United States Patent (19)
`Brown
`
`III
`
`US005259.399A
`11) Patent Number:
`45) Date of Patent:
`
`5,259,399
`Nov. 9, 1993
`
`(56)
`
`54) DEVICE AND METHOD OF CAUSING
`WEIGHT LOSS USNG REMOVABLE
`VARIABLE VOLUMENTRAGASTRIC
`BLADDER
`76 Inventor:
`Alan Brown, 202 Twin Hills Rd.,
`Longmeadow, Mass. 01106
`(21) Appl. No.: 844,135
`22 Filed:
`Mar. 2, 1992
`51) Int. Cl............................................... A61B 19/00
`52 U.S. C. ..............
`... 128/897; 128/8
`58) Field of Search ................................ 128/897-899,
`128/8; 606/191, 192, 196, 198; 604/96-103, 54
`References Cited
`U.S. PATENT DOCUMENTS
`4,133,315 l/1979 Berman et al. .
`4,246,893 1/1981 Berson .
`4,485,805 12/1984 Foster, Jr. .
`4,592,339 6/1986 Kuzmak et al. .
`4,648,383 3/1987 Angelchik.
`4,694,827 9/1987 Weiner et al. .
`4,723,547 2/1988 Kullas et al. .
`4,739,758 4/1988 Lai et al. .
`4,826,481 5/1989 Sacks et al. .
`4,899,747 2/1990 Garren et al. .
`5,084,061 1/1992 Gau et al. .
`FOREIGN PATENT DOCUMENTS
`2822925 11/1979 Fed. Rep. of Germany ...... 128/899
`OTHER PUBLICATIONS
`Holt, Stephen et al., "Intragastric Devices for Weight
`Loss: Fact or Fancy?', The American Journal of Gas
`troenterology, vol. 83, No. 5, 1988, pp 554-555.
`Schapiro, Melvin, M. D., "Has Bubble Therapy for
`
`
`
`Obesity Been Deflated?", Gastroenterology, vol. 95,
`No. 3, Sep. 1988, pp. 834-836.
`The Gastric Bubble product literature of American
`Edwards Laboratories.
`
`Primary Examiner-William E. Kamm
`Assistant Examiner-J. P. Lacyk
`Attorney, Agent, or Firm-Fish & Richardson
`57
`ABSTRACT
`A method and apparatus for causing weight loss in
`obese humans by occupying a segment of the stomach
`volume using a variable volume bladder filled with
`fluid. The bladder is inserted into the upper part of the
`stomach including the fundus through a percutaneous
`endoscopic gastrostony tube, which was non-surgically
`placed to create a permanent channel to the stomach.
`The inserted bladder is filled and emptied using a filling
`system for pumping fluid in and out of the bladder ac
`cording to a predetermined scheme. The filling system
`comprises a reversible pump, a two-way valve con
`nected to the filling tube, an electronic control means
`for automatically controlling the action of the filling
`system, and a battery. The electronic control means is
`connected to a plurality of sensors placed on the human
`body to detect digestion cycle and hemodynamic pa
`rameters. The electronic control means collects infor
`mation detected by the sensors, governs the filling sys
`ten according to the obtained information and prede
`termined operation scheme, and records times and vol
`umes of the fluid transferred through the two-way
`valve.
`
`15 Claims, 9 Drawing Sheets
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`Fulfillium Exhibit 2011, Page 1
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`U.S. Patent
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`Nov. 9, 1993
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`Sheet 2 of 9
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`5,259,399
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`Fulfillium Exhibit 2011, Page 3
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`U.S. Patent
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`Noy. 9, 1993
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`Sheet 3 of 9
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`5,259,399
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`f
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`FIG. 2a
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`42
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`FIG. 2b
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`40
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`42
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`FIG. 2c
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`U.S. Patent
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`Nov. 9, 1993
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`Sheet 4 of 9
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`5,259,399
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`1
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`~~
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`\\-42
`
`LTTIL.
