U.S. patent number RE47,902 [Application Number 15/625,871] was granted by the patent office on 2020-03-17 for method and apparatus for treating obesity and controlling weight gain using self-expanding intragastric devices.
This patent grant is currently assigned to ReShape Lifesciences, Inc.. The grantee listed for this patent is Acorn Subsidiary Holdings LLC. Invention is credited to Raj Nihalani.
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United States Patent |
RE47,902 |
Nihalani |
March 17, 2020 |
Method and apparatus for treating obesity and controlling weight
gain using self-expanding intragastric devices
Abstract
The invention generally relates to a method and apparatus to
treat obesity and controlling weight gain. In an exemplary
embodiment, the invention relates to a covered cage device that is
implanted within a human's stomach to occupy volume and cause a
reduced desire for eating. The covered cage device is made from a
wire-mesh, such a Nitinol, and can be adjustable and collapsible.
In another embodiment, the covered cage device has edges that
provide stimulation to the stomach to induce a feeling of
fullness.
Inventors: |
Nihalani; Raj (Irvine, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Acorn Subsidiary Holdings LLC |
Wilmington |
DE |
US |
|
|
Assignee: |
ReShape Lifesciences, Inc. (San
Clemente, CA)
|
Family
ID: |
1000004349307 |
Appl.
No.: |
15/625,871 |
Filed: |
June 16, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
12415823 |
Jan 24, 2012 |
8100932 |
|
|
Reissue of: |
13356361 |
Jan 23, 2012 |
9055994 |
Jun 16, 2015 |
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/12099 (20130101); A61B 17/12172 (20130101); A61B
17/12136 (20130101); A61F 5/0036 (20130101); A61B
17/12163 (20130101); A61B 17/12163 (20130101); A61B
17/12136 (20130101); A61B 17/12099 (20130101); A61B
17/12172 (20130101); A61F 5/0036 (20130101); A61B
2017/00818 (20130101); A61B 2017/00818 (20130101) |
Current International
Class: |
A61F
5/00 (20060101); A61B 17/12 (20060101); A61B
17/00 (20060101) |
Field of
Search: |
;606/192
;604/104-109 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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101193610 |
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Jun 2008 |
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CN |
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1205148 |
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May 2002 |
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EP |
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1002464 |
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Nov 1996 |
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GR |
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2007/0100015 |
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Sep 2008 |
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GR |
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WO 01/41671 |
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Jun 2001 |
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WO |
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WO 2004/014245 |
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Feb 2004 |
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WO |
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WO 2008/122713 |
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Oct 2008 |
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WO |
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WO 2009/059803 |
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May 2009 |
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WO |
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Primary Examiner: Wehner; Cary E
Attorney, Agent or Firm: Merchant & Gould P.C.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application .Iadd.is a reissue of U.S. application Ser. No.
13/356,361, filed Jan. 23, 2012, now U.S. Pat. No. 9,055,994, which
.Iaddend.is a continuation application of U.S. patent application
Ser. No. 12/415,823, filed on Mar. 31, 2009, issued as U.S. Pat.
No. 8,100,932, the entire contents of which is incorporated herein
by reference.
Claims
What is claimed is:
1. An intragastric space-occupying apparatus configured to be
endoscopically delivered into a stomach of a mammal for treating
excessive weight or obesity, comprising: a top portion made of a
self-expanding wire material and being formed in the shape of at
least eight non-planar triangles; a middle portion positioned
adjacent to the top portion, the middle portion being made of the
self-expanding wire material and being formed in the shape of an
octagon with sides of the octagon defining eight edges parallel to
a longitudinal axis of the intragastric space-occupying apparatus,
wherein the eight edges are configured to innervate gastric tissue
inside the stomach of the mammal, thus creating a sensation of
satiety to the mammal; a bottom portion made of the self-expanding
wire material and being formed in the shape of at least eight
non-planar triangles, the bottom portion being positioned adjacent
to the middle portion, wherein the top portion, the middle portion
and the bottom portion form a first self-expanding wire cage that
when expanded forms the shape of a first lantern; a second
self-expanding wire cage formed in the shape of a second lantern
having at least eight edges connected to the bottom portion, the
first lantern larger in volume than the second lantern; and a third
self-expanding wire cage formed in the shape of a third lantern
having at least eight edges connected to the top portion, the third
lantern larger in volume than the second lantern, but smaller in
volume than the first lantern; wherein the second lantern is
adapted to be positioned near the distal stomach and the third
lantern is adapted to be positioned in the upper stomach near the
fundus.
2. The intragastric space-occupying apparatus of claim 1, wherein
all of the at least eight non-planar triangles of the top portion
have a tip that converges at the same point.
3. The intragastric space-occupying apparatus of claim 2, wherein
all of the at least eight non-planar triangles of the bottom
portion have a tip that converges at the same point.
4. The intragastric space-occupying apparatus of claim 1, wherein
the self-expanding wire material is selected from a group
consisting of Nitinol, stainless steel, stainless steel alloy,
copper, and tungsten.
5. The intragastric space-occupying apparatus of claim 1, wherein
the top portion, the middle portion and the bottom portion are
filled with air.
6. The intragastric space-occupying apparatus of claim 1, further
comprising a non-porous material for covering the self-expanding
wire material.
7. The intragastric space-occupying apparatus of claim 6, wherein
the non-porous material is selected from a group consisting of
ePTFE, Dacron, silicon, and combinations thereof.
8. The intragastric space-occupying apparatus of claim 1, further
comprising a semi-porous material for covering the self-expanding
wire material.
9. The intragastric space-occupying apparatus of claim 1, wherein
the top portion and the bottom portion each have at least eight
edges that innervate gastric tissue inside the stomach of the
mammal, thus creating a sensation of satiety to the mammal.
10. An intragastric space-occupying apparatus configured to be
endoscopically delivered into a stomach of a mammal for treating
excessive weight or obesity, comprising: a first self-expanding
wire cage defining a cavity that is filled with air and formed in
the shape of a first lantern having at least eight edges parallel
to a longitudinal axis of the intragastric space-occupying device,
wherein the at least eight edges are configured to innervate
gastric tissue inside the stomach of the mammal, thus creating a
sensation of satiety to the mammal; and a non-porous material for
covering the first self-expanding wire cage to prevent liquid or
food from entering into the cavity of the first self-expanding wire
cage; a second self-expanding wire cage formed in the shape of a
second lantern having at least eight edges connected to a bottom
portion of the first self-expanding wire cage, the first lantern
larger in volume than the second lantern; and a third
self-expanding wire cage formed in the shape of a third lantern
having at least eight edges connected to a top portion of the first
self-expanding wire cage, the third lantern larger in volume than
the second lantern, but smaller in volume than the first lantern;
wherein the second lantern is adapted to be positioned near the
distal stomach and the third lantern is adapted to be positioned in
the upper stomach near the fundus.
11. The intragastric space-occupying apparatus of claim 10, further
comprising a central spine positioned lengthwise through the cavity
of the first self-expanding wire cage.
12. The intragastric space-occupying apparatus of claim 11, wherein
the first self-expanding wire cage has a top tip and a bottom tip
that are coupled to the central spine.
13. The intragastric space-occupying apparatus of claim 10, wherein
the first self-expanding wire cage is made from a material selected
from a group consisting of Nitinol, stainless steel, stainless
steel alloy, copper, and tungsten.
14. The intragastric space-occupying apparatus of claim 10, wherein
the non-porous material is sutured to the first self-expanding wire
cage.
