U.S. patent application number 15/402976 was filed with the patent office on 2017-05-25 for stomach-spanning gastric implants.
This patent application is currently assigned to Apollo Endosurgery, Inc.. The applicant listed for this patent is Apollo Endosurgery, Inc.. Invention is credited to Mitchell H. Babkes, Zachary Dominguez.
Application Number | 20170143523 15/402976 |
Document ID | / |
Family ID | 44863263 |
Filed Date | 2017-05-25 |
United States Patent
Application |
20170143523 |
Kind Code |
A1 |
Babkes; Mitchell H. ; et
al. |
May 25, 2017 |
Stomach-Spanning Gastric Implants
Abstract
A variety of passive intragastric implant devices for obesity
treatment are disclosed. Such passive implants do not autonomously
change shape, but instead react within the stomach to induce
satiety. The implants may take up volume within the stomach, thus
reducing the digestive capacity. Additionally, the implants may
contact areas within the stomach, such as the cardia surrounding
the esophageal sphincter, to stimulate satiety-inducing nerves.
Also, a number of implants slow gastric emptying by blocking or
otherwise impeding flow through the pyloric sphincter. Other
implants delay digestion by providing a duodenal sleeve. A number
of implants combine two or more of these satiety-inducing features.
Methods of implant are disclosed including compressing the implants
within a delivery tube and transorally advancing the implants
through the esophagus to be deployed within the stomach. Removal of
the implants occurs in the reverse.
Inventors: |
Babkes; Mitchell H.; (Santa
Clarita, CA) ; Dominguez; Zachary; (Santa Barbara,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Apollo Endosurgery, Inc. |
Austin |
TX |
US |
|
|
Assignee: |
Apollo Endosurgery, Inc.
Austin
TX
|
Family ID: |
44863263 |
Appl. No.: |
15/402976 |
Filed: |
January 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13931561 |
Jun 28, 2013 |
9539133 |
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15402976 |
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13275170 |
Oct 17, 2011 |
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13931561 |
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61485009 |
May 11, 2011 |
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61394592 |
Oct 19, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
Y10T 24/44564 20150115;
Y10T 24/44342 20150115; A61F 5/003 20130101; A61F 5/0073 20130101;
A61F 5/0036 20130101; A61F 5/0079 20130101; Y10T 24/4453 20150115;
A61F 5/0003 20130101; A61F 5/0086 20130101; A61F 5/0013 20130101;
A61F 5/0076 20130101; A61F 5/0033 20130101; A61F 5/0089
20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1. A passive intragastric obesity treatment implant, comprising: a
cardia flange sized and shaped to conform to a cardia region of the
stomach and resist passage through the esophageal sphincter and
having a central through hole centered at the esophageal sphincter
through which food passes; an antrum stent sized and shaped to seat
within the antrum; and a plurality of struts connecting the cardia
flange and antrum stent that are flexible enough to straighten out
and be passed transorally down an access tube, while also being
somewhat stiff to provide light pressure to both the cardia flange
and antrum stent on each end, the struts of sufficient length to
cause the cardia flange and the antrum stent to provide slight
pressure against the cardia and the antrum, the implant being
formed of materials that permit it to be compressed into a
substantially linear transoral delivery configuration and that will
resist degradation over a period of at least six months within the
stomach.
2. The implant of claim 1, wherein the cardia flange is a flexible,
flat partial conical ring that includes a central through hole.
3. The implant of claim 1, wherein the cardia flange comprises a
braided wire mesh covered with a soft polymer.
4. The implant of claim 3, wherein the braided wire mesh includes
nitinol wires, and the polymer is a silicone.
5. The implant of claim 1, wherein the antrum stent comprises a
braided wire mesh covered with a soft polymer.
6. The implant of claim 5, wherein the braided wire mesh includes
nitinol wires, and the polymer is a silicone.
7. The implant of claim 1, wherein the cardia flange comprises a
solid silicone member with wire reinforcements.
8. The implant of claim 1, wherein the antrum stent comprises a
solid silicone member with wire reinforcements.
9. The implant of claim 1, further comprising a narrow neck region
attached to a distal end of the antrum stent that fits within the
pylorus.
10. The implant of claim 1, further comprising a duodenal stent
connected in series with the antrum stent at a narrow neck region
such that the antrum stent, neck region, and duodenal stent
conforms closely to the antrum, pylorus and upper end of the
duodenum.
11. The implant of claim 1, wherein the plurality of struts
consists of three struts.
12. The implant of claim 1, wherein the entire implant is made of
silicone and nitinol.
