United States Patent (19)
`Berson
`
`54
`
`76
`
`NFLATABLE GASTRIC DEVICE FOR
`TREATING OBESTY
`Inventor:
`Daniel Berson, 199 Kings Highway,
`Congers, N.Y. 10920
`Appl. No.: 922,229
`Filed:
`Jul. 5, 1978
`Int. Cl. ....................... A61B 19/00; A61B 17/00
`U.S.C. ..................................... 128/1 R; 128/346
`Field of Search ................... 128/303 R, 311, 341,
`128/1 R, 325, DIG. 9
`References Cited
`U.S. PATENT DOCUMENTS
`7/1962 Moreau et al. ....................... 128/328
`3,046,988
`9/1962 Kulick ............
`3,055,971
`... 128/329
`9/1969 Fogarty et al.
`3,467,101
`... 128/341
`3,538,917 11/1970 Selker .........
`... 128/326
`3,600,718
`8/1971 Boone .....
`... 128/1 R
`3,646,929
`3/1972 Bonnar ...
`3,739,750
`6/1973 Shinjo .................................. 128/344
`
`21
`22)
`(51)
`52)
`(58)
`
`(56)
`
`- - - - - - - - 3/36
`
`(11)
`45
`
`4,246,893
`Jan. 27, 1981
`
`Edmunds et al. ................... 128/1 R
`Jones ....................
`. 28/1 R
`McGhan et al. .......................... 3/36
`Kleaveland ...
`... 128/334 R
`Lynch ....................................... 3/36
`Rosen et al. .
`. .28/346
`Sanders et al. ............................ 3/36
`Fitzgerald ...
`... 128/1 R
`Lake ........................................... 3/36
`Akiyama et al. ..................... 128/325
`Berman et al. ....................... 128/344
`
`3,831,583
`8/1974
`3,841,304
`10/1974
`3,852,832
`12/1974
`3,863,639
`2/1975
`3,883,902
`5/1975
`3,903,894
`9/1975
`3,919,724
`1/1975
`4,019,499
`4/1977
`4,095,295
`6/1978
`4,102,342
`7/1978
`4,133,315
`1/1979
`Primary Examiner-Robert W. Michell
`Assistant Examiner-Thomas Wallen
`Attorney, Agent, or Firm-Kenyon & Kenyon
`57
`ABSTRACT
`Apparatus for treating extreme obesity comprising
`means for compressing the stomach and reducing its
`capacity and procedures employing said apparatus.
`
`1 Claim, 6 Drawing Figures
`
`
`
`AzSSea/ Zaad
`Gas Ce4.cola
`Saezy
`
`Fulfillium Exhibit 2009, Page 1
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`U.S. Patent Jan. 27, 1981
`
`Sheet 1 of 3
`
`4,246,893
`
`/essexe/zza
`Gas Ce4/gov/o
`5/42/y
`
`32
`
`é.
`: ga
`
`5
`
`3C
`3
`>, SS
`^4&s
`/
`7
`N, / N- a
`f 3- 2.
`
`
`
`
`
`
`
`
`
`
`
`2éas
`
`MN
`O Q
`
`C.
`
`Fulfillium Exhibit 2009, Page 2
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`U.S. Patent Jan. 27, 1981
`
`Sheet 2 of 3
`
`4,246,893
`
`
`
`Fulfillium Exhibit 2009, Page 3
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`U.S. Patent Jan. 27, 1981
`
`Sheet 3 of 3
`
`4,246,893
`
`
`
`Fulfillium Exhibit 2009, Page 4
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`1.
`INFLATABLE GASTRIC DEVICE FOR TREATING
`OBESITY
`
`5
`
`BACKGROUND OF THE INVENTION,
`This invention relates to procedures and apparatus
`for treating obesity in human patients.
`In the past, rather drastic surgical procedures have
`been employed to treat morbidly or mortally obese
`10
`patients, i.e., patients whose body weight is at least
`twice their appropriate weight. One set of surgical pro
`cedures induces a pathophysiologic abnormality of the
`gastrointestinal tract by gastric or jejunoileal bypass
`operations in which as much as 95% of the tract is
`surgically bypassed. These procedures result in a pa
`15
`tient who is a metabolic cripple having surgically in
`duced malabsorption, and are associated with long term
`complications often requiring additional surgical proce
`dures. The jejunoileal bypass, for example, has been
`used extensively in this country and around the world.