`
`FIG. 2d
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`2
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`,
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`FIG. 2e
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`U.S. Patent
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`Nov. 9, 1993
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`Sheet 5 of 9
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`5,259,399
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`FIG. 2f
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`Fulfillium Exhibit 2011, Page 6
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`U.S. Patent
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`Nov. 9, 1993
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`Sheet 6 of 9
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`5,259,399
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`Fulfillium Exhibit 2011, Page 7
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`U.S. Patent
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`Nov. 9, 1993
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`Sheet 70f9
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`5,259,399 -
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`FIG. 4
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`Fulfillium Exhibit 2011, Page 8
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`U.S. Patent
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`Nov. 9, 1993
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`Sheet 8 of 9
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`5,259,399
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`Fulfillium Exhibit 2011, Page 9
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`U.S. Patent
`
`Nov. 9, 1993
`
`Sheet 9 of 9
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`5,259,399
`
`
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`Fulfillium Exhibit 2011, Page 10
`ReShape v. Fulfillium
`Case IPR2018-00958
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`1.
`
`DEVICE AND METHOD OF CAUSING WEIGHT
`LOSS USNG REMOVABLE VARIABLE VOLUME
`NTRAGASTRIC BLADDER
`
`10
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`5,259,399
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`nias, or to revise original surgery because of intolerable
`side effects.
`Many weight loss devices are based on placing within
`the lumen of the stomach a bag or a balloon filled with
`air or liquid, which controls the patient's desire to eat
`by distension of the stomach. Theoretically, the disten
`sion of gastric by objects such as balloons as well as by
`food stimulates the neuroreceptors located in the sub
`mucosa of the upper fundus of the stomach, and these
`receptors send signals to the brain causing the patient to
`experience the sensation of satiety.
`To date, two main approaches have been suggested
`to introduce inflatable balloon-like devices into the
`abdomen of obese patients. The first approach, sug
`gested by Berson (U.S. Pat. No. 4,246,893), was surgical
`placement of the balloon-like device through an incision
`in the abdominal wall and the peritoneum into the upper
`abdomen adjacent and anterior to the stomach. The
`balloon is intended to exert pressure on the stomach
`from outside.
`The second approach is placing the distensible device
`within the lumen of the stomach. This approach was
`described in the patent of Berman (U.S. Pat. No.
`4,133,315), wherein an inflatable bag with a flexible tube
`is positioned in the stomach either non-surgically (i.e.,
`through the mouth, down the esophagus and into the
`stomach), or surgically by creating a direct incision in
`the abdominal wall and performing a gastrostomy, with
`the filling tube surgically placed through the abdominal
`wall.
`The surgical placement of the intragastric bag by
`performing a gastrostomy, as described by Berman, can
`be accompanied by serious complications and side ef
`fects associated with any surgical procedure and pres
`ents complications when the balloon needs to be re
`placed. In the case of having a filling tube permanently
`extended up through the esophagus and out of the nasal
`cavity or out of the mouth, as again described by Ber
`man, is a major inconvenience for the patient. On the
`other hand, it is beneficial for the patient to fill and
`empty the intragastric balloon periodically. The empty
`ing of the balloon provides periods of relief and feelings
`of well being for the patient.
`The need for improvements over these approaches
`has been recognized for a number of years. Several
`proposals (Foster, Jr., U.S. Pat. No. 4,485,805; Lai et al.,
`U.S. Pat. No. 4,739,758; Kullas et al., U.S. Pat. No.
`4,723,547) use a free-floating balloon in the patient's
`stomach without having the filling tube attached. Since
`they recognized the importance of inflating and deflat
`ing the balloon and the above-discussed disadvantages
`of having a permanently attached filling tube, they con
`structed detachable means for filling or emptying the
`balloon introduced through the esophagus.
