United States Patent (19)
`Garren et al.
`
`11
`45
`
`4,416,267
`Nov. 22, 1983
`
`54
`
`76)
`
`21
`22)
`51
`(52)
`(58)
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`(56)
`
`METHOD AND APPARATUS FOR
`TREATING OBESTY
`Inventors: Lloyd R. Garren; Mary L. Garren,
`both of P.O. Box 3738, Wilmington,
`Del. 19807
`Appl. No.: 329,182
`Filed:
`Dec. 10, 1981
`Int. Clº. A61B 17/00
`U.S. Cl. .… 128/1 R; 128/344;
`128/303 R; 604/96; 604/103
`Field of Search ............... 128/1 R, 344, 346, 325,
`128/129, 303 R; 604/93, 96-97, 101-103
`References Cited
`U.S. PATENT DOCUMENTS
`4,085,757 4/1978 Pevsner ............................. - 604/96 X
`4,102,342 7/1978 Akiyama et al...
`... 128/325
`4,133,315 1/1979 Berman et al. . ... 604/96 X
`4, 134,405 l/1979 Smit ................................ 128/303 R
`4,246,893
`/1981 Berson ............................ 128/346 X
`4,311,146 1/1982 Wonder .......................... 128/344 X
`
`4,315,509 2/1982 Smit ................................ 128/303 R
`FOREIGN PATENT DOCUMENTS
`WO80/00007 1/1980 PCT Int'l Appl. ................. 128/344
`Primary Examiner-Lee S. Cohen
`Assistant Examiner-Angela D. Sykes
`Attorney, Agent, or Firm-Connolly and Hutz
`57
`ABSTRACT
`A stomach insert for treating obesity in humans by
`reducing the stomach volume comprises a flexible
`torus-shaped inflatable balloon having a central opening
`extending therethrough. At least a portion of the bal
`loon has a self-sealing substance to facilitate puncture
`thereof with a needle for inflating the balloon and seal
`ing of the puncture upon removal of the needle. The
`method herein comprises positioning the balloon inside
`the stomach of the person being treated for obesity so as
`to reduce the stomach volume.
`
`7 Claims, 6 Drawing Figures
`
`
`
`Fulfillium Exhibit 2010, Page 1
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`U.S. Patent
`
`Nov. 22, 1983
`
`4,416.267
`
`
`
`Fulfillium Exhibit 2010, Page 2
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`1.
`
`4,416,267
`
`METHOD AND APPARATUS FOR TREATING
`OBESTY
`
`
`
`10
`
`15.
`
`BACKGROUND OF THE INVENTION
`The present invention relates to the medical treat
`ment of obesity in humans, and more particularly to
`apparatus and methods for curbing the appetite of per
`sons being treated for obesity.
`s'; Extreme obesity is a major illness in the United States
`and other countries. Its complications include hyperten
`sion, diabetes, coronary artery disease, stroke, conges
`tive heart failure, venous disease, multiple orthopedic
`problems and pulmonary insufficiency with markedly
`decreased life expectancy. Medical management includ
`ing dietary, psychotherapy, medications and behavioral
`modification techniques have yielded extremely poor
`results, in multiple trials. Several surgical techniques
`have been tried which have bypassed the absorptive
`surface of the small intestine or have been aimed at
`reducing the stomach size by either partition or bypass.
`These procedures have been proven both hazardous to
`perform in morbidly obese patients and have been
`fraught, with numerous life-threatening postoperative
`complications. Moreover such operative procedures are
`often difficult to reverse.
`?
`?
`Non-surgical approaches for the treatment of obesity
`30
`include voluntary dieting which is often unsuccessful
`since most persons do not possess sufficient willpower
`to limit the intake of food. Other approaches include the
`use of stomach fillers such as methyl cellulose, often
`taken in the form of tablets. The methyl cellulose ex
`35
`pands in the stomach leaving the person with a filled-up
`feeling. Also, inflatable bag and tube combinations have
`been proposed wherein, the bag is swallowed into the
`stomach and the tube attached thereto is used to period
`ically, inflate the bag, particulary just prior to mealtime.
`or during the meal. Once the person has eaten, the bag
`can be deflated all at once, or it can be deflated gradu
`ally over a period of a few hours so as to simulate the
`condition of digestion occurring and the gradual reduc
`45
`tion of stomach contents.
`U.S. Pat. No. 4,133,315 granted Jan. 9, 1979 discloses
`such an inflatable bag and tube combination. The tubing
`remains attached to the bag and inside the esophagus of
`the person being treated. These tubes are often the
`50
`cause of erosions and ulcerations of the esophagus. This
`patent also discloses a gastrotomy method wherein the
`permanently attached tube used to distend the stomach
`bag extends through an opening in the stomach wall as
`well as an opening in the abdomen.
