U.S. patent application number 14/706770 was filed with the patent office on 2015-08-27 for gastric space filler delivery system and related methods.
The applicant listed for this patent is Reshape Medical, Inc.. Invention is credited to Tyler John Holschlag, Daniel Eugene Kincade, Stephen A. Sosnowski.
Application Number | 20150238342 14/706770 |
Document ID | / |
Family ID | 40137294 |
Filed Date | 2015-08-27 |
United States Patent
Application |
20150238342 |
Kind Code |
A1 |
Sosnowski; Stephen A. ; et
al. |
August 27, 2015 |
GASTRIC SPACE FILLER DELIVERY SYSTEM AND RELATED METHODS
Abstract
According to features of the present disclosure, a gastric space
filler device and methods effective for reducing stomach volume are
disclosed. A gastric space filler comprising at least one
inflatable space filler and a sleeve to prevent leakage out of the
gastric space filler device is disclosed. The gastric space filler
device may be inflated with an insufflation fluid and with mineral
oil, which further has the effect of reducing leakage. Delivery
systems and methods for inserting a gastric space filler device
into a patient are also disclosed. Sheaths and methods for covering
a gastric space filler device during delivery into a patient are
also disclosed.
Inventors: |
Sosnowski; Stephen A.;
(Vista, CA) ; Holschlag; Tyler John; (Carlsbad,
CA) ; Kincade; Daniel Eugene; (Chula Vista,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Reshape Medical, Inc. |
San Clemente |
CA |
US |
|
|
Family ID: |
40137294 |
Appl. No.: |
14/706770 |
Filed: |
May 7, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13074956 |
Mar 29, 2011 |
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14706770 |
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11768152 |
Jun 25, 2007 |
8142469 |
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13074956 |
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Current U.S.
Class: |
600/585 ;
606/192 |
Current CPC
Class: |
A61F 5/0036 20130101;
A61M 2025/0177 20130101; A61F 5/0033 20130101; A61M 25/09 20130101;
A61F 5/0089 20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00; A61M 25/09 20060101 A61M025/09 |
Claims
1-20. (canceled)
21. A gastric space filler device, comprising: a flexible, elongate
infusing member having a proximal end, a distal end, and a guide
wire channel extending completely through the infusing member from
the proximal end to the distal end; and a plurality of inflatable
gastric space fillers secured to the infusing member, wherein the
infusing member extends completely through the gastric space
fillers, and wherein the inflatable gastric space fillers are
configured to be implanted and inflated in a stomach of a human
patient.
22. The gastric space filler device of claim 21, further comprising
a delivery system configured to be releasably attached to the
gastric space filler device, wherein the delivery system comprises:
a proximal barb positioned to engage a proximal delivery lumen of
the infusing member and provide fluid communication between the
delivery system and a proximal inflatable space filler coupled to
the infusing member; and a distal barb positioned to engage a
distal lumen of the infusing member and provide fluid communication
between the delivery system and a distal inflatable space filler
coupled to the infusing member.
23. The gastric space filler device of claim 22 wherein the
delivery system is configured to be attached to the gastric space
filler device with the proximal barb and/or the distal barb of the
delivery system inserted into a gate at the proximal end of the
infusing member.
24. The gastric space filler device of claim 22 wherein the
delivery system further comprises a delivery guide wire channel
aligned with the guide wire channel when the delivery system is
releasably attached to the gastric space filler device.
25. The gastric space filler device of claim 24, further comprising
a guidewire threaded through the filler guide wire channel and the
delivery guide wire channel.
26. The gastric space filler device of claim 21 wherein at least
one of the gastric space fillers has an outer diameter of at least
about 40 mm when inflated with a fluid.
27. The gastric space filler device of claim 21 wherein the gastric
space fillers are configured to at least partially fill a portion
of the stomach of the human patient to create a feeling of
satiety.
28. The gastric space filler device of claim 22 wherein the
infusing member comprises a gate at the proximal end, and wherein
the gate is configured to close when the proximal barb and/or the
distal barb is removed from the proximal end of the infusing
member.
29. The gastric space filler device of claim 21 wherein the gastric
space filler device is configured to be at least partially covered
with a sheath before guiding the gastric space filler device along
a guide wire.
30. The gastric space filler device of claim 21 wherein: the
infusing member includes a docking notch; and wherein the gastric
space filler device further comprises a delivery system having a
docking clip configured to be releasably attached over the docking
notch of the infusing member.