`Similarly, Gan et al. (U.S. Pat. No. 5,084,061) re
`cently proposed a free-floating inflatable intragastric
`balloon with a self-sealing valve, wherein the balloon is
`inflated or deflated using an endoscope introduced
`through the esophagus down to the stomach.
`However, these proposals still have not allowed a
`frequent filling and emptying of the balloon on an
`hourly or daily basis since they require introduction of
`an endoscope through the esophagus, which is a proce
`dure conducted by a physician on a sedated patient.
`In summary, there continues to be a need for an intra
`gastric device which can be nonsurgically placed in the
`lumen of the stomach and frequently filled and emptied,
`and in particular an intragastric device that is also easily
`
`BACKGROUND OF THE INVENTION
`This invention relates to devices for medical treat
`ment of morbid obesity in humans.
`Morbid obesity is a chronic medical illness defined as
`overweight of 50 to 100 percent or 100 pounds above
`the ideal body weight.
`Characteristic features of this illness include predomi
`nantly genetic origin, onset of disease in youth, a gener
`ally relentless progression throughout life, and a long
`term cure rate of less than 5 percent. Morbid obesity has
`many serious health ramifications. A strong association
`exists between obesity and hypertension, hyperlipid
`emia and exacerbation of diabetes mellitus. These condi
`tions, in turn, increase the risk factors for coronary
`20
`artery disease (heart attack) and cardiovascular disease
`(stroke), which are leading causes of premature mortal
`ity and morbidity. Obesity also produces mechanical
`and physical stresses that aggravate or cause sciatica
`and joint problems, especially arthritis of the hips and
`25
`knees. Another serious disease limited to obese individ
`uals is a Pickwickian syndrome. This syndrome is char
`acterized by nighttime episodes of upper airway ob
`struction which cause hypoxemia and, if left untreated,
`30
`lead to pulmonary hypertension and heart failure.
`Weight loss will reverse this disease completely if insti
`tuted before permanent cardiac damage develops. Mul
`tiple other medical problems are more common in obese
`individuals such as gallstones, varicose veins, thrombo
`35
`embolism and hernias. In addition, morbid obesity can
`lead to psychosocial difficulties such as depression, loss
`of self-esteem and decreased employability.
`To date, numerous attempts have been made to cause
`weight loss in morbidly obese patients. None of them
`40
`have been entirely successful. The weight loss methods
`can be broadly divided into behavior modification and
`medical diets, surgical procedures, and devices.
`Medical dietary regimes and behavior modification
`are used as a first line of treatment of obesity since they
`45
`have almost no side effects or complications, when
`properly applied and monitored. However, these meth
`ods are usually unsuccessful in the treatment of morbid
`obesity because they depend solely upon the willpower
`of the patients. Only after these methods of treatment
`50
`fail and the health risks of staying morbidly obese are
`judged to be serious, should interventional methods,
`including devices and surgical procedures, be em
`ployed. Behavior modification and medical diets, never
`theless, remain useful and necessary adjuncts to treat
`ment by devices or surgery.
`Surgical procedures for treatment of obesity include
`procedures that lead to weight loss by malabsorption
`such as jejunoileal or gastric bypass surgery, gastro
`plasty and gastric stapling and oral surgical procedures
`such as wiring shut the patient's jaws to reduce food
`intake. These procedures are usually quite effective in
`producing weight loss but some of them have been
`accompanied by serious complications and side effects,
`including operative mortality as high as three to six
`percent, postoperative wound infection, liver disfunc
`tion and failure, kidney stones, diarrhea and the need for
`further surgeries to treat intestinal obstruction or her
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`inserting an endoscope into the gastric lumen through
`withdrawn from the lumen of the stomach, inspected,
`the P.E.G. tube and examining the lumen for trauma or
`replaced if needed, and reinserted into the lumen of the
`ulceration, and re-inserting through the P.E.G. tube a
`stomach. Preferably, all these steps should be done
`bladder into the stomach so that the size and shape of
`without any sedation or any major discomfort to the
`the bladder, cooperating with the position of placement
`patient.
