United States Patent (19)
`Foster, Jr.
`
`Patent Number:
`11
`(45) Date of Patent:
`
`4,485,805
`Dec. 4, 1984
`
`56)
`
`73) Assignee:
`
`(54) WEIGHT LOSS DEVICE AND METHOD
`75 Inventor: Lawrence H. Foster, Jr., Zephyr
`Cove, Nev.
`Gunther Pacific Limited of Hong
`Kong, Central, Hong Kong
`(21) Appl. No.: 411,053
`22 Filed:
`Aug. 24, 1982
`51) Int. Cl. .............................................. A61B 17/00
`52 U.S. Cl. .................................... 128/1 R; 128/344;
`604/54; 604/96
`58) Field of Search ...................... 604/49, 54, 96-100;
`128/1 R, 325, 344, 303 R
`References Cited
`U.S. PATENT DOCUMENTS
`4,133,315 l/1979 Berman ........................... 128A344 X
`4,236,521 12/1980 Lauterjung ......................... 604/270
`4,416,267 11/1983 Garren et al. ...................... 128/ R
`FOREIGN PATENT DOCUMENTS
`2822925 11/1979 Fed. Rep. of Germany ...... 28/344
`WO80/00007 1/1980 PCT Int'l Appl. ................. 128/344
`2090747 7/1982 United Kingdom ................ 128/344
`Primary Examiner-Dalton L. Truluck
`Attorney, Agent, or Firm-John W. Huckert
`57
`ABSTRACT
`The intra-gastric weight loss system apparatus and
`method of the present invention includes an intra-gas
`tric 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 bal
`loon 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 rub
`ber 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 liq
`uid. 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 Then the fill tube is withdrawn and the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, adminis
`tration 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.
`
`5 Claims, 4 Drawing Figures
`
`COOK
`Exhibit 1029-0001
`
`

`

`U.S. Patent Dec. 4, 1984
`
`Sheet 1 of 2
`
`4,485,805
`
`
`
`A/G 2
`
`COOK
`Exhibit 1029-0002
`
`

`

`U.S. Patent Dec. 4, 1984
`
`Sheet 2 of 2
`
`4,485,805
`
`A/G 3
`
`A/G 4
`
`
`
`COOK
`Exhibit 1029-0003
`
`

`

`1.
`
`WEIGHT LOSS DEVICE AND METHOD
`
`10
`
`15
`
`20
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`This invention relates generally to devices for effect
`ing 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 meth
`ods 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 re
`quire surgical procedures, which always involve some
`risk.
`Existing prior patents which may be pertinent to this
`25
`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 in
`vention because first, the esophageal nasogastric tube is
`30
`intended to control bleeding from the esophageal vari
`ces and not to cause weight loss. Secondly, the esopha
`geal nasogastric tube remains indwelling through the
`esophagus, nasopharnyx and nose of the patient during
`the entire time of use. In contrast thereto, the intra-gas
`35
`tric 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 40
`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 bal
`loon of the present invention occupies the majority of
`the cavity inside the stomach and conforms to the shape
`45
`of the stomach. Lastly, patients with an esophageal
`nasogastric tube in place are unable to take any nourish
`ment 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
`50
`food has been consumed thus, reducing the desire to
`continue eating by the patient.
`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. How
`ever, 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
`65
`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
`
`4,485,805
`2
`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 of safety.
`Another known device uses a stomach compression
`balloon which is designed to produce weight loss, how
`ever, the balloon is placed surgically inside the abdomi
`nal peritoneal cavity and outside the gastric (stomach)
`cavity with a fill tube penetrating the abdominal wall
`ending in a reservoir buried in the subcutaneous loca
`tion. 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 in
`vention avoids all surgery.
`Applicant is aware of still another weight loss system
`which uses air to inflate a balloon in the patient's ston
`ach. 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
`Se.
`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, mak
`ing 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 inven
`tion is to provide a system of weight loss which is flexi
`ble 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 stom
`ach 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
`
`55
`
`60
`
`COOK
`Exhibit 1029-0004
`
`