13. A passive intragastric obesity treatment implant, consisting
of: a cardia flange sized and shaped to conform to a cardia region
of the stomach and resist passage through the esophageal sphincter
and having a central through hole centered at the esophageal
sphincter through which food passes; an antrum stent sized and
shaped to seat within the antrum; and a plurality of struts
connecting the cardia flange and antrum stent that are flexible
enough to straighten out and be passed transorally down an access
tube, while also being somewhat stiff to provide light pressure to
both the cardia flange and antrum stent on each end, the struts of
sufficient length to cause the cardia flange and the antrum stent
to provide slight pressure against the cardia and the antrum, the
implant being formed of materials that permit it to be compressed
into a substantially linear transoral delivery configuration and
that will resist degradation over a period of at least six months
within the stomach.
14. A passive intragastric obesity treatment implant, consisting
of: a cardia flange sized and shaped to conform to a cardia region
of the stomach and resist passage through the esophageal sphincter
and having a central through hole centered at the esophageal
sphincter through which food passes; an antrum stent sized and
shaped to seat within the antrum; a duodenal stent connected in
series with the antrum stent at a narrow neck region such that the
antrum stent, neck region, and duodenal stent conforms closely to
the antrum, pylorus and upper end of the duodenum; and a plurality
of struts connecting the cardia flange and antrum stent that are
flexible enough to straighten out and be passed transorally down an
access tube, while also being somewhat stiff to provide light
pressure to both the cardia flange and antrum stent on each end,
the struts of sufficient length to cause the cardia flange and the
antrum stent to provide slight pressure against the cardia and the
antrum, the implant being formed of materials that permit it to be
compressed into a substantially linear transoral delivery
configuration and that will resist degradation over a period of at
least six months within the stomach.
Description
RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 13/931,561, filed Jun. 28, 2013, now issued as
U.S. Pat. No. 9,539,133, which is a continuation of U.S. patent
application Ser. No. 13/275,170, filed Oct. 17, 2011, which claims
priority under 35 U.S.C. .sctn.119 to U.S. Provisional Application
No. 61/485,009, filed May 11, 2011, and to 61/394,592, filed Oct.
19, 2010, the disclosures of which are incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] The present invention is directed to intragastric implants
used for the treatment of obesity, and in particular to implants
for placement in and spanning the stomach cavity.
BACKGROUND OF THE INVENTION
[0003] Over the last 50 years, obesity has been increasing at an
alarming rate and is now recognized by leading government health
authorities, such as the Centers for Disease Control (CDC) and
National Institutes of Health (NIH), as a disease. In the United
States alone, obesity affects more than 60 million individuals and
is considered the second leading cause of preventable death.
Worldwide, approximately 1.6 billion adults are overweight, and it
is estimated that obesity affects at least 400 million adults.
[0004] Obesity is caused by a wide range of factors including
genetics, metabolic disorders, physical and psychological issues,
lifestyle, and poor nutrition. Millions of obese and overweight
individuals first turn to diet, fitness and medication to lose
weight; however, these efforts alone are often not enough to keep
weight at a level that is optimal for good health. Surgery is
another increasingly viable alternative for those with a Body Mass
Index (BMI) of greater than 40. In fact, the number of bariatric
surgeries in the United States was estimated to be about 400,000 in
2010.
[0005] Examples of surgical methods and devices used to treat
obesity include the LAP-BAND.RTM. (Allergan Medical of Irvine,
Calif.) gastric band and the LAP-BAND AP.RTM. (Allergan). However,
surgery might not be an option for every obese individual; for
certain patients, non-surgical therapies or minimal-surgery options
are more effective or appropriate.
[0006] In the early 1980s, physicians began to experiment with the
placement of intragastric balloons to reduce the size of the
stomach reservoir, and consequently its capacity for food. Once
deployed in the stomach, the balloon helps to trigger a sensation
of fullness and a decreased feeling of hunger. These devices are
designed to provide therapy for moderately obese individuals who
need to shed pounds in preparation for surgery, or as part of a
dietary or behavioral modification program. These balloons are
typically cylindrical or pear-shaped, generally range in size from
200-500 ml or more, are made of an elastomer such as silicone,
polyurethane, or latex, and are filled with air, an inert gas,
water, or saline.
[0007] One such inflatable intragastric balloon is described in
U.S. Pat. No. 5,084,061 and is commercially available as the
BioEnterics Intragastric Balloon System ("BIB System," sold under
the trademark ORBERA). The BIB System comprises a silicone
elastomer intragastric balloon that is inserted into the stomach
and filled with fluid. Conventionally, the balloons are placed in
the stomach in an empty or deflated state and thereafter filled
(fully or partially) with a suitable fluid. The balloon occupies
space in the stomach, thereby leaving less room available for food
and creating a feeling of satiety for the patient. Placement of the
intragastric balloon is non-surgical, trans-oral, usually requiring
no more than 20-30 minutes. The procedure is performed
gastroscopically in an outpatient setting, typically using local
anesthesia and sedation. Placement of such balloons is temporary,
and such balloons are typically removed after about six months.