`of the P.E.G. tube, again maintains the bladder in the
`upper part of the stomach including the fundus and
`body of the stomach.
`Preferred embodiments of this aspect of the invention
`may also include the feature of repeated filling and
`emptying of the bladder manually employing a filling
`system. The feature of repeated by filling and emptying
`the bladder automatically under control of an automatic
`filling system.
`In another aspect of the invention, a medical device
`for treatment of morbidly obese patients comprising a
`bladder and a filling tube. The bladder is sized and
`shaped for occupying the upper part of the stomach.
`The bladder and the connectable filling tube are in
`collapsed condition before they are inserted through a
`P.E.G. tube into the stomach. The filling tube extends
`proximally through the P.E.G. tube for filling and emp
`tying of the bladder.
`Preferred embodiments of this aspect of the invention
`include a stylet extending into the bladder to enable
`thrusting of the collapsed bladder through the P.E.G.
`tube into the stomach.
`In another aspect of the invention, a system for auto
`matically filling and emptying a bladder positioned in
`the stomach is provided to cause weight loss in obese
`humans. The system is connected to the bladder
`through a filling tube and the system comprises a valve
`for controlling the amount of fluid introduced or evacu
`ated from the bladder through the filling tube, a fluid
`reservoir for introducing fluid into the bladder through
`the valve, and electronic control means for controlling
`filling and emptying of the bladder according to a
`schedule or a set of selected conditions.
`Preferred embodiments of this aspect of the invention
`include a plurality of sensors, connected to send infor
`mation to the electronic control means, the sensors
`being placed in the human body to detect indicators of
`digestion and hemodynamic parameters in order to
`control the filling and emptying of the bladder.
`Preferred embodiments of this aspect of the invention
`also include an electronic control means capable of
`keeping an electronic record of filling and emptying
`times and of the volume of fluid passed through the
`valve.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 shows a cross-sectional view of a patient lying
`in a supine position with a percutaneous endoscopic
`gastrostomy (P.E.G.) tube forming a channel across a
`thick abdominal wall of an morbidly obese person to the
`stomach.
`FIG. 2 shows the apparatus placed in the gastric
`lumen through the P.E.G. tube.
`FIGS. 2a-20c illustrate a method of introducing the
`P.E.G. tube.
`FIG. 3 shows a device comprising an inflatable blad
`der stretched by a stylet before insertion through the
`P.E.G. tube.
`FIG. 4 shows the device positioned in the lumen of
`the stomach through the P.E.G. tube.
`FIG. 5 shows a ball valve screwed on the filling tube
`of the apparatus.
`
`SUMMARY OF THE INVENTION
`In one aspect of the invention, a method and system
`for use with the method is provided to cause weight loss
`in obese humans by occupying a segment of the stom
`ach volume using a variable volume bladder, the blad
`der being positioned into and withdrawn from the stom
`ach through a percutaneous endoscopic gastrostomy
`tube permanently placed to provide ready access to the
`lumen of the stomach through the thick abdominal wall.
`The method includes the steps of measuring the volume
`and location of the stomach including the fundus by .
`radiological techniques, introducing the percutaneous
`endoscopic gastrostomy tube (P.E.G.) to establish ac
`cess to the fundus of the stomach through the abdomi
`nal wall, selecting a bladder of size and shape to sub
`stantially occupy the upper part of the stomach includ
`ing the fundus and the body of the stomach according
`to the performed radiological measurements, and insert
`ing the bladder through the P.E.G. tube into the stom
`25
`ach so the size and shape of the bladder, cooperating
`with the position of placement of the P.E.G. tube, main
`tains the bladder in the upper part of the stomach in
`cluding the fundus.
`The method further includes the steps of filling and
`30
`emptying the bladder repeatedly through a perma
`nently connected filling tube that extends through the
`P.E.G. tube. The filled bladder occupies a large portion
`of the stomach to cause a feeling of satiety and to
`achieve decreased consumption of food by a patient.
