Weight loss 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 according to a predetermined scheme. The
filling system comprises a reversible pump, a two-way valve connected
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
parameters. The electronic control means collects information detected
by the sensors, governs the filling system according to the obtained
information and predetermined operation scheme, and records times
and volumes of the fluid transferred through the two-way valve.
Weight loss claims
What is claimed is:
1. A method of causing weight loss in obese humans by occupying
a segment of the stomach volume using an inflated bladder, said
method comprising the steps of:
(a) measuring the volume and location of the stomach including
the fundus by radiological techniques,
(b) selecting a bladder contoured in size and shape to substantially
occupy the fundus or the body of the stomach measurement,
(c) introducing by percutaneous endscopic techniques a percutaneous
endoscopic gastrostomy (P.E.G.) tube to establish access from the
outside to the body of the stomach through the abdominal wall,
(d) inserting said bladder through said percutaneous endoscopic
gastrostomy tube into the stomach so the size and shape of said
bladder, cooperating with the position of placement of said gastrostomy
tube, maintains said bladder in the upper part of the stomach including
the fundus, and
(e) filling and emptying said bladder with fluid repeatedly over
time through a filling tube that extends through said gastrostomy
tube, in the manner that said bladder when filled occupies a large
portion of said stomach to cause a feeling of satiety, thereby to
achieve decreased consumption of food by a patient, and said emptying
of said bladder provides periods of reduced trauma to the stomach
to promote the patient's health and feeling of well being, said
bladder capable of being withdrawn from said stomach through said
P.E. G. tube to enable inspection and replacement and to enable
ready access to the lumen of the stomach through the abdominal wall.
2. The method of claim 1 wherein said measurement of the volume
and location of said stomach is conducted by employing an air contrast
upper GI series, including the making of frontal and lateral projection
3. The method of claim 1 wherein said measurement of the volume
and location of said stomach is conducted by employing computerized
4. The method of claim 1 wherein said introduction of said P.E.G.
tube in said obese person comprises the steps of:
(a) inspecting said stomach of said obese person using both an
endoscope and a fluoroscope, said endoscope introduced into the
stomach through the mouth down through the esophagus,
(b) establishing a location for said gastrostomy tube placed to
maintain said bladder in the desired position,
(c) when a needle, forming a puncture in the abdomen at said location,
the needle passing through the thick layer of abdominal fat of said
obese person, and via said puncture inserting a guidewire from outside
through the abdominal wall into said fundus of said stomach, grasping
the distal portion of said guidewire using said introduced endoscope
and by pulling said endoscope out of the mouth extracting the distal
end of said guidewire out of the mouth while the proximal end of
said guidewire is held outside of the puncture formed in the abdomen,
(d) placing said gastrostomy tube through the abdominal wall by
attaching said gastrostomy tube to the distal portion of said guidewire
while said portion extends out of the patient's mouth and pulling
on the proximal end of said guidewire until said percutaneous endoscopic
gastrostomy tube passes through the esophagus, stomach, and abdominal
wall to the outside, and
(e) securing said sealing said placed gastrostomy tube on the stomach
wall and on the abdominal wall and cutting said gastrostomy tube
to the appropriate length.
5. The method of claim 1 further comprising the steps of:
(a) removing said bladder from the stomach through said gastrostomy
(b) inserting an endoscope into the stomach through said gastrostomy
tube in order to examine the gastric wall for trauma and ulceration,
(c) re-inserting said bladder through said gastrostomy tube into
the stomach so the size and shape of said bladder, cooperating with
the position of placement of said gastrostomy tube, again maintains
said bladder in the fundus or the body of the stomach.
6. The method of claim 1 wherein said repeated filling or emptying
said bladder is automatically controlled by a filling system.
7. The method of claim 1 further including the steps of:
(a) detecting condition of said obese patient with sensors measuring
indicators of digestion and hemodynamic parameters,
(b) transmitting information from said sensors to an electronic
control means linked to a filling system used for filling and emptying
said bladder, and
(c) controlling filling and emptying of said bladder by said filling
system using said electronic control means.
8. The method of claim 6 wherein said filling and emptying of said
bladder being performed by a reversible air pump forcing air into
said bladder or releasing air from said bladder as governed by said
electronics control means receiving input from said sensors and
operating according a predetermined procedure.