15. The intragastric space-occupying apparatus of claim 10, wherein
the non-porous material is selected from a group consisting of
ePTFE, Dacron, silicon, and combinations thereof.
.Iadd.16. The intragastric space-occupying apparatus of claim 1,
wherein the mammal is a human. .Iaddend.
Description
BACKGROUND
1. Field
The invention generally relates to a method and apparatus for
treating obesity, excess weight gain, and controlling weight gain
in mammals. More specifically, the invention relates to
intragastric devices (e.g., one or more cages) placed within the
stomach of a mammal to occupy volume and to cause a reduced desire
for eating for treating obesity and controlling weight gain.
2. Related Art
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.
Medical management of obesity, such as dietary, psychotherapy,
medication and behavioral modification techniques, have yielded
extremely poor results in terms of treating obesity. In addition,
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
surgical 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.
Currently, in cases of morbid or severe obesity, patients may
undergo several types of bariatric surgery, such as gastric bypass,
either to tie off or staple portions of the large or small
intestine or stomach, and/or to bypass portions of the same to
reduce the amount of food desired by the patient, and the amount
absorbed by the intestinal track. In addition, procedures such as
laparoscopic banding, where a device is used to constrict a portion
of the stomach, can also achieve these results.
In the case of gastric bypass surgery, laparoscopic banding and
other highly invasive surgical procedures, several complications
can arise that make these procedures clinically suboptimal. The
surgical procedures require the patient to submit to an
intervention under general anesthesia, and may require large
incisions and lengthy recovery times. In addition, many of these
surgical procedures are irreversible.
Therefore, a need exists for a minimally-invasive procedure and
device that eliminates the above-mentioned drawbacks of
conventional methods and devices that are currently being used to
treat obesity and control weight gain.
SUMMARY
In one embodiment, the invention includes an intragastric
space-occupying device configured to be positioned within a stomach
for treating excessive weight or obesity in mammals, the device
comprising: a first cage configured to be positioned along a lesser
curvature of a stomach, the first cage having closed ends; a second
cage configured to be connected to the first cage, the second cage
having open ends and a hollow channel; and a third cage configured
to be connected to the second cage, and further configured to be
positioned along a greater curvature of the stomach, the third cage
having closed ends.
In one embodiment, the invention includes an intragastric
space-occupying device configured to be positioned within a stomach
for treating excessive weight or obesity in mammals. The
intragastric space-occupying device comprising a self-expanding
wire mesh having an open top portion and an open bottom portion, a
hollow center channel extending from the open top portion to the
open bottom portion, and an elastomeric material positioned on the
self-expanding wire mesh.
BRIEF DESCRIPTION OF THE DRAWINGS
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:
FIG. 1 is a partial view of a patient with an implanted
intragastric triple-cage device according to an embodiment of the
invention;
FIG. 2 is an exploded view of the triple-cage device implanted
within the stomach of a human according to an embodiment of the
invention;
FIG. 3 is a cross-sectional top view of the stomach with the
triple-cage device positioned within the stomach according to an
embodiment of the invention;
FIG. 4 is a perspective side view of the triple-cage device
according to an embodiment of the invention;
FIG. 5 is a view of three unconnected cages that make up the
triple-cage device according to an embodiment of the invention;
FIG. 6 is a view of the triple-cage device with connecting members
according to an embodiment of the invention;
FIG. 7 is a view of an unconnected rail and track for the
triple-cage device according to an embodiment of the invention;
FIG. 8 is a view of a crimped triple-cage device within a sheath
for delivery into the stomach according to an embodiment of the
invention;
FIG. 9 is a view of the second cage with the hollow channel
according to an embodiment of the invention;
FIG. 10 is a view of a single lantern-shaped cage device positioned
within the stomach according to an embodiment of the invention;
FIG. 11 is a side view of a single lantern-shaped cage device
according to an embodiment of the invention;
FIG. 12 is a view of the wire knitting of a lantern-shaped cage
device according to an embodiment of the invention;
FIG. 13 is a view of a lantern-shaped cage device with a hollow
center channel according to an embodiment of the invention;
FIG. 14 is a view of a triple-lantern device implanted within the
stomach according to an embodiment of the invention;
FIG. 15 is a view of a crimped triple-lantern device within a
sheath prior to delivery into the stomach according to an
embodiment of the invention;
FIG. 16 is a view of an S-shaped cage with a hollow channel
according to an embodiment of the invention;
FIG. 17 is a view of unconnected hexagonal-shaped cages that make
up a triple-cage device according to an embodiment of the
invention;
FIG. 18 is a view of unconnected vest-shaped cages that make up a
triple-cage device according to an embodiment of the invention;
FIG. 19 is a view of a triple-cage with a central spine according
to an embodiment of the invention;
FIG. 20 is a view of a snap-locking ball and socket joint according
to an embodiment of the invention;
FIG. 21 is a view of a spring-loaded ball and socket joint
according to an embodiment of the invention;
FIG. 22 is a view of a diamond-shaped cage device according to an
embodiment of the invention;
FIG. 23 is a view of fully-extended support structures of a
diamond-shaped cage device according to an embodiment of the
invention;
FIG. 24 is a view of collapsed support structures of a
diamond-shaped cage device according to an embodiment of the
invention;
FIG. 25 is a perspective view of fully-extended support structures
of a diamond-shaped cage device according to an embodiment of the
invention;
FIG. 26 is a view of fully-extended support structures of a
diamond-shaped cage device according to an embodiment of the
invention;
FIG. 27 is a view of semi-extended support structures of a
diamond-shaped cage device according to an embodiment of the
invention;
FIG. 28 is a view of collapsed support structures of a
diamond-shaped cage device according to an embodiment of the
invention;
FIG. 29 is a view of a triple diamond-shaped cage device according
to an embodiment of the invention;
FIG. 30 is a perspective view of fully-extended support structures
of a diamond-shaped cage device with a covering according to an
embodiment of the invention;
FIG. 31 is a perspective view of a portion of a collapsed support
structure of a diamond-shaped cage device according to an
embodiment of the invention;
FIG. 32 is a view of a locking mechanism according to an embodiment
of the invention;
FIG. 33 is a view of a connector according to an embodiment of the
invention; and
FIG. 34 is a view of an outer rod according to an embodiment of the
invention.
DETAILED DESCRIPTION
FIG. 1 is a partial view of a patient with an implanted
intragastric triple-cage device 120. The triple-cage device 120 is
placed within a stomach 108 of a mammal 100 (e.g., human) by a
healthcare professional, such as a surgeon, a bariatric surgeon, or
a gastrointestinal specialist trained in endoscopic surgery
procedures. The triple-cage device 120 can be positioned within the
stomach 108 using a routine endoscopic procedure. Furthermore, the
triple-cage device 120 can be placed within the stomach 108 using
newer techniques, methods and procedures for endoscopic surgery.
Even though three cages are described herein, one, two, three,
four, five, etc. cage(s) or device(s) may be positioned within the
stomach 108 depending on the particular application and desired
results.
The endoscopic delivery system includes an endoscopic device 102
and a sheath 104. The endoscopic device is used to insert a sheath
104 into an esophagus 106 of a human 100. Once the end of the
sheath 104 reaches the stomach 108, a first cage 114, a second cage
116, and a third cage 118 are deployed into the stomach 108. The
first cage 114 is configured to be positioned along a lesser
curvature 112 of the stomach 108, while the third cage 118 is
configured to be positioned along a greater curvature 110 of the
stomach 108. The second cage 116 is configured to be positioned
between the first cage 114 and the third cage 118.
