U.S. patent application number 12/999180 was filed with the patent office on 2011-06-09 for methods and devices for delivering or delaying lipids within a duodenum.
Invention is credited to Zhenyong Keck, James T. McKinley, Fiona M. Sander.
Application Number | 20110137227 12/999180 |
Document ID | / |
Family ID | 44114303 |
Filed Date | 2011-06-09 |
United States Patent
Application |
20110137227 |
Kind Code |
A1 |
McKinley; James T. ; et
al. |
June 9, 2011 |
METHODS AND DEVICES FOR DELIVERING OR DELAYING LIPIDS WITHIN A
DUODENUM
Abstract
Devices are described that are adapted and configured for use
within the duodenum of a mammal. One aspect of the device includes
a spine having a proximal end and a distal end; an atraumatic
feature positioned on at least one of the proximal end and the
distal end of the spine; and a flow reduction element positioned
along the spine and having a variable porosity along its length. In
another aspect, there is a flow reduction device adapted and
configured for use within the duodenum of a mammal having a spine
having a length, a proximal end and a distal end; a first
atraumatic feature positioned adjacent to the spine proximal end; a
second atraumatic feature positioned adjacent to the spine distal
end wherein the length of the spine is selected so that when the
first atraumatic feature is in the stomach the second atraumatic
feature is in the fourth portion of the duodenum; and a flow
reduction element having a proximal end, a distal end, an interior
portion, an exterior portion and a variable porosity between the
proximal end and the distal end. Additionally or alternatively,
some or all of the components of the device may be formed from or
coated with a lipid-philic material. There is also provided a
method for adjusting the passage of ingesta through the duodenum of
a mammal. The method includes placing the distal end of a flow
reduction device in the duodenum of a mammal; placing the proximal
end of the flow reduction device in a stomach of the mammal;
expanding within the duodenum of the mammal a variable porosity
flow reduction element supported by the flow reduction device; and
directing at least a portion of the flow of ingesta through the
duodenum through the proximal end of the variable porosity flow
reduction element and into an interior portion of the variable
porosity flow reduction element.
Inventors: |
McKinley; James T.; (Redwood
City, CA) ; Keck; Zhenyong; (Redwood City, CA)
; Sander; Fiona M.; (Los Altos Hills, CA) |
Family ID: |
44114303 |
Appl. No.: |
12/999180 |
Filed: |
July 2, 2009 |
PCT Filed: |
July 2, 2009 |
PCT NO: |
PCT/US09/49586 |
371 Date: |
January 31, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US08/70226 |
Jul 16, 2008 |
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12999180 |
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61077579 |
Jul 2, 2008 |
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60950071 |
Jul 16, 2007 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61M 27/002 20130101;
A61F 5/0079 20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 16, 2008 |
US |
PCT/US2008/070226 |
Claims
1. A device adapted and configured for use within the duodenum of a
mammal, comprising: a spine having a proximal end and a distal end;
an atraumatic feature positioned on at least one of the proximal
end and the distal end of the spine; and a flow reduction element
positioned along the spine and having a variable porosity along its
length.
2. The device of claim 1 wherein the variable porosity of the flow
reduction element is selected so that a portion of a flow over the
proximal end of the flow reduction element flows into an interior
portion of the flow reduction element.
3. The device of claim 1 wherein the variable porosity of the flow
reduction element is selected so that flow within an interior of
the flow reduction element is at least partially inhibited from
flowing through the distal portion of the variable porosity
structure.
4. The device of claim 1 wherein a proximal portion of the flow
reduction element comprises a material, a mesh or a braid having a
porosity or altered to provide a porosity selected to permit a flow
into an interior portion of the flow reduction element.
5. The device of claim 1 wherein a distal portion of the flow
reduction element comprises a material, a mesh or a braid having a
porosity or altered to provide a porosity selected to at least
partially inhibit a flow from within an interior portion of the
flow reduction element.
6. The device of claim 1 wherein the length of the spine is
selected so when the atraumatic feature is positioned in a stomach
the flow reduction element is positioned on the spine and distal to
a pylorus.
7. The device of claim 1 wherein the length of the spine is
selected so when the atraumatic feature is positioned in a stomach
the distal end of the spine is in the fourth portion of the
duodenum and the flow reduction element is positioned within a
portion of the duodenum.