9. The method of claim 6 further including manually inducing said
filling or emptying of said bladder by overriding said electronics
control means connected to said filling system.
10. A medical device for treatment of obese humans by occupying
a segment of the stomach volume comprising
a bladder sized and shaped to substantially occupy the fundus or
the body of the stomach,
a filling tube connectable to said bladder for repeated filling
and emptying of said bladder located in the stomach of said obese
said filling tube and said bladder collapsed in condition to pass
through a percutaneous endoscopic gastrostomy (P.E.G.) tube into
the stomach, said filling tube having sufficient lengths to extend
proximally through said gastrostomy tube to enable said filling
and emptying of said bladder.
11. The device of claim 10 including a stylet extending into the
bladder to enable thrusting of the collapsed bladder through said
P.E.G. tube into the stomach.
12. A system for automatically filling and emptying a bladder positioned
in the stomach to enable weight loss in obese humans, said system
being connected to a bladder through a filling tube, said system
(a) a valve adapted to control amount of fluid introduced or released
from said bladder through said filling tube,
(b) a reservoir of fluid for introduction into said bladder through
said valve, and
(c) an electronics control means for controlling filling and emptying
said bladder with said fluid according to a predetermined set of
13. A system for automatically filling and emptying a bladder positioned
in the stomach in order to cause weight loss in obese humans, said
system being connected to said bladder through a filling tube, said
(a) a valve for controlling amount of fluid introduced or released
from said bladder through said filling tube,
(b) a pump for introducing air into said bladder through said valve,
(c) an electronics control means for controlling filling and emptying
said bladder with said fluid according to a predetermined set of
14. The system of claim 12 or 13 further comprising a plurality
of sensors connected to provide information to said electronic control
said sensors being placed in the human body to monitor indicators
of digestion or hemodynamic parameters and said electronic control
means adapted to control said filling and emptying of said bladder
in accordance with digestive cycles corresponding to said indicators.
15. A system of claim 12 or 13 wherein said electronic control
means is adapted to keep an electronic record of inflation and deflation
times and volumes of fluid passed through said valve.
Weight loss description
BACKGROUND OF THE INVENTION
This invention relates to devices for medical treatment 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 predominantly genetic
origin, onset of disease in youth, a generally 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, hyperlipidemia and exacerbation
of diabetes mellitus. These conditions, in turn, increase the risk
factors for coronary artery disease (heart attack) and cardiovascular
disease (stroke), which are leading causes of premature mortality
and morbidity. Obesity also produces mechanical and physical stresses
that aggravate or cause sciatica and joint problems, especially
arthritis of the hips and knees. Another serious disease limited
to obese individuals is a Pickwickian syndrome. This syndrome is
characterized by nighttime episodes of upper airway obstruction
which cause hypoxemia and, if left untreated, lead to pulmonary
hypertension and heart failure. Weight loss will reverse this disease
completely if instituted before permanent cardiac damage develops.
Multiple other medical problems are more common in obese individuals
such as gallstones, varicose veins, thromboembolism 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 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 have almost no side
effects or complications, when properly applied and monitored. However,
these methods 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 fail and the health risks
of staying morbidly obese are judged to be serious, should interventional
methods, including devices and surgical procedures, be employed.
Behavior modification and medical diets, nevertheless, remain useful
and necessary adjuncts to treatment 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, gastroplasty 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 disfunction
and failure, kidney stones, diarrhea and the need for further surgeries
to treat intestinal obstruction or hernias, 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 distension 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, suggested 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 effects associated with any surgical procedure
and presents complications when the balloon needs to be replaced.
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 Berman, 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 emptying of the
balloon provides periods of relief and feelings of well being for
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 deflating the balloon and the above-discussed
disadvantages of having a permanently attached filling tube, they
constructed detachable means for filling or emptying the balloon
introduced through the esophagus.
Similarly, Gan et al. (U.S. Pat. No. 5,084,061) recently 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 procedure conducted by a physician on a sedated patient.
In summary, there continues to be a need for an intragastric 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 withdrawn from the lumen of the stomach,
inspected, replaced if needed, and reinserted into the lumen of
the stomach. Preferably, all these steps should be done without
any sedation or any major discomfort to the patient.
