U.S. patent application number 14/133999 was filed with the patent office on 2014-06-26 for systems and methods for bariatric therapy.
This patent application is currently assigned to Pavilion Medical Innovations, LLC. The applicant listed for this patent is Pavilion Medical Innovations, LLC. Invention is credited to Lishan Aklog, Albert K. Chin, Brian deGuzman, Amar Kendale.
Application Number | 20140180188 14/133999 |
Document ID | / |
Family ID | 47072691 |
Filed Date | 2014-06-26 |
United States Patent
Application |
20140180188 |
Kind Code |
A1 |
Chin; Albert K. ; et
al. |
June 26, 2014 |
SYSTEMS AND METHODS FOR BARIATRIC THERAPY
Abstract
The present invention provides bariatric therapy systems. One
system includes a gastrointestinal implant device and a delivery
mechanism therefor. The device can include a sleeve for placement
into a small intestine and to minimize absorption of nutrients by
its walls. An anchoring mechanism coupled to a proximal end of the
sleeve and designed to be secured within the stomach can be
provided. A passageway extending through the anchoring mechanism
and the sleeve can also be provided, along which food can be
directed from the stomach to the small intestine. The delivery
mechanism can include a housing for accommodating the device, and a
deploying balloon situated within the housing and which can be
actuated to direct the sleeve of the device from within the housing
to the site of implantation. Methods for providing bariatric
therapy are also provided by the present invention.
Inventors: |
Chin; Albert K.; (Palo Alto,
CA) ; Kendale; Amar; (Palo Alto, CA) ; Aklog;
Lishan; (Scottsdale, AZ) ; deGuzman; Brian;
(Paradise Valley, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Pavilion Medical Innovations, LLC |
Norwell |
MA |
US |
|
|
Assignee: |
Pavilion Medical Innovations,
LLC
Norwell
MA
|
Family ID: |
47072691 |
Appl. No.: |
14/133999 |
Filed: |
December 19, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13089722 |
Apr 19, 2011 |
8636683 |
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14133999 |
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13007344 |
Jan 14, 2011 |
8491519 |
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13089722 |
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61295012 |
Jan 14, 2010 |
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61300663 |
Feb 2, 2010 |
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61360653 |
Jul 1, 2010 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61F 2002/045 20130101;
A61F 5/0076 20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1. A gastrointestinal implant device comprising: a plurality of
struts that are interconnected to define an expandable body; a
plurality of openings situated between the struts, the openings
designed to allow food to enter into the expandable body through a
first opening and to exit from the expandable body through a second
opening; and a sleeve having an entrance that is coupled to the
expandable body, such that the entrance is in alignment with the
second opening to direct the food into the sleeve, the sleeve being
designed for placement into a small intestine and to minimize
absorption of nutrients by a wall of the small intestine.
2. The gastrointestinal implant device of claim 1, wherein the
expandable body is sufficiently elastic and capable of contracting
and expanding along with stomach peristalsis without being expelled
therefrom.
3. The gastrointestinal implant device of claim 1, wherein the
expandable body is designed to exert a pressure against a wall of
the stomach to distend the stomach and provide a feeling of satiety
upon expansion.
4. The gastrointestinal implant device of claim 1, wherein the
expandable body includes an expandable mechanism which, upon
expansion, reduces a functional volume of the stomach.
5. The gastrointestinal implant device of claim 1, wherein the
sleeve is made from a sufficiently flexible material to permit the
sleeve to move between an inverted position and an everted
position.
6. The gastrointestinal implant device of claim 1, wherein the
plurality of struts define a spherical or a partially spherical
body.
7. A gastrointestinal implant device comprising: a first anchoring
mechanism designed to be secured along a gastrointestinal tract and
within a stomach; a second anchoring mechanism spaced from the
first anchoring mechanism, the second anchoring mechanism designed
to be secured further along the gastrointestinal tract and beyond
the stomach; and a sleeve coupled to and positioned outside the
second anchoring mechanism, the sleeve designed for placement into
a small intestine and to minimize absorption of nutrients by a wall
of the small intestine, wherein a proximal portion of the sleeve
extends between the first anchor and the second anchor to couple
the anchors.
8. The gastrointestinal implant device of claim 7, wherein the
first anchoring mechanism is expandable to reduce a functional
volume of the stomach.
9. The gastrointestinal implant device of claim 7, wherein the
second anchoring mechanism is designed to be secured within a
duodenum by exerting a radial force against a wall of the
duodenum.
10. The gastrointestinal implant device of claim 9, wherein the
second anchoring mechanism is designed to expand to contact the
wall of the duodenum, so as to seal the sleeve against the wall of
the duodenum.
11. The gastrointestinal implant device of claim 7, wherein the
proximal portion is sufficiently elastic to allow the first and/or
second anchoring mechanism to exert a compressive force on a
pylorus, so as to maximize anchoring of the first and second
anchoring mechanisms adjacent the pylorus.
12. The gastrointestinal implant device of claim 7, wherein the
proximal portion of the sleeve is configured to allow rotational
movement of the second anchoring mechanism relative to the first
anchoring mechanism following implantation of the gastrointestinal
implant device, while limiting movement of the second anchoring
mechanism along the gastrointestinal track away from the first
anchoring mechanism.
13. The gastrointestinal implant device of claim 7, wherein the
sleeve is circumferentially situated about an outer surface of the
second anchoring mechanism.
14. The gastrointestinal implant device of claim 7, wherein the
sleeve is made from a sufficiently flexible material to permit the
sleeve to move between an inverted position and an everted
position, and wherein the sleeve is designed to securely extend
into the small intestine in the everted position.
15. The gastrointestinal implant device of claim 7, wherein the
second anchoring mechanism is a three dimensional array of struts
defining a spherical or a partially spherical shape.
16. The gastrointestinal implant device of claim 7, wherein the
second anchoring mechanism is configured to maintain a seal between
the sleeve and the duodenal or intestinal wall to ensure that food
from the stomach passes into the sleeve while minimizing leaking
into the small intestine.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 13/089,722, filed Apr. 19, 2011,
which is a continuation-in-part application of U.S. patent
application Ser. No. 13/007,344 filed Jan. 14, 2011, which claims
priority to and the benefit of U.S. Provisional Application No.
61/295,012 filed Jan. 14, 2010, U.S. Provisional Application No.
61/300,663 filed Feb. 2, 2010, and U.S. Provisional Application No.
61/360,653 filed Jul. 1, 2010, the disclosures of all of which
applications are incorporated herein by reference in their
entirety.
BACKGROUND
[0002] According to the Center for Disease Control (CDC), over
sixty percent of the United States population is overweight, and
almost twenty percent are obese. This translates into about 38.8
million adults in the United States with a Body Mass Index (BMI) of
30 or above. The BMI is generally defined as the weight (e.g., in
kilograms) of an individual divided by the height (e.g., in meters)
of the individual, squared. To be considered clinically, morbidly
obese, one must meet one of three criteria: BMI over 35, 100 lbs.
overweight, or 100% above ideal body weight. There is also a
category for the super-obese for those weighing over 350 lbs.
[0003] Obesity is thus an overwhelming health problem in the U.S.
Moreover, because of the enormous strain associated with carrying
this excess weight, organs are affected, as are the nervous and
circulatory systems in an individual who is overweight or obese. In
2000, the National Institute of Diabetes, Digestive and Kidney
Diseases (NIDDK) estimated that there were 280,000 deaths directly
related to obesity. The NIDDK further estimated that the direct
cost of healthcare in the US associated with obesity is $51
billion. In addition, Americans spend approximately $33 billion per
year on weight loss products. In spite of this economic cost and
consumer commitment, the prevalence of obesity continues to rise at
alarming rates. From 1991 to 2000, obesity in the US grew by about
61%. Not exclusively a US problem, worldwide obesity percentages
are also increasing dramatically.
[0004] There have been many attempts in the past to surgically
modify anatomies of a patient to address the consumption problem by
reducing the desire to eat. Stomach staplings, or gastroplasties,
in order to reduce the volumetric size of the stomach, therein
achieving faster satiety, were initially performed in the 1980's
and early 1990's. Although able to achieve early weight loss,
sustained reduction in connection with gastroplasties was not
obtained. The reasons are not all known, but are believed to be
related to several factors. One of which is that the stomach
stretches over time, thereby increasing volume, while psychological
drivers motivate patients to find creative approaches to literally
eat around the smaller pouch.
[0005] Space-occupying gastric balloons have also been used to
treat obesity since the 1980's. One such balloon is described by
Garren et al. (U.S. Pat. No. 4,899,747 Method and apparatus for
treating obesity). Gastric balloons are generally designed to
decrease the functional volume of the stomach.
[0006] Similarly, intestinal sleeves are also being used for
obesity treatment (Levine et al., U.S. Pat. No. 7,347,875 Methods
of treatment using a bariatric sleeve; Levine et al. U.S. Pat. No.
7,025,791 Bariatric sleeve). These sleeves consist of an anchoring
mechanism that attaches at one end of a thin walled plastic sleeve
and extends from the pylorus to allow the sleeve to extend past the
Ligament of Treitz. Intestinal sleeves function to decrease
absorption from the portion of bowel covered by the sleeve.
Presently, a guidewire is advanced into the patient's jejunum under
fluoroscopic guidance (Gersin K S, Keller J E, Stefanidis D, et al.
Duodenal jejuna bypass sleeve: A totally endoscopic device for the
treatment of morbid obesity. Surg Innov 2007:14;275). A gastroscope
is then used to deploy the stent-like anchor in the pylorus, and
gastroscopic instruments; e.g. graspers, are used to hold the
sheath and advance it along the intestine to the Ligament of
Treitz. However, complications often associate with delivery of
intestinal sleeves. In addition, the sleeves are difficult to
manipulate, and especially the current methods for advancing the
sleeves along the intestine are time consuming and inefficient.
[0007] In another approach, an open bariatric surgical procedure
known as the "Roux-en-Y" procedure, a small stomach pouch is
created by stapling part of the stomach together. This small pouch
can limit how much food an individual can eat. In addition, a
Y-shaped section of the small intestine is attached to the pouch to
allow food to bypass the duodenum as well as the first portion of
the jejunum. This causes reduced calorie and nutrient absorption.