FIG. 2 is an exploded view of the triple-cage device 120 implanted
within the stomach 108 of a human 100. The stomach 108 has at least
two curvatures, the lesser curvature 112 and the greater curvature
110. The cardia or proximal stomach 206 is located in the upper
left portion of the stomach 108 and serves as the junction between
the esophagus 106 and the body or inside of the stomach 108. The
fundus 210 is located in the upper right portion of the stomach
108. The lower portion of the stomach 108 is known as the distal
stomach 208, which includes a pyloric notch 204. The distal stomach
208 is where food is mixed with gastric juices. The pyloric notch
204 has a muscular pyloric sphincter that acts as a valve to
control emptying of food and stomach contents into the proximal
segment of the small intestine 202 (partially shown).
As shown in FIG. 2, the first cage 114 is positioned along the
lesser curvature 112 of the stomach 108. The first cage 114 is
substantially smaller in length than the second cage 116, and
slightly smaller in length than the third cage 118. The second cage
116 is positioned between the first cage 114 and the third cage
118. The third cage 118 is positioned along the greater curvature
110. In an embodiment, the lengths of each of the cages can
vary.
Each of the cages in the triple-cage device 120 has a curved
cylindrical shape, such as a tube, similar to a banana, to conform
to the natural shape of the stomach 108. In another embodiment,
each cage can be rectangular or another multi-sided or smooth
geometric shape instead of a cylindrical shape. Furthermore, the
cages can be any type of geometric shape, such as, but not limited
to, a sphere, square, cone, oval, torroid or doughnut. The cages
can each have a different shape and size, and the design of the
triple-cage device 120 is not limited to the illustration shown in
FIG. 2.
The triple-cage device 120 can occupy approximately 50% to 95% of
the volume of the stomach body. Preferably, the triple-cage device
120 can occupy approximately 70% to 80% of the volume of the
stomach body. The triple-cage device 120 can be self-expanding to
conform to size changes and movement of the stomach 108. In this
way, the triple-cage device 120 can continually occupy a constant
volume of the stomach 108 regardless of the shape or size of the
stomach 108.
As shown in FIG. 2, the triple-cage device 120 does not completely
occupy the fundus 210 or the cardia 206. The upper portion of the
stomach 108 is not completely occupied so that food may accumulate
in the upper portion of the stomach 108. Likewise, the distal
stomach 208 is not completely occupied by the triple-cage device
120. Thus, the proximal segment of the small intestine 202 is not
blocked and there can be proper channeling of food and stomach
contents. In some prior art intragastric cage devices, the proximal
segment of the small intestine 202 become covered by the device,
thus restricting proper channeling of food out of the stomach 108.
The blockage of the proximal segment of the small intestine 202
causes food accumulation within the stomach 108, and can lead to
various gastro-intestinal ailments or symptoms.
In an embodiment, the second cage 116 has open ends and a hollow
channel therebetween. Food can travel from the proximal stomach 206
to the distal stomach 208 via the hollow channel. The hollow
channel of the second cage 116 allows a gaseous exchange between
the lower and upper portions of the stomach 108. The second cage
116 increases gastric filling and slows gastric emptying as only a
limited amount of food can travel through the hollow channel.
In an embodiment, the second cage 116 can extend through the
duodenum of the intestine (not shown). The extension of the second
cage 116 can form an endoluminal sleeve which empties contents of
the stomach into the jejunum. The sleeve can be anchored at a top
portion by the first cage 112 and the third cage 118, as the second
cage 116 is connected to the first cage 112 and the third cage 118.
In an embodiment, the sleeve can be held in place by staples to the
intestine wall or held in place by the self-expanding force of the
wire mesh.
In another embodiment, the sleeve can be covered by an elastomeric
material, or alternatively, made entirely of an elastomeric
material, such as silicone, thermoplastic polymers, or any
combination thereof. The sleeve can be self-expanding or filled
with air or liquid, such as, for example, saline or methylene blue.
The methylene blue can be used to detect leaks in the sleeve. The
sleeve can be used to fill the residual stomach called the gastric
sleeve created after a partial removal of the stomach called sleeve
gastrectomy procedure. The cage may also assist in resolving any
leaks associated post operatively with a gastric sleeve
procedure.
In an embodiment, the sleeve can be used to fill a residual portion
of the stomach called the "gastric sleeve" that is created after a
partial removal of the stomach during a sleeve gastrectomy
procedure. The cage may also assist in resolving any leaks
post-operative leaking which may be associated with a sleeve
gastrectomy procedure.
Furthermore, the second cage 116 can help in reducing
gastro-esophageal reflux ("gastric reflux") as the hollow channel
allows food to channel from the upper portion of the stomach and
prevents excessive accumulation of food near the cardia 206 and the
fundus 210.
FIG. 3 is a cross-sectional top view of the stomach 108 with the
triple-cage device 120 positioned within the stomach 108. In an
embodiment, the first cage 114, the second cage 116, and the third
cage 118 are positioned in a substantially linear fashion, so that
the second cage 116 is positioned between the first cage 114 and
the third cage 118. As shown in FIG. 3, the triple-cage device 120
does not occupy the entire area of the stomach 108. As such,
approximately 5% to 50% of open space 302 remains in the stomach
108 when the triple-cage device 120 is implanted. The open space
302 allows food to accumulate and slowly and properly channel
toward the lower portion of the stomach 108 (not shown) as
described above. In an embodiment, the first cage 114 may have a
closed end 304, and the third cage 118 may have a closed end 306.
Both ends of the first cage 114 and the third cage 118 may be
closed and may be filled with air or other gas. The second cage 116
has an open top end 308 and an open bottom end (see also FIG. 2)
which allow food to channel to the lower portion of the stomach
108, as well as allows a gaseous exchange between the lower and
upper portions of the stomach 108.
In another embodiment, the first cage 114, the second cage 116, and
the third cage 118 may not be positioned in a linear fashion, but
rather can be positioned in a staggered manner so that the
triple-cage device 120 is arranged in a different shape, for
example, a triangular shape. Alternatively, the first cage 114 may
not be positioned along the lesser curvature 112, and the third
cage 118 may not be positioned along the greater curvature 110.
FIG. 4 is a perspective side view of the triple-cage device 120.
The first cage 114 has a closed top end 304 and a closed bottom end
408. The third cage 118 also has a closed top end 306 and a closed
bottom end 402. The second cage 116 has an open top end 308 and an
open bottom end 410. Alternatively, the first cage 114 and the
third cage 118 can each have an open top end and an open bottom end
which allows food to channel to the lower portion of the stomach
108, as well as allows a gaseous exchange between the lower and
upper portions of the stomach 108.
Each cage can be a cylindrical air-filled cage, and can be coated
or covered with an elastomeric material, such as ePTFE,
Dacron.RTM., or silicon. The cage cages are a wire mesh and are
preferably made of nickel titanium (Nitinol) or stainless steel
wire cage, Aluminum, Tungsten, Copper, Cobalt, Chromium, Gold, or
other alloys which provide each cage with a self-expanding memory.
The unique characteristic of Nitinol is that it has a thermally
triggered shape memory. This allows each cage to be crimped per a
desired length, width, and volume based on the cage sizes required
per the patient's stomach dimensions. The crimped cages are then
enclosed into a sheath for endoscopic delivery. The cages regain
their desired shape when deployed into the stomach at body
temperature, such as the temperature of the human body or the
temperature of the stomach body. The term "stent" or "wire mesh"
can also be used in place of the term "cage" throughout the
disclosure.