`35
`The emptying of the bladder provides periods of re
`duced trauma to the stomach.
`Preferred embodiments of this aspect of the invention
`include introduction of the P.E.G. tube in the stomach
`of the obese person performed including the steps of
`40
`inspecting the lumen of the stomach of the obese person
`using both an endoscope and a fluoroscope, wherein the
`endoscope is introduced into the stomach through the
`mouth down the esophagus, puncturing the abdominal
`wall with a needle, inserting a guidewire from outside
`through the puncture in the abdominal wall into the
`fundus of the stomach, and grasping the guidewire
`using the introduced endoscope and by pulling the en
`doscope out of the mouth extracting one end of the
`guidewire out of the mouth while the other end of the
`50
`guidewire still remains outside of the abdomen. Subse
`quently, the P.E.G. tube is placed through the abdomi
`nal wall by performing the steps of attaching the ta
`pered leading end of the P.E.G. tube to the guidewire
`extended out of the patient's mouth and pulling on the
`other end of the guidewire until the tapered end of the
`tube is pulled through the puncture opening in the ab
`dominal wall, securing and sealing the placed gastros
`tomy tube on the stomach wall and on the abdominal
`wall, and cutting the P.E.G. tube to the appropriate
`length.
`Preferred embodiments of this aspect of the invention
`may also include measuring the volume and location of
`the stomach employing an air contrast upper GI series
`by performing frontal and lateral projection radio
`65
`graphs or employing computerized tomography; re
`moving the bladder from the gastric lumen through the
`P.E.G. tube as when it is desired to inspect or replace it;
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`FIG. 3 illustrates a system and method for introduc
`FIGS. 6 and 7 show a simple way of closing the
`ing the bladder 10 or device 8 into the stomach through
`filling tube on the apparatus inserted in the stomach
`P.E.G. tube 2. A hollow stylet 13 extends through a
`through the P.E.G. tube.
`filling tube 9 into bladder 10 of apparatus 8. Hollow
`FIG. 8 shows a filling system designed to automati
`stylet 13 is longer than the device 8 so that a distal
`cally fill and empty the bladder of the apparatus.
`portion 13 extends beyond the filling tube and engages
`DESCRIPTION OF THE PREFERRED
`the far wall of the bladder. A proximal portion 15 also
`EMBODIMENT(s)
`protrudes proximally from stylet cap 12. Vacuum is
`applied to extended portion 15 of hollow stylet 13 caus
`Referring to FIG. 1, a morbidly obese patient, lying
`ing bladder 10 to collapse to the maximum degree i.e.
`in a supine position on his back with his head to the left
`vacuum compressed. The assembly 8 is then inserted
`and his legs to the right, is shown in vertical longitudi
`through P.E.G. tube 2 into the stomach, the distal por
`nal cross-section with a percutaneous endoscopic gas
`tion 13a of the stylet serving to stiffen the assembly so
`trostomy (P.E.G.) tube 2 in place. P.E.G. tube 2, creat
`that it can be slid axially through the P.E.G. tube and
`ing a permanent channel to the stomach 4, is inserted
`into the stomach by thrust applied outside the abdomen.
`into the fundus of the stomach by the Sacks-Vine
`Once the bladder 10 reaches the stomach, air is intro
`method, or by the fastener method. The P.E.G. tube 2
`duced through hollow stylet 13 into bladder 10 and the
`has an outside diameter of about 26 to 30 French (about
`inflated part of the bladder can help draw the rest of
`8.3 to 9.5 millimeters) and its one end forms a locking
`bladder 10 into the stomach.