`20
`This procedure bypasses about 95% of the small bowel,
`leaving about 40 cm. of functioning jejunum and ileum.
`The physiologic effect of this is massive diarrhea and
`malabsorption of nutrients, leading to weight loss sec
`ondary to poor absorption of nutrients, as well as aver
`25
`sion to eating. The procedure is performed an estimated
`five thousand to twenty thousand times per year in the
`United States, but has been abandoned by many institu
`tions, including the Cleveland Clinic, because of unac
`ceptable operative mortality averaging 6% nationwide,
`30
`as well as severe complications including wound infec
`tion and breakdown, progressive liver failure, hypocal
`cemia, calcium oxalate urinary calculi and bypass enter
`opathy. Mechanical problems such as intestinal obstruc
`tion and hernia formation are frequent.
`35
`Approximately 32% of the patients having jejunoileal
`bypass operations are rehospitalized within one year.
`These operations have also been associated with liver
`dysfunctions most likely caused by the preferential ab
`sorption of carbohydrates in the remaining small bowel,
`40
`with resulting relative protein starvation.
`Because of all these problems, attention has been
`directed toward gastric surgical procedures to induce
`weight loss. A gastroplasty procedure was performed
`by Mason et al. (University of Iowa) to change the
`45
`shape of the stomach but abandoned because of the
`technical difficulty of obtaining a proper partial outflow
`obstruction of the proximal gastric pouch. Instead,
`these investigators now recommend a 90% gastric by
`pass in which the proximal 10% of the stomach is anas
`50
`tomosed to the jejunum. This procedure is associated
`with a 3% operative mortality, as well as frequent
`would infections, anastomotic breakdowns, and a fre
`quent need to revise the anastomosis. Other approaches
`to reducing the size of the stomach to cause weight loss
`55
`include that of Wilkinson (Cited in Alden) who per
`formed a "gastric inversion" with Marlex mesh wrap
`ping in 2 cases, and that of Tretbar, who performed a
`gastric plication in 20 cases.
`r
`Another set of surgical procedures has involved oral
`60
`surgical techniques to wire shut a patient's jaws to re
`duce food intake. This involves the serious possibility
`that any vomiting which may occur can result in aspira
`tion of food and gastric secretions into the lungs.
`Non-surgical treatment of obesity by the use of non
`65
`nutritive means such as methyl cellulose to fill the stom
`ach is also known. For example, the use of tablets is
`known which after ingestion together with a fluid swell
`
`4,246,893
`2
`to a soft, stomach-filling bolus. However, it is appreci
`ated that these means are not usually a satisfactory treat
`ment for patients having the extreme disorder here
`described.
`Mechanical apparatuses are known for insertion
`through the esophagus into the stomach to conform to
`the internal shape of the stomach, for example, to fill the
`stomach and to prevent hemorraging into the stomach
`from blood vessels at the stomach wall. For example,
`U.S. Pat. Nos. 3,046,988 and 3,055,371 describe the use
`of esophago-gastric balloons for such purposes. How
`ever, these apparatuses, when utilized, would obstruct
`the esophagus and, by filling the stomach, interfere with
`all ingestion of food.
`Incontinence devices are also known which may be
`non-surgically inserted into a patient through an exter
`nal orifice to entirely seal off passages to an internal
`organ. For example, U.S. Pat. No. 3,841,304 discloses
`an inflatable balloon-like bulb for non-surgical partial
`insertion into the bladder of a female to temporarily seal
`the entrance from that organ to the urethra so as to
`restore control over the flow of urine from the bladder,
`U.S. Pat. No. 3,646,929 discloses a more complex de
`vice for vaginal insertion to accomplish control over
`bladder emission. This device can be made to expand so
`that a flexible diaphragm displaces the urethra and blad
`der neck and prevents emptying of the bladder. In both
`of these cases the control of these devices is accom
`plished by means of an inflation bulb extending outside
`the patient's body.