Description
RELATED APPLICATION
[0001] This application claims full Paris Convention benefit of and
priority to U.S. patent application (a) Ser. No. 11/694,536, filed
Mar. 30, 2007 and PCT applications (b) Serial No. PCT/US06/142,336,
filed Oct. 31, 2006, (c) Serial No. PCT/US06/42711, filed Oct. 31,
2006, and (d) Serial No. PCT/US06/42710, filed Oct. 31, 2006, and
(e) Serial No. PCT/US06/48647, filed Dec. 20, 2006, the contents of
which are hereby incorporated by reference in their entirety, as if
fully set forth herein.
BACKGROUND
[0002] 1. Field
[0003] This disclosure relates to implantable weight control
devices. More particularly, this disclosure relates to a gastric
space filler device which is retrievably implantable in a patient,
an improved device and method for delivery of a gastric space
filler device, and a method and device for retaining fluid in a
gastric space filler device, among other things.
[0004] 2. General Background
[0005] Gastric space fillers used for achieving loss of weight in
extremely obese persons have been known in the art. Some gastric
space fillers utilized for this purpose function on the principle
that an empty bag or space filler is placed into the stomach
through the esophagus. Thereafter, the bag or space filler is fully
or partially filled with a suitable insufflation fluid, such as
saline solution, through a filler tube or catheter which is
inserted into the stomach through the mouth or the nose. The space
filler occupies space in the stomach thereby leaving less room
available for food and creating a feeling of satiety for the obese
person. Clinical experience has shown that, for many obese
patients, reducing the size of the gastric compartment with gastric
space fillers significantly helps to control appetite and
accomplish weight loss. The present disclosure is directed to a
device which non-operatively reduces the size of the gastric
compartment and which is easily removed. Artisans shall readily
appreciate that emergency operative morbidity rates and
co-morbidity statistics relating to such devices which have
migrated beyond the stomach underscore the need for an effective
medical device that can be removed.
SUMMARY
[0006] According to features of the present disclosure, a gastric
space filler device and methods effective for reducing stomach
volume are disclosed. A gastric space filler comprising at least
one inflatable space filler and a sleeve to prevent leakage out of
the gastric space filler device is disclosed. The gastric space
filler device may be inflated with an insufflation fluid and with
mineral oil, which further has the effect of reducing leakage.
Delivery systems and methods for inserting a gastric space filler
device into a patient are also disclosed. Sheaths and methods for
covering a gastric space filler device during delivery into a
patient are also disclosed.
[0007] According to embodiments of the instant teachings, there is
disclosed a gastric space filler device comprising a space filler,
an opening to inflate the space filler, and a sleeve that is
configured to receive mineral oil between the sleeve and the
opening. According to at least one embodiment, the sleeve is
disposed between the opening and the outer periphery of the space
filler. According to at least one embodiment, the sleeve allows
fluid to enter the space filler during inflation, but does not
allow fluid to exit the space filler when mineral oil is received
between the sleeve and the opening.
[0008] According to embodiments of the instant teachings, there is
disclosed a gastric space filler device comprising a space filler
and a sheath, wherein the sheath at least partially covers the
space filler. According to at least one embodiment, the sheath is
secured around the space filler with a stitch that can be released
by pulling on the stitch. According to at least one embodiment, the
sheath automatically uncovers the space filler as the space filler
is inflated.
[0009] According to embodiments of the instant teachings, there is
disclosed a delivery system comprising a delivery lumen, a barb
configured for coupling with an infusing lumen of a gastric space
filler device, and a docking clip configured for securely attaching
the delivery system to the gastric space filler device. According
to at least one embodiment, the delivery system contains a handle
that, when removed from the infusing lumen, pulls a stitch to
release a space filler and simultaneously uncovers a luer for
infusing a fluid into the gastric space filler device.
[0010] According to embodiments of the instant teachings, there is
disclosed a method for treating obesity challenged patients
comprising providing a gastric space filler device comprising a
space filler, an opening to inflate the space filler with a fluid,
and a sleeve disposed between the opening and an outer periphery of
the space filler; allowing the fluid to enter the space filler
through the opening; and preventing the fluid from exiting the
space filler through the opening.
