U.S. patent application number 13/476837 was filed with the patent office on 2012-11-22 for methods and devices for intragastric support of functional or prosthetic gastrointestinal devices.
Invention is credited to Cole Chen, Mitchell Dann, Greg Fluet, John Hancock, Gerard von Hoffmann, Christopher Paul Swain, Josiab Verkaik, James Wright.
Application Number | 20120296254 13/476837 |
Document ID | / |
Family ID | 40130167 |
Filed Date | 2012-11-22 |
United States Patent
Application |
20120296254 |
Kind Code |
A1 |
Swain; Christopher Paul ; et
al. |
November 22, 2012 |
METHODS AND DEVICES FOR INTRAGASTRIC SUPPORT OF FUNCTIONAL OR
PROSTHETIC GASTROINTESTINAL DEVICES
Abstract
Disclosed herein are systems and methods for attaching or
maintaining the position of a therapeutic or diagnostic device in a
body lumen, such as the GI tract without necessarily requiring any
penetrating attachments through any body walls. The system can
include at least two elements: a proximal orientation element and a
distal support element. The proximal orientation element can be
configured to reside at least partially within the esophageal lumen
and the distal support element can be configured to reside in the
stomach, such as along the greater curve of the stomach.
Inventors: |
Swain; Christopher Paul;
(London, GB) ; Chen; Cole; (Westlake Village,
CA) ; Dann; Mitchell; (Wilson, WY) ; Fluet;
Greg; (Minneapolis, MN) ; Hancock; John;
(Santa Barbara, CA) ; Verkaik; Josiab; (Lompoc,
CA) ; Hoffmann; Gerard von; (Trabuco Canyon, CA)
; Wright; James; (Carpinteria, CA) |
Family ID: |
40130167 |
Appl. No.: |
13/476837 |
Filed: |
May 21, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12136003 |
Jun 9, 2008 |
8182441 |
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13476837 |
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60942975 |
Jun 8, 2007 |
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61023809 |
Jan 25, 2008 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61J 15/0049 20130101;
A61J 15/003 20130101; A61J 15/0084 20150501; A61F 5/0076 20130101;
A61J 15/0003 20130101; A61M 31/00 20130101; A61J 15/0069
20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. An intragastric support system comprising: a proximal
orientation element having a proximal end and a distal end, wherein
the proximal orientation element has a diameter sized to fit within
the lumen of an esophagus; wherein the long axis of the proximal
orientation element is configured to be substantially parallel with
the long axis of the esophagus; and a distal support element
configured to reside non-circumferentially against only a portion
of the stomach cavity; wherein the distal support element is
transformable from a first configuration where a long axis of the
distal support element is configured to be substantially parallel
with the long axis of the proximal orientation element during
delivery to a second configuration where the long axis of the
distal support element is configured to be not substantially
parallel with the long axis of the proximal orientation element
when implanted in the body, wherein the support system is
configured such that the proximal end of the proximal orientation
element is in the esophagus and the distal end of the proximal
orientation element is in the stomach when implanted in the body,
wherein a longitudinal dimension of the distal support element is
no more than about a longitudinal dimension of the proximal
orientation element.
2. The intragastric support system of claim 1, wherein the
longitudinal dimension of the distal support element is no more
than about 70% of the longitudinal dimension of the proximal
orientation element.
3. The intragastric support system of claim 1, wherein the
longitudinal dimension of the distal support element is no more
than about 60% of the longitudinal dimension of the proximal
orientation element.
4. The intragastric support system of claim 1, wherein the
longitudinal dimension of the distal support element is no more
than about 50% of the longitudinal dimension of the proximal
orientation element.
5. The intragastric support system of claim 1, further comprising a
gastrointestinal bypass sleeve.
6. The intragastric support system of claim 1, wherein the distal
support element comprises a drug reservoir.
7. The intragastric support system of claim 1, wherein the proximal
orientation element comprises a rounded proximal head to prevent
esophageal trauma.
8. The intragastric support system of claim 1, wherein the proximal
orientation element has a variable-length cross section.
9. The intragastric support system of claim 1, wherein the proximal
orientation element comprises a plurality of strut members.
10. The intragastric support system of claim 1, wherein the distal
support element is transformable between a first reduced
configuration and a second expanded configuration.
11. An intragastric support system comprising: a proximal
orientation element having a proximal end and a distal end, wherein
the proximal orientation element has a diameter sized to fit within
the lumen of an esophagus; wherein the long axis of the proximal
orientation element is configured to be substantially parallel with
the long axis of the esophagus; a distal support element configured
to reside non-circumferentially against only a portion of the
stomach cavity; and a joint configured to pivotably couple the
proximal orientation element to the distal support element, wherein
the distal support element is transformable from a first
configuration where a long axis of the distal support element is
configured to be substantially parallel with the long axis of the
proximal orientation element during delivery to a second
configuration where the long axis of the distal support element is
configured to be not substantially parallel with the long axis of
the proximal orientation element when implanted in the body,
wherein the support system is configured such that the proximal end
of the proximal orientation element is in the esophagus and the
distal end of the proximal orientation element is in the stomach
when implanted in the body.
12. The intragastric support system of claim 11, wherein the joint
comprises a ball-and-socket joint.
13. The intragastric support system of claim 11, wherein the joint
comprises a hinged joint.
14. The intragastric support system of claim 11, wherein the joint
is a uniaxial joint.
15. A method for treating a patient, comprising: providing an
intragastric support system, the system comprising a proximal
orientation element having a proximal end and a distal end, a
distal support element, and a food collecting ring; inserting the
proximal orientation element and the distal support element into a
gastrointestinal tract lumen, wherein a long axis of the proximal
orientation element is substantially parallel to a long axis of the
distal support element; positioning the system such that the
proximal end of the proximal orientation element is within the
esophagus of a patient and the distal support element is within the
stomach of a patient; and transforming the distal support element
such that the long axis of the distal support element is not
substantially parallel to the long axis of the proximal orientation
element, wherein after the transforming step the distal support
element resides non-circumferentially along less than the entirety
of the wall of the stomach and a longitudinal dimension of the
distal support element is no more than about a longitudinal
dimension of the proximal orientation element.
16. The method of claim 15, wherein transforming the distal support
element is such that the long axis of the distal support element is
substantially perpendicular to the long axis of the proximal
orientation element.
17. The method of claim 15, wherein the intragastric support system
further comprises a joint configured to pivotably couple the distal
support element to the proximal orientation element, the joint
having a locked state to prevent movement of the distal support
element with respect to the proximal orientation element.
18. The method of claim 15, further comprising the step of: locking
the joint at a position wherein a long axis of the proximal
orientation element is at least substantially coaxial with a long
axis of the distal support element during delivery; and unlocking
the joint to allow the distal support element to pivot within a
range of motion with respect to the proximal orientation element
when the distal support element is implanted in the stomach.
Description
PRIORITY CLAIM
[0001] This application claims the benefit under 35 U.S.C.
.sctn.120 as a continuation of U.S. patent application Ser. No.
12/136,003 filed Jun. 9, 2008, which claims priority under 35
U.S.C. .sctn.119(e) to U.S. Provisional Application No. 60/942,975,
filed Jun. 8, 2007, and U.S. Provisional Application No.
61/023,809, filed Jan. 25, 2008. All of the aforementioned priority
application are hereby incorporated by reference in their
entireties.
APPLICATIONS INCORPORATED BY REFERENCE
[0002] Various features of, for example, gastrointestinal bypass
sleeves, attachment cuffs, and/or toposcopic delivery methods that
can be used or adapted for use with systems and methods disclosed
herein can be found, for example, at U.S. patent application Ser.
No. 10/698,148, filed Oct. 31, 2003, published May 13, 2004 as U.S.
Patent Pub. No. 2004-0092892 A1 and entitled "APPARATUS AND METHODS
FOR TREATMENT OF MORBID OBESITY" (and may be referred to herein as
the "Kagan '148 application or Kagan '892 publication"); U.S.
patent application Ser. No. 11/025,364, filed Dec. 29, 2004,
published Aug. 11, 2005 as U.S. Patent Pub. No. 2005-0177181 A1 and
entitled "DEVICES AND METHODS FOR TREATING MORBID OBESITY" (and may
be referred to herein as the "Kagan '181 publication"); U.S. patent
application Ser. No. 11/124,634, filed May 5, 2005, published Jan.
26, 2006 as U.S. Patent Pub. No. 2006-0020247 A1 and entitled
"DEVICES AND METHODS FOR ATTACHMENT OF AN ENDOLUMENAL
GASTROINTESTINAL IMPLANT" (and may be referred to herein as the
"Kagan '247 publication"); U.S. patent application Ser. No.
11/400,724, filed Apr. 7, 2006, published Jan. 11, 2007 as U.S.
Patent Pub. No. 2007-0010794 A1 and entitled "DEVICES AND METHODS
FOR ENDOLUMENAL GASTROINTESTINAL BYPASS" (and may be referred to
herein as the "Dann '794 publication"); and U.S. patent application
Ser. No. 11/548,605, filed Oct. 11, 2006, published Aug. 23, 2007
as U.S. Pub. No. 2007-0198074 A1 and entitled "DEVICES AND METHODS
FOR ENDOLUMENAL GASTROINTESTINAL BYPASS" (and may be referred to
herein as the "Dann '605 application" or "Dann '074 publication")
are hereby incorporated by reference in their entireties herein, as
well as any additional applications, patents, or publications noted
in the specification below.
SUMMARY OF THE INVENTION
[0003] In one embodiment, disclosed herein is an intraluminal
support system, which can be a gastrointestinal, or intragastric
support system in some embodiments, that includes a proximal
orientation element and a distal support element. The proximal
orientation element includes a proximal end and a distal end, and
has a diameter sized to fit within the lumen of an esophagus. The
long axis of the proximal orientation element can be substantially
parallel with the long axis of the esophagus. The distal support
element can be configured to reside within the stomach, such as
along the greater curve of the stomach. The distal support element
can be transformable from a first configuration where a long axis
of the distal support element is configured to be substantially
parallel with the long axis of the proximal orientation element
during delivery to a second configuration where the long axis of
the distal support element is configured to be not substantially
parallel with the long axis of the proximal orientation element
when implanted in the body. The proximal orientation element can
include a food-collecting ring, which can include a proximal
tapered portion and a distal cylindrical portion in some
embodiments. The proximal tapered portion can include a first
shoulder and a second shoulder. The second shoulder can be
longitudinally offset from the first shoulder. The system can
further include a joint configured to pivotably couple the proximal
orientation element to the distal support element. The joint could
be, for example, a ball-and-socket joint, or a hinged joint in
other embodiments. The system can also include a gastrointestinal
bypass sleeve, which can be attached to the food-collecting ring in
some embodiments. The distal support element can include an
enlarged distal end to retain the distal support element within the
stomach. The distal support element can include a drug reservoir.
The proximal orientation element can include a rounded proximal
head to prevent esophageal trauma. In some embodiments, the
proximal orientation element has a variable-length cross-section.
The proximal orientation element can include a plurality of strut
members in some embodiments. The distal support element can be
transformable from a first reduced configuration to a second
expanded configuration. In some embodiments, the system includes a
restrictive element and/or an obstructive element operably
connected to the food-collecting ring.
[0004] Also disclosed herein is a method of treating a patient,
including the steps of providing an providing an intragastric
support system, the system comprising a proximal orientation
element having a proximal end and a distal end, and a distal
support element; inserting the proximal orientation element and the
distal support element into a gastrointestinal tract lumen, wherein
a long axis of the proximal orientation element is substantially
parallel to a long axis of the distal support element; positioning
the system such that at least a portion of the proximal orientation
element is within the esophagus of a patient and the distal support
element is within the stomach of a patient; and transforming the
distal support element such that the long axis of the distal
support element is not substantially parallel to the long axis of
the proximal orientation element. In some embodiments, transforming
the distal support element is such that the long axis of the distal
support element is substantially perpendicular to the long axis of
the proximal orientation element. In some embodiments, the
intragastric support system further includes a joint configured to
pivotably couple the distal support element to the proximal
orientation element, the joint having a locked state to prevent
movement of the distal support element with respect to the proximal
orientation element. In some embodiments, the method further
includes the step of locking the joint at a position wherein a long
axis of the proximal orientation element is at least substantially
coaxial with a long axis of the distal support element during
delivery; and unlocking the joint to allow the distal support
element to pivot within a range of motion with respect to the
proximal orientation element when the distal support element is
implanted in the stomach.
[0005] In some embodiments, the proximal orientation element is
configured to reside at least partially within the esophageal lumen
while the distal support element is configured to reside within the
stomach, such as along the greater curve of the stomach. The
gastrointestinal support system has a first configuration in which
the long axis of the proximal orientation element is coaxial or
substantially coaxial with the long axis of the distal support
element, and a second configuration in which the long axis of the
proximal orientation element is not substantially coaxial with the
long axis of the distal support element, to retain the
gastrointestinal support system in place and prevent unwanted
proximal migration of the distal support element into the esophagus
or distal migration into the intestine.