Common problems associated with Roux-en-Y include pouch stretching,
where the stomach gets bigger overtime and can stretch back to its
original size over time; a breakdown of staple lines where the
staples fall apart and reverse the procedure; and a leakage of
stomach contents into the abdomen (this is dangerous because the
acid can eat away other organs. In addition, as the Roux-en-Y
procedure requires open surgery, it is a painful, time-consuming
operation and requires relatively long recovery time.
[0008] Accordingly, it would be desirable to have an effective
system for bariatric therapy, reducing the harmful side effects
such as painful surgical operations. In particular, there is a need
for effective systems and delivery mechanisms for bariatric therapy
that can minimize complications and recovery time, reduce operation
time and resources, and improve therapy efficiency, success rate,
and safety.
BRIEF DESCRIPTION OF DRAWINGS
[0009] FIGS. 1A-1B illustrate an Intestinal Sleeve Delivery system
in accordance with an embodiment of the present invention.
[0010] FIGS. 2A-2B illustrate another Intestinal Sleeve Delivery
system in accordance with an embodiment of the present
invention.
[0011] FIGS. 3A-3B illustrate an Intestinal Sleeve Delivery system
from an everted position to a deployed position in accordance with
an embodiment of the present invention.
[0012] FIG. 4 illustrates still another Intestinal Sleeve Delivery
system in accordance with an embodiment of the present
invention.
[0013] FIGS. 5A-5B illustrate a further Intestinal Sleeve Delivery
system from an everted position to a deployed position in
accordance with an embodiment of the present invention.
[0014] FIG. 6 illustrates still a further Intestinal Sleeve
Delivery system in a deployed position in accordance with an
embodiment of the present invention.
[0015] FIGS. 7-8 illustrate various stages of everting a Intestinal
Sleeve Delivery system in accordance with an embodiment of the
present invention.
[0016] FIG. 9A, FIG. 9B, FIG. 10, FIG. 11, FIG. 12A, FIG. 12B, FIG.
12C, FIG. 13A, and FIG. 13B illustrate still another Intestinal
Sleeve Delivery system in accordance with an embodiment of the
present invention.
[0017] FIG. 14 illustrates an anchoring mechanism for use in
connection with the gastrointestinal implant device in accordance
with an embodiment of the present invention.
[0018] FIG. 15A, FIG. 15B, FIG. 15C, and FIG. 16A, FIG. 16B, FIG.
16C illustrate an gastrointestinal implant device in accordance
with an embodiment of the present invention.
[0019] FIG. 17A, FIG. 17B, FIG. 17C, FIG. 17D, FIG. 17E, FIG. 18,
FIG. 19A, FIG. 19B and FIG. 19C illustrate other anchoring
mechanisms for use in connection with the gastrointestinal implant
device in accordance with an embodiment of the present
invention.
SUMMARY OF THE INVENTION
[0020] The present invention provides, in an embodiment, a
gastrointestinal implant device. The gastrointestinal implant
device can include a sleeve for placement into a small intestine
and to minimize absorption of nutrients by a wall of the small
intestine. The sleeve, in an embodiment, may be made from a
sufficiently flexible material to permit the sleeve to move between
an inverted position and an everted position. In certain
embodiments, the sleeve may be made from a material having
substantially low permeability, so as to minimize absorption of
nutrients from the digested food by the wall of the small
intestine. The gastrointestinal implant device, in an embodiment,
can also include an anchoring mechanism coupled to a proximal end
of the sleeve and designed to be secured within a stomach, so as to
allow the sleeve to securely extend into the small intestine. In
some embodiments, the anchoring mechanism is designed to reduce
functional volume of the stomach. The anchoring mechanism, in one
example, can be an inflatable balloon sufficiently large to prevent
the inflatable balloon from entry into the small intestine. To that
end, the anchoring mechanism may include a port for inflating the
anchoring mechanism. The anchoring mechanism may alternatively be a
self-expanding frame which, upon expansion, can be substantially
frustoconical in shape for securing against a wall of the stomach,
while allowing the stomach to maintain a substantially full
functional volume. The gastrointestinal implant device, in an
embodiment, can further include a passageway extending through the
anchoring mechanism and the sleeve, and along which digested food
can be directed from the stomach into the small intestine.
[0021] The present invention further provides, in another
embodiment, a bariatric therapy system. The system can include a
gastrointestinal implant device. The device, in an embodiment, can
include a sleeve for placement into a small intestine and to
minimize absorption of nutrients by a wall of the small intestine.
The device can also include an anchoring mechanism coupled to a
proximal end of the sleeve and designed to be secured within a
stomach so as to allow the sleeve to securely extend into the small
intestine. In some embodiments, the anchoring mechanism can be an
inflatable balloon designed to reduce functional volume of the
stomach upon inflation and may be designed to include a port for
inflating the anchoring mechanism. The anchoring mechanism, in
certain embodiments, can also be a self-expanding frame which, upon
expansion, can be substantially frustoconical in shape for securing
against a wall of the stomach while allowing the stomach to
maintain a substantially full functional volume. The device can
further include a passageway extending through the anchoring
mechanism and the sleeve, and along which digested food can be
directed from the stomach to the small intestine. In addition to
the device, the system can further include a delivery mechanism for
directing the device to a site of implantation. The delivery
mechanism, in an embodiment, can include a housing for
accommodating the device. The housing can be provided with a
delivery end, an opposing proximal end, and a passageway
therebetween. In certain embodiments, the housing can be
substantially tubular in shape and/or made from a sufficiently
flexible material for accommodating the device. The delivery
mechanism, in an embodiment, can also include a deploying balloon,
situated within the passageway of the housing, for accommodating
the sleeve of the device. The balloon may be provided with an open
end attached to the delivery end of the housing and a closed end
situated within the housing, such that in the presence of positive
pressure within the passageway of the housing, the balloon can be
everted from within the housing to direct the sleeve of the device
into the small intestine. A port, in an example, can be provided on
the housing through which positive pressure can be introduced into
the housing. The port, in an embodiment, can be provided with an
inflation device detachably connected thereto. In addition, a
gastroscope for guiding the system to the site of implantation can
also be provided for use in connection with the system of the
present invention.
[0022] The present invention also provides, in another embodiment,
a delivery mechanism. The delivery mechanism can include a housing.
The housing can be provided with a delivery end, an opposing
proximal end, and a passageway therebetween. The delivery
mechanism, in an embodiment, can also include a deploying balloon,
situated within the passageway of the housing, for accommodating a
sleeve of an implant device. The balloon may be provided with an
open end attached to the delivery end of the housing and a closed
end situated within the housing, such that in the presence of
positive pressure within the passageway of the housing, the balloon
can be everted from within the housing to direct the sleeve of the
device into the small intestine. In some embodiments, the housing
can be a reservoir capable of expanding to permit eversion of the
balloon from within the passageway of the housing. In certain
embodiments, the delivery mechanism can further include a port
through which positive pressure can be introduced into the
passageway of the housing to evert the balloon from within the
passageway. To that end, the delivery mechanism may further include
an inflation device detachably connected to the port and designed
to introduce positive pressure into the housing via the port to
deploy the implant device. In addition, a gastroscope for guiding
the delivery mechanism to the site of implantation can also be
provided for use in connection with the delivery mechanism of the
present invention.
[0023] The present invention additionally provides, in another
embodiment, a method for providing bariatric therapy. The method
can include everting a sleeve from an inverted position into a
small intestine. In an embodiment, positive pressure can be used to
cause eversion of the sleeve. The method can further include
anchoring the sleeve at its proximal end adjacent a pyloric
junction between stomach and mall intestine. The anchoring step, in
an embodiment, can include securing an anchoring mechanism coupled
to a proximal end of the sleeve within the stomach so as to allow
the sleeve to securely extend into the small intestine. The method,
in some embodiments, can further include allowing digested food to
be directed from the stomach through the anchoring mechanism into
the sleeve, while minimizing absorption of nutrients from the
digested food by a wall of the small intestine. In addition, to the
extend desired, the method can further include guiding the sleeve
to a site of implantation with a gastroscope.
[0024] The present invention further provides, in an embodiment,
another gastrointestinal implant device. The device includes a
plurality of struts that are interconnected to define an expandable
body. In some embodiments, the expandable body is sufficiently
elastic and capable of contracting and expanding along with stomach
peristalsis without being expelled therefrom. The expandable body
may also be designed to exert a pressure against a wall of the
stomach to distend the stomach and provide a feeling of satiety
upon expansion. In addition, the expandable body may include an
expandable mechanism which, upon expansion, reduces a functional
volume of the stomach. The device additionally includes a plurality
of openings situated between the struts, the openings designed to
allow food to enter into the expandable body through a first
opening and to exit from the expandable body through a second
opening. The device further includes a sleeve having an entrance
that is coupled to the expandable body, such that the entrance is
in alignment with the second opening to direct the food into the
sleeve. In certain embodiments, the sleeve is designed for
placement into a small intestine and to minimize absorption of
nutrients by a wall of the small intestine.
[0025] The present invention also provides, in a further
embodiment, yet another gastrointestinal implant device. The device
includes a first anchoring mechanism designed to be secured along a
gastrointestinal tract and within a stomach. The first anchoring
mechanism, in an embodiment, is expandable to reduce a functional
volume of the stomach. The device further includes a second
anchoring mechanism coupled to and spaced from the first anchoring
mechanism, the second anchoring mechanism being designed to be
secured further along the gastrointestinal tract and beyond the
stomach. In an embodiment, the second anchoring mechanism is
designed to be secured within a duodenum by exerting a radial force
against a wall of the duodenum. The second anchoring mechanism may
be coupled to the first anchoring mechanism via a tethering
mechanism. For example, the tethering mechanism may be a proximal
portion of the sleeve, or one or more tethers. The tethering
mechanism, in an embodiment, may be sufficiently elastic to allow
the first and/or second anchoring mechanism to exert a compressive
force on a pylorus, so as to maximize anchoring of the first and
second anchoring mechanisms adjacent the pylorus. The device
additionally includes a sleeve coupled to and positioned outside
the second anchoring mechanism, the sleeve being designed for
placement into a small intestine and to minimize absorption of
nutrients by a wall of the small intestine. In an embodiment, the
sleeve is circumferentially situated about an outer surface of the
second anchoring mechanism. In some embodiments, the second
anchoring mechanism may be designed to expand to contact the wall
of the duodenum, so as to seal the sleeve against the wall of the
duodenum.