`

`10
`
`5
`
`20
`
`4,485,805
`3
`4.
`space-occupying device, the balloon will decrease gas
`Preferably, the flexible fill tube 13 is of conventional
`tric capacity to the point that saity (the feeling of full
`construction, and the three-way valve 33 is designed so
`as to permit filling of the syringe 12 with the desired
`ness) will occur after very little food has been con
`sumed. Most of the advantages of gastric and intestinal
`balloon inflation liquid in the conventional manner. The
`by-pass surgery as now practiced for morbid obesity
`naso-gastric (N-G) tube 14 is also of conventional con
`struction. It is flexible, hollow, and approximately 36'
`(more than 100 pounds overweight) will be realized,
`(91.44 cm) long. The stiffener (stylette) 16 has a hook 46
`without surgery. And, thus all of the many complica
`on one end, and is '' to 1' (1.27 to 2.54 cm) shorter than
`tions of surgery will be avoided.
`the N-G tube 14. The hook prevents the stiffener 16
`The main device of the present apparatus is an elasto
`from accidentally being inserted too far into the N-G
`meric balloon which is gastric shaped. It is inflated with
`tube 14, and the shorter length assures that it will not
`a liquid, such as saline and X-ray contrast media.
`protrude into the patient's stomach.
`Because after installation of the present device, total
`The pull string 15 (preferably of nylon) with finger
`food consumption will be markedly reduced, protein,
`cot 17 attached is used, as described below, to place the
`vitamins and mineral supplements should be taken daily
`balloon 11 in the patient's stomach.
`and progress should be monitored by a physician
`The balloon 11 (see FIG. 4) is very similar to saline
`weekly. Periodic X-rays can confirm proper presence
`inflatable breast implants as presently manufactured by
`and position of the balloon in the patient. Habit re-train
`Wright Dow-Corning, Heyer-Schulte, Medical Engi
`ing instruction is preferably given the patient by a tape
`neering and Mammatech. The significant difference is
`recorded instructional course which can be listed to
`that the device of the present invention is in the shape of
`while pedaling a stationary bicycle or walking on a
`a distended human gastric cavity instead of a breast.
`treadmill.
`Radio-opaque, X-ray marking threads 41 are built
`After the desired weight of the patient is reached, the
`into the balloon during the manufacture thereof, so that
`balloon is withdrawn by the gastro-enterologist
`the position thereof can be readily ascertained through
`through the esophagus by a gastroscope after perforat
`conventional X-ray techniques. Also, a self-closing,
`25
`ing the balloon to deflate it. Of course, the liquid re
`liquid retention when closed, fill valve 31 is provided as
`leased from the balloon passes through the patient in the
`well as a withdrawal loop 51 for later use in removing
`normal manner without harm.
`the balloon. The balloon 11 is placed in position in a
`Follow-up examination and weight monitoring
`patient's stomach by passing the standard naso-gastric
`should be continued weekly for several months, then
`(N-G) tube 14 through the mouth. The N-G tube has
`30
`monthly for two years, or so, if the weight loss is to be
`the previously placed nylon pull string 15 through the
`maintained.
`lumen and back up the exterior thereof. After the tip 24
`These together with other objects and advantages
`of the tube 14 is confirmed to be in the stomach, the
`which will become subsequently apparent reside in the
`metal stiffener (stylette) 16 is run down the lumen to
`details of construction and operation as more fully here
`within 1' of the distal end of the N-G tube. The balloon
`35
`inafter described and claimed, reference being had to
`11 with the fill tube 13 attached is rolled up and inserted
`the accompanying drawings forming a part hereof,
`into the rubber finger cot 17 to which the pull string 15
`wherein like numerals refer to like parts throughout.
`is attached. Then, by pulling the string 15 through the
`lumen of the N-G tube 14, the balloon containing finger
`BRIEF DESCRIPTION OF THE DRAWINGS
`cot 17 is drawn down into the stomach. After confirma
`FIG. 1 is a perspective view of the component parts
`tion of the placement of the balloon 11 in the stomach
`of the present invention;
`the stylette 16 is removed and the balloon 11 is inflated
`FIG. 2 is a side elevational view of the balloon of the
`with saline plus contrast media (to make X-ray visual
`present invention being placed in the stomach of an
`ization possible) and Kanamycin (to maintain sterility
`obese patient.
`inside the balloon). Inflation of the balloon causes the
`45
`FIG. 3 is a side elevational view of the balloon after
`finger cot 17 to roll up and remove itself. The balloon
`placement and inflation thereof, and with the insertion
`11 is inflated to occupy the majority of the gastric cav
`apparatus ready for removal; and
`ity, then the fill tube 13 is withdrawn and the pull-string
`FIG. 4 is a perspective view of the stomach shaped
`15 with the finger cot attached is withdrawn. The self
`balloon structure per se, as inflated and with X-ray
`sealing valve 31 prevents leakage after the fill tube 13 is
`opaque threads and withdrawal loop incorporated
`removed from the balloon.
`therewith.
`Because total food consumption will be markedly
`reduced by use of this device, food supplements includ
`DESCRIPTION OF THE PREFERRED
`ing protein, vitamins and minerals should be taken daily
`EMBODIMENT
`and progress must be monitored by a physician weekly.
`55
`Referring to FIG. 1 of the drawings, reference nu
`Good eating habit training instruction may be given
`meral 10 indicates in general the component parts of the
`with a tape recorded instructional course which can be
`weight loss apparatus of the present invention. The
`listened to while following a regular exercise program.
`deflated and rolled up balloon device is shown in FIG.
`When the desired weight has been achieved, the bal
`2 being placed (pulled) into place in the stomach (gas
`loon is withdrawn by a gastro-enterologist through the
`60
`tric cavity) of an obese patient.
`esophagus by a gastroscope after perforating the bal
`The main component parts of the apparatus, as
`loon to deflate it.
`clearly shown in FIG. 1, are the stomach (gastric)
`Follow-up examination and weight monitoring must
`shaped, pre-formed balloon 11, the syringe 12 con
`be continued for several years thereafter if the weight
`nected to the fill tube 13 by way of a three-way stop
`loss is to be maintained.
`65
`cock or valve 33, a flexible hollow naso-gastric (N-G)
`The entire intra-gastric balloon weight loss system is
`tube 14, a stiffener rod or wire (stylette) 16, and a pull
`much more than just a balloon as can be seen. It com
`string 15 having attached at one a finger cot 17.
`prises
`
`50
`
`COOK
`Exhibit 1029-0005
`
`

