U.S. patent application number 14/683268 was filed with the patent office on 2015-08-06 for apparatus for treating obesity by extracting food.
The applicant listed for this patent is ASPIRE BARIATRICS, INC.. Invention is credited to DAVID E. ALTOBELLI, MICHAEL AMBROGI, DEAN KAMEN, SAMUEL KLEIN, MOSHE SHIKE, STEPHEN B. SOLOMON, ERIC YEATON.
Application Number | 20150216696 14/683268 |
Document ID | / |
Family ID | 46304895 |
Filed Date | 2015-08-06 |
United States Patent
Application |
20150216696 |
Kind Code |
A1 |
KLEIN; SAMUEL ; et
al. |
August 6, 2015 |
APPARATUS FOR TREATING OBESITY BY EXTRACTING FOOD
Abstract
The present invention is directed to an apparatus and method for
treating obesity. A tube is positioned that passes through a
patient's abdominal wall into the upper digestive system of the
patient. The patient is allowed to carry out his/her everyday
affairs including ingesting food. After the patient has ingested
food, the food is extracted by pumping it out of the upper
digestive system through the tube. The present invention is less
invasive than current surgical procedures for reducing weight and
allows patients to live a normal and active lifestyle without
experiencing adverse side effects.
Inventors: |
KLEIN; SAMUEL; (CLAYTON,
MO) ; SOLOMON; STEPHEN B.; (NEW YORK, NY) ;
SHIKE; MOSHE; (LARCHMONT, NY) ; KAMEN; DEAN;
(BEDFORD, NH) ; AMBROGI; MICHAEL; (NORTH HAMPTON,
NH) ; ALTOBELLI; DAVID E.; (HOLLIS, NH) ;
YEATON; ERIC; (EPSOM, NH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ASPIRE BARIATRICS, INC. |
WILMINGTON |
DE |
US |
|
|
Family ID: |
46304895 |
Appl. No.: |
14/683268 |
Filed: |
April 10, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13610617 |
Sep 11, 2012 |
9039677 |
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14683268 |
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12792322 |
Jun 2, 2010 |
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13610617 |
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11191449 |
Jul 27, 2005 |
7815629 |
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12792322 |
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10702194 |
Nov 4, 2003 |
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11191449 |
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60423645 |
Nov 4, 2002 |
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60600496 |
Aug 10, 2004 |
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60618346 |
Oct 12, 2004 |
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Current U.S.
Class: |
604/516 ;
604/151; 604/174; 604/523; 604/96.01 |
Current CPC
Class: |
A61M 1/0023 20130101;
A61M 1/0082 20140204; A61F 5/0076 20130101; A61M 1/0072 20140204;
A61F 5/003 20130101; A61M 25/04 20130101; A61F 2002/044 20130101;
A61M 27/002 20130101; A61M 1/0068 20140204; A61M 2210/1053
20130101; A61M 1/008 20130101; A61J 15/0015 20130101; A61F 5/004
20130101; A61M 1/0062 20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00; A61M 27/00 20060101 A61M027/00; A61M 1/00 20060101
A61M001/00 |
Claims
1. An apparatus comprising: a. a tube comprising i. a distal end
portion having a sidewall with a plurality of holes located
therein, wherein said distal end portion is configured to be
disposed in an upper digestive system of a patient; and ii. a
proximal end portion that is configured to pass through the
patient's abdominal wall when the distal end portion of the tube is
disposed in the upper digestive system of the patient; and b. a
first retention member that is disposed on the distal portion of
the gastrostomy tube and attached to the tube to prevent
dislodgement of the tube, wherein the first retention member is
configured with respect to the tube so that the proximal end
portion of the tube will lie substantially flush with the patient's
abdominal surface when the distal end portion of the tube is
disposed in the upper digestive system of the patient, and wherein
the first retention member is configured with respect to the tube
so that a position of the retention member is adjustable with
respect to the tube to accommodate changes in thickness of the
abdominal wall.
2. The apparatus of claim 1, wherein the distal end portion of the
tube is adapted to automatically assume to a curved configuration
while it is positioned in an upper digestive system of the
patient.
3. The apparatus of claim 1, wherein the tube has a diameter that
is greater than 9.3 mm (28 French) in size.
4. The apparatus of claim 1, further comprising an inflatable
balloon attached to the distal end portion of the tube.
5. The apparatus of claim 1, further comprising valve configured to
permit removal of food from the upper digestive system through the
tube and to prevent matter from entering the upper digestive system
through the tube.
6. The apparatus of claim 1, further comprising a pump that is
attachable or permanently attached to the tube for removing food
from the upper digestive system of the patient.
7. The apparatus of claim 1, wherein the distal end portion of the
tube is at least 10 cm long.
8. The apparatus of any one of claims 1, wherein the holes are
about 5.times.7 mm in size and are spaced about 1-1.5 cm apart.
9. The apparatus of claim 1, wherein the first retention member is
attached to the tube via friction.
10. The apparatus of claim 1, wherein the first retention member is
attached to the tube via interference.
11. The apparatus of claim 1, wherein the proximal end portion of
the tube is configured to pass through the patient's abdominal wall
via the patient's mouth and esophagus.
12. The apparatus of claim 5, wherein the balloon is inflatable to
a volume of 100 mL to 850 mL.
13. The apparatus of claim 5, wherein the balloon is intermittently
inflatable.
14. The apparatus of claim 1, wherein the holes are located on the
sidewall in a spiral fashion.
15. The apparatus of claim 1, wherein the holes are spaced 1-1.5 cm
apart.
16. The apparatus of claim 1, wherein the distal end portion of the
tube has a funnel shaped tip.
17. The apparatus of claim 1, wherein the gastrostomy tube
comprises silicone.
18. A tube configured for being disposed into a patient's stomach
via the patient's mouth and esophagus, comprising a. a distal end
portion having a sidewall with a plurality of holes located
therein, wherein said distal end portion is configured to be
disposed in an upper digestive system of a patient; and b. a
proximal end portion that is configured to pass through the
patient's abdominal wall when the distal end portion of the tube is
disposed in the upper digestive system of the patient; said
proximal end having a coned tip to facilitate passage through the
abdominal wall.