[0006] In one embodiment, disclosed is an intragastric support
system. In some embodiments, the system can be used for positioning
a prosthetic or functional device within the GI tract. While the
intragastric support most preferably includes at least one
component within the stomach, other components of the system may
reside partially or completely outside of the stomach, such as, for
example, in the esophagus and/or intestines as well. The system
need not be attached transmurally to a wall of the GI tract. The
system can include a proximal orientation element, a support
component, and a distal retention component (also referred to as a
pyloric support component). The system can also include a sleeve
connected to the support component and/or proximal orientation
element, or other various devices such as an anti-reflux device, a
drug-eluting device, a stimulator, a volume-occupying device, or a
chemical, biochemical or physiologic parameter sensor such as a pH
sensor. In some embodiments, the sleeve can be a gastric and/or
intestinal bypass sleeve for bypassing at least a portion of the
stomach and/or intestines.
[0007] In some embodiments, the proximal orientation component is
connected to or is a part of the intragastric support component.
The sleeve is connected to the intragastric support at one or more
points, preferably at a location at or near the GEJ so that food
leaving the esophagus flows into the sleeve with minimal leak. In
other embodiments, the sleeve may be connected to a portion, such
as a ring element of the proximal orientation element, which can be
an esophageal post above the GEJ. One way to accomplish this is if
the intragastric support component includes a gasket or baffle
element, that may be dome-shaped in some embodiments, in the upper
part of the stomach, the sleeve can be connected to an opening in
the dome that aligns with the GEJ. The sleeve may also include a
cuff portion as disclosed in, for example, the Kagan '148
application. The term "cuff/sleeve" as used herein may encompass
embodiments with a sleeve, such as a gastric and/or intestinal
bypass sleeve, cuff alone, or sleeve that includes a cuff. As used
herein proximal refers to closer to the mouth in the implanted
orientation, while distal refers to the "downstream" GI tract
toward the anus. The proximal orientation component can be
substantially linear, or spiral shaped in some embodiments. The
proximal orientation component can also include one or more
V-shaped posts. The proximal orientation component can also have an
atraumatic tip portion that is flexible, or a rounded ball-like
tip. In some embodiments, the proximal orientation component can be
coated with a coating, such as a hydrophilic coating material. The
proximal orientation component is preferably configured to reside
at least partially within the esophagus. In some embodiments, the
length of the proximal orientation component is no greater than the
distance between the gastroesophageal junction distally and the
level of the cricopharyngeous muscle proximally. In some
embodiments, a proximal orientation element is configured to reduce
reflux of gastric acids into the esophagus.
[0008] In other embodiments, the proximal orientation component may
be or could include one or more strips of material attached to a
sleeve. The strips may be made of a woven fiber, polymer, or a
tissue graft and adhere to the walls of a body lumen such as the
esophagus. In some embodiments, the strips are configured to
promote tissue in-growth. In some embodiments, at least a portion
of the mucosal surface of the esophagus is ablated or otherwise
injured prior to installation of an attachment system. The ablation
could be controlled to increase bonding of the system to the
esophageal wall, accelerate tissue in-growth, and/or alter the
tissue layers to provide a more durable attachment substrate. The
surface may be injured using various energy forms, such as a laser,
Argon Plasma Coagulation (APC), RF, microwave, thermal, cryo, or
ultrasound energy, mechanical abrasion, or any of a variety of
sclerosing agents known in the art.
[0009] In some embodiments, the distal support element can include
a conical or dome-shaped support element that may be convex or
concave or some complex form that is designed to mimic the shape of
the upper part of the stomach. While this can be referred to as a
dome-shaped element herein, the structure could be any other
complex form as noted to mimic or fit within the upper part of the
stomach and that can help prevent the device from migrating
proximally into the esophagus. The dome-shaped element may have a
lumen in which the cuff/sleeve can pass therethrough. The
dome-shaped element may be sized and shaped such that the forces of
the stomach acting on the proximal end are not able to
significantly move the device where the cuff/sleeve is no longer
aligned with the GEJ. In addition, the proximal end may be
supplementally attached at or near the gastroesophageal junction or
along the lesser or greater curve of the stomach at one or more
places if necessary using any of the attachment methods previously
disclosed in the disclosures incorporated by reference, above.
[0010] In some embodiments, the dome-shaped element may be
implanted within the stomach in a first configuration with a low
crossing profile and expanded to a second configuration with a
second crossing profile. The dome-shaped element may be made of a
polymeric or metal shape memory material to facilitate the
transformation from the first to the second configuration. In other
embodiments, the dome-shaped element may be transformed using a
filler, such as a liquid polymerizable in situ. In some
embodiments, the support element may be a nitinol basket, or
helical shaped. In addition, the dome shaped element could be made
up of component parts that lock together after placement in the
stomach. This could be accomplished using key-slot type locking
mechanisms or preferably magnets implanted in the components so the
device self-assembles when the components are placed in the
stomach.
[0011] The distal support element can include a connecting support
element that can be arcuate-shaped, such as banana-shaped in some
embodiments. The arcuate support element is preferably shaped to
conform or cooperate with the shape of the greater curvature, or
alternately in some embodiments, the lesser curvature of the
stomach. The arcuate support element is preferably connected to or
forms distally a pyloric retention element configured to prevent
the system from migrating distally past the pylorus into the
intestine. The support element could be a wire such as Nitinol or
other alloy or metal with a distal stop such as a loop configured
such that the system cannot pass through the pylorus. The wire can
be covered with a silicon or polyurethane or other coating to make
the device less traumatic to the wall of the stomach. In addition,
the device could have a hydrophilic coating such as the
HARMONY.RTM. Advanced Hydrophilic Coating from SurModics (Eden
Prairie, Minn.).
[0012] In some embodiments, the arcuate element may be actuatable
from a straighter or flexible configuration to a more rigid arcuate
configuration. In this way, the device could be placed in the
stomach while in a flexible or generally linear form and then
utilizing a mechanical mechanism or the properties of the shape
memory nature of nitinol be triggered to take an arcuate shape. One
method to achieve this would be to shape set the nitinol in an
arcuate form and then cool the material so that it is flexible. The
device can be first implanted in a cold, more flexible form and
then when the device warms due to the ambient temperature in the
stomach it takes its arcuate shape.
[0013] The pyloric retention element may form a loop such that a
sleeve configured to contain orally ingested materials may pass
therethrough. Alternatively, the sleeve could go outside the loop
so it is pinched between the stomach wall and the loop. This would
in essence form a pinch valve and may be desirable to regulate the
flow of food through the pylorus. The dome element, arcuate
element, and pyloric support element may be integrally formed or
assembled from component parts. In some embodiments, the distal
support element includes one or more balloons. The balloons may be
positioned near the gastroesophageal junction and/or the distal
stomach near the pylorus. The balloons could serve to help anchor
the device in place and keep it from being passed through the
pylorus. In addition, the balloon or balloons could serve as volume
occupying devices. Preferably the design of the structure is such
that it does not significantly interfere with the ability of the
stomach walls to move and have that motion transfer forces to the
sleeve that helps move material through the sleeve. By having an
arcuate structure in the greater curve, the stomach can still
contract around the arcuate element and contact the sleeve. This
allows the transmission of peristaltic motion to the sleeve to help
keep food or other material moving through the sleeve.
[0014] In some embodiments, an intragastric support system (which
can also be referred to as a GI attachment system) includes a
proximal orientation element that can be in some embodiments an
esophageal post with a ringed tubular element for connecting a
sleeve above the GEJ, and a distal (e.g., intragastric) support
element hingably connected to the proximal orientation element
(e.g., esophageal post).
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A schematically illustrates an intragastric support
system that includes a proximal orientation element and a distal
support element, according to one embodiment of the invention.
[0016] FIG. 1B illustrates an intragastric support system with a
first delivery configuration and a second implanted configuration,
according to one embodiment of the invention.
[0017] FIG. 1C is a side perspective view of an intragastric
support system that includes a proximal orientation element, a
distal support element operably connected to a cuff/sleeve element,
wherein the distal support element includes an arcuate support
element, and a pyloric support element, according to one embodiment
of the invention.
[0018] FIG. 1D is a top perspective view of the intragastric
support system of FIG. 1C that better depicts the top portion of
the distal support element.
[0019] FIG. 1E is a side perspective view of an intragastric
support system with a proximal orientation element that has an
atraumatic tip portion, according to one embodiment of the
invention.
[0020] FIGS. 2A-2E schematically illustrate embodiments of proximal
orientation elements that are "V" shaped, according to one
embodiment of the invention.
[0021] FIG. 2F schematically illustrates an embodiment of a
proximal orientation element that includes a ring for collection of
ingested contents, according to one embodiment of the
invention.
[0022] FIG. 2G schematically illustrates a proximal orientation
element, e.g., an esophageal post element that includes a
asymmetrically tapered food-collecting ring, according to one
embodiment of the invention.
[0023] FIG. 2H schematically illustrates another embodiment of an
intragastric support system with a proximal orientation element
that includes a strut with a variable-diameter cross-section,
according to one embodiment of the invention.
[0024] FIG. 2I schematically illustrates an embodiment of an
intragastric support system including a proximal orientation
element having a strut with a plurality of strut members, according
to one embodiment of the invention.
[0025] FIG. 2J illustrates an embodiment of an intragastric support
system with a spiral proximal orientation element, according to one
embodiment of the invention.
[0026] FIG. 2K illustrates an embodiment of a proximal orientation
element with a plurality of strip elements attached to a cuff,
according to one embodiment of the invention.
[0027] FIGS. 3A-3F depict various views of a dome-shaped component
of a distal support element, according to one embodiment of the
invention.
[0028] FIG. 4 illustrates an intragastric support system that
includes a braided distal support structure, according to one
embodiment of the invention.
[0029] FIG. 5 shows an intragastric support system with a distal
support element having proximal and distal toroidal supports such
as balloons, according to one embodiment of the invention.
[0030] FIGS. 6A-6B illustrates an intragastric support system with
a proximal orientation element that includes an esophageal strut
element pivotably attached to a distal support element, according
to one embodiment of the invention.
[0031] FIG. 7A is a close-up perspective view of a distal (e.g.,
intragastric) support element, according to one embodiment of the
invention.
[0032] FIG. 7B illustrates an intragastric support system similar
to that illustrated in FIGS. 6A-6B.
[0033] FIG. 7C illustrates an intragastric support system where the
long axis of the proximal orientation element is coaxial with the
long axis of the distal support element, according to one
embodiment of the invention.
[0034] FIG. 7D schematically illustrates an intragastric support
system with a radiused pivoting distal support element, according
to one embodiment of the invention.
[0035] FIG. 7E schematically illustrates an intragastric support
system that can be delivered endoscopically in a first reduced
configuration and then expanded in a second expanded configuration,
according to one embodiment of the invention.
[0036] FIG. 7F schematically illustrates an intragastric support
system with an expandable distal support element, according to one
embodiment of the invention.
[0037] FIG. 7G schematically illustrates an intragastric support
system with a distal support element with an enlarged distal end,
according to one embodiment of the invention.
[0038] FIG. 7H schematically illustrates an intragastric support
system with a distal support element that includes electronics,
according to one embodiment of the invention.
[0039] FIGS. 8A-8D schematically illustrates an intragastric
support system with a distal support element that includes a wire,
according to one embodiment of the invention.
[0040] FIGS. 9A-9B illustrates a sleeve system with a support lumen
configured to house a guidewire that can have one or more preset
curves, according to one embodiment of the invention.
[0041] FIG. 10 illustrates a sleeve system with a guidewire that
has a proximal portion extending above the proximal sleeve and
forming a spiral shape, according to one embodiment of the
invention.
[0042] FIGS. 11A-D schematically illustrate an intragastric support
system that includes a reservoir with a restrictive outlet,
according to one embodiment of the invention.
[0043] FIG. 11E schematically illustrates an intragastric support
system that includes a reservoir with an obstructive element,
according to one embodiment of the invention.
[0044] FIG. 12 schematically illustrates an intragastric support
system that includes a gastrointestinal bypass sleeve, according to
one embodiment of the invention.
[0045] FIG. 13 schematically illustrates an intragastric support
system that includes an expandable structure to occupy space in the
stomach, according to one embodiment of the invention.
[0046] FIG. 14 schematically illustrates an intragastric support
system that includes a pyloric valve to delay gastric emptying,
according to one embodiment of the invention.
[0047] FIG. 15 schematically illustrates an intragastric support
system that includes a pacing or stimulating element, according to
one embodiment of the invention.
[0048] FIG. 16 schematically illustrates an intragastric support
system that includes a reservoir configured to alter ingested
materials, according to one embodiment of the invention.
[0049] FIG. 17 schematically illustrates an intragastric support
system with a distal support component that includes an implantable
diagnostic device, according to one embodiment of the
invention.
[0050] FIG. 17A schematically illustrates an intragastric support
system with a distal support component that includes a stent or
graft support feature, according to one embodiment of the
invention.
[0051] FIGS. 18A-18L schematically illustrate a method for
delivering an intragastric support system utilizing a guidewire,
according to one embodiment of the invention.
[0052] FIGS. 19A-I schematically illustrate delivery of an
intragastric support system that includes a woven nitinol dome,
according to one embodiment of the invention.
[0053] FIGS. 20A-E schematically illustrate another method for
delivering an intragastric support system, according to one
embodiment of the invention.
[0054] FIGS. 21A-D schematically illustrate a piecemeal method for
delivering an intragastric support system, according to one
embodiment of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0055] The invention relates, in some embodiments, to various
structures forming a system for attaching or maintaining the
position of a therapeutic or diagnostic device in a body lumen,
such as the GI tract without necessarily requiring any penetrating
attachments through any body walls. The system 501 can include at
least two elements: (1) a proximal orientation element 500 and (2)
a distal support element 502, as shown schematically in FIG. 1A.
