Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2002-07-02
2004-08-10
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S157000
Reexamination Certificate
active
06773440
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical apparatus and methods and more particularly to devices and methods for dividing a hollow body organ or otherwise restricting or partitioning a certain section of that organ, particularly a stomach, intestine or gastrointestinal tract for purposes of reducing the volume of the hollow body organ. In addition, such tools and techniques may be used to exclude specified tissue sections within a hollow body organ either to reduce volume, or to exclude the portion of tissue that is clinically undesirable, such as in the case of gastroesophogeal reflux disease (GERD) or exclusion of certain sections of the stomach relating to the nuero hormonal pathways for hunger. These devices may be used alone or in conjunction with each other and may be permanently implanted, or removed once they have served their purpose, e.g., the desired tissue effect has occurred (healing), or the clinical benefit has been achieved, for example, the patient has lost the directed or desired amount of weight, or the patient is no longer experiencing reflux.
BACKGROUND OF THE INVENTION
In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to “tie off” or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
Typically, these stomach reduction procedures are performed surgically through an open incision and staples or sutures are applied externally to the stomach or hollow body organ. Such procedures can also be performed laparoscopically, through the use of smaller incisions, or ports, through trocars and other specialized devices. In the case of laparoscopic banding, an adjustable band is placed around the proximal section of the stomach reaching from the lesser curve (LC) of the stomach around to the greater curve (GC), thereby creating a constriction or “waist” in a vertical manner between the esophagus (ES) and the pylorus (PY) (See Prior Art FIG.
1
). During a VBG (See Prior Art
FIG. 2
) a small pouch (P) (approximately 20 cc in volume) is constructed by forming a vertical partition from the gastroesophageal junction (GEJ) to midway down the lesser curvature of the stomach by externally applying staples, and optionally dividing or resecting a portion of the stomach, followed by creation of a stoma (ST) at the outlet of the partition to prevent dilation of the outlet channel and restrict intake. In a Roux-En-Y gastric bypass (see Prior Art FIG.
3
), the stomach is surgically divided into a smaller upper pouch connected to the esophageal inflow, and a lower portion, detached from the upper pouch but still connected to the intestinal tract for purposes of secreting digestive juices. A resected portion of the small intestine is then anastomosed using an end-to-side anastomosis to the upper pouch, thereby bypassing the majority of the intestine and reducing absorption of caloric intake and causing rapid “dumping” of highly caloric or “junk foods”.
Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, general anesthesia, healing of the incisions and other complications attendant to major surgery. In addition, these procedures are only available to a small segment of the obese population (morbid obesity, Body Mass Index ≧40) due to their complications, leaving patients who are considered obese or moderately obese with few, if any, interventional options.
In addition to surgical procedures, certain tools exist for approximating or otherwise securing tissue such as the stapling devices used in the above-described surgical procedures and others such as in the treatment of gastroesophogeal reflux (GERD). These devices include the GIA® device (Gastrointestinal Anastomosis device manufactured by Ethicon Endosurgery, Inc. and a similar product by USSC), and certain clamping and stapling devices as described in U.S. Pat. Nos. 5,897,562 and 5,571,116 and 5,676,674, Non-Invasive Apparatus for Treatment of Gastroesophageal Reflux Disease (Bolanos, et al) and U.S. Pat. No. 5,403,326 Method for Performing a Gastric Wrap of the Esophagus for Use in the Treatment of Esophageal Reflux (Harrison et al) for methods and devices for fundoplication of the stomach to the esophagus for treatment of gastro esophageal reflux (GERD). In addition, certain tools as described in U.S. Pat. No. 5,788,715 Telescoping Serial Elastic Band Ligator (Watson et al), U.S. Pat. No. 5,947,983 Tissue Cutting and Stitching Device and Method (Solar et al) detail an endoscopic suturing device that is inserted through an endoscope and placed at the site where the esophagus and the stomach meet. Vacuum is then applied to acquire the adjacent tissue, and a series of stitches are placed to create a pleat in the sphincter to reduce the backflow of acid from the stomach up through the esophagus. These devices can also be used transorally for the endoscopic treatment of esophageal varices (dilated blood vessels within the wall of the esophagus).
Further, certain devices are employed to approximate tissue such as in bowel anastomosis, via traditional suturing or stapling, or employing tools such as the commercially available Valtrac (Devis & Geck Company) and the AKA 2 (see British Journal of Surgery, Vol 87, Iss 8, Page 1071, August 2000), which are circular clamping devices used to affect “compression anastomosis” (e.g. once sufficient clamping force is applied, tissue of the bowel heals together and the device is no longer essential to the joining of the tissue). See also U.S. Pat. No. 5,250,058 Absorbable Anastomotic Fastener Means (Miller et al) and U.S. Pat. No. 5,697,943 Apparatus and Method for Performing Compressional Anastomosis(Sauer et al) and PCT Publication No. WO 99/17662 Anastomosis Ring Insertion Device (Phillips et al).
There is a need for improved devices and procedures. In addition, because of the invasiveness of most of the surgeries used to treat obesity, and the limited success of others, there remains a need for improved devices and methods for more effective, less invasive hollow organ restriction procedures.
SUMMARY OF THE INVENTION
The present invention provides for improved methods and apparatus for the transoral, or endoscopic, division of a hollow body organ, such as the creation of a small stomach pouch. In the case of the present invention, the surgeon or endoscopist may insert devices as described below through the patient's mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient's stomach or other organ, and does not require any external incision. The end result of the procedure is the formation of a variety of organ divisions or plications that serve as barriers or “partitions” or “pouches” that are substantially sealed off from the majority of the organ cavity. For example, in the case of dividing the stomach, the “pouch” or partitions that are created may seal a small portion of the stomach just below the esophagus to allow only small amounts of food or liquid to be consumed by the patient. This pouch or partition will mimic the section of stomach sealed off from the majority of the organ in a traditional obesity surgery heretofore described; however, it can be formed and secured entirely from inside the stomach endoscopically, obviating the need for a prolonged procedure, external incisions, and in some cases, general
Gannoe Jamy
Gerbi Craig
Mata, Jr. Gilbert
Scott J. Stephen
Sutton Douglas S.
Milano Michael J.
Morrison & Foerster / LLP
Roberts Paul
Satiety, Inc.
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