[0026] The present invention additionally provides, in an
embodiment, another method for providing bariatric therapy. The
method includes first securing a first anchoring mechanism along a
gastrointestinal tract and within a stomach. In an embodiment, the
securing step includes expanding the first anchoring mechanism to
contact a wall of the stomach. The method also includes positioning
a second anchoring mechanism further along the gastrointestinal
tract and beyond the stomach, the second anchoring mechanism being
coupled to and spaced from the first anchoring mechanism. The
positioning step, in an embodiment, includes expanding the second
anchoring mechanism within a duodenum so as to contact a wall of
the duodenum. The method further includes placing a sleeve about an
outer surface of the second anchoring mechanism to permit the
sleeve to extend into a small intestine, and to minimize absorption
of nutrients by a wall of the small intestine. The placing step
may, for example, include situating the sleeve circumferentially
about the outer surface of the second anchoring mechanism. In an
embodiment, the placing step includes everting the sleeve from an
inverted position and allowing the sleeve to extend into the small
intestine. The sleeve may be sealed against the wall of the
duodenum, for example, by act of the second anchoring
mechanism.
DESCRIPTION OF SPECIFIC EMBODIMENTS
[0027] In accordance with one embodiment of the present invention,
a system is provided herein for bariatric therapy. One system, as
described hereinafter, may be used to employ volume restriction
within the stomach and/or enhance malabsorption within the small
intestine. Such a system of the present invention includes, in one
embodiment, a gastrointestinal implant device having an anchoring
mechanism designed to be positioned within the stomach to anchor
the device, and an intestinal sleeve attached at one end to the
anchoring mechanism. The sleeve can be designed to extend along a
portion of the small intestine to minimize or prevent nutrient
absorption by the small intestine. In one embodiment, the anchoring
mechanism may be a space occupying ring, an inflatable balloon, a
self-expanding anchor or frame, or any combination thereof. As will
be seen hereinafter, the system can also include a delivery
mechanism for delivering or placing the device at a site of
implantation.
[0028] Generally, food to be digested enters the stomach through
the cardiac orifice from the esophagus. Once in the stomach, food
is at least partially digested to produce chyme, a semi-fluid
substance that can be homogeneous, creamy or gruel-like. Once
produced, the chyme can then exit the stomach through the pylorus
or pyloric junction and enter the small intestine. The pylorus is a
distal aperture of the stomach surrounded by a strong band of
circular muscle. The small intestine, about nine feet in length, is
a convoluted tube, extending from the pylorus to the ileo-caecal
valve where it terminates in the large intestine. The small
intestine has three sections including the duodenum, jejunum and
the ileum.
[0029] The duodenum has four sections including the superior,
descending, transverse and ascending sections which typically form
a U-shape. The superior section is about two inches long and ends
at the neck of the gall bladder. The descending section is about
three to four inches long and includes a nipple shaped structure
(papilla of vater) through which pancreatic juice from the pancreas
and bile produced by the liver and stored by the gall bladder can
enter the duodenum from the pancreatic duct. The pancreatic juice
typically contains enzymes essential to protein digestion and bile
that can be used to dissolve the products of fat digestion. The
ascending section, on the other hand, is about two inches long and
forms the duodenal-jejunal flexure where it joins the jejunum, the
next section of the small intestine. The duodenal-jejunal flexure
is fixed to the ligament of Treitz (musculus supensionus duodeni).
The juices secreted in the duodenum can break the partially
digested food down into particles small enough to be absorbed by
the body.
[0030] Referring now to FIG. 1A, a system 100 for providing
bariatric therapy according to one embodiment of the present
invention is shown. System 100 may include a gastrointestinal
implant device 105 for facilitating weight loss. In one embodiment,
the device 105 can be used to reduce the size of the stomach while
simultaneously reducing absorption of food nutrients within the
small intestine. In accordance to an embodiment of the present
invention, the device 105 may include an intestinal sleeve 130
designed to extend from within the stomach and along a portion of
the intestine below the pylorus, to minimize absorption of
nutrients by the intestinal walls.
[0031] As illustrated, the sleeve 130 may include a proximal end
132 that may be designed for placement adjacent the pyloric
junction, an area around the pylorus where the stomach and the
small intestine meet. The sleeve 130 may further include a
passageway 136 extending from the proximal end 132 to allow passage
of food and other food material through sleeve 130. As used herein,
"food" or "other food material" can be used interchangeably; "food"
can also include undigested, partially digested, and completely
digested food. The sleeve 130 may further include a distal end 134.
The distal end 134, in an embodiment, can be open-ended to provide
an opening through which food and other food material can exit
sleeve 130.
[0032] The sleeve 130, in an embodiment, can be designed to reduce
absorption and digestion of food by the intestinal walls. In
particular, sleeve 130 can line and cover the intestinal wall, and
act to reduce absorption and digestion of food by delaying the
mixing of food with bile and pancreatic juices until after the food
exits the distal end 134 of sleeve 130. In other words, by
preventing the mixing of bile and pancreatic juices with food in
the duodenum, digested (partially or completely) food material is
not broken down into particles small enough to be absorbed by the
body. As a result, the absorption of nutrients (e.g., fats and
carbohydrates) is reduced.
[0033] To that end, the sleeve 130 can be made from any material
that can aid in the passage of food through the sleeve 130. In one
embodiment, the sleeve 130 can be made from a material that
minimizes resistance and friction so as to allow food to slide more
easily through the sleeve. For instance, the sleeve 130 can be made
from a material that is substantially smooth and/or has a
relatively low coefficient of friction. The sleeve 130 material may
further have substantially low permeability to fluids to minimize
the occurrence of digested food leaking through the sleeve 130 and
coming into contact with the intestinal wall where it can be
absorbed. The sleeve 130 can also be made from any material that
helps to minimize or prevent tissue in-growth, as well as a
material that can be non-irritating to the bowel, so as to aid in
the removal of the sleeve 130, once removal is desired. Since the
sleeve 130 can be designed to be implanted within an intestine of a
human or animal body, the sleeve 130 should also be made from a
material that is biocompatible. The biocompatibility of the
material may help minimize occurrence of adverse reactions due to
constant contact of the sleeve 130 with the gastrointestinal tract.
In an embodiment, the sleeve 130 can be made from any material that
can be obtained commercially.
[0034] Should it be desired, sleeve 130 may further include a
coating that can aid in reducing absorption of nutrients, minimize
resistance to provide a smooth passageway for food, minimizing
porosity, preventing tissue in-growth, allowing subsequent removal
of the device from the intestinal tract, or any other
characteristic that may be desirable for the sleeve 130. The
coating may be applied to the sleeve 130 on an inner surface, an
outer surface, or a combination thereof to minimize any porous
characteristics of the sleeve material.
[0035] In one embodiment, the sleeve 130 can also be made from any
material that allows the sleeve 130 to expand and collapse in
accordance with the digestive process. When food enters and passes
through the sleeve 130, the sleeve material can be such that it may
allow the sleeve 130 to expand sufficiently to accommodate the
digested food. Once the food from the stomach has passed through
the sleeve 130, however, the sleeve material can be such that is
may allow the sleeve 130 to become flexible or floppy, permitting
the sleeve 130 to contour toward one side of the intestine. In this
floppy state, the sleeve 130 may permit the pancreatic juice to
flow with minimal resistance into the duodenum through the papilla
of vater. Of course, in some instances, it may be desirable for the
sleeve 130 to maintain a substantially constant form throughout the
digestive process. In these instances, the sleeve 130 may be made
from a material that can maintain such a substantially constant
form.
[0036] The length of the sleeve 130 may, in an embodiment, vary
depending on a variety of characteristics. In certain instances,
the length of the sleeve 130 may be dependent on the patient's Body
Mass Index (BMI). In other instances, the length of the sleeve 130
may be selected based on the amount of absorption desired. A longer
sleeve 130, for example, may minimize absorption of nutrients by
the intestinal walls over a longer distance than a shorter sleeve
130. In some instances, the length of the sleeve 130 may be
selected based on the distance necessary to bypass the duodenum and
allow the sleeve 130 to couple with the jejunum. It should be noted
that the length of the sleeve 130 should also permit the sleeve 130
to fit within the delivery mechanism 115 as well as within the
intestine.
[0037] The sleeve 130 may have any shape desirable, so long as the
shape allows the sleeve 130 to fit within the intestine. In one
embodiment, the sleeve 130 may have a substantially tubular shape
to allow the sleeve 130 to substantially conform to the intestine.
Of course, other geometric shapes may be possible.
[0038] The sleeve 130 may further have any diameter desirable so
long as the diameter allows food to travel through the sleeve 130
without substantial hindrance. In one embodiment, the sleeve 130
may have a diameter to allow the sleeve 130 to substantially
conform to the intestinal walls when in an expanded state. By
substantially conforming to the intestinal walls in an expanded
state, the sleeve 130 can maximize the amount of food traveling
through. Of course, smaller diameters may also be possible.
[0039] The gastrointestinal implant device 105 may further include,
in accordance with an embodiment of the present invention, an
anchoring mechanism 140, coupled to the proximal end 132 of the
sleeve 130. The anchoring mechanism 140 may be designed to be
positioned, in certain instances, in the stomach to anchor the
device 105 thereat. In an embodiment, the anchoring mechanism 140
can be an anchor that acts to reduce the functional volume of the
stomach. An example of such an anchoring mechanism 140 can be a
space occupying inflatable ring or balloon, or any other anchoring
mechanism 140 adapted to adequately engage and secure the proximal
end 132 of the sleeve 130 at the pyloric junction, while reducing
the volume of the stomach. In an embodiment, the anchoring
mechanism 140 can be integral with the sleeve 130 at the proximal
end 132, so that the anchoring mechanism 140 and sleeve 130 are
formed from one piece of material. Alternatively, the anchoring
mechanism 140 can be separate and independent from the sleeve so
that the anchoring mechanism and sleeve 130 are formed from two
pieces of material and are coupled to one another.
[0040] FIG. 1B shows the gastrointestinal implant device 105 in a
deployed position. In particular, the anchoring mechanism 140 is
positioned at a point within the stomach 145 just above the pylorus
149. The proximal end 134 of the sleeve 130, on the other hand, can
extend from the anchoring mechanism 140 within the stomach 145,
across the pylorus 149, and into the small intestine 147. It should
be appreciated that anchoring mechanism 140 can also extend into
the pylorus 149 and proximal end 134 of the sleeve 130 can be
situated adjacent the pylorus 149. A passageway 150, in an
embodiment, can extend through the anchoring mechanism 140 and the
sleeve 130, so that food can be directed from the stomach 145, into
the device 105 and moved along the passageway 150, and into the
small intestine 147.
