Weight loss abstract
The intra-gastric weight loss system apparatus and method of the
present invention includes an intra-gastric elastomeric rubber balloon
with self-sealing fill valve, to be placed and retrieved without
surgery. As a benign space-occupying device, it will decrease gastric
capacity to the point that saiety (the feeling of fullness) will
occur after very little food has been consumed. Thus, the advantages
of gastric and intestinal by-pass surgery will be realized, without
surgery and the many resulting complications thereof. The elastomeric
balloon is inflated with a liquid, preferably a saline solution
containing an X-ray contrast media. The balloon is placed in a person's
stomach by passing a naso-gastric tube through the mouth. The N-G
tube has a previously placed nylon pull string through the lumen
and back up the exterior. After this, a metal stylette is run down
the lumen to very near the end of the N-G tube. The rolled up balloon
with fill tube attached is inserted into a rubber finger cot attached
to the pull string. By pulling the string the balloon containing
finger cot is drawn down into the stomach. After placement in the
stomach the stylette is removed and the balloon is inflated with
liquid. Inflation causes the rubber finger cot to roll up and remove
itself. Then the fill tube is withdrawn and the pull string with
the finger cot attached is withdrawn. The balloon is now free-floating
in the person's stomach without any tube attached. Regular check-ups,
administration of food supplements, etc., follow thereafter. When
the desired weight loss has been achieved the balloon can be easily
deflated, and passed in normal fashion, or removed by use of a gastroscope
and snaring of an attached withdrawal loop on the balloon.
Weight loss claims
What is claimed is:
1. Apparatus for use in achieving a loss of weight in an overweight
an inflatable device;
means for placing said device within the stomach of the person
additional means for inflating said device with liquid after it
has been placed in the person's stomach;
further means for allowing both said placing means and said inflating
means to be completely removed from the person so as to leave the
inflated device floating in the person's stomach; and said further
a pull string having a rollable finger cot attached at one end,
and a releasable, self-closing fill valve as part of the inflatable
2. Apparatus as set forth in claim 1, wherein said releasable,
self-closing fill valve receives one end of a flexible fill tube
prior to the device being rolled up and associated with the extended
finger cot for placing of the inflatable device in the person's
stomach, said fill tube being connected to liquid supply means so
that the inflatable device can be inflated with liquid after it
has been placed in the person's stomach, and such inflation in turn
effecting rolling up and disengagement of said finger cot from the
3. The method of placing a gastric cavity filling device within
an obese person's gastric cavity without any surgery, comprising
the steps of:
providing an inflatable device in deflated form;
attaching a fill tube to the inflatable device;
inserting a hollow tube containing a string therethrough into the
person's mouth, esophagus and gastric cavity;
releasably attaching the deflated device with fill tube attached
to one end of the string;
pulling the other end of the string to pull the deflated device
into the person's gastric cavity;
inflating the deflated device through the fill tube and after suitable
inflation of the device;
removing all the placing apparatus so that the inflated device
remains free-floating in the person's gastric cavity without any
4. The method of claim 3, with the further steps of:
inserting a stiffener member into the hollow tube containing the
string therethrough prior to the step of pulling the string.
5. The method of claim 4, with the additional step of using liquid
containing an X-ray opaque substance therein for inflating the device.
Weight loss description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to devices for effecting loss
of weight in grossly obese human beings. These persons have generally
been unable to lose weight by usual, conventional methods, thus
requiring that more structured and stringent methods be used.
2. Description of the Prior Art
A common problem with known devices and methods for weight loss
of the conventional type is that in most cases they depend upon
the will power of the patient (obese person) to achieve the desired
results. Many people do not have the necessary strong will to succeed,
and therefore failure is the end result.
There have been balloon type devices devised to fit in a person's
stomach to create a sensation of "fullness", but often
times these are far from effective. Similarly, other type structures
for reducing the obese person's stomach volume leave much to be
desired. Many require surgical procedures, which always involve
Existing prior patents which may be pertinent to this invention
are as follows: Moreau et al U.S. Pat. No. 3,046,988, July 31, 1962,
Berman et al U.S. Pat. No. 4,133,315, Jan. 9, 1979.
