Sapala-wood

Details Sapala-wood Sapala-wood

2002-09-06

2004-07-06

McDermott, Corrine (Department: 3738)

Surgery

Miscellaneous

Methods

C606S151000

Reexamination Certificate

active

06758219

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an improved surgical method for gastric bypass for treating obesity.
BACKGROUND OF THE INVENTION
Obesity is increasing in epidemic proportions world-wide. Even mild degrees of obesity have adverse health effects and are associated with diminished longevity. For this reason aggressive dietary intervention is recommended. Patients with body mass indices exceeding 40 have medically significant obesity in which the risk of serious health consequences is substantial, with concomitant significant reductions in life expectancy. For these patients, sustained weight loss rarely occurs with dietary intervention. For the appropriately selected patients, surgery, (bariatric surgery), is associated with sustained weight loss for seriously obese patients who uniformly fail nonsurgical treatment. Various operations have been proposed for the treatment of obesity, many of which proved to have serious complications precluding their efficacy. A National Institutes of Health Consensus Panel reviewed the indications and types of operations, concluding that the banded gastroplasty and gastric bypass were acceptable operations for treating seriously obese patients. Following weight loss there is a high cure rate for diabetes and sleep apnea, with significant improvement in other complications of obesity such as hypertension and osteoarthritis (Livingston,
Amer J Surg
, 2002; 292: 60-61).
Open gastric bypass surgery is a surgical procedure aiming to decrease the size of patient's stomach. It includes transecting the stomach and constructing a pouch from a portion of the stomach as well as connecting the pouch to the intestine (anastomosis) so that the digested food from the pouch moves into the small bowel (Sapala et al.,
Obes Surg
1998; 8: 253-261). Although, gastric bypass surgery helps patients to lose weight and relieves life-threatening diseases associated with extreme obesity, there are several major post-surgery complications which may require additional treatment. These complications include pouch enlargement, marginal ulceration and staple line separation (dehiscence) (Sapala et al.,
Obes Surg
1998; 8: 505-516).
Marginal ulcer (MU) is defined as a gastric ulcer of the jejunal mucosa near the site of a gastrojejunostomy (Dorland's
Medical Dictionary
1994). The incidence of marginal ulcers after Roux-en-Y gastric bypass varies between 1% and 16% (MacLean et al.,
J Am Coll Surg
1997; 185: 1-7; Printen et al,
Arch Surg
1980; 115: 525-527). Known factors that contribute to the development of MU are disruption of the gastric reservoir staple line, large gastric pouches, mucosal ischemia, and the presence of foreign bodies such as silk, Marlex™, or Gore-Tex™ (Sapala et al.,
Obes Surg
1998; 8: 505-516).
One of the most common causes of MU is the presence of a large gastric pouch (MacLean et aL,
J Am Coll Surg
1997; 185: 1-7; Printen et al.,
Arch Surg
1980; 115: 525-527). In the large gastric bypass pouches (>50 cc), oxynic cell concentration on both sides of the partitioned staple line may lead to MU. The parietal cell mass in the pouch may be large enough in the absence of vagotomy to produce acid-pepsin digestion of the jejunal mucosa. By the contrast, the size of the parietal cell mass below the gastric partition may be reduced, which results in loss of duodenal acidification and secretin stimulation. Unopposed G-cell production of gastrin leads to increased hydrochloric acid secretion by the gastric reservoir parietal cells and subsequent MU (Mason in
Major Problems in Clinical Surgery
, 1981: 1-60, Ebert P A, ed. Vol. XXVI, Philadelphia: W. B. Saunders).
In gastric bypass procedures with vagally innervated pouches <50 cc in volume, the critical size of the parietal cell mass necessary to produce MU is not known. Moreover, gastric pouches initially measured at 50 cc may become greatly enlarged over time. Chronic overeating in the presence of an unrestricted elastic fundus can change the original size of the pouch significantly. Therefore, many surgeons prefer to isolate the fundus from the pouch by limiting the pouch to the lesser curvature (MacLean et al.,
J Am Coll Surg
1997; 185: 1-7; Fox S R et al.,
Obes Surg
1996; 6: 421-425; Sapala J A et al.,
Obes Surg
1997; 7: 207-210). Unfortunately, oxynic cell mass is concentrated along the proximal magenstrasse, which explains why MU in lesser-curvature pouches appears to be more common than in greater-curvature pouches (Sapala et al.,
Surg Gynecol Obstet
1984; 158: 178-180).
Given the benefits of gastric bypass surgery to morbidly obese patients, there is need in the field for improvement of the procedure in order to minimize complications specified above. The present invention is an improved gastric bypass method that helps to avoid common post-operational complications associated with classic gastric bypass.
SUMMARY OF THE INVENTION
The present invention relates to an improved method for gastric bypass surgery which aids in reducing the incidence of common side effects associated with other bariatric surgical methods. Briefly, the method comprises incising the abdominal cavity of the patient, mobilizing the gastrocolic omentum from the watershed to the angle of His and incising the left phrenoesophageal ligament to expose the junction of the longitudinal muscle fibers of the esophagus with the serosa of the cardia. Once the junction is identified, a window is opened along the lesser curvature of the stomach through the gastrohepatic ligament just proximal to the coronary vein. The proximal jejunum is then divided and the Roux-en-Y limb of jejunum (Sapala et al.,
Obes Surg
1998; 8: 505-516) is delivered through an opening in the transverse mesocolon. The proximal end of the stomach is then transected at the junction of the cardia and the fundus. The cardia of the stomach is then used to construct a micropouch. A retrocolic side-to-side Roux-en-Y cardiojejunostomy along greater curvature of the stomach is then performed. The proximal fundus of the cardia is then incorporated into the stoma of the anastomosis which is about 10 mm to about 12 mm in diameter. The gastrotomy and jejunotomy incisions are then closed with interrupted serosal sutures without inverting the staple line at the apex of the micropouch. Fibrin glue (e.g., Hemaseel™) is then applied over the closure. The biliopancreatic limb is then connected to a common conduit consisting of both distal jejunum and the entire ileum. The connection is a stapled anastomosis with a 2.5-cm lumen. The anastomosis is sutured and no glue is applied over the closure.