[0011] According to embodiments of the instant teachings, there is
disclosed a method for emplacing a gastric space filler device in a
patient comprising providing a delivery system attached to a
gastric space filler device comprising a space filler; covering at
least part of the space filler with a sheath; and delivering the
delivery system and the gastric space filler device through an
esophagus into a stomach of a patient.
DRAWINGS
[0012] The above-mentioned features and objects of the present
disclosure will become more apparent with reference to the
following description taken in conjunction with the accompanying
drawings wherein like reference numerals denote like elements and
in which:
[0013] FIG. 1 shows an embodiment of a gastric space filler device
and delivery system;
[0014] FIG. 2A shows an embodiment of an infusing member without
proximal sleeve or distal sleeve;
[0015] FIG. 2B shows an embodiment of an infusing member with a
proximal sleeve and a distal sleeve;
[0016] FIG. 3 shows a cross-sectional view of an embodiment of an
infusing member, a proximal sleeve, and a proximal opening;
[0017] FIG. 4 shows a cross-sectional view of an embodiment of an
infusing member, a distal sleeve, and a distal opening;
[0018] FIG. 5 shows a rear view of an embodiment of a gastric space
filler device containing a distal space filler;
[0019] FIG. 6 shows a front view of an embodiment of a gastric
space filler device containing a proximal space filler;
[0020] FIG. 7 shows a cross-sectional view of an embodiment of a
gastric space filler device and a delivery system containing a
proximal delivery lumen and a distal delivery lumen;
[0021] FIG. 8 shows a cross-sectional view of an embodiment of a
gastric space filler device and a delivery system containing a
stitch channel and a delivery guide wire channel;
[0022] FIG. 9 shows an embodiment of a gastric space filler device
and a delivery system containing a sheath, a stitch, and a sheath
release cap;
[0023] FIG. 10A shows an embodiment of a delivery system containing
a handle;
[0024] FIG. 10B shows a cross-sectional view of an embodiment of a
delivery system containing a handle;
[0025] FIG. 10C shows an embodiment of a delivery system and a
handle detached from delivery system;
[0026] FIG. 11A shows an embodiment of a gastric space filler
device and sheaths wherein a proximal space filler and a distal
space filler are deflated;
[0027] FIG. 11B shows an embodiment of a gastric space filler
device, wherein a distal space filler is inflated;
[0028] FIG. 11C shows an embodiment of a gastric space filler
device, wherein a proximal space filler is inflated.
DETAILED DESCRIPTION
[0029] According to an embodiment as schematically depicted in FIG.
1, gastric space filler device 19 comprises proximal space filler
91A, distal space filler 91B, and infusing member 93. Proximal
space filler 91A is filled with an insufflation fluid through
proximal opening 96A of infusing member 93, and distal space filler
91B is filled with fluid from distal opening 96B of infusing member
93. Delivery system 200 infuses and expands gastric space filler
device 19.
[0030] According to an illustrative embodiment, proximal space
filler 91A and distal space filler 91B are spaced apart and secured
to each other by infusing member 93. According to an illustrative
embodiment, the distance between the two space fillers is between
at least about 10 to approximately 40 mm. The overall axial length
of gastric space filler device 19 is between about 100 and about
300 mm. According to an illustrative embodiment, infusing member 93
may be made of semi-flexible or flexible material. The
semi-flexible material may be selected from space filler-compatible
polymer, such as, polyethylene, polystyrene, polyurethane,
silicone, fluoro-polymer, and co-polymers thereof.
[0031] According to an illustrative embodiment, the longitudinal
length of proximal space filler 91A is between about 70 and about
80 mm, preferably about 75 mm. Proximal space filler 91A may be
expanded to a space volume of between about 100 and about 600 cc.
In an embodiment, the longitudinal length of distal space filler
91B is between about 60 and about 70 mm, preferably about 65
mm.
[0032] Distal space filler 91B may be expanded to a space volume of
between about 100 and about 400 cc. According to a further
embodiment, a radial diameter of proximal space filler 91A may be
expanded to a diameter between about 40 and about 60 mm, and a
radial diameter of distal space filler 91B may be expanded to a
diameter between about 20 and about 40 mm. According to an
illustrative embodiment, proximal space filler 91A is substantially
larger than distal space filler 91B in gastric space filler device
19 to take the advantage of the restricted space at the entrance
region of the stomach and to create a better feeling of satiety for
the patient. According to an illustrative embodiment, the thickness
of proximal space filler 91A and distal space filler 91B is between
about 0.2 and about 1.0 mm, effectively between about 0.3 to about
0.5 mm.