Removing the balloon requires deflation by puncturing with a
gastroscopic instrument, and either aspirating the contents of the
balloon and removing it, or allowing the fluid to pass into the
patient's stomach. Clinical results with these devices show that
for many obese patients, the intragastric balloons significantly
help to control appetite and accomplish weight loss.
[0008] Some attempted solutions for weight loss by placing devices
in the stomach result in unintended consequences. For instance,
some devices tend to cause food and liquid to back up in the
stomach, leading to symptoms of gastroesophageal reflux disease
(GERD), a condition in which the stomach contents (food or liquid)
leak backwards from the stomach into the esophagus. Also, the
stomach acclimates to some gastric implant devices, leading to an
expansion of stomach volume and consequent reduction in the
efficacy of the device.
[0009] Therefore, despite many advances in the design of
intragastric obesity treatment implants, there remains a need for
improved devices that can be implanted for longer periods than
before or otherwise address certain drawbacks of intragastric
balloons and other such implants.
SUMMARY OF THE INVENTION
[0010] The present invention addresses the above-described problems
by providing passive intragastric apparatuses and methods for
inducing satiety and therefore treating obesity. Such passive
devices do not autonomously change shape, but instead react within
the stomach to induce satiety. The devices may reduce volume within
the stomach, thus reducing the digestive capacity. Additionally,
the devices may contact areas within the stomach, such as the
cardia surrounding the esophageal sphincter, to stimulate
satiety-inducing nerves. Also, a number of devices slow gastric
emptying by blocking or otherwise impeding flow through the pyloric
sphincter. Other devices delay digestion by providing a duodenal
sleeve. A number of devices combine two or more of these
satiety-inducing features. Methods of implant are disclosed
including compressing the devices within a delivery tube and
transorally advancing the devices through the esophagus to be
deployed within the stomach. Removal of the devices occurs in the
reverse.
[0011] Each of the implants described herein is formed of materials
that permit it to be compressed into a substantially linear
transoral delivery configuration and that will resist degradation
over a period of at least six months within the stomach.
[0012] In accordance with a first embodiment, a passive
intragastric obesity treatment implant comprises an esophageal
stent sized to anchor within the esophagus just above the
esophageal sphincter. A tubular body has a length sufficient to
extend between the esophageal sphincter and the pyloric sphincter
upon implant in the stomach, the tubular body having perforations
therein to permit ingress of stomach juices. A duodenal tube
extends in series from the tubular body. Collapsible tubular
connectors extend between the esophageal stent and the tubular
body, and between the tubular body and the duodenal tube, the
connectors each having longitudinal slits therein. Finally, a
bulbous flange surrounds and connects to the distal end of the
tubular body, the bulbous flange having a size that prevents
passage through the pyloric sphincter. The implant may further
include an enlargement surrounding the duodenal tube and sized to
prevent passage through the pyloric sphincter. The duodenal tube
and enlargement may extend only up to 5-10 cm in length. The
implant desirably further includes perforations along the tubular
body to allow ingress of digestive stomach juices. The bulbous
flange is preferably molded with relatively thick walls to maintain
its as-molded shape without inflation. In one embodiment, the
entire implant is made of silicone.
[0013] Another passive intragastric obesity treatment implant
disclosed herein has an esophageal stent sized to anchor within the
esophagus just above the esophageal sphincter. A tubular body has a
length sufficient to extend between the esophageal sphincter and
the pyloric sphincter upon implant in the stomach, the esophageal
stent attaching to a proximal end of the tubular body with a first
tether. The tubular body has perforations therein to permit ingress
of stomach juices. A duodenal sleeve extends distally from the
tubular body and attaches to the distal end of the tubular body
with a second tether. Proximal and distal circular shelves surround
free ends of the tubular body, the shelves having sizes that resist
passage through the esophageal sphincter and the pyloric sphincter,
respectively. Finally, a plurality of positioning rings attach to
mid-portions of the tubular body, the positioning rings having a
sufficient diameter so as to contact the interior stomach walls
upon contraction thereof. The esophageal stent desirably comprises
a helical coil of plastic wire. The first tether may be an
extension of the helical coil of plastic wire. There are preferably
positioning rings on both sides of the tubular body to maintain
spacing of the tubular body with walls of the stomach and ensure
the tubular body tracks a gradual arc from the esophageal sphincter
to the pylorus rather than taking the shortest path. Also, the
tubular body and positioning rings are preferably molded together
from the same material. Indeed, the entire implant may be made of
silicone.