The proximal orientation element 500 can be configured to reside at
least partially within the esophageal lumen and the distal support
element 502 can be configured to reside in the stomach, such as
along the greater curve of the stomach, in some embodiments. The
proximal orientation element 500 may be integrally formed with the
distal support element 502, or separately formed and coupled, such
as via a joint 510 as will be described elsewhere in the
application. The distal support element 502 could be unitary, or
include several different subcomponents in other embodiments. As
illustrated in FIG. 1B, the intragastric support system has a first
configuration 501 (shown in phantom) in which the long axis of the
proximal orientation 500 element is coaxial or substantially
coaxial with the long axis of the distal support element 502, and a
second configuration 501' in which the long axis of the proximal
orientation element 500 is not substantially coaxial with the long
axis of the distal support element 502. The second configuration
501' can thus advantageously retain the intragastric support system
in place and prevent unwanted proximal migration of the distal
support element 502 into the esophagus or distal migration into the
intestine, as the distal support element 502 has at least one
diameter that is larger than a diameter of the distal esophagus and
pylorus, respectively. In some embodiments, in the second implanted
configuration of the intragastric support system, the long axis of
the distal support element and the long axis of the proximal
orientation element intersect and form an angle of between about
30-90 or 45-75 degrees, or are perpendicular or substantially
perpendicular in other embodiments. The system can transform from
the first configuration 501 to the second configuration 501' via a
variety of mechanisms, such as, for example, actuation of a hinge
or ball-and-socket joint between the proximal orientation element
500 and distal support element 502, deformation of the distal
support element 502 via bending or shape memory material, expansion
via, e.g., a balloon or expandable polymer. The system can, in some
embodiments, transform from the second non-coaxial configuration
501' back into the first coaxial configuration 501 to promote
removal of the system from the body lumen.
[0056] Methods and devices disclosed to accomplish this could be
used in conjunction with a wide variety of devices including any of
the embodiments, combinations, or subcombinations of those
described in any of the aforementioned applications listed above in
the section "Applications Incorporated by Reference" above. For
illustrative purposes, an intragastric support system described, in
some embodiments, is configured to support a cuff and/or
gastrointestinal bypass sleeve and/or optional stoma device that
has been previously described in some of the aforementioned
applications previously incorporated by reference. Instead of, or
in addition to a cuff and/or sleeve, these intragastric support
systems as described could also aid in the placement of various
diagnostic and therapeutic devices, such as gastric stimulators,
volume occupying devices such as bezoars or balloons, or diagnostic
devices such pH detectors. Some other non-limiting examples of
devices that can be secured using the attachment systems described
herein include: a drug eluting device which could release
substances into the stomach and be refilled endoscopically; hanging
device for cameras or capsules in the stomach; device that monitors
consumption of specific substances (calories, fat, cholesterol,
alcohol, drugs, poisons) and optionally triggers a system to reduce
the effects of consumption through one or more of: stimulation to
increase or decrease motility or regurgitation, release of a stored
emetic, release of a diuretic, release of an antidote; volume
and/or flow restrictive device (with or without sleeve), and/or a
device which stores, emits, and receives data. The device may also
function as a device to reduce gastroesophageal reflux, creating a
barrier to reflux with the use of a valve or flap.
[0057] A preferred location for the cuff/sleeve device, in some
embodiments, is to have the cuff placed at or near the
gastro-esophageal junction (GEJ) and the sleeve attached or coupled
to the cuff. In a preferred embodiment, the distal end of the
sleeve resides in the intestine, distal to the ligament of Treitz.
This preferred embodiment is intended to replicate a Roux-en-Y
gastric bypass with an endoscopically implanted device. However,
other implantation locations are also within the scope of the
invention, and can be selected by one of ordinary skill in the art
depending on the desired clinical result. The intragastric support
systems described could be used and/or modified to attach any of
the aforementioned disclosed devices in any position of the GI
tract that can, for example, provide the desired results of
reduction in weight and/or resolution of comorbidities associated
with obesity. Alternatively, the bypass sleeve could be held with
the proximal end of the sleeve at or past the pylorus or elsewhere
in the structure. In this example, a restrictive element could
still be provided by modifying the design by adding a GEJ flow
restrictor, such as by modifying a silicone dome, to restrict flow
out of the GEJ. In other embodiments, the dome could support a
separate stoma device at the GEJ, or there could be no restrictive
element at all. In addition, the cuff may not be necessary in some
cases and the device could just be a bypass sleeve. For ease of
description, the words "cuff/sleeve" and bypass sleeve will often
be used to describe any bypass sleeve that is used as a conduit for
ingested food or liquid to bypass a section of the GI tract. Note
the bypass sleeve could be any embodiment of those described in the
previous aforementioned applications incorporated by reference. For
example, sleeve material and embodiments, for example, can be as
described in previous disclosures, such as disclosed in the Kagan
'892 publication, for example, at FIGS. 11-31 and the accompanying
disclosure at, e.g., paragraphs [0241] to [0312] of the '892
publication, or, for example, at paragraphs [0174] to [0185] of the
Dann '074 publication, both of which are incorporated by reference
in their entirety.
[0058] Attachment of the device can be achieved through a wide
variety of means; attachment as disclosed herein refers to the fact
that the device can hold its position in or near a desired location
in the GI tract. The attachment need not necessarily penetrate any
wall of the GI tract.
[0059] As illustrated in FIGS. 1C-1E, which are perspective views
of one embodiment of an intragastric support system for holding a
prosthetic or functional device within the GI tract. One preferred
embodiment of the system 199 includes three primary components: (1)
a proximal (e.g., esophageal) orientation element 500 (e.g., a
proximally extending tube or post), (2) a cuff 204 and/or sleeve
(only a cuff 204 is shown in FIGS. 1C-1E for clarity), and (3) a
distal (e.g., intragastric) support component 502. The distal
support component 502 shown here includes a flexible dome 208
(which can be other shapes as well to conform to the shape of the
upper stomach and prevent migration of the distal support element
proximally into the esophagus), arcuate support component 206, and
a pyloric support element 212. While all of these elements are
shown together in this device 199, it should be understood that
some of these elements could be used by themselves or with other
embodiments to provide additional securement in addition to other
previously described ways to attach a bypass sleeve such as
transmural attachment. FIG. 1D illustrates that the cuff can be
configured to fit at least partially within a lumen of the flexible
dome 208 as shown.
Proximal Orientation Element
[0060] Structures are disclosed that may be deployed in the
esophagus, and are designed to attach to or extend from the
proximal end of the cuff/sleeve construct or proximal gastric
support construct. These structures can also be configured to keep
the proximal opening of the cuff/sleeve oriented in communication
with the opening from the GEJ. In a preferred embodiment, the
proximal orientation elements have mechanical properties that keep
them in position without being anchored to or causing trauma to the
esophageal wall. Alternatively, these structures could be fixedly
attached to the lumen of the esophagus using a variety of possible
devices including t-tags, adhesives, sutures, stents, or other
devices that will be appreciated by one of ordinary skill in the
art. In some embodiments, the proximal orientation element 500
could be actively or passively expanded or contracted in one or
more dimensions. In other words, the proximal orientation element
could be expanded or contracted, for example, in an axial direction
with a motor or some control means that could be mechanical. In
some embodiments, there is a telescoping or spring-loaded component
to produce the desired clinical result. This may be, in some
embodiments, controlled via a remote transmitter, or automated,
such as by a sensing mechanism.
[0061] As shown in the schematic FIGS. 2A-2E, in one embodiment,
the proximal orientation element could be an esophageal post, e.g.,
a substantially linear element that can receive, for example, the
proximal end of the cuff/sleeve construct. The proximal orientation
element is preferably flexible enough to be atraumatic to the
esophageal mucosa, yet stiff enough to resist dislocation from its
preferred orientation that keeps the cuff approximately coaxially
aligned with the GEJ. In some embodiments, the proximal end of the
proximal orientation element could have an atraumatic tip to reduce
the risk of damage to the esophagus. This can be done, for example,
with either a very flexible proximal segment or with a rounded loop
or ball-like tip as shown in FIGS. 2A-2E. An embodiment 199 with a
single post 202 and an atraumatic tip portion 201 is shown
schematically in FIG. 1E. Two or three or four or more alignment
structures (e.g., posts) may alternatively be used. The atraumatic
tip 201 can also be a soft and/or spongy ball, bullet-shaped
silicone tip or ball, or other type of atraumatic tip. In some
embodiments, the entire post 202 can be coated with a hydrophilic
coating or other material to help reduce the risk of food adhering
to the construct, reduce corrosion, or reduce its impact on
surrounding tissue. The post 202 can have a variable durometer
along its length. One example would be to have a higher durometer
near the GEJ and a lower durometer over its length up the
esophagus.
[0062] The length of the proximal orientation element 202 is
preferably configured such that the proximal end does not come far
enough proximally up the esophagus (toward the oral cavity) to be
felt or sensed by the patient. The level of the cricopharyngeous
muscle is considered to be the most proximal point (toward the oral
cavity) in the esophagus where an object would be felt by the
patient, therefore the length of the post should be such that the
proximal end is below the cricopharyngeous. Generally, in some
embodiments the alignment structure will extend at least about 1
cm, more preferably at least about 2 cm but no more than about 20
cm or no more than about 25 cm above the distal support element
(and/or above the gastroesophageal junction).
[0063] A proximal orientation element as described above would
preferably not provide force against the wall of the esophagus to
"hang" the cuff/sleeve construct in place.
[0064] As shown in the embodiment 216 of FIG. 2A, the proximal
orientation element can include two posts 202 attached at their
base 218 to form a "V" alignment element could be used in a way to
help proximally secure the cuff 204/sleeve 100 device. In this
configuration the posts 202 would attach to the cuff 204 and have a
"V"-like shape 222 as shown. The base 218 of the "V" element would
be the proximal edge of the cuff 204 and/or gastric support at or
near the GEJ. The posts 202 would spread the esophageal lumen open,
which would help to orient the device 216 and the round tips 201 of
the posts 202 would help provide resistance to vertical
displacement. When not filled with food, the esophagus tends to lay
flat on itself (in other words, the esophageal walls tend to keep
the lumen relatively closed) so this would be a natural state.
Because the "V" shape 222 will help to bias the esophageal lumen
closed "flat", this can also advantageously prevent acid reflux
back into the esophagus and treat GERD as well. In one embodiment
220, as shown in FIG. 2E, there could be more than one "V" element
222 used. The posts 202 comprising the "V" element 222 are
preferably disposed at identical or substantially similar angles
224a, 224b relative to the long axis 224 of the cuff 204/sleeve
100, although different angles may be used. In one embodiment 226,
as shown in FIG. 2D, two "V" elements 222 could be attached at
opposite sides of the cuff 204. In this configuration, they could
be optionally joined at the proximal end and separate at the base.
This type of configuration could make a "change purse" type
mechanism of action where squeezing the ends of the "V" opens the
proximal end of the sleeve 100 and/or cuff, as shown in the system
228 illustrated in FIG. 2C.
[0065] FIG. 2B illustrates a proximal orientation element that
includes an esophageal post element 230 with a distance x between
tips 201 of two posts 202 of a "V", a diameter y of a proximal end
of a sleeve 100 and/or cuff 204; and a distance z representing a
width of the posts at the intersection of the "V". As shown, the
distance x is preferably greater than the distance y if the
proximal end of the cuff/sleeve is connected to the attachment
system 230 at the level of the GEJ. If the cuff 204 hangs distal to
and is larger than the GEJ, the distance x could be the same or
substantially the same as the distance y. In some embodiments, the
distance x is wider than the relaxed width of the cuff 204, if the
cuff 204 is sized to match the dimensions of the esophagus. The
distance x can also be wider than the luminal diameter of the
esophagus. However, it is preferred that the distance x is not so
much greater than the diameter of the esophagus as to cause
esophageal trauma from overstretching of the lumen. Preferably, the
distance x is no more than about 130%, 125%, 120%, 115%, 110%,
105%, or less of the width of the diameter of either the cuff 204,
the esophageal lumen, or both. In some embodiments, the cuff 204
can have a diameter of between about 20-40 mm, more preferably
between about 23-31 mm. In other embodiments, the cuff 204 has a
diameter of at least about 25 mm.
[0066] In some embodiments as shown in FIG. 2F, the proximal
orientation element 500 includes an esophageal post 500 having a
tubular, or ringed element 520 with a proximal end 236 and a distal
end 238 that can direct peroral contents such as food and liquids
into a sleeve 100 (not shown) connectable to the ringed element
520. The proximal end 236 of the ringed element 500 may be tapered
or beveled as shown in some embodiments, which may assist in
collecting peroral contents.
[0067] The food-collecting ring 520, in some embodiments, has an
outside diameter of between about 10-30 mm, such as between about
15-25 mm in some embodiments. The food collecting ring 520 is
preferably configured to have sufficient column strength to keep a
relaxed esophagus open, although the food collecting ring 520 can
be collapsible by a peristaltic wave of the esophagus.
[0068] In some embodiments, the food collecting ring 520 has a
distal cylindrical segment 522 and a proximal tapered segment 524,
that may be beveled in some embodiments. The length of the proximal
tapered segment 524 may be, in some embodiments, between about
30-70%, such as 40-60% of the entire length of the ring 520 in some
embodiments. While the tapered segments 524 may be symmetric, in
some embodiments as illustrated in FIG. 2G the tapered segment 524
may include a first shoulder portion 526 and a second shoulder
portion 528 longitudinally offset from the first shoulder portion
526 in some embodiments, to form a "double helix"-like geometry.