`means 1 which securely holds the P.E.G. tube 2 in the
`Expansion of the gastric lumen by gas enables easy
`stomach. Locking means 1 is formed either by a flange,
`sliding of the apparatus 8 into the stomach. Bladder 10
`or by a balloon or by other configuration of protrusions
`is filled with fluid until it is fully extended in the lumen
`preventing the tube to be pulled out of the stomach. The
`of the stomach. The position of bladder 10, which con
`other end of P.E.G. tube 2 has an adapter 5 with outside
`tains a layer of a radiopaque dye is confirmed using
`threads 5 fitted to a plug 7. Plug 7, used when the
`fluoroscopy.
`25
`weight-loss apparatus is not in place, can be threaded or
`The placement procedure includes measuring the size
`friction set into adapter 5. A resilient skin disk 3 which
`of the stomach and the location of the fundus and the
`tightly grips tube 2 is usually placed over P.E.G. tube 2;
`pylorus of the stomach. On day 1 the patient comes to
`it secures P.E.G. tube 2 in place from outside against the
`the radiology department and has an air contrast upper
`abdominal wall.
`GI series taken after the patient has swallowed gas
`30
`Referring to FIGS. 2 and 4, a weight-loss device 8
`producing granules and radiology contrast fluid. The
`comprises a flexible filling tube 9, sized to pass through
`radiographs are taken in supine and erect position with
`P.E.G. tube 2 connected to a selected bladder 10. Blad
`a frontal projection and a lateral projection. The size
`der 10 is a non-elastic bag made of a biocompatible
`and location of the stomach is thus determined from
`material with a layer of radiopaque dye and is shaped to
`these radiographs. The computer tomography scanner
`35
`fit the stomach of this patient. The bladder has a volume
`can also be used; however, most of the morbidly obese
`of 1 to 2 liters and is envisioned to be selected from a set
`patients will exceed the weight limit on the computer
`of sizes and shapes to custom fit to the size and shape of
`tomograph table. After the upper gastrointestinal series
`the particular patient's stomach. Filling tube 9 is much
`the patient is allowed to eat during day 1 including the
`stiffer than bladder 10 so that it will retain its shape
`evening meal. However, the patient is not allowed to
`under pressure. Filling tube 9 is closely fitted to P.E.G.
`eat thereafter.
`tube 2 without placing it under compression or disturb
`On day 2, by the morning the x-ray contrast has now
`ing it. Furthermore, filling tube 9 of P.E.G. tube 2 is
`progressed into the colon. Under the fluoroscope the
`fitted with several inches of a waterproof seal 17. Seal
`colon is now clearly visible. Referring to FIGS. 2a-2f
`17 prevents leakage of the stomach juices onto the pa
`an endoscope 40 is inserted down the esophagus in the
`45
`tient's skin. The length of filling tube 9 is between 20 to
`usual way, and the stomach is inflated with air in order
`30 centimeters so that some excess length is attained.
`to examine the stomach walls. A proper location in the
`The portion of the filling tube extending from the
`body of the stomach is chosen for insertion of the
`P.E.G. tube. That place is locally anesthetized. A tiny
`P.E.G. tube is attached to the stomach wall. Outside,
`threads 11 of the free end of filling tube 9 are con
`incision on the skin only is made and a needle is pushed
`50
`structed to fit inside matching threads 14 of a screw-on
`through the abdominal wall from outside into the stom
`stylet cap 12, as shown in FIG. 3. All parts used in
`ach while it is visualized by the endoscope, FIG. 2a.
`Through this needle a guidewire 42 is passed into the
`construction of device 8 are made of durable and bi
`ocompatible material.