REFERENCES:
patent: 4315509 (1982-02-01), Smit
patent: 5226429 (1993-07-01), Kuzmak
Fox SR, Oh KH, Fox K. Vertical banded gastroplasty and distal bypass as primary procedures: a comparison. Obes Surg 1996; 6: 421-425.
Livingston EH. Obesity and its Surgical management. The American Journal of Surgery 2002; 184: 103-113.
MacLean LD, Rhode BM, Nohr C, et al. Stomal ulcer after gastric bypass. J Am Coll Surg 1997; 185: 1-7.
Mason EE. Development of operations for obesity. Surgical treatment of obesity. Major problems in clinical surgery, Ebert PA, ed. vol. XXVI. Philadelphia: W.B. Saunders, 1981:1-60.
Printen KJ, Scott D, Mason EE. Stomal ulcers after gastric bypass. arch Surg 1980; 115: 525-527.
Sapala MA, Sapala JA, and Hurtado M. Technique for the anatomic placement of the Angelchik anti-reflux prosthesis. Surg Gynecol Obstet 1984; 158: 178-180.
Sapala JA, Brown TE, Sapala MA. Anatomic closure of midline incision of the upper part of the abdomen. Surg Gynecol Obstet 1986; 153: 179-180.
Sapala MA, Sapala JA, Resto Soto AD, et al. Gastric bypass in patients weighing more than 500 pounds: Technical innovations for the “ultra-obese.” Obes Surg 1992; 2:253-261.
Sapala JA, Sapala MA, and Wood MH. Nealry total gastric bypass for morbid obesity: a preliminary report in 173 patients. Obes Surg 1996; 6: 126-129.
Sapala JA, Wood MH, Sapala MA, et al. Stapler division of the omentum and the small bowel mesentery in morbidly obese patients undergoing

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