach
43
and the thorax, and partially by the resiliency and the anatomical structure of the GEFV
49
, thus providing the valving function. The GEFV
49
is similar to a flutter valve, with the gastroesophageal flap
50
being flexible and closeable against the other more stationary side.
The esophageal tract is controlled by an upper esophageal sphincter (UES) near the mouth for swallowing, and by the LES
48
and the GEFV
49
at the stomach. The normal antireflux barrier is primarily formed by the LES
48
and the GEFV
49
acting in concert to allow food and liquid to enter the stomach, and to considerably resist reflux of stomach contents into the esophagus
48
past the gastroesophageal tissue junction
52
. Tissue aboral of the gastroesophageal tissue junction
52
is generally considered part of the stomach because the tissue protected from stomach acid by its own protective mechanisms. Tissue oral of the gastroesophageal junction
52
is generally considered part of the esophagus and it is not protected from injury by prolonged exposure to stomach acid. At the gastroesophageal junction
52
, the juncture of the stomach and esophageal tissues form a zigzag line, which is sometimes referred to as the “Z-line.” For the purposes of these specifications, including the claims, “stomach” means the tissue aboral of the gastroesophageal junction
52
. As pressure in the stomach
43
increases, the pressure tightly closes the normal gastroesophageal flap
50
of the GEFV
49
against the lesser curve portion
45
of the stomach. The tissues are tightly opposed preventing reflux. The stomach
43
provides for burping by the diaphragm
53
pushing down on and flattening the fundus
46
, temporarily resulting in the cardiac notch
47
being straightened and the Angle of His
57
becoming less acute. The normal gastroesophageal flap
50
of the GEFV
49
opens to allow the burp to pass into the esophagus
41
.
FIG. 2
is a front cross-sectional view of the esophageal-gastro-intestinal tract
40
illustrating a Grade I normal appearance movable flap
50
of the GEFV
49
and a Grade IV reflux appearance gastroesophageal flap
55
of the GEFV
49
. A principal reason for regurgitation associated with GERD is the mechanical failure of the deteriorated (or reflux appearance) gastroesophageal flap
55
of the GEFV
49
to close and seal against the high pressure in the stomach. Due to reasons including lifestyle, a Grade I normal gastroesophageal flap
50
of the GEFV
49
may deteriorate into a Grade IV deteriorated (or reflux appearance) gastroesophageal flap
55
. The anatomical results of the deterioration include moving a portion of the esophagus
41
that includes the gastroesophageal junction
52
and LES
48
toward the mouth, straightening of the cardiac notch
47
, and increasing the Angle of His
57
. This effectively reshapes the anatomy aboral of the gastroesophageal junction
52
and forms a flattened fundus
56
. The deteriorated gastroesophageal flap
55
illustrates a gastroesophageal flap valve
49
and cardiac notch
47
that have both significantly degraded. Dr. Hill and colleagues developed a grading system to describe the appearance of the GEFV and the likelihood that a patient will experience chronic acid reflux. L. D. Hill, et al.,
The gastroesophageal flap valve: in vitro and in vivo observations
, Gastrointestinal Endoscopy 1996:44:541-547. Under Dr. Hill's grading system, the normal movable flap
50
of the GEFV
49
illustrates a Grade I flap valve that is the least likely to experience reflux. The deteriorated gastroesophageal flap
55
of the GEFV
49
illustrates a Grade IV flap valve that is the most likely to experience reflux. Grades II and III reflect intermediate grades of the likelihood of experiencing reflux. In the Grade IV condition with the deteriorated GEFV represented by deteriorated gastroesophageal flap
55
and the fundus
46
moved inferior, the stomach contents are presented a funnel-like opening directing the contents into the esophagus
41
.
With the deteriorated gastroesophageal flap
55
, the stomach contents are more likely to be regurgitated into the esophagus
41
, the mouth, and even the lungs. The LES
48
by itself is relatively weak and does not provide sufficient resistance to prevent reflux or regurgitation by itself. The regurgitation is referred to as “heartburn” because the most common symptom is a burning discomfort in the chest under the breastbone. Burning discomfort in the chest and regurgitation (burping up) of sour-tasting gastric juice into the mouth are classic symptoms of gastroesophageal reflux disease (GERD). When stomach acid is regurgitated into the esophagus, it is usually cleared quickly by esophageal contractions. Heartburn (backwashing of stomach acid and bile onto the esophagus
41
) results when stomach acid is frequently regurgitated into the esophagus
41
, or if it is not promptly cleared. Chronic heartburn or GERD occurs because of a mechanical failure by the deteriorated gastroesophageal flap
55
of the GEFV
49
and the LES
48
to keep stomach acid and digestive juices out of the esophagus
41
. The GEFV
49
and LES
48
fail to maintain the normally higher pressure in the stomach
43
and keep stomach contents out of the esophagus
41
. People with a normal movable flap
50
may experience occasional transient GEFV
49
and LES
48
relaxations that lead to backwashing of stomach contents onto the esoph
Adams John M.
Kraemer Stefan J. M.
Vincent Stephen T.
EsophyX, Inc.
Graybeal Jackson Haley LLP
Pantuck Bradford C
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