[0041] As noted, the anchoring mechanism 140 can be designed, in
certain instances, to facilitate weight loss by reducing the
functional volume of the stomach 145. In other words, by occupying
a portion of the stomach 145, the anchoring mechanism 140 can act
to decrease the functional volume of the stomach 145, and thus, the
amount of food intake by the patient. To that end, The anchoring
mechanism 140, in an embodiment, may have any size desirable,
depending on the particular application, as the size of the
anchoring mechanism 140 may affect the functional volume by which
the stomach 145 is reduced. For instance, a larger anchoring
mechanism 140 may occupy a larger space within the stomach and may,
accordingly, reduce the functional volume of the stomach by a
larger amount than a smaller anchoring mechanism. It should be
noted that the size of the anchoring mechanism 140 needs to permit
the anchoring mechanism 140 to be securely positioned within the
stomach at a site of implantation. That is, the anchoring mechanism
140 can be sufficiently large to prevent it from entry into the
small intestine.
[0042] The anchoring mechanism 140, as illustrated in FIGS. 1A-1B,
may have a donut shape. A donut shape may allow the anchoring
mechanism 140 to be positioned within the stomach, such that the
anchoring mechanism 140 can substantially conform to the shape of
the stomach and may, simultaneously, provide an exit for food to
leave the stomach. Of course, other shapes for the anchoring
mechanism 140 may be possible.
[0043] To adequately secure the anchoring mechanism 140 within the
stomach, the anchoring mechanism 140 can be made from a material
that can radially expand to exert a sufficient radial force to push
the anchoring mechanism 140 against the walls of the stomach at the
site of implantation. It should be appreciated that the material
used should permit the anchoring mechanism 140 to conform to the
dimensions of the stomach at the implantation site, even when the
dimensions of the stomach vary. In one embodiment, an
anti-inflammatory agent such as dexamethasone, prednisolone,
corticosterone, budesonide, estrogen, sulfasalazine, mesalamine, or
any suitable combination or mixture thereof may be applied to the
anchoring mechanism 140 to prevent inflammation or any other
adverse reaction caused by the engagement of the anchoring
mechanism 140 within the stomach.
[0044] In accordance with one embodiment, as illustrated in FIGS.
1A-1B, the anchoring mechanism 140 may be provided with a port or
valve 142 to which an inflation mechanism may be detachably
connected for inflation purposes. To that end, the valve can be a
one-way valve designed to prevent premature and unintentional
deflation and removal of the device 105 from the intestinal tract.
The one-way valve may be an elastomeric plug, a spring loaded
valve, or any other valve known in the art as the present invention
is not intended to be limited in this manner.
[0045] An inflation mechanism (not shown) for inflating the
anchoring mechanism 140 can include, for instance, an inflation
catheter or any other inflation device capable of inflating the
anchoring mechanism 140. As the inflation mechanism can be
detachably coupled to port or valve 142 of the anchoring mechanism
140, the inflation mechanism can be disconnected and detached from
the port or valve 142 of anchoring mechanism 140 following
inflation. It should be appreciated that the anchoring mechanism
140 can be deflated when removal of the device 105 is desired.
[0046] Connection of the inflation mechanism to port or valve 142
of the anchoring mechanism 140 may occur, in certain embodiments,
through the use of a connector (not shown). The connector can act
to couple the inflation mechanism to the anchoring mechanism 140
allowing the inflation mechanism to inflate the anchoring mechanism
140. In an embodiment, the connector may be situated on either the
inflation mechanism or the anchoring mechanism 140. Alternatively,
the connector may include a two-piece design having two
complimentary pieces to permit coupling between the inflation
mechanism and the anchoring mechanism 140. Examples of connectors
include a mating luer connector, a metal tube, or any other
connectors known in the art.
[0047] Although an inflation mechanism is described herein, it
should be appreciated that the anchoring mechanism 140 can be
self-expanding to allow expansion of anchoring mechanism 140
without the aid of additional inflation mechanisms. Such
self-expanding mechanism, similar to a life vest, are known in the
art.
[0048] Still referring to FIG. 1A, system 100 for providing
bariatric therapy may further include, in an embodiment, a delivery
mechanism 115 for delivering the gastrointestinal implant device
105 to a site of implantation. In an embodiment, the delivery
mechanism 115 can include a housing 110 having a delivery end 112,
an opposing end 114, and a passageway 116 therebetween. In one
embodiment, the delivery end 112 can be designed to permit sleeve
130 of device 105 to be inserted (e.g., in an inverted position)
into delivery mechanism 115. In addition, the delivery end 112 may
be sufficiently sized to permit anchoring mechanism 140 to be
securely positioned about delivery end 112.
[0049] In one embodiment, the housing 110 can be made from any
material capable of passing through the intestine and delivering
device 105 to a site of implantation. To that end, housing 110 may
be formed from a substantially hard material, so as to minimize
deformation of the housing 110 during delivery. Examples of
materials that are substantially hard include metals, plastics,
ceramics, or any other materials that can maintain a substantially
consistent shape. Housing 110 can also be made from a sufficiently
flexible material to permit compression of the housing 110. For
example, housing 110 may be formed from a thin-walled membrane such
as nylon laminated with polyurethane.
[0050] Since the housing 110 is designed to be inserted into an
intestine of a human or animal body, the housing 110, in an
embodiment, can be made from a material that is biocompatible. The
biocompatibility of the material may help minimize occurrence of
adverse reactions due to use of the housing 110 within an
intestine. The housing 110 may further include a coating on an
outer surface to reduce friction between the housing 110 and the
intestinal wall upon insertion into the intestine. Likewise, the
housing 110 may include a coating on an inner surface to reduce
friction during deployment of the sleeve 130 situated within the
housing 110.
[0051] It should be appreciated that the housing 110 may be
provided with any shape desirable, depending on the particular
application, as the shape of the housing 110 may affect ability of
the housing 110 to deliver the device 105 to a site for
implantation. For instance, housing 110 may be tubular in shape.
Housing 110, in other embodiments, may be triangular in shape. Of
course, other shapes can be used as the present invention is not
intended to be limited in this manner.
[0052] The delivery mechanism 115, as shown in FIG. 1A, can also
include a deploying balloon 120 for use in advancing the sleeve 130
of device 105 from within housing 110 to the site of implantation
(e.g., stomach and/or small intestine). The deploying balloon 120,
in an embodiment, may include an open end 122 and a closed end 124,
and may be provided with a length sufficient to accommodate sleeve
130. In an embodiment, open end 122 of deploying balloon 120 can be
provided with a tight fitting seal with the delivery end 112 of
housing 110. By providing such a seal at the delivery end 112 of
housing 110 and by providing the deploying balloon 120 with closed
end 124, positive pressure can be introduced into the housing 110
to evert the deploying balloon 120 from within the housing 110, and
to aid in deployment of the sleeve 130 from the deploying balloon
120. Of course, deploying balloon 120 and housing 110 can be
integral to each other (e.g., as a one-piece design) where
additional seal may not be necessary to keep positive pressure in
the housing 110.
[0053] To deploy device 105 to a site of implantation, deploying
balloon 120 can be made from a material capable of withstanding a
sufficient force, so as to permit eversion of the deploying balloon
120, and thus advancement of the sleeve 130 from within the housing
110. In an embodiment, the deploying balloon 120 may be made from a
thin-walled membrane. For example, the deploying balloon 120 may be
made from nylon laminated with polyurethane or any similar
materials. In an embodiment, the deploying balloon 120 may have a
thickness ranging from about 0.05 mm to about 0.09 mm. In an
embodiment, the thickness of the deploying balloon 120 may be about
0.076 mm or 0.003 inches. The material of the deploying balloon 120
may also be impermeable to fluids in order to allow the deploying
balloon 120 to withstand sufficient positive pressure. Since the
deploying balloon 120 is designed to be inserted within an
intestine of a human or animal body, the deploying balloon 120 can
be made from a material that is biocompatible. The biocompatibility
of the material may help minimize occurrence of adverse reactions
due to use of the deploying balloon 120 within an intestine.
[0054] As shown in FIGS. 2A-2B, the housing 110 and the deploying
balloon 120 can be integral with one another (FIG. 2A) or may be
provided as two separated components (FIG. 2B). In the embodiment
where housing 110 and deploying balloon 120 can be integral with
one another, housing 110 and deploying balloon 120 can be made of
the same material, e.g., a continuous sheet of the same
sufficiently flexible material. This way, no attachment or
connection mechanism is required for connecting housing 110 and
deploying balloon 120. Suitable materials include without
limitation, plastics, rubber, polymers, resin, cloth, and so on.
Alternatively, in the embodiment where housing 110 and deploying
balloon 120 can be two separate components, housing 110 and
deploying balloon 120 can be made of different materials. For
example, housing 110 can be made of a sufficiently rigid material,
while the deploying balloon 120 being made of a sufficiently
flexible material. Of course, the same material can be used for
both the housing 110 and the deploying balloon 120. Suitable
attachment or connection mechanism known in the art may also be
provided, to the extent desired, so as to connect housing 110 and
deploying balloon 120.
[0055] As shown in FIG. 2A, the housing 110 can have a diameter
substantially smaller than that of the deploying balloon 120. In
one example, the diameter of the housing 110 can be about half of
the deploying balloon 120 while still able to accommodate the
deploying balloon 120. In other examples (e.g., FIG. 2B), the
housing 110 can have a diameter that is larger than that of the
deploying balloon 120. It should be noted that FIGS. 2A-2B
illustrate the deploying balloon 120 in its everted or deployed
position, and that before eversion or deployment, the deploying
balloon 120 can be inverted for placement within the housing 110.
Of course, the diameter of the housing 110 and deploying balloon
120 may remain substantially constant throughout.
[0056] It should be appreciated that regardless of the size of the
housing 110 relative to that of the deploying balloon 120, the
diameter of each should be sufficient to accommodate the sleeve
130. It should be appreciated that the length of the housing 110
should permit the delivery mechanism 115 to be inserted into an
intestine and advanced along the intestine to a site for
implantation.
[0057] The housing 110, in an embodiment, may have any shape
desirable, depending on the particular application, as the shape of
housing 110 can facilitate delivery of the device 105 to a site for
implantation. For instance, housing 110 may be tubular in shape. Of
course, other shapes can be used as the present invention is not
intended to be limited in this manner.