`

`5
`
`O
`
`15
`
`4,485,805
`6
`5
`1. The free floating intra-gastric balloon (without tubes
`without surgery and without the need for general anes
`thesia. The method of removal is by gastroscopy, perfo
`attached).
`2. The method by which it is placed and filled in a
`ration of the balloon, and by aspiration of the contents
`patient's stomach.
`thereof, then forceps are used for grasping and/or snar
`3. The protein, vitamin and mineral supplements taken
`ing of the attached withdrawal loop. Then withdrawal
`by the patient while losing weight with this appara
`of the balloon is effected through the esophagus in the
`same manner in which the gastroscope is withdrawn.
`tS.
`4. Eating habit re-training instructional tapes for use by
`After balloon removal, follow-up examination, eating
`the patient.
`habits and weight monitoring may be continued weekly
`5. The process of listening to the tapes while exercising
`for several months and then monthly for two or more
`on a stationary bicycle.
`years, if necessary, to maintain the weight loss.
`In summary, the present invention includes a free
`6. The method by which the balloon is removed from
`the patient.
`floating intragastric balloon which will help over
`weight users lose weight. This benign, space occupying
`7. The subsequent monitoring of the patient to supervise
`maintenance of the weight loss long enough for the
`device will decrease the gastric capacity to the point
`new eating habit patterns to be firmly entrenched.
`that saiety (the feeling of fullness) will occur after very
`The main features of the present invention encompass
`little food has been consumed.
`The balloon is designed to occupy the majority of the
`Items 1 and 2. However, all seven items are an integral
`available intragastric space and float freely in the gastric
`part of the overall weight loss system as used with the
`intra-gastric balloon.
`cavity. It may act as a ball valve obstruction to gastric
`The actual method of placing a balloon 11 in a per
`drainage. After the fill tube is withdrawn and the self
`son's stomach is quick, easy, pain free, and without any
`sealing valve closes, there are no tubes left attached and
`surgery. The pull string 15 is passed through the lumen
`no tubes remain in the esophagus or nasopharnyx. This
`device can be placed in an awake patient in the same
`(center) of a standard nasogastric (N-G) tube 14 and
`back up the outside of the tube. The tube is passed,
`manner as a orogastric tube is passed without the need
`for surgery or general anesthesia, although it may be
`without the need for general anesthesia, through the
`passed under anesthesia according to the patient's pref
`mouth, down the esophagus, and, after its presence in
`the stomach is confirmed, inflated. Inflation is by inject
`efence.
`ing liquid and listening over the stomach with a stethe
`The balloon may be inflated with water, saline, cellu
`scope. A stiffener rod or stylette 16 is passed through
`lose, gel, food, X-ray contrast media or any combina
`tion of the above and it may contain pharmacologically
`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
`active drugs for sustained release or other administra
`lumen of the tube 14 is then pulled, drawing the finger
`tion. The volume may be adjusted at any time by rein
`cot 17 containing the collapsed balloon with fill tube
`serting the swallowed fill tube into the self-sealing valve
`under gastroscopy. If the balloon should suffer a sponta
`attached, through the mouth, down the esophagus and
`35
`neous deflation, it could be passed through the intestines
`into the stomach. The fill tube is then injected by use of
`physiologically or it could be regurgitated without
`the syringe 12 with a predetermined volume of water,
`harm to the user. Radio-opaque thread incorporated
`saline, cellulose, gel, food, X-ray contrast media, drugs,
`into the construction of the balloon would identify its
`antibiotics or any combination of the above. Thus, in
`position in the gastrointestinal tract.
`flating the balloon which causes the finger cot container
`40
`Water, protein, carbohydrate, fat, vitamins and min
`to unroll itself off the balloon. After the balloon 11 is
`eral supplements may be recommended or required
`filled to a predetermined volume, the nasogastric tube
`while the user is losing weight. Eating habit re-training,
`14 with stiffener 16, pull string 15 and finger cot 17 is
`instructional tape recorded lessons, suggestions and
`withdrawn. Then the fill tube 13 is withdrawn and the
`self-sealing valve 31 on the balloon closes, leaving the
`directions for self-motivation and self-hypnotism may
`balloon 11 free-floating in the person's gastric cavity
`be recommended or required while the user is under
`treatment. Aerobic exercise while listening to the in
`with no tubes attached.
`Presence of the balloon in the proper position in
`structional and motivational tapes for a minimum of
`human being's gastric cavity can be confirmed by X-ray
`fifteen minutes, three times per week, would be recom
`immediately, and periodically, because of a radio
`mended or required while the user is under treatment
`opaque thread incorporated into the construction of the
`and under maintenance.
`The device may be removed at any time without
`balloon and the volume can be confirmed if the balloon
`is filled with a radio-opaque media such as Cysto-con
`surgery and without the need for general anesthesia by
`gastroscopy, perforation of the balloon, aspiration of
`ray II.
`the contents and forceps grasping or snaring the at
`Water, and food supplements including the minimum
`55
`daily requirement of protein, vitamins and minerals may
`tached withdrawal loop, then withdrawal through the
`be recommended or required. Eating habit re-training,
`esophagus in the same manner in which the gastroscope
`instructional tape recorded lessons, suggestions and
`is withdrawn.
`directions for self-motivation, and self-hypnotism, may
`The intragastric balloon weight loss system is a
`method for weight loss in overweight patients in which
`be recommended or required for self-motivation, and
`60
`a collapsed, free-floating intragastric balloon with filler
`self-hypnotism, may be recommended or required mul
`tiple times daily and when falling asleep at night. Aero
`tube attached is rolled up inside a rubber finger cot to
`which a pull string is attached, and thus placed without
`bic exercise while listening to the tapes may be recom
`surgery of any type.
`mended or required a minimum of three times per week
`while the patient is under treatment and during mainte
`The foregoing is considered as illustrative only of the
`65
`principles of the invention. Further, since numerous
`aCe
`modifications and changes will readily occur to those
`The balloon may be removed when the fat loss goal
`has been achieved or any time before or after that time,
`skilled in the art, it is not desired to limit the invention
`
`30
`
`25
`
`45
`
`50
`
`COOK
`Exhibit 1029-0006
`
`