[0033] According to an embodiment as depicted in FIG. 2B, infusing
member 93 contains proximal sleeve 110A that wraps around infusing
member 93 and covers proximal opening 96A, which connects proximal
space filler 91A to proximal infusing lumen 94A. Infusing member 93
also contains distal sleeve 110B that wraps around infusing member
93 and covers distal opening 96B, which connects distal space
filler 91B to distal infusing lumen 94B.
[0034] According to an embodiment as depicted in FIG. 3, proximal
infusing lumen 94A of infusing member 93 has proximal opening 96A
that provides fluid communication between infusing lumen 94A and
proximal space filler 91A. According to an embodiment as depicted
in FIG. 4, distal infusing lumen 94B of infusing member 93 has
distal opening 96B that provides fluid communication between distal
infusing lumen 94B and distal space filler 91B. Proximal space
filler 91A and proximal infusing lumen 94A are not in fluid
communication with either distal space filler 91B or distal
infusing lumen 94B. According to an illustrative embodiment,
infusing member 93 has an inner diameter of between about 1 and
about 6 mm. According to an illustrative embodiment, proximal
infusing lumen 94A is substantially larger than distal infusing
lumen 94B.
[0035] According to an illustrative embodiment, proximal opening
96A connects proximal space filler 91A to proximal infusing lumen
94A. According to an illustrative embodiment, proximal sleeve 110A
wraps around infusing member 93 and covers proximal opening 96A.
Proximal sleeve 110A may be disposed between proximal opening 96A
and outer periphery of proximal space filler 91A.
[0036] As proximal space filler 91A is being inflated, proximal
sleeve 110A allows an insufflation fluid to enter proximal space
filler 91A from proximal infusing lumen 94A through proximal
opening 96A. According to an illustrative embodiment, proximal
sleeve 110A allows an insufflation fluid to enter proximal space
filler 91A by moving at least part of proximal sleeve 110A away
from proximal opening 96A. According to an illustrative embodiment,
at least part of proximal sleeve 110A is moved away from proximal
opening 96A as a result of higher pressure outside proximal space
filler 91A in relation to pressure inside proximal space filler
91A.
[0037] According to an illustrative embodiment, after proximal
space filler 91A is inflated, proximal sleeve 110A is pressed
against proximal opening 96A; thus proximal sleeve 110A does not
allow fluid to exit proximal space filler 91A through proximal
opening 96A. According to an illustrative embodiment, higher
pressure inside proximal space filler 91A, relative to pressure
outside proximal space filler 91A, presses proximal sleeve 110A
against proximal opening 96A.
[0038] According to another embodiment, proximal sleeve 110A is not
wrapped around infusing member 93, but is attached to infusing
member 93 and is configured to move at least partially away from
proximal opening 96A while proximal space filler 91A is being
inflated and is also configured to block proximal opening 96A after
proximal space filler 91A has been inflated.
[0039] According to an embodiment as depicted in FIG. 4, distal
sleeve 1103 covers distal opening 96B. Distal sleeve 110B allows
inflation of distal space filler 91B through distal opening 96B and
prevents deflation of distal space filler 91B through distal
opening 96B while distal space filler 91B is inflated. Appropriate
materials for proximal sleeve 110A or distal sleeve 110B include
any elastomeric material, such as silicone.
[0040] According to an illustrative embodiment, an insufflation
fluid, such as a saline solution, is used to inflate proximal space
filler 91A or distal space filler 91B to a desired volume effective
to fill the desired portion of a stomach of a patient and create
the desired feeling of satiety. When proximal space filler 91A is
inflated to this point, mineral oil is infused through proximal
opening 96A and received between proximal sleeve 110A and proximal
opening 96A. The mineral oil displaces the insufflation fluid in
the area between proximal sleeve 110A and proximal opening 96A.
Mineral oil between proximal sleeve 110A and proximal opening 96A
has the effect of decreasing leakage of the insufflation fluid out
of proximal space filler 91A through proximal opening 96A.
According to an illustrative embodiment, an effective amount of
mineral oil is the amount of mineral oil with volume equal to the
volume of the insufflation fluid to be displaced by the mineral
oil. According to an illustrative embodiment, mineral oil is
received between distal sleeve 110B and distal opening 96B.