In an embodiment, the semi-rigid or rigid Nitinol or thicker
stainless steel wire frame is covered with ePTFE, silicone,
Dacron.RTM. or any other elastomeric or thermo-elastomeric
material. The desired shape of each cage is retained even under
pressure from the stomach lining (not shown) since the cages are
rigid wire cages made from Nitinol, stainless steel, or titanium
that have a memory-retained shape. In a preferred embodiment, the
self-expanding Nitinol cages are covered with a slightly dense,
non-porous or semi-porous ePTFE.
The Nitinol or stainless steel wire used to create the cages allows
the triple-cage device is designed to remain within a patient for a
longer duration than conventional intragastric cages made of
silicone. In contrast, a conventional intragastric cage made of
silicone and filled with saline may be subject to degradation and
leakage, and may be removed within a six months of being implanted
into the patient, and in many cases, must be removed within 6
months or less. The triple-cage device 120 can remain implanted in
the human for an extended period of time so that the human can
achieve a desired weight loss.
In another embodiment, the first cage 114 and the second cage 118
are 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. The methylene blue is
used to detect leaks in the cages.
FIG. 5 is a view of three unconnected cages that make up the
triple-cage device 120. Each of the cages has a diameter d ranging
from approximately 2 centimeters to 6 centimeters. In a preferred
embodiment, the diameter d is approximately 4 centimeters. The
first cage 114 can have a length L1 of approximately 5 centimeters
to 19 centimeters, and in a preferred embodiment, has a length L1
of approximately 15 centimeters. The second cage 116 can have a
length L2 of approximately 6 centimeters to 30 centimeters, and in
a preferred embodiment, has a length L2 of approximately 20-25
centimeters. The third cage 118 can have a length L3 of
approximately 6 centimeters to 30 centimeters, and in a preferred
embodiment, has a length L3 of approximately 15-20 centimeters.
In a preferred embodiment, the first cage 114 has a volume of
approximately 150-300 cubic centimeters, the second cage 116 has a
volume of approximately 200-400 cubic centimeters, and the third
cage 118 has a volume of approximately 200-500 cubic
centimeters.
In another embodiment, all of the cages, or alternatively, only two
of the cages, can have the same length. Furthermore, each of the
cages can have a different diameter. The diameters and lengths of
each cage can be adjusted by a healthcare professional based on the
specific characteristics of the patient's stomach.
FIG. 6 is a view of the triple-cage device with connecting members.
In an embodiment, the second cage 116 includes a first track 602
and a second track 604. The first track 602 is designed to slide
into a rail 606 on the first cage 114, and the second track 604 is
designed to slide into a rail 608 on the third cage 118. The tracks
and rails are preferably made from a hardened surgical-grade
stainless steel material. Alternatively, the tracks and rails can
be made from a medical-grade, rigid polymer or thermoplastic
material.
In another embodiment, the second cage 116 has only one track,
either the first track 602 or the second track 604, and the second
cage 116 is connected to only one of the other cages. In yet
another embodiment, the triple-cage device 120 does not have any
tracks, and each of the cages is held into position by the force of
the inner wall pressure of the stomach.
In an embodiment, the connecting members can extend along the
entire length of the cages. This design prevents the first cage 114
and the third cage 118 from shifting or bending in an opposite
direction from the second cage 116. Furthermore, each side of the
second cage 116 can have multiple tracks spaced apart along its
exterior in a linear fashion instead of a single track on each side
of the second cage 116.
In another embodiment, the track 602 can be positioned off-center
toward the open top end 308 of the second cage 116. The track 602
can be positioned off-center in an opposite direction toward the
open bottom end 410 of the second cage 116. This design allows a
staggered placement of the first cage 114 relative to the third
cage 118. The triple-cage device 120 also provides the center cage
support to avoid kinking of the central tract. The cage can be
viewed via an X-ray, ultrasound or CT to observe the placement of
the cages.
FIG. 7 is a view of an unconnected rail and track for the
triple-cage device. In one embodiment, the rail 606 is designed to
slide into the track 602. The shape of the rail head 702 allows it
to fit inside the receiving cavity 704 on the track 602,
interlocking the rail 606 and the track 602. The rail head 702 can
have any type of design which permits it to be interlocked with a
corresponding design of the receiving cavity 704.
The connecting members are not limited to the rail design shown in
FIGS. 6 and 7, and the second cage 116 can be equipped with clips,
interlocking members, fasteners, or any other type of connecting
means so that the second cage 116 can be secured to the first cage
114 and the third cage 118. In another embodiment, the first cage
114 and the third cage 118 can be directly connected to one another
with any type of connecting means.
In another embodiment, the three cages are connected by a string,
rope, or wrap that encircles the triple-cage device and holds the
cages together. The string, rope or wrap can be made from an
elastomeric material, such as silicone, or alternatively, can be
made from Nitinol, a steel wire mesh, or a bioabsorbable polymer or
material or a combination of polymers.
FIG. 8 is a view of a crimped triple-cage device 120 within a
sheath 104 for delivery into the stomach. The triple-cage device
120 is crimped or collapsed so that is fits within the diameter of
the sheath 104. A push-pull rod 802 operated by the healthcare
professional via the endoscopic device 102 is used to deliver the
triple-cage device 120 into the stomach.
In an embodiment, the first cage 114, the second cage 116, and the
third cage 118 are pre-connected so that the triple-cage device is
pre-assembled and the tracks are connected to their respective
rails prior to being implanted into the human. Upon delivery into
the stomach, each cage expands and the triple-cage device 120 is
positioned between the inner curvature and the outer curvature of
the stomach. In another embodiment, the healthcare professional can
adjust the position of the triple-cage device 120 after the cages
have expanded using the endoscopic device 102. In another
embodiment, each of the crimped cages can be color coded to assist
the healthcare professional with orienting the triple-cage device
120 into the sheath 104.
The endoscopic device 102 can also be fitted with a cage retrieval
device (not shown) that is used to retrieve the cages from the
human's stomach. In an embodiment, the retrieval device is a clamp
or a plurality of claws configured to exert a clamping force onto a
section of one or more of the cages. The cages can then be
retracted into the sheath 104, or any type of endoscopic sheath,
one by one by the healthcare professional using the endoscopic
device 102.
FIG. 9 is a view of the second cage 116 with the hollow channel
908. The second cage 116 has the hollow channel 908 to channel food
from the upper portion of the stomach to the lower portion of the
stomach as described above. In an embodiment, the wire cage 904 of
the second cage 116 is covered with an outer layer 902 made of
ePTFE, Dacron.RTM., or silicon or any other elastomeric or
thermo-elastomeric material. The wire cage 904 is also covered with
an inner layer 906 made of an elastomeric material. The outer layer
902 and the inner layer 906 can be the same material, or
alternatively, can be different materials. The inner layer 906
prevents food and other stomach contents from being stuck onto the
wire cage 904 when passing through the hollow channel 908. In an
alternative embodiment, the second cage 116 only contains the inner
layer 906 and does not contain the outer layer 902.
The diameter d2 of the hollow channel 908 is preferably
approximately 3 centimeters, and can vary based on the thicknesses
of the outer layer 902 and the inner layer 906. The thickness of
the outer layer 902 can range from approximately 5/1000 to 60/1000
inches.
FIG. 10 is a view of a single lantern-shaped cage device 1002
positioned within the stomach 108. The lantern 1002 is air-filled,
as opposed to being filled with a fluid or a liquid. In one
embodiment, the lantern 1002 has an octagonal shape. However, the
lantern 1002 can be formed in the shape of a circle, cylinder,
triangle, tetragon, pentagon, hexagon, septagon, nonagon, decagon,
or any other geometric shape. The lantern 1002 has a tip 1004 that
allows the lantern 1002 to be collapsed and retrieved through an
endoscopic procedure.
