U.S. patent application number 14/571144 was filed with the patent office on 2017-07-20 for gastric restriction devices for treating obesity.
The applicant listed for this patent is Raj Nihalani. Invention is credited to Raj Nihalani.
Application Number | 20170202693 14/571144 |
Document ID | / |
Family ID | 56110063 |
Filed Date | 2017-07-20 |
United States Patent
Application |
20170202693 |
Kind Code |
A9 |
Nihalani; Raj |
July 20, 2017 |
GASTRIC RESTRICTION DEVICES FOR TREATING OBESITY
Abstract
A gastric restraining device for treating excessive weight or
obesity in mammals. The gastric restraining device includes an
elastomeric sheet configured to be placed around a stomach of a
mammal, an ablation device attached to the elastomeric sheet, the
ablation device configured to emit energy toward an outer surface
of the stomach when the elastomeric sheet is placed around the
stomach, and an energy device coupled to the ablation device to
generate the energy and to transfer the energy to the ablation
device.
Inventors: |
Nihalani; Raj; (Irvine,
CA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Nihalani; Raj |
Irvine |
CA |
US |
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Prior
Publication: |
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Document Identifier |
Publication Date |
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US 20160166417 A1 |
June 16, 2016 |
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Family ID: |
56110063 |
Appl. No.: |
14/571144 |
Filed: |
December 15, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12474254 |
May 28, 2009 |
8911346 |
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14571144 |
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12328979 |
Dec 5, 2008 |
8357081 |
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12474254 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/0053 20130101;
A61F 5/003 20130101; A61F 5/0063 20130101; A61F 5/0066 20130101;
A61F 5/0033 20130101; A61F 5/005 20130101; A61F 5/0089
20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1.-20. (canceled)
21. A gastric restriction device for treating excessive weight or
obesity in mammals, comprising: a skirt having an interior surface
and an exterior surface having a surface area of at least 14 square
centimeters, the skirt having a left edge, a right edge, a top edge
with a first indentation located at the center of the top edge, and
a bottom edge with a second indentation located at the center of
the bottom edge, the skirt having a narrow surface located between
the first indentation and the second indentation and a broad
surface formed from the left edge connecting to the right edge, the
narrow surface operable to envelop a lesser curvature of an
internal stomach organ of a mammal and the broad surface operable
to envelop a greater curvature of the internal stomach organ; a
first attachment device attached to the right edge of the skirt;
and a second attachment device attached to the left edge of the
skirt and adapted to engage the first attachment device and
maintain the left edge in proximity to the right edge.
22. The gastric restriction device of claim 21, wherein the skirt
or the first and second attachment devices completely covers an
entire area between the left edge and the right edge when the left
edge is in proximity to the right edge and the first and second
attachment devices adapted to be positioned around the greater
curvature of the internal stomach organ, thereby preventing
expansion of the internal stomach organ when the first attachment
device is fastened to the second attachment device.
23. The gastric restriction device of claim 21, wherein the skirt
is adapted to be positioned around and in direct contact with the
internal stomach organ of the mammal to tightly engage the internal
stomach organ when the left edge is in proximity to the right
edge.
24. The gastric restriction device of claim 21, wherein the top
edge is a concave edge and the bottom edge is a concave edge.
25. The gastric restriction device of claim 21, wherein the skirt
is made of an implantable silicon material or an ePTFE
material.
26. A gastric constriction device for treating excessive weight or
obesity in mammals, comprising: a butterfly-shaped skirt including
an interior surface and an exterior surface, the exterior surface
with a surface area of at least 14 square centimeters, the
butterfly-shaped skirt having a left edge, a right edge, a top
edge, and a bottom edge, the top edge having a first indentation
located at the center of the top edge, the bottom edge having a
second indentation located at the center of the bottom edge, the
butterfly-shaped skirt having a narrow surface located between the
first indentation and the second indentation and a broad surface
formed from the left edge connecting to the right edge, the narrow
surface operable to cover a lesser curvature of a stomach of a
mammal and the broad surface operable to cover a greater curvature
of the stomach; a first attachment device attached to the right
edge of the skirt; and a second attachment device attached to the
left edge of the skirt and adapted to engage the first attachment
device and maintain the left edge in proximity to the right
edge.
27. The gastric constriction device of claim 26, wherein the skirt
or the first and second attachment devices completely covers an
entire area between the left edge and the right edge when the left
edge is in proximity to the right edge and the first and second
attachment devices adapted to be positioned around the greater
curvature of the internal stomach organ, thereby preventing
expansion of the internal stomach organ when the first attachment
device is fastened to the second attachment device.
28. The gastric constriction device of claim 26, wherein the skirt
is adapted to be positioned around and in direct contact with the
internal stomach organ of the mammal to tightly engage the internal
stomach organ when the left edge is in proximity to the right
edge.
29. The gastric constriction device of claim 26, wherein the skirt
is made of silicone.
30. The gastric constriction device of claim 26, wherein the skirt
is made of a biodegradable and absorbable polymer.
31. The gastric constriction device of claim 26, wherein the skirt
has a parallelogram shape.
32. The gastric constriction device of claim 26, wherein the first
indentation has a concave shape and the second indentation has a
concave shape.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/474,254, entitled "Gastric Restriction
Devices with Fillable Chambers and Ablation Means for Treating
Obesity," filed May 28, 2009 and now U.S. Pat. No. 8,911,346, which
is a continuation-in-part of U.S. patent application Ser. No.
12/328,979, entitled "Method and Apparatus for Gastric Restriction
of the Stomach to Treat Obesity," filed Dec. 5, 2008, now U.S. Pat.
No. 8,357,081, the entire contents of both applications are hereby
incorporated by reference herein for all purposes.
BACKGROUND
[0002] 1. Field
[0003] The invention relates to a method and apparatus for treating
obesity and controlling weight gain in mammals, and more
specifically, to an inflatable gastric skirt placed around the
stomach to cause a reduced desire for eating for treating obesity
and controlling weight gain in mammals.
[0004] 2. Description of the Related Art
[0005] Extreme obesity is a major illness in the United States and
other developed countries. More than half of Americans are
overweight, while nearly one-third are categorized as obese.
Obesity is the accumulation of excess fat on the body, and is
defined as having a body mass index (BMI) of greater than 30. Many
serious long-term health consequences are associated with obesity,
such as, hypertension, diabetes, coronary artery disease, stroke,
congestive heart failure, venous disease, multiple orthopedic
problems and pulmonary insufficiency with markedly decreased life
expectancy.
[0006] Medical management of obesity including dietary,
psychotherapy, medications and behavioral modification techniques
have yielded extremely poor results in terms of treating obesity.
Several surgical procedures have been tried which have bypassed the
absorptive surface of the small intestine or have been aimed at
reducing the stomach size by either partition or bypass. These
procedures have been proven both hazardous to perform in morbidly
obese patients and have been fraught with numerous life-threatening
postoperative complications. Moreover, such operative procedures
are often difficult to reverse.
[0007] One procedure for treating morbid obesity is referred to as
a "biliopancreatic diversion." Biliopancreatic diversion surgery is
a reduction of the stomach volume and a diversion of food from the
stomach to the final segment of the small intestine, bypassing the
beginning and middle portions of the small intestine to limit the
amount of nutrients and calories absorbed by the body. This
procedure removes about one half of the stomach, and then connects
the stomach to the last 250 cm of the small intestine. Some
disadvantages of this surgery include patients suffering from
protein malnutrition, anemia, gastric retention, diarrhea,
abdominal bloating, and intestinal obstruction.
[0008] Another bariatric surgery, "gastric bypass," is a bypass
connecting the lower compartment of the stomach to the initial
portion of the small intestine. This procedure limits the amount of
food that can be ingested at one sitting and reduces absorption of
food across the small intestine. In addition to surgical
complications, patients may also suffer from acute gastric
dilation, anastomotic leak, anemia, and dumping syndrome.
[0009] Yet another bariatric surgical procedure is "vertical-banded
gastroplasty," which restricts the volume of the stomach by using
staples. In this procedure, staples are placed in the upper stomach
region to create a small pouch with a narrow outlet to the
remaining portion of the stomach. A band is placed around the
narrow outlet to provide support and inhibit stretching of the
stomach. In addition to surgical complications, patients undergoing
this procedure may suffer from vomiting, ulcers, band erosion, and
leaks.
[0010] Recently, minimally invasive procedures and devices which
create a feeling of early satiety have been introduced into the
marketplace in an attempt to address some of the issues above. The
LAP-BAND.RTM. is a band which encircles the stomach at the region
of the fundus-cardia junction; it is a restrictive procedure
similar to stomach stapling. The procedure requires general
anesthesia, a pneumoperitoneum, muscle paralysis, and extensive
dissection of the stomach at the region of the gastro esophageal
junction. The procedure also requires continual adjustment of the
band, or restriction of a portion of the device. Although less
invasive than other bariatric surgical procedures and potentially
reversible, the LAP-BAND.RTM. does not reduce the volume of the
stomach by any great extent and some patients report a feeling of
hunger most of the time. Furthermore, once implanted, the
LAP-BAND.RTM., although it is adjustable by percutaneous means, may
require many iterative adjustments before it is optimally
positioned. In addition, the port used to adjust the LAP-BAND.RTM.
is left inside the patient's body.
[0011] Therefore, there is a need for minimally-invasive procedures
and devices that eliminate the above-mentioned drawbacks of
conventional methods and devices that are currently being used to
treat obesity.
SUMMARY
[0012] In one embodiment, the invention includes a gastric
restraining device for treating excessive weight or obesity in
mammals. The gastric restraining device includes a skirt having an
interior surface and an exterior surface having a surface area of
at least 14 square centimeters, a chamber attached to the interior
surface of the skirt and capable of holding a fluid, the chamber
configured to be positioned around a stomach of a mammal so that
the chamber covers a portion of a greater curvature of the stomach
and a portion of a lesser curvature of the stomach, and a tube
connected to the chamber for delivering the fluid into and out of
the chamber to cause the chamber to expand and contract.
[0013] In one embodiment, the invention includes a gastric
restraining device for treating excessive weight or obesity in
mammals. The gastric restraining device includes an elastomeric
sheet configured to be placed around a stomach of a mammal, an
ablation device attached to the elastomeric sheet, the ablation
device configured to emit energy toward an outer surface of the
stomach when the elastomeric sheet is placed around the stomach,
and an energy device coupled to the ablation device to generate the
energy and to transfer the energy to the ablation device.