Unexpectedly, this teaching substantially improves leakage and has
yet to have been disclosed.
[0041] According to an embodiment as depicted in FIG. 6, proximal
infusing lumen 94A contains proximal gate 112A, and distal infusing
lumen 94B contains distal gate 112B, disposed at proximal end of
infusing member 93. Proximal gate 112A prevents at least some of
any fluid from traveling into or out of proximal infusing lumen 94A
until proximal barb 206A is inserted through proximal gate 112A and
into proximal infusing lumen 94A. Similarly, distal gate 112B
prevents at least some of any fluid from traveling into or out of
distal infusing lumen 94B until distal barb 206B is inserted
through distal gate 112B and into distal infusing lumen 94B.
Proximal gate 112A or distal gate 112B may be made of a flexible
material that substantially covers proximal infusing lumen 94A or
distal infusing lumen 94B and can be manipulated to allow insertion
of proximal barb 206A or distal barb 206B.
[0042] According to an embodiment as depicted in FIG. 7, after
gastric space filler device 19 is delivered to the stomach of a
patient, delivery system 200 is inserted through the mouth to
securely couple with proximal end of gastric space filler device
19. According to another embodiment, delivery system 200 is
securely coupled to gastric space filler device 19 before gastric
space filler device 19 and delivery system 200 are delivered to the
stomach of a patient. According to an illustrative embodiment,
delivery system 200 may be coupled to gastric space filler device
19 by docking clip 222 of delivery system 200, which is configured
to securely attach to docking notch 208 of gastric space filler
device 19.
[0043] According to an illustrative embodiment, delivery system 200
contains proximal barb 206A and distal barb 206B. Proximal barb
206A is in fluid communication with proximal delivery lumen 210A,
and distal barb 206B is in fluid communication with distal delivery
lumen 210B. When delivery system 200 is securely coupled with
proximal end of gastric space filler device 19, proximal barb 206A
and distal barb 206B are at least partially inserted into proximal
infusing lumen 94A and distal infusing lumen 94B, respectively.
[0044] Proximal space filler 91A may be inflated by delivering an
insufflation fluid into proximal delivery lumen 210A, thereby
delivering insufflation fluid through proximal barb 206A and into
proximal infusing lumen 94A. Similarly, distal space filler 91B may
be inflated by delivering an insufflation fluid into distal
delivery lumen 210B, thereby delivering insufflation fluid through
distal barb 206B and into the distal infusing lumen 94B.
[0045] According to an embodiment as depicted in FIG. 8, gastric
space filler device 19 contains filler guide wire channel 108, and
delivery system 200 contains delivery guide wire channel 224.
According to an illustrative embodiment, guide wire 218 is laid
along a path to be traveled by gastric space filler device 19 or
delivery system 200. Guide wire 218 is then threaded through at
least one of guide wire channel 108 of gastric space filler device
19 and delivery guide wire channel 224 of delivery system 200. Once
threaded, gastric space filler device 19 or delivery system 200 may
travel along guide wire 218.
[0046] According to an embodiment as depicted in FIG. 9, sheath 202
at least partially covers proximal space filler 91A and distal
space filler 91B before or during insertion through an esophagus of
a patient. Sheath 202 may be made from flexible or semi-flexible
materials, including mesh fabric and silicone. According to an
illustrative embodiment, sheath 202 is secured to gastric space
filler device 19 by stitch 204. Various stitching patterns are
known in the art. Stitch 204 may comprise an easily releasable
stitching pattern, such as one that may be released by pulling on
one end of stitch 204. When proximal space filer 91A or distal
space filer 91B is ready to inflate, stitch 204 is removed.
[0047] According to an illustrative embodiment, at least part of
stitch 204 is secured by sheath release clip 212 until gastric
space filler device 19 is ready to be inserted into patient. Sheath
release clip 212, while engaged, secures at least part of stitch
204, such that stitch 204 may not be released. When sheath release
clip 212 is removed, stitch 204 is capable of being released.
[0048] According to an illustrative embodiment, at least part of
stitch 204 is located inside stitch channel 214 of delivery system
200. This allows stitch 204 to be pulled away from gastric space
filler device 19 without additional instruments. Where stitch 204
is released from sheath 202 by pulling on an end of stitch 204,
stitch 204 may be released by pulling stitch 204 through stitch
channel 214.