8. The device of claim 1 further comprising: a flow reduction
element having a non-variable porosity along its length.
9. The device of claim 8 wherein the flow reduction element is at
least partially formed from a lipid-philic material.
10. The device of claim 8 wherein at least a portion of the
interior or the exterior of the flow reduction element is at least
partially coated with a lipid-philic material.
11. The device of claim 1 further comprising: a feature on the
spine positioned to restrict movement of the flow reduction element
relative to the spine.
12. The device of claim 1 wherein the flow reduction element is at
least partially formed from a lipid-philic material.
13. The device of claim 1 wherein at least a portion of the
interior or the exterior of the flow reduction element is at least
partially coated with a lipid-philic material.
14. The device of claim 1 further comprising: a lipid-philic
structure within the flow reduction element.
15. The device of claim 14 wherein the lipid-philic structure
within the flow reduction element is attached to the spine.
16. The device of claim 14 wherein the lipid-philic structure
within the flow reduction element is attached to the flow reduction
element.
17. A device adapted and configured for use within the duodenum of
a mammal, comprising: a spine having a length, a proximal end and a
distal end; a first atraumatic feature positioned adjacent to the
spine proximal end; a second atraumatic feature positioned adjacent
to the spine distal end wherein the length of the spine is selected
so that when the first atraumatic feature is in the stomach the
second atraumatic feature is in the fourth portion of the duodenum;
and a flow reduction element positioned along the spine and having
a proximal end, a distal end, an interior portion, an exterior
portion and a variable porosity between the proximal end and the
distal end.
18. The device of claim 10 wherein the porosity of the proximal end
is selected to the allow flow to pass from the exterior portion to
the interior portion.
19. The flow reduction device of claim 10 wherein the porosity of
the distal end is selected to impede flow from the interior portion
to the exterior portion.
20. The flow reduction device of claim 10 wherein the proximal
portion is more porous than the distal portion.
21. The device of claim 10 wherein the proximal end has a porous
structure configured to permit flow into the interior portion and
the distal end has a solid portion to retain material within the
interior portion.
22. The device of claim 10 further comprising: another flow
reduction element between the proximal and distal ends of the
spine.
23. The device of claim 15 wherein the another flow reduction
element has variable porosity between the proximal and distal ends
of the flow reduction element.
24. The device of claim 10 wherein the length of the spine is
selected so that when the first atraumatic feature is positioned in
a stomach the second atraumatic feature is positioned within the
duodenum and adjacent to the first atraumatic feature.
25. The device of claim 10 wherein the length of the spine is
selected so that when the first atraumatic feature is positioned in
a stomach the second atraumatic feature is positioned within the
duodenum and in proximity to the ligament of Treitz.
26. The device of claim 10 wherein the flow reduction element is at
least partially formed from a lipid-philic material.
27. The device of claim 10 wherein at least a portion of the
interior or the exterior of the flow reduction element is at least
partially coated with a lipid-philic material.
28. The device of claim 10 further comprising: a lipid-philic
structure within the flow reduction element.
29. The device of claim 28 wherein the lipid-philic structure
within the flow reduction element is attached to the spine.
30. The device of claim 28 wherein the lipid-philic structure
within the flow reduction element is attached to the flow reduction
element.
31. A method for adjusting the passage of ingesta through the
duodenum of a mammal, comprising: placing the distal end of a
device in the duodenum of a mammal; placing the proximal end of the
device in a stomach of the mammal; expanding within the duodenum of
the mammal a variable porosity flow reduction element supported by
the device; and directing at least a portion of the flow of ingesta
through the duodenum through the proximal end of the variable
porosity flow reduction element and into an interior portion of the
variable porosity flow reduction element.
32. The method for adjusting the passage of ingesta according to
claim 19 further comprising: retaining a portion of the ingesta
within the interior portion of the variable porosity flow reduction
element until the ingesta is pushed out of the interior portion by
peristaltic action of the duodenum.
33. The method for adjusting the passage of ingesta according to
claim 20 wherein the ingesta is pushed out of the interior portion
by passing through a distal portion of the variable porosity flow
reduction element.
34. The method for adjusting the passage of ingesta according to
claim 20 wherein the ingesta is pushed out of the interior portion
by passing through the proximal portion and thereafter passing
around the variable porosity flow reduction element.
