Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2000-09-05
2004-08-10
Woo, Julian W. (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S220000, C128S898000
Reexamination Certificate
active
06773441
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to endoscopic methods and devices for reconfiguring tissue within a hollow body organ and more particularly to such methods and apparatus used to reduce the reflux of contents of one hollow organ into another hollow organ.
BACKGROUND OF THE INVENTION
Gastroesophageal reflux disease (GERD) is a common upper-gastrointestinal disorder with a prevalence of approximately 5 percent in the Western world. GERD is a condition in which acidic contents of the stomach flow inappropriately from the stomach into the esophagus. GERD causes heartburn when accompanied by irritation of the esophagus. Chronic irritation of the esophagus leads to inflammation of the esophagus, known as esophagitis. In addition to esophagitis, complications of GERD include Barrett's esophagus, esophageal stricture, intractable vomiting, asthma, chronic bronchitis, and aspiration pneumonia. Approximately 25 percent of individuals with GERD fail pharmacological therapy and become candidates for a surgical anti-reflux procedure. The estimated total direct and indirect costs of GERD treatment in the United States are in excess of 100 billion dollars annually.
The focus of attention in understanding the pathophysiology of GERD has for many years been the lower esophageal sphincter (LES), thought to be a ring of smooth muscle located at the gastroesophageal junction (GEJ) near where the lower esophagus communicates with the entrance to the stomach. Normally the LES allows food to pass from the esophagus to the stomach, while otherwise remaining closed, thus preventing reflux. Closure of the LES is an active process, requiring a combination of proper mechanics and intact innervation. Additionally, the diaphragm may act on the esophagus normally to keep it closed at the LES.
Backflow of gastric contents into the esophagus results when gastric pressure is sufficient to overcome the pressure gradient that normally exists at the GEJ or when gravity acting on the contents is sufficient to cause flow through the GEJ. This situation arises when the gastric pressure is elevated or when the competence of the LES is compromised. Gastric pressure is elevated in association with eating, bending at the waist or squatting, constriction of the waist by clothing, obesity, pregnancy, partial or complete bowel obstruction, etc. Gravitational effects occur when a patient with this condition becomes recumbent. Incompetence of the LES can be functional or anatomic in origin. Functional incompetence is associated with hiatus hernia, denervation, myopathy, scleroderma, and chemical or pharmacological influences (smoking, smooth muscle relaxants, caffeine, fatty foods, and peppermint). Dodds W J et al. 1982,
N Engl J Med
307:1547-52. Anatomic incompetence is associated with congenital malformation, surgical disruption (myotomy, balloon dilatation or bouginage), neoplasm, etc.
Recently, the existence and importance of the gastroesophageal flap valve have come to be appreciated as a significant first line of defense against GERD. Hill L D et al. 1996,
Gastrointest Endosc
44:541-7; Contractor QQ et al. 1999,
J Clin Gasroenterol
28:233-7. The gastroesophageal flap valve appears as a semicircular musculo-mucosal fold extending for 3-4 cm along the lesser curvature of the stomach.
The recent advent of a range of new medications for the treatment of reflux disease, including omeprazole and other proton pump inhibitors, high-dose histamine-2 antagonists, and cisapride, has markedly improved the treatment for many patients. Despite these dramatic advances in medical therapy for GERD, they are not always fully satisfactory. There are cost implications of very long-term treatment of patients with these relatively expensive medications (Spechler S J 1992,
N Engl J Med
326:786-92) as well as some concern about the safety of very long-term potent acid suppression with the possibility of gastrin (G) cell hyperplasia (Solcia E et al. 1993,
Aliment Pharmacol Ther
7(supp. 1):25-8; Poynter D et al. 1985,
Gut
26:1284-95; Lambert R et al. 1993,
Gastroenterology
104:1554-7) from prolonged hypergastrinemia. Furthermore, a significant number of patients are resistant to or intolerant of available medical therapy (Klinkenberg-Knol E C and Meuwissen S G 1988
Aliment Pharmacol Ther
2:221-7; Klinkenberg-Knol E C and Meuwissen S G 1989,
Digestion
1:47-53), and many patients relapse quickly if medical treatment is stopped. Hetzel D J et al. 1988,
Gastroenterology
95:903-12.