[0058] In accordance with one embodiment, the delivery mechanism
115 can further include an inflation mechanism (such as inflation
device 250 shown in FIG. 4) for introducing positive pressure into
the housing 110, so as to cause eversion of the deploying balloon
120 from within the housing 110. Suitable inflation mechanism can
include, for instance, an inflation catheter, a pump, or any other
inflation device capable of introducing positive pressure the
housing 110. As the inflation mechanism can be detachably coupled
to the housing 110, the inflation mechanism can be disconnected and
detached from the housing 110 following inflation. Connection of
the inflation mechanism to the housing 110 may be achieved using
any method known in the art.
[0059] In order to introduce positive pressure into housing 110
through the use of an inflatable mechanism, the system 100 of the
present invention may be provided with an inflation port 170 in the
housing 110 through which fluids (e.g., air, liquids, gas or other
substances) can enter with sufficient positive pressure to evert
deploying balloon 120 and subsequently deploy the gastrointestinal
implant device 105. In one embodiment, inflation port 170 can be
situated at end 114 of housing 110. Of course, other locations for
the inflation port 170 may be possible, as long as fluids can enter
with a sufficient force to deploy the device 105.
[0060] Now referring to FIGS. 3A-3B, the system 100 of the present
invention can be used in connection with a gastroscope 160, 160'.
The gastroscope 160, 160' may help guide the system 100 through the
gastrointestinal tract. In an embodiment, the gastroscope 160 in
FIG. 3A may be provided with a body designed to be situated about
or adjacent the housing 110. The gastroscope 160 may also be
provided with tip 162 to be positioned against a surface of the
anchoring mechanism 140. In such an embodiment, the anchoring
mechanism 140 may be constructed of transparent material to allow
visualization out the end of the gastroscope 160 as shown in FIG.
3A. No X-ray exposure or any other mechanism may be needed to help
deploy the gastrointestinal implant device 105 of the present
invention. Should it be desired, delivery mechanism 115 and device
105 may include an opaque substance to permit visualization by a
user during implantation.
[0061] In certain embodiments, the system 100 of the present
invention may be designed to allow a gastroscope 160' to help guide
the system 100 through the intestinal tract. As shown in FIG. 3B,
gastroscope 160' may be used with the deploying balloon 120' and
sleeve 130' in their everted or deployed position to help guide the
sleeve 130' to its desired location (e.g., to further extend along
the small intestine). The gastroscope 160', as shown, may be
positioned through the housing 110 and beyond and designed to
maintain the stability of the system 100 as the system 100 is
advanced along the gastrointestinal tract. It should be noted that
while the gastroscope 160 can be positioned in any manner to allow
guidance of the system 100, its design should minimize any
obstructions of the deploying balloon 120 and sleeve 130 from
everting. In an embodiment, the gastroscope 160 may be any
guidewire that is commercially available.
[0062] Looking now at FIGS. 4-6, there are illustrated alternative
system of the present invention. As illustrated, system 200 can be
used to provide bariatric therapy. System 200, in an embodiment,
can include a delivery mechanism 215 and an implant device 205. In
accordance with the embodiments shown in FIGS. 4-6, delivery
mechanism 215 may be substantially similar to the delivery
mechanism 115 described above, but the housing 110 delivery
mechanism 215 may be a reservoir 210 for use in connection with the
deployment of the device 205. Such a housing 210 can allow the
delivery mechanism 215 to reside in different organs, such as the
stomach in a patient, in addition to being inserted into the
intestine. The delivery mechanism 215, in accordance with one
embodiment, may include a reservoir 210 for use in connection with
implantation of device 205. In one embodiment, the reservoir 210
may serve substantially the same functions as housing 110 in that
the reservoir 210 can be used to accommodate at least a part of the
device 205 and deliver the device 205 to a site for implantation.
Reservoir 210, if desired, may be designed to accommodate sleeve
230 in reservoir 210 and may be designed to facilitate eversion of
sleeve 230.
[0063] In an embodiment, the reservoir 210 can be made from a
material that can be sufficiently strong to allow the reservoir 210
to be directed within the body of a patient without rupturing. The
material, in an embodiment, can also be sufficiently flexible to
allow the reservoir 210 to expand and collapse during deployment of
the device 205.
[0064] The reservoir 210 may have any shape, as long as the shape
can fit within the intestine or esophagus for delivery. In an
embodiment, the reservoir 210 can be substantially circular in
shape and can be expanded to any shape desired. In another
embodiment, the reservoir 210 can be tubular in shape. Of course,
other shapes are possible. The reservoir 210, in another
embodiment, may have a size and/or length sufficient to accommodate
balloon 220 and/or sleeve 230. As shown in FIG. 5A, the size and/or
length of the reservoir 210 may be such that it may accommodate
balloon 220 and/or sleeve 230 in a folded or rolled up manner.
[0065] The reservoir 210 may also be provided with any size
desirable, as the size the reservoir 210 may facilitate delivery of
device 205 and sleeve 230. For example, a smaller sized reservoir
210 may be used to deliver device 205 through an individual's
esophagus, while a larger one may not be able to fit through an
esophagus.
[0066] The delivery mechanism 215, in an embodiment, may further
include a deploying balloon 220, similar to deploying balloon 120,
for use in placement of the device 205 at the site of implantation
within the gastrointestinal tract. It should be noted that the
length and shape of the deploying balloon 220 should be such that
the balloon 220 can fit (e.g., in a folded or rolled up manner), at
least partially within the reservoir 210. In an embodiment, the
balloon 220 can be attached to or positioned about an end of the
reservoir 210 at its open end 222.
[0067] A sleeve 230 may be stored (e.g., in an inverted state)
within deploying balloon 220 similar to the manner in which the
sleeve 130 can be stored within deploying balloon 120 and housing
110, as described above. In an embodiment, the sleeve 230 may be
stored in a folded state such as shown in FIG. 5A or may be stored
in a rolled up state. Of course, the sleeve 230 may be stored in
other manners so long as it fits, at least partially within the
reservoir 210. An anchoring mechanism 240 for anchoring and
securing device 205 to a site of implantation, similar to the one
described above, may be situated at the proximal end 232 of sleeve
230, as shown in FIG. 4.
[0068] To deploy the gastrointestinal implant device 205, an
inflation device 250 may be connected to the reservoir 210. The
inflation device 250, in an embodiment, may be designed so as to
permit insertion of the gastrointestinal implant device 205 through
the esophagus of a patient. In an embodiment, the inflation device
250 can be sufficiently thin and narrow. A seal 280, can be
provided at the end of the inflation device 250, as desired, to
minimize leakage of fluid being introduced by inflation device
250.
[0069] FIGS. 5A, 5B, and 6 show the use of a gastroscope 260 to
help guide the system 200 through the intestinal tract to a site of
interest. The gastroscope 260, as shown in FIG. 5A, can be
positioned through the inflation device 250 and the reservoir 210.
In another embodiment shown in FIG. 6, gastroscope 260' can extend
to reservoir 210 without going through the inflation device 250. It
should be noted that FIGS. 5B and 6 show the system 200' in a fully
deployed state, with the deploying balloon 220' and sleeve 230' in
their everted position.
[0070] To prepare the system 100 for insertion in the body, a user
can initially position a deploying balloon 120 within housing 110
of delivery mechanism 115. In one embodiment, the open end 122 of
the deploying balloon 120 can be situated adjacent or attached to
the delivery end 112 of the housing 110, and the closed end 124 of
the deploying balloon 120 can be situated adjacent the opposing end
114 of the housing 110. An open ended sleeve 130 may then be placed
within cavity 126 of deploying balloon 120 with the open ended
distal end 134 of the sleeve 130 situated adjacent the closed end
124 of the deploying balloon 120, while the proximal end 132 of the
sleeve 130 situated adjacent the open end 122 of the deploying
balloon 120. Additionally, anchoring mechanism 140, being coupled
to the proximal end 132 of the sleeve 130, can be positioned about
the delivery end 112 of the housing 110.
[0071] Once loaded, the system 100 may be inserted into the body,
and advanced along the intestine within the body to a site of
interest for implantation. A gastroscope 160 may be used to help
guide the system 100 through the intestinal tract to a site of
implantation. In an embodiment, a guidewire (not shown) may be used
to maintain the stability of the system 100 as the system 100
advances through the tract. Once at the site of implantation, the
system 100 can be prepared for deploying the device 105.
Implantation may first require the anchoring mechanism 140,
attached to the proximal end 132 of the sleeve 130, to be inflated
using an inflation mechanism. Inflation of the anchoring mechanism
140 can act to hold the gastrointestinal implant device 105 in a
desired position during the eversion process. For example, the
anchoring mechanism 140 can be placed within the stomach or in the
small intestine adjacent the pyloric junction. After the anchoring
mechanism 140 is anchored at the site of interest, the sleeve 130
may be everted. Eversion may require the direction of pressurized
or unpressurized fluid (e.g., gas, liquid, or a combination
thereof) into housing 110 via inflation port 170. As fluid is
directed into housing 110, the fluid acts to evert and advance
deploying balloon 120 from within housing 110, while pushing sleeve
130 from housing 110 along with deploying balloon 120, as shown in
FIG. 3B. In some embodiments, the sleeve 130 is a shorter length
than the deploying balloon 120, which can allow complete delivery
of the sleeve 130 upon full eversion of deploying balloon 120.
[0072] FIG. 7-8 show the deploying balloon 120 and sleeve 130 of
the system 100 in partial eversion and subsequent deployment upon
full eversion. In FIG. 7, gastrointestinal implant device 105' is
in the process of being everted from within the passageway 116 of
the housing 110, where everting deploying balloon 120' pushes and
everts the sleeve 130' from therewithin. The everting deploying
balloon 120', thereafter, can distend the intestine as it is
deploying the everting sleeve 130', and can automatically follow
the course of the bowel. FIG. 8 shows the implant device 105'' in a
fully deployed state, with everted deploying balloon 120''
extending beyond the everted sleeve 130''. With the
gastrointestinal implant device 105'' deployed and engaged within
the intestinal wall, food and other food material can be passed
from the stomach through the everted sleeve 130''.