35. A method for adjusting the passage of ingesta through the
duodenum of a mammal, comprising: placing the distal end of a
device in the duodenum of a mammal; placing the proximal end of the
device in a stomach of the mammal; expanding within the duodenum of
the mammal a flow reduction element supported by the device wherein
at least one component of the device is at least partially formed
from or coated with a lipid-philic material; and joining a lipid
comprising compound to the at least one component of the device
that is at least partially formed from or coated with a
lipid-philic material.
36. The method of claim 35 further comprising: Releasing at least a
portion of the lipid comprising compound from the at least one
component of the device.
37. The method of claim 35 wherein the at least one component is a
flow reduction element and the lipid comprising compound is
attached to the exterior of the flow reduction element.
38. The method of claim 35 wherein the at least one component is a
flow reduction element and the lipid comprising compound is
attached to the interior of the flow reduction element.
39. The method of claim 35 wherein the at least one component is a
spine of the device and the lipid comprising compound is attached
to the spine adjacent to a flow reduction element.
40. The method of claim 35 further comprising: After the joining
step, contacting an interior wall of the duodenum with a portion of
the at least one component.
41. A device adapted and configured for use within the duodenum of
a mammal, comprising: a spine having a length, a proximal end and a
distal end; a first atraumatic feature positioned adjacent to the
spine proximal end; a second atraumatic feature positioned adjacent
to the spine distal end wherein the length of the spine is selected
so that when the first atraumatic feature is in the stomach the
second atraumatic feature is in the fourth portion of the duodenum;
and a flow reduction element positioned along the spine and having
a proximal end, a distal end, an interior portion, an exterior
portion, wherein at least a portion of the device is at least
partially made from or coated with a lipid-philic material.
42. The device of claim 41 wherein the at least a portion of the
device that is at least partially made from or coated with a
lipid-philic material is the flow reduction element.
43. The device of claim 41 wherein the at least a portion of the
device that is at least partially made from or coated with a
lipid-philic material is the spine.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority of U.S.
Provisional Patent Application Ser. No. 61/077,579 filed Jul. 2,
2008 and is a continuation in part of International Patent
Application No. PCT/US2008/070226 filed on Jul. 16, 2008, published
as WO 2009/012335 A1, the entirety of each of these applications is
incorporated herein by reference in its entirety.
[0002] Various aspects of the design, function, deployment,
operation and delivery of conformal flow reduction devices for use
in the duodenum are described in the following related
applications: U.S. Provisional Patent Application No. 60/950,071,
filed Jul. 16, 2007, entitled "CONFORMATIONALLY-STABILIZED
INTRALUMINAL DEVICE FOR MEDICAL APPLICATIONS," now International
Patent Application No. PCT/US2008/070226 filed Jul. 16, 2008
entitled "A Conformationally-Stabilized Intraluminal Device for
Medical Applications;" U.S. patent application Ser. No. 10/999,410,
filed Nov. 30, 2004, entitled "METHOD AND APPARATUS FOR REDUCING
OBESITY," now publication no. 2005-0192614; U.S. patent application
Ser. No.: 11/300,283, filed Dec. 15, 2005, entitled "METHODS AND
DEVICES TO CURB APPETITE AND/OR REDUCE FOOD INTAKE," now
publication no. 2006-0178691; and U.S. patent application Ser. No.
11/807,107, filed May 25, 2007, entitled "METHODS AND DEVICES TO
CURB APPETITE AND/OR REDUCE FOOD INTAKE," now publication no.
2007-0293885.
INCORPORATION BY REFERENCE
[0003] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BACKGROUND OF THE INVENTION
[0004] Obesity and type 2 diabetes are diseases of insufficient or
deficient regulation. We know from human studies that the small
intestine plays a critical role in both energy and glucose
homeostasis: when the duodenum is exposed to lipids, appetite is
diminished and native (liver) glucose production is down-regulated.
Previously we have invented a device that can be implanted into the
duodenum and remain in place; we have described devices and methods
for slowing the passage of food through the duodenum to cause
increased tissue-nutrient contact, thereby causing amplified
hormonal signaling from the duodenum; and, we have invented methods
and devices for delivering chemicals, drugs or other compounds to
the duodenum.