The longitudinal offset distance 530 may be, for example, between
about 1-15 mm, such as between about 2-10 mm in some
embodiments.
[0069] Such tapered ring configurations may be advantageous to more
easily allow the device to move proximally and distally within the
esophagus during delivery, removal, as well as while in use and to
reduce friction and prevent "snagging" of the device within the
esophagus. The ring structure can be configured to interface with a
gastrointestinal bypass sleeve. The sleeve is preferably bonded on
an internal luminal surface of the ring in some embodiments to
advantageously prevent trauma to the esophageal wall.
[0070] FIG. 2H illustrates schematically another embodiment of an
intragastric support system 536 with a proximal orientation element
500 that includes a strut member with a variable-diameter
cross-section, which can advantageously allow the strut to have
differing stiffness properties along its length and thus bending
properties. In some embodiments, a proximal orientation element 500
includes a strut having a first point 538 with a cross-sectional
diameter that is at least about 10%, 20%, 30%, 40%, 50%, 75%, 100%,
150%, 200%, or more greater than a cross-sectional diameter on a
second point 540 of the strut.
[0071] FIG. 2I illustrates schematically an embodiment of an
intragastric support system 544 including a proximal orientation
element 500 with a plurality of strut members 540, 542, such as a
bifurcated portion as shown, which can allow the proximal
orientation element 500 to have differing bending properties
depending on the desired clinical result.
Spiral Construct
[0072] In some embodiments, the proximal orientation element 500
could be either linear or complex in shape, such as a spiral, or
some combination of both. One embodiment of such a spiral proximal
orientation element 240 is shown schematically in FIG. 2J. If the
spring rate and radial force of the spiral form are configured such
that the radial force is greater than the minimum required to
maintain contact with the esophageal wall 164 and less than an
amount that would cause damage to the tissue yet still have enough
radial force to support the device, this can provide an alternative
method of attachment. In this case, the cuff 204 would hang at the
GEJ supported by the spiral connective element 240 without
requiring any support distally.
[0073] In other embodiments, if the radial force of the spiral 240
does not have sufficient opposing force to the esophagus 164 to
keep the cuff 204/sleeve 100 in place, the spiral construct 240
could facilitate orientation of the cuff 204/sleeve 100 with a
distal support element 502 described elsewhere in the application.
Alternatively, in other embodiments, the spiral 240 would not
oppose the esophagus 164 at all, but rather be made of a relatively
atraumatic material and float freely in the esophagus 164. Such a
non-opposing spiral would maintain the position of the distal
support element 502 such that food and liquid flowing through the
esophagus 164 would enter the bypass sleeve 100 and bypass the
stomach.
[0074] Once in the esophagus, the proximal orientation element
could take the form of a spiral. Most preferably, in some
embodiments, any spiral shape in the esophagus would be very
compliant so as not to interfere with the peristaltic movement of
the esophagus. The spiral element would then connect to the cuff.
An advantage of having a spiral shape element may be that it could
help keep the cuff in an orientation so that the plane of the
opening of the cuff remains as perpendicular as possible to the
flow of ingested material to minimize any leaks. This would enable
most if not all of the contents passing through the esophagus to
enter the sleeve and thereby bypass the stomach. In addition, the
spiral shape of the connective element could have some minimal
amount of radial force to help keep the cuff in contact with the
walls of the GEJ to help minimize leaks. In some embodiments, the
spiral element could be formed from an elastic material such as a
polymer or other plastic or it could be formed from a super elastic
material such as Nitinol. Preferably, the amount of radial force
would be just enough to help keep the lumen of the cuff open and
oppose the walls of the GEJ without causing any expansion of the
GEJ or damage to the tissue. In other embodiments, the opening
pressure would be less than that of the GEJ, such that when the GEJ
was closed or flaccid, the opening of the sleeve would also be
closed or flaccid. When the GEJ opens, the outward force would be
such that the opening of the sleeve would then open.
[0075] The spiral proximal orientation element can preferably
extend through at least about one or two and in some embodiments at
least about 3, 4, 5, 6, 7, 8, 9, 10 complete revolutions, or more
about the longitudinal axis of the esophagus.
[0076] In some embodiments, the proximal orientation element 500
includes an esophageal strut that can be an elongate member that is
between about 10-50 cm, such as about 20-40 cm in length in some
embodiments. The proximal orientation element 500, in some
embodiments, can be made of a wire made of an appropriate material,
such as steel or nitinol. The wire, or a proximal portion of the
wire, such as at least about 60%, 70%, 80%, or more of the total
length of the wire, may be tapered in some embodiments, such that
the wire has a greater diameter proximally and a lesser diameter
distally, such that the stiffness of the wire increases from a
proximal to distal direction. In some embodiments, the wire can be
covered by a biocompatible covering, such as silicone, with a
durometer of between 30a-50a, such as about 40a in some
embodiments. The proximal end of the proximal orientation element
may comprise a soft arcuate tip with a full radius to prevent
trauma to the esophagus, and may be formed of the biocompatible
covering extending beyond the proximal end of the wire.
Strips
[0077] In order to promote tissue ingrowth/adherence of the
proximal orientation element to the esophagus, strips of material
attached to a cuff could be applied to the walls of the esophagus.
There could be at least one, two, three, four, or more strips that
can attach at the GEJ area to the cuff and extend cephalad
(proximally) up the esophagus. FIG. 2K schematically illustrates an
embodiment of these strips 232 attached to a cuff 204 and sleeve
100. Such strip 232 materials can include tissue graft materials,
such as, for example, collagen, small intestinal submucosa, a
tissue growth factor, or various tissue graft materials from
Genzyme Corporation (Cambridge, Mass.). In some embodiments, these
strips 232 could be of a woven or non-woven fiber or polymer or
could be some form of tissue graft or a combination of these
materials. These strips 232 may be held in place with adhesives or
stitches or through tissue ingrowth or some combination of these
methods. One possible adhesive could be fibrin glue, an example of
which is the TISSEEL.RTM. product distributed by Baxter, PMMA or
other polymeric glue. The adhesive could be selected such that it
forms a long-term bond lasting at least a week, two weeks, a month,
a year, or more, or it could be intended for shorter term use and
lose much of its strength for no more than about a month, two
weeks, one week, 3 days, 2 days, or even less. Cyanoacrylate is an
example of a potential longer-term adhesive. The strips 232 may be
intended to only be bonded with the adhesive, or alternatively
could be designed to heal into the wall of the esophagus, or could
be a substrate for tissue in-growth. The strips 232 could be
applied to the walls of the esophagus with a balloon or other
expandable device. While the strips 232 would not deliver
substantial radial force to the esophagus they would allow the
esophagus to remain compliant and not affect its movement
substantially. The strips 232 could have a free end or the strips
232 may have another flexible member that connects the ends if this
is determined to be beneficial to either attachment or deployment
of the device.
Surface Preparation
[0078] In some embodiments, it may be beneficial to prepare the
surface of the esophagus before applying any of the esophageal
attachment devices described above. The goal of the surface
preparation of the esophagus would be one or more of the following:
(1) increase ability of an adhesive to bond; (2) accelerate the
rate of tissue in growth or (3) alter the tissue layers to help
provide a more durable attachment substrate. Possible non-limiting
methods used to prepare the surface could include the delivery of
any of: optical energy, such as a laser for example an Argon laser;
RF energy; microwave energy; Argon plasma coagulation (APC),
thermal energy; cryo energy; ultrasound, focused or unfocused; high
or low pH materials; sclerosing agents, friction, or the like. The
surface preparation could have the goal of damaging the mucosal
layer or removing the mucosal layer completely to expose the
submucosa.
[0079] There are devices described in the art to mechanically
remove, such as by sucking in and then cutting off a layer of
tissue, the mucosa of the esophagus in order to remove strips of
mucosal tissue. These devices are described for the use of removing
abnormal tissue that may be precancerous from the walls of the
esophagus (e.g., Barrett's esophagus). In this indication, they
could be used to prepare the inner surface of the esophagus for the
attachment of devices described above. In some embodiments, the
method could also entail removing the submucosa to expose the
muscularis.
[0080] Alternatively, proximal orientation elements as described
above could be used with a distal support element or as part of an
element in complex intragastric support systems as described
below.
Distal Support Element
[0081] Another component to provide support to an implanted device
to help maintain position in a body lumen such as the GI tract is
to provide support by maintaining a position in the GI tract, for
example, the stomach. A simple example of this would be a pillar
like device in the stomach that supports a cuff at the GEJ as shown
in FIG. 25 of the Kagan '148 application. A rigid pillar is less
preferred because of the amount of motility of the stomach and the
dynamic nature of the environment. However, other elements could
provide similar support. Similar to the device as described in U.S.
Patent Publication No. 2006-0015125 to Swain et al., which is
hereby incorporated by reference herein in its entirety, in one
embodiment, disclosed is a dynamic-shaped element that if
surrounding or supporting the sleeve could hold or help hold the
sleeve in place at the GEJ. FIG. 1 of the Swain '125 publication
incorporated by reference above illustrates a distal support
element that could be used to help support the cuff/sleeve
construct at the GEJ.
[0082] Referencing FIGS. 1C-1E of the present application, in some
embodiments, the distal (e.g., intragastric) support element 502
illustrated here includes a flexible dome-shaped element 208
designed to reside in the upper portion of the stomach, a support
structure 210 that may be arcuate-shaped in some embodiments that
connects the flexible dome 208 to the pyloric support element
212.
[0083] FIGS. 3A-3F depict various views of one embodiment of a
dome-shaped component 208 of a distal support element 502 with an
aperture 209 that can be configured to receive a bypass sleeve 100
(not shown), according to one embodiment of the invention. In some
embodiments, the dome 208 has a diameter of between about 1-10
inches, such as between about 2-6 inches, 2-4 inches, or 2.5-3.5
inches at its widest point, and between about 0.5-5 inches, 0.5-3
inches, or 0.5-2 inches as the diameter of aperture 209. The
flexible dome 208 could be made from silicone, latex, polyurethane
or any other material that is sufficiently resistant to gastric
acid, biocompatible, and will remain flexible in the stomach. Other
possible materials the dome 208 could be made of, for example,
include Nitinol (that may be woven Nitinol), plastics, and
polymers. Other possible materials can be selected according to the
desired clinical indication. The dome 208 illustrated is convex,
however it could have concave portions either to act as a funnel to
direct food into the bypass sleeve or to help accommodate natural
structures in the stomach to maintain its location. Furthermore,
the dome 208 need not be round, and may have other arcuate or even
non-arcuate shapes. The dome 208 can also have one-way check-valves
that would allow air or fluid to flow up the esophagus when there
is sufficient pressure, e.g., during vomiting. In some embodiments,
the dome 208 could also incorporate other funnel shaped structures
or channels to direct food that passes the GEJ but does not get
forced into the cuff/sleeve to once again get directed back into
the sleeve.
[0084] The pyloric support element 212 of the distal support
element 502 as shown, for example, in FIGS. 1C-1E can be the
integral distal part of, or attached to the arcuate support
structure 206 in other embodiments. The configuration of the
pyloric support element 212 most preferably prevents the distal
support element 502 from migrating through the pylorus. In some
embodiments, the device can be deployed in a collapsed state and
then expanded in the stomach. Alternatively, the distal end (e.g.,
the pyloric support element) could be enlarged after passing
through the pylorus and provide support by anchoring against the
wall of the duodenal bulge.
[0085] Various methods known in the art could be used to create a
distal end (e.g., pyloric support component 212) that expands from
a first configuration with a smaller cross-sectional area to a
second configuration with a larger cross sectional area to resist
passage of the device through the GI tract. The distal end 212
could be made of a shape memory metal or polymer that when
delivered is in a collapsed state, and when in the selected region
of the GI tract, such as the stomach, expands to a diameter greater
than could pass through the selected region of the GI tract. If the
arcuate support element 206 is a rod-like structure that is bent
back on itself with the bend at the pylorus, the pyloric element
212 could be preformed into a hoop shape at the bend as shown that
is biased to compress for delivery and expand and rotate to form a
loop upon placement in the stomach. In other embodiments, multiple
stent structures could accomplish this; Malecot-type or other
devices having mechanically enlargeable cross sections or surface
area could also be used. Inflatable elements or injectable bags of
material optionally with a hardenable polymer could also provide
the same interference fit with the lumen. In a preferred
embodiment, the pyloric support element 212 has a central lumen
through which the sleeve can fit therethrough to allow free flow of
food and other contents through the system without being pinched
between the pyloric element and the wall of the stomach or pylorus.
Alternatively, it can be desirable in some cases to have the sleeve
pinched between the pyloric support element 212 and the stomach
wall to form a restrictive element to slow up the passage of food.
Some examples of pyloric support elements 212 have been described,
for example, in the Kagan '148 application, previously incorporated
by reference in its entirety.