[0014] In one embodiment, the invention includes a method for
treating excessive weight or obesity in mammals by gastric
constriction or restraining. The method includes using an
endoscopic device, inserting a bougie into the stomach adjacent to
a lesser curvature of the stomach. The method also includes tucking
a portion of a greater curvature of the stomach toward the bougie
which results in a first untucked stomach portion, a second
untucked stomach portion, and a cavity between the first untucked
stomach portion and the second untucked stomach portion. The method
also includes using a ligation device, inserting a ligature through
the first untucked portion, the cavity, and the second untucked
portion and using the endoscopic device, removing the bougie from
the stomach.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] These and other embodiments of the invention will be
discussed with reference to the following exemplary and
non-limiting illustrations, in which like elements are numbered
similarly, and where:
[0016] FIG. 1A is a view of a stomach of a mammal;
[0017] FIG. 1B is a view of a partially tucked-in stomach of a
mammal;
[0018] FIG. 2A is a view of a laid-open gastric skirt;
[0019] FIG. 2B is a view of a modular laid-open gastric skirt;
[0020] FIG. 3 is a view of a rolled gastric skirt;
[0021] FIG. 4 is a view of a folded conical cylinder-shaped gastric
skirt;
[0022] FIG. 5A is a view of a gastric skirt placed in position
around a stomach;
[0023] FIG. 5B is a view of a modular gastric skirt placed in
position around a stomach;
[0024] FIG. 5C is a view of a gastric skirt placed in position
around a stomach that shows a tucked-in portion of the stomach;
[0025] FIG. 6 is a view of a laid-open butterfly-shaped gastric
skirt;
[0026] FIG. 7 is a view of a folded butterfly-shaped gastric
skirt;
[0027] FIG. 8A is a view of a laid-open oval or pear-shaped
skirt;
[0028] FIG. 8B is a view of a laid-open oval or pear-shaped skirt
having a pouch that holds a balloon;
[0029] FIG. 8C is a view of a modular laid-open oval or pear-shaped
skirt having a pouch that holds a balloon;
[0030] FIG. 9A is a view of a folded gastric skirt with locking
clips;
[0031] FIG. 9B is a view of a locking clip for a gastric skirt;
[0032] FIG. 10A is a view of a gastric skirt with a harness
system;
[0033] FIG. 10B is a side-view of a gastric skirt with a harness
system;
[0034] FIG. 11 is a view of a gastric wrap with a harness system in
position around a stomach;
[0035] FIG. 12 is a view of an exemplary connector;
[0036] FIG. 13A is a view of a collar with wings;
[0037] FIG. 13B is a view of a locking clip for a collar;
[0038] FIG. 13C is a view of a collar without wings;
[0039] FIG. 13D is a view of a laid-open collar;
[0040] FIG. 14 is a cross-sectional view of a stomach and a balloon
positioned within a greater curvature of the stomach when the
greater curvature is tucked into the stomach;
[0041] FIG. 15A is a view of the balloon of FIG. 14;
[0042] FIG. 15B is a view of a sealed balloon with a port;
[0043] FIG. 16 is a view of the gastric wrap of FIG. 6 and the
balloon in position around a stomach;
[0044] FIG. 17 is a view of one or more ropes wrapped around a
tucked-in stomach;
[0045] FIG. 18 is a view of one or more tentacles wrapped around a
tucked-in stomach where the tentacles can be independently pulled
and locked in place using a ring and clip system or a tie lock;
[0046] FIG. 19 is a view of an inflatable gastric skirt positioned
around a stomach;
[0047] FIG. 20 is a view of an inflatable gastric skirt and a
triple-lumen tube;
[0048] FIG. 21 is a view of an inflatable gastric skirt without a
harness system;
[0049] FIG. 22A is a view of a gastric skirt having one or more
inflatable chambers;
[0050] FIG. 22B is a view of a cavity of a triple-lumen tube;
[0051] FIG. 23 is a view of the interior of a triple-lumen
tube;
[0052] FIG. 24 is an interior view of an inflatable gastric
skirt;
[0053] FIG. 25 is a view of a triple-lumen port inlet;
[0054] FIG. 26 is view of an inflatable gastric skirt and an
inflation device;
[0055] FIG. 27 is a view of a laid-open inflatable gastric
skirt;
[0056] FIG. 28 is a view of a connector strap;
[0057] FIG. 29 is a lateral view of an inflatable gastric
skirt;
[0058] FIG. 30 is a view of an inflatable collar;
[0059] FIG. 31 is a view of an inflatable gastric skirt with dual
inflatable collars;
[0060] FIG. 32 is a view of the internal surface of an inflatable
gastric skirt;
[0061] FIG. 33 is a view of a valve and the steps of inflation and
deflation;
[0062] FIG. 34 is a view of an inflatable antral skirt;
[0063] FIG. 35 is a laid-open view of an inflatable antral
skirt;
[0064] FIG. 36 is a view of a double-side inflatable gastric
skirt;
[0065] FIG. 37 is a view of an inflatable gastric skirt with radio
frequency coils;
[0066] FIG. 38 is a view of an inflatable gastric skirt with steam
ablation holes;
[0067] FIG. 39 is a lateral view of an inflatable gastric skirt
with steam ablation holes;
[0068] FIG. 40 is a view of an inflatable gastric skirt with an
ultrasound probe;
[0069] FIG. 41 is a view of an inflatable gastric skirt with
alternating ablation and inflation chambers;
[0070] FIG. 42 is a view of a physiological connection between
stomach receptors and a brain;
[0071] FIG. 43 is a view of a stomach prior to ligation;
[0072] FIG. 44 is a lateral view of a tucked-in stomach prior to
ligation;
[0073] FIG. 45 is a view of a ligated stomach;
[0074] FIG. 46 is a lateral view of a gastric skirt positioned
around a ligated stomach;
[0075] FIG. 47 is a flowchart illustrating a process of positioning
a gastric skirt around a ligated stomach;
[0076] FIG. 48A is a view of unconnected clip members; and
[0077] FIG. 48B is a view of connected clip members.
DETAILED DESCRIPTION
[0078] Throughout this description, the term gastric "skirt" is
used to refer to a device made of a flexible, semi-flexible, or
minimally stretchable material that can be tightly wrapped around
portions of a stomach to provide constriction to the stomach. The
term "skirt" can be used interchangeably with "vest", "wrap",
"wrapping", "wrapper", "bandage", "blanket", "cape", "cloak",
"cover", "jacket", "envelope", and equivalents thereof.
[0079] FIG. 1A is a view of a stomach 100 of a mammal (e.g.,
human). As shown in FIG. 1A, the stomach 100 has at least two
curvatures, a lesser curvature 110 and a greater curvature 112. The
cardia or proximal stomach 108 is located in the upper left portion
of the stomach 100 and serves as the junction between the esophagus
102 and the body of the stomach 106. The fundus 104 is located in
the upper right portion of the stomach 100. The lower portion of
the stomach 100 is known as the distal stomach and includes the
antrum 114 and the pylorus 116. The antrum 114 is where food is
mixed with gastric juices. The pylorus 116 has a muscular pyloric
sphincter that acts as a valve to control emptying of the stomach
contents into the proximal segment of the small intestine 118
(partially shown). The inner lining 120 of the stomach 100
separates the body 106 from the outer wall 122.
[0080] The invention is directed to a gastric skirt that is placed
around the stomach 100 by a healthcare professional, such as a
surgeon, a bariatric surgeon or a gastrointestinal specialist
trained in laparoscopic and/or general surgery procedures. The
gastric skirt can be positioned using a routine laparoscopic
procedure or a conventional open-surgical procedure. Furthermore,
the gastric skirt can be placed around the stomach 100 using newer
techniques, methods and procedures for laparoscopic surgery.
[0081] The invention can be utilized in conjunction with the
LAP-BAND.RTM. procedure and/or other post-gastric bypass procedures
such as vertical gastric sleeve procedure treatments that provide
reinforcement and restraining devices to prevent further expansion
or re-expansion of the stomach 100.
[0082] FIG. 1B is a view of a partially tucked-in stomach 100 of a
human. Prior to placing the gastric skirt around the stomach 100, a
linear portion of the greater curvature 112 is tucked inwards into
the stomach 100. As shown in FIG. 1B, the inner lining 120 is
depressed within the stomach 100 as a result of the tucking
procedure, and the tucked-in portion occupies space within the
stomach 100. Thus, the internal volume of the stomach 100 is
substantially decreased, creating a ridge like effect, leading to
the slowing of the passage of food, and thus less food consumption,
while still enabling absorption of vital fluids and nutrients
(unlike a gastric bypass procedure). In addition, the internal
volume of the fundus 104 is reduced.
[0083] In another embodiment, the tucked-in portion of the stomach
100 may be a linear portion of the lesser curvature 110, a portion
of the body 106, or a portion of the fundus 104, not along either
the greater curvature 112 or the lesser curvature 110. Therefore,
any portion of the stomach 100 may be tucked-in and wrapped using
the gastric skirts disclosed herein.
[0084] FIG. 2A is a view of a laid-open gastric skirt 200. The
gastric skirt 200 may be formed as a sheet 224 prior to being
wrapped around a patient's stomach. For illustrative purposes, the
gastric skirt 200 has a left side 232, a right side 230, a bottom
portion 220, and a top portion 222. Each connector 208, 210, and
212 may be offset or staggered relative to its adjacent connector.
Similarly, each receiver 214, 216, and 218 may be offset or
staggered relative to its adjacent receiver. In one embodiment,
each offset may be approximately 1-3 centimeters. The bottom
portion 220 and the top portion 222 may have an inward curved or
concave edge. The gastric skirt 200 may have a length L of
approximately 6-16 centimeters, a central width W1 of approximately
3-7 centimeters, and an outer width W2 of approximately 6-10
centimeters.
[0085] In a preferred embodiment, the length L is at least 8
centimeters, the central width W1 is at least 4 centimeters, and
the outer width W2 is at least 7 centimeters.
[0086] The gastric skirt 200 may have a staggered step design and
may be formed in the shape of a parallelogram when laid-open, where
the opposing ends of the gastric skirt 200 interconnect in a
stepped fashion when the gastric skirt 200 is folded. For example,
step element 201 is staggered relative to immediately opposing step
element 202. Likewise, step element 203 and step element 205 are
staggered relative to their immediately opposing step elements 204
and 206, respectively. When the gastric skirt 200 is wrapped or
folded into position around a patient's stomach 100, the opposing
step elements interconnect with each other, forming the end at the
greater curvature 112 and the gastric skirt 200 is formed into a
conical cylindrical shape, which is described in more detail
below.
[0087] Attached to each step element is a male connector or a
female receiver or vice versa. In the exemplary embodiment, a male
connector 208 is attached to a female receiver 214. When the
gastric skirt 200 is folded into position, the male connector 208
couples with the female receiver 214. The male connectors 210 and
212 couple with the female receivers 216 and 218, respectively,
when the gastric skirt 200 is wrapped or folded into position
around the stomach. In other embodiments, the gastric skirt 200 may
have one set of connectors (e.g., a single male connector 208 and a
single female receiver 214) or two sets of connectors (e.g., 2 male
connectors 208 and 210 and 2 female receivers 214 and 216). The
connectors can be of various shapes and sizes, and are not limited
to the connector design shown in FIG. 2A. Furthermore, the
connectors can be positioned at various locations on the gastric
skirt 200, and are not limited to being positioned at the left side
232 and the right side 230 of the gastric skirt 200.
[0088] The gastric skirt 200 has a bottom portion 220 that is
inward curving. Opposite the bottom portion 220, the gastric skirt
200 has a top portion 222 that is inward curving. When the gastric
skirt 200 is folded into position, the bottom and top portions 220
and 222 come into contact with the lesser curvature 110 and provide
the gastric skirt 200 with a contoured, conical shape. The conical
shape allows the gastric skirt 200 to properly fit around the
stomach 100.
[0089] Furthermore, one or more optional connectors or wings 226
and 228 are attached to the top portion 222 of the gastric skirt
200 and one or more optional connectors or wings 248 and 250 are
attached to the bottom portion 220 of the gastric skirt 200. The
connectors or wings 226 and 228 may be used to attach the gastric
skirt 200 to collar connector straps (shown in FIGS. 10A, 10B, and
11). The connectors or wings 248 and 250 may be used to attach the
gastric skirt 200 to connector straps (shown in FIG. 11).
[0090] The body or sheet 224 of the gastric skirt 200 is relatively
flexible, or semi-flexible, and may be made of an elastic polymer
("elastomer"), such as, but not limited to, silicone,
polypropylene, polyethylene terephthalate, polytetrafluoroethylene,
polyaryletherketone, nylon, fluorinated ethylene propylene,
polybutester, or any combination thereof. Furthermore, the
elastomer may be non-porous. Alternatively, the elastomer may be
microporous or porous to allow for better expansibility and
oxygenation and for tissue in-growth to better hold the gastric
skirt 200 in place.