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 stomach volume using a variable volume bladder,
the bladder being positioned into and withdrawn from the stomach
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 access to the fundus of the stomach through
the abdominal wall, selecting a bladder of size and shape to substantially
occupy the upper part of the stomach including the fundus and the
body of the stomach according to the performed radiological measurements,
and inserting the bladder through the P.E.G. tube into the stomach
so the size and shape of the bladder, cooperating with the position
of placement of the P.E.G. tube, maintains the bladder in the upper
part of the stomach including the fundus.
The method further includes the steps of filling and emptying the
bladder repeatedly through a permanently 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. The emptying
of the bladder provides periods of reduced 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 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 endoscope out of the
mouth extracting one end of the guidewire out of the mouth while
the other end of the guidewire still remains outside of the abdomen.
Subsequently, the P.E.G. tube is placed through the abdominal wall
by performing the steps of attaching the tapered 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 abdominal
wall, securing and sealing the placed gastrostomy tube on the stomach
wall and on the abdominal wall, and cutting the P.E.G. tube to the
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 radiographs or employing computerized tomography; removing
the bladder from the gastric lumen through the P.E.G. tube as when
it is desired to inspect or replace it; inserting an endoscope into
the gastric lumen through the P.E.G. tube and examining the lumen
for trauma or ulceration, and re-inserting through the P.E.G. tube
a bladder into the stomach so that the size and shape of the bladder,
cooperating with the position of placement 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 emptying 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 automatically
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 evacuated 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 information 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 bladder 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.
FIGS. 6 and 7 show a simple way of closing the filling tube on
the apparatus inserted in the stomach through the P.E.G. tube.
FIG. 8 shows a filling system designed to automatically fill and
empty the bladder of the apparatus.
DESCRIPTION OF THE PREFERRED EMBODIMENT(s)
Referring to FIG. 1, a morbidly obese patient, lying in a supine
position on his back with his head to the left and his legs to the
right, is shown in vertical longitudinal cross-section with a percutaneous
endoscopic gastrostomy (P.E.G.) tube 2 in place. P.E.G. tube 2,
creating a permanent channel to the stomach 4, is inserted into
the fundus of the stomach by the Sacks-Vine method, or by the fastener
method. The P.E.G. tube 2 has an outside diameter of about 26 to
30 French (about 8.3 to 9.5 millimeters) and its one end forms a
locking means 1 which securely holds the P.E.G. tube 2 in the stomach.
Locking means 1 is formed either by a flange, or by a balloon or
by other configuration of protrusions preventing the tube to be
pulled out of the stomach. The other end of P.E.G. tube 2 has an
adapter 5 with outside threads 5 fitted to a plug 7. Plug 7, used
when the weight-loss apparatus is not in place, can be threaded
or friction set into adapter 5. A resilient skin disk 3 which tightly
grips tube 2 is usually placed over P.E.G. tube 2; it secures P.E.G.
tube 2 in place from outside against the abdominal wall.
Referring to FIGS. 2 and 4, a weight-loss device 8 comprises a
flexible filling tube 9, sized to pass through P.E.G. tube 2 connected
to a selected bladder 10. Bladder 10 is a non-elastic bag made of
a biocompatible material with a layer of radiopaque dye and is shaped
to fit the stomach of this patient. The bladder has a volume of
1 to 2 liters and is envisioned to be selected from a set of sizes
and shapes to custom fit to the size and shape of the particular
patient's stomach. Filling tube 9 is much stiffer than bladder 10
so that it will retain its shape under pressure. Filling tube 9
is closely fitted to P.E.G. tube 2 without placing it under compression
or disturbing it. Furthermore, filling tube 9 of P.E.G. tube 2 is
fitted with several inches of a waterproof seal 17. Seal 17 prevents
leakage of the stomach juices onto the patient's skin. The length
of filling tube 9 is between 20 to 30 centimeters so that some excess
length is attained. The portion of the filling tube extending from
the P.E.G. tube is attached to the stomach wall. Outside, threads
11 of the free end of filling tube 9 are constructed to fit inside
matching threads 14 of a screw-on stylet cap 12, as shown in FIG.
3. All parts used in construction of device 8 are made of durable
and biocompatible material.
