U.S. patent application number 09/792234 was filed with the patent office on 2001-11-01 for percutaneous intragastric balloon catheter for the treatment of obesity.
Invention is credited to De Hoyos Garza, Andres.
Application Number | 20010037127 09/792234 |
Document ID | / |
Family ID | 32986009 |
Filed Date | 2001-11-01 |
United States Patent
Application |
20010037127 |
Kind Code |
A1 |
De Hoyos Garza, Andres |
November 1, 2001 |
Percutaneous intragastric balloon catheter for the treatment of
obesity
Abstract
The present invention relates to a percutaneous intragastric
balloon catheter for the treatment of obesity. The invention
occupies a portion of the gastric cavity causing a feeling of
satiety and decreasing the consumption of food by an obese patient.
This invention consists in a percutaneous intragastric balloon that
is placed in a non-surgically form. The percutaneous intragastric
balloon catheter is collocated by percutaneous endoscopic
gastrotomy (PEG). The invention comprises an affixed valve for
regulating the amount of fluid introduced or evacuated from the
percutaneous intragastric balloon.
Inventors: |
De Hoyos Garza, Andres;
(Mexico City, MX) |
Correspondence
Address: |
Paul J. Ethington
REISING ,ETHINGTON , BARNES, KISSELLE,
LEARMAN & McCULLOCH, P.C.
Post Office Box 4390
Troy
MI
48099
US
|
Family ID: |
32986009 |
Appl. No.: |
09/792234 |
Filed: |
February 23, 2001 |
Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61F 5/003 20130101;
A61M 25/04 20130101; A61M 2210/1053 20130101; A61M 25/10 20130101;
A61M 2025/0008 20130101; A61F 5/0036 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 029/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 24, 2000 |
MX |
001922 |
Claims
What is claimed is:
1. A percutaneous intragastric balloon catheter for the treatment
of obesity that occupies a segment of the stomach volume, said
device comprising: a percutaneous intragastric balloon shaped for
occupying a portion of the gastric cavity; a fillant catheter
connected to said percutaneous intragastric balloon for repeated
filling and emptying with a fluid and as means for supporting two
anchors and a valve; two anchors, external and internal, for
providing suitable surfaces that prevent movement of the
percutaneous intragastric balloon catheter while in the gastric
cavity; a valve for controlling the amount of fluid introduced or
evacuated from the percutaneous intragastric balloon through the
fillant catheter; a detachable cover that envelopes the extreme end
of the valve, which connects with the fillant device, during the
placement procedure; and, a fillant device that is loaded with the
appropriate amount of fluid for filling the percutaneous
intragastric balloon.
2. The percutaneous intragastric balloon catheter of claim 1,
wherein said percutaneous intragastric balloon, in its non-inflated
position, is covered with a plastic membrane during the placement
procedure.
3. The percutaneous intragastric balloon catheter of claim 1, which
is easily positioned into the stomach through the "Pull" or "Push"
technique, a preferred embodiment is by Percutaneous Endoscopic
Gastrostomy (PEG); and withdrawn by endoscopy.
4. The percutaneous intragastric balloon catheter of claim 1,
wherein said percutaneous intragastric balloon has a smooth surface
and is preferably constructed of a durable and biocompatible
material, such as surgical grade latex rubber.
5. The percutaneous intragastric balloon catheter of claim 1,
wherein said fillant catheter is non-rigid, circular and made of a
plastic material.
6. The percutaneous intragastric balloon catheter of claim 1,
wherein said fluid may be a gas, liquid, gel or a mixture
thereof.
7. The percutaneous intragastric balloon catheter of claim 1,
wherein a filament or thread is positioned on the surface of said
valve and underneath said detachable cover as means for
facilitating the placement procedure.
8. The percutaneous intragastric balloon catheter of claim 1,
wherein said external anchor is collocated on the abdominal wall
after the placement procedure.
9. The percutaneous intragastric balloon catheter of claim 1,
wherein said fillant device may be a pump or a hypodermic syringe.
Description
FIELD OF THE INVENTION
[0001] This invention relates to gastrostomy devices for use in the
treatment of obesity. More particularly, the invention relates to
percutaneous balloon catheters positioned in the stomach for
medical treatment of morbid obesity in humans.