`Also, U.S. Pat. No. 4,246,893 granted Jan. 27, 1981
`discloses an inflatable bag and tube combination which
`is surgically positioned outside and adjacent to the
`stomach. Upon inflation of the bag the upper abdomen
`60
`is distended and the stomach compressed to thereby
`produce a sense of satiety which reduces the persons's
`desire to ingest food.
`Hence, reducing the size of the gastric compartment
`has been shown to induce weight loss in a significant
`65
`percentage of people, and the present invention is aimed
`at a device which nonoperatively reduces the size of the
`gastric compartment and which is easily removed.
`
`55
`
`2
`SUMMARY OF THE INVENTION
`Accordingly, it is an object of the present invention
`to treat obesity by curbing a person's appetite in a man
`ner which is safe, convenient and effective.
`Another object of the present invention is to treat
`obesity by effectively reducing the stomach volume of
`the person being treated.
`In accordance with the present invention, a stomach
`insert for treating obesity in humans by reducing the
`stomach volume comprises a flexible torus-shaped in
`flatable balloon having a central opening extending
`therethrough. At least a portion of the balloon has a
`self-sealing substance to facilitate puncture thereof with
`a needle for inflating the balloon and sealing of the
`puncture upon removal of the needle.
`Preferably, the stomach balloon has an inflated vol
`ume of approximately 200 to 800 cc. and the central
`opening thereof includes flared outer ends.
`The method for treating obesity in humans according
`20
`- to the present, invention comprises the steps of assem
`bling a deflated stomach balloon with an insufflation
`tube releasably attached thereto inside a standard stom
`ach tube. Thereafter the stomach tube is introduced
`through the mouth and into the stomach, and the bal
`25
`: loon is urged out of the stomach tube into the stomach
`compartment. The attached insufflation tube is then
`used to inflate the balloon with air or other fluids. Fi
`nally, the insufflation tube is detached from the inflated
`balloon and along with the stomach tube removed from
`the body of the person. Usually the balloon is inflated to
`a volume approximately 80% of the stomach volume.
`BRIEF DESCRIPTION OF THE DRAWINGS
`Novel features and advantages of the present inven
`tion in addition to those mentioned above will become
`apparent to those skilled in the art from a reading of the
`detailed invention in conjunction with the accompany
`ing drawings wherein similar reference characters refer
`to similar parts and in which:
`FIG. 1 is a side elevational view of a stomach tube
`according to the present invention partially broken
`away to show details of the deflated balloon and its
`insufflation tube;
`FIG. 2 is a schematic side elevational view illustrat
`ing the balloon outside the stomach tube and partially
`inflated inside the stomach;
`FIG. 3 is a schematic side elevational view of the
`balloon fully inflated inside the stomach with the insuf
`flation tube detached from the balloon and both tubes
`being withdrawn from the person;
`FIG. 4 is a cross-sectional side elevational view of the
`fully inflated balloon shown in FIG. 3;
`FIG. 5 is a schematic side elevational view of a fiber
`optic gastroscope with needle biopsy forceps extending
`therefrom in the process of puncturing and removing
`the balloon from the stomach; and
`FIG. 6 is a schematic side elevational view similar to
`FIG. 5 with the balloon fully deflated and ready for
`removal.
`DETAILED DESCRIPTION OF THE
`INVENTION
`Referring in more particularity to the drawings, the
`several figures herein illustrate a stomach implant or
`insert for treating obesity in humans by reducing the
`stomach volume. Specifically, the stomach insert com
`prises a flexible torus-shaped inflatable balloon 10 hav
`
`Fulfillium Exhibit 2010, Page 3
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`10
`
`30
`
`35
`
`4,416,267
`3
`4.
`ing a central opening 12 extending therethrough. The
`period the person is being treated for obesity, perhaps a
`balloon may be fabricated from medical grade rubber or
`period of three months or more, and it functions to
`synthetic rubber-like material, one criteria being that
`reduce the volume size of the stomach and thereby curb
`the appetite of the person being treated for obesity.
`such material be impervious so that the balloon is capa
`ble of holding a charge of air or other fluid.
`Upon completion of the treatment, the balloon is
`As explained more fully below, the central opening
`easily removed from the stomach by means of a fiberop
`12 provides a passageway for solids and liquids as they
`tic gastroscope 28 with needle biopsy forceps 30. As
`pass through the stomach cavity 14. As shown best in
`shown in FIG. 5, the needle biopsy forceps grasp and
`puncture the balloon 10, and once the balloon is fully
`FIG. 4, the central opening 12 includes flared outer
`deflated it is simply drawn out of the stomach into the
`ends 16 that function to provide wide entrances to the
`esophagus and out through the mouth of the person
`central opening.
`Continuing, the balloon 10 includes an injection site
`being treated.
`18 fabricated from any self-sealing substance such as
`What is claimed:
`1. A stomach insert for treating obesity in humans by
`used in the injection site of standard intravenous tubing.