`

`5
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`O
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`5
`
`4,485,805
`7
`8
`in turn effecting rolling up and disengagement of said
`to the exact construction and operation shown and
`described, and accordingly all suitable modifications
`finger cot from the device.
`and equivalents may be resorted to, falling within the
`3. The method of placing a gastric cavity filling de
`scope of the invention.
`vice within an obese person's gastric cavity without any
`What is claimed is:
`Surgery, comprising the steps of:
`1. Apparatus for use in achieving a loss of weight in
`providing an inflatable device in deflated form;
`an overweight person comprising:
`attaching a fill tube to the inflatable device;
`an inflatable device;
`inserting a hollow tube containing a string there
`means for placing said device within the stomach of
`through into the person's mouth, esophagus and
`the person without surgery;
`gastric cavity;
`additional means for inflating said device with liquid
`releasably attaching the deflated device with fill tube
`after it has been placed in the person's stomach;
`attached to one end of the string;
`further means for allowing both said placing means
`pulling the other end of the string to pull the deflated
`and said inflating means to be completely removed
`device into the person's gastric cavity;
`from the person so as to leave the inflated device
`inflating the deflated device through the fill tube and
`floating in the person's stomach; and said further
`after suitable inflation of the device;
`means including
`renoving all the placing apparatus so that the inflated
`a pull string having a rollable finger cot attached at
`device remains free-floating in the person's gastric
`one end, and a releasable, self-closing fill valve as
`cavity without any attachments thereto.
`part of the inflatable device.
`4. The method of claim 3, with the further steps of:
`2. Apparatus as set forth in claim 1, wherein said
`inserting a stiffener member into the hollow tube
`releasable, self-closing fill valve receives one end of a
`containing the string therethrough prior to the step
`flexible fill tube prior to the device being rolled up and
`of pulling the string.
`associated with the extended finger cot for placing of
`5. The method of claim 4, with the additional step of
`the inflatable device in the person's stomach, said fill
`25
`using liquid containing an X-ray opaque substance
`tube being connected to liquid supply means so that the
`inflatable device can be inflated with liquid after it has
`therein for inflating the device.
`been placed in the person's stomach, and such inflation
`
`k
`
`s
`
`35
`
`45
`
`SO
`
`55
`
`60
`
`65
`
`COOK
`Exhibit 1029-0007
`
`