BACKGROUND OF THE INVENTION
[0002] Morbid obesity is a chronic medical illness defined as
overweight of 50 to 100 percent above the ideal body weight.
Obesity is a major medical problem affecting millions of people
worldwide. In addition to the phychosocial stigmas associated with
the condition or disease, many serious health ramifications may
develop. Hypertension, hyperlipidemia, exacerbation of diabetes
mellitus, heart disease, degenerative arthritis, and Pickwickian
syndrome. Certain types of cancer, gallstones, varicose veins,
thromboembolism and hernias are more common among overweight
individuals. In addition, morbid obesity can lead to psychosocial
difficulties such as depression, loss of self-esteem and decreased
employability.
[0003] 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
behavioral modification, vigorous exercise, use of pharmaceuticals,
medical diets, surgical procedures and devices.
[0004] The recommended methods for weight loss are medical diets
and behavioral modification. However, many persons are unable to
achieve significant or sustained results using these methods
because they depend solely upon the willpower of the patients.
Sometimes vigorous exercise is recommended to achieve an increase
in energy output. However many obese individuals risk further
damage to their health from such activity (for example, heart
attacks).
[0005] Another solution involves pharmaceuticals, their use may
cause drawbacks such as the individual becoming addicted or
ill-affected by side effects. Sometimes, these drugs become less
potent over time due to the development of a high drug
tolerance.
[0006] 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.
[0007] In U.S. Pat. No. 4,133,315, Berman proposes placing a
distensible device within the lumen of the stomach having a filling
tube permanently extended up through the esophagus and out of the
nasal cavity or out of the mouth. While this method basically
assures retrieval of the balloon upon deflation, the extreme
discomfort and major inconvenience for the patient with this method
should be selfevident.
[0008] A surgical adjunct is described in U.S. Pat. No. 4,246,893.
An inflatable balloon-like device is implanted surgically through
an incision in the abdominal wall and the peritoneum into the upper
abdomen and anterior to the stomach, reducing its capacity.
[0009] U.S. Pat. Nos. 4,416,267 and 4,899,747 of Garren et al.,
disclose an intragastric balloon which is discharged into the
stomach through an orogastric introducer tube to provide satiety.
However, spontaneous deflation of the balloon is possible and
passage of the deflated device through the pylorus often results in
small bowel obstruction which requires surgery. Also it is believed
that the failure to show any significant increased weight loss may
be caused by a high incidence of spontaneous balloon deflation.
Furthermore this kind of adjunct presents the inconvenience of not
regulating the volume of the balloon according to the results in
weightloss or gastric discomfort of the patient.
[0010] A similar device for weight loss is set forth in U.S. Pat.
Nos. 4,485,805; 4,739,758 and 4,723,547 wherein a free-floating
intragastric balloon is placed in the stomach. The intragastric
balloon may be withdrawn by endoscopy using a loop that is placed
on the balloon. It is believed that mucosal erosion and gastric
ulceration in some patients are caused by the cylindrical shape of
the device and the balloon edges.
[0011] Catheters are commonly used as providing nourishment and for
gastrostomy tubes for the purpose of lavaging a patient's stomach.
Such gastrostomy devices have been the subject of U.S. Pat. Nos.
4,315,513 and 4,666,433. The use of an inflatable balloon as part
of the tube for holding it in place while feeding or lavaging is
set forth in U.S. Pat. Nos. 4,624,657 and 4,861,334.
[0012] A similar device is presented in U.S. Pat. No. 2,687,131;
the inflatable balloon is placed adjacent the drainage eyes of the
catheter.
[0013] U.S. Pat. No. 4,057,065 presents the use of two balloons
within a catheter: the gastrointestinal tube has an inflatable
balloon within the stomach to decompress it. A second inflatable
balloon is provided at the distal end of the tube which is
threatened through the pyloris, jejunum and ligament of Trietz and
into the small intestine where it may be inflated.
[0014] Gan et al., in U.S. Pat. No. 5,084,061 propose a
free-floating intragastric balloon with a self-sealing valve, using
an endoscope for inflating or deflating the balloon.
[0015] Bangs (U.S. Pat. No. 5,234,454), describes a fixation device
employing nylon garment T-fasteners to affix the anterior gastric
wall to the abdominal wall for percutaneous gastrostomy.
Nevertheless the intragastric balloon catheter is placed with
surgery.