[0091] In a preferred embodiment, the elastomer is silicone.
Silicone provides an ample amount of rigidity, while still
providing flexibility to accommodate changes in stomach shape and
size during peristalsis. A silicone body may be preferred over a
porous body, as larger pores may allow the stomach muscles or
tissue to seep through and grow onto the outside of the body 224.
This overgrowth of the stomach through the body 224 may make it
difficult to remove the gastric skirt 200 from the patient if
needed. Furthermore, the silicone allows some expandability of the
stomach 100, which is the stomach's natural function. Thus, the
gastric skirt 200 allows the stomach to accommodate some gases and
larger pieces of food or meat.
[0092] Alternatively, more rigid materials, such as Teflon.RTM.,
Dacron.RTM., ePTFE or wire mesh may be used if they provide an
adequate level of flexibility, and do not significantly irritate or
erode the stomach surface. That is, the gastric skirt 200 should be
relatively flexible, as a very rigid stomach wrap may cause
discomfort to the patient, as well as injury to the stomach and
other gastric organs. The gastric skirt 200 is tightly positioned
around the tucked-in stomach so little to no open space is provided
between the gastric skirt 200 and the outer surface of the
stomach.
[0093] In another embodiment, the body 224 of the gastric skirt 200
may be made of a biodegradable and absorbable polymer or copolymer,
such as, but not limited to, polyglycolic acid (PGA), polylactic
acid (PLA), polycaprolactone, polyhydroxyalkanoate, various
thermoplastic materials, or any combination thereof. Once placed
around the stomach 100, the gastric skirt 200 stays in position for
a predetermined amount of time. After the predetermined amount of
time has elapsed, the gastric skirt 200 may be absorbed by the
patient's bodily fluids, eliminating the need for a second
procedure to remove the gastric skirt 100. In this particular
embodiment, the entire gastric skirt 200, including the male
connectors and the female receivers, are made of a biodegradable
material.
[0094] The staggered step design allows the gastric skirt 200,
including all of the connectors and receivers, to be rolled into a
highly compact fashion. In one embodiment, the gastric skirt 200
can be placed around a patient's stomach using a routine
laparoscopic procedure, referred to as a laparoscopy. During a
laparoscopy, the gastric skirt 200 is inserted into the patient via
a trocar through a hole made in the patient's abdomen. The
staggered step design minimizes the diameter of the gastric skirt
200 when it is rolled for insertion through the trocar. That is,
the connectors and receivers are not positioned on top of each
other in the rolled position to minimize the thickness for
insertion.
[0095] In another embodiment, male connectors are connected to
their respective female receivers with an elastic material. For
example, male connector 208 is connected to female receiver 214
with a strap made from an elastic material. The strap is positioned
within an internal channel that runs lengthwise from the left side
232 to the right side 230 within the gastric skirt 200. The strap
is preferably made of a more elastic material than the gastric
skirt 200 so that the connectors can accommodate peristalsis and
movement of the stomach. This embodiment allows stress to be placed
on the strap rather than the gastric skirt 200, thereby preventing
the gastric skirt 200 from being overstretched due to
peristalsis.
[0096] FIG. 2B is a view of a modular laid-open gastric skirt 200.
The modular gastric skirt 200 may have two or more rectangular
strips or modules 234, 236, and 238. Each strip may have a ridge
240 (and 244) and/or a groove 242 (and 246) for attachment to
adjacent strips. The ridge 240 securely fits into the groove 242
along the length of each strip to prevent unwanted detachment of
adjacent strips and any in-growth of tissue between adjacent
strips. Some advantages of the strips include each strip can be
inserted separately and the size of the gastric skirt 200 can be
adjusted at the time of surgery to account for the amount of
tucking, size and orientation of the stomach 100. The modular
gastric skirt 200 may have a width W3 of approximately 1-3
centimeters, a width W4 of approximately 1-4 centimeters, and a
width W5 of approximately 1-3 centimeters. The widths may vary
depending on the size and amount of tucking needed. The modular
gastric skirt 200 may have a length L of approximately 6-16
centimeters.
[0097] In an embodiment, the modular gastric skirt 200 may utilize
only two of the rectangular strips or modules 234, 236, and 238.
For example, module 234 can be connected to module 236 to form the
modular gastric skirt 200. Alternatively, module 234 can be
connected to module 238 to form the modular gastric skirt 200.
[0098] FIG. 3 is a view of a rolled gastric skirt 300. The gastric
skirt 300 is tightly rolled so that it can be inserted through a
trocar as described above or other means. The staggered step design
allows the male connectors 208, 210, and 212, and the female
connectors 214, 216, and 218 to not overlap with each other when
the gastric skirt 300 is rolled. By not overlapping, the male
connectors 208, 210, and 212 and the female receivers 214, 216, and
218 are evenly flush with each other, so the diameter of the rolled
gastric skirt 300 is minimized. Similarly, the connectors, the
cardia collar and the antral collar may be passed through the
trocar into the stomach for connection to the gastric skirt
200.
[0099] FIG. 4 is a view of a folded conical cylinder-shaped gastric
skirt 400. As shown, step elements 412, 410, and 408 are each
connected to their immediately opposing step elements 418, 416, and
414, respectively, to form a conical cylinder-shaped gastric skirt
400. In an embodiment, the outer or upper curvature 403 has a
convex shape and is outwardly curving. The inner or lower curvature
404 has a concave shape and is inwardly curving. The conical
cylinder shape allows the gastric skirt 400 to properly fit around
and contact the stomach. The upper portion of the stomach 100 is
covered by the gastric skirt 400 near the upper curvature 403, as
the upper portion of the stomach has a larger diameter than the
lower portion of the stomach. The lower portion of the stomach is
covered by the gastric skirt 400 near the lower curvature 404.
[0100] The diameter of the upper curvature opening 420 (i.e.,
cardia end) and the lower curvature opening 406 (i.e., antral end)
are similar. The gastric skirt 400 can be a "one-size fits all"
design, where a single-sized gastric skirt 400 is used for all or
most stomach sizes. To adjust to a "one-size fits all" gastric
skirt 400, the stomach is tucked in per physician's preference and
the gastric skirt 400 is simply tightened accordingly when it is
being positioned around the stomach.
[0101] Furthermore, the one or more optional wings 422 and 424 are
attached on the circumference of the upper curvature 403. The wings
422 and 424 are used to attach the gastric skirt 400 to collar
connector straps (see also FIGS. 10A and 10B). Similarly, the
circumference of the lower curvature 404 can also have one or more
wings 426 and 428 attached. In another embodiment, the gastric
skirt 400 can have no wings attached, or wings only on one side,
either on the upper curvature 403 or the lower curvature 404.
[0102] In another embodiment, a healthcare professional can
estimate or measure the size of the patient's stomach beforehand.
Using this measurement, the gastric skirt 400 can be tailored to
provide a customized fit (for example, 10-30% smaller in diameter
than the measurement to accommodate the tuck). The prior
measurement reduces the risk of overtucking or overstretching or
damaging the gastric skirt 400 when it is being positioned around
the stomach, and can allow for a smooth and even customized fit
(see also FIGS. 5A, 5B, and 5C).
[0103] This conical cylinder design allows a single gastric skirt
to properly hold various portions of the stomach, even though the
stomach may vary in size throughout. The use of a single gastric
skirt reduces the complexity of the system and reduces the
possibility of complications which may arise due to uneven pressure
resulting from multiple skirts around the stomach. Alternatively,
multiple, separately-sized gastric skirts, such as, one for a
larger portion of the stomach, and one for a smaller portion of the
stomach, may be used.
[0104] FIG. 5A is a view of a gastric skirt 500 placed in position
around a stomach. The gastric skirt 510 is designed to cover
substantially all of the greater or outer curvature 502, and
substantially all of the lesser or inner curvature 504. As shown in
FIG. 5A, a portion of the fundus 506 and the antrum/pylorus 508 may
be tucked or covered or restricted by the gastric skirt 510.
[0105] In another embodiment, the gastric skirt 510 can be designed
to cover a smaller portion of the greater curvature 502 and/or a
smaller portion of the lesser curvature 504, instead of covering
the entire respective surfaces. Furthermore, the gastric skirt 510
can be designed to cover other surfaces of the stomach in addition
to the greater curvature 502 and/or the lesser curvature 504. For
example, the gastric skirt 510 may have a larger surface area and
cover the fundus 506 and/or the antrum/pylorus 508, or portions
thereof, in addition to portions of the greater curvature 502
and/or the lesser curvature 504.
[0106] Unlike conventional gastric-restraint devices, such as the
LAP-BAND.RTM., the gastric skirt 510 is not placed between the
cardia 514 and the fundus 506 forming a pouch. Furthermore, the
gastric skirt 510 is not placed around the esophagus 512. As
described above, the gastric skirt 510 is instead fitted or
positioned around the body of the stomach 500 (i.e., around
surfaces of the greater curvature 502 and the lesser curvature 504
of the stomach 500).
[0107] FIG. 5B is a view of a modular gastric skirt placed in
position around a stomach 500. The modular skirt 510 is shown as
three strips 510A, 510B, and 510C connected to one another. The
male and female connectors are shown as 516, 518, and 520,
respectively.
[0108] FIG. 5C is a view of a gastric skirt 510 placed in position
around a stomach 500 that shows a tucked-in portion of the stomach.
In this example, the greater curvature 502 is tucked into the body
of the stomach 500 and the gastric skirt 510 is placed around the
tucked stomach to secure the tucked portion in place. The tucked
portion is pushed into the body of the stomach, thus reducing the
internal volume of the stomach.
[0109] FIG. 6 is a view of a laid-open butterfly-shaped gastric
skirt 600. The gastric skirt 600 has an indentation 602 on one side
and an indentation 604 on the opposing side. The proximal end 606
and the distal end 608 can include connectors and receivers,
respectively, so that when the gastric skirt 600 is folded, the
proximal end 606 and the distal end 608 can be connected
together.
[0110] Indentations 602 and 604 can be any shape such as an
ellipse, oval, hourglass, or semicircular shape as shown in FIG. 6.
For example, each of the indentations 602 and 604 can be formed in
the shape of a square, a triangle, an oval, a semi-circle, an
ellipse, a wave, a curve, or any other shape that creates an
indentation. The size of each indentation 602 and 604 can be varied
in order to provide an optimal fit around the stomach. Indentations
602 and 604 do not necessarily have to be the same shape or size as
one another.
[0111] Furthermore, optional wing 610 is attached on one
substantially horizontal portion adjacent to indentation 604, and
optional wing 612 is attached on the other substantially horizontal
portion adjacent to indentation 604. The wings 610 and 612 are used
to attach the gastric skirt 600 to collar connector straps (shown
in FIGS. 10A, 10B, and 11). Similarly, the side of the gastric
skirt 600 with indentation 602 has wings 614 and 616 attached. In
another embodiment, the gastric skirt 600 can have no wings
attached, or wings only on one side. The dashed line indicates that
the gastric skirt 600 can have two or more modular pieces connected
to one another similar to that shown in FIG. 2B.
[0112] FIG. 7 is a view of a folded butterfly or step ladder-shaped
gastric skirt 700. Once the distal end 712 and the proximal end 714
are connected together by coupling the connectors and receivers, a
narrow surface 702 fits the lesser curvature of the stomach and is
formed on one side of the gastric skirt 700 between indentation 704
and indentation 706. On the side opposite to the narrow surface 702
is the wide surface 708 which fits the greater curvature of the
stomach.
