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United States Patent  [,i] Patent Number: 4,739,758
Lai et al.  Date of Patent: Apr. 26, 1988
U.S. Patent Apr. 24 im sheet 1 of 2 4,739,758
 APPARATUS FOR STOMACH CAVITY REDUCTION
 Inventors: N. C. Joseph Lai, Brookfield; Wilfred Lynch, Racine, both of Wis.
 Assignee: Criticare Systems, Inc., Milwaukee, Wis.
 Appl. No.: 864,426
 Filed: May 19,1986
 Int. CI.* A61M 29/02
 U.S. a 128/303 R; 128/344
 Field of Search 128/303 R, 344;
 References Cited
U.S. PATENT DOCUMENTS
2,508,690 5/1950 Schmerl 604/265
3,155,097 11/1964 Barron 604/265
3,736,939 6/1973 Taylor 604/265
4,249,535 2/1981 Hargest 604/265 X
FOREIGN PATENT DOCUMENTS 3310234 9/1984 Fed. Rep. of Germany ... 128/303 R
Primary Examiner—Michael H. Thaler
Attorney, Agent, or Firm—Willian Brinks Olds Hofer
Gilson & Lione Ltd.
A method and apparatus for reducing the size of the stomach cavity in humans. A collapsed balloon is packaged in water soluble material and releasably attached to a filler tube. The balloon is inserted into the cavity through the mouth and esophagus and pumped up to a desired volume through the tube after water soluble material packaging has dissolved and the balloon deployed. After stomach fluids also dissolve the releasing mechanism, the filler tube is removed from the stomach. The balloon remains in the stomach for the required dieting time. Its volume prevents the usual ingestion of food into the stomach by obese patients, causing them to feel full, and reducing the desire for food. At the end of this period a puncturing mechanism is introduced into the stomach, punctures the balloon, grasps it and the balloon is removed through the esophagus and mouth.
3 Claims, 2 Drawing Sheets
U.S. Patent Apr. 26,1988 Sheet 2 of 2 4,739,758
APPARATUS FOR STOMACH CAVITY
FIELD OF THE INVENTION 5
This invention relates in general to the medical treatment of obesity in human beings. It relates particularly to treatment by reduction in size of the stomach cavity.
BACKGROUND OF THE INVENTION 10
Inducing weight reduction in human beings by effectively reducing the size of the stomach cavity is not a new procedure. It has been accomplished in various ways, with varying degrees of difficulty, and with varying results.
For example, "stapling" of the stomach walls together along a line which reduces stomach cavity size is a well known surgical approach to combatting obesity. Since it involves surgery there is an element of danger, 20 of course. It is also a relatively expensive procedure. Nevertheless, thousands of these operations are performed each year in the U.S. alone.
Another approach is disclosed in Berman et al. U.S. Pat. No. 4,133,315, issued Jan. 9, 1979, on a METHOD AND APPARATUS FOR REDUCING OBESITY. As described in this patent, stomach cavity size reduction is effected by inserting an inflatable bag or balloon into the patient's stomach through the esophagus, with an inflation tube extending out through the mouth. This 30 device remains in place, according to the inventors, and can be inflated or deflated over a period of days or weeks to vary stomach cavity size as desired. When suitable results are achieved, the bag is removed through the esophagus with the inflation tube. 35
An improvement on the method disclosed in the Berman et al patent has also been practiced by Doctors Ole Gyring Nieben and Henrik Harboe at the University of Copenhagen's Hvidovre Hospital. Their approach has been to inflate a rubber balloon in the patient's stomach 40 after inserting it in uniflated form through the esophagus. There the similarity to Berman et al. ends, however. The Nieben- Harboe method involves inflating the balloon with gas and then disconnecting the tube, withdrawing it from a valve on the balloon which closes 45 automatically when the tube is pulled out. The balloon stays inflated for 7 to 21 days. When it collapses it passes out of the digestive track and is excreted.
SUMMARY OF THE INVENTION 5Q
It is an object of the present invention to provide an improvement on the Nieben-Harboe method of reducing stomach cavity size.
It is another object to provide a new and improved balloon construction for use in stomach cavity reduc- 55 tion treatment.
It is still another object to provide a new and improved balloon and balloon insertion tube assembly for use in stomach cavity reduction treatment.
The foregoing and other objects are realized in accor- 60 dance with the present invention by providing a balloon which, when inflated, is generally spherical and measures approximately 2 \ to 3 inches in diameter. The balloon skin is fabricated of inert material, preferably a copolymer such as Ethylene-Vinyl Acetate (EVA). A 65 thin layer of silicone rubber may be bonded to the outer surface of the balloon to provide additional bio-compatibility with the patient.
The balloon has a substantial number of outwardly protruding blisters formed in it. These blisters provide an irregular periphery around the balloon which prevents the balloon from seating tightly against the cardia, or cardial orifice, and closing it. Similarly, the presence of these outwardly protruding blisters prevents the balloon from closing the stomach cavity opening, or the orifice into the duodenum.
The balloon is formed with an inverted inflation neck in an opening at what will be referred to as its top end. The inflation neck has a "duck-bill" valve extending inwardly from it, toward the center of the balloon. The neck is designed to receive and hold the flared tip of a filler tube. The valve functions as a check valve, permitting inflation of the balloon through the filler tube but preventing escape of gas from the balloon when the filler tube is removed.
The filler tube is a thirty inch section of thin, flexible, hollow tubing fabricated of DuPont Hytrel plastic or the like. The flared tip is formed at its lower end and a female Luer connection is mounted on its upper end.
With the filler tube tip seated in the inverted balloon neck a first thin strip of polyvinyl alcohol (PVA) plastic is moistened and wrapped snugly around the portion of the balloon surrounding the neck, the neck itself, and the flared filler tube tip. It seals the filler tube tip to the balloon.
A thin, plastic capillary tube longer than the filler tube is then inserted through it, from the Luer fitting end, into the collapsed balloon. This serves to permit any air still trapped in the collapsed balloon to escape as the balloon is packaged in the next operation.
At this point the balloon is rolled or folded tightly into a cigar-shaped package, axially aligned with the filler tube. After being moistened a second thin strip of PVA plastic is wrapped around the package, from one end to the other, to hold it in this tightly wrapped form. This second strip is also wrapped over the first strip of plastic. The capillary tube is removed.
In use, the PVA plastic strip wrapped package is inserted through a patient's mouth and esophagus into the stomach, the filler tube being used to effect insertion and, when the package has reached the stomach, still extending out of the patient's mouth. The PVA plastic is water soluble. Accordingly, the second strip begins to dissolve immediately upon being moistened in the patient's mouth. This causes the package to slide very easily into the stomach.
With the package in position in the patient's stomach, an air pump (syringe) or the like is seated in the Luer fitting. After two to five minutes the second strip of PVA plastic has been dissolved by moisture in the patient's stomach and the balloon is free to be deployed. Sensing when this occurs by applying pressure to the syring, the physician immediately inflates the balloon.
Meanwhile, the first strip of PVA plastic has begun to dissolve also. In another two to five minutes it has dissolved, releasing the filler tube tip. The filler tube can then be withdrawn from the patient. The inflated balloon remains in the patient's stomach.
In practice, the physician first X-rays the patient's stomach to determine the size balloon needed. The average inflated balloon size required would be 200 to 500 cubic centimeters.
After inroduction and inflation, the balloon might be left in place for 60 to several hundred days. The double wall material from which it is made will remain inflated indefinitely. When removal is desired, a flexible fiber