[0073] In accordance with the embodiments depicted in FIGS. 4-6,
the method of deploying device 205 using a reservoir 210 may be
substantially similar to the method described above with several
changes to reflect the use of a reservoir 210. Once loaded into the
reservoir 210, system 200 may be inserted into the body, and
advanced along the intestine within the body to a site of
implantation. A gastroscope 260 may be used to guide the system 200
through the gastrointestinal tract. Implantation may first require
the anchoring mechanism 240, attached to the proximal end 232 of
the sleeve 230, to be inflated using an inflation mechanism. After
the anchoring mechanism 240 is anchored to the stomach or small
intestine at the site of implantation, the device 205 may be
everted. Eversion may require activation of the inflation device
250, which can result in the reservoir 210 being inflated, as shown
in FIG. 5A. Inflation of the reservoir 210 can cause the reservoir
210 to enlarge and/or become pressurized, allowing the balloon 220
to evert and deploy the device 205. FIGS. 5B and 6 show embodiments
of the system 200 in a fully deployed state. In an embodiment, the
reservoir 210 can provide a low friction compartment for everting
the balloon 220 and sleeve 230.
[0074] Following deployment of the sleeve 130, the deploying
balloon 120 can be deflated and a vacuum can be drawn to constrict
the deploying balloon 120. Constriction of the deploying balloon
120 can allow the deploying balloon 120 to be pulled out of the
sleeve 130, leaving the sleeve 130 in position within the
intestine. Since the diameter of the deploying balloon 120 can be
less than the diameter of the sleeve 130, deploying balloon 120
withdrawal is performed upon deflation and formation of a vacuum in
the deploying balloon 120. As previously stated, a coating or
lubrication may be placed between the sleeve 130 and the deploying
balloon 120 during manufacture, to ensure easy deploying balloon
120 removal.
[0075] With reference now to FIG. 9A, FIG. 9B, FIG. 10, FIG. 11,
FIG. 12A, FIG. 12B, FIG. 12C, FIG. 13A, and FIG. 13B, there are
illustrated another bariatric therapy system 300 in accordance with
an embodiment of the present invention. System 300, in an
embodiment, can include a delivery mechanism 315 and an implant
device 305. As shown in FIG. 9A, FIG. 9B, FIG. 10, FIG. 11, FIG.
12A, FIG. 12B, FIG. 12C, FIG. 13A, and FIG. 13B, the delivery
mechanism 315 may be substantially similar to the delivery
mechanism 115, 215 described above, but no separate housing may be
necessary to deploy the device 305. The delivery mechanism 315, in
an embodiment, may include a deploying balloon 320, similar to
deploying balloon 120 and housing 110 in the embodiments described
above, for use in the placement of device 305 at the site of
implantation within the gastrointestinal tract. It should be noted
that the length and shape of the deploying balloon 320 should be
such that the balloon 320 can fit within the intestinal track. In
an embodiment, the deploying balloon 320 may be formed from a
continuous piece of material as shown in FIG. 9A. The deploying
balloon 320 may also be formed from a soft and flexible material
such that upon inflation of the balloon 320, the pressure therein
can allow the device 305 to be advanced through the intestinal
track. The material from which deploying balloon 320 can be made
can also be inelastic to withstand a sufficient pressure for
deploying the device 305. In an embodiment, the deploying balloon
320 may be formed from a single thin-walled membrane. For example,
the deploying balloon 320 may be made from nylon laminated with
polyurethane. In an embodiment, the deploying balloon 320 may have
a thickness ranging from about 0.05 mm to about 0.09 mm. In an
embodiment, the thickness of the deploying balloon 320 may be about
0.076 mm or 0.003 inches.
[0076] Referring still to FIG. 9A, the delivery mechanism 315, in
an embodiment, may further include a sleeve 330 that may be
positioned within deploying balloon 320, similar to the manner in
which the sleeve 230 can be stored within deploying balloon 220, as
described above. The sleeve 330, in one embodiment, may be formed
from a membrane that can be less thick than the thickness of the
membrane used to form the deploying balloon 320. In an example, the
sleeve 330 may be approximately 0.025 mm (0.001'') in thickness.
The materials from which sleeve 330 may be formed includes without
limitation, polyethylene, polyvinyl chloride, nylon, polyethylene
terephthalate, or other polymer. The relative thickness of the
intestinal sleeve 330 compared to the deploying balloon 320 can be
important, as such thickness can provide less friction during
eversion of the sleeve 330 and the deploying balloon 320. In one
example, when a sleeve material has a thickness less than the
thickness of the balloon material, air eversion may be possible and
the everting structure may be sufficiently soft to advance through
tortuous bowel. In one embodiment, a sleeve material can have a
thickness that is about one-third of the thickness of the balloon
material. In other examples, when a sleeve material has a
substantially similar thickness to that of the balloon material,
friction between the membrane layers may cause inflation pressure
to rise to a sufficiently high level, such that an incompressible
fluid (water or saline) may be required to deploy the sleeve 330.
This may, in turn, cause increased rigidity of the everting closed
ended balloon 320.
[0077] The device 305 may further include an anchoring mechanism
340 for anchoring and securing device 305 to a site of
implantation. In an embodiment, anchoring mechanism 340 may be
situated at proximal end 332 of sleeve 330. Anchoring mechanism 340
may be designed to be self-expanding and/or with a minimal profile
so that when it is positioned within the stomach, the anchoring
mechanism 340 can allow the stomach to retain substantially its
full functional volume. In accordance with the embodiments shown in
FIG. 9A, FIG. 9B, FIG. 10, FIG. 11, FIG. 12A, FIG. 12B, FIG. 12C,
FIG. 13A, and FIG. 13B, the anchoring mechanism 340 may be a
self-expanding anchor or frame, for securing against the stomach
wall. The anchoring mechanism 340, as shown in FIG. 10, may be a
thin structure that can be designed to expand immediately proximal
to the pylorus, and remains in the stomach, to allow the intestinal
sleeve 330 to extend into the small intestine (e.g., into the
duodenum and jejunum). The proximal end 332 of sleeve 330, in some
embodiments, may be situated within the stomach just above the
pylorus.
[0078] The anchoring mechanism 340, in one embodiment, may be
constructed of spring metal, such as stainless steel, or it may be
formed of a rigid plastic, such as polyurethane or polyethylene or
polyethylene terephthalate. The anchoring mechanism 340 may be
processed to have shape memory properties. The anchoring mechanism
340 may also be designed to present a smaller packing profile, as a
thin frame can occupy less space than multiple layers of membrane
in an inflatable anchor, and may present less obstruction to
outflow of stomach contents.
[0079] The system 300 may also be designed to accommodate a
gastroscope 360. The gastroscope 360 may be used to provide or
enhance columnal strength for advancement of the device into the
duodenum in preparation for deployment of the intestinal sleeve in
the bowel. In an embodiment, the gastroscope 360 can be a part of
the system 300. The gastroscope 360 may be constructed from a
plastic material such as polyethylene, polyethylene terephthalate,
polyvinyl chloride, polyurethane, polytetrafluoroethylene (Teflon),
or any other known strong material. In an embodiment, the
gastroscope 360 may contain fiber or wire strands or braid for
reinforcement. FIG. 11 shows a system 300 having gastroscope tube
380, gastroscope 360, anchor 340, and inverted deploying balloon
320 and sleeve 330.
[0080] The gastroscope 360, in an embodiment, may be provided
within a gastroscope tube 380. The gastroscope 360 and/or tube 380
may be coupled to the deploying balloon 320, for example, through
the use of a coupling mechanism 335, so as secure the device 305
thereto. The deploying balloon 320 may also be bonded to the
gastroscope 360 and/or tube 380 to form a compact unit. The
bonding, in an embodiment, can be along one line axially. In some
embodiments, the gastroscope 360 and/or tube 380 may be coupled to
the deploying balloon 320 through the use of an adhesive, such as
glue or tape. In other embodiments, the gastroscope tube 360 and/or
380 may be coupled to the deploying balloon 320 through the use of
a nail, screw, clip or other coupling mechanism 335 capable to
bonding the gastroscope tube 360 and/or 380 to the balloon 320. Of
course, those skilled in the art may appreciate that other coupling
mechanisms 335 may also be possible as the present invention is not
intended to be limited in this manner.
[0081] The gastroscope 360 may also contain a connecting mechanism
342, as shown in FIGS. 13A and 13B, for holding the anchoring
mechanism 340 in position during deployment of the intestinal
sleeve. The connecting mechanism 342 may be designed to couple the
deploying balloon 320 to the gastroscope 360. In one embodiment,
the connecting mechanism 342 may include a suture 343 to couple the
deploying balloon 320 to the gastroscope 360. An opening in the
side of the gastroscope 360 may be provided to allow the suture 343
to pass therethrough. As shown in FIG. 13B, the suture 343 may run
the length of the gastroscope 360, out the side opening, through a
loop in the anchoring mechanism 340, and end at a proximal port, to
secure the anchoring mechanism 340 to the gastroscope 360. In an
embodiment, the suture 343 may be designed so that it can be
severed and removed so as to release the anchoring mechanism 340
and sleeve 330 following deployment. In another embodiment, the
connecting mechanism 342 may further be designed to provide
reference positioning for intestinal sleeve deployment.
[0082] The system 300 of the present embodiment may further include
a sheath 310, as shown in FIGS. 12A-12C, designed to for placement
over the anchoring mechanism 340, the proximal end of deploying
balloon 320, and the proximal end of the sleeve 330. The sheath 310
may be made from a semi-flexible material with a length sufficient
to cover substantially the entire length of the anchoring mechanism
340. Of course, the length of sheath 310 can be varied according to
specific designs. In an embodiment, sheath 310 can be sufficiently
long so as to cover substantially the entire length of the
deploying balloon 320 and sleeve 330. A wire 365 may be coupled to
the sheath 310 and may extend substantially along the length of the
device 305 or beyond. The wire 365 may be designed to be pulled, so
as to withdraw the sheath 310 (prior to deployment of the sleeve
330) as illustrated in FIG. 12C, with the anchoring mechanism 340
in an expanded state.
[0083] To deploy the gastrointestinal implant device 305, as shown
in FIG. 9B, delivery mechanism 315 of system 300 may be provided
with an inflation port 370. In an embodiment, the inflation port
370 may be designed to allow fluids (e.g., air, liquids, gas or
other substances) to enter with sufficient pressure to evert
deploying balloon 320 and deploy the gastrointestinal implant
device 305. In one embodiment, inflation port 370 can be coupled to
deploying balloon 320. Of course, other locations for the inflation
port 370 are possible as long as fluids can enter delivery
mechanism 315 with a sufficient force to deploy the device 305.