[0005] What is needed are devices and/or methods for additional
lipid uptake, delaying ingesta passage/prolonging ingesta contact,
delivering or providing lipids or other appetite and glucose
reducing nutrients and/or combinations of these
characteristics.
SUMMARY OF THE INVENTION
[0006] In one aspect of the present invention, there is provided a
device adapted and configured for use within the duodenum of a
mammal. The device has a spine having a proximal end and a distal
end; an atraumatic feature positioned on at least one of the
proximal end and the distal end of the spine; and, positioned along
the spine, a flow reduction element having variable porosity along
its length. In one embodiment, the variable porosity of the flow
reduction element is selected so that a portion of a flow over the
proximal end of the flow reduction element flows into an interior
portion of the flow reduction element. In one embodiment, the
variable porosity of the flow reduction element is selected so that
flow within an interior of the flow reduction element is at least
partially inhibited from flowing through the distal portion of the
variable porosity structure. In one embodiment, the proximal
portion of the flow reduction element comprises a material, a mesh
or a braid having a porosity or altered to provide a porosity
selected to permit a flow into an interior portion of the flow
reduction element. In one embodiment, the distal portion of the
flow reduction element comprises a material, a mesh or a braid
having a porosity or altered to provide a porosity selected to at
least partially inhibit a flow from within an interior portion of
the flow reduction element. In one embodiment, the length of the
spine is selected so when the atraumatic feature is positioned in a
stomach the flow reduction element is positioned on the spine and
distal to a pylorus. In one embodiment, the length of the spine is
selected so when the atraumatic feature is positioned in a stomach
the distal end of the spine is in the fourth portion of the
duodenum and the flow reduction element is positioned within a
portion of the duodenum. In one embodiment, there is also a flow
reduction element having a non-variable porosity along its length.
In one embodiment, there is also a feature on the spine positioned
to restrict movement of the flow reduction element relative to the
spine.
[0007] In still another aspect of the present invention, there is
provided a device adapted and configured for use within the
duodenum of a mammal. The device has a spine with a length, a
proximal end and a distal end; a first atraumatic feature
positioned adjacent to the spine proximal end; a second atraumatic
feature positioned adjacent to the spine distal end wherein the
length of the spine is selected so that when the first atraumatic
feature is in the stomach the second atraumatic feature is in the
fourth portion of the duodenum; and a flow reduction element having
a proximal end, a distal end, an interior portion, an exterior
portion and a variable porosity between the proximal end and the
distal end. In one embodiment, the porosity of the proximal end is
selected to the allow flow to pass from the exterior portion to the
interior portion. In one embodiment, the porosity of the distal end
is selected to impede flow from the interior portion to the
exterior portion. In one embodiment, the proximal portion is more
porous than the distal portion. In one embodiment, the proximal end
has a porous structure configured to permit flow into the interior
portion and the distal end has a solid portion to retain material
within the interior portion. In one embodiment, there is provided
another flow reduction element between the proximal and distal ends
of the spine. In one embodiment, the another flow reduction element
has variable porosity between the proximal and distal ends of the
flow reduction element. In one embodiment, the length of the spine
is selected so that when the first atraumatic feature is positioned
in a stomach the second atraumatic feature is positioned within the
duodenum and adjacent to the first atraumatic feature. In one
embodiment, the length of the spine is selected so that when the
first atraumatic feature is positioned in a stomach the second
atraumatic feature is positioned within the duodenum and in
proximity to the ligament of Treitz.
[0008] In still another aspect, there is provided a method for
adjusting the passage of ingesta through the duodenum of a mammal
by placing the distal end of a flow reduction device in the
duodenum of a mammal; placing the proximal end of the flow
reduction device in a stomach of the mammal; expanding within the
duodenum of the mammal a variable porosity flow reduction element
supported by the flow reduction device; and directing at least a
portion of the flow of ingesta through the duodenum through the
proximal end of the variable porosity flow reduction element and
into an interior portion of the variable porosity flow reduction
element. In one embodiment, there is also provided a method
retaining a portion of the ingesta within the interior portion of
the variable porosity flow reduction element until the ingesta is
pushed out of the interior portion by peristaltic action of the
duodenum. In still another embodiment, there is provided a method
of adjusting the passage of ingesta wherein the ingesta is pushed
out of the interior portion by passing through a distal portion of
the variable porosity flow reduction element. In still another
alternative method for adjusting the passage of ingesta, the
ingesta is pushed out of the interior portion by passing through
the proximal portion and thereafter passing around the variable
porosity flow reduction element.