U.S. Pat. No. 3,046,988 differs from the present invention because
first, the esophageal nasogastric tube is intended to control bleeding
from the esophageal varices and not to cause weight loss. Secondly,
the esophageal nasogastric tube remains indwelling through the esophagus,
nasopharnyx and nose of the patient during the entire time of use.
In contrast thereto, the intra-gastric balloon of the present invention
is designed to be filled, and then the fill tube is removed, leaving
the balloon free-floating in the gastric cavity. Thirdly, the esophageal
nasogastric tube of the Moreau et al patent has balloons in the
esophagus and in the fundus only of the stomach. The intra-gastric
portion of the balloon is small and was never intended to fill the
entire gastric volume. While the intra-gastric weight loss system
balloon of the present invention occupies the majority of the cavity
inside the stomach and conforms to the shape of the stomach. Lastly,
patients with an esophageal nasogastric tube in place are unable
to take any nourishment by mouth. Patients with the balloon of the
present invention are able to eat and drink as before, however,
the feeling of fullness occurs after just a small amount of food
has been consumed thus, reducing the desire to continue eating by
The differences between the method and apparatus for reducing obesity
of patient U.S. Pat. No. 4,133,315 and the intra-gastric balloon
weight loss system of the present invention are: The Berman apparatus
is an intra-gastric balloon intended to promote weight loss. However,
the balloon remains attached to its fill tube which remains indwelling
in the esophagus and out through the nasal passage while in use.
This, of course, is quite inconvenient for the patient. The present
invention has a removable fill tube, thus leaving the filled balloon
free-floating in the gastric cavity. For other than short term use,
the Berman apparatus must have the fill tube brought out through
a gastrostomy operation (cutting a hole in both the stomach and
the abdominal wall). The present invention is intended to be used
without surgery of any type. Furthermore, the Berman apparatus is
pushed down the esophagus, whereas, the apparatus of the present
invention is pulled down the esophagus by a pull-string attached
to a standard small nasogastric tube, affording a significant margin
Another known device uses a stomach compression balloon which is
designed to produce weight loss, however, the balloon is placed
surgically inside the abdominal peritoneal cavity and outside the
gastric (stomach) cavity with a fill tube penetrating the abdominal
wall ending in a reservoir buried in the subcutaneous location.
This balloon is extragastric and the balloon of the present invention
is intra-gastric. Of course, the balloon of this extragastric system
requires major surgery for instillation. The balloon and method
of the present invention avoids all surgery.
Applicant is aware of still another weight loss system which uses
air to inflate a balloon in the patient's stomach. However, when
air is used the balloon deflates fairly quickly, usually within
a week or so. And, of course, this system can be very dangerous
for anyone travelling to a higher altitude after the initial inflation
of the balloon.
None of the known prior art devices offers the new and novel features
of the present invention.
SUMMARY OF THE INVENTION
An object of the present invention is to provide an apparatus and
method for reducing weight in obese humans without any substantial
risk because of surgery, and a system which is relatively easy and
convenient to use.
Another object of the present invention is to provide an easily
installed device for creating the sensation of fullness in an obese
patient after only a small amount of food has been eaten in the
normal manner. Thus, making it easy for the patient to adhere to
a rigid diet, and substantially reduces total food intake.
A further object of this invention is to provide a balloon-type
device which can be easily and with a high degree of safety used
with an obese person to assist in weight loss thereof.
A still further important object of the present invention is to
provide a system of weight loss which is flexible in that it can
be used with a conventional type of diet, and thus will help a patient
lose weight in a more normal manner than other known type systems.
Another object of the present invention is to provide a balloon
type weight loss device which can be placed in a person's stomach
through the mouth and esophagus without great discomfort, or risk,
and furthermore the structure used to properly place the balloon
is entirely removed once the balloon is properly installed so that
the balloon alone remains in the stomach.