`stomach. As shown in FIG.2b, the guidewire is grasped
`by flexible forceps which are introduced through the
`Referring to FIG. 4, P.E.G. tube 2 is introduced at a
`endoscope's operating channel which is a part of the
`preselected point to ensure that access is gained to the
`endoscope. The guidewire is then drawn up the esopha
`upper part of the stomach called "fundus", in which it is
`gus and out of the mouth. The tapered end of P.E.G. 2
`desired to locate the bladder. In order to effectively
`control the patient's desire to eat, inflated bladder 10 is
`tube also called the Sacks-Vine tube is attached to the
`positioned primarily in the fundus where most of the
`wire which protrudes out of the mouth. The narrow
`neuroreceptors are located in the mucosa of the gastric
`end of the P.E.G. tube with a loop at the end is attached
`wall. If pressure on the gastric wall is exerted, they send
`to guidewire 42 shown in FIG. 2c. The wire with the
`attached tube is then drawn back through the esophagus
`signals to the brain which cause satiety. Therefore it is
`into the stomach by pulling on the end of the wire pro
`critical to properly position bladder 10 in the stomach
`truding from the abdomen. As the guidewire is slowly
`by selection of the point of percutaneous placement of
`65
`pulled out, the tapered end of the P.E.G. tube enters
`the P.E.G. tube, as well as to select a bladder of an
`and slowly increases the size of the puncture through
`appropriate size. Thus, bladder 10 will primarily oc
`the abdominal wall shown in FIG. 2d. The entire proce
`cupy the fundus and the upper part of the gastric lumen.
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`mately 1 kg. Electronic control means 38 shares the
`dure is done only under local anesthesia. The tapered
`information from the sensors and governs the filling and
`Sacks-Vine tube wedges through the layer of fat of the
`emptying process according to predetermined criteria.
`morbidly obese patient, typically six to eight inches.
`Two-way valve 32 is adapted to measure volume of
`This process continues until flange 1 located at the end
`fluid pumped through by pump 34. This information
`of the P.E.G. tube is tightly pressed against the stomach
`and the filling and emptying times are also recorded by
`wall shown in FIG.2e. Once a tight fit is achieved, the
`outside part of P.E.G. tube 2 is cut off to be the appro
`electronic control means 38.
`In another embodiment pump 34 is an air pump
`priate length. Skin disk 3 friction fed in place, and the
`which forces air in and out of bladder 10. In this ar
`P.E.G. tube is closed with a plug.
`rangement there is no fluid reservoir needed and an air
`Seven to ten days later, the patient returns to have the
`port 35 is used. This pump may be actuated by the
`pre-packaged and vacuum prepacked device 8, FIG. 3
`patient according to times or other criteria prescribed
`inserted into the stomach. This time period is needed for
`by the physician wherever the patient may be. In any
`proper healing of the abdominal wall, where the P.E.G.
`event, a regime of frequent filling and emptying of the
`tube is inserted. The patient is asked to swallow gas
`bladder is essential in order to prevent trauma to the
`producing granules in order to introduce air into the
`gastric mucosa, which could be caused by permanently
`stomach. This opens a free space inside of the stomach,
`so that there is enough space for the bladder to be intro
`inflated bladder.
`To remove apparatus 8 from the stomach of the pa
`duced and opened without any pressure against other
`tient one can simply withdraw the fluid from the blad
`organs. Accordingly, through the assistance of the dis
`der 10 through the stylet 13 by a syringe or using pump
`talend 13a of the distending stylet, the bladder 10 of the
`20
`34 and then pull the apparatus out of the stomach.
`device is introduced into the stomach.
`FIG. 4 shows the device 8 thus positioned in place.
`In another embodiment, bladder 10 is filled with a
`mixture of 80 to 90 percent of liquid such as water, or
`P.E.G. tube 2 has flange 1 which seals the gastric wall
`saline adding radiopaque contrast fluid and 10 to 20
`to prevent leakage of the gastric juices out of the gastric
`percent of air. This mixture of liquid and air will tend to
`lumen. On the outside, friction skin disc 3 seals P.E.G.
`25
`keep the filled bladder 10 floating on top of the solid and
`tube 2 against the abdomen and prevents the tube from
`liquid food in the upper anterior part of the stomach and
`falling into the stomach. A sealing O-ring 17 forms a
`away from the pylorus, thus making an gastric outlet
`water tight seal between P.E.G. tube 2 and filling tube
`9 of apparatus 8 in order to prevent the gastric juices
`obstruction by bladder 8 less likely.