`It has been known to place an inflatable apparatus
`within a patient's abdomen during surgery for use as a
`retractor to retain the viscera during suturing, for exam
`ple, as described in U.S. Pat. No. 3,863,639. Such an
`apparatus, however, is not an implant apparatus, i.e., it
`is not adapted to remain entirely within the patient
`postoperatively, and plays no direct role in the control
`of any disorder.
`Accordingly, an object of the invention is to treat
`mortally or morbidly obese patents without including
`malabsorption of nutrients in the gastrointestinal tract.
`Another object of the present invention is to avoid
`the complications associated with bypass operations on
`the gastrointestinal tract.
`A further object of the invention is to treat mortally
`or morbidly obese patients whereby the patient's stom
`ach may be compressed to a controlled degree and
`adjustments made from time to time in the amount of
`compression by outpatient treatment.
`A still further object of the invention is to provide a
`relatively simple procedure for treating mortally or
`morbidly obese patients whereby a feeling of satiety
`from hunger and a reduction in the capacity of the
`stomach is produced without intrusion into the gastro
`intestinal tract.
`A still further object of the invention is to provide a
`surgical implant apparatus that is simple to manufacture
`for the control of morbid obesity in patients.
`These and other objects of the invention will appear
`more fully in the following specification taken with the
`accompanying drawings.
`SUMMARY OF THE INVENTION
`Briefly, this invention provides surgical implant appa
`ratus which is useful for treating a condition of extreme
`obesity and related procedures employing the apparatus
`for such treatment.
`
`Fulfillium Exhibit 2009, Page 5
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`10
`
`15
`
`20
`
`4,246,893
`3
`4.
`The implant apparatus comprises an adjustable gas
`tionally for younger patients. The balloon 2 may be
`tric compression means capable of providing substan
`made of any material that will not deteriorate in or
`tially constant upper abdominal distension to give a
`interfere with the environment of the peritoneal cavity.
`sensation of satiety or fullness and reducing the capacity
`Preferred materials are latex rubber or a medical grade
`of the stomach. The gastric compression means includes
`silicone elastomer, such as Silastic, coated latex rubber.
`a distensible means, for example, a balloon of rubber or
`The balloon 2 has a single opening 5 which communi
`similar flexible composition, an attached filling tube for
`cates with the filling tube 3 and may be formed integral
`inflating the balloon with a fluid or gas and an adjusting
`with the balloon 2 or fastened by suitable adhesives 6 to
`port mated to the filling tube for controlling the amount
`form an airtight seal.
`The filling tube 3 is in the form of an elongated neck
`of fluid or gas retained in the balloon.
`The procedure for using the implant apparatus in
`fashioned of a flexible material suitable for use in the
`abdominal cavity such as plastic tubing and can be rein
`volves abdominal surgery, wherein the distensible
`means is placed adjacent to the stomach and preferably
`forced against twisting and collapse by a wire helix 7 or
`other reinforcing means. The helix 7 is preferably em
`anterior to the stomach, posterior to the left lobe of the
`liver. During the procedure, the filling tube may be
`bedded in the wall of the filling tube 3 but may be at
`tached in some other manner that permits the filling
`brought out to a suitable subcutaneous location and
`trimmed to an appropriate length while the adjusting
`tube 3 to be easily cut during the implantation at any
`port is then attached and left in a subcutaneous position
`convenient point (to be described below) to a length
`at completion of the surgery.
`appropriate for the patient without fraying or unravel
`When in place entirely within the patient and filled
`ing. The filling tube 3 is made of materials that will not
`with fluid (which may be either a liquid or gas), the
`resist lateral bending, which bending may otherwise
`balloon compresses the stomach (or at least prevents the
`cause discomfort to the patient, yet should be suffi
`expansion of the stomach into the space that would
`ciently stiff to permit insertion of an attachment nozzle
`otherwise be available to it) and reduces the stomach's
`(described below). Medical grade silicone elastomer is a
`capacity for food. The extent of compression is adjust
`preferred material. The diameter of the filling tube 3
`25
`should preferably be uniform at least at the positions
`able by addition or withdrawal of fluid from the bal
`loon, for example, by employing a hypodermic syringe
`where the tube 3 may be cut. The length of the filling
`to remove fluid from the subcutaneously located adjust
`tube 3 should be sufficient to reach from a patient's
`ing port. The apparatus is believed to impart the same
`stomach to his anterior abdominal subcutaneous area.