The lantern 1002 is preferably made of Nitinol, a stainless steel
or a stainless steel alloy, copper or tungsten wire cage which
provides the lantern 1002 with a self-expanding memory. This allows
the lantern 1002 to be crimped per a desired length, width, and
volume based on the human's stomach dimensions, and then placed
into a sheath for endoscopic delivery. The lantern 1002 regains its
desired shape when deployed into the stomach 108 at a certain
temperature, such as the temperature of the human body or the
temperature of the body of the stomach 108.
In one embodiment, the self-expanding Nitinol cage or stainless
steel wire cage lantern 1002 is covered with an ePTFE, Dacron.RTM.,
or silicon coating or covering. In a preferred embodiment, the
lantern 1002 is covered with a slightly dense, non-porous or
semi-porous ePTFE.
FIG. 11 is a side view of a single lantern-shaped cage device 1002.
The lantern 1002 has a top portion 1102, a bottom portion 1104, and
edges 1106. In the shown embodiment, the lantern 1002 has an
octagonal shape, thus the top portion 1102 has eight edges, and the
bottom portion 1104 has eight edges. The edges 1106 innervate the
gastric tissue along the inside of the stomach 108, thus creating a
sensation of satiety to the human. In an alternative embodiment,
the lantern 1002 can have multiple smooth, rounded edges.
In a preferred embodiment, the width W4 of the lantern 1002 is
approximately 5-15 cm, the length L4 of the sides between the top
portion 1102 and the bottom portion 1104 is approximately 7-20
centimeters, and the length L5 of the entire lantern 1002 is
approximately 5-25 centimeters.
In an embodiment, the lantern 1002 can occupy between approximately
0.25 L and 1.5 L of volume within the stomach body. In a preferred
embodiment, the lantern 1002 is designed to occupy approximately
1.26 L of volume within the stomach body.
The width and length of the lantern 1002 can be modified based on
the dimensions of the human's stomach. Thus, each individual may
have a lantern 1002 with specific dimensions based on their stomach
size, and the space required to be occupied in their stomach in
order to achieve a desired weight loss. In another embodiment, the
lantern 1002 is manufactured so that one size fits all adult
humans, while another smaller lantern is manufactured so that one
size fits all pediatric humans.
In another embodiment, the cage can be tapered, so that one end has
a larger diameter than the other. The cage can also have a
double-tapered design, or just tapered ends. The tapered-end design
is similar to the lantern design described above. In another
embodiment, the cage has an hour-glass shape.
In an embodiment, all of the single-cage designs described above
have are made from a self-expanding Nitinol cage or stainless steel
wire cage that is covered with an ePTFE, Dacron.RTM., or silicon
coating or covering. The covering forms an air-tight,
non-permeable, leak-proof seal that prevents air, liquid, food, and
other matter from entering the diamond-shaped cage device. In
another embodiment, a single wire, instead of a wire mesh or cage,
can be used to construct the cage device.
FIG. 12 is a view of the wire knitting of the lantern-shaped cage
device 1002. The knitting 1202 illustrates the manner in which the
Nitinol cage or stainless steel wire cage is constructed. The
knitting 1202 can be done by hand, or alternatively, manufactured
by a machine. The knitting 1202 used to connect the lantern wires
can be achieved using any type of knot or tie, and is not limited
by the embodiment shown in FIGS. 11 and 12. The lantern 1002 has a
central spine 1108 that helps reinforce the shape. The central
spine 1108 is also used in delivery and retrieval of the
lantern.
In an embodiment, the knitting 1202 connects the wire mesh in a
collapsible fashion. A string, cord, or spring (not shown) is
attached at the top end 1102 and/or the bottom end 1104. Upon
pressure to the string, cord, or spring, from an endoscopic
retrieval device, the wire mesh collapses so that the
lantern-shaped cage device 1002 can be pulled into a sheath.
In an embodiment, the cage device 1102 is in a collapsed or crimped
form prior to being delivered into the patient's stomach. Once the
collapsed cage device is released from the sheath into the stomach,
it self-expands into a lantern shape. The self-expansion of the
cage device occurs because of the Nitinol or wire mesh which has a
shape-retaining memory. The present invention does not require the
use of air, silicone, or any other substance to be pumped or
inserted into the cage device in order to expand the device.
FIG. 13 is a view of a lantern-shaped cage device 1300 with a
hollow center channel 1302. In this embodiment, the lantern 1002
contains a hollow center channel 1302 with a top opening 1304 and a
bottom opening 1306. The top opening 1304 allows some food to be
channeled from the cardia and the fundus areas of the stomach down
to the distal stomach. The hollow center channel 1302 operates in a
similar manner and serves the same or a similar purpose as the
hollow channel of the second cage 216 as described above in FIG.
2.
FIG. 14 is a view of a triple-lantern device 1400 implanted within
the stomach 108. The triple-lantern device 1400 includes a first
lantern 1402 that is positioned near the distal stomach 208. The
first lantern 1402 is connected to a second lantern 1404 via a
connector 1408. The second lantern 1404 is larger in volume than
the first lantern 1402, and is connected to a third lantern 1406
via a connector 1410. The third lantern 1406 is larger in volume
than the first lantern 1402, but smaller in volume than the second
lantern 1404. The third lantern 1406 is positioned in the upper
stomach near the fundus 210.
Each of the lanterns has a similar design and is made of similar
materials as the lantern-shaped cage 1002 described in FIG. 10.
Furthermore, the lanterns are not limited to the octagonal shape
shown in FIG. 14, and can be any geometric shape as described above
for the lantern-shaped cage 1002.
In an embodiment, the first lantern 1402 can occupy up to 0.3 L
(300 cubic centimeters) of volume within the stomach body. In a
preferred embodiment, the first lantern 1402 is designed to occupy
approximately 150 cubic centimeters of volume within the stomach
body. The first lantern 1402 can have a length of between
approximately 3 centimeters and 5 centimeters, and in a preferred
embodiment, can have a length of approximately 4 centimeters. The
diameter of the first lantern 1402 can be between approximately 3
centimeters to 8 centimeters. In a preferred embodiment, the
diameter of the first lantern 1402 is approximately 4
centimeters.
In an embodiment, the second lantern 1404 can occupy between
approximately 0.1 L (500 cubic centimeters) and 0.8 L (800 cubic
centimeters) of volume within the stomach body. In a preferred
embodiment, the second lantern 1404 is designed to occupy
approximately 700 cubic centimeters of volume within the stomach
body. The second lantern 1404 can have a length of between
approximately 5 centimeters and 8 centimeters, and in a preferred
embodiment, can have a length of approximately 6 centimeters. The
diameter of the second lantern 1404 can be between approximately 3
centimeters and 10 centimeters. In a preferred embodiment, the
diameter of the second lantern 1404 is approximately 6
centimeters.
In an embodiment, the third lantern 1406 can occupy between
approximately 0.1 L (300 cubic centimeters) and 0.5 L (500 cubic
centimeters) of volume within the stomach body. In a preferred
embodiment, the third lantern 1406 is designed to occupy
approximately up to 250 cubic centimeters of volume within the
stomach body. In a preferred embodiment, the entire triple-lantern
device 1400 is designed to occupy approximately up to 1.2 L of
volume within the stomach body. One, two, three, or more lantern
devices 1400 can be used depending on the human's desired weight
loss goals.