The present invention has a number of new and novel features. A
gastric shaped balloon is placed in the stomach of an obese person
desiring to lose weight by a convenient and risk-free structure
and method. This method of placing the balloon, the balloon structure
itself, and the apparatus used for properly placing the balloon
in a person's stomach are all included in the present invention.
Also the method of balloon removal at the end of the overall diet
system process is believed to be new and unique.
The intra-gastric balloon weight loss system of the present invention
includes an intra-gastric elastomeric rubber balloon with self-sealing
fill valve, intended to be placed and retrieved without surgery.
As a benign space-occupying device, the balloon will decrease gastric
capacity to the point that saity (the feeling of fullness) will
occur after very little food has been consumed. Most of the advantages
of gastric and intestinal by-pass surgery as now practiced for morbid
obesity (more than 100 pounds overweight) will be realized, without
surgery. And, thus all of the many complications of surgery will
The main device of the present apparatus is an elastomeric balloon
which is gastric shaped. It is inflated with a liquid, such as saline
and X-ray contrast media.
Because after installation of the present device, total food consumption
will be markedly reduced, protein, vitamins and mineral supplements
should be taken daily and progress should be monitored by a physician
weekly. Periodic X-rays can confirm proper presence and position
of the balloon in the patient. Habit re-training instruction is
preferably given the patient by a tape recorded instructional course
which can be listed to while pedaling a stationary bicycle or walking
on a treadmill.
After the desired weight of the patient is reached, the balloon
is withdrawn by the gastro-enterologist through the esophagus by
a gastroscope after perforating the balloon to deflate it. Of course,
the liquid released from the balloon passes through the patient
in the normal manner without harm.
Follow-up examination and weight monitoring should be continued
weekly for several months, then monthly for two years, or so, if
the weight loss is to be maintained.
These together with other objects and advantages which will become
subsequently apparent reside in the details of construction and
operation as more fully hereinafter described and claimed, reference
being had to the accompanying drawings forming a part hereof, wherein
like numerals refer to like parts throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the component parts of the present
FIG. 2 is a side elevational view of the balloon of the present
invention being placed in the stomach of an obese patient.
FIG. 3 is a side elevational view of the balloon after placement
and inflation thereof, and with the insertion apparatus ready for
FIG. 4 is a perspective view of the stomach shaped balloon structure
per se, as inflated and with X-ray opaque threads and withdrawal
loop incorporated therewith.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1 of the drawings, reference numeral 10 indicates
in general the component parts of the weight loss apparatus of the
present invention. The deflated and rolled up balloon device is
shown in FIG. 2 being placed (pulled) into place in the stomach
(gastric cavity) of an obese patient.
The main component parts of the apparatus, as clearly shown in
FIG. 1, are the stomach (gastric) shaped, pre-formed balloon 11,
the syringe 12 connected to the fill tube 13 by way of a three-way
stop cock or valve 33, a flexible hollow naso-gastric (N-G) tube
14, a stiffener rod or wire (stylette) 16, and a pull string 15
having attached at one a finger cot 17.
Preferably, the flexible fill tube 13 is of conventional construction,
and the three-way valve 33 is designed so as to permit filling of
the syringe 12 with the desired balloon inflation liquid in the
conventional manner. The naso-gastric (N-G) tube 14 is also of conventional
construction. It is flexible, hollow, and approximately 36"
(91.44 cm) long. The stiffener (stylette) 16 has a hook 46 on one
end, and is 1/2" to 1" (1.27 to 2.54 cm) shorter than
the N-G tube 14. The hook prevents the stiffener 16 from accidentally
being inserted too far into the N-G tube 14, and the shorter length
assures that it will not protrude into the patient's stomach.
The pull string 15 (preferably of nylon) with finger cot 17 attached
is used, as described below, to place the balloon 11 in the patient's
The balloon 11 (see FIG. 4) is very similar to saline inflatable
breast implants as presently manufactured by Wright Dow-Corning,
Heyer-Schulte, Medical Engineering and Mammatech. The significant
difference is that the device of the present invention is in the
shape of a distended human gastric cavity instead of a breast.