[0016] U.S. Pat. No. 5,259,399 relates to a bladder being
positioned into and withdrawn from the stomach through a
percutaneous endoscopic gastrostomy tube permanently placed. The
method for collocating the tube is very complex and elaborate.
[0017] Chan et al. (U.S. Pat. No. 5,993,473), mention a device that
requires a gastrocutaneous fistula established in the obese
individual via a percutaneous endoscopic gastrostomy. The
disadvantage is that the fistula track is allowed to mature over a
long period of time, from 1 to 2 weeks.
[0018] Notwithstanding the above described art, there continues to
be a need for a percutaneous intragastric balloon catheter which
can be non-surgically placed in the lumen of the stomach with easy
collocation consisting of just one step, of simple and low cost
manufacture, with few collateral effects and that will provide
satiety to a patient without significant risk of morbidity.
SUMMARY OF THE INVENTION
[0019] It is a first object of the invention to provide an improved
percutaneous intragastric balloon catheter for the treatment of
obesity.
[0020] It is a second object of the invention to provide an
improved percutaneous intragastric balloon catheter which is easily
introduced by Percutaneous Endoscopic Gastrostomy (PEG).
[0021] It is a third object of the invention to provide an improved
percutaneous intragastric balloon catheter which has a low
ulceration and erosion potencial.
[0022] It is a fourth object of the invention to provide an
improved percutaneous intragastric balloon catheter which is
prevented from moving and/or prevented from excessive movement
while in the gastric cavity.
[0023] It is a fifth object of the invention to provide an improved
percutaneous intragastric balloon catheter for the gastric cavity
which is safe to use causing a feeling of satiety and that achieves
less consumption of food by a patient.
[0024] It is a sixth object of the invention to provide an improved
percutaneous intragastric balloon catheter having a low risk of
small bowel obstruction or esophageal obstruction.
[0025] It is a seventh object of the invention to provide a
percutaneous intragastric balloon catheter which comprises an
affixed valve, which permits to regulate the volume (filling and
emptying) of the percutaneous intragastric balloon since the
placement procedure thorough the treatment.
[0026] In one aspect of the invention, a percutaneous intragastric
balloon catheter is provided to cause weight loss in obese persons
by occupying a portion of the stomach volume. The balloon catheter
is positioned into the stomach through the "Pull" or "Push"
technique, more especifically by Percutaneous Endoscopic
Gastrostomy (PEG) and withdrawn by endoscopy, both are non-surgical
procedures.
[0027] The balloon is filled to occupy a large portion of the
stomach to cause a feeling of satiety and to decrease the
consumption of food by an obese patient. The emptying of the
balloon provides periods of reduced trauma to the stomach.
[0028] In another aspect of the invention, it is disclosed a
medical device for treatment of obese patients comprising a
percutaneous intragastric balloon, two anchors (internal and
external), a fillant catheter, a valve, a detachable cover, a
plastic membrane and a fillant device. The percutaneous
intragastric balloon is shaped for occupying a portion of the
stomach and is preferably constructed of a durable and
biocompatible material, such as surgical grade latex rubber. Both
anchors are present to provide suitable surfaces that prevent
movement of the percutaneous intragastric balloon catheter while in
the gastric cavity. The purpose of the fillant catheter, which is
connected to said percutaneous intragastric balloon, is having
means for filling and emptying the percutaneous intragastric
balloon and as means for supporting both anchors and the valve. The
above referenced system comprises a valve for controlling the
amount of fluid introduced or evacuated from the percutaneous
intragastric balloon through the fillant catheter. The detachable
cover envelopes the extreme end of the valve, which connects with
the fillant device, during the placement procedure of the
percutaneous intragastric balloon catheter. The purpose of the
plastic membrane is to envelop the percutaneous intragastric
balloon, in its non-inflated position, facilitating its passage
through the gastrointestinal tract while collocating the system.
The fillant device is loaded with the appropriate amount of fluid
for filling the percutaneous intragastric balloon.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] FIG. 1 shows a longitudinal cross-sectional view of the
percutaneous intragastric balloon catheter in its inflated position
according to the present invention.
[0030] FIGS. 2 and 3 show the placement procedure for the
percutaneous intragastric balloon catheter.