[0086] The arcuate support component 206 of a distal support
element 502 is preferably configured to hold in place the proximal
end of the cuff 204/sleeve 100 and/or flexible dome 208. To form a
support structure, the distal support element 502 can be more rigid
in some aspects, however still have flexibility and compliance in
some motion directions to accommodate the natural motion of the
stomach, allowing the stomach to act on the sleeve and propel food
through it The cuff 204 or cuff 204/sleeve 100 could have a
columnar strength or it could have one or more spines to provide
vertical support. The arcuate support element 206 preferably
provides support from the proximal end of the cuff and/or sleeve to
its base of support either against the greater curve of the stomach
or against some aspect of the pylorus or preferably some
combination of both in some embodiments. In one embodiment the
arcuate support element 206 is banana shaped with dimensions that
tend to match, or are proportional to, the greater curve of the
stomach. The arcuate support element 206 could have an arc angle
from the attachment at the GEJ to the pylorus depending on the
particular stomach configuration of the patient. In some
embodiments, the arc angle is at least about 45, 60, 75, 90, 105,
120, 135, 150, 165, 180, 195, 210 degrees, or more. The device can
be made of a shape memory metal, plastic, or other biocompatible
material and most preferably would have a hydrophilic or lubricious
coating. The pyloric support element can 212 be on the distal end
of the banana-shaped arcuate support 206. Alternatively, the
support device can be expanded by inflation with, for example, a
liquid, a gas, a liquid that becomes a solid, or a foam. In one
embodiment, the banana-shaped arcuate support element 206 can be
made of two telescoping pieces with an internal spring much like a
banana shaped shock absorber. This would allow for some compression
along the length of the device to accommodate contractions of the
stomach. The arc of the banana would provide predisposition to flex
along the length of the arc. It could be more compliant in the
approximate direction defined by an axis drawn from the esophagus
to the pylorus than in a direction perpendicular to that axis or
vice versa. In some embodiments, the device could be made from a
shape memory metal or polymer that has a preferred shape when at
body temperature but is cooled before implantation to make it very
flexible for delivery through an endoscope. The flexibility allows
for nearly free motion of the stomach wall, and the device would be
low enough in profile to not significantly interfere with the
stomach transferring its motion to the sleeve and thus the contents
thereof.
[0087] In some embodiments with separate dome support components
and pyloric support components of a distal support element, the
arcuate support structure between the dome support element and the
pyloric support element could be actuated. In other words, the arc
could be expanded or contracted with a motor or some control means
that expand or contract the stomach to induce satiety or another
desired therapeutic purpose. This may be manually controlled via a
transmitter, or automated, such as by a sensing mechanism.
[0088] The device design of the distal support element most
preferably prevents it from migrating through the pylorus as noted
above, in some embodiments. The entire device can be deployed in a
collapsed state and then expanded in the stomach. Optimally, it
would be collapsed enough so it can be delivered perorally, such as
via endoscopic assistance.
[0089] In another embodiment, as shown in FIG. 4, a distal support
element 242 could be a non-arcuate shape, for example, a woven
basket as illustrated. Nitinol, Elgiloy, Spring Steel or other wire
or ribbon may be used. The woven material may be coated with a
material such as silicone, polyurethane or other polymer, PTFE,
ePTFE, Dacron, or other material depending on the desired clinical
result. In other embodiments, the distal support element could be
helical shaped, or have arms that would expand to apply force
against the walls of the stomach. In other embodiments, examples of
devices of this configuration that could be modified to be used as
distal support elements are those used to occlude left atrial
appendages, such as those manufactured by Atritech, or devices used
to close patent foramen ovales, such as devices made by Velocimed
and AGA. Scaling up of such devices to accommodate the dimensions
of the stomach to serve as a distal support can be performed
depending on the desired clinical result.
[0090] FIG. 5 illustrates an embodiment 252 of a distal support
element that includes a plurality of toroidal balloons 244,246, on
the proximal 248 and distal 250 ends. The device 252 also can
include a braided nitinol structure 254 over at least a portion of
a sleeve 100 configured to pass between the balloons 244, 246. The
device 252 may be covered or coated with a suitable material as
noted above. The arcuate support element and a stiffening element
of the sleeve could be the same structure. In one such embodiment,
the portion of the stiffening element of the sleeve distal to the
pylorus can be floppier or more flexible. The proximal segment
preferably has an arcuate shape set into the material so once
deployed within the sleeve the sleeve takes a curve following the
greater curve of the stomach.
[0091] FIG. 6A illustrates an intragastric support system 300 with
a proximal orientation element 500 having a tapered esophageal ring
element 520 as shown in FIG. 2G and described above. The distal end
498 of the proximal orientation element 500 is hingably connected,
such as via a pivot point 510, to a distal support element 502 at
the midpoint of the distal support element 502 as shown. In other
embodiments, the hinge/pivot joint 510 may be offset from the
midpoint, or at an end of the distal support element 502. Also
shown is a gastrointestinal bypass sleeve 100 operably connected to
the intragastric support system 300 at the distal end 522 of the
ring element 520 of the proximal orientation element 500. Not to be
limited by theory, the hingably connected distal support element
502 can be advantageous in several ways. It can allow the
intragastric support system 300 to adjust to gastric motility and
stomachs of various sizes. Furthermore, bending stresses against
the esophagus can be minimized as the pivot element 510 can allow
the esophageal post portion 500 to be maintained relatively
coaxially with the walls of the esophagus. Moreover, such
embodiments can prevent the esophageal post 500 from collapsing
into the stomach, and as such a dome-shaped element would not be
required. Also, the hingably connected distal support element 502
can provide distributed support for the proximal orientation
element 500, along the more muscular region of the stomach,
avoiding the more elastic fundus region which may provide less
predictable support.
[0092] Similar to the embodiment described in FIG. 6A, FIG. 6B
schematically illustrates that the distal support element 502 can
be movable, such as pivotably movable with respect to the proximal
orientation element 500 (as illustrated schematically in phantom)
at a joint 510 as shown. The joint 510 is preferably completely or
at least substantially smooth at its external surface, and recessed
or potted in some embodiments. The joint 510 can be, for example, a
bidirectional joint, such as a hinge-type joint, or a
multidirectional joint, such as a ball-and-socket type joint. The
joint 510 can be configured to, in some embodiments: (1) freely
pivot, (2) pivot within a particular range of motion, such as no
more than about 330, 300, 270, 240, 210, 180, 150 degrees, or less
in some embodiments, and/or (3) be locked in a fixed position. For
example, in some embodiments, activating or deactivating a locking
control (not shown) will allow the joint 510 to change mode from
being locked in a fixed position to pivot within a range of
motion.
[0093] The distal support element 502, and/or at least a portion of
the proximal orientation element 500, shown in FIG. 7A may be made
of any appropriate biocompatible material, such as a metal, e.g.,
polished titanium in some embodiments. The distal support element
502 may also include a coating as described elsewhere in the
application. The intragastric support 502 may have an arcuate shape
to contour with a wall of the stomach, or other shapes depending on
the desired clinical result. FIG. 7B is another view of the device
shown in FIG. 6. FIG. 7B illustrates the intragastric support
system 300 of FIG. 6, wherein the distal support element 502 is
moved from the configuration shown in FIG. 7C such that the long
axis of the distal support element 502 as shown in FIG. 7C (a
"straight" configuration) is at least substantially parallel to,
and/or coaxial with the long axis of the proximal orientation
element 500. This lower-profile configuration may be advantageous
for endoscopic delivery. In some embodiments, the system can be
configured to be deployed within no more than about a 30 mm, 28 mm,
24 mm, 22 mm, 20 mm, 18 mm, 16 mm, or less inside diameter
esophagus.
[0094] The distal support element 502 is preferably atraumatic and
smooth to prevent damage to the stomach mucosa as well as
associated structures. In some embodiments, the distal support
element 502 is configured to conform to the anatomy of the stomach,
such as having a portion configured to conform to the greater
curvature of the stomach as shown. The distal support element 502
may be made of any appropriate material, and may be made of
titanium in some embodiments.
[0095] In some embodiments, as shown schematically in FIG. 7D, the
distal support element 502 is radiused on all sides, with a
preferably arcuate proximal end 506 ("heel portion") and distal end
508 ("toe portion") and can be between about 60-180 mm in length,
such as between about 90-150 mm in length, or about 100-130 mm in
length in some embodiments. The distal support element 502 can have
a height of between about 5-40 mm, such as between about 10-30 mm,
or between about 15-25 mm in some embodiments. The distal support
element 502 can have a width of between about 5-35 mm, 5-25 mm, or
10-20 mm in some embodiments. In some embodiments, the length of
the distal support element 502 is no more than about 70%, 60%, 50%,
40%, 30%, 20%, 10%, or less of the length of the length of the
proximal orientation element 500.
[0096] The device 504 or a portion of the device, such as the
distal support element 502, may be inserted into a body lumen in a
first, reduced configuration for delivery 504' (shown in phantom)
and then transformed into a second, enlarged configuration 504 as
shown in FIG. 7E. Expansion of the device can be achieved by, for
example, filling of the device with a filler material (as described
below in connection with FIG. 7F), or a shape memory material. In
some embodiments, the device can be transformed back into a reduced
configuration if the device is removed from the body.
[0097] FIG. 7F schematically illustrates an embodiment 532 where
the distal support element 502 is configured to be fillable with a
filler material 534, such as a solid, liquid, or gas depending on
the desired clinical result. However, the distal support element
may only be partially fillable or solid (non-fillable) in some
embodiments. In some embodiments, the distal support element may be
made of a rigid, semi-rigid, or rigid transitioning to a semi-rigid
material. In some embodiments, the distal support element can be
configured to be filled with, for example, between about 1-10,000
cc, between about 10-5000 cc, 100-3000 cc, 200-1000 cc, or between
about 200-500 cc of a filler in some embodiments.
[0098] FIG. 7G illustrates an embodiment of an intragastric support
system 546 with a distal support element 502 with an enlarged "toe
portion" or distal end 550. The enlarged toe portion 550 may have a
height 552, for example, that is at least about 5%, 10%, 15%, 20%,
25%, 30%, 40%, 50% or more greater than a height 554 of the
proximal end 548 of the distal support element 502, in some
embodiments. The elongated distal end portion 550 can
advantageously help prevent the system 546 from migrating distally
through the pylorus into the intestine. In some embodiments, the
enlarged toe portion has a dimension greater than that of the
pylorus, such as at least about 3 cm, 4 cm, 5 cm, 6 cm, or
more.
[0099] FIG. 7H schematically illustrates an embodiment of a
gastrointestinal support system 556 in which the distal support
element 502 and/or proximal orientation element 500 could include
electronics 558, for example, a pressure or volume sensor that can
detect the presence of food in the esophagus or stomach, or monitor
the pressure of the lower esophageal sphincter to prevent reflux.
The distal support element 502 and/or proximal orientation element
500 could also include a drug reservoir, as described in greater
detail elsewhere herein.
[0100] In some embodiments, the distal support element can be made
of a wire such as stainless steel, nitinol, or other appropriate
material as shown in FIGS. 8A-8C and can be made having a shape
similar to that of the greater curve of the stomach, as shown in
FIG. 8D. The distal end 258 of the wire 256 preferably forms a hoop
258 that is larger than can fit through the pylorus. The wire 256
is preferably coated with a hydrophilic coating that is acid
resistant, such as, e.g., the HARMONY.RTM. Advanced Hydrophilic
Coating from SurModics (Eden Prairie, Minn.). In some embodiments,
the wire has a total length of between about 1-36 inches, such as
between about 6 to 24 inches in some embodiments. In some
embodiments, the wire 256 has a diameter of between about 0.001-020
inches, such as between about 0.020 and 0.080 inches. In some
embodiments, the hoop portion has a radius of between about 0.1-2
inches, such as between about 0.2-1 inch, or 0.3-0.8 inches in some
embodiments. In certain embodiments, there is a gap 259 between
segments of the wire that is approximately 0.03-0.5 inches,
0.05-0.2 inches, or about 0.125 inches in some embodiments.
System Embodiments
Hybrid Attachment System
[0101] In some embodiments, the entire intragastric support system
could be a combination of non-transmural attachment elements each
designed to share the load of the device and one or more transmural
attachment points. Disclosed below is one embodiment of a potential
hybrid attachment system. Note the preferred attachment system may
include any combination or subcombination of elements as described
below.
[0102] The proximal orientation element, in one embodiment, is made
out of nitinol coated with a hydrophilic coating with a soft tip on
the free end. In some embodiments, the cuff would preferably be
disposed within a funnel shaped opening in the top of a silicone
dome as described above. In one embodiment, the dome preferably
resides on top of a banana shaped support element that can be made
of nitinol wire and has a similar shape as the greater curve of the
stomach. The distal end of the nitinol wire preferably forms a hoop
that is larger than can fit through the pylorus. One embodiment and
dimensions of one preferred nitinol wire that may be part of a
distal support element is shown in FIGS. 8A-8D and described above.
The nitinol is preferably coated with a hydrophilic coating that is
acid resistant, such as the HARMONY.RTM. Advanced Hydrophilic
Coating from SurModics (Eden Prairie, Minn.). The sleeve is
attached to the cuff and is configured to pass through the pylorus
through the loop of the pyloric support element. The entire
structure is designed to allow the stomach to collapse around it
and transfer normal stomach forces and movement to the sleeve
element.