Referring to FIG. 4, P.E.G. tube 2 is introduced at a preselected
point to ensure that access is gained to the upper part of the stomach
called "fundus", in which it is desired to locate the
bladder. In order to effectively control the patient's desire to
eat, inflated bladder 10 is positioned primarily in the fundus where
most of the neuroreceptors are located in the mucosa of the gastric
wall. If pressure on the gastric wall is exerted, they send signals
to the brain which cause satiety. Therefore it is critical to properly
position bladder 10 in the stomach by selection of the point of
percutaneous placement of the P.E.G. tube, as well as to select
a bladder of an appropriate size. Thus, bladder 10 will primarily
occupy the fundus and the upper part of the gastric lumen.
FIG. 3 illustrates a system and method for introducing the bladder
10 or device 8 into the stomach through P.E.G. tube 2. A hollow
stylet 13 extends through a filling tube 9 into bladder 10 of apparatus
8. Hollow stylet 13 is longer than the device 8 so that a distal
portion 13 extends beyond the filling tube and engages the far wall
of the bladder. A proximal portion 15 also protrudes proximally
from stylet cap 12. Vacuum is applied to extended portion 15 of
hollow stylet 13 causing bladder 10 to collapse to the maximum degree
i.e. vacuum compressed. The assembly 8 is then inserted through
P.E.G. tube 2 into the stomach, the distal portion 13a of the stylet
serving to stiffen the assembly so that it can be slid axially through
the P.E.G. tube and into the stomach by thrust applied outside the
abdomen. Once the bladder 10 reaches the stomach, air is introduced
through hollow stylet 13 into bladder 10 and the inflated part of
the bladder can help draw the rest of bladder 10 into the stomach.
Expansion of the gastric lumen by gas enables easy sliding of the
apparatus 8 into the stomach. Bladder 10 is filled with fluid until
it is fully extended in the lumen of the stomach. The position of
bladder 10, which contains a layer of a radiopaque dye is confirmed
The placement procedure includes measuring the size of the stomach
and the location of the fundus and the pylorus of the stomach. On
day 1 the patient comes to the radiology department and has an air
contrast upper GI series taken after the patient has swallowed gas
producing granules and radiology contrast fluid. The radiographs
are taken in supine and erect position with a frontal projection
and a lateral projection. The size and location of the stomach is
thus determined from these radiographs. The computer tomography
scanner can also be used; however, most of the morbidly obese patients
will exceed the weight limit on the computer tomograph table. After
the upper gastrointestinal series the patient is allowed to eat
during day 1 including the evening meal. However, the patient is
not allowed to eat thereafter.
On day 2, by the morning the x-ray contrast has now progressed
into the colon. Under the fluoroscope the colon is now clearly visible.
Referring to FIGS. 2a-2f, an endoscope 40 is inserted down the esophagus
in the usual way, and the stomach is inflated with air in order
to examine the stomach walls. A proper location in the body of the
stomach is chosen for insertion of the P.E.G. tube. That place is
locally anesthetized. A tiny incision on the skin only is made and
a needle is pushed through the abdominal wall from outside into
the stomach while it is visualized by the endoscope, FIG. 2a. Through
this needle a guidewire 42 is passed into the stomach. As shown
in FIG. 2b, the guidewire is grasped by flexible forceps which are
introduced through the endoscope's operating channel which is a
part of the endoscope. The guidewire is then drawn up the esophagus
and out of the mouth. The tapered end of P.E.G. 2 tube also called
the Sacks-Vine tube is attached to the wire which protrudes out
of the mouth. The narrow end of the P.E.G. tube with a loop at the
end is attached to guidewire 42 shown in FIG. 2c. The wire with
the attached tube is then drawn back through the esophagus into
the stomach by pulling on the end of the wire protruding from the
abdomen. As the guidewire is slowly pulled out, the tapered end
of the P.E.G. tube enters and slowly increases the size of the puncture
through the abdominal wall shown in FIG. 2d. The entire procedure
is done only under local anesthesia. The tapered Sacks-Vine tube
wedges through the layer of fat of the morbidly obese patient, typically
six to eight inches. This process continues until flange 1 located
at the end of the P.E.G. tube is tightly pressed against the stomach
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 appropriate length. Skin
disk 3 friction fed in place, and the P.E.G. tube is closed with
Seven to ten days later, the patient returns to have the pre-packaged
and vacuum prepacked device 8, FIG. 3 inserted into the stomach.