`from leaking out onto the skin.
`What is claimed is:
`30
`1. A method of causing weight loss in obese humans
`Referring to the embodiment of FIG. 5, filling tube 9
`by occupying a segment of the stomach volume using
`is in this case sealed at the top by a ball valve 19. Ball
`an inflated bladder, said method comprising the steps of:
`valve 19 has an inlet passage 20, ball 22, a spring 24 and
`(a) measuring the volume and location of the stomach
`inside threads 26 which fit onto outside threads 11 of
`including the fundus by radiological techniques,
`filling tube 9. The mechanism of the ball valve 19 pre
`35
`(b) selecting a bladder contoured in size and shape to
`vents the bladder from emptying itself since the bladder
`substantially occupy the fundus or the body of the
`is most of the time under positive pressure exerted by
`stomach measurement,
`the abdomen. Ball valve 19 is designed to be used with
`(c) introducing by percutaneous endscopic tech
`a syringe to allow easy filling and emptying of bladder
`niques a percutaneous endoscopic gastrostomy
`10. If a tip of a syringe is introduced to inlet passage 20,
`40
`ball 22 is pressed against spring 24; this enables filling or
`(P.E.G.) tube to establish access from the outside
`to the body of the stomach through the abdominal
`emptying of bladder 10 with gas or liquid.
`wall,
`In another embodiment, filling tube 9 can be sealed
`(d) inserting said bladder through said percutaneous
`by simply folding it, as shown in FIG. 6. To hold filling
`endoscopic gastrostomy tube into the stomach so
`tube 9 folded, a clamp 26 is used. Clamp 26 can be
`45
`the size and shape of said bladder, cooperating with
`replaced by a ring or rubber band. FIG. 7 shows ring 19
`the position of placement of said gastrostomy tube,
`bonded to filling tube 9 used to close apparatus 8.
`maintains said bladder in the upper part of the
`In another embodiment shown in FIG. 8, a filling
`system 30 automatically performs filling and emptying
`stomach including the fundus, and
`(e) filling and emptying said bladder with fluid re
`of the bladder. A two-way valve 32 of filling system 30
`50
`peatedly over time through a filling tube that ex
`is attached to outside threads 11 of filling tube 9. Two
`tends through said gastrostomy tube, in the manner
`way valve 32 is connected to a pump 34 which forces
`that said bladder when filled occupies a large por
`fluid which advantageously may be liquid, in and out of
`tion of said stomach to cause a feeling of satiety,
`the bladder into a fluid reservoir 36 according to a
`thereby to achieve decreased consumption of food
`desired sequence. Operation of two-way valve 32 and
`55
`by a patient, and said emptying of said bladder
`pump 34 is automatically controlled by an electronic
`provides periods of reduced trauma to the stomach
`control means 38. Electronic control means 38 powered
`to promote the patient's health and feeling of well
`by a battery is connected to a plurality of sensors 40,
`being, said bladder capable of being withdrawn
`which are placed on apparatus 8 and in several locations
`from said stomach through said P.E. G. tube to
`of the patient's body. The sensors monitor indicators of
`60
`enable inspection and replacement and to enable
`digestion and hemodynamic parameters of the patient.
`ready access to the lumen of the stomach through
`The sensors placed on bladder 10 in the gastric lumen
`can measure the acidity of the gastric juices, pressure on
`the abdominal wall.
`2. The method of claim 1 wherein said measurement
`bladder 10 from outside exerted by the smooth muscle
`of the stomach and food present in the stomach. The
`of the volume and location of said stomach is conducted
`65
`by employing an air contrast upper GI series, including
`sensors can further measure the body temperature, the
`pulse and other hemodynamic parameters. Filling sys
`the making of frontal and lateral projection radio
`graphs.
`tem 30