[0113] In this embodiment, the narrow surface 702 of the
butterfly-shaped gastric skirt 700 can be used to cover the lesser
curvature of the stomach. Likewise, the broad surface 708 can be
used to cover the greater curvature of the stomach.
[0114] In another embodiment, instead of having connectors and
receivers to couple the gastric skirt 700, the distal end 712 and
the proximal end 714 can be sutured or stapled together.
[0115] FIG. 8A is a view of a laid-open oval or pear-shaped skirt
800. In this embodiment, the gastric skirt 800 has a protrusion 802
on one side and a protrusion 804 on the opposing side. The proximal
end 806 includes female connectors 820 and 821, and the distal end
808 includes male connectors 818 and 819. Therefore, when the
gastric skirt 800 is folded, the proximal end 806 and the distal
end 808 can be connected by securing the male connectors 818 and
819 into the female connector 820 and 821, respectively. In an
embodiment, the width of the proximal end 806 and the distal end
808 is from about 4 centimeters to about 6 centimeters and the
width between the protrusion 802 and the protrusion 804 is from
about 8 centimeters to about 14 centimeters.
[0116] Outward protrusions 802 and 804 can be any shape, and not
limited to, an oval, pear or semicircular shape as shown in FIG.
8A. For example, each of the outward protrusions 802 and 804 can be
formed in the shape of a square, a triangle, or any other shape.
The size of each outward protrusion 802 and 804 can also be varied
in order to provide an optimal fit around the stomach. Furthermore,
the outward protrusions 802 and 804 do not necessarily have to be
the same shape or size as one another. Optional wings 810 and 812
may be attached to outward protrusion 804, and optional wings 814
and 816 may be attached to outward protrusion 802. In another
embodiment, the gastric skirt 800 can have no wings attached, or
wings only on one side.
[0117] FIG. 8B is a view of a laid-open oval or pear-shaped skirt
800 having a pouch 822 that holds a balloon 1500. When the skirt
800 is wrapped around the stomach, the balloon 1500 can be secured
in the pouch 822 or be inserted into the pouch 822 to keep the
tucked-in portion within the stomach.
[0118] FIG. 8C is a view of a modular laid-open oval or pear-shaped
skirt 800 having a pouch 822A and 822B that holds a balloon. The
modular gastric skirt 800 may have two or more strips or modules.
Each strip may have a ridge 824 and/or a groove 826 for attachment
to adjacent strips. The ridge 824 securely fits into the groove 826
along the length of each strip to prevent unwanted detachment of
adjacent strips and any in-growth of tissue between adjacent
strips. The pouch 822 comprises two pieces 822A and 822B since the
skirt 800 is modular.
[0119] FIG. 9A is a view of a folded gastric skirt 900 with locking
clips. The gastric skirt 900 includes a proximal end 903 and a
distal end 905. When the gastric skirt 900 is folded so that the
proximal end 903 and the distal end 905 connect, a hollow shaped
gastric skirt 900 is formed with a skirt body 902. Each locking
clip comprises a male connector 904, 906, or 908, and a
corresponding female receiver 914, 912, or 910, respectively. A
right wing 916 and a left wing 918 are placed on opposite sides of
one end of the skirt body 902. The wings 916 and 918 are used to
connect the gastric skirt 900 to a collar (see also FIG. 11).
[0120] FIG. 9B is a view of a locking clip for the gastric skirt
900 shown in FIG. 9A. The locking clip 920 comprises the male
connector 908, which includes a connector strap pin 922. The
locking clip 920 also comprises the female connector 910. To engage
the locking clip 920, the connector strap pin 922 interlocks with
an opening in the female connector 910. Once the male connector 908
and the female connector 910 are engaged, the locking clip 920
holds a portion of the skirt body together. Furthermore, the male
connector 908 includes a lower portion 926 which extends outwards.
The female connector 910 includes an upper portion 924 which also
extends outwards. When the male connector 908 and the female
connector 910 are engaged, the lower portion 926 rests underneath
the upper portion 924.
[0121] FIG. 10A is a view of a gastric skirt 1002 with a harness
system 1000. The harness system 1000 may include a gastric skirt
1002, an upper collar 1004, and connector straps 1006 and 1008. The
gastric skirt 1002 is placed around the body of the stomach as
previously described in FIG. 5A. In another embodiment, a lower
collar (not pictured) is also included, allowing the upper collar
1004 and the lower collar to work in conjunction to hold the
gastric skirt 1002 in position.
[0122] The upper collar 1004 is connected to the gastric skirt 1002
via the connector strap 1006 and the connector strap 1008, which
are both, for example, connecting straps. The connector strap 1006
includes a skirt hook 1016 and a collar hook 1018. Likewise, the
connector strap 1008 includes a skirt hook 1020 and a collar hook
1022. Regarding the connector strap 1008, the skirt hook 1020
connects to the gastric skirt 1002 at a wing 1012. The collar hook
1022 connects to the collar 1004 at a wing 1014. Regarding the
connector strap 1006, the skirt hook 1016 connects to the gastric
skirt 1002 at a wing 1010. The collar hook 1019 connects to the
collar at a wing (not shown) located at a substantially parallel
location as wing 1014 on the opposite side of collar 1004.
[0123] The connector strap 1006 has a flexible connector strap 1024
to accommodate angulations to various anatomical differences where
the skirt hook 1016 and the collar hook 1018 connect with each
other. Likewise, the connector strap 1008 has a flexible connector
strap 1026 where the skirt hook 1020 and the collar hook 1022
connect with each other. The flexible connector straps 1024 and
1026 help to accommodate any angulations of the stomach in relation
to the lower esophagus and the fundus or the stomach and the
pylorus, as well as help to accommodate the angles and
contractility or peristaltic movements of the stomach. In an
embodiment, the connector straps 1024 and 1026 can bend from 1
degree to 90 degrees in any direction, and in a preferred
embodiment, the connector straps 1024 and 1026 can bend from 10
degrees to 60 degrees in any direction to accommodate movements of
the stomach.
[0124] FIG. 10B is a side-view of the gastric skirt 1002 with a
harness system 1000. In an embodiment, the gastric skirt 1002, the
upper collar 1004, the lower collar (not shown), the connector
strap 1008, and the connector strap 1006, all have the same
thickness and are all made of the same material. In an embodiment,
this thickness is up to 1/35,000th of an inch.
[0125] FIG. 11 is a view of a gastric skirt 1102 with a harness
system in position around a stomach 1100. The gastric skirt 1102 is
placed along the greater curvature 1122 and the lesser curvature
1120 of the stomach 1100. An upper collar 1104, also known as the
cardia collar, is placed around the lower end of esophagus 1108 at
a position near or adjacent to the cardiac receiver 1112. The upper
or cardia collar 1104 is large enough in diameter to encircle the
lower esophagus 1108, but small enough so that it cannot encircle
the larger diameter portion of the esophagus 1110. The upper collar
1104 is connected to the gastric skirt 1102 via a connector strap
1126. The connector strap 1126 is attached to the upper or cardia
collar 1104 at a wing 1122, and the connector strap 1126 is
attached to the gastric skirt 1102 at a wing 1124. This design
prevents the upper collar 1104 from moving very high up the
esophagus 1110, helps to hold the gastric skirt 1102 in place, and
may help in reducing gastro esophageal reflux ("gastric reflux") or
achalasia or dysphagia after the procedure.
[0126] The lower collar 1106, also known as the antral collar, is
placed around a lower portion of the stomach near the angular
receiver 1134 at the pylorus 1116, also known as the pyloric antrum
receiver. The lower collar 1106 is large enough in diameter to
encircle part of the lower portion of the stomach near the pylorus
1116, but small enough so that it cannot encircle the larger
diameter portion of the small intestine 1118. The lower collar 1106
is connected to the gastric skirt 1102 via connector strap 1132.
The connector strap 1132 is attached to the lower collar 1106 at a
wing 1128, and connector strap 1132 is attached to the gastric
skirt 1102 at a wing 1130. This design prevents the lower collar
1106 from moving down into the small intestine 1118, and helps to
hold the gastric skirt 1102 in place. Furthermore, the lower collar
1106 may assist in slowing the gastric emptying from the stomach
into the small intestine 1118. The lower collar 1106 may also
assist in anchoring the gastric skirt 1102 in place.
[0127] In another embodiment, only the upper collar 1104 is
attached to the gastric skirt 1102, and a lower collar 1106 is not
present. As the volume of the fundus 1114 fills with food, the
fundus 1114 stretches and expands, preventing the gastric skirt
1102 from sliding upwards. Thus, the lower collar 1106 may not
necessarily be required in all patients to help hold the gastric
skirt 1102 in place around the stomach 1100. Alternatively, in
another embodiment, only the lower collar 1106 is attached to the
gastric skirt 1102 and an upper collar 1104 is not present.
[0128] The gastric skirt 1102 and harness system are modular, and
provides patients with at least three different options. In the
first option, only the gastric skirt 1102 is utilized, without the
collars 1104 and 1106 and the connector straps 1126 and 1132. In
this embodiment, the healthcare professional may decide to not
include the collars 1104 and 1106 if there is not a high risk of
gastric reflux or achalasia, or if there is not a high risk that
the gastric skirt 1102 may be displaced.
[0129] In the second option, the gastric skirt 1102 is utilized
along with the collar 1104, but without the collar 1106 and without
the connector straps 1126 and 1132. In this embodiment, the gastric
skirt 1102 and the collar 1104 are not connected to each other. The
healthcare professional may decide on this option if there is a
risk of gastric reflux, achalasia, dysphagia but not a high risk
that the gastric skirt 1002 or the collar 1104 may be
displaced.
[0130] In the third option, the gastric skirt 1102 is utilized with
the collars 1104 and 1106 and the connector straps 1126 and 1132.
The healthcare professional may decide on this option if there is a
risk of gastric reflux, or dysphagia and a risk of that the gastric
skirt 1102 or collars 1104 and 1106 may be displaced. In this
option, both the upper collar 1104 and the lower collar 1106 do not
need be utilized, and only one of the collars 1104 or 1106 can be
used. The upper collar 1104 not only serves to hold the gastric
skirt 1102 in place, but is also a mechanism to help reduce gastric
reflux and dysphagia.
[0131] The modular design allows the healthcare professional to
decide which components of the gastric skirt system will be
utilized, as well as the order of insertion of the various
components.
[0132] In an embodiment, the upper collar 1104 and the lower collar
1106 each have a diameter from about 4 centimeters to about 6
centimeters. The upper collar 1104 can have a larger diameter up to
about 11 centimeters in cases where the patient suffers from
esophageal achalasia. In an embodiment, the length of the upper
collar 1104 and the lower collar 1106 is up to about 4
centimeters.
[0133] The length of connector straps 1126 and 1132 can be varied
to accommodate various stomach sizes. In a preferred embodiment,
connector strap 1126 and connector strap 1132 have a length of
about 5 centimeters.
[0134] The gastric skirt 1102 can have a length of about 6
centimeters to about 14 centimeters. In a preferred embodiment, the
length of the gastric skirt 1102 is from about 8 centimeters to
about 12 centimeters. The width of the greater curvature side of
the gastric skirt 1102 is from about 7 centimeters to about 10
centimeters, and the width of the lesser curvature side of the
gastric skirt 1102 is from about 3 centimeters to about 5
centimeters.