This time period is needed for proper healing of the abdominal wall,
where the P.E.G. tube is inserted. The patient is asked to swallow
gas producing granules in order to introduce air into the stomach.
This opens a free space inside of the stomach, so that there is
enough space for the bladder to be introduced and opened without
any pressure against other organs. Accordingly, through the assistance
of the distal end 13a of the distending stylet, the bladder 10 of
the device is introduced into the stomach.
FIG. 4 shows the device 8 thus positioned in place. P.E.G. tube
2 has flange 1 which seals the gastric wall to prevent leakage of
the gastric juices out of the gastric lumen. On the outside, friction
skin disc 3 seals P.E.G. tube 2 against the abdomen and prevents
the tube from falling into the stomach. A sealing O-ring 17 forms
a water tight seal between P.E.G. tube 2 and filling tube 9 of apparatus
8 in order to prevent the gastric juices from leaking out onto the
Referring to the embodiment of FIG. 5, filling tube 9 is in this
case sealed at the top by a ball valve 19. Ball valve 19 has an
inlet passage 20, ball 22, a spring 24 and inside threads 26 which
fit onto outside threads 11 of filling tube 9. The mechanism of
the ball valve 19 prevents the bladder from emptying itself since
the bladder is most of the time under positive pressure exerted
by the abdomen. Ball valve 19 is designed to be used with a syringe
to allow easy filling and emptying of bladder 10. If a tip of a
syringe is introduced to inlet passage 20, ball 22 is pressed against
spring 24; this enables filling or emptying of bladder 10 with gas
In another embodiment, filling tube 9 can be sealed by simply folding
it, as shown in FIG. 6. To hold filling tube 9 folded, a clamp 26
is used. Clamp 26 can be replaced by a ring or rubber band. FIG.
7 shows ring 19 bonded to filling tube 9 used to close apparatus
In another embodiment shown in FIG. 8, a filling system 30 automatically
performs filling and emptying of the bladder. A two-way valve 32
of filling system 30 is attached to outside threads 11 of filling
tube 9. Two-way valve 32 is connected to a pump 34 which forces
fluid which advantageously may be liquid, in and out of the bladder
into a fluid reservoir 36 according to a desired sequence. Operation
of two-way valve 32 and pump 34 is automatically controlled by an
electronic control means 38. Electronic control means 38 powered
by a battery is connected to a plurality of sensors 40, which are
placed on apparatus 8 and in several locations of the patient's
body. The sensors monitor indicators of digestion and hemodynamic
parameters of the patient. The sensors placed on bladder 10 in the
gastric lumen can measure the acidity of the gastric juices, pressure
on bladder 10 from outside exerted by the smooth muscle of the stomach
and food present in the stomach. The sensors can further measure
the body temperature, the pulse and other hemodynamic parameters.
Filling system 30 is of hand-held size and weighs less than approximately
1 kg. Electronic control means 38 shares the information from the
sensors and governs the filling and emptying process according to
predetermined criteria. Two-way valve 32 is adapted to measure volume
of fluid pumped through by pump 34. This information and the filling
and emptying times are also recorded by electronic control means
In another embodiment pump 34 is an air pump which forces air in
and out of bladder 10. In this arrangement there is no fluid reservoir
needed and an air port 35 is used. This pump may be actuated by
the patient according to times or other criteria prescribed by the
physician wherever the patient may be. In any event, a regime of
frequent filling and emptying of the bladder is essential in order
to prevent trauma to the gastric mucosa, which could be caused by
permanently inflated bladder.
To remove apparatus 8 from the stomach of the patient one can simply
withdraw the fluid from the bladder 10 through the stylet 13 by
a syringe or using pump 34 and then pull the apparatus out of the
In another embodiment, bladder 10 is filled with a mixture of 80
to 90 percent of liquid such as water, or saline adding radiopaque
contrast fluid and 10 to 20 percent of air. This mixture of liquid
and air will tend to keep the filled bladder 10 floating on top
of the solid and liquid food in the upper anterior part of the stomach
and away from the pylorus, thus making an gastric outlet obstruction
by bladder 8 less likely.