`feeling of satiety and result in similar weight loss that
`Referring to FIGS. 2 and 3, the adjusting port 4 is
`30
`patients have experienced who have had tumors or
`formed from an elastomeric material adapted to be pen
`pancreatic pseudo-cysts that press on the stomach.
`etrated by a hypodermic needle 30 and to reseal upon
`removal of the needle. The adjusting port 4 is preferably
`BRIEF DESCRIPTION OF THE DRAWINGS
`a hollow spheroid having an interior space 8 communi
`FIG. 1 illustrates a partially cut away view of a pa
`cating with an insert nozzle 9 extending outwardly from
`35
`tient after implantation and during outpatient adjust
`the surface of the port 4. The shape and diameter of the
`ment of an implant apparatus according to the inven
`insert nozzle 9 should be adapted for insertion into and
`retention by the open end of the filling tube 3. The
`tion;
`FIG. 2 illustrates a perspective view of an implant
`outside diameter of the adjusting port 4, i.e., the widest
`apparatus according to the invention;
`dimension, should be chosen large enough so as to be
`easily struck with a hypodermic needle after being lo
`FIG. 3 illustrates a view taken on line 3-3 of FIG. 1;
`cated by feeling the port 4 as a lump under the patient's
`FIG. 4 illustrates a cross-sectional view of the human
`anatomy at the T-12 level after implantation and prior
`skin. The diameter should be chosen as small as conve
`to inflation of an implant apparatus according to the
`nient so as not to produce an unsightly lump after the
`invention; and
`patient has lost substantial weight. A reasonable diame
`45
`ter would be 3 centimeters (cm.). The surface of the
`FIG. 5 illustrates a cross-sectional view of the human
`anatomy at the T-12 level after implantation and infla
`port 4 is preferably a material such as medical grade
`tion of the implant apparatus of FIG. 4.
`silicone elastomer coated latex rubber which will reseal
`itself after removal of a hypodermic syringe. Tabs 33
`FIG. 6 illustrates a longitudinal cross-section view of
`the human anatomy after implantation and inflation of
`allow the adjusting port to be secured to the fascia with
`SO
`the implant apparatus.
`Sutures.
`In use, the gastric compression means 1 is implanted
`DETAILED DESCRIPTION OF A PREFERRED
`using standard surgical techniques. The patient may be
`EMBODEMENT
`placed under general anaesthesia and an incision made
`Referring to FIG. 2, the implant apparatus is in the
`in the midline of the abdomen between the xiphoid
`form of a gastric compression means 1 comprised of a
`process and the umbilicus. As shown in FIG. 4, the
`gastric compression distensible means, such as a balloon
`distensible balloon 2, together with the attached filling
`2, for example, of rubber, a filling tube 3 and an adjust
`tube 3 may be placed in the abdominal cavity in position
`ing port 4.
`to bear against the stomach 10 when inflated. The pre
`The balloon 2 is distensible and is of a size adapted for
`ferred position is shown in FIG. 4 as anterior to the
`implantation in an abdominal cavity of an obese patient
`stomach 10 and posterior to the left lobe of the liver 11.
`The filling tube 3 is then brought out to a suitable
`5 (FIG. 1). The dimensions of the balloon 2 are not
`location anterior to the fascia beneath the skin, in the
`critical but should be chosen so that a distension to a
`fatty layer 13 at the patient's abdomen as shown in FIG.