[0103] In some embodiments, such as with the hybrid attachment
system described above, in addition to the proximal orientation
element and distal support element, one or more transmural anchors
could optionally be placed through the cuff, silicone dome, cuff
loops, or other appropriate structure to help provide additional
fixation. Because of the additional orientation from the proximal
orientation element and distal support elements, fewer anchors may
be needed than have been previously disclosed in other applications
referenced above and incorporated by reference. In one embodiment,
no more than about 6, 5, 4, 3, 2, or 1 anchors would need to be
placed. The anchors could be placed in areas of the GEJ where the
strength of the attachment points could be optimized and at the
same time the risk to adjacent structures could be minimized. For
example, there could be three anchors placed along a 180.degree.
arc of the GEJ on the side of the lesser curve if this was known to
be farther away from any critical adjacent structures and have
greater anchor strength than the greater curve. Note that this is a
non-limiting example only and it may be preferred to place the
anchors along the greater curve of the stomach. In some
embodiments, the anchors could have transverse elements that
preferably have a length that is greater than a thickness of the
stomach wall. For example, the length of the transverse elements
could be at least about 150%, 200%, 250%, 300%, or more of the
thickness of the stomach wall such that the transverse element
functions as a tether assisting the post in maintaining the
position of the intragastric support and/or sleeve such that
alignment between the esophagus and sleeve is maintained.
[0104] In one embodiment of the above, the system could be attached
with the following components: a proximal orientation element
attached to the greater curve side of the cuff or distal support
element; 2-4 transmural t-tags placed around the lesser curve of
the cuff; a sleeve with a stiffening element; and an arcuate
support portion with a pyloric support portion of the distal
support element.
Sleeve with Support Lumen
[0105] In one embodiment, an intragastric support system could
include a cuff/sleeve with one or more lumens built into the sleeve
wall that run approximately from the proximal end to the distal
end, as disclosed in the Kagan '148 application. Such a cuff/sleeve
with one or more lumens in the sleeve wall can advantageously hold
the sleeve in place with a stiffening element inserted into the
lumen to resist movement of the sleeve proximally or distally. In
other words, the sleeve could potentially be self-supporting with
an elongate support element, such as a stiffening element (e.g., a
guidewire) without other support or attachment structures.
Following placement of the cuff/sleeve, a flowable polymer that
polymerizes in situ can be injected into the lumen. Once this
hardens, it will not only act as a stiffening member in the sleeve
but will also keep the device from undesirably migrating proximally
or distally along the GI tract. Instead of filling the lumen with a
polymer, a support wire, for example a standard guide wire used for
interventional procedures could be placed down a lumen in the wall
of the sleeve. Alternatively, the sleeve could have support wire or
wires built into the wall of the sleeve (as disclosed in the Kagan
'148 application) to keep the sleeve in place or provide any radial
force if desired. It may be that a sleeve with a stiffening element
could have enough resistance to avoid displacement proximally or
distally that it could function as a stand alone device. A stand
alone supported bypass sleeve could run from above the GEJ, at the
GEJ or immediately below the GEJ to the small intestine. Placement
of the sleeve above the GEJ can advantageously help align the
proximal sleeve with the esophagus. In one embodiment 293 depicted
in FIGS. 9A-B, the sleeve 100 is a constant diameter so that food
entering the sleeve 100 transfers minimal force that could displace
the sleeve 100 distally. The proximal end 101 of the sleeve 100 in
this configuration can have a slight radial hoop strength to keep
opposition to the esophageal wall 164 but not enough to force the
esophagus 164 open. The guidewire 274 could be as described above,
or it could have one more preset curves 290, 292 as shown. The
preset curves 290, 292 would combine many of the tasks of the
separate elements of the intragastric support system described
elsewhere. The preset curves 290, 292 would act as both the
esophageal post 500, arcuate support element 206 along the greater
curve and replace the looped pyloric support element 212 with a set
curve 292 that braces along the outer curve of the duodenum. In
some embodiments, the curve could be a reverse S type curve with
the upper part 290 matching close to the greater curve of the
stomach and the lower part 292 of the S close to the shape of the
pylorus and upper duodenum. There would be no gasket (e.g.,
dome-shaped) element in this configuration. The sleeve 100 could be
deployed inverted within a delivery catheter advanced to the
pylorus 116 and toposcopically deployed in the small intestine 112.
The delivery catheter still attached to the sleeve would be
retracted up into the esophagus or to the desired location for the
proximal end of the sleeve. While attached to the delivery catheter
to keep from displacing the sleeve 100 distally the preset
guidewire 274 would be advanced down the lumen. The guidewire 274
could be made of a shape memory metal such as nitinol or elgiloy.
Ideally it would be cooled immediately before advancement so it
would be as flexible as possible for advancement in the lumen. The
guidewire 274 could have an atraumatic tip proximally or it could
be slightly shorter than the lumen so it would not stick out after
placement and a plug could be placed to lock the wire in the lumen.
In another embodiment 295, as shown in FIG. 10, a portion 276 of
the wire 274 can extend proximally beyond the sleeve 100. This
proximal wire segment 276 may be an expandable element can assume a
complex shape, such as a spiral shape, zig-zag stent, and the like
to provide additional support within the esophagus 164 for the
sleeve 100. Any of these sleeve stiffening methods could also be
used with any sleeve embodiments as disclosed in any of the prior
applications incorporated by reference above. In addition, any of
the adhesive and ablation techniques described above could be used
with the previously disclosed cuff embodiments. In these
embodiments, the cuff could be made at least in part from materials
such as tissue grafts, or other materials. The cuff could have a
hybrid design with an annular cuff of one material and an outer
cuff or section of cuff that is made of a material that encourages
ingrowth or adhesion following the steps described above for
surface preparation.
[0106] The total weight of the intragastric support system 504 in
some embodiments, can be between about 0.05-0.5 kg, or between
about 0.1-0.2 kg. The system 504 can have a low center of gravity
in some embodiments, with at least about 60%, 65%, 70%, 75%, 80%,
85%, 90%, or more of the weight present in the distal support
element 502 compared to the total weight of the system 504.
Obstructive or Restrictive Device
[0107] In some embodiments, the gastrointestinal support device may
include an obstructive or restrictive component positionable in the
esophagus and/or stomach. The obstructive or restrictive component
can cause a portion of the gastrointestinal wall, such as at the
lower esophageal sphincter in one embodiment, to expand, provoking
a feeling of satiety in a patient and suppressing appetite.
[0108] As shown schematically in FIG. 11A, intragastric support
system 560 includes a proximal orientation element 500 with a
food-collection ring element 520 and distal support element 502
that can be as previously described. A reservoir 562 that can be
stretchable, such as a balloon may be connected to ring element 520
as shown and extend distally into the distal esophagus or proximal
stomach. The reservoir 562 can be, for example, a sponge-like
bladder that expands, such as radially, in the presence of food or
liquids. In some embodiments, the reservoir 562 is configured to
radially expand in diameter by at least about 25%, 50%, 75%, 100%,
150%, 200%, or more of its unstressed diameter. The reservoir 562
is preferably easily compressible such that the lower esophageal
sphincter 566 can still close down upon it, not impeding its normal
function, as schematically illustrated in FIG. 11B. The
balloon-like reservoir 562 can include a restrictive outlet 564,
such as a smaller-diameter portion, a one-way valve, or the like to
expand a portion of the gastrointestinal wall, e.g., at the GEJ and
induce a feeling of satiety in the patient, as schematically
illustrated in FIG. 11C.
[0109] FIG. 11D illustrates another embodiment of an intragastric
support system 570 including a restrictive element 568. Shown are
proximal orientation element 500 and distal support element 502. A
diaphragm 568 with a funnel-like portion 569 and a distal
restrictive outlet 567 may be positioned in the proximal stomach to
collect food and liquids from the esophagus as illustrated. The
narrow restrictive outlet 567 can cause food and liquids to exert
pressure on the GEJ, inducing a feeling of satiety in the
patient.
[0110] FIG. 11E illustrates an embodiment where the intragastric
support system 572 includes an obstructive element 574 operably
connected to the proximal orientation element 500 and is configured
to be positioned, for example, at the GEJ. The obstructive element
574 may be a balloon or sponge that can expand, contract, or
otherwise change shape. Food and liquids from the esophagus can be
forced to flow around the obstructive element 574 into the stomach
(rather than through the restrictive elements illustrated in FIGS.
11A-D above) exerting pressure on the GEJ and inducing a feeling of
satiety in the patient. In some embodiments, the obstructive
element can include a filter, to function as a sieve for ingested
materials.
[0111] In some embodiments, the restrictive or obstructive element
includes a control that can allow the degree of expansion of the
reservoir and/or the degree of the restriction. In some
embodiments, the reservoir includes a sensor that can measure a
pressure change, e.g., at the LES and cause dilation of the GEJ,
such as to prevent reflux or induce satiety.
Gastric Bypass Device
[0112] In some embodiments, as illustrated schematically in FIG.
12, the intragastric support system 576 may be as previously shown
with proximal orientation element 500 including a food collection
ring 520, as well as a distal support element 502 as previously
described. There can be a balloon-like reservoir with a restrictive
outlet (not shown) to receive food and expands against the
gastro-esophageal junction (GEJ) due to the restrictive outlet.
This element is easily compressible so that the LES can still close
down on it not impeding its normal function. Also illustrated in
FIG. 12 is a gastrointestinal sleeve 100 that can be connected
proximally to an esophageal ringed element 520 on the proximal
orientation element 500 at the GEJ, or in other embodiments, a
reservoir structure below the GEJ. The sleeve 100 may be made of a
pliable or collapsible material, or be as described, for example,
in U.S. Patent Pub. No. 2007/0198074 A1 to Dann et al., hereby
incorporated by reference in its entirety. The length of the bypass
sleeve 100 may vary, and can be at least about 50 cm, 75 cm, 100
cm, 125 cm, or more in some embodiments. The sleeve 100 can be made
to bypass the stomach only, bypass stomach+intestine, or bypass
intestine only. In the case of a partial intestinal bypass, the
sleeve 100 could be operably attached to the intragastric support
component 502 (such as through an aperture of the distal support
element) near the pyloric antrum. Additional features such as, for
example, a balloon or sponge can also be attached to the system to
enable the stomach to better act on the sleeve during peristalsis,
as contraction of the stomach can exert a pressure on the balloon
or sponge which will in turn exert a pressure on the sleeve.
Gastric Space-Occupying Device
[0113] In one embodiment, as illustrated schematically in FIG. 13,
a intragastric support system 578 includes one or more expandable
structures 580, 580 that may be, for example, balloons tethered to
a portion of the system 578. In some embodiments, the expandable
structures 580, 580 can be finable with air, fluid, or other
material to occupy the empty space of the stomach, to reduce free
gastric capacity and induce a sense of satiety.
Delayed Gastric Emptying Device
[0114] In one embodiment, illustrated schematically in FIG. 14, an
intragastric support system 582 that may be otherwise as previously
described can include a pyloric valve 588 tethered to a portion of
the system 582 to control or regulate the food passage from the
stomach into the duodenum. The valve 588 could span the pylorus or
be fixed in front of the pylorus partially blocking food from
passage out of the stomach. The intragastric support system 582
could tether a large reservoir 584 (e.g., a bag) in the stomach
with a restrictive outlet 586 as shown, thus limiting the rate of
food passage through the pylorus.
Pacing Device
[0115] In one embodiment, illustrated schematically in FIG. 15, the
intragastric support system 590 can include a pacing/stimulating
element 592 whereby the pacing device could be housed, for example,
in the distal support element 502 (or "foot") of the device and
one, two, or more leads 594 could be attached to the gastric wall,
pyloric antrum, or nerves (such as the vagal trunk) to stimulate
the muscles or nerves via electrodes/leads to treat, for example,
motility disorders such as gastroparesis. The device could
incorporate a basket-like sensing array (not shown) used in
conjunction with the pacing features. Some pacing elements 592 that
can be used in conjunction with the IGS systems described herein
are described, for example, in U.S. Patent Pub. No. 2008/0058887 to
Griffin et al., which is hereby incorporated by reference in its
entirety.
Food Incinerator
[0116] In one embodiment, as shown schematically in FIG. 16, an
intragastric support system 596 could support a reservoir 598 which
chemically or mechanically alters or neutralize potential calories,
proteins, fats, sugars, etc. contained in the food or liquids
ingested. For example, the reservoir 598 may contain acids, bases,
pharmaceutical agents, and/or enzymes such as amylase, lipase, or
proteinases. In some embodiments, the food or liquid is altered
into a form that is more or less absorbable by the digestive tract.
In some embodiments, the reservoir 598 is configured to metabolize
a drug or substance, such as alcohol to increase or reduce
absorption of the drug or substance or convert it to a more, less
or non-active metabolite.
Implantable Diagnostic Device
[0117] As shown schematically in FIG. 17, the distal support
element 502 of an intragastric support system 600 could house or
tether various imaging technologies 602 such as endoscopic
ultrasound (EUS), a sensor, probe, camera (such as a capsule
endoscope), or the like that is tethered via a tether line 604 in
the stomach and allowed to travel into the intestine. The imaging
element 602 can later be retrieved mechanically, such as manually
or via an automated retraction feature. Alternatively, the tether
604 may be degradable over time allowing the diagnostic device 602
to pass through the colon and exit the body. A tethered device 602
or an element incorporated within the intragastric support system
600 itself can measure, for example, one or more of pH level,
intra-gastric pressure, food intake amount and rate, gastric
temperature, electrical activity from the heart (e.g., EKG), or
other hemodynamic parameters noninvasively, such as systolic and
diastolic blood pressure, atrial, ventricular, central venous, and
pulmonary artery pressures. The device 602 can transmit the
information to an external and/or internal receiver. In some
embodiments, the device 602 can be a comprehensive implantable ICU
monitoring unit.