`reducing the stomach volume comprising a flexible,
`The injection site 18 serves as a location for inflation of 15
`free-floating and unattached, inflatable balloon having a
`the balloon 10, and the balloon is sized so that its in
`central opening extending therethrough, the balloon
`flated volume is approximately 200 to 800 cc.
`being inflatable to a volume of a person being treated, at
`A standard levine or stomach tube 20 is utilized to
`least a portion of the balloon having a self-sealing sub
`position the balloon 10 inside the stomach. Also, prior
`stance to facilitate puncture thereof with insufflation
`to positioning the balloon inside the stomach, an insuf
`means through which the balloon is inflated and to
`flation tube 22 in the form of small bore polyethylene
`facilitate sealing of the puncture upon removal of the
`tubing is attached to the deflated balloon. In this regard
`insufflation means.
`the free end of the insufflation tube carries a needle 24
`which punctures the balloon in the injection site 18. As
`2. A stomach insert as in claim 1 wherein the balloon
`has an inflated volume of approximately 200 to 800 cc.
`shown best in FIG. 1, the deflated stomach balloon 10
`25
`3. A stomach insert as in claim 1 wherein the central
`with the insufflation tube 22 attached thereto are stored
`inside the stomach tube 20 just prior to introducing the
`opening in the balloon includes flared outer ends. .
`4. A method of treating obesity in humans comprising
`stomach tube through the mouth and into the stomach
`of the person being treated for obesity. The procedure is
`the steps of assembling a deflated stomach balloon with
`an insufflation tube releasably attached thereto inside a
`as follows.
`Once the components are assembled as shown in
`standard stomach tube, thereafter having a central
`opening extending therethrough introducing the stom
`FIG. 1, the stomach tube is fed through the mouth and
`esophagus 24 into the stomach cavity 14. Next, the
`ach tube through the mouth and into the stomach,
`insufflation tube 22 is urged inwardly relative to the
`urging the balloon out of the stomach tube and into the
`stomach, inflating the balloon through the insufflation
`stomach tube 20 to thereby position the deflated balloon
`tube with a given amount of fluid to increase the vol
`10 inside the stomach. Air or another fluid is then intro
`ume thereof while enabling the inflated balloon to
`duced into the balloon 10 via the insufflation tube 22, as
`freely float within the stomach, and then removing the
`shown in FIG. 2. After the balloon is inflated to approx
`stomach tube and the insufflation tube from the stomach
`imately 80% of the stomach volume, the needle end 26
`and out through the mouth whereby the inflated bal
`of the insufflation tube is removed from the injection
`loon is unattached and free to float within the stomach.
`site 18 which self seals after such removal. The needle
`5. A method as in claim 4 wherein the balloon is
`26 is then housed inside the stomach tube and the stom
`inflated to a volume approximately 80% of the stomach
`ach tube then withdrawn from the body of the person
`leaving a free-floating and unattached inflated balloon.
`volume.
`6. A method as in claim 4 including the step of remov
`The inflated balloon is positioned as shown in FIG. 3
`45
`ing the balloon from the stomach by introducing extrac
`with the central opening therein serving as a passage
`tion means through the mouth and into the stomach,
`way through the stomach for both liquids and solids.
`grasping and puncturing the balloon with the extraction
`Also, liquid and solid foods pass around the exterior
`means, and then withdrawing the deflated balloon out
`surface of the balloon between that surface and the
`of the stomach and through the mouth.
`50
`interior of the stomach wall. As noted above, the bal
`loon is inflated to a volume of approximately 80% of the
`7. A method as in claim 6 wherein the extraction
`means includes a fiberoptic gastroscope with needle
`stomach volume and this phase of the procedure may be
`biopsy forceps.
`accomplished with the aid of x-ray examination, for
`example. The balloon remains in the stomach for the
`
`? ? ?
`
`k
`
`55
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`65
`
`Fulfillium Exhibit 2010, Page 4
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`O
`
`O
`
`PATENT NO. : 4, 416, 267
`DATED
`: November 22, 1983
`INVENTOR (S); Lloyd R. Garren; Mary L. Garren
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Column 1, line 62, 'persons 's' should be -- person's --
`Column 4, claim l, line 18, after 'volume' should read
`-- effective to reduce the stomach volume --
`
`?
`
`Column 4, claim 4, 1ine 29, after 'balloon' should read
`-- having a central opening extending
`therethrough. --
`
`lines 31-32, after 'thereafter' the
`phrase "having a central opening extending
`therethrough' should be deleted
`eigned and escaled this
`Seventh Day of February 1984
`
`?SEAL
`
`"^x
`
`Attest:
`
`Attesting Officer
`
`GERALD J MOSSINGHOFF
`Commissioner of Patents and Trademarks
`
`()
`
`()
`
`..)
`
`p
`
`
`
`Fulfillium Exhibit 2010, Page 5
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`