[0009] In another aspect, the flow reduction elements positioned
along the device backbone could be coated with, manufactured from
or contain lipid-philic materials. For example, one or more of the
flow reduction elements of the intraduodenal device could be
manufactured from a lipid absorbing or adsorbing material. A flow
reduction element manufactured in this way will attract and collect
lipids from passing ingesta and hold the lipids for a period of
time. The length of time that the lipids will remain attached to
the flow reduction element will vary based on a number of factors.
For example, the flow reduction element may exude the lipids as
peristalsis continues to squeeze the device. The prolonged presence
of and/or sustained release of lipids within the duodenum is
believed to benefit and in some cases to increase hormonal
regulation. It is to be appreciated that embodiments of the present
invention provide prolonged presence of and/or sustained release of
lipids within the duodenum through the use of one or more of:
making flow reduction elements and/or other components of the flow
reduction device (i.e., any of the components of FIG. 1 for
example) at least partially or even completely from one or more
lipid-philic materials; coating flow reduction elements and/or
other components of the flow reduction device entirely or at least
partially form lipid-philic materials; and/or placing within a flow
reduction element, or attaching to a component of the flow
reduction device an additional element or component formed from or
at least partially coated with a lipid-philic material.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a prospective view of a device for use in the
duodenum.
[0011] FIG. 2 is an enlarged view of one of the flow reduction
elements of FIG. 1 showing the upper and lower portions of the
element;
[0012] FIG. 2A is an enlarged view of a material used to provide
variable porosity to a flow portion of a flow reduction
element;
[0013] FIG. 2B is an enlarged view of a solid or semi permeable
sheet where a pattern of holes are used to provided variable
porosity to a portion of a flow reduction element;
[0014] FIG. 3 illustrates a flow reduction element embodiment where
more of the flow reduction device is utilized for allowing flow
through the use of a larger proximal portion having a more porous
construction and a smaller distal portion having a less porous
construction;
[0015] FIG. 4 illustrates a flow reduction element embodiment where
more of the flow reduction device is utilized for preventing flow
than for allowing flow through the use of a smaller proximal
portion having a more porous construction and a larger distal
portion having a less porous construction.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The present application relates to methods and devices for
providing a sense of fullness/satiety and/or glucose production
inhibition. The devices and methods described herein provide for
additional lipid presence in the duodenum by delaying ingesta
passage/prolonging ingesta contact, delivering or providing lipids
or other satiety and/or glucose reducing nutrients and/or
combinations thereof.
[0017] Lipids can be generally defined as substances such as a fat,
oil or wax that dissolve in alcohol but not in water. Lipids
contain carbon, hydrogen and oxygen but have far less oxygen
proportionally than carbohydrates. They serve as a source of fuel
and are an important constituent of the structure of cells. As used
herein, lipids refer to any of fatty acids, glycerides, complex
lipids and nonglycerides. Fatty acids include both saturated and
unsaturated. Glycerides include, for example, neutral
phosphoglycerides. Complex lipids are lipids complexed with another
type of chemical compound and include, for example, lipoproteins,
phospholipids and glycolipids. Nonglycerides include, for example,
sphingolipds, steroids and waxes.
[0018] Because most ingesta contain lipids, it is believed that the
methods and devices described herein for prolonging lipid residence
time, delaying lipid passage and/or providing lipids would enhance
the operating characteristics of a duodenal positioned flow
reduction device, such as those described in the related
applications. In other words, the methods and devices described
herein not only slow the passage of food but may also detain or
delay the passage of food. The delay or detention may allow for
prolonged nutrient release and aid in achieving health objectives.
Additionally or alternatively, the devices and methods described
herein may also provide for active introduction of lipids into the
duodenum.
[0019] Catch and hold food, some of which is lipid. By using flow
reduction bulges along the spine of the device pictured in FIG. 1,
ingesta can be caught and held temporarily. The mesh bulges may
have a more open structure on the end from which nutrients arrive
from the stomach and smaller openings on the end from which
nutrients depart as one way to hold nutrients longer.
