Surgery – Instruments – Sutureless closure
Reexamination Certificate
2000-09-29
2004-05-18
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S151000, C606S220000
Reexamination Certificate
active
06736828
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the art of fundoplicating the stomach to the esophagus. More specifically, the present invention relates to a method for performing such a fundoplication endoluminally, and to an apparatus for securing the fundus to the esophagus.
BACKGROUND OF THE INVENTION
Fundoplication is a surgical procedure which is typically used to treat Gastroesophageal Reflux (GER) condition, a malady often resulting from a deformity of the gastroesophageal junction (GEJ), and/or a dysfunctional lower esophageal sphincter (LES). One symptom commonly associated with GER is regurgitation or reflux of stomach contents into the esophagus. Fundoplication procedures are directed towards manipulating esophageal and gastric tissue so as to form a valve at the GEJ which limits reflux into the esophagus. The valve is formed by manipulation of the esophagus so as to invaginate the stomach, then wrapping the fundus of the stomach around the distal end of the esophagus and securing the stomach in that wrapped position.
The most commonly used fundoplication procedures require abdominal or thoracic incisions through which the abdominal wrapping and securing can be performed. Due to the highly invasive nature of such surgery, 2 complications and morbidity occur in a significant percentage of cases. In addition, these procedures are lengthy, often taking a number of hours to perform, and may leave disfiguring scars where the incisions were made.
Other recently developed fundoplication procedures somewhat limit the necessity of making large surgical incisions by utilizing laparoscopic ports or percutaneous endoscopic gastrostomy. (See, e.g. U.S. Pat. Nos. 5,403,326, and 5,088,979, the contents of which are hereby incorporated by reference). Although these procedures are less invasive than those involving large abdominal and thoracic incisions, they are invasive nonetheless, and have costs and risks associated with such invasive surgery. For example, general anaesthesia is typically used during these procedures which adds to the expense of these procedures and entails well known risks.
In addition to the complications, risks, and costs associated with the invasive nature of current fundoplication methods, these methods have other problems as well. One such problem is unwrapping of the fundus, also referred to as slippage of the fundal wrap. Slippage frequently occurs with current methods, as they fail to adequately secure the plicated fundus.
SUMMARY OF THE INVENTION
The present invention is directed to a method for endoluminal fundoplication in which a flexible endoscope is first used to locate an attachment site at the gastroesophageal junction. A tissue grasping device is then positioned at the distal end of the endoscope, and attached to the body tissue at the located attachment site. Next, a tissue displacement device is positioned at the distal end of the endoscope and used to displace the fundus of the stomach, so as to create an intussusception of the esophagus into the gastric lumen. A fastener delivery device is then positioned adjacent to a first desired fastener delivery location and used to place a first fastener through the tissue which forms the intussusception at the desired fastener delivery location. The first fastener secures a first portion of the gastric fundus to the esophagus. The fastener delivery device is then used to place additional fasteners at a plurality of additional desired fastener locations, thus securing the gastric fundus around the esophagus. In one exemplary embodiment, the fastener delivery device, the tissue grasping device, and the tissue displacement device can be incorporated into a single unit.
Finally, an injection device is positioned at the distal end of the endoscope and used to inject a bonding agent into the tissue which forms the intussusception. For example, the bonding agent can be an agent for fibrotic fixation or adhesion.
In one embodiment, the invention is a method for performing endoluminal fundoplication of a patient's esophagus and stomach, having the steps of forming an intussusception of the esophagus into the stomach by pulling a selected portion of the esophagus into the stomach, and by displacing a fundus portion of the stomach towards the esophagus, placing a fastener across the intussusception, said fastener maintaining an esophageal wall and a gastric wall forming the intussusception adjacent to one another, and injecting a bonding agent between the esophageal wall and a gastric wall to bond the intussusception.
In another embodiment, the invention is a device for performing endoluminal fundoplication of a patient's esophagus and stomach, comprising a flexible tube having a distal end adapted for insertion in the stomach through the esophagus, a tissue grasping device disposed at the distal end of the flexible tube, adapted to grasp a selected portion of the esophagus, a tissue displacement device disposed adjacent the tissue grasping device, adapted to move a fundus portion of the stomach towards the esophagus and an anvil portion, pivotable relative the tissue displacement portion, wherein the tissue displacement device and the anvil portion releasably carry complementary portions of a fastener, such that said complementary portions are joined when the fundus portion is moved towards the esophagus.
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Pentax Literature: Product Information.
Netter's Atlas of Human Anatomy, Plates 258 & 259.
Gastrointestinal Endoscopy, Copyright 1997, “A New Intraluminal Antigastroesophageal Reflux Procedure in Babons”.
Annals of Surgerty, vol. 220. No. 4, 472-483, 1994 J. B. Lippincott Company, Laparoscopic Nissen Fundoplication Is An Effective Treatment for Gastroesophageal Reflux Disease.
Adams Ronald D.
Pugsley, Jr. Charles H.
Baxter Jessica R
Finnegan Henderson Farabow Garrett & Dunner L.L.P.
Milano Michael J.
Sci-Med Life Systems, Inc.
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