[0135] Some patients who undergo various gastric banding procedures
experience gastric reflux, and it is believed that gastric banding
procedures may cause or aggravate gastric reflux. Gastric reflux
occurs when irritating stomach contents, such as acid, accumulate
in the stomach outside of the lower esophagus entrance, and
eventually, leak or regurgitate back into the esophagus. This
leakage, over time, causes the lower esophagus to lose its tone,
leaving the lower esophagus entrance poorly controlled, tortuous,
unconstructed or floppy.
[0136] The upper collar 1104 may be approximately the same size as
the lower esophagus or may be slightly larger. Once in position,
the upper collar 1104 applies support by forming a significant wrap
around the lower end of the esophagus 1108 or the cardia. The upper
collar 1104 restricts the lower end of the esophagus opening 1108
and attempts to minimize regurgitation, thereby reducing gastric
reflux.
[0137] FIG. 12 is a view of an exemplary connector strap. The
connector strap 1200 has a lower portion 1232 and an upper portion
1234. The lower portion 1232 corresponds to the skirt hook 1202.
The upper portion 1234 corresponds to the collar hook 1204. The
connector strap 1200 has a skirt hook 1202 and a collar hook 1204.
The skirt hook 1202 includes connector strap pin 1206, connector
strap pin 1208, and extending portion 1226. The collar hook 1204
includes a hole 1210 through ridge 1222 and a second hole (not
shown) through ridge 1224. The collar hook 1204 also includes a
cavity 1220. The connector strap pins 1206 and 1208 are smaller in
diameter than the diameters of hole 1210 and the second hole
through ridge 1224. This design allows increased flexibility as the
connector strap pins 1206 and 1208 have space to re-position with
their respective holes when the connector strap 1200 is rotated or
shifted.
[0138] To connect the skirt hook 1202 and the collar hook 1204
together, connector strap pin 1206 is inserted into hole 1210, and
connector strap pin 1208 is inserted into the second hole through
ridge 1224. The extending portion 1226 is inserted into the cavity
1220. Once the skirt hook 1202 and the collar hook 1204 are
connected, the connector strap 1200 is formed.
[0139] The skirt hook 1202 also includes hole 1216 and connector
strap pin 1218. To attach the connector strap 1200 to a wing (not
shown) on the gastric skirt (not shown), the wing is placed inside
the connector strap cavity 1228 so that connector strap pin 1218 is
inserted through the wing. To secure the wing to the skirt hook
1202, the connector strap pin 1218 is pushed through the hole 1216.
The connector strap pin 1218 has a triangular shape, with a narrow
top and a wide base. The diameter of the base of the connector
strap pin 1218 is larger than the diameter of hole 1216. This
design allows the connector strap pin 1218 to be securely fastened
once it is inserted through hole 1216. Likewise, the collar hook
1204 includes a hole 1212, a connector strap pin 1214, and a
connector strap cavity 1230 to secure the collar hook 1204 to a
wing on the collar (not shown).
[0140] In an embodiment, the connector strap 1200 is made of an
elastomer, such as silicone. However, the connector can be made
from other types of elastomers or thermoplastic polymers, ePTFE,
Dacron.RTM., or any combination thereof.
[0141] FIG. 13A is a view of a collar. The collar 1300 includes a
locking clip 1302. The collar 1300 has a distal end 1304 and a
proximal end 1306. The distal end 1304 and the proximal end 1306
are connected by the locking clip 1302. The collar 1300 further
includes a first wing 1308 and a second wing 1310 that are used to
secure the collar 1300 to the gastric skirt connector strap (not
shown).
[0142] In order to place the collar 1300 around the lower esophagus
or cardia, the locking clip 1302 is not engaged, so that the distal
end 1304 and the proximal end 1306 are laid open. The collar 1300
is then fitted around a portion of the lower esophagus as described
above. Once the collar 1300 is in place, the locking clip 1302 is
engaged by connecting the distal end 1304 and the proximal end 1306
together.
[0143] FIG. 13B is a view of a locking clip for a collar 1300. The
male connector 1312 includes a connector strap pin 1316 which
interlocks with an opening in the female connector 1314. Once the
male connector 1312 and the female connector 1314 are engaged, the
locking clip holds the collar in position.
[0144] FIG. 13C is a view of a collar 1300 without wings. The
collar 1318 is used when a collar is not required to be connected
to the gastric skirt (not shown), such as in surgical option one
discussed above.
[0145] The locking clip 1302 can be any type of locking, coupling,
or clasping mechanism, and is not limited to the male connector
1312 and female connector 1314 designs shown in FIGS. 13A-D. For
example, the male connector may be an insertable clip, and the
female connector can include an opening to receive and secure the
insertable clip. In another embodiment, the clip can slide in and
out of the body of the skirt, and can have an elastic component
that stretches to accommodate the size and shape of the
stomach.
[0146] In an embodiment, the collar 1300 and locking clip 1302 are
made from a composition of silicone and PTFE/ePTFE. However, the
collar 1300 and locking clip 1302 can be made from other elastomers
or thermoplastic polymers, or any combination thereof.
[0147] In another embodiment, the distal end 1304 and proximal end
1306 can be sutured or stapled together at the time of positioning
by the healthcare professional.
[0148] In yet another embodiment, the collar 1300 can be shaped as
a semicircular ring, or in a "C" shape, and be made of a
memory-retaining material. Once the collar 1300 is placed around a
portion of the lower esophagus, it retains its shape. Thus, a
locking clip is not required.
[0149] FIG. 13D is a view of a laid-open collar 1300. The collar
1300 is in a strap form when the male connector 1312 and the female
connector 1314 are not connected.
[0150] As described above and shown in FIG. 1B, a portion of the
stomach is tucked inwards prior to application of the gastric skirt
around the stomach.
[0151] FIG. 14 is a cross-sectional view of a stomach 1400 and a
balloon 1402 positioned within a greater curvature 1406 of the
stomach 1400 when the greater curvature 1406 is tucked into the
stomach 1400. In an embodiment, after the greater curvature 1406 of
the stomach 1400 is tucked inwards, a cavity 1404 is formed as a
result of the tucking procedure and a balloon 1402 is placed within
the cavity 1404, which can be left open, and a gastric skirt 1412
is tightly positioned around the stomach 1400 to hold the balloon
1402 in place within the cavity 1404. Hence, the balloon 1402 is
placed within the tucked-in portion of the stomach 1400.
Alternatively, the balloon 1402 may be placed within a pouch 1414
that is attached to the gastric skirt 1412. The greater curvature
1406 of the stomach 1400 is pushed inwards to reduce the inner
volume 1410 of the stomach 1400. The balloon 1402 applies pressure
against the greater curvature 1406 of the stomach 1400 and helps to
maintain the shape of the cavity 1404. Following the placement of
the balloon 1402, the gastric skirt 1412 is placed around the
stomach 1400 as described above. In this embodiment, when the
gastric skirt 1412 is positioned around the stomach 1400, the
connectors as shown in FIG. 5B connect with one another along the
lesser curvature 1408 of the stomach 1400.
[0152] As described above, the greater curvature 1406 of the
stomach 1400 is the preferred tucking portion. However, the
tucked-in portion of the stomach 1400 may be a portion of the
lesser curvature 1408, or any portion of the stomach 1400 not along
either the greater curvature 1406 or the lesser curvature 1408. If
the tucked-in portion of the stomach 1400 is along the lesser
curvature 1408, then the connectors as shown in FIG. 5B connect
with one another along the greater curvature 1406 of the stomach
1400.
[0153] FIG. 15A is a view of the balloon of FIG. 14. The balloon
1500 can be a sealed or open ended stent, cylindrical air filled or
saline filled device with an ePTFE, Dacron.RTM., or silicon coating
or covering. The balloon 1500 is preferably made of an alloy of
nickel and titanium (Nitinol) or stainless steel wire cage which
provides the balloon 1500 with a self-expanding memory. The unique
characteristic of this alloy, known generally as "Nitinol," is that
it has a thermally triggered shape memory. This allows the balloon
cage to be crimped per a desired length, width, and volume based on
the balloon size required per patient's stomach dimensions, and
then the balloon 1500 is crimped into a sheath so that it can fit
through a trocar (not shown). The balloon 1500 regains its desired
shape when deployed at room temperature, such as the temperature of
the human body or outer stomach lining.
[0154] The semi-rigid or rigid Nitinol or stainless steel wire
frame is covered with ePTFE, silicone, Dacron.RTM. or any other
elastomer or thermoplastic elastomer, nitinol cage. The balloon
1500 provides support to the outer lining of the stomach when the
balloon 1500 is placed in position within the cavity 1404 of FIG.
14. The desired shape of the balloon 1500 is retained even under
pressure from the stomach lining or the gastric skirt (not shown)
since Nitinol or stainless steel or titanium wire cage is rigid and
has memory. After the balloon 1500 is placed in position, the
gastric skirt is placed around the stomach as described above.
[0155] In one embodiment, the self-expanding nitinol cage or
stainless steel wire cage balloon 1500 is covered with silicone,
and is formed in the shape of a cylindrical balloon, and can have
open or closed ends. In another embodiment, the self-expanding
nitinol balloon 1500 is covered with ePTFE, and can have open or
closed ends.
[0156] FIG. 15B is a view of a balloon 1502 with a port 1504. The
balloon 1502 is made entirely of silicone, other elastomers,
thermoplastic polymers, or any combination thereof, and may be
filled with air or liquid (e.g., saline) and methylene blue and has
a closed end and a port 1504 to inject air, liquid or methylene
blue. The methylene blue is used to detect leaks of the balloon
1502.
[0157] The balloon 1500 has a length of about 7 centimeters to
about 10 centimeters. In an embodiment, the diameter of the balloon
1500 is from about 1 centimeter to about 3 centimeters. However,
the diameter of the balloon 1500 can be adjusted by the healthcare
professional based on the amount of stomach that is tucked-in.
[0158] FIG. 16 is a view of the gastric skirt of FIG. 6 and the
balloon in position around a stomach. As seen in FIG. 16,
connectors 1604 and 1606 are positioned on the lesser curvature
side 1610 of the stomach 1600. Balloon 1602 is positioned on the
greater curvature side 1612 of the stomach 1600. In this
embodiment, the connectors 1604 and 1606 are not on the greater
curvature side 1612 so that there is room for the balloon 1602 to
be retained and held in place by the gastric skirt 1608 within the
tucked-in portion (not shown) of the stomach.
[0159] Furthermore, optional wings 1612 and 1614 are attached to
the gastric skirt 1608 to attach the gastric skirt 1608 to collar
connector straps (not shown).
[0160] FIG. 17 is a view of one or more ropes 1702 wrapped around a
tucked-in stomach 1700. The ropes 1702 may be made of a
biodegradable material or a woven silicon material or any other
material described herein. The stomach 1700 is tucked-in and then
the ropes 1702 are wrapped around the stomach 1700. Each rope 1702
can be a silicone rope, a mesh made of biodegradable elastomer, a
metal, an alloy, a silicone or thermo-elastic material to harness
the stomach or to create the pouch proximally or distal to the body
of the stomach or to produce the same effect as the gastric skirt
by tucking the stomach.
[0161] FIG. 18 is a view of one or more tentacles 1802 wrapped
around a tucked-in stomach 1800 where the tentacles 1802 can be
independently pulled and locked in place using a ring and clip
system 1808 or a tie lock (not shown). Each tentacle 1802 can be
independently tighten and loosened to control the tension. Each
tentacle 1802 can be pulled through a ring or hole and the clip can
lock the tentacle in place. The tentacles 1802 can be wrapped
around the greater curvature 1806 and the lesser curvature 1804 of
the stomach 1800. The tentacles 1802 can be any shape, such as
straight or curved, and are not limited to the design shown in FIG.