FIG. 15 is a view of a crimped triple-lantern device 1502 within a
sheath 104 prior to delivery into the stomach. The triple-lantern
device 1502 is crimped or compressed so that is fits within the
diameter of the sheath 104. A push-pull rod 802 operated by the
healthcare professional via the endoscopic device 102 is used to
deliver the triple-lantern device 1502 into the stomach 108. Each
of the cages can have a central spine for providing support as the
cages travel to the stomach 108.
In an embodiment, the first lantern 1402, the second lantern 1404,
and the third lantern 1406 are pre-connected via the connectors
1408 and 1410 as described above. Upon delivery into the stomach
108, each lantern expands and the triple-lantern device 1502 is
positioned within the inner curvature and the outer curvature of
the stomach 108. In another embodiment, the healthcare professional
can adjust the position of the triple-lantern device 1502 after the
lanterns have expanded using the endoscopic device 102. In an
embodiment, each of the crimped lanterns can be color-coded to
assist the healthcare professional with orienting the
triple-lantern device 1502 into the sheath 104.
The endoscopic device 102 can also be fitted with a lantern
retrieval device (not shown) that is used to retrieve the lanterns
from the human's stomach as described above. The lanterns can then
be retracted into the sheath 104 one by one by the healthcare
professional using the endoscopic device 102. The endoscopic device
102 can be adjusted if the human has obstruction or discomfort. For
example, a single cage can be removed and the other two can be
remain in the stomach.
In another embodiment, the first cage 114 and the third cage 118
can be made of silicone instead of wire cages. The silicone cages
are filled with air that is injected through a port. The port can
be locked in place once the desired amount of air pressure in the
cage has been achieved. Alternatively, the silicone cages can be
filled with saline, silicone, or nutrient supplements or bulking
agents in a similar manner as above.
The benefit of having air, saline or nutrient or food supplement or
bulking agent filled silicone cages is that they can diffuse
nutrients and cause a feeling of fullness, and thus the cages will
not settle at the lower portion of the stomach, and will remain in
position at the upper and central location within the stomach.
Having objects settle at the bottom of the stomach may cause
discomfort to the patient. The silicone cages are lightweight and
do not cause a feeling of heaviness in the stomach. Furthermore, by
remaining in the central location within the stomach, the cages
cause satiety and provide a feeling of fullness.
FIG. 16 is a view of an S-shaped cage with a hollow channel. The
S-shaped cage 1602 has a wide opening 1604. The opening 1604 has a
diameter wider than the lumen on the intestine in order to prevent
obstruction. The cage 1602 is a tubular cage and is made of
self-expanding wire as described above, and can be covered with
ePTFE, Dacron, or silicone. Alternatively, the cage 1602 can be a
silicone cage that is air or silicone filled and has an injection
port. The cage 1602 is not limited to an "S" shape, and can be in
any spiral shape such as an "M" shape or "Z" shape. In an
embodiment, the S-shaped cage can be a spiral cage which can slow
down the food and induce satiety by occupying volume.
FIG. 17 is a view of unconnected hexagonal-shaped cages that make
up a triple-cage device 1700. In this embodiment, the three cages
have similar dimensions as the first cage 114, the second cage 116,
and the third cage 118, respectively shown in FIG. 5. However, the
cages are hexagonal-shaped and have six sides instead of a round
cylindrical shape.
FIG. 18 is a view of unconnected vest-shaped cages that make up a
triple-cage device 1800. In this embodiment, the three cages have
similar dimensions as the first cage 114, the second cage 116, and
the third cage 118, respectively shown in FIG. 5. However, the
cages each have a vest shape instead of a round cylindrical
shape.
FIG. 19 is a view of a triple-cage 1902 with a central spine 1914.
The triple-cage device 1902 has a lower cage 1904 that is
positioned near the distal stomach. The lower cage 1904 is
connected to a central cage 1906 via a ball and socket joint 1910.
The central cage 1906 is larger in volume than the lower cage 1904,
and is connected to an upper cage 1908 via a ball and socket joint
1912. The upper cage 1908 is larger in volume than the lower cage
1904, but is smaller in volume than the central cage 1906. The
upper cage 1908 is positioned in the upper stomach near the fundus.
The ball and socket joints 1910 and 1912 allow angulations in the
central spine 1914 so that the triple cage device 1902 can bend to
accommodate various stomach sizes and shapes.
In an embodiment, the lower cage 1904 can occupy up to 0.3 L (300
cubic centimeters) of volume within the stomach body. In a
preferred embodiment, the lower cage 1904 is designed to occupy
approximately 200 cubic centimeters of volume within the stomach
body. The lower cage 1904 can have a length of between
approximately 3 centimeters and 15 centimeters, and in a preferred
embodiment, can have a length of approximately 7 centimeters. The
diameter of the lower cage 1904 can be between approximately 3
centimeters and 10 centimeters. In a preferred embodiment, the
diameter of the lower cage 1904 is approximately 6 centimeters.
In an embodiment, the central cage 1906 can occupy between
approximately 0.1 L (500 cubic centimeters) and 0.8 L (800 cubic
centimeters) of volume within the stomach body. In a preferred
embodiment, the central cage 1906 is designed to occupy
approximately 500 cubic centimeters of volume within the stomach
body. The central cage 1906 can have a length of between
approximately 5 centimeters and 20 centimeters, and in a preferred
embodiment, can have a length of approximately 9 centimeters. The
diameter of the central cage 1906 can be between approximately 3
centimeters and 10 centimeters. In a preferred embodiment, the
diameter of the central cage 1906 is approximately 8
centimeters.
In an embodiment, the upper cage 1908 can occupy up to
approximately 0.3 L (300 cubic centimeters) of volume within the
stomach body. In a preferred embodiment, the upper cage 1908 is
designed to occupy approximately 250 cubic centimeters of volume
within the stomach body. In a preferred embodiment, the entire
triple-lantern device is designed to occupy up to approximately
1.03 L of volume within the stomach body.
FIG. 20 is a view of a snap-locking ball and socket joint 1910. The
joint 1910 includes a socket member 2002 and a ball member 2004.
The joint 1910 is secured by placing the ball member 2004 into a
hollow cavity 2006 within the socket member 2002. The ball member
2004 is retained within the hollow cavity 2006 since it is sized
slightly smaller than the opening of the hollow cavity 2006.
Alternatively, a spring-loaded ball and socket joint can be used to
connect the cages. FIG. 21 is a view of a spring-loaded ball and
socket joint. The socket member 2102 includes a spring 2106. The
spring 2106 is actuated when the ball member 2104 is inserted into
the socket member 2102, and secures the ball member 2104 within the
socket member 2102.
In another embodiment (not shown), the joint has a claw member and
a ball member. The claw member has fingers, claws, or spaced grips
which securely hold a ball member in place, while at the same time,
allows the ball member to freely rotate within the claw member. The
claw member can release the ball member upon the spine of the cage
being pulled, by an endoscopic retrieval device. The pull/release
mechanism can be a string, cord, spring, or any other means which
provides a pulling pressure.
The means to connect the cages are not limited to the ball and
socket designs shown in FIGS. 20 and 21, and can be any type of
connecting mechanism which allows the central spine to bend so that
the triple-cage device can accommodate various sized and shaped
stomachs.
Furthermore, the lanterns are not limited to the circular or
cylindrical shape shown in FIG. 19, and can be any geometric shape
as described above for the lantern-shaped cage 1002.