Chemical Detector
[0118] In some embodiments, a tethered device or the intragastric
support system itself is incorporated with a sensor configured to
detect, for example, the presence of one or more toxins (e.g., a
heavy metal, a poison) or allergen that can send the alert to an
external device and/or can administer therapy (e.g., an antidote, a
chemical to break down the toxin or allergen, epinephrine, a
corticosteroid, an antihistamine) to prevent toxicity or an
allergic reaction.
Implantable Therapeutic Device
[0119] In some embodiments, at least a portion of the intragastric
support system is incorporated with a drug delivery function in,
for example, the esophagus, stomach or intestine. This could
deliver therapies as one or more of the following: a reaction to
the sensing feature; administer prophylactic treatment;
time-release medication, neutralize hormonal releases; and/or other
therapeutic applications. In one embodiment, a capsule tethered to
the device could also serve as a cautery in the stomach or
intestine to treat ulcers, polyps, cancers, arteriovenous
malformations, areas of infection, and the like.
[0120] In some embodiments, the intragastric support system is
incorporated with a reservoir to store an energy source, such as
glucose for endurance-type activity or for outdoor sports to
provide sustained energy. The reservoir may be replenishable. This
can be used advantageously in recreational or military training or
combat situations, for example.
[0121] In some embodiments, the intragastric support system may
include a thermoregulatory element such as a heat source or cooling
source to maintain body temperature in extreme weather
conditions.
[0122] In some embodiments, the intragastric support system can
include a power generator, such as a battery, to provide energy to
electronics or electrical devices internal and/or external to the
body.
[0123] In some embodiments, the intragastric support system can
include an accelerometer to detect body motions or orientation;
data can be transmitted to a processing unit inside or external to
the body.
[0124] In some embodiments, the drug delivery platform can include
a drug to treat a wide variety of conditions depending on the
clinical result. For example, in some embodiments, the distal
support element can include a drug to treat peptic ulcer disease,
gastritis, or GERD such as a proton-pump inhibitor, H2 receptor
blocker, prostaglandin or prostaglandin analogue, sucralfate, or
bismuth subsalicylate. The distal support element could include a
drug to treat a motility disorder or chronic nausea/vomiting such
as a pro-motility agent such as metoclopramide or an anti-emetic
agent such as ondansetron, chlorpromazine, or droperidol, for
example. The distal support element could include a
chemotherapeutic agent to treat cancer, such as gastric cancer,
e.g., 5-FU, cisplatin, epirubicin, etoposide, docetaxel, or
irinotecan. The distal support element could include an
anti-obesity drug, such as, for example, orlistat, metformin,
sibtramine, exenatide, pramlintide, rimonabant, an amphetamine,
naloxone, or a hydrogel. An intragastric drug delivery platform can
be especially advantageous for patients who have difficulty with
compliance with orally administered medications that may need to be
taken chronically. In some embodiments, other non-limiting examples
of drugs that can be included on the drug delivery platform could
include an antipsychotic, an antidepressant, an oral contraceptive,
a hypoglycemic agent, an anti-hypertensive, an anti-coagulant, an
antibiotic, an-antiepileptic, and many other drugs depending on the
desired clinical result. In some embodiments, the proximal
orientation element could also include a drug delivery platform,
such as, for example, a chemotherapeutic agent to treat esophageal
cancer.
Reflux Treatment
[0125] In some embodiments, the intragastric support system (also
referred to herein as the IGS) includes one or more sensors that
can measure pH levels in the esophagus. In some embodiments, the
IGS includes a reservoir of a basic substance such as sodium
bicarbonate to neutralize gastric acid. The IGS may also include a
pressure sensor to measure pressure at, for example, the lower
esophageal sphincter (LES). If LES pressure are too low, the sensor
could trigger filling of a bladder operably connected to the IGS
device that compensates for poor LES function and prevents acid
reflux into the esophagus. Such a system can be controlled
remotely. In some embodiments, the IGS device is incorporated with
a plug of cotton or other absorbent material (tampon-like) feature
to absorb acid at the lower esophageal sphincter (LES).
Gastric Prosthesis
[0126] In some embodiments, the IGS includes features to restore an
anatomical defect, such as a hiatal hernia, by acting as a
prosthetic device to prevent or to correct the deformity. There
could have dome-like elements as described above or different
geometries attached to the IGS to restore or prevent tissue
abnormalities.
Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Applications:
[0127] In some embodiments, the IGS is incorporated with an
intra-gastric "workstation" to facilitate NOTES procedures so that
the surgeons can stage items or instruments necessary during the
operation without the need to transport items multiple times into
the body cavity. For example, the IGS device can include one or
more dilators as a space creator in the stomach. In some
embodiments, the IGS device is incorporated with a secondary
instruments leverage point to support NOTES procedure
intra-gastrically.
Stent Placement Applications
[0128] In some embodiments, the IGS 606 can include a gastric stent
support or graft support feature 598 to provide alternate stent
placement technique, as illustrated schematically in FIG. 17A with
proximal orientation element 500 and distal support element 502.
Stents, such as those used for esophageal cancers or leaks, rely on
outward force against the esophagus, to hold them in place. The IGS
would support such stents from below.
Delivery Methods
[0129] One delivery method for an intragastric support system is
disclosed. In some embodiments, as disclosed in the Dann '605
application, as well as U.S. Provisional Patent Application No.
60/826,862 to Dann et al., filed Sep. 25, 2006 and hereby
incorporated by reference in its entirety, a cuff/sleeve 100 that
includes an attached guidewire 152, as illustrated schematically in
cross-section in FIG. 18D within delivery catheter 400 and overtube
480, can be delivered toposcopically. Furthermore, additional
details regarding toposcopic delivery of a gastrointestinal sleeve
100 may be as described, for example, in U.S. patent application
Ser. No. 11/861,156 filed Sep. 25, 2007, and hereby incorporated by
reference in its entirety. More specifically, for example, FIGS.
1A-2E of the Ser. No. 11/861,156 application and the accompanying
text at paragraphs [0054] to [0064] disclose various embodiments of
toposcopic sleeves; FIG. 15H and the accompanying text at paragraph
[0143] disclose an embodiment of a filling catheter and sleeve kit;
and FIGS. 3A-16B and the accompanying text at paragraphs [0065] to
[0142] and [0144] to [0150] disclose various toposcopic delivery
systems and components including collapsible and steerable filling
catheters, guidewires, techniques for occluding the distal end of
the sleeve, and loop snares, all of which can be used or modified
for use with the systems and methods described herein.
[0130] The overtube 480 of FIG. 18D is not shown in some of the
following figures for clarity. An intragastric support system for
securing the cuff/sleeve in position, such as an intragastric
support system that includes a proximal orientation element, distal
support element including a pyloric support element, arcuate
element connected to a dome element and the pyloric support element
(e.g., the system described above in FIGS. 1C-1E), can then be
delivered over the guidewire. Other systems disclosed herein can
also be delivered using similar methods.
[0131] Referring to FIG. 18A, there is illustrated a toposcopic
delivery device in accordance with the present invention. The
delivery device includes a filling catheter 400, illustrated as
extending across the stomach such that a distal end 402 is in the
vicinity of the pylorus 116. Preferably, the distal end 402 would
be placed across the pylorus 116 before delivery of the sleeve 100.
A sleeve 100 can be inverted within the filling catheter 400 for
toposcopic delivery as disclosed in the Kagan '148 application.
Stages of partial and complete eversion of the sleeve 100 is
illustrated in FIGS. 18B-18C.
[0132] The proximal end of the sleeve 100 is connected to a
guidewire 152. The guidewire 152 lies along the outside of the
delivery catheter 400 during delivery of the sleeve 100. There may
be one or more guidewires 152 connected to the proximal end of the
sleeve. The guidewire 152 allows control of the sleeve 100 after
deployment of the sleeve 100 into the small intestine 114. The
guidewire 152 also functions as a control element for the sleeve
100 and should not be limited to a wire concept. A catheter
connected to the sleeve 100, multiple catheters or any other linear
device which would allow retraction of the sleeve 100 up to the GEJ
from outside the body could be used instead of a guidewire 152.
[0133] The guidewire 152 is preferably releasably connected to the
proximal end of the sleeve 100. Following connection of the sleeve
100 to the intragastric support system shown in FIG. 18K, the
guidewire 152 is disconnected from the sleeve. Release may be
accomplished in any of a variety of ways, such as thermally
releasing a polymeric link through the use of a monopolar or
bipolar electrical circuit as is understood in the detachable
intracranial aneurysm coil field, or the like. Alternatively, the
guidewire 152 may comprise a hollow outer sleeve which axially
slideably receives an inner core. Axial, proximal or distal
displacement of the core with respect to the sleeve can be utilized
to detach the guidewire 152. The guidewire 152 may also be
forceably detached, by a pushing, twisting or pulling motion. A
catheter could be advanced over the guidewire 152 such that when
the tip of the catheter comes into contact with the proximal end of
the sleeve 100 the guidewire is disconnected by force or through
the actuation of a cutting mechanism.
[0134] With the sleeve 100 deployed in the intestine 114 and the
delivery catheter 400 removed, the intragastric support system can
then be introduced perorally over the guidewire 152, as illustrated
in FIG. 18F. In one method, each of the components when in its
compressed or more linear form, in other words, with the long axis
of the proximal orientation element 500 coaxial or substantially
coaxial with the long axis of the distal support element 502, would
be loaded into a delivery sheath 450 to control advancement into
the stomach 104 and allow retrieval of the device before final
deployment as shown in FIGS. 18G-18H. Delivery sheaths 450 that
provide a similar function as described here are common in the art
for other devices such as AAA grafts, percutaneous heart valves and
other devices of the sort. In this example, the guidewire 152 is
threaded through the proximal orientation element 500 and the loop
of the pyloric support element 212 of the distal support element
502 outside of the body before advancement. In one preferred
embodiment, the proximal orientation element 500 and the distal
support element including pyloric element 212 and the arcuate
support element 206 are all one structure. This portion of the
intragastric support system 199 is preferably in a first low
crossing profile configuration for delivery into the GI tract, as
shown schematically in FIG. 18F and can be later expanded to a
second post-delivery configuration, as shown schematically in FIG.
18H and described elsewhere in the disclosure. The system can be
moved down the guidewire 152 through the oral cavity until the
pyloric support element 212 is positioned near the pylorus 116. The
dome shaped element 208, which can be other shapes in certain
embodiments as previously described, can then be pushed down into
the proximal stomach over the guidewire 152. Ideally, the dome
shaped element 208 will be advanced while in a smaller profile and
is advanced over the proximal orientation element 500 as shown in
FIG. 7J. This smaller profile can be achieved by rolling the device
or collapsing the device like an umbrella and loading into a
delivery sheath (not shown). The dome element 208 can then be
deployed and locked into a desired position on the element(s) of
the intragastric support system that is already in place, such as
near the gastroesophageal junction, and secured in place. It can
lock onto the system using a snap fit connection, bayonet style
lock, adhesive or by using a endoscopically placed suture, staple
or other anchor. Alternatively, the dome 208 and the support
elements 500, 206, 212 comprising the intragastric support system
can be assembled outside the body and forced into a small enough
crossing profile by nature of any of the previously described
configurations of these devices so that they can be deployed all at
once as opposed to in stages. The IGS system would be compressed
and loaded into a delivery sheath 450 as shown in FIG. 19C. The
wire 152 would be threaded through the IGS system 199 in the
delivery sheath 450 outside the body. The delivery sheath 450 would
be advanced over the wire 152 into the stomach 104 and then a
plunger 452 would be advanced in the sheath 450 to eject the IGS
199 into the stomach 104. Alternatively, the sheath 450 could be
retracted and the plunger 452 held in place so the retraction of
the sheath 452 exposes the IGS 199 and allows it to take its biased
state. Next, the sleeve 100 can be pulled proximally by pulling on
wire 152 through the pyloric support element 212 and up to the dome
element 208, as shown in FIG. 18K. In some embodiments, the dome
element 208 and proximal sleeve are configured such that a rotation
tool can be used to lock the two into place. Alternatively, there
could be a snap fit connection with an outward biased element in
the proximal end of the sleeve, an interference fit, hook and loop
connectors, adhesives could be used to connect the devices, or they
could be connected with the use of endoscopic attachment methods
previously described. Following deployment of the system, the
guidewire 152 can be removed, as illustrated in FIG. 18L as
previously described. If desired, a radioopaque contrast medium,
such as barium, can be introduced into the esophagus 164 prior to
removal of the guidewire 152 (or swallowed by the patient at a
later time) in order to observe for any undesired leaking around
the sleeve 100. The use of delivery sheaths 452 is not mandatory
for any or all of the components. If the components are designed
such that they can be in a deliverable state with out being
constrained to maintain a small enough profile for peroral delivery
the delivery sheath 450 may not be necessary, especially if an
esophageal overtube is in place.