18. Furthermore, the tentacles 1802 can be made of an expandable
material originating from the body at the lesser curvature 1804 or
the greater curvature 1806.
[0162] FIG. 19 is a view of an inflatable gastric skirt 1902
positioned around a stomach. In an embodiment, the gastric skirt
1902 is positioned around the stomach along the lesser curvature
110 and the greater curvature 112, similar to the gastric skirt 200
described above. The gastric skirt 1902 includes one or more
finable or inflatable chambers that are attached to an interior
surface of the gastric skirt 1902.
[0163] In an embodiment, the gastric skirt 1902 is inflated via a
tube 1904 that is connected to the one or more inflatable chambers.
The tube 1904 includes an inlet 1906 that can be located slightly
beneath the skin of the patient. The tube 1904 also includes an
outlet 1908 which is connected to the one or more inflatable
chambers 2008 (see also FIG. 20). In an embodiment, the inlet 1906
can be sutured or stapled beneath the skin so that it is accessible
via an incision.
[0164] In another embodiment, the inlet 1906 can include an RFID
tag with an antenna to assist a healthcare professional in locating
the inlet 1906 for subsequent adjustments. An external RFID locator
or reader, such as in a handheld device, can be used to locate the
inlet 1906 so that a syringe can be inserted directly into an
access cavity of the inlet 1906.
[0165] FIG. 20 is a view of an inflatable gastric skirt and a
triple-lumen tube 1904. In an embodiment, the tube 1904 includes
three separate lumens 2002, with each lumen connected to a separate
inflatable chamber 2008. In another embodiment, the tube 1904 can
include a single lumen or a double lumen. In yet another
embodiment, the tube 1904 can include four or more lumens, with
each lumen connected to a separate inflatable chamber that can be
filled with a fluid.
[0166] In an embodiment, the gastric skirt 1902 can be positioned
around the stomach and secured into place via clips 2010. In an
embodiment, the gastric skirt 1902 is configured to cover at least
14 square centimeters of the outer surface of the stomach 100.
Thus, the gastric skirt 1902 has a surface area of at least 14
square centimeters. Once in place, the gastric skirt 1902 can be
further tightened around the stomach by inflating, filling, or
expanding the chambers 2008. Upon inflation of the inflatable
chambers 2008, the gastric skirt 1902 applies constriction pressure
around or to the stomach. The level of inflation can be determined
based on a desired stomach constriction level.
[0167] In an embodiment, the gastric skirt 1902 includes an
inflatable collar 2006 configured to surround the lower
esophageal/cardia portion of the stomach. The inflatable collar
2006 is coupled to the gastric skirt 1902 via two or more connector
straps 2004. The inflatable collar 2006 provides a harness and adds
stability to the gastric skirt 1902 after the gastric skirt 1902
has been positioned around the stomach.
[0168] Referring to FIGS. 48A-B, the clips 2010 can each include a
male tooth 4802 and a female receiver 4804 configured to engage the
male tooth 4802. Upon insertion of the male tooth 4802 into the
female receiver 4804, the male tooth 4802 releasbly locks with the
female receiver 4804 as shown in FIG. 48B. The clips 2010 may
include a release tab 4806 which releases the male tooth 4802 from
the female receiver 4804 upon the application of pressure to the
release tab 4806. Further, the locking mechanism can have a
"pop-fit" design that provides a tactile indication that the
gastric skirt 1902 is secured in place. The locking mechanism of
the gastric skirt 1902 is not limited to the clips 2010 shown in
FIGS. 48A-B, but can be any type of connecting mechanism which can
securely connect the two opposite ends of the gastric skirt 1902
around the stomach.
[0169] In another embodiment, the gastric skirt 1902 does not have
connectors, but the ends of the gastric skirt 1902 are attached to
one another by staples, sutures, or heat fusion after the gastric
skirt 1902 is positioned around the stomach 100.
[0170] FIG. 21 is a view of an inflatable gastric skirt without a
harness system. The gastric skirt 1902 includes connector holes
2102 where the connector straps 2004 (not shown) are attached. The
connector holes 2102 and corresponding tabs 2104 are optional
depending on whether the harness system is being used. In an
embodiment, the gastric skirt 1902 is a standalone device without
the harness system, and can be positioned around the stomach
without the collar 2006 and the connector straps 2004.
[0171] FIG. 22A is a view of a gastric skirt 1902 having one or
more inflatable chambers 2008. In an embodiment, each of the lumens
2002 is connected to a valve 2202. Each valve 2002 is connected to
a separate inflatable chamber. In another embodiment, a single
valve is located on the tube 1904 near the inlet 1906, and controls
delivery to all of the chambers 2008. Each lumen 2002 can also be
directly connected to a separate inflatable chamber 2008 without a
valve 2002.
[0172] FIG. 22B is a view of a cavity 2204 of a triple-lumen tube
1904. The tube 1904 has a cavity 2204 that contains three separate
lumens 2002. Each of the lumens 2002 is connected via a valve 2002
to a separate inflatable chamber, as shown in FIG. 22A. In an
embodiment, each of the lumens 2002 has a separate inlet so that a
different fluid can be administered through each of the lumens
2002. In another embodiment, the tube 1904 can include switches
which allow an operator to close or open certain lumens 2002. Thus,
a single inlet can be used to administer the fluid; however, a
switch or valve can be used to close the second and third lumens,
while allowing the fluid to pass through the first lumen and into
the first chamber.
[0173] FIG. 23 is a view of the interior of a triple-lumen tube.
The tube 1904 includes three separate lumens, a first lumen 2302, a
second lumen 2304, and a third lumen 2306. Surrounding the lumens
2002 is the tube 1904. The tube 1904 and the lumens 2002 are
relatively flexible and may be made of a non-porous elastomer, such
as, but not limited to, silicone, polypropylene, polyethylene
terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon,
fluorinated ethylene propylene, polybutester, or any combination
thereof. In an embodiment, the tube 1904 and the lumens 2002 are
made of the same material. In an alternative embodiment, the tube
1904 and the lumens 2002 are made of different materials.
[0174] FIG. 24 is an interior view of an inflatable gastric skirt.
In an embodiment, the tube 1904 has a staggered lumen design, so
that each of the three lumens has a different length. The first
lumen 2302 outputs into the first chamber 2408, the second lumen
2304 outputs into the second chamber 2410, and the third lumen 2306
outputs into the third chamber 2412. In an embodiment, the third
lumen 2306 is longer than the second lumen 2304, and the second
lumen 2304 is longer than the first lumen 2302, thus creating a
staggered lumen design within the tube 1904. In another embodiment,
each of the lumens 2002 in the tube 1904 has approximately the same
length, and each lumen directly connects to its respective
chamber.
[0175] In an embodiment, the chambers 2008 are relatively flexible
or semi-flexible and may be made of a non-porous elastomer such as,
but not limited to, silicone, polypropylene, polyethylene
terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon,
fluorinated ethylene propylene, polybutester, or any combination
thereof. In an embodiment, certain chambers can be selectively
filled with fluid. For example, fluid can be administered to only
the first chamber 2408 and the third chamber 2412, leaving the
second chamber 2410 unfilled or deflated. In another embodiment,
each of the chambers 2008 can be inflated to different fluid
amounts resulting in different pressure levels within each
chamber.
[0176] The fluid administered into each chamber 2008 can include
saline, air, water, gel, gas, or any other biocompatible fluid or
viscous solid. In a preferred embodiment, the fluid is concentrated
saline. In another embodiment, the fluid includes methylene blue.
Different fluids can be administered through each lumen, thus,
allowing each chamber to be filled with a different amount and/or
type of fluid. For example, the fluid administered through the
first lumen 2302 and the second lumen 2304 can be saline, and the
fluid administered through the third lumen 2306 can be a gas.
[0177] FIG. 25 is a view of a triple-lumen inlet port. The inlet
1906 includes an access hole 2502 or a septum 2502 that covers all
the lumen openings. A needle may be used to pierce the septum 2502
and allow a healthcare professional to fill fluid into the lumens
2302, 2304, and 2306. The septum 2502 may have a visible marker on
top to indicate where the needle should be positioned for filling
each of the lumens. The septum 2502 may automatically be sealed
when the needle is removed to prevent fluid for exiting the lumens.
In one embodiment, the inlet 1906 is made of a semi-rigid
elastomer.
[0178] FIG. 26 is a view of an inflatable gastric skirt and an
inflation device. In an embodiment, to inflate the gastric skirt, a
non-coring needle and syringe 2602 can be used to administer fluid
to the access hole or septum 2502. To deflate the chambers 2008,
the inlet 1906 is connected to a suction device 2602 which pulls
the fluid out from the chambers 2008 or the needle 2602 can be
reinserted through the septum 2502 which is used to remove the
fluid from the lumens, which results in fluid being removed from
the chambers 2008. The suction device 2602 can be, for example, a
syringe, a vacuum, or any other means to withdraw inflation fluid
from the chambers 2008. In another embodiment, the inlet 1906 can
be connected to an automated system for inflation and deflation of
the chambers, so that manual adjustment of the gastric skirt 1902
is not required.
[0179] In an embodiment, the inlet 1906 includes a reservoir which
holds fluid. For example, the reservoir can be pre-filled during
insertion of the gastric skirt 1902 around the stomach. The
reservoir can automatically administer fluid to the lumens 2002
over a pre-determined time period. In another embodiment, the
reservoir can include dual tanks, one tank to deliver fluid to the
chamber, and another tank to remove fluid from the chamber. The
dual tanks can automatically inflate or deflate the chambers 2008
based on fluid pressure changes resulting from movement of the
patient and the stomach.
[0180] The gastric skirt 1902 can have a microprocessor and sensors
attached thereto to determine the fluid pressure and free volume
within each chamber. Upon receipt of the fluid pressure and free
volume data, the microprocessor can be used to activate fluid
transfer between the different chambers in order to compensate for
fluid displacement due to patient and stomach movements. The fluid
transfer can ensure that a desired amount of pressure is constantly
being applied from each chamber to the stomach. In another
embodiment, the microprocessor can control the reservoir, and
administer or draw fluid based on the sensor readings.
[0181] The gastric skirt 1902 may include at least one pressure
sensor located within the tube 1904 and at least one pressure
sensors located within the chambers 2008 to measure fluid movement
and fluid pressure within the chambers 2008. A receiver located
within the gastric skirt 1902 can transmit data to a remote
controller, such as, for example, an external handheld computer,
desktop computer, monitoring system, or an online web-based
monitoring portal.
[0182] In an embodiment, the remote controller includes
microprocessors to analyze the data for pressure variations and
determine optimal fill volumes for the chambers 2008. This analysis
can assist a healthcare professional in adjusting the inflation
levels in the chambers 2008. Alternatively, the data can be used by
the remote controller to automatically adjust the fluid levels
based on pre-determined constriction pressures. In an embodiment,
each of the different chambers can have a separate pressure sensor,
allowing monitoring and adjustment of fluid within each individual
chamber.
[0183] Each chamber can have multiple entry points for the lumens,
so that a blockage in one portion of a lumen or a chamber will not
prevent the chamber from being filled with fluid. For example, the
first lumen 2302 can have multiple branches which allow inflation
fluid into the first chamber 2408. Thus, if one of the branches is
blocked or obstructed, the other branches on the first lumen 2302
will continue to fill the first chamber 2408.
[0184] In another embodiment, the reservoir can be controlled via
an implantable pump that is powered by an implantable energy
source, such as batteries or capacitors. Alternatively, the pump
can be powered by a passive device located outside the body via
energy transferred through, for example, radio frequency,
induction, or electromagnetic energy.