[0084] To prepare the delivery mechanism 315 for insertion in the
body, a user can initially position an open ended sleeve 330 within
deploying balloon 320. In an embodiment, the proximal end 332 of
the sleeve 330 may be situated adjacent the open end 322 of the
deploying balloon 320, while the distal end 334 of the sleeve 330
may be situated adjacent the closed end 324 of the deploying
balloon 320. Additionally, anchoring mechanism 340, can be coupled
to the proximal end 332 of the sleeve 330. The open ended sleeve
330, deploying balloon 320 and anchoring mechanism 340, in one
embodiment, may be compressed and encased within sheath 310.
[0085] Once loaded, the delivery mechanism 315 may be inserted into
the body, and advanced along the intestine within the body to a
site of interest for implantation. The gastroscope 360 may be used
to help guide the delivery mechanism 315 through the intestinal
tract to a site of implantation. In an embodiment, a guidewire (not
shown) may be used to maintain the stability of the delivery
mechanism 315, as the delivery mechanism 315 advances through the
tract. Once at the site of implantation, the delivery mechanism 315
can be prepared for deploying the device 305. Deployment may first
require removal of the sheath 310 by pulling wire 365 to withdraw
the sheath 310, prior to deployment of the sleeve 330, which may
act to cause subsequent expansion of the anchoring mechanism 340.
Expansion of the anchoring mechanism 340 can act to hold the
gastrointestinal implant device 305 in a desired position during
the eversion process. After the anchoring mechanism 340 is anchored
to the stomach wall or intestinal wall at the site of interest, the
sleeve 330 may be everted from within the deploying balloon 320.
Eversion may require activation of the inflation port 350, which
can result in the deploying balloon 320 being inflated. Inflation
of the deploying balloon 320 can cause the deploying balloon 320 to
enlarge and/or become pressurized, allowing the deploying balloon
320 to evert and deploy the device 305. In an embodiment, the
deploying balloon 320 can provide a low friction compartment for
everting the sleeve 330. With the gastrointestinal implant device
305 deployed and engaged within the intestinal wall, food and other
food material can be passed through the sleeve 330.
[0086] Following deployment of the sleeve 330, the gastroscope 360,
deploying balloon 320 and sheath 310 can be removed from the body.
For example, the suture 343 may be severed and removed so as to
release the anchoring mechanism 340 and sleeve 330 following
deployment. In an embodiment, the deploying balloon 320 may be
constricted to allow the deploying balloon 320 to be pulled out of
the sleeve 330, leaving the sleeve 330 in position within the
intestine. Since the diameter of the deploying balloon 320 can be
less than the diameter of the sleeve 330, deploying balloon 320
withdrawal may be performed upon deflation and formation of a
vacuum in the deploying balloon 320. As previously stated, a
coating or layer of lubrication may be placed between the sleeve
330 and the deploying balloon 320 during manufacture, to ensure
easy deploying balloon 320 removal.
[0087] Turning now to FIG. 14, there is illustrated an expandable
body 400 for use, for example, as an anchor in connection with the
gastrointestinal implant devices of the present invention. In an
embodiment, expandable body 400 can be used to secure placement of
the sleeve in the gastrointestinal tract (e.g., from within the
stomach, the duodenum, adjacent the pylorus, or within the small
intestine). Expandable body 400 may include a geometric array of
struts that may form a three-dimensional structure, such as a
geodesic sphere, a system of interconnected loops or hoops 410, an
ellipsoid structure, or other elastic forms that may define a
three-dimensional structure.
[0088] Expandable body 400, in an embodiment, may be constructed
from any suitable elastic or shape-memory materials described
herein, such as spring metal (e.g., stainless steel) and/or spring
plastic (e.g., polyurethane, polyethylene, or polyethylene
terephthalate). The materials used, in an embodiment, should
provide sufficient elasticity may be provided by such materials,
such that expandable body 400 may collapse, for instance, by
compression and expand, for instance, after deployment as
desired.
[0089] Expandable body 400, in an embodiment, may also include one
or more expandable mechanism (not shown). For example, expandable
body 400 may be an expandable array of struts or loops that form an
elastic structure which, upon expansion, may occupy a greater
degree of volume to provide a space occupying effect. Such space
occupying effect in the stomach may act to reduce the functional
volume of the stomach and/or provide a feeling of satiety. In
another embodiment, expandable body 400 may also be a metal or
plastic frame (e.g., formed by struts 410) with one or more
secondary expandable structures attached thereto. In some instance,
the expandable mechanism may be inflatable.
[0090] Expandable body 400 may contain at least two openings 420,
through which undigested, partially digested, or completely
digested food can be directed from the stomach into the intestinal
sleeve, such as sleeve 130 shown in FIG. 1B. In particular, one
opening may be sufficiently large and in alignment with the
entrance, such as the proximal end of the intestinal sleeve, so as
to hold the intestinal sleeve open to allow entry of food.
[0091] In certain embodiments, expandable body 400 may be provided
with sufficient elasticity. This may be advantageous for use as an
anchoring mechanism in the stomach. Without wishing to be bound by
any theory, advantages of a sufficiently elastic expandable body
400 for use in the stomach may be explained as follows: The stomach
undergoes contraction and peristalsis, as it moves food out into
the duodenum. A sufficiently elastic expandable body 400 placed
inside the stomach may contract and expand as the stomach contracts
and relaxes. This way, expandable body 400 may be prevented from
being expelled out of the stomach as may occur to a substantially
rigid anchor.
[0092] Expandable body 400 may be configured with a diameter as
large as needed to achieve anchoring, for example, from
approximately 6 cm to 12 cm or greater. Both the elasticity and
geometric structure, as described, may help anchor expandable body
400 within the stomach, and prevent it from being expelled by the
stomach. As such, while stomach peristalsis tends to move food
towards the pylorus, and expandable body 400 tends to move down to
the antrum, an intestinal sleeve that is coupled to expandable body
400 may remain anchored in the desired position (e.g., within the
antrum). The anchoring effect of the elastic expandable body 400 to
stay within the stomach may be analogized to the physiologic
mechanism of a gas embolus in the arterial system: Gas is
compressible, and a volume of gas residing in an artery while
compressing and expanding along with the arterial pulse, does not
significantly move down the artery.
[0093] In addition to the anchoring and space occupying potential
of expandable body 400 described above, expandable body 400 may
also be designed to expand in circle to contact the stomach wall,
distend the stomach, and/or act to provide a feeling of satiety to
the patient implanted with such a framework. In an embodiment,
stomach distention may result in neural feedback of fullness,
adding to the therapeutic bariatric effects of the implant device,
which may include volume restriction or reduction by the anchoring
mechanism and nutrient malabsorption by the intestinal sleeve.
[0094] With reference now to FIG. 15A, FIG. 15B, FIG. 15C, and FIG.
16A, FIG. 16B, FIG. 16C, there is illustrated a gastrointestinal
implant device 500 having two anchoring mechanisms 510 and 520. A
first anchoring mechanism 510 may be designed for secure placement
within the stomach, as discussed above. A second anchoring
mechanism 520 may be coupled to and spaced from the first anchoring
mechanism 510. The second anchoring mechanism 520 may be designed
to be secured within a gastrointestinal tract and outside the
stomach. In an embodiment, the second anchoring mechanism 520 may
be placed within the duodenum just past the pylorus, or anywhere in
the small intestine. It should be noted that the spacing between
the two anchoring mechanisms 510 and 520 may be chosen according to
their desired placement in the gastrointestinal tract. In an
embodiment, sufficient spacing may be provided to allow lateral
movement and/or axial rotation, such that relative movement between
the two anchoring mechanisms 510 and 520 can be accommodated.
[0095] As illustrated in FIGS. 15A-15C, the first anchoring
mechanism 510 may or may not be coupled to sleeve 530, while the
second anchoring mechanism 520 may be coupled to and at least
partially positioned within sleeve 530. That is, sleeve 530 may be
circumferentially situated and attached on an outer surface of the
second anchoring mechanism 520 to partially or substantially
completely cover the second anchoring mechanism 520. In certain
embodiments, sleeve 530 may extend from the second anchoring
mechanism 520 into the small intestine, after eversion and
deployment. Sleeve 530 may also be expanded outwardly by the second
anchoring mechanism 520 to provide a passageway 540 therethrough.
In addition, sleeve 530 may be anchored by the second anchoring
mechanism 520 against retrograde movement that may be caused by a
back force, for example, during patient vomiting.
[0096] It should be noted that FIGS. 15A-15C show sectional views
of gastrointestinal implant device 500, with the first and second
anchoring mechanisms 510 and 520 being shown as disk-like
structures, for illustration purposes only. While the corresponding
three-dimensional view may be substantially spherical, the first
and second anchoring mechanisms 510 and 520 may independently have
any other suitable geometry such as a geodesic sphere, a truncated
icosahedron, an ellipsoid structure, or a half or partial structure
thereof.
[0097] In certain embodiments, the second anchoring mechanism 520
may have a smaller diameter than the first anchoring mechanism 510,
so as to fit within the duodenum or along other parts in the small
intestine. The second anchoring mechanism 520 may also have a
substantially similar or larger diameter than the first anchoring
mechanism 510, depending on the relative anatomical size of the
duodenum, small intestine, and stomach of the patient requiring the
implant. Regardless of their relative size, anchoring mechanisms
510 and 520 may expand outwardly against the stomach, duodenum, or
small intestine, without significantly overstretching the
respective tissue.
[0098] The first and second anchoring mechanisms 510 and 520, in an
embodiment, may be connected to each other via any suitable
coupling mechanisms known in the art. Exemplary coupling mechanisms
include, without limitation, threading, tethering, and tying.
Suitable coupling mechanisms may be connected to anchoring
mechanisms via methods known in the art such as gluing, bonding,
interlocking, fastening, molding, welding, clamping, etc.