[0135] Optionally, the order of the implantation can be changed. In
another embodiment, the distal support element 502 is placed in the
stomach first in one piece. The elements including the proximal
orientation element 500, arcuate support element 206 and pyloric
support element 212 are made out of a continuous piece of nitinol
wire with one end of the nitinol wire stopping at the atraumatic
tip 201 of the proximal orientation element 500 and the other end
ending where the dome 208 is attached after making a bend, such as
an approximately 180.degree. bend to form the pyloric support
element 212 as shown in FIGS. 19A-19D. The dome 208 in this
embodiment could be made out of woven nitinol that is dipped in
silicone or covered by spray coated silicone or other material as
previously disclosed. A cut-away view of a nitinol dome 480 is
shown in FIG. 19A. The dome 480 is preattached to the nitinol wire
481 through any of the mechanism that would be known to those with
knowledge of this art including thermal bonding, adhesives, laser
welding, etc. In an alternate embodiment, the nitinol wire 481 of
the main construct 483 is threaded through the weaves of the
nitinol dome 480. Then the entire construct 483 is dipcoated in
silicone. This device can incorporate any of the atraumatic tip
designs previously described for the esophageal post and coatings
or features for the rest of the construct. As shown in FIG. 19B,
this device made of a shape memory alloy can be placed in a relaxed
state in a straightened or linear orientation with the dome 480
collapsed down around the straightened support element or it could
be forced into this configuration using a crimping or loading
device to help load the compressed IGS 198 into the delivery sheath
450 (shown in FIG. 19C). It is then loaded into a delivery sheath
450, which can be a larger catheter that can fit down the esophagus
or esophageal overtube and is large enough to hold the collapsed
construct 198. The delivery sheath 450 and intragastric support
system 198 in a low crossing profile configuration is shown in FIG.
19C. The delivery sheath 450 is then advanced into the distal end
of the stomach and as the sheath 450 is retracted a pusher element
452 or plunger in the sheath 450 keeps the construct 198 in place
and it expands into its biased form as the sheath 450 is retracted.
After the device 198 expands, the delivery catheter 400 (not shown)
is advanced through the center of the expanded device 198 to
deliver the sleeve 100. This can be accomplished using the
toposcopic delivery methods previously described. However in this
case, the delivery catheter 400 would be placed down the esophagus,
through the hole in the nitinol dome 480 that aligns with the
esophagus, through the pyloric support element 212 and into the
pylorus 116. Next, the sleeve 100 would be deployed as described,
the delivery catheter 400 would stay attached to the sleeve 100,
and when it is retracted it would pull the proximal end of the
sleeve 100 up to the attachment point in the nitinol dome 480. In
this case the delivery catheter 400 would replace the function of
the guidewire 152 in FIGS. 18A-18L. The sleeve 100 would then be
attached to a support element such as the dome as previously
described and the delivery catheter 400 would release the sleeve
100 and be removed from the body.
[0136] In yet another embodiment, the sleeve could be attached to
the intragastric support system before implantation. In this
method, the intragastric support system (IGS) would be collapsed or
crimped down around the delivery catheter with the sleeve attached
and inverted as shown in FIG. 19D. FIG. 19D is a cut-away view of
an IGS delivery sheath 450 with the intragastric support system 198
loaded with the delivery catheter 400 and sleeve 100. The
intragastric support system 198 would have to be able to fit in the
space between the delivery catheter 400 and the IGS delivery sheath
450. The sleeve 100 would be attached at the hole in the dome 480
and lay distally along the outside of the sleeve delivery catheter
400 until it is through the pyloric support element 212 where it
would then invert around the end 402 of the delivery catheter 400
and up through its center. The entire system 198 would then be
loaded into an IGS delivery sheath 450. The loaded IGS delivery
sheath 450 would be advanced to the pylorus, as shown in FIG. 19E.
The delivery catheter 400 would be advanced slightly out past the
end of the IGS delivery sheath 450 until the tip of the sleeve
delivery catheter 400 is past the pylorus as shown in FIG. 19F,
then the sleeve 100 would be deployed toposcopically as depicted in
FIG. 19G. Then the IGS delivery sheath 450 would be fully retracted
allowing the IGS system to expand to its natural state as shown in
FIGS. 19H-19I. When it expands it would release the sleeve delivery
catheter 400 so it would then be withdrawn and the entire system
would be in place with the sleeve 100 deployed in the small
intestine.
[0137] While delivery of the sleeve as described herein has
generally focused on toposcopic delivery, it should be noted that
any of the sleeve delivery methods as previously described in prior
applications or known in the art, such as the Kagan '148
application, could be used including using a pushing catheter,
peristaltic delivery, double balloon enteroscopic delivery,
etc.
[0138] In the above described disclosure, it is most preferred that
there is as little risk as possible of damage to the esophagus
during any of the implantation steps. Thus before any of the
devices as described are advanced perorally, it is preferred that
an overtube would be placed. Overtubes such as those described in
the Dann '605 application, may be used for delivery. The overtube
may be only long enough to protect the esophagus, or it may be long
enough, such as at least about 100 cm, 110 cm 120 cm, 130 cm, 140
cm, 150 cm or longer, to reach the pylorus. If the later, it could
be advanced with the delivery catheter and the inverted sleeve in
its lumen and used to approach or cannulate the pylorus for
toposcopic delivery of the sleeve. After sleeve delivery, the
overtube would then be retracted to the level of the GEJ for the
rest of the procedure.
[0139] In some embodiments, an intragastric support system, such as
illustrated, for example, in FIGS. 7B-7C may be deployed using the
following steps:
[0140] (1) Move device to the collinear position (e.g., long axis
of proximal orientation element at least substantially collinear
(coaxial) with the long axis of the distal support element)
[0141] (2) Attach a pushing device to the distal support
element
[0142] (3) Thread distal support element through guidewire and
insert into overtube
[0143] (4) Orient the distal support element such that pivot
direction is towards greater curve, and away from lesser curve
[0144] (5) Insert a small diameter endoscope that rides alongside
the proximal orientation element directly proximal to the distal
support element.
[0145] (6) Fill stomach with air
[0146] (7) Push past LES and into the stomach
[0147] (8) Once proximal part of the distal support element is into
the stomach, remove the pushing rod by pulling back or delinking in
(unscrewing, etc.)
[0148] (9) A spring mechanism may bias the distal support element
to open. Pressing the distal support element against the greater
curve of the stomach will increase opening (towards perpendicular
position relative to the proximal orientation element)
[0149] (10) Once the distal support element passes approximately 30
degrees from normal position, it locks into place.
[0150] If sleeve is to be attached:
[0151] (11) Sleeve would be delivered in advance of placing IGS
into the stomach
[0152] (12) Sleeve sutures are threaded through ring support before
delivering IGS.
[0153] (13) IGS is pushed into stomach as described above
[0154] (14) Once in the stomach, sleeve ring in collapsed and
pulled up into the food collecting ring of the proximal orientation
element
[0155] (15) Once in the food collecting ring, sleeve ring is
released and opened
[0156] (16) By pushing it down with an instrument, it locks into
food collecting ring
[0157] Another method for delivering an IGS system 501, such as the
system illustrated, for example, in FIG. 6A above, and includes a
gastrointestinal bypass sleeve 100 is schematically illustrated in
FIGS. 20A-20E, according to one embodiment of the invention. First,
the sleeve 100 is connected to and inverted within a delivery
catheter 400, as described in U.S. patent application Ser. No.
11/861,156 filed Sep. 25, 2007, and hereby incorporated by
reference in its entirety. Next, as illustrated in FIG. 20A, a long
overtube 480 is inserted perorally and advanced into the esophagus
164, stomach 104, and the duodenum 114. The sleeve 100 preferably
includes at least one tether 484, such as a suture on its proximal
end that can run alongside the delivery catheter 400 and proximally
out of the long overtube 480 and preferably secured proximal to the
mouth of the patient. The sleeve 100 can then be toposcopically
delivered as described in the Ser. No. 11/861,156 application. As
illustrated in FIGS. 20B-C, the sleeve 100 is then released from
the delivery catheter 400 and pushed out of the overtube 480 into
the stomach 104. Then, the long overtube 480 and delivery catheter
400 are removed, and a shorter overtube 490 inserted (shown in
phantom). Next, the proximal ends of the tether(s) 484 are pulled
through the esophageal ringed food collector 520 of the proximal
orientation element 500 from a distal to proximal direction. The
system 501', in its delivery configuration, where the long axis of
the proximal orientation element 500 is coaxial with the long axis
of the distal support element 502, is then connected to a pusher
tool 486. The pusher tool 486 facilitates movement, such as pushing
and/or pulling of the intragastric support system 501' relative to
a body lumen when the system 501' is being delivered or removed.
The pusher tool 486 is preferably releasably coupled to a portion
of the system 501' such as, for example, by a threaded connector,
lock, or other mechanism.
[0158] Next, the system 501 releasably connected to pusher tool 486
and endoscope 488 are inserted into the short overtube 490. As
shown in FIG. 20D, the intragastric support system 501 is then
pushed down into the stomach 104 using the pusher tool 486. The
pusher tool 486 can then be decoupled from the intragastric support
system 501 and removed from the body. As illustrated in FIGS.
20D-E, the intragastric support system 501 can then be expanded to
a implanted configuration where the long axis of the distal support
element 502 is not coaxial 501 with the long axis of the proximal
orientation element 500, preventing migration of the system 501
either proximally into the esophagus 164 or down into the intestine
114. Next, the proximal end of the bypass sleeve 100 can be pulled
proximally into the esophagus 164 by pulling proximally on the
tether 484 running through the esophageal food collecting ring 520.
The sleeve 100 can then be secured within the inside diameter of
the esophageal food collecting ring 520 using, for example, a
quick-connect interface 491. The short overtube 490 can then be
removed. The tether 484 can then be cut and removed from the body,
followed by the endoscope 488.
[0159] In some embodiments, the intragastric support system 501 can
be delivered within the body in multiple pieces, e.g., the distal
support element 502 and the proximal orientation element 500 are
delivered separately as illustrated schematically in FIGS. 21A-21D.
First, a short overtube 490 is delivered perorally to within the
esophagus 490, as illustrated in FIG. 21A. Next, a guidewire 152 is
threaded distally such that the distal end of the guidewire 152 is
in the intestine 114. Then, a portion of the system, such as the
distal support element 502, can be releasably coupled to a pusher
tool 486 as described above, and deployed over the guidewire 152
(e.g., through a guidewire aperture of the distal support element
502) into the stomach 104. The distal support element 502 is
preferably deployed such that the long axis of the distal support
element 502 is coaxial with the long axis of the esophagus 164
during delivery. Next, the distal support element 502 is
transformed into an implanted configuration where the long axis of
the distal support element 502 is not coaxial with the long axis of
the proximal orientation element 500, and substantially conforms to
the greater curve of the stomach in some embodiments, as
illustrated in FIG. 21B. The pushing tool 486 is then detached from
the distal support element 502 and removed from the body. Next, the
proximal orientation element 500 of the system is attached to a
delivery catheter 400. The gastrointestinal bypass sleeve 100 is
preattached to the esophageal food collecting ring 520 of the
proximal orientation element 500, and inverted into the delivery
catheter 400. Next, the short overtube 490 is withdrawn from the
body lumen, and replaced by a long overtube 480, which is placed
distally into the duodenum 114, as illustrated in FIG. 21C. The
guidewire 152 is then fed through a portion of the proximal
orientation element 500 configured to receive the guidewire 152.
The delivery catheter 400 is then advanced to the distal end of the
overtube 480. Any slack from the guidewire 152 is pulled proximally
as the delivery catheter 400 is pushed distally. The sleeve 100 can
then be toposcopically delivered as previously described. The long
overtube 480 can then be pulled back into the esophagus 164. The
delivery catheter 400 is removed from the body and an endoscope 488
inserted, as illustrated in FIG. 21D. Next, the proximal
orientation element 500 is pushed out into the esophagus 164. The
proximal orientation element 500 and the distal support element 502
(which may also include a distal portion of the proximal
orientation element 500 when delivered as shown) are connected via
the guidewire 152 and coupled together, e.g., via complementary
quick connect interfaces 165. The overtube 480, guidewire 152, and
scope 488 are then removed from the body, leaving the intragastric
support system 501 in place.
System Removal
[0160] A method sequence to remove an intragastric support system,
such as the system described in FIG. 6A for example, from the GI
tract according to one embodiment of the invention is now
described. If a sleeve is attached, an operator can reach into the
food collecting ring of the proximal orientation element with a
grasping element and grab a suture to collapse the sleeve ring and
detach from food collecting ring interface. The sleeve can then be
pulled out through an overtube. Next, an unlocking instrument can
be inserted to release the lock on the distal support element
(arch). Once released, a snare may be used to align the distal
support element collinear with the proximal orientation element. A
pulling instrument is interfaced with the distal support element,
and then the device can be pulled up into the overtube.
[0161] While this invention has been particularly shown and
described with references to embodiments thereof, it will be
understood by those skilled in the art that various changes in form
and details may be made therein without departing from the scope of
the invention. For example, while the embodiments herein have
primarily described components of an intragastric support system,
the system can also be adapted for positioning in other body
lumens, for example, a system with a distal support element
configured to be placed in the bladder and the proximal orientation
element in a ureter, or a system with a distal support element
configured to be placed in the uterus with a proximal orientation
element in a fallopian tube, in some embodiments. Furthermore, the
intragastric systems and methods disclosed herein can be used or
adapted for positioning a device in a patient concurrent with or
after bariatric surgery as described, for example, in U.S.
Provisional Application No. 61/023,809, hereby incorporated by
reference in its entirety, e.g, as described in FIGS. 2-6, 9-12,
14-22, and the accompanying text at paragraphs [0016] to [0018],
[0020] to [0051] and [0058] to [0067] of that application.
[0162] For all of the embodiments described above, the steps of the
methods need not be performed sequentially. While any above-listed
applications may have been incorporated by reference for particular
subject matter as described earlier in this application, Applicants
intend the entire disclosures of the above-identified applications
to be incorporated by reference into the present application, in
that any and all of the disclosures in these incorporated by
reference applications may be combined and incorporated with the
embodiments described in the present application.
* * * * *