Radio-opaque, X-ray marking threads 41 are built into the balloon
during the manufacture thereof, so that the position thereof can
be readily ascertained through conventional X-ray techniques. Also,
a self-closing, liquid retention when closed, fill valve 31 is provided
as well as a withdrawal loop 51 for later use in removing the balloon.
The balloon 11 is placed in position in a patient's stomach by passing
the standard naso-gastric (N-G) tube 14 through the mouth. The N-G
tube has the previously placed nylon pull string 15 through the
lumen and back up the exterior thereof. After the tip 24 of the
tube 14 is confirmed to be in the stomach, the metal stiffener (stylette)
16 is run down the lumen to within 1" of the distal end of
the N-G tube. The balloon 11 with the fill tube 13 attached is rolled
up and inserted into the rubber finger cot 17 to which the pull
string 15 is attached. Then, by pulling the string 15 through the
lumen of the N-G tube 14, the balloon containing finger cot 17 is
drawn down into the stomach. After confirmation of the placement
of the balloon 11 in the stomach the stylette 16 is removed and
the balloon 11 is inflated with saline plus contrast media (to make
X-ray visualization possible) and Kanamycin (to maintain sterility
inside the balloon). Inflation of the balloon causes the finger
cot 17 to roll up and remove itself. The balloon 11 is inflated
to occupy the majority of the gastric cavity, then the fill tube
13 is withdrawn and the pull-string 15 with the finger cot attached
is withdrawn. The self-sealing valve 31 prevents leakage after the
fill tube 13 is removed from the balloon.
Because total food consumption will be markedly reduced by use
of this device, food supplements including protein, vitamins and
minerals should be taken daily and progress must be monitored by
a physician weekly. Good eating habit training instruction may be
given with a tape recorded instructional course which can be listened
to while following a regular exercise program.
When the desired weight has been achieved, the balloon is withdrawn
by a gastro-enterologist through the esophagus by a gastroscope
after perforating the balloon to deflate it.
Follow-up examination and weight monitoring must be continued for
several years thereafter if the weight loss is to be maintained.
The entire intra-gastric balloon weight loss system is much more
than just a balloon as can be seen. It comprises
1. The free floating intra-gastric balloon (without tubes attached).
2. The method by which it is placed and filled in a patient's stomach.
3. The protein, vitamin and mineral supplements taken by the patient
while losing weight with this apparatus.
4. Eating habit re-training instructional tapes for use by the
5. The process of listening to the tapes while exercising on a
6. The method by which the balloon is removed from the patient.
7. The subsequent monitoring of the patient to supervise maintenance
of the weight loss long enough for the new eating habit patterns
to be firmly entrenched.
The main features of the present invention encompass Items 1 and
2. However, all seven items are an integral part of the overall
weight loss system as used with the intra-gastric balloon.
The actual method of placing a balloon 11 in a person's stomach
is quick, easy, pain free, and without any surgery. The pull string
15 is passed through the lumen (center) of a standard nasogastric
(N-G) tube 14 and back up the outside of the tube. The tube is passed,
without the need for general anesthesia, through the mouth, down
the esophagus, and, after its presence in the stomach is confirmed,
inflated. Inflation is by injecting liquid and listening over the
stomach with a stethescope. A stiffener rod or stylette 16 is passed
through the lumen of the N-G tube 14 to, but not past, the final
one-half inch of the tube 14. The pull string 15 in the lumen of
the tube 14 is then pulled, drawing the finger cot 17 containing
the collapsed balloon with fill tube attached, through the mouth,
down the esophagus and into the stomach. The fill tube is then injected
by use of the syringe 12 with a predetermined volume of water, saline,
cellulose, gel, food, X-ray contrast media, drugs, antibiotics or
any combination of the above. Thus, inflating the balloon which
causes the finger cot container to unroll itself off the balloon.