[0099] For example, the first and second anchoring mechanisms 510
and 520 may be connected by a portion 535 of the sleeve 530, as
shown in FIG. 15A. In an embodiment, sleeve portion 535 between
anchoring mechanisms 510 and 520 may be sufficiently inelastic, so
as to minimize sleeve portion 535 from twisting. Such inelasticity
may also help hold anchoring mechanisms 510 and 520 in a
substantially fixed relative position. In some cases, sleeve
portion 535 and anchoring mechanisms 510, 520 may be molded or
formed as a one-piece design. To the extent desired, sleeve portion
535 (or a portion thereof) may have a diameter that fits in the
pylorus in its closed position. Alternatively, sleeve portion 535
may be substantially elastic while holding anchoring mechanisms 510
and 520 in a substantially fixed relative position (e.g., at either
side of the pylorus). For example, a substantially elastic sleeve
portion 535 may be in a stretched state which may exert a
contracting or pulling force to anchoring mechanisms 510 and 520
toward one another. This way, a compressive force may be exerted on
the pylorus by anchoring mechanisms 510 and 520, thereby increasing
the anchoring function of the implant device 500, with minimal
relative movement of anchoring mechanisms 510, 520 and sleeve 530.
It should be noted that while sleeve portion 535 may have various
degree of elasticity depending on the specific device design, it
should be sufficiently flexible to bend or move according to the
patient's body movement. In addition, such flexibility of sleeve
portion 535 and/or other portions of sleeve 530 may be desirable,
for example, to allow the portion extending distally from the
second anchoring mechanism 520 to move between an inverted position
and an everted position.
[0100] In the embodiments illustrated in FIGS. 15B and 15C, the
first and second anchoring mechanisms 510 and 520 may be connected
by one or more tethering mechanism 550 or 560. In this case, sleeve
530 is attached to the second anchoring mechanism 520 only. As
discussed above, the second anchoring mechanism 520 may be designed
to expand to contact the inner wall of the duodenum, or other parts
of the small intestine. This design may help seal sleeve 530
against the duodenal or intestinal wall to ensure that food exiting
the stomach passes into sleeve 530, without leaking into the small
intestine. Such a design may also help securely anchor sleeve 530
at its point of contact with the duodenal or intestinal wall.
[0101] Where the second anchoring mechanism 520 is connected to the
first anchoring mechanism 510 by multiple tethering mechanisms 550,
as shown in FIG. 15B, the multiple tethering mechanisms 550 may be
configured in such a way that they do not substantially interfere
with the opening or closing of the pylorus as it occurs in
accordance with the digestive process. For example, the multiple
tethering mechanisms 550 may attach, at either end, adjacent the
respective central axis of anchoring mechanisms 510 and 520, such
that the multiple tethering mechanisms 550 may be arranged in
proximity to one another. In addition, spacing between adjacent
tethering mechanisms should be designed in a way such that even
upon twisting of the multiple tethering mechanisms 550, food
passageway between anchoring mechanisms 510 and 520 is neither
blocked nor occluded. That is, food should still be able to pass
through the spaces between adjacent tethering mechanisms to enter
sleeve 530.
[0102] A single tethering mechanism 560 may also be used, as shown
in FIG. 15C. This design may be preferred, in some embodiments,
allowing more space for the passageway between anchoring mechanisms
510 and 520.
[0103] Tethering mechanisms 550, 560 may be made from any suitable
structure or material known in the art. In an embodiment, tethering
mechanisms 550, 560 may be a connecting cords, wires, strings,
cables, rods, ropes, and the like. The diameter of tethering
mechanisms 550, 560 maybe sufficiently small so as to not
substantially occlude the passageway between anchoring mechanisms
510 and 520 when food passes therethrough. The length of tethering
mechanisms 550, 560 may also be chosen (e.g., a few centimeters or
longer) such that different anatomical pyloric lengths may be
accommodated by one or few versions of implant device 500.
Alternatively, the length of tethering mechanisms 550, 560 may be
custom made for the patient.
[0104] Tethering mechanisms 550, 560 may have sufficient
flexibility to bend or move along with movement of the patient's
body. In an embodiment, tethering mechanisms 550, 560 may be made
of spring metal or plastic. In some embodiments, tethering
mechanisms 550, 560 may be sufficiently elastic while holding
anchoring mechanisms 510 and 520 in a substantially fixed relative
position at either side of the pylorus. As discussed above, such
design may impart a compressive force on the pylorus to enhance
anchoring of the anchoring mechanisms 510 and 520 adjacent the
pylorus. Tethering mechanisms 550, 560, in another embodiment, may
be substantially inelastic, such that no significant compression is
exerted on the pylorus. When substantially inelastic tethering
mechanism(s) are used, a limited degree of movement may be
experienced by the implant device 500 relative to the pylorus, to
the extent that the respective anchoring mechanism 510 or 520
contacts either side of the pylorus.
[0105] To the extent desired, anchoring mechanisms 510, 520 and the
tethering mechanism(s) therebetween may be molded or formed as a
one-piece design. Alternatively, these parts can be formed
separately and then attached together. Various suitable
attaching/connecting methods known in the art can be used to attach
the tethering mechanism and the anchoring mechanism. For instance,
suitable methods include glue, key-lock structures or the like,
sucking disks, clamps, hooks, screws, latches, and so on.
[0106] Other suitable tethering mechanisms for connecting anchoring
mechanisms 510 and 520 may also be used. For example, an expandable
metal or plastic frame (e.g., having shape memory property) may be
used, which may expand or collapse along with the opening or
closing movement of the pylorus. Upon expansion, a passageway may
extend between anchoring mechanisms 510 and 520 to allow food to
pass through and enter sleeve 530.
[0107] FIG. 16A illustrates a perspective view of a
gastrointestinal implant device 500 having two anchoring mechanisms
510 and 520. In an embodiment, anchoring mechanisms 510 and 520 may
each include a plurality of struts 515 to form a framework. One or
more of struts 515 may be expandable, as discussed above. Multiple
tethering mechanisms 550 may be provided to connect anchoring
mechanisms 510 and 520. FIGS. 16B and 16C are side views of
anchoring mechanisms 510, 520 and tethering mechanisms 550
therebetween, FIG. 16C being turned 90 degrees relative to FIG.
16B.
[0108] In addition to the structural configurations for the
anchoring mechanisms discussed above, any suitable shapes that
offer sufficiently small strut profile, desired structural
integrity, and sufficient spacing between struts for food passage
may also be used. By way of example, suitable shapes include
spherical or non-spherical truncated icosahedrons as shown in FIGS.
17A and 17B, geodesic spheres as shown in FIGS. 17C and 17D, and
full or partial spheres as shown in FIG. 17E.
[0109] With reference now to FIG. 18, FIG. 19A, FIG. 19B and FIG.
19C, there is illustrated another two-anchor device 505 for use in
connection with an intestinal sleeve (not shown) to form a
gastrointestinal implant device, as discussed herein. In an
embodiment, the two anchoring mechanisms 510 and 520 may be partial
spheres (FIG. 18) or partial geodesic spheres (FIG. 19A, FIG. 19B
and FIG. 19C). Anchoring mechanisms 510 and 520 have substantially
the same diameter as illustrated, or different diameters in
accordance with the relative anatomical size of the stomach and
duodenum.
[0110] Anchoring mechanisms 510 and 520 may each include a
plurality of interconnected members 515 such as loops (FIG. 18) or
struts (FIG. 19A, FIG. 19B and FIG. 19C). Both anchoring mechanisms
510 and 520, in an embodiment, may be constructed from suitable
expandable materials described herein, such as spring metal (e.g.,
stainless steel) and/or spring plastic (e.g., polyurethane,
polyethylene, or polyethylene terephthalate). As discussed above,
one or more of the interconnected members 515 may be expandable.
For example, the first anchoring mechanism 510 may be provided with
one or more expandable mechanism which, upon inflation, may occupy
a greater degree of volume to reduce the functional volume of the
stomach. Such inflated mechanism may also exert an additional
pressure to the stomach wall, enhancing the secured placement of
the first anchoring mechanism 510 within the stomach. Similarly,
the second anchoring mechanism 520 may also include one or more
expandable mechanism which, upon inflation, may exert a radial
force against the duodenal wall, for securing the second anchoring
mechanism 520 within the duodenum. It should also be appreciated
that where sleeve 530 is attached to the outer surface of the
second anchoring mechanism 520, such radial force may also act to
secure and anchor sleeve 530 against the duodenal wall.
[0111] A single tethering mechanism 560 may be provided between
anchoring mechanisms 510 and 520 to connect them. More than one
tethering mechanisms may also be used, as discussed above. For ease
of construction, tethering mechanism 560 may be molded as one piece
together with anchoring mechanisms 510 and 520 (e.g., as a metal or
plastic structure). Alternatively, these parts can be formed
separately and then assembled into the two-anchor device 505. In
this case, tethering mechanism 560 may be connected at either end
to anchoring mechanisms 510 and 520 by designs 562 and 564 shown in
FIG. 18. Other suitable designs or connecting mechanisms known in
the art may also be used. For example, tethering mechanism 560 may
be mounted on, bonded to, glued to, molded with, assembled into, or
interlocked with anchoring mechanisms 510 and 520.
[0112] In a preferred embodiment, FIGS. 19A-19C illustrate a
two-anchor device 505 in side view (FIG. 19A), perspective view
(FIG. 19B), and top view (FIG. 19C). In an example, the major
diameter (a) and height (b) of anchoring mechanisms 510, 520, as
well as the length (c) of tethering mechanism 560, may be chosen
according to average anatomical size of the gastrointestinal
system. Alternatively, these measurements may be custom made for
each patient or patient group.
[0113] In operation, the first and second anchoring mechanism 510
and 520 may first be secured along a gastrointestinal tract of a
patient. For example, the first anchoring mechanism 510 may be
secured within a stomach, and the second anchoring mechanism 520
may be secured beyond the stomach, such as in a duodenum. Next,
sleeve 530 may be placed about an outer surface of the second
anchoring mechanism 520 and extend therefrom into a small
intestine. In an embodiment, sleeve 530 may be situated
circumferentially about the outer surface of the second anchoring
mechanism 520. The second anchoring mechanism 520 may also expand
and act to seal sleeve 530 against the wall of the duodenum. This
way, food can be directed through first anchoring mechanism 510,
second anchoring mechanism 520, and sleeve 530, sequentially,
without leaking into the small intestine.
[0114] While the invention has been described in connection with
the specific embodiments thereof, it will be understood that it is
capable of further modification. For instance, it should be
appreciated that any of the anchors or anchoring mechanisms
described above may be modified, for use in connection with
gastrointestinal implant devices and/or intestinal sleeve delivery
systems described herein. Furthermore, this application is intended
to cover any variations, uses, or adaptations of the invention,
including such departures from the present disclosure as come
within known or customary practice in the art to which the
invention pertains, and as fall within the scope of the appended
claims.
* * * * *