Alternatively, the spheres could themselves become `buckets` in
which food is captured and retained. The bucket may be provided by
having a solid bottom portion so that chyme entering remains in the
bottom of the bucket until pushed out by peristaltic action or my
movement of additional chyme to displace it.
[0020] The flow restriction devices may be any of a wide variety of
shapes and dimensions as described in the incorporated patent
applications. The adjustment of the flow characteristics of ingesta
or chyme: (a) around the outside of a flow reduction element, (b)
through a wall of a flow or portion of a flow reduction element and
(c) retained within a flow reduction element may be accomplished in
a number of ways. One way to adjust the flow characteristics within
a flow regulated duodenum (i.e., a duodenum having a flow reduction
device implanted within it) is through the porosity or flow
characteristics of the flow reduction elements.
[0021] FIG. 1 illustrates a perspective view of a device 100 having
a spine 105, a proximal end 110, a distal end 115, atraumatic
features 120 on both the proximal and distal ends. A series of five
flow reduction elements 130 are shown in position along the spine
105. There may be one or more features 135 on the spine to prevent
unwanted proximal or distal movement of the flow reduction elements
130 along the spine 105. The flow reduction elements 130 are shown
in a deployed configuration as they would be in use within the
duodenum. In the most basic form, one or more of the flow reduction
elements may be formed from a material or materials with porosity
characteristics that adjust the flow characteristics of chyme or
ingesta flow relative to the material and the flow reduction
element.
[0022] As shown in FIG. 1, the device 100 is orientated as it would
be implanted with the proximal end 110 in the stomach and the
distal end 115 in the duodenum near the ligament of Trietz.
Chyme/ingesta flow is from the proximal end 110 to the distal end
115 in FIG. 1. The more porous portion of the flow reduction
element 140 will interact with the chyme first. Because of the
porosity of this part of the flow reduction element, chyme will
flow into the interior portion of the flow reduction element as
well as around the flow reduction element. As peristaltic action in
the duodenum continues to move the chyme, the portion inside of the
flow reduction element is urged distally towards the portion of the
flow reduction device that is less porous 150. Some of the chyme
entering the flow reduction element portion 150 will be retained
within the flow reduction element for some period of time based
upon a number of factors such as how much the person has eaten and
the porosity of this portion of the flow reduction element among
others. As a result of the variable porosity of the structure of
the flow reduction element, chyme enters but then is delayed in
leaving the flow reduction element interior. It is believed that
increasing the residence time of chyme within a flow reduction
element will increase the time of interaction of the nutrients in
that trapped portion and/or provide for an extended release of the
lipids in the trapped portion of chyme. The retained food could be
nutrient rich or lipid rich so that the prolonged exposure produces
a sense of satiety and/or the inhibition of liver glucose
production in the individual. One such mechanism that may be
achieved or fostered by the embodiments described herein is
described in "Upper intestinal lipids trigger a gut-brain-liver
axis to regulate glucose production" by Penny Y. T. Wang et al
(Nature, Vol. 452:24 April 2008 doi:10.1038/nature06852).
[0023] The flow characteristics of the flow reduction element may
be adjusted in a number of ways. FIG. 2 is an enlarged view of a
flow reduction element 130 in FIG. 1. The flow reduction element is
divided roughly in half with an upper portion 140 (the part to
first contact with the flow of chyme) having a porosity that allows
flow through it and into the interior of the flow reduction
element. The bottom portion 150 of the flow reduction element is
less porous or allows less flow of chyme from the interior of the
flow reduction element. The variable porosity or flow
characteristics of the flow reduction elements may be adjusted by
selecting material with different sizes (FIG. 2A), shapes,
construction, and/or filaments with different characteristics to
enhance or diminish flow as needed for the upper or lower portions.
The flow characteristics of a flow reduction element may be
obtained by overlapping (i.e., joined or crossed without joining)
filaments to form cells that will, to the desired degree, permit or
impede chyme passage. Alternatively or additionally, the flow
reduction element could be formed from a solid or semi-permeable
sheet 160 with holes 161 formed in it as shown in FIG. 2B. The
size, shape, pattern and distribution of the openings may be used
to adjust the amount of relative flow through a flow reduction
element.