`diameter of at least 20 centimeters (cm) would result if
`4. The preferred path of the filling tube 3 is shown in
`the balloon 2 were filled with fluid to an internal pres
`65
`sure of about 20 millimeters of mercury (mmHg) out
`FIG. 4 extending from the balloon 2 around the left lobe
`side the patient in ambient air. These dimensions are
`of the liver 11 anterior through the muscle wall 12 of
`suitable for an adult patient and may be scaled propor
`the abdomen to a position beneath the skin and fatty
`
`55
`
`60
`
`Fulfillium Exhibit 2009, Page 6
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`

`

`4,246,893
`6
`5
`FIG. 6 are the esophagus 40, small intestine 42, colon
`layers 13 of the abdomen. The exact length of the tube
`50, diaphragm 44, duodenum (3rd part) 46, and sternum,
`3 is not critical for this purpose and 40 cm. would be
`adequate for an adult patient.
`48.
`For reference' sake, the other organs of the body
`Carbon dioxide is used as the preferred fluid because
`located in proximity to the gastric compression appara- 5
`there may be some inadvertent diffusion of the fluid into
`tus shown in FIG. 4 are the spleen 14, left and right
`a patient's body cavity during use. As carbon dioxide
`kidney 16 and 18, respectively, aorta 20, inferior vena
`has a relatively high diffusion rate into the blood
`cava 22, pancreas 24, and T-12 vertebral body 26.
`stream, any tendency to collect in the patient is reduced.
`The open end of the filling tube 3 may then be cut to
`Further, experience with the use of carbon dioxide in
`the appropriate length described above and the adjust- 10
`laparoscopy indicates its safety. Of course, any other
`ing port 4 attached by inserting the insert nozzle 9
`fluid or gas which can be safely utilized may be used.
`therein. The attachment may then be secured with non
`I claim:
`absorbable sutures 28 (FIG. 3) and/or non-toxic adhe
`1. The method of treating extreme obesity in a patient
`sives. The adjusting port 4 is then located subcutane
`comprising the steps of
`ously as shown in FIGS. 3, 4 and 5, and may be sutured 15
`forming an incision in the abdomen of an obese pa
`to the fascia using non-absorbable sutures passed
`tient;
`through suture tabs 33. The skin incision is closed using
`surgically implanting an inflatable balloon in the ab
`standard techniques.
`dominal cavity of the patient adjacent to the stom
`After recovery from the abdominal surgery, the pa
`ach, said balloon having a filling tube the distal end
`tient may be treated on an outpatient basis to increase or 20
`of which is sealingly attached in communication
`decrease the amount of inflation of the balloon 2 and
`with a hollow spheroidal adjusting port of self-seal
`thereby the amount of compression of the stomach 10.
`ing elastomeric material;
`To induce a feeling of satiety and reduce the capacity of
`suturing the adjusting port subcutaneously to the
`the stomach 10, a hypodermic needle 30 is introduced
`anterior wall of the fascia of the patient adjacent to
`directly through the skin and fatty layers 13 into the 25
`the incision;
`adjusting port 4 as shown in FIGS. 1, 3 and 6. Fluid is
`closing the incision over the adjusting port and subse
`then supplied to the needle 30 from a pressurized gas or
`quently locating the adjusting port by palpation;
`liquid supply 32, preferably carbon dioxide gas at low
`pressure and body temperature. An appropriate pres
`and
`inserting a hypodermic needle through the skin of the
`sure is about 20 mmHg. The carbon dioxide or other 30
`patient into the adjusting port and introducing a
`fluid then flows through the filling tube 3 to the balloon
`fluid under pressure into the port for passage
`2 which is then made to expand while compressing the
`through the filling tube into the balloon to expand
`stomach 10 as shown in FIGS. 5 and 6. FIG. 6 shows
`the balloon to distend the upper abdomen and pro
`the location of the balloon in the patient after inflation
`duce a sense of satiety, thereby reducing the pa
`and in connection with FIGS. 4 and 5 illustrates the 35
`tient's desire to ingest food, and to compress the
`placement of the gastric compression means. For refer
`stomach, thereby reducing its capacity.
`ence' sake, the other organs of the body located in prox
`imity to the gastric compression apparatus shown in
`
`t
`
`k
`
`sk
`
`xk
`
`ck
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Fulfillium Exhibit 2009, Page 7
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`