FIG. 22 is a view of a diamond-shaped cage device according to an
embodiment of the invention. The device is covered with a covering
2200, which is preferably made from an elastomeric material, such
as ePTFE, Dacron.RTM., or silicon. Alternatively, the covering 2200
can be made from any flexible material which is biocompatible with
the human body. The covering 2200 is connected to a first outer rod
2202 and a second outer rod 2212 by sutures, staples, adhesives
such as the DYMAX MD.RTM. "1000", "CTH" and "MSK" series adhesives
that cure within seconds upon exposure to UV and visible light and
permit bonding of elastomeric materials, or any other method or
mechanism that can secure the covering 2200 to the outer rods 2202
and 2212. The covering 2200 forms an air-tight, non-permeable,
leak-proof seal with the outer rods 2202 and 2212 to prevent air,
liquid, food, and other matter from entering inside the
diamond-shaped cage device. In an embodiment, the covering 2200 is
also sutured, stapled or adhesively attached to other parts of the
device, such as internal support structures (not shown).
FIG. 23 is a view of fully-extended support structures of a
diamond-shaped cage device according to an embodiment of the
invention. In an embodiment, the diamond-shaped cage comprises a
first structure 2304 which faces and is adjacent to a second
structure 2310. The structures 2304 and 2310 may be made of a wire
mesh. The structures 2304 and 2310 or wire mesh preferably being
made of nickel titanium (Nitinol), stainless steel, aluminum,
tungsten, copper, gold, cobalt chromium, other alloys and PEEK
material or other polymer materials. In an embodiment, the
diamond-shaped cage device is made of a self-expanding wire mesh.
The wire mesh can have a diameter of approximately 1/1000th of an
inch to approximately 100/1000th of an inch. In a preferred
embodiment, the wire mesh preferably has a diameter of
approximately 20/1000th of an inch.
The cage device includes a first outer rod 2202 and a second outer
rod 2212. The first support structure 2304 is connected to the
first outer rod 2202 via a first connector 2306 and a second
connector 2308. Similarly, the second support structure 2310 is
connected to the second outer rod 2212 via a first connector 2307
and a second connector 2309. In an embodiment, to collapse the
cages, the first and second outer rods 2202 and 2212 are pulled
outwards and the first and second support structures 2304 and 2310
fold into a collapsed position as shown in FIG. 24. When the first
outer rod 2202 is pulled in a direction away from the second outer
rod 2212, and the movement of the first outer rod 2202 causes the
first support structure 2304 to fold downward and inward.
Similarly, when the second outer rod 2212 is pulled in a direction
away from the first outer rod 2202, and the movement of the second
outer rod 2212 causes the second support structure 2310 to fold
downward and inward.
The first outer rod 2202 and the second outer rod 2212 are movable
along a central inner rod 2300. In an embodiment, the first outer
rod 2202 includes a first channel 2316, and the second outer rod
2212 includes a second channel 2314. The first connecter 2306 is
connected to the inner rod 2300 through the first channel 2316, and
the second connector 2308 is connected to the first outer rod 2202.
In a fully-extended position, the first connector 2306 contacts the
first channel 2316 at a side of the first channel 2316 farthest
away from the second support structure 2310. Similarly, the first
connecter 2307 is connected to the inner rod 2300 through the
second channel 2314, and the second connector 2309 is connected to
the second outer rod 2212. The inner rod 2300 fits into the first
outer rod 2202 and the second outer rod 2212 so there is little
space between the rods to allow the inner rod 2300 to slide within
the outer rods 2202 and 2212.
When the first outer rod 2202 is pulled in a direction away from
the second outer rod 2212, the first connector 2306 remains in a
fixed position as it is connected to the inner rod 2300 while the
second connector 2308 moves with the first outer rod 2202, as it is
connected to the first outer rod 2202.
Likewise, the second support structure 2310 is collapsed in a
similar fashion when the second outer rod 2212 is pulled in a
direction away from the first outer rod 2202. The second outer rod
2212 is moved in a direction away from the first outer rod 2202
along the inner rod 2300, causing the second support structure 2310
to fold downward and inward as shown in FIG. 24.
FIG. 24 is a view of collapsed support structures of a
diamond-shaped cage device according to an embodiment of the
invention. In an embodiment, applying pressure to one of the outer
rods causes both of the support structures to collapse. In a
collapsed position, the first connector 2306 contacts the first
channel 2316 at a side of the first channel 2316 closest to the
second support structure 2310. In another embodiment, to retrieve
the cage device into a sheath, pressure applied to the support
structure from the sheath entrance causes the device to collapse so
that it can fit into the sheath for retrieval. In another
embodiment, when pressure is applied to the first outer rod 2202,
the first support structure 2304 and the second support structure
2310 both fold downward and inward. The first outer rod 2202 can
have an actuating mechanism which causes or triggers the second
outer rod 2212 to move in a direction away from the first outer rod
2202 upon an exertion of pressure to the first outer rod 2202.
FIG. 25 is a perspective view of fully-extended support structures
of a diamond-shaped cage device according to an embodiment of the
invention. The diamond-shaped cage has multiple support structures
which form the support structures of the cage device. In an
embodiment, the cage device can have from two to ten support
structures. In a preferred embodiment, the cage device has at least
six support structures. In another embodiment, the support
structures can be shaped in the form of a square, triangle,
semi-circle, or any other geometric shape.
FIG. 26 is a view of fully-extended support structures of a
diamond-shaped cage device according to an embodiment of the
invention. In this embodiment, the first support structure 2304 is
attached to the inner rod 2300 at anchor 2600. The first support
structure 2304 is connected to the first outer rod 2202 at anchor
2602. The first outer rod 2202 and the second outer rod 2212 can
provide support to the support structures as they are adjacent to
the inner anchors when the cage device is in a fully-extended
position. When the first outer rod 2202 is pulled in a direction
away from the second outer rod 2212, or when pressure is applied to
the first outer rod 2202, the first support structure 2304 is
collapsed downward and inward, as shown in FIG. 27.
In a fully-extended position, the first outer rod 2202 and the
second outer rod 2212 are locked into position by at least one
locking mechanism (not shown) which prevents movement of the rods
2202 and 2212. The locking mechanism can be a pin, wedge, or ball
and groove system that secures the outer rods 2202 and 2212 to the
inner rod 2300 which prevents the rods from moving until a certain
amount of pressure is applied. The locking mechanisms can be
connected to the outer rods, or alternatively, placed along the
inner rod 2300. In another embodiment, the first outer rod 2202 and
the second outer rod 2212 can be locking into position by at least
one locking mechanism when the outer rods are in the collapsed
position. The first and second outer rods 2202 and 2212 are movable
between a first position where the support structures 2304 and 2310
are in a fully-extended position (FIG. 26), a second position where
the support structures 2304 and 2310 are in a partially-collapsed
position (FIG. 27), and a third position where the support
structures 2304 and 2310 are in a fully-collapsed position (FIG.
28).
In an embodiment, a covering 2612, similar to the covering 2200
described above, covers the entire cage device, including both the
first support structure 2304 and the second support structure 2310.
The covering 2612 is preferably made from an elastomeric material,
such as ePTFE, Dacron.RTM., or silicon, and can be knitted to form
a cloth. Alternatively, the covering 2612 can be made from any
flexible material which is biocompatible with the human body. The
covering 2612 may be connected to the first support structure 2304
at a first connection point 2604 and a second connection point
2606. The covering 2612 is connected to the second support
structure 2310 at a first connection point 2608 and a second
connection point 2610. The covering 2612 is also connected to the
first outer rod 2202 and the second outer rod 2212 to form an
airtight, non-permeable, leak-proof seal that prevents air, liquid,
food, and other matter from entering the diamond-shaped cage
device. The covering 2612 can be connected to the cage device with
sutures, staples, adhesives, or any other method or mechanism that
can secure the covering 2612 to the outer rods 2202 and 2212 and
the support structures 2304 and 2310. In an embodiment, the
covering 2612 is also sutured, stapled or adhesively attached to
other parts of the device, such as internal support structures (not
shown).