After the balloon 11 is filled to a predetermined volume, the nasogastric
tube 14 with stiffener 16, pull string 15 and finger cot 17 is withdrawn.
Then the fill tube 13 is withdrawn and the self-sealing valve 31
on the balloon closes, leaving the balloon 11 free-floating in the
person's gastric cavity with no tubes attached.
Presence of the balloon in the proper position in human being's
gastric cavity can be confirmed by X-ray immediately, and periodically,
because of a radio-opaque thread incorporated into the construction
of the balloon and the volume can be confirmed if the balloon is
filled with a radio-opaque media such as Cysto-conray II.
Water, and food supplements including the minimum daily requirement
of protein, vitamins and minerals may be recommended or required.
Eating habit re-training, instructional tape recorded lessons, suggestions
and directions for self-motivation, and self-hypnotism, may be recommended
or required for self-motivation, and self-hypnotism, may be recommended
or required multiple times daily and when falling asleep at night.
Aerobic exercise while listening to the tapes may be recommended
or required a minimum of three times per week while the patient
is under treatment and during maintenance.
The balloon may be removed when the fat loss goal has been achieved
or any time before or after that time, without surgery and without
the need for general anesthesia. The method of removal is by gastroscopy,
perforation of the balloon, and by aspiration of the contents thereof,
then forceps are used for grasping and/or snaring of the attached
withdrawal loop. Then withdrawal of the balloon is effected through
the esophagus in the same manner in which the gastroscope is withdrawn.
After balloon removal, follow-up examination, eating habits and
weight monitoring may be continued weekly for several months and
then monthly for two or more years, if necessary, to maintain the
In summary, the present invention includes a free floating intragastric
balloon which will help overweight users lose weight. This benign,
space occupying device will decrease the gastric capacity to the
point that saiety (the feeling of fullness) will occur after very
little food has been consumed.
The balloon is designed to occupy the majority of the available
intragastric space and float freely in the gastric cavity. It may
act as a ball valve obstruction to gastric drainage. After the fill
tube is withdrawn and the self-sealing valve closes, there are no
tubes left attached and no tubes remain in the esophagus or nasopharnyx.
This device can be placed in an awake patient in the same manner
as a orogastric tube is passed without the need for surgery or general
anesthesia, although it may be passed under anesthesia according
to the patient's preference.
The balloon may be inflated with water, saline, cellulose, gel,
food, X-ray contrast media or any combination of the above and it
may contain pharmacologically active drugs for sustained release
or other administration. The volume may be adjusted at any time
by reinserting the swallowed fill tube into the self-sealing valve
under gastroscopy. If the balloon should suffer a spontaneous deflation,
it could be passed through the intestines physiologically or it
could be regurgitated without harm to the user. Radio-opaque thread
incorporated into the construction of the balloon would identify
its position in the gastrointestinal tract.
Water, protein, carbohydrate, fat, vitamins and mineral supplements
may be recommended or required while the user is losing weight.
Eating habit re-training, instructional tape recorded lessons, suggestions
and directions for self-motivation and self-hypnotism may be recommended
or required while the user is under treatment. Aerobic exercise
while listening to the instructional and motivational tapes for
a minimum of fifteen minutes, three times per week, would be recommended
or required while the user is under treatment and under maintenance.
The device may be removed at any time without surgery and without
the need for general anesthesia by gastroscopy, perforation of the
balloon, aspiration of the contents and forceps grasping or snaring
the attached withdrawal loop, then withdrawal through the esophagus
in the same manner in which the gastroscope is withdrawn.
The intragastric balloon weight loss system is a method for weight
loss in overweight patients in which a collapsed, free-floating
intragastric balloon with filler tube attached is rolled up inside
a rubber finger cot to which a pull string is attached, and thus
placed without surgery of any type.
The foregoing is considered as illustrative only of the principles
of the invention. Further, since numerous modifications and changes
will readily occur to those skilled in the art, it is not desired
to limit the invention to the exact construction and operation shown
and described, and accordingly all suitable modifications and equivalents
may be resorted to, falling within the scope of the invention.