[0031] FIG. 4 shows a partial longitudinal cross-sectional view of
the percutaneous intragastric balloon catheter within the gastric
cavity of a person.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0032] With reference to FIG. 1, the present invention, the
percutaneous intragastric balloon catheter, is depicted by the
number 1. It comprises a non-rigid circular plastic fillant
catheter 6 having a distal end that includes a slot 11, through
which the fluid fills the percutaneous intragastric balloon 10,
shown in its inflated position. The aforementioned fluid may be a
gas, liquid, gel or a mixture thereof. An internal anchor 9 is
placed near the distal end of the fillant catheter to prevent
excessive movement of the percutaneous balloon 10 while in the
gastric cavity. As it can be appreciated in this figure, after
internal anchor 9 there is a portion 8 of the fillant catheter.
This portion 8 trespasses the abdominal wall. The external anchor 7
has the purpose of securing the percutaneous intragastric balloon
10 to the outside flank of the abdominal wall. On the proximal end
of the fillant catheter 6 there is a valve 5 for allowing the
fillant fluid to be introduced and evacuated from the fillant
catheter 6. The purpose of detachable cover 3 is to envelop the
extreme end of the valve 5, where the fillant device 13 (FIG. 4) is
connected, during the placement procedure (FIG. 2) and to
facilitate the passage of the valve 5 and fillant catheter 6
through the tiny incision on the skin made by a needle, as
described in FIG. 2. On the surface of the valve 5 and underneath
the detachable cover 3, a filament or thread 2 is positioned as
means for attaching the guidewire 15 (FIG. 2) during the process of
collocation.
[0033] FIGS. 2 and 3 show the placement procedure, and function of
the components of the percutaneous intragastric balloon catheter,
that include: inspecting with an endoscope 16 the lumen of the
stomach of the obese person. The endoscope 16 is introduced through
the mouth down the esophagus into the stomach, with a needle
puncturing the abdominal wall 12, through this puncture in the
abdominal wall inserting the guidewire 15 from the outside into the
fundus of the stomach, and grasping with the endoscope 16 the said
guidewire 15. Extracting one end of the guidewire 15 by pulling the
endoscope 16 out of the mouth while the other end of the guidewire
15 still remains outside of the abdomen 12. The percutaneous
intragastric balloon catheter 1 is placed through the abdominal
wall 12 by attaching the filament or thread 2 of the percutaneous
intragastric balloon catheter 1 to the guidewire 15 extended out of
the patient's mouth and pulling on the other end of the guidewire
15 until the filament or thread 2 of the percutaneous intragastric
balloon catheter 1 is pulled through the puncture opening in the
abdominal wall 12. The placed percutaneous intragastric balloon
catheter 1 is secured on the stomach wall with the internal anchor
9, then the external anchor 7 is collocated through the proximal
end, after the procedure of Percutaneous Endoscopic Gastrostomy
(PEG), further securing the medical device 1 on the abdominal wall.
As it can be seen in both figures, a plastic membrane 14 is
covering the percutaneous intragastric balloon catheter 1. This
membrane 14 has the function of compacting the percutaneous
intragastric balloon, also the membrane 14 can be covered with a
biocompatible lubricant to facilitate the passage through the
mouth, esophagus and stomach. After the placement procedure, the
membrane 14 is removed (FIG. 3) using biopsy clamps 17 attached to
an endoscope 16.
[0034] FIG. 4 shows the percutaneous intragastric balloon catheter
1 as it is collocated within the gastric cavity of a person. In
this figure, it can be appreciate that the percutaneous
intragastric balloon 10, in its inflated position, has a smooth
surface to prevent gastric erosion. Anchors 7 and 9 are holding the
percutaneous intragastric balloon catheter 1 attached to the
abdominal wall 12 preventing accidental withdrawal of the
percutaneous intragastric balloon associated with deflation and
passage of the above mentioned balloon into the small bowel and
esophagus. Valve 5 is connected with the fillant device 13 that
provides an adequate amount of fluid for filling the percutaneous
intragastric balloon 10, as it can be observed in the schematic
representation. Fillant device 13 may be a pump or a hypodermic
syringe that forces the fluid in and out of the percutaneous
intragastric balloon 10.
[0035] Based upon the foregoing disclosure, certain embodiments and
details have been described for the purpose of illustrating the
present invention, it will be apparent to those skilled in the art
that variations and modifications may be made without departing
from the scope of the invention.
* * * * *