In an embodiment, the cage device can have multiple locking
positions (e.g., can be locked in the first, second, and third
positions described above) and is adjustable, allowing a physician
or healthcare professional to expand the cage device to a desired
size. For example, FIG. 27 is a view of semi-extended support
structures of a diamond-shaped cage device according to an
embodiment of the invention. In the semi-extended position, the
cage device is only partially expanded to accommodate a smaller
sized stomach or in order to provide less fullness in the patient's
stomach.
In FIG. 27, the covering 2612 is attached the first support
structure 2304 at a first connection point 2702 and a second
connection point 2704. The covering 2612 is attached to the second
support structure 2310 at a first connection point 2706 and a
second connection point 2708. The covering 2612 is also connected
to the first outer rod 2202 and the second outer rod 2212 to form
an air-tight, non-permeable, leak-proof seal that prevents air,
liquid, food, and other matter from entering the diamond-shaped
cage device.
FIG. 28 is a view of collapsed support structures of a
diamond-shaped cage device according to an embodiment of the
invention. In the collapsed position, the cage device can be
inserted into a sheath for deployment into the stomach or retrieval
from the stomach. In the collapsed position, the cage device has a
height of approximately 1 centimeter or less, and a length of
approximately 11.5 centimeters or less. However, the height and
width of the collapsed cage device can vary based upon the
fully-extended size and dimensions of the cage device. The
fully-extended size of the cage device can depend on the dimensions
of the patient's stomach and the amount of volume desired to be
occupied by the cage device.
In another embodiment, the cage system includes a single
pyramid-shaped cage, instead of two opposing cage structures. The
single cage system operates in the same or similar manner as the
diamond-shaped cage device described above. In another embodiment,
the single cage device has a lantern shape or a cylindrical
shape.
FIG. 29 is a view of a triple diamond-shaped cage device according
to an embodiment of the invention. The device includes at least
three diamond-shaped cage devices connected serially. Each cage
device is connected to the other in a manner similar to that shown
in FIGS. 20 and 21. Alternatively, each cage device can be
connected to the other using a claw member and a ball member as
described above. In an embodiment, each of the three diamond-shaped
cage devices can be of a varying shape and size.
In an embodiment, the single cage device or the triple cage device
can be sized and dimensioned when fully or partially extended to
fit snugly within the stomach so that the side walls of the stomach
hold each of the cages in place. For example, after a sleeve
gastrectomy procedure, a significant portion of the stomach is
removed, leaving a cylindrical or sleeve-shaped stomach. The one or
more cage devices can be sized and dimensioned or adjusted to fit
flush against the stomach walls when the stomach size has been
reduced after the gastrectomy procedure.
FIG. 30 is a perspective view of fully-extended support structures
of a diamond-shaped cage device with a covering according to an
embodiment of the invention. The cage device includes a first
support structure 2304 and a second support structure 2310. The
first support structure has an outer rod 3000 that is movable along
the central inner rod 2300. The outer rod 3000 includes a locking
mechanism 3002 and a stopping mechanism 3004. The outer rod 3000
also includes a first connector 2306 and a second connector 2308.
The first connector 2306 is an anchor for all of the long wires of
the first support structure 2304. The second connector 2308 is an
anchor for all of the shorter wires of the first support structure
2304.
When the outer rod 3000 is pulled in a direction away from the
second support structure 2310, the stopping mechanism 3004 comes
into contact with the first connector 2306 and prevents the outer
rod 3000 from being pulled out further. Thus, the stopping
mechanism 3004 restricts the size of the cage device upon collapse.
In an embodiment, the stopping mechanism 3004 can be a circular or
semi-circular protrusion that extends outward from the outer rod
3000. In another embodiment, the stopping mechanism 3004 can be a
lip, latch, pin, button, or any other means which prevents the
outer rod 3000 from extending a certain distance beyond the first
connector 2306.
In an embodiment, the covering 2612 is connected directly to the
first connector 2306, creating a non-permeable, air tight seal.
When the cage device is in a fully-extended position, the locking
mechanism 3002 is attached to the first connector 2306. The locking
mechanism 3002 provides a non-permeable, air tight seal at the
junction between the first connector 2306 and the outer rod 3000.
Likewise, when the cage device is in a collapsed position, the
stopping mechanism 3004 provides a non-permeable, air tight seal at
the junction between the first connector 2306 and the outer rod
3000.
In another embodiment, the outer rod 3000 has multiple stopping
mechanisms and locking mechanisms located at various positions
along the outer rod 3000. The multiple stopping mechanisms and
locking mechanisms allow the cage device to be collapsed, expanded
and locked to different sizes and shapes.
The locking mechanism 3002 prevents the cage device from expanding
further past a fully-expanded position. When the outer rod 3000 is
pushed inwards toward the second support structure 2310, the
locking mechanism 3002 comes into contact with the first connector
2306. The pushing pressure causes the locking mechanism 3002 to be
locked and securely held into place with the first connector 2306.
An exemplary locking mechanism 3002 is shown in more detail in FIG.
32.
FIG. 31 is a perspective view of a portion of a collapsed support
structure of a diamond-shaped cage device according to an
embodiment of the invention. In the collapsed position, the
stopping mechanism 3004 is in contact with the first connector
2306. When the stopping mechanism 3004 comes into contact with the
first connector 2306, the pulling pressure exerted on the outer rod
3000 causes the stopping mechanism 3004 to become affixed to the
first connector 2306 so that the outer rod 3000 does not slide back
towards the second support structure 2310. This prevents the cage
device from re-expanding or opening. When the cage device is in the
collapsed position, the locking mechanism 3002 is no longer in
contact with the first connector 2306.
FIG. 32 is a view of a locking mechanism according to an embodiment
of the invention. In an embodiment, the locking mechanism 3002 is
located at a fixed position on the outer rod 3000 and is
permanently attached to the outer rod 3000. The locking mechanism
3002 can be made of rubber, plastic, steel, a thermoplastic
material, or any other material with sufficient rigidity to lock
with the outer rod 3000. In an embodiment, the inner surface 3200
of the locking mechanism 3002 has male grooves configured to lock
with female grooves on a locking member (not shown) on the first
connector 2306 and secures the first connector 2306 in place upon
contact.
FIG. 33 is a view of a connector according to an embodiment of the
invention. The first connector 2306 has a locking member 3300 which
is designed to receive the locking mechanism 3002. The inner
surface 3302 of the locking member 3300 has female grooves which
align and lock with the male grooves of the inner surface 3200 of
the locking mechanism 3002. In another embodiment, the inner
surface 3302 and the inner surface 3200 can have button grooves,
pins, interlocking teeth, or any other type of design which allows
the two surfaces to lock with each other upon contact.
FIG. 34 is a view of an outer rod according to an embodiment of the
invention. The outer rod 3000 includes a stopping mechanism 3004
and a locking mechanism 3002. In an embodiment, the outer rod 3000
can include only a stopping mechanism 3004 or only a locking
mechanism 3002. In another embodiment, the outer rod 3000 can
include multiple stopping mechanisms and multiple locking
mechanisms. In yet another embodiment, the outer rod 3000 includes
no locking mechanisms and no stopping mechanisms.
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.
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