[0185] In another embodiment, the tube 1904 is removable. After the
gastric skirt 1902 has been placed around the stomach, and adjusted
to provide a desired constriction pressure, the healthcare
professional can remove the tube 1904. In this embodiment, the
gastric skirt 1902 is designed to be inflated and adjusted only at
the time of insertion. Following the initial inflation and
adjustment, the outlet 1908 can be detached from the gastric skirt
1902, and the tube 1904 can be removed from the body. In order to
inflate or deflate the gastric skirt 1902 after the initial surgery
to insert the gastric skirt 1902, the outlet 1908 of the tube 1904
needs to be re-attached to the gastric skirt 1902 via a surgical
procedure.
[0186] FIG. 27 is a view of a laid-open inflatable gastric skirt.
In an embodiment, the chambers 2408, 2410 and 2412 are attached to
or integrated with an interior portion 2702 of the gastric skirt
1902. The first lumen 2302 has an output into the first chamber
2408, the second lumen 2304 has an output into the second chamber
2410, and the third lumen 2306 has an output into the third chamber
2412. In another embodiment, a single lumen can be utilized instead
of multiple lumens. The single lumen can have outlets branching
into each of the chambers 2408, 2410 and 2412.
[0187] FIG. 28 is a view of a connector strap. The connector strap
2004 has buttons 2802 that are used to secure the connector strap
2004 to the upper collar 2006 and the gastric skirt 1902. The
buttons 2802 are configured to snap into the connector holes 2102
on the gastric skirt 1902 and corresponding connector holes on the
upper collar 2006. The connector strap 2004 is relatively flexible
or semi-flexible and may be made of a non-porous elastomer, such
as, but not limited to, silicone, polypropylene, polyethylene
terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon,
fluorinated ethylene propylene, polybutester, or any combination
thereof. The connection means between the upper collar 2006 and the
gastric skirt 1902 is not limited to the connector strap 2004, and
can be any type of connector which allows a limited movement of the
upper collar 2006 irrespective of the movement of the gastric skirt
1902.
[0188] FIG. 29 is a lateral view of the inflatable gastric skirt.
In an embodiment, the chambers 2008 can have a thickness of 0.05
millimeters to 0.5 millimeters in a collapsed state. In an inflated
state, the chambers can have a thickness of 0.5 millimeters to 1.5
centimeters. The thickness of the chambers 2008 can be varied based
on a desired constriction pressure. Furthermore, each of the
different chambers 2008 can be inflated to a different thickness or
filled to provide a different level of rigidity.
[0189] FIG. 30 is a view of an inflatable collar. In an embodiment,
an inflatable collar 3002 can be utilized for a harness system. The
inflatable collar 3000 has a chamber 3002 and a tube 3004. In an
embodiment, the inflatable collar 3000 has multiple chambers
similar to the chambers 2008 described above for the gastric skirt
1902. The tube 3004 can have a single lumen or multiple lumens
similar to the tube 1904. The inflatable collar 3002 can be used to
apply pressure to the antral portion and/or to the lower
esophageal/cardia portion of the stomach.
[0190] FIG. 31 is a view of an inflatable gastric skirt with dual
inflatable collars. In an embodiment, the lower collar 3102, also
known as the antral collar, is placed around a lower portion of the
stomach near the angular receiver at the pylorus, also known as the
pyloric antrum receiver. In an embodiment, the lower collar 3102 is
large enough in diameter to encircle part of the lower portion of
the stomach near the pylorus, but small enough so that it cannot
encircle the larger diameter portion of the small intestine. The
lower collar 3102 is connected to the gastric skirt 1902 via the
connector straps 2004. This system prevents the lower collar 3102
from moving down into the small intestine, and helps to anchor the
gastric skirt 1902 in place. Furthermore, the lower collar 3102 may
assist in slowing the gastric emptying from the stomach into the
small intestine.
[0191] In an embodiment, the lower collar 3102 and the upper collar
3000 are both inflatable. The lower collar has a port 3104, and the
upper collar has a separate port 3006. These ports operate in a
similar fashion to the port 1906 that is used to inflate the
chambers of the gastric skirt 1902. In another embodiment, the tube
1904 can be connected to the gastric skirt 1902, the lower collar
3102, and the upper collar 3000, so that a single tube 1904 is used
to fill or inflate all of the chambers.
[0192] FIG. 32 is a view of an internal surface of an inflatable
gastric skirt. In an embodiment, the first chamber 2408, the second
chamber 2410, and the third chamber 2412 may be enclosed within a
covering 3202. The lumens 2002 are enclosed within the covering
3202 in a staggered fashion as described above. In an alternative
embodiment, a single inflatable chamber is utilized, and can be
inflated using a single-lumen port.
[0193] FIG. 33 is a view of a valve and the steps of inflation and
deflation. In an embodiment, the valve 3302 is fitted at the inlet
1906 of the tube 1904. The valve 3302 has a slitted diaphragm to
allow a syringe nozzle to enter. In step 3300, the valve is in a
closed position. In step 3304, a syringe nozzle 3303 is inserted
through the slitted diaphragm of the valve 3302. The slitted
diaphragm opens up and allows fluid to be inserted through the
syringe nozzle 3303. In step 3306, the fluid is inserted through
the open valve 3302. In step 3308, the syringe nozzle 3303 is
removed from the valve 3302, and the slitted diaphragm of the valve
3302 returns to a closed position.
[0194] In an embodiment, to deflate or remove fluid from the
chambers, the syringe nozzle 3303 is inserted into the slitted
diaphragm of the valve 3302 as shown in step 3310. The syringe
nozzle 3303 is used to aspirate the inflation fluid from the lumens
and chamber, thereby deflating or removing fluid from the chambers.
In step 3312, the syringe nozzle 3303 is removed from the valve
3302 and the slitted diaphragm returns to a closed position. In
another embodiment, the inlet 1906 can have a similar design as the
valve described in FIG. 33.
[0195] FIG. 34 is a view of an inflatable antral skirt. In an
embodiment, the antral skirt 3402 can be positioned around the
pyloric antrum 114, which is located between the pyloric sphincter
3408 and the angular receiver 3406 in the lower part of the stomach
3404. In an embodiment, the antral skirt 3402 is designed to be
placed around a stomach that has undergone a VSG procedure, which
is also known as sleeve gastrectomy, vertical gastrectomy, greater
curvature gastrectomy, parietal gastrectomy, gastric reduction,
longitudinal gastrectomy, or vertical gastroplasty. In the VSG
procedure, the stomach 3404 is restricted by stapling and dividing
it vertically and removing more than 85% of its surface area. As
shown in FIG. 34, the greater curvature 112 of the stomach 3404 is
taken in closer to the lesser curvature 110, creating a
sleeve-shaped stomach 3404. In an embodiment, the antral skirt 3402
is configured to cover at least 14 square centimeters of the outer
surface of the pyloric antrum 114. Thus, the antral skirt 3402 has
a surface area of at least 14 square centimeters. In an embodiment,
the antral skirt 3402 has a length of at least 10 centimeters and a
width of at least 4 centimeters. In one embodiment, the thickness
of the antral skirt 3402 is up to about 1/35,000th of an inch.
[0196] In an embodiment, the antral skirt 3402 is inflatable or
fillable with fluid through a tube 3410, which operates similar to
the tube 1904 described above for the gastric skirt 1902. The
antral skirt 3402 can be inflated and deflated to provide a desired
constriction level around the pyloric antrum 114. In another
embodiment, the antral skirt 3402 can be applied around the pyloric
antrum 114 of a stomach that has not undergone a VSG procedure. In
yet another embodiment, the antral skirt 3402 can be applied in
conjunction with a gastric skirt or other type of gastric
constriction device that is placed around the body or fundus of the
stomach.
[0197] Inflation of the antral skirt 3402 constricts the pyloric
antrum 114. The pyloric antrum 114 is a portion of the stomach
where food and particles are collected and pumped into the lower
intestine. The pyloric antrum 114 also contains receptors that
provide indications of fullness to the brain. When food is pumped
into the pyloric antrum 114 from the stomach, the pyloric antrum
114 expands, and receptors provide an indication that the stomach
is full. This results in a pumping action by the pyloric antrum 114
to empty the stomach contents into the intestine. The antral skirt
3402 provides a constant restriction to the pyloric antrum, which
leads to early gastric emptying. This mechanism is described in
more detail by the disclosure below.
[0198] The antral skirt 3402 is relatively flexible or
semi-flexible and may be made of a non-porous elastomer, such as,
but not limited to, silicone, polypropylene, polyethylene
terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon,
fluorinated ethylene propylene, polybutester, or any combination
thereof. In another embodiment, the antral skirt 3402 can be made
of a biodegradable mesh.
[0199] FIG. 35 is a laid-open view of an inflatable antral skirt.
In an embodiment, the antral skirt 3402 includes an inflatable
chamber 3506. The antral skirt 3402 may or may not include an
inflatable chamber 3506. The inflatable chamber 3506 can be
inflated or filled with inflation fluid through the tube 3410. The
antral skirt 3402 includes a male connector 3502 and an opposing
female connector 3504. When then antral skirt 3402 is positioned
around the pyloric antrum, the male connector 3502 and the female
connector 3504 interlock to securely hold the antral skirt 3402 in
place. The connection means is not limited to the embodiment shown
in FIG. 35, and the antral skirt 3402 can be securely held in place
by clips, straps, sutures, stitching, staples, other types of
connectors, and/or other attachment means.
[0200] FIG. 36 is a view of a double-side inflatable gastric skirt.
In an embodiment, the gastric skirt 1902 includes a top inflatable
layer 3604 attached to an exterior surface of the gastric skirt
1902 and a bottom inflatable layer 3606 attached to an interior
surface of the gastric skirt 1902. The top inflatable layer 3604
provides cushions from pressure exerted onto the stomach from other
body organs that are adjacent to the stomach. The bottom inflatable
layer 3606 provides constriction pressure on the stomach as
described above. A double-lumen port 3602 provides separate
inflation fluid to each of the inflatable layers. In an embodiment,
the top inflatable layer 3604 and bottom inflatable layer 3606 can
include multiple inflatable or fillable chambers. Each of the
lumens in the double-lumen port 3602 can each contain multiple
lumens to deliver different fluids to each of the multiple chambers
within each inflatable layer.
[0201] FIG. 37 is a view of an inflatable gastric skirt with
radio-frequency (RF) coils. In an embodiment, each of the
inflatable chambers 2008 has a RF coil 3702 surrounding the
exterior of the chamber 2008. The RF coils 3702 are activated when
a RF receiver 3704, either coupled to the gastric skirt 1902, or
embedded within the gastric skirt 1902, receives an activation
signal from an energy device, such as an RF generator, controller
or transmitter. In an embodiment, the energy device is located
outside of the patient's body and transmits wireless energy signals
to the RF receiver 3704. The RF receiver 3704 can be used to store
energy or the energy signals. In another embodiment, the energy
device can be located inside the patient's body. In an embodiment,
the RF coils 3702 provide RF energy, such as heat and ultrasonic
energy, to the exterior stomach wall, and create scarring in the
shape of the RF coils 3702 in the exterior stomach wall. The
scarred tissue reduces the stomach volume.
[0202] In an embodiment, immediately after the tissue scarring
process in completed the chambers 2008 can be filled with a cooled
fluid, such as cooled saline. The cooled fluid may assist in better
healing of the scarred tissue. Furthermore, once the chambers 2008
are inflated, they inflate into the space created by the scarred
tissue, providing localized cushioning of the scarred regions. When
the chambers 2008 expand or fill into the scarred tissue region
that has been indented into the exterior stomach wall, the gastric
skirt 1902 is secured into its intended site.