Although several open surgical procedures are effective in the treatment of GERD, they are now used in a minority of patients because of the major nature of the surgery and the occasionally poor results achieved. These occasionally poor results may be due in part to the lack of clear patient selection criteria. At least ten different open antireflux operations have been described and used in patients. Jamieson G G, ed. 1988,
Surgery of the Oesophagus
London: Churchill Livingstone, 233-45. The principal types of operations have included some type of reconstruction of the antireflux barrier, which may include a gastric wrap, as in classic Nissen fundoplication (Nissen R 1956,
Schweiz Med Wochenschr
86:590-2; Polk H C et al. 1971,
Ann Surg
173:775-81; DeMeester T R et al. 1986,
Ann Surg
204:9-20), Toupet fundoplication (Thor K 1988, The modified Toupet procedure, In: Hill L et al.,
The Esophagus, Medical and Surgical Management,
W B Saunders Co., pp 135-8) or Belsey repair (Skinner D B et al. 1967,
J Thorac Cardiovasc Surg
53:33-54), a nongastric wrap, e.g., the Angelchik prosthesis (Starling J R et al. 1982,
Ann Surg
195:686-91), a ligamentum teres cardiopexy (Rampal M et al. 1967,
Presse Medicale
75:617-9; Pedinielli L et al. 1964,
Ann Chir
18:1461-74; Janssen I M et al. 1993,
Br J Surg
80:875-8), and fixation of a part of the stomach to an immobile structure, e.g., the preaortic fascia, as in the Hill repair (Hill L D 1967,
Ann Surg
166:681-92) or the anterior rectus sheath (as in an anterior gastropexy). Boerma J 1969,
Surgery
65:884-9. Several of these operations also include a crural repair of the esophageal hiatus in the diaphragm. In the 1950s, Collis popularized gastroplasty as an alternative operation for gastroesophageal reflux, especially for those patients with a short esophagus. Collis J L 1957,
J Thoracic Surg
34:768-78. He created a gastric tube (neoesophagus) in continuity with the shortened esophagus, which effectively increased the total and intra-abdominal length of the esophagus and resulted in clinical improvement in patients with GERD. Collis J L 1968,
Am J Surg
115:465-71.
With the development of minimally invasive surgical techniques, especially laparoscopic cholecystectomy in the early 1990s, a few of the open surgical antireflux operations were developed and modified for use with laparoscopy. The laparoscopic Nissen fundoplication is currently the most widely used laparoscopic antireflux operation. Jamieson G G et al. 1994,
Ann Surg
220:137-45. Other laparoscopic antireflux operations, for example the laparoscopic Hill repair (Kraemer S J et al. 1994,
Gastrointest Endosc
40:155-9), ligamentum teres cardiopexy (Nathanson L K et al. 1991,
Br J Surg
78:947-51), and some modified operations with partial wraps (Cuschieri A et al. 1993,
Surg Endosc
7:505-10; McKernan J B 1994,
Surg Endosc
8:851-6) have also been reported. These laparoscopic antireflux operations appear to produce good results with relatively short, pain-free postoperative recovery times in most patients. Falk G L et al. 1992,
Aust N Z J Surg
62:969-72. However, laparoscopic operations themselves remain lengthy, technically demanding procedures requiring general anesthesia, best reserved for a small subset of patients with severe symptoms refractory to proton pump inhibitor or other medical treatments for GERD.
Attempts at laparoscopic transgastric antireflux surgery in animals have also been reported. Jennings et al. developed a method of forming a gastric fundoplication by creating an esophageal int
Cerier Jeffrey C.
Cruz Amos G.
Laufer Michael D.
ndo Surgical, Inc.
Woo Julian W.
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