[0024] The flow reduction element adjustment may also be
accomplished by adjusting the relative amounts of the flow
reduction element used for allowing flow (more porous 140) or
preventing flow (less porous 150). FIG. 3 illustrates a flow
reduction element embodiment where more of the flow reduction
device is utilized for allowing flow than for preventing flow. In
contrast, FIG. 4 illustrates a flow reduction element embodiment
where more of the flow reduction device is utilized for preventing
flow than for allowing flow.
[0025] The foregoing are merely examples. More than one flow
allowing or more than one flow preventing zone or portion may be
used in a flow reduction element. While the relative distribution
of the flow zones has been generally perpendicular to the spine or
flow within the duodenum, other orientations relative to the spine
or the duodenum are possible depending upon the desired flow
profile. Moreover, a device may have flow reduction elements having
one or more flow adjustment zones, or no flow adjustment zones. The
type of flow reduction elements and the flow characteristics of
those flow reduction elements may be mixed within a flow reduction
device depending upon the desired flow characteristics desired.
[0026] Other flow reduction element properties such as the shape
and size of a reduction element, the relative size between
reduction elements, the alignment or orientation of a reduction
element to the central shaft or spine and other properties are
further described in the incorporated applications and may also be
adjusted to accomplish the nutrient delivery aspects described
herein.
[0027] Alternatively, the flow reduction elements could also be
configured to capture and hold a lipid For instance, to maintain a
certain lipid level in the spheres, the patient could periodically
swallow a lipid `pill` or other form that engages the device and
remains in place. The nutrient could also take the form of an
extended release compound that releases an amount of the nutrient
over time. The nutrient could also be mixed with another compound
that is released when the patient consumes a releasing agent, such
as before a meal or at a time of day prone to hunger pangs or
higher than desired blood glucose levels. The releasing agent mixes
with the nutrient compound mixture causing the release of
nutrients, such as lipids, to aid in regulation of hunger and/or
glucose.
[0028] In another aspect, the flow reduction device could be coated
with, manufactured with or contain nutrients such as lipids or
lipid-philic materials. For example, the flow reduction elements
could be one or more bulges manufactured using lipid leaching
materials; or the bulges could be manufactured with lipid-philic
materials or a sponge like membrane inside the bulges or otherwise
connected to the device backbone, that would absorb and distribute
temporally lipids from passing ingesta to increase hormonal
regulation.
[0029] In another aspect, the flow reduction elements positioned
along the device backbone could be coated with, manufactured from
or contain lipid-philic materials. For example, one or more of the
flow reduction elements of the intraduodenal device could be
manufactured from a lipid absorbing or adsorbing material. A flow
reduction element manufactured in this way will attract and collect
lipids from passing ingesta and hold the lipids for a period of
time. The length of time that the lipids will remain attached to
the flow reduction element will vary based on a number of factors.
For example, the flow reduction element may exude the lipids as
peristalsis continues to squeeze the device. The prolonged presence
of and/or sustained release of lipids within the duodenum is
believed to benefit and in some cases to increase hormonal
regulation. It is to be appreciated that embodiments of the present
invention provide prolonged presence of and/or sustained release of
lipids within the duodenum through the use of one or more of:
[0030] making flow reduction elements and/or other components of
the flow reduction device (i.e., any of the components of FIG. 1
for example) at least partially or even completely from one or more
lipid-philic materials; coating flow reduction elements and/or
other components of the flow reduction device entirely or at least
partially form lipid-philic materials; and/or placing within a flow
reduction element, or attaching to a component of the flow
reduction device an additional element or component formed from or
at least partially coated with a lipid-philic material.
[0031] The spine could be configured as a central tube with plural
inlet/outlet ports in communication with a flow reduction element
and/or the outside of the tube as described in the incorporated
applications. Additionally or alternatively, a portion of the
device itself, i.e.: the backbone or spine, could be hollow such
that it could be filled with lipids that would leach out or
otherwise be delivered to the duodenum. A nutrient reservoir may be
implanted within the patient, within the flow reduction device or
separately injected into the device during implantation, after
insertion or periodically while the patient has the device inserted
in his duodenum.
[0032] Additionally or alternatively, the lipid equipped hormonal
regulatory device could be configured to release lipids on demand
using an internal or external controller or device as described in
U.S. patent application Ser. No. 11/807,107, filed May 25, 2007,
entitled "METHODS AND DEVICES TO CURB APPETITE AND/OR REDUCE FOOD
INTAKE," now publication no. 2007-0293885.
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