19. The tube of claim 18, further comprising a wire at the tip of
the cone to facilitate passage through the abdominal wall.
20. The tube of claim 18, wherein the plurality of holes is located
on the sidewall in a spiral fashion.
21. The tube of claim 18, wherein the holes are spaced 1-1.5 cm
apart.
22. The tube of claim 18, wherein the holes are about 5.times.7 mm
in size.
23. The tube of claim 18, wherein the tube comprises silicone.
24. The tube of claim 18, wherein the distal end portion of the
tube is adapted to automatically assume to a curved
configuration.
25. The tube of claim 18, wherein the tube has a diameter that is
greater than 9.3 mm (28 French) in size.
26. The tube of claim 18, wherein the tube further comprises a
retention member attached to the tube to prevent dislodgement of
the tube after insertion through the abdominal wall.
27. The tube of claim 26, wherein the retention member is
inflatable.
28. The tube of claim 18, further comprising an inflatable balloon
attached to the distal end portion of the tube.
29. The tube of claim 18 suitable for implantation in a human
patient.
30. A method for resizing a gastrostomy tube placed through a
patient's abdominal wall to accommodate a reduction in an amount of
tissue in the patient's abdominal wall comprising: moving a
retention member attached to a proximal end portion of the
gastrostomy tube towards the patient's abdomen; and cutting off the
proximal end portion of the gastrostomy tube.
31. A method for placing a gastrostomy tube through a patient's
abdominal wall, wherein the gastrostomy tube comprises a tubular
sidewall, a distal end portion, and a proximal end portion,
comprising: visualizing an insertion site on the patient's abdomen;
making an incision at the insertion site; inserting a cannula
through the incision; inserting a guide wire comprising a proximal
end and a distal end through the cannula, such that the distal end
of the guide wire is inserted into the patient's stomach and the
proximal end of the guide wire extends out of the patient's
abdomen; pulling the distal end of the guidewire from the patient's
stomach and out of the patient's mouth; attaching the proximal end
portion of the gastrostomy tube to the distal end of the guide
wire; pulling the proximal end portion of the gastrostomy tube
through the incision by pulling the proximal end of the guide wire;
cutting the gastrostomy tube so that the proximal end portion of
the gastrostomy tube is substantially flush with the patient's
abdomen; and attaching a second retention member to the proximal
end portion of the gastrostomy tube so that the second retention
member lies substantially flush with the patient's abdomen.
32. The method of claim 31, wherein the step of pulling the
proximal end portion of the gastrostomy tube through the incision
continues until the proximal end portion of the gastrostomy tube
extends from the patient's abdomen and the distal end portion of
the gastrostomy tube is placed in the patient's stomach.
33. The method of claim 31, wherein the gastrostomy tube further
comprises a first retention member attached to the distal end
portion of the gastrostomy tube and wherein the step of pulling the
proximal end of the guide wire is performed until the proximal end
of the gastrostomy tube is pulled through the incision.
34. The method of claim 31, wherein the gastrostomy tube further
comprises a first retention member attached to the distal end
portion of the gastrostomy tube and wherein the step of pulling the
proximal end portion of the gastrostomy tube through the incision
continues until the proximal end portion of the gastrostomy tube
extends from the patient's abdomen and the first retention member
is flush with a wall of the patient's stomach.
35. The method of claim 31, wherein the step of visualizing an
insertion site is performed endoscopically.
36. The method of claim 31, wherein the step of visualizing an
insertion site is performed radiologically.
37. The method of claim 31, wherein the step of pulling the distal
end of the guidewire is performed with an endoscope.
38. The method of claim 31 further comprising insufflating the
patient's stomach with air, wherein the step of insufflating the
patient's stomach is performed before visualizing an insertion
site.
39. The method of claim 31, wherein the proximal end portion of the
gastrostomy tube comprises a conical tip, the method further
comprising cutting off the conical tip of the proximal end portion
of the gastrostomy tube, wherein the step of cutting off the
conical tip of the proximal end portion of the gastrostomy tube is
performed after the proximal end portion of the gastrostomy tube is
pulled through the incision.
40. The method of claim 31, further comprising removing the cannula
from the incision as the proximal end portion of the gastrostomy
tube is pulled through the incision.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 13/610,617, filed Sep. 11, 2012, which itself is a
divisional of U.S. patent application Ser. No. 12/792,322, filed
Jun. 2, 2010, now abandoned, which is a divisional of U.S. patent
application Ser. No. 11/191,449, filed Jul. 27, 2005, now U.S. Pat.
No. 7,815,629 which issued Oct. 19, 2010, which (a) is a
continuation-in-part application of U.S. patent application Ser.
No. 10/702,194, filed Nov. 4, 2003, now abandoned, which claims the
benefit of U.S. Provisional Application Ser. No. 60/423,645, filed
Nov. 4, 2002; and (b) claims benefit to U.S. Provisional
Application Ser. No. 60/600,496, filed Aug. 10, 2004 and U.S.
Provisional Application Ser. No. 60/618,346, filed Oct. 12, 2004.
The disclosures of the above-identified applications are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] Obesity is a major health problem in the United States and
other countries. The National Health and Nutrition Examination
Survey (1988-1994) reported that approximately 20-25% of Americans
are obese, while another study estimated the percentage of
overweight Americans to be between 60% and 65% (Flegal K M, Carroll
M D, Ogden C L, Johnson C L "Prevalence and trends in obesity among
US adults, 1999-2000" JAMA 2002; 288: 1723-1727). Obesity can cause
numerous health problems, including diabetes, degenerative joint
disease, hypertension, and heart disease. Weight reduction can be
achieved by increased caloric expenditure through exercise and/or
by reduced caloric consumption through diet. However, in most
cases, weight gain often recurs and improvements in related
co-morbidities are often not sustained.
[0003] Surgical procedures present an increasingly common solution
for obese patients. Surgical procedures include, for example,
stapled gastroplasty, banded gastroplasty, gastric banding, gastric
bypass surgery, and bilopancreatic bypass. However, these surgical
procedures are invasive, risky and expensive to perform, and many
patients regain a substantial portion of the lost weight.
SUMMARY OF THE INVENTION
[0004] The present invention is directed to apparatuses and methods
for treating obesity or facilitating weight loss. A passageway is
introduced into a patient's upper digestive system such that it
passes through the patient's abdominal wall. The patient is allowed
to carry out his/her everyday affairs including ingesting food.