[0014] Another passive intragastric obesity treatment implant of
the present application has a cardia flange sized and shaped to
conform to a cardia region of the stomach and resist passage
through the esophageal sphincter and having a central through hole
centered at the esophageal sphincter through which food passes. An
antrum stent sized and shaped to conform closely to the antrum
connects to the cardia flange via a plurality of struts that are
flexible enough to straighten out and be passed transorally down an
access tube, while also being somewhat stiff to provide light
pressure to both the cardia flange and antrum stent on each end.
The cardia flange is preferably a flexible, flat partial conical
ring that includes a central through hole. The cardia flange may be
formed by a braided Nitninol wire mesh covered with a soft
silicone. The antrum stent may also be formed by a braided Nitninol
wire mesh covered with a soft silicone. The implant preferably
further comprises a narrow neck region attached to a distal end of
the antrum stent that fits within the pylorus. Further, a duodenal
stent may be connected in series with the antrum stent at a narrow
neck region such that a generally hourglass shape of the antrum
stent, neck region, and duodenal stent conforms closely to the
antrum, pylorus and upper end of the duodenum. In one embodiment,
the entire implant is made of silicone and Nitinol.
[0015] A further understanding of the nature and advantages of the
invention will become apparent by reference to the remaining
portions of the specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Features and advantages of the present invention will become
appreciated as the same become better understood with reference to
the specification, claims, and appended drawings wherein:
[0017] FIG. 1 is a sectional view through a patient's stomach
illustrating an implanted stomach-spanning intragastric obesity
treatment implant connected to a duodenal sleeve;
[0018] FIG. 1A is a perspective view of the implant of FIG. 1;
[0019] FIG. 1B is an enlarged sectional view through a portion of
FIG. 1;
[0020] FIG. 1C is an enlarged sectional view through an alternative
distal end configuration for the implant shown in FIG. 1;
[0021] FIG. 2 is a sectional view through a patient's stomach
illustrating a further implanted stomach-spanning intragastric
obesity treatment implant having positioning rings and shelves, and
attached to a duodenal sleeve;
[0022] FIG. 3 is a sectional view through a patient's stomach
illustrating a still further implanted stomach-spanning
intragastric obesity treatment implant having an esophageal flange
and a pyloric stent; and
[0023] FIG. 4 is a perspective view of the implant of FIG. 3.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] The present invention is directed to a variety of different
intragastric implants that passively treat obesity by taking up
space within the stomach or contact areas in and around the stomach
to induce feelings of satiety. Furthermore, some implants described
herein affect the rate of stomach emptying. It should be understood
that a number of the disclosed implants provide more than one of
these passive aspects, and also that any disclosed structure could
be combined with another disclosed structure unless physically
impossible. As such, combinations of the passive satiety-inducing
features disclosed herein, even if not explicitly stated, are
contemplated. The term "passive" refers primarily to a lack of any
moving parts within the implants, but in general to the inert
nature of the various devices. A passive implant as defined herein,
however, is not one that cannot affect change or stimulate the
stomach, but rather one that may do so without any physical or
chemical changes to its basic makeup.
[0025] FIG. 1 illustrates a first stomach-spanning implant 20, but
also illustrates the anatomy of the human stomach, which will be
described first. The major function of the stomach is to
temporarily store food and release it slowly into the duodenum. The
esophagus extending downward from the mouth connects to the stomach
via esophageal sphincter, which regulates flow food into the
stomach cavity. The cardia surrounds the superior opening of the
stomach. The rounded portion superior to the body and adjacent the
cardia is the fundus. Inferior to the fundus is the large central
portion of the stomach, called the body, that is lined with muscles
that contract and relax repetitively to churn the food therein. The
stomach processes the food to a semi-solid "chyme," which enables
better contact with the mucous membrane of the intestines, thereby
facilitating absorption of nutrients. In addition, the stomach is
an important site of enzyme production.
[0026] Lower down in the stomach the antrum connects the body to
the pylorus, which leads into the duodenum. Below the stomach, the
duodenum leads into the upper part of the small intestine (not
shown); the jejunum makes up about one-third of the small
intestine. The region of the stomach that connects to the duodenum
is the pylorus. The pylorus communicates with the duodenum of the
small intestine via the pyloric sphincter (valve). This valve
regulates the passage of chyme from stomach to duodenum and it
prevents backflow of chyme from duodenum to stomach.
[0027] One general category of passive satiety-inducing implants
disclosed herein includes both a space-occupying member and a