[0203] In an embodiment, the RF coils 3702 may be covered with a
sleeve or pouch made from Teflon.RTM., Dacron.RTM., ePTFE, or any
combination thereof. The sleeve is glued or sutured to the gastric
skirt 1902 and/or the chambers 2008. In another embodiment, the
sleeve is molded with the gastric skirt 1902 and/the chambers 2008
to form a single molded structure.
[0204] FIG. 38 is a view of an inflatable gastric skirt with steam
ablation holes. Each of the inflatable chambers 2008 are covered
with a thin ablation layer 3802, which contain an ablation device,
and have top holes 3804 to allow thermal energy in the form of
steam to pass through and ablate the exterior stomach wall. Steam
is delivered to the ablation layers 3802 via a steam receiver 3806.
In an embodiment, the steam can be delivered through the tube 1904
prior to delivery of fluid to the chambers 2008. In another
embodiment, thermal steam ablation can be used in conjunction with
laser ablation to provide scarring of the stomach tissue.
[0205] FIG. 39 is a lateral view of an inflatable gastric skirt
with steam ablation holes. The gastric skirt 1902 includes ablation
layers 3802 on top of each of the chambers 2008. The ablation
layers 3802 include side holes 3902. The top holes 3802 and the
side holes 3902 allows steam ablation to create an indentation
within the exterior stomach wall so that the stomach can
accommodate the chambers 2008.
[0206] FIG. 40 is a view of an inflatable gastric skirt with an
ultrasound probe. The gastric skirt 1902 includes ultrasound layers
4002 on top of each of the chambers 2008. The ultrasound layers
include an ultrasound receiver 4004 which delivers ultrasound waves
to the exterior stomach wall. The ultrasound energy, such as
ultrasonic waves, creates indentations within the exterior stomach
wall so that the stomach can accommodate the chambers 2008. In an
embodiment, the ultrasound receiver 4004 can be embedded within the
gastric skirt 1902 and activated by a receiver or controller
located outside of the patient's body.
[0207] In another embodiment, laser energy, heat, microwave
radiation, high-intensity light, or other tissue scarring
mechanisms can be used to deliver energy to scar the exterior
stomach wall. In each of these embodiments, an implanted receiver
and an external energy source, such as a generator located outside
of the body, can be used to activate the tissue ablation
device.
[0208] In another embodiment, the energy source is implanted with
the body, and can be embedded within the gastric skirt 1902,
embedded within the ablation layers, or located adjacent to the
gastric skirt 1902.
[0209] In an embodiment, the ablation device can be activated by a
remote or external controller, such as for example, an external
handheld computer, desktop computer, monitoring system, or an
online web-based monitoring portal. The remote controller ablation
energy to be delivered remotely after the gastric skirt
implantation surgery has been completed. The remote controller
activates the transmission of energy from an external energy source
to the transmitter, which in turn delivers energy to the ablation
layer. The ablation device then emits the energy toward the outer
surface of the stomach in order to ablate stomach tissue. In an
embodiment, the energy emission to the stomach tissue can last from
0.5 seconds to 20 seconds, depending on a desired level of ablation
or scarring.
[0210] In another embodiment, the ablation device is positioned on
the exterior surface of the gastric skirt 1902. In this embodiment,
the ablation device, such as an ultrasound probe, transmits
ultrasound energy signals towards the outer surface of the stomach
through the gastric skirt 1902.
[0211] In another embodiment, the gastric skirt 1902 is comprised
of an interior elastomeric sheet and an exterior elastomeric sheet.
The ablation device is sandwiched between the first elastomeric
sheet and the second elastomeric sheet. In yet another embodiment,
the ablation device is integral to an elastomeric casing, and is
contained within the elastomeric casing.
[0212] FIG. 41 is a view of an inflatable gastric skirt with
alternating ablation layers and inflation chambers. In an
embodiment, the thermal ablation layers 4102 are positioned in an
alternating fashion with the chambers 2008. The thermal ablation
layers 4102 are positioned between the chambers 2008, so that the
inner surface of the gastric skirt 1902 has a smooth and even
surface. In another embodiment, the ablation layers can be an
ultrasound probe or RF coils positioned between the chambers 2008
in an alternating fashion as described above.
[0213] In another embodiment, different ablation layers can be
activated to selectively scar different portions of the exterior
stomach wall. For example, in the gastric skirt shown in FIG. 40,
only two of the four ablation layers can be activated based on a
desired area and amount of scarring. Furthermore, different
ablation layers can be activated at different times so that a large
portion of the stomach is not undergoing scarring at once, and the
scarring procedure can be spread out over time.
[0214] In yet another embodiment, the chambers can be semiporous,
allowing for fluid to leak onto the exterior stomach wall. The
inflation fluid can be a neurotoxin, such as botulinum toxin types
A, B, C.sub.1, D, E, F and G. When the neurotoxin is administered
at the site where the inflatable chambers contact the stomach, the
site administered takes a relaxed muscle tone. The inflatable
chambers would then fall into these regions with the relaxed muscle
tone, securing the gastric skirt 1902 in its intended site.
[0215] In an alternative embodiment, the gastric skirt does not
include inflatable or fillable chambers. Instead, the gastric skirt
includes only an ablation or tissue scarring mechanism, such as,
for example, RF coils, thermal ablation layers, or ultrasound
layers, to deliver energy to the exterior tissue, surface, wall or
lining of the stomach. In this embodiment, the gastric skirt can be
applied around a portion of the stomach in order to ablate the
stomach and reduce the internal volume of the stomach. The gastric
skirt can provide a barrier between the scarred exterior stomach
wall and other body organs. This allows the scarred tissue to heal
faster and with a minimal risk of infections or complications, as
opposed to normal scarring procedures where the scarred tissue is
left exposed during healing.
[0216] In an embodiment, the antral skirt 3402 can include an
ablation device, such as, for example, RF coils, thermal ablation
layers, or ultrasound layers, in conjunction with fillable or
inflatable chambers. The antral skirt 3402 can provide constriction
as well as ablation or scarring to the pyloric antrum 114.
[0217] FIG. 42 is a view of a physiological connection between
stomach receptors and a brain. After a VSG procedure, many of the
cardia stretch receptors 4202 and the stomach body stretch
receptors 4204 are removed. However, the pyloric antrum 114 is not
modified by the VSG procedure, and the antral stretch receptors
4204 in the pyloric antrum 114 remain intact. Upon being filled
with food and stomach contents, the pyloric antrum 114 expands, and
the stretch receptors 4206 in the pyloric antrum 114 send
neurological signals to the hypothalamus 4210 in the brain 4208,
indicating the stomach is full. Upon receipt of these signals, the
hypothalamus 4210 sends a signal via the afferent vagal nerve 4212
to the pyloric antrum 114 to pump out the food into the
intestines.
[0218] The antral skirt 3402 provides a constant pressure around
the pyloric antrum 114, so that when pyloric antrum 114 even
slightly expands, the antral stretch receptors 4206 are constrained
from further expansion. Upon being prevented from further
expansion, the antral stretch receptors 4206 send a signal to the
brain 4208, and in turn, the pyloric antrum 114 is caused to pump
out food contents. The combination of the antral skirt 3402 and the
antral stretch receptors 4206 create an equal and opposite
reaction, causing a continual gastric emptying by the pyloric
antrum 114. Thus, the invention takes advantage of the antral
stretch receptors 4206 that remain after a VSG procedure in order
to provide an indication of fullness to the brain 4208 and cause
rapid and early gastric emptying.
[0219] FIG. 43 is a view of a stomach prior to ligation. In an
embodiment, the gastric skirt 1902 is designed to accommodate a
stomach that has undergone tucking and ligation procedures. Prior
to placing the gastric skirt 1902 around the stomach 100, a linear
portion of the greater curvature 112 is tucked inwards into the
stomach 100 and towards the lesser curvature 110. As shown above in
FIG. 1B, the inner lining 120 is depressed within the stomach 100
as a result of the tucking procedure, and the tucked-in portion
4302 occupies space within the body of the stomach 106. After the
tucking procedure, a first untucked stomach portion 4304 and a
second untucked stomach portion 4306. Thus, the internal volume of
the stomach 100 is substantially decreased.
[0220] In an embodiment, in order to assist the healthcare provider
in determining how far to tuck in the stomach, a bougie 4308 is
endoscopically inserted through the esophagus 102 and into the
stomach body 106 (Step 4702). The bougie 4308 is inserted adjacent
to or along the lesser curvature 110. Next, a portion of the
stomach 100 is tucked or pushed inwards towards the lesser
curvature 110 until the bougie 4308 is reached (Step 4704). The
bougie 4308 prevents the tucked-in portion 4302 from completely
blocking off the stomach body 106, and allows for a channel to
remain in the stomach body 106 after the stomach ligation procedure
is completed. In another embodiment, a guidewire dilator, balloon
dilator, or any other mechanism can be used to assist the
healthcare professional in tucking in the stomach 100 without
closing off the stomach body 106.
[0221] After the stomach 100 has been tucked-in, a ligation
procedure is performed (Step 4706). The first untucked stomach
portion 4304 and the second untucked stomach portion 4306 are
ligated by inserting a ligature, such as bioabsorbable surgical
staples, sutures, stitches, thread, wired and/or clamps, using a
ligation device. Thus procedure closes off any space which was
created by the tucked-in portion 4302 between the first untucked
stomach portion 4304 and the second untucked stomach portion 4306.
In another embodiment, the ligation procedure can be performed
using bioabsorbable staples or stitches. The ligation procedure can
be conducted either laparoscopically or during an open-surgical
procedure. After the ligation procedure is completed, the bougie
4308 is removed from the stomach 100 (Step 4708) using the
endoscopic device. In an embodiment, the stomach 100 is then
covered with the gastric skirt 1902 (Step 4710), and the gastric
skirt 1902 is filled or inflated to provide a desired level of
constriction around the stomach (Step 4712).
[0222] FIG. 44 is a lateral view of a tucked-in stomach prior to
ligation. The greater curvature 112 is tucked-in towards the lesser
curvature 110, until the greater curvature 112 comes into contact
with the bougie 4308. The tucked-in portion 4302 leaves the first
untucked stomach portion 4304, the second untucked stomach portion
4306, and a cavity 4402 between the first untucked stomach portion
4304 and the second untucked stomach portion 4306.
[0223] FIG. 45 is a view of a ligated stomach. After the ligation
procedure is completed, the internal volume of the stomach 100 is
reduced to approximately one-third of its original volume. The
ligation procedure is reversible, as the sutures 4310 can be
removed. In an embodiment, the gastric skirt 1902 is positioned
around the ligated stomach as shown in FIG. 19. In another
embodiment, the stomach 100 undergoes a VSG procedure instead of a
ligation procedure prior to the gastric skirt 1902 being placed
around the stomach.
[0224] FIG. 46 is a lateral view of a gastric skirt positioned
around a ligated stomach. The volume of the stomach body 106 is
approximately one-third of its original volume. The sutures 4310
are inserted through the first untucked portion of the stomach
4304, the cavity 4402, and the second untucked portion of the
stomach 4306. The sutures 4310 prevent food and stomach contents
from entering and accumulating in the first untucked portion of the
stomach 4304 and the second untucked portion of the stomach 4306.
In an embodiment, the stomach 100 is covered with the gastric skirt
1902.
[0225] While the principles of the disclosure have been illustrated
in relation to the exemplary embodiments shown herein, the
principles of the disclosure are not limited thereto and include
any modification, variation or permutation thereof.
* * * * *