After the patient has ingested food, the food is extracted by
pumping it out of the upper digestive system through the
passageway. This approach is less invasive than the procedures
discussed above, easy to perform, easy to reverse and has
successfully resulted in significant weight loss in obese
patients.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 is a schematic view of a first embodiment of the
present invention installed in a patient;
[0006] FIG. 1A is a schematic view of a tube;
[0007] FIG. 1B is an alternate view of a tube;
[0008] FIG. 1C is a cross sectional schematic view of a tube;
[0009] FIG. 2 is a schematic view of a variation of an embodiment
of the present invention that uses a manual bulb pump;
[0010] FIG. 3 is a schematic view of a variation of an embodiment
of the present invention that uses a syringe as a pump;
[0011] FIG. 4 is a schematic view of a variation of an embodiment
of the present invention that uses a bag connected to a pump;
[0012] FIG. 5 is a schematic view of how an embodiment of the
present invention can be cleaned;
[0013] FIG. 6 is a schematic view of a second embodiment of the
present invention that uses an inflated balloon anchor;
[0014] FIG. 7 is an axial cross sectional schematic view showing
valves provided in the lumens of a tube in an embodiment of the
present invention;
[0015] FIG. 8 is a schematic view of a third embodiment of the
present invention having a tube with two balloons attached to that
portion of the tube that is disposed within the patient's digestive
system;
[0016] FIG. 9 is a schematic view of a fourth embodiment of the
present invention having a tube with a curved configuration and a
plurality of holes in a sidewall;
[0017] FIG. 10 is a schematic view of a fifth embodiment of the
present invention having a tube with a curved configuration,
multiple holes in a sidewall, and a morcellation device housed
within a cage at its distal end portion;
[0018] FIG. 11 is a schematic view of the proximal end portion of a
tube lying substantially flush with a patient's abdominal wall;
[0019] FIG. 12 is a schematic view of a luer lock at the proximal
end portion of a tube;
[0020] FIG. 13 is a schematic view of a variation of an embodiment
of the present invention having a tube with a funnel shaped
tip;
[0021] FIG. 14 is a schematic view of a sixth embodiment of the
present invention having two intake tubes;
[0022] FIG. 15A and FIG. 15B are schematic views of an embodiment
of the present invention installed in a patient illustrating how
the apparatus accommodates changes in thickness of the abdominal
wall of a patient;
[0023] FIG. 16 illustrates how an embodiment of the present
invention installed in a patient is used.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0024] As used herein, the term "food" includes both solid and
liquid substances that have been ingested by the patient, the term
"ingest" or "ingested" includes eating and drinking, and the term
"upper digestive system" includes the stomach 3, duodenum 4 and
proximal jejunum of the patient.
[0025] In a first embodiment of the present invention as shown in
FIG. 1, a transabdominal tube 1 is placed through a patient's
abdominal wall such that a distal end portion 17 of the tube 1 is
disposed inside the stomach 3 of the patient and a proximal end
portion 16 of the tube 1 extends out from the skin 5 of the
patient. The tube 1 preferably has a diameter that is 20 to 36
French or 26 to 36 French in size (1 French=1/3 mm). Most
preferably, the diameter is greater than 28 French and the tube
resists collapsing when extraction is performed. Optionally, the
tube 1 may be stiffened, made durable and less collapsible by, for
example, braiding the tube using nylon. Alternatively, the tube may
be wrapped with wire material. Suitable materials for the tube 1
include polyurethane, silicone and other similar materials. The
tube 1 may be opaque.
[0026] A retention member is attached to the tube 1 to prevent the
tube 1 from falling out of the patient. In one embodiment, the
retention member is inflatable such as the inflation portion 2
(balloon anchor) shown in FIG. 1. As shown in FIG. 1, the inflation
portion 2 is provided at the distal end portion 17 of the tube 1 to
prevent the tube 1 from coming out of the stomach 3. FIG. 1 also
illustrates a non-inflatable retention member flange 2' at the
proximal end portion 16 of the tube 1 to prevent the tube 1 from
falling into the patient's upper digestive system. A cap 13 is
detachably provided at the end of the proximal end portion 16 and
seals the tube 1 when it is attached. The cap 13 is removed when a
pump 8, 9 (shown in FIGS. 2 and 3, respectively) is attached to the
tube 1 to remove food from the upper digestive system of the
patient.
[0027] Reference is now made to methods which may be used to insert
the tube 1. These methods entail less risk of complications and
less cost than conventional, surgical methods of treating obesity,
and patients who undergo these treatments are typically discharged
the same day of the operation. These methods are therefore
especially advantageous for use in treating obese patients because
such patients are at increased risk for surgical complications due
to their obesity.
[0028] The tube 1 may be inserted, for example, through a procedure
similar to insertion of feeding tubes by Percutaneous Endoscopic
Gastrostomy (PEG). A variety of methods of performing PEG are well
known in the art, and any one of the methods may be used to insert
the tube 1. PEG procedures have been successfully completed in over
90 percent of attempts. PEG may be performed under conscious
sedation induced by, for example, meperidine and midazolam.
According to one method of PEG known as the pull method, an
endoscope is inserted into the stomach through the mouth of the
patient. The stomach is insufflated by blowing air into the stomach
through the endoscope. The insufflation brings the stomach in
apposition to the abdominal wall and allows for direct access from
the skin to the stomach of the patient.
[0029] An insertion site is located by surveying the interior of
the stomach with the endoscope. The endoscope is then used to
illuminate the selected insertion site in such a way that the light
of the endoscope is visible from outside of the patient's body
through the skin of the patient.
[0030] An incision is made at the place on the patient's skin
indicated by the light from the endoscope and at the corresponding
location on the exterior wall of the stomach. A cannula is then
inserted through the incision and a guide wire is inserted into the
stomach through the cannula. Graspers on the end of the endoscope
grab hold of the distal portion of the guide wire in the stomach
and the endoscope is withdrawn from the patient while the graspers
hold the guide wire. The guide wire is of sufficient length to
allow a proximal portion of it to extend out of the patient from
the cannula after the distal portion is withdrawn from the stomach
and through the patient's mouth by the endoscope.