[0049] According to an embodiment as depicted in FIG. 10A, delivery
system 200 may contain handle 216, which may be removably attached
to delivery system 200. According to an embodiment as depicted in
FIG. 10B, handle 216 contains inner compartment 226. Proximal luer
220A and distal luer 220B may be contained within inner compartment
226 while handle is attached to delivery system 200. While handle
216 is attached to delivery system 200, proximal luer 220A and
distal luer 220B may not be accessed to infuse fluid into proximal
space filler 91A or distal space filler 91B.
[0050] According to an embodiment as depicted in FIG. 100, stitch
204 may be attached to handle 216, such that when handle 216 is
removed from delivery system 200, stitch 204 is pulled away from
sheath 202, thereby releasing sheath 202 from covering proximal
space filler 91A or distal space filler 91B. Likewise, removal of
handle 216 exposes proximal luer 220A and distal luer 220B, such
that proximal space filler 91A and distal space filler 91B can be
infused only when handle 216 is removed. In this embodiment,
proximal space filler 91A and distal space filler 91B cannot be
inflated until sheath 202 is released.
[0051] According to an embodiment as depicted in FIG. 11A, FIG.
11B, and FIG. 110, gastric space filler device 19 is at least
partially covered by three sheaths: proximal sheath 202A, central
sheath 202C, and distal sheath 202B. Distal sheath 202B at least
partially covers distal portion of distal space filler 91B, central
sheath 202C at least partially covers proximal portion of distal
space filler 91B and distal portion of proximal space filler 91A,
and proximal sheath 202A at least partially covers proximal portion
of proximal space filler 91A.
[0052] As distal space filler 91B is inflated, distal sheath 202B
is rolled onto itself toward distal end of gastric space filler
device 19 and distal portion of central sheath 2020 is rolled onto
itself toward center of gastric space filler device 19. As proximal
space filler 91A is inflated, proximal sheath 202A is rolled onto
itself toward proximal end of gastric space filler device 19, and
proximal portion of central sheath 2020 is rolled onto itself
toward center of gastric space filler device 19. In an illustrative
embodiment, as proximal space filler 91A is inflated, proximal
sheath 202A is rolled onto itself toward delivery system 200
attached to proximal end of gastric space filler device 19, such
that when proximal space filler 91A is inflated, proximal sheath
202A is rolled onto delivery system 200 and when delivery system
200 is detached and removed, proximal sheath 202A is removed with
delivery system 200.
[0053] In an illustrative embodiment, gastric spacer filler device
19 is at least partially covered by two sheaths: proximal sheath
202A and distal sheath 202B. Distal sheath 202B at least partially
covers distal space filler 91B until distal space filler 91B is
inflated, which causes distal sheath 202B to be rolled onto itself,
either toward distal end of gastric space filler device 19 or
toward center of gastric space filler device 19. Similarly,
proximal sheath 202A at least partially covers proximal space
filler 91A until proximal space filler 91A is inflated, which
causes proximal sheath 202A to be rolled onto itself, either toward
proximal end of gastric space filler device 19 or toward the center
of gastric space filler device 19.
[0054] In an illustrative embodiment, gastric space filler device
19 is at least partially covered by a single sheath: central sheath
202C. Central sheath 202C at least partially covers each of
proximal space filler 91A and distal space filler 91B. As distal
space filler 91B is inflated, central sheath 2020 is rolled onto
itself from proximal end of gastric space filler device 19 toward
center of gastric space filler device 19 until central sheath 202C
no longer covers distal space filler 91B. As proximal space filler
91A is inflated, central sheath 202C is rolled onto itself from
proximal end of gastric space filler device 19 toward center of
gastric space filler device 19 until central sheath 2020 no longer
covers proximal space filler 91A. Alternatively, as proximal space
filler 91A is inflated, central sheath 202C may be rolled from
center of gastric space filler device 19 toward proximal end of
gastric space filler device 19.
[0055] While the apparatus and method have been described in terms
of what are presently considered to be the most practical
embodiments, it is to be understood that the disclosure need not be
limited to the disclosed embodiments. It is intended to cover
various modifications and similar arrangements included within the
spirit and scope of the claims, the scope of which should be
accorded the broadest interpretation so as to encompass all such
modifications and similar structures. The present disclosure
includes any and all embodiments of the following claims.
* * * * *