[0031] The end of the guide wire extending out from the patient's
mouth is attached to the proximal end of the tube 1, which is drawn
though the mouth and esophagus and into the stomach of the patient
by pulling on the proximal end of the guide wire. The tube 1 is
then pulled through the incision in the stomach and skin of the
patient until only the distal end portion 17 and the inflation
portion 2 of the tube 1 remain inside of the stomach. Optionally,
the tube 1 may have a coned tip to help move the tube 1 through the
incision in the stomach. Optionally, a wire at the tip of the cone
may be used for pulling the tube 1 through the incision. Once the
tube 1 is in place, the coned tip may be cut off. The cannula is
removed as the proximal end 16 of the tube 1 is drawn through the
incision in the stomach, and is removed entirely when the proximal
end 16 of the tube 1 is disposed at the patient's skin. The
inflation portion 2 of the tube 1 is then inflated by introducing
fluid into the inflation portion 2 through the inflation lumen 26.
The inflated inflation portion holds the tube 1 in place and the
guide wire is removed from the tube 1. A non-inflatable retention
member such as a flange 2' may be placed on the proximal end
portion 16 of the tube 1 to keep the tube 1 disposed at the
patient's skin.
[0032] An alternate method of PEG known as push PEG may also be
used to insert the tube 1. The tube 1 is pushed through the
incision in the stomach and the skin of the patient until it is
disposed as described hereinabove with respect to the pull
method.
[0033] A third method which may be used for inserting the tube 1
via PEG is known as the Russell method. As with both the push
method and the pull method, the insertion site is located via
endoscopy. An incision is made in the skin and stomach and a guide
wire is inserted through the incision into the stomach via a
cannula or needle. A dilator (or introducer) with a peel away
sheath is guided along the guide wire and inserted into the
stomach. After the dilator (introducer) and sheath are inside the
gastric lumen, the dilator is removed and the tube 1 is inserted
along the guide wire and through the peel away sheath. The sheath
is then peeled away and the tube 1 is fixed in place.
[0034] The tube 1 may also be inserted without using an endoscope,
for example, through a procedure similar to insertion of feeding
tubes by Percutaneous Radiological Gastrostomy (PRG). According to
PRG, the stomach is insufflated via a nasogastric tube. Organs
which may be interposed between the stomach and the abdominal wall,
such as the colon, are excluded by CT scan or ultrasonography.
Exclusion of interposed organs may also be accomplished after
insufflation by fluoroscopy. The selection of the insertion site is
also determined by fluoroscopy or a similar method.
[0035] After the insertion site has been located, the tube 1 may be
inserted transabdominally as in the Russell method of PEG.
Alternatively, a guide wire may be inserted as in the endoscopic
pull method. The wire is then maneuvered through the stomach and
esophagus and out of the patient's mouth and is used to guide the
tube 1 back through the mouth, esophagus and stomach and out of the
insertion site (see, e.g., Mustafa N. Zmen et al. "Percutaneous
Radiologic Gastrostomy" European Journal of Radiology 43:
186-95).
[0036] The tube 1 may be inserted surgically. One suitable surgical
technique that may be used to insert the tube 1 is the laparoscopic
method. In this method, after pneumoperitoneum has been created, a
5 mm trocar is used to grasp a site on the anterior stomach wall
that is appropriate for tube placement without excessive tension on
the stomach. A skin incision down to the rectus sheath is made. A
trocar is placed through the rectus sheath and the stomach wall is
grasped and pulled upwards. An incision is made in the stomach and
the tube 1 is inserted. Using the retention member at the distal
end portion 17 of the tube 1, the stomach is brought snugly against
the abdominal wall. The tissue is sutured around the tube 1. (see,
e.g., Andrew Luck et al. "Laparoscopic Gastrostomy: Towards the
Ideal Technique" Aust. N.Z. J. Surg. (1998) 68:281-283).
[0037] The tube 1 may be inserted in other portions of the upper
digestive system besides the stomach. For example, direct
jejunostomy, wherein a tube is inserted transabdominally into the
jejunum, may be accomplished through methods similar to those
described hereinabove with reference to gastrostomy tube placement.
The retention member of the device should generally be smaller for
jejunostomy procedures to avoid irritation of the jejunum or
obstruction of the jejunal lumen.
[0038] FIG. 1 illustrates an inflatable retention member, i.e. the
inflation portion 2, that is attached to the tube 1 to prevent the
tube 1 from falling out of the patient. FIGS. 1, 1A and 1B
illustrate two alternative non-inflatable retention members that
may be used in place of and/or in addition to the inflatable
portion 2. FIGS. 1 and 1A illustrate a flange 2' and FIG. 1B
illustrates a dome 2''. A flange 2' or dome 2'' that is located at
the distal end portion 17 of the tube 1 helps to prevent the tube 1
from coming out of the stomach 3 or other section of the upper
digestive system. A flange 2' or dome 2'' that is located at the
proximal end portion 16 of the tube 1 helps to prevent the tube
from falling into the patient's upper digestive system.
[0039] When an inflatable retention member is used, the tube 1
preferably has an inflation lumen 26 so that the inflatable
retention member can be inflated. FIG. 1C shows a cross section of
the tube 1 taken perpendicular to the axis of tube 1. Inflation
lumen 26 extends from the inflation portion 2 to the proximal end
portion 16 of the tube 1 and is a pathway for introducing fluid,
such as water or air, to the inflation portion 2 from outside of
the patient. Removal lumen 25 extends from the proximal end portion
16 to the distal end portion 17 of the tube 1 and is a pathway for
the removal of food from the stomach 3 or other part of the upper
digestive system of the patient. The inflation lumen 26 is
preferably minimal in size to allow the removal lumen 25 to be as
wide as possible within the tube 1. In the illustrated embodiment,
valves 15, 27 are provided in lumens 25, 26, respectively, as shown
in FIG. 7. With the non-inflatable retention members 2' and 2''
shown in FIGS. 1A and 1B, the second lumen 26 in tube 1 can be
eliminated.
[0040] Inflatable retention members are suitable for use with
procedures similar to the push method, while either inflatable or
rigid retention members are suitable for use with procedures
similar to the pull method. One example of a tube that has an
inflatable retention member is taught in Tiefenthal et al. (U.S.
Pat. No. 6,506,179), the entire contents of which are incorporated
herein by reference. An alternative deformable retention member is
taught in Snow et al. (U.S. Pat. No. 6,077,250), the entire
contents of which are incorporated herein by reference.
[0041] Retention members that may be deformed in situ allow the
tube 1 to be removed without additional endoscopy. The retention
member is deflated or deformed and the tube 1 is pulled out using
traction. In cases where the retention member is rigid, the tube 1
may be cut close to the skin and removed endoscopically.
[0042] It is preferable for the stomach to be positioned up against
the inner abdominal wall. This may be accomplished by insufflation
during the tube placement procedure and after the tube 1 has been
placed due to the retention member. For example, as shown in FIG.
1, retention members at the proximal end portion 16 and distal end
portion 17 of the tube 1 anchor the stomach up against the
abdominal wall. The stomach may also be anchored to the abdominal
wall by gastropexy, which may prevent complications arising from
tube placement and may facilitate the placement procedure. In
addition, jejunopexy is important in jejunostomy procedures in
order to secure the jejunum during the tube placement procedure
(see Zmen et al., supra). For example, to secure the stomach or
jejunum to the abdominal wall, T-shaped metal or nylon fixing
members may be inserted trans-gastrically or trans-jejunally close
to the tube insertion site. The fixing members assume a T shape
after insertion and are tied near to the skin. Four fixing members
are typically disposed in a square pattern around the tube
insertion site to secure the stomach or jejunum. (see, e.g., F. J.
Thornton et al. "Percutaneous Radiologic Gastrostomy with and
without T-Fastener Gastropexy: a Randomized Comparison Study"
Cardiovasc Intervent Radiol. 2002 November-December;
25(6):467-71).
[0043] Reference is now made to various forms of pumps which are
attachable to the proximal end portion 16 of the tube 1. Any
conventional pump, the construction of which will be readily
understood to one skilled in the art, may be used. FIGS. 2 and 3,
for example, display pumps 8 and 9 which are attachable to the
proximal end portion 16 of the tube 1 for removal of food from the
stomach 3 or upper digestive system of the patient. It would be
suitable to use a pump that extracts more than 750 ml of food from
the upper digestive system of a patient within 30 minutes or less.
The pump may be operated intermittently to prevent tube collapse,
tube clogging or mucosal irritation. The pump may be manual or
battery operated. Optionally, a rechargeable power supply may be
incorporated into the pump, and the pump may be configured to be
carried on a patient's belt.
[0044] FIG. 2 depicts a manual bulb pump 8 that is attached to the
proximal end portion 16 of the tube 1 and is operated to remove
food from the patient's upper digestive system through the tube 1.
The manual bulb pump 8 preferably comprises silicone rubber or a
similar flexible material so as to permit the contents of the bulb
pump 8 to be evacuated by squeezing the bulbous end of the bulb
pump 8. The circumference of a tapered end essentially corresponds
to an interior circumference of the lumen 25 of the tube 1. To
operate the manual bulb pump 8, air is first evacuated from the
bulb pump 8 by squeezing the bulb, and then the tapered end of the
bulb pump 8 is inserted into the lumen 25 of the proximal end
portion 16 of the tube 1 so as to create a seal between the tapered
end and the tube 1. The bulb is then released to allow it to
reinflate. The negative pressure in the bulb pump 8 (when it is
released) causes food to flow out from the upper digestive system
toward the proximal end portion 16 of the tube 1 and into the bulb
of the manual bulb pump 8. The bulb pump 8 is then disengaged from
the tube 1 and the removed food is evacuated from the bulb. The
cycle may be repeated until a desired amount of food is removed
from the upper digestive system of the patient.
[0045] FIG. 3 depicts another pumping arrangement in which a pump
in the form of a syringe 9 is attached to the proximal end portion
16 of the tube 1 and is operated to remove food from the patient's
upper digestive system through the tube 1. The syringe 9 preferably
comprises a tapered end portion with an aperture at the distal end
thereof. The circumference of the tapered end portion 9a
corresponds to the interior circumference of the lumen 25 of the
tube 1. To operate the syringe 9 to remove food from the upper
digestive system of the patient, the contents (air or food) of the
syringe 9 are evacuated by depressing the plunger. The tapered end
portion 9a of the syringe 9 is inserted into the proximal end
portion 16 of the tube 1 so as to create a seal between the tapered
end portion 9a and the tube 1. The plunger of the syringe 9 is then
withdrawn so as to create negative pressure to draw food out from
the upper digestive system through the tube 1 and into the syringe
9. The syringe 9 is then disengaged from the tube 1 and evacuated
by, for example, depressing the plunger thereof 60 cc is an example
of a suitable size for the syringe 9. The cycle may be repeated
until a desired amount of food is removed from the upper digestive
system of the patient.
[0046] The manual bulb pump 8 and syringe 9 may be activated by the
patient or by a health care provider at a predetermined time after
eating. The predetermined time is preferably set by a physician
and, for example, may be 20-30 minutes. A physician may also
determine a maximum volume of food to be removed from the upper
digestive system of the patient after each meal. The maximum volume
may be set in terms of a maximum number of pumping cycles which is
told to the patient or health care provider if the pump 8, 9 is
manually operated.
[0047] In a preferred embodiment, the pump that is used to extract
food from the patient's upper digestive system periodically
reverses direction and pumps air and/or water into the upper
digestive system of the patient during the periods of reverse
operation. The air and/or water helps to solubilize or breakdown
the food in the upper digestive system so that it can be pumped out
easily. In addition, the air and/or water helps prevent the tube 1
from being suctioned up against the stomach wall while food is
extracted from the upper digestive out through the tube 1. For
example, every seven seconds of pumping may be followed by two
seconds of reverse operation.
[0048] FIG. 4 illustrates a variation of an embodiment of the
present invention in which the extracted food is evacuated from a
pump 6 into a bag 12 that is attached to the pump 6. As shown in
FIG. 4, after the food is pumped out of the upper digestive system
of the patient by the pump 6, the food may be stored in a bag 12
that is attachable to the proximal end portion of the pump 6. The
bag 12 may be opaque, scented, biodegradeable and worn by the
patient on a belt or other strap. Alternatively, as shown in FIGS.
11 and 16, the food may be pumped from the patient's upper
digestive system into the pump 6 and then into a tube 28 attached
to the pump 6. The contents of the tube 28 attached to the pump 6
may be emptied into a toilet. The tube 28 may be opaque, scented,
biodegradeable and flushable down the toilet.
[0049] FIG. 5 illustrates a cleaning device being used to clean the
tube 1 after food has been extracted from the patient's upper
digestive system through the tube 1. As shown in FIG. 5, the tube 1
may be cleaned using a brush 14 that is adapted to clean the inside
of the tube 1. The pump 6, manual bulb pump 8 and syringe 9 may be
cleaned by flushing them with saline and/or a disinfectant solution
after use.
[0050] FIG. 6 illustrates a second embodiment of the present
invention in which a feeling of satiety is created in the patient
by inflating the balloon anchor. Creating a feeling of satiety
curbs the patient's hunger and desire to eat food thereby allowing
the patient to eat less and lose weight. As shown in FIG. 6, the
inflation portion 2, which is the retention member that holds the
tube 1 in the patient's stomach, also serves the function of
decreasing stomach capacity to create a feeling of satiety when it
is inflated. The inflation portion 2 may be variably inflated by
adding or removing fluid through the inflation lumen 26 of the tube
1 (shown in FIG. 1C).
[0051] FIG. 7 shows an axial cross sectional view of the tube 1
extending out from the skin 5 of the patient in which the removal
lumen 25 and the inflation lumen 26 are visible. In a feature which
may be incorporated into any of the various embodiments of the
present invention, a valve 15 is provided at the proximal end
portion 16 of the tube 1 in the removal lumen 25. The valve 15
ordinarily prevents food from leaving the tube 1. The valve 15 is
opened when a pump is attached to the proximal end portion 16 of
the tube 1. For example, the tapered end portion of the manual bulb
pump 8 (shown in FIG. 2) and the tapered end portion of the syringe
9 (shown in FIG. 3) each push open the valve 15 when they are
inserted into the proximal end portion 16 of the tube 1. When the
valve 15 is opened by the ends of the pumps, food can be removed as
described hereinabove. A cap 13 (shown in FIG. 1) is preferably
placed on the proximal end portion 16 of the tube 1 when a pump is
not attached. The cap 13 may be pressed onto the end of the tube 1,
threaded on the end of the tube 1, or may have projections which
are frictionally inserted into the ends of lumens 25, 26 to seal
them in a closed condition.
[0052] FIG. 7 also shows a valve 27 provided at the proximal end
portion 16 of the tube 1 in the inflation lumen 26. The valve 27
prevents the fluid used to inflate the inflation portion 2 from
escaping the inflation portion 2 through the inflation lumen 26.
That is, the valve 27 prevents the inflation portion 2 from
deflating. If it becomes necessary to deflate the inflation portion
2 to remove the tube 1 from the upper digestive system of the
patient, or to further inflate the portion 2, a needle on a syringe
may be inserted into the inflation portion 26 so as to open the
valve 27 by pushing the needle through the valve members. The fluid
used to inflate the inflation portion 2 may then be removed or
added with the syringe.
[0053] FIG. 8 illustrates a third embodiment of the present
invention showing a tube having two balloons attached to that
portion of the tube that is disposed within the patient's upper
digestive system. The balloon anchor 2 is expandable to about 10 ml
and is positioned up against the stomach wall to prevent the tube 1
from falling out. The inflatable balloon 29 is expandable from
about 100 mL to about 850 mL and may be expanded intermittently to
limit the capacity of the stomach. For example, the balloon 29 may
be inflated via an inflation lumen prior to a meal to create the
sensation of being full. After the meal, the balloon 29 may be
deflated to prevent chronic accommodation. An electrically or a
manually operated pump may be used to cause the inflation.
[0054] The tube 1 in this embodiment has a long inner tube length
of about 10 cm or longer and a diameter of 28 French (9.3 mm) in
size or greater. The tube 1 may have multiple holes 32 in the
sidewall of its distal end portion 17 as shown in FIG. 8 and also
in FIGS. 10 and 13-15B. The holes 32 may be 5.times.7 mm in size.
The holes 32 provide non-vascular drainage from the patient.
Preferably, the holes 32 are arranged in a spiral pattern 1 cm to
1.5 cm apart without losing structural integrity. More preferably,
cushions or bumpers (not shown) are located on the tube 1 and in
between the holes 32 to prevent the tube from being sucked up
against the stomach wall while food is extracted from the upper
digestive system out through the tube 1. For example, cushions or
bumpers that are raised 3-4 mm above the surface of the tube 1 may
be used for this purpose.
[0055] As shown in FIG. 8, a second retention member 33 may be
attached at the proximal end portion 16 of the tube 1 to keep the
tube 1 fixed to the abdominal surface. This second retention member
may be similar to the retention members described hereinabove and
shown in FIGS. 1, 1A, 1B and 6. The distance between the second
retention member 33 at the proximal end portion 16 of the tube 1
and the balloon anchor 2 at the distal end portion 17 of the tube 1
can be adjusted to account for the varying amount of intervening
tissue 40, 40' as shown in FIGS. 15A and 15B. For example, the
second retention member 33 may be attached to the tube 1 via an
interference or friction fit. Specifically, the second retention
member 33 may be placed around the outer surface of the proximal
end portion 16 of the tube 1 and held in place on the tube 1 if it
has an inner diameter that is slightly smaller than the outer
diameter of the tube 1. As the patient loses weight, the proximal
end portion 16 of the tube 1 extends farther and farther away from
the patient's abdominal surface. A physician or the patient can
slide the second retention member 33 down towards the abdominal
surface and the excess amount of the tube 1 can be cut off.
[0056] FIG. 9 illustrates a fourth embodiment of the present
invention with a tube 1 having a curved configuration at its distal
end portion 17 and a plurality of holes 32 in a sidewall. As shown
in FIG. 9, the distal end portion 17 of the tube 1 is adapted to
assume a curved configuration when disposed in the upper digestive
system of a patient. Specifically, the distal end portion 17 of the
tube 1 is flexible to facilitate insertion and removal from the
patient. When the distal end portion 17 of the tube 1 is disposed
in the upper digestive system of the patient, it returns to its
natural curved configuration. The tube's tendency to return to its
natural curved configuration may be achieved, for example, by
bending the tube into a desired curved shape during the
manufacturing process before the tube has fully cured or cooled, or
by incorporating shape memory materials into the tube. As used
herein, the term "curved" includes flexed, bent, rounded, arched,
curled, coiled, spiral, and pigtail. This curved configuration is
preferable because it increases the intake area within the upper
digestive system. In addition, the coiled distal end portion 17 of
the tube 1 as shown in FIG. 10 helps to maintain the position of
the tube 1 within the patient's upper digestive system. The distal
end portion 17 of the tube 1 may, for example, be about 10 cm long
or longer to improve the intake of the food from the upper
digestive system. Retention members (not shown) similar to the ones
described in the above embodiments may also be used in this
embodiment.
[0057] In an alternative embodiment (not shown), an actuating
mechanism is configured to bend the distal end portion 17 of the
tube 1 into a curved configuration. The actuating mechanism may,
for example, be a string attached to the distal end portion 17 of
the tube 1 that, when retracted causes the tube to assume a curved
configuration (e.g. a loop with an arc that measures between about
270.degree.-360.degree.). A Cope Loop is a well known example of
this arrangement.
[0058] FIG. 10 illustrates a fifth embodiment of the present
invention showing a tube 1 having a curved configuration, multiple
holes 32 in a sidewall, and a morcellation device 36 housed within
a housing 37 at its distal end portion 17. Examples of morcellation
devices are disclosed in U.S. Pat. Nos. 5,618,296, 5,741,287 and
5,520,634, herein incorporated by reference in their entirety. As
shown in FIG. 10, a morcellation device 36 is provided at the
distal end portion 17 of the tube 1 to divide and grind food into
smaller pieces as it enters the tube 1. The morcellation device 36
thus allows large food to be removed from the patient without
clogging the tube 1. The morcellation device 36 can be, for
example, a mechanical propeller provided within a housing 37 at the
distal end portion 17 of the tube 1. The housing 37 is constructed
to protect body tissue from the morcellation device 36. In the
illustrated embodiment, the housing 37 has an opening to permit the
entry of food from the patient into the tube 1 and may, for
example, be a cage that surrounds the morcellation device 36 at the
distal end portion 17 of the tube 1. It is preferable that the
housing 37 is collapsible in both directions so that it can be
easily inserted into and taken out of the patient. The housing 37
is necessary to prevent damage to the stomach.
[0059] FIG. 11 illustrates a feature that may be used with any
embodiment of the present invention in which the proximal end
portion 16 of the tube 1 lies substantially flush with the outer
surface of the patient's abdomen. This may be achieved by using
ribbons attached to the tube 1, for example at the internal
retention member. The ribbons are used to pull the tube 1 taut when
the distal end portion 17 of the tube 1 is disposed in the upper
digestive system of a patient. While the ribbons are pulled, the
proximal end portion 16 of the tube 1 is cut so that the proximal
end portion 16 lies flush with the abdominal surface and a thin,
hollow cylinder with flanges is wedged onto the outside or inside
surface of the tube 1 via friction or by screwing it onto the tube
1 to retain the tube 1 in its position and to keep it flush with
the abdominal surface. In alternative embodiments, the proximal end
portion 16 of the tube 1 may extend out past the abdominal surface
by any desired length (e.g., 1-10 inches).
[0060] FIG. 12 illustrates another feature that may be used with
any embodiment of the present invention in which a luer lock 34 is
utilized at the proximal end portion 16 of the tube 1. In this
embodiment, the pump 6 is attached to the tube 1 by screwing the
pump 6 onto the tube 1 around the external portion of the proximal
end portion 16 of the tube 1 rather than being inserted into the
tube 1. More specifically, the proximal end portion 16 of the tube
1 comprises concentric grooves or threads on the outside to
accommodate the pump 6, which prevents the pump 6 from reducing the
size of the removal lumen 25. Likewise, the pump 6 may have
corresponding concentric grooves or threads that allow it to
interact and connect with the luer lock 34. In this way, large
pieces of food can still be extracted out of the tube 1 because the
inner diameter of the tube 1 is not compromised or decreased due to
the pump 6 being inserted into the tube 1. Instead, the pump 6 is
coupled to or threaded onto the outside of the proximal end portion
16 of the tube 1.
[0061] FIG. 13 illustrates yet another feature that may be used
with any embodiment of the present invention in which the tube 1
has a funnel shaped tip 35. The funnel tip is advantageous because
it facilitates the extraction of larger pieces of food into the
tube 1 from the patient's digestive system.
[0062] FIG. 14 illustrates a sixth embodiment of the present
invention that has two intake tubes. In this embodiment, both of
the intake tubes 38 have a curved configuration and a sidewall with
a plurality of holes 32 located therein. Each intake tube 38
comprises a proximal end portion 39 and distal end portion 40. The
apparatus also comprises an output tube 41 having a proximal end
portion and a distal end portion 42. One or more retention members
(not shown) are preferably attached to the output tube 41 to
prevent the apparatus from coming out of the upper digestive
system. The plurality of intake tubes 38 are configured to be
disposed in the upper digestive system of the patient and the
output tube 41 is configured to pass through the patient's
abdominal wall when the plurality of intake tubes 38 are so
disposed. The distal end portion 42 of the output tube 41 is
operatively connected to the proximal end portion 39 of each of the
plurality of intake tubes 38 so that food can be extracted from the
upper digestive system of the patient through the distal end
portion 40 of each of the plurality of intake tubes 38 and out
through the proximal end portion of the output tube 41.
[0063] Optionally, pressure and/or flow sensors (not shown) may be
placed on and/or in the tube 1. Pressure sensors placed on the tube
1 inside and outside the stomach 3 may be used to estimate the
satiety of the patient. Alternatively or in addition to, flow
sensors that are placed inside the tube 1 may be used to calculate
the volume of food extracted through the tube 1.
[0064] Reference is now made to various methods for extracting
food, for limiting absorption of food, and for treating obese
patients.
[0065] Installation of any of the above-described embodiments forms
a passageway into a patient's upper digestive system through the
patient's abdominal wall. The patient is allowed to carry out
his/her everyday affairs including ingesting food. After the
patient has ingested food, the food is extracted by pumping it out
of the upper digestive system through the passageway before it is
completely digested. This method and the others described below are
less invasive than the alternative surgical procedures for reducing
weight, are easy to perform, easy to reverse and have successfully
resulted in significant weight loss in obese patients.
[0066] In one method, a tube is positioned so that it passes
through a patient's abdominal wall into his/her upper digestive
system. The patient is allowed to go about his/her daily activities
including ingesting food. After the patient has ingested the food,
the food is extracted from the upper digestive system of the
patient through the tube. The patient may eat and extract the eaten
food from his/her upper digestive system through the tube
repeatedly until a desired weight loss is attained. The food that
has been extracted is not reintroduced into the patient. The tube
may be kept in the patient's upper digestive system for extended
periods of time (e.g., one month or more) while the
eating/extracting is repeated numerous times (e.g., 20 times or
more) while the tube is in place.
[0067] In a second method, a tube is positioned so that it passes
through the obese patient's abdominal wall into his/her upper
digestive system. The obese patient is allowed to go about his/her
daily activities including ingesting food. After the obese patient
has ingested the food, the food is extracted from the upper
digestive system of the obese patient through the tube. The obese
patient may eat and extract the eaten food from his/her upper
digestive system through the tube repeatedly until the obese
patient has lost at least 40 pounds. The food that has been
extracted is not reintroduced back into the obese patient.
[0068] In a third method, a tube is positioned so that it passes
through a patient's abdominal wall into the upper digestive system
of the patient whose gastrointestinal tract is unobstructed. The
term "unobstructed," as used herein, refers to a gastrointestinal
tract that is not mechanically obstructed and is also not
functionally obstructed. The patient is allowed to go about his/her
daily activities including ingesting food. After the patient has
ingested the food, the food is extracted from the upper digestive
system of the patient through the tube. The patient may eat and
extract the eaten food from his/her upper digestive system through
the tube repeatedly until a desired weight loss is attained. The
tube may be kept in the patient's upper digestive system for
extended periods of time (e.g., one month or more) while the
eating/extracting is repeated numerous times (e.g., 20 times or
more) while the tube is in place.
[0069] Preliminary trials in human patients have been successful.
For example, one female patient, middle aged and weighing 100
kilograms (approximately 220 pounds), had a tube installed in her
stomach for 59 weeks and successfully lost 38.45 kilograms
(approximately 85 pounds) without experiencing any serious adverse
side effects. During the 59 weeks, the female patient aspirated
after breakfast and lunch meals daily. She consumed meals without
any fluids over approximately 30 minutes. At the end of the meal,
she consumed 52 ounces of water in approximately 3-4 minutes. She
waited approximately 20 minutes after consuming the water before
beginning the extraction procedure. Accordingly, the patient
uncapped the tube, connected a 60 cc syringe to the tube and
extracted food from her stomach twice. This resulted in a siphon
effect, which permitted the subject to freely drain the stomach by
allowing the open tube to empty into a bucket. The patient squeezed
the tube to enhance propulsion and to break up large food. After
draining stopped, the patient usually drank another 52 ounces of
water and repeated the extraction procedure. She usually repeated
this procedure (drinking and extracting) about 2 more times, until
she felt her stomach was empty. The total amount of food extracted
was approximately 2-3 liters and the entire procedure took about 20
minutes. If resistance to extraction occurred during the procedure,
the patient flushed the tube with 30 cc of water. The water helped
to extract the food by dissolving it and by cleaning the
passageway. The patient changed her dietary intake to avoid tube
clogging. She avoided eating cauliflower, broccoli, Chinese food,
stir fry, snow peas, pretzels, chips, and steak. In addition, her
diet was supplemented with potassium. The chart below illustrates
her weight loss.
TABLE-US-00001 weight Week (kg) 0 100.9 2 96.8 3 96.8 4 94.7 4 94.7
5 94.0 7 93.6 8 90.9 9 92.9 10 92.7 11 90.4 12 89 13 89.3 14 88.6
15 87.7 16 86.5 17 86.5 18 86.3 19 85.9 20 83.9 21 82.9 22 81.6 23
80.45 24 79.7 25 78.6 26 78.6 27 77.2 28 78 29 76.2 30 76 31 75.2
31 77.1 32 76.4 33 76.4 34 76.4 35 74 36 74 37 74 38 73.6 39 73.5
40 73.2 41 72.6 42 71.22 43 69.5 44 69.8 45 69.45 46 68.45 47 66.6
48 65.5 49 65.5 50 65.5 51 65.2 52 65 53 65 54 64.5 55 64.8 56 64.8
57 63.8 58 63 59 62.45
[0070] It is noted that the food extraction apparatuses and methods
described above are preferably combined with a behavior
modification program that ideally educates patients in modifying
caloric intake, lifestyle and attitudes toward food. Learned
activities and support for weight loss may include activities such
as self-monitoring by recording food intake and physical activity,
avoiding triggers that prompt eating, assistance from family and
friends, problem solving skills and relapse prevention. The program
may be taught by an instructor or offered over the internet. In
addition, the program preferably includes a series of regular
check-ups by a health care provider. The check-ups ideally include
regularly testing blood for electrolytes, supplementing patients'
diets with vitamins, and administering medications to prevent
gallstone formation as needed. Ideally, the behavior modification
program will educate patients to change their lifestyle so as to
eliminate the need for food extraction.
[0071] The above described embodiments allow obese patients to lose
weight without undergoing drastic and invasive surgeries. As a
result, obese patients avoid many of the complications associated
with such surgeries. In addition, the present invention is easy to
perform, easy to reverse and allows obese patients to live a normal
and active lifestyle with fewer adverse side effects.
[0072] Additional advantages and modifications will readily occur
to those skilled in the art. For example, the features of any of
the embodiments may be used singularly or in combination with any
other of the embodiments of the present invention. In addition, the
insertion technique for placing the tube is not limited to known
gastrostomy techniques. Accordingly, various modifications may be
made without departing from the spirit or scope of the general
inventive concept as defined by the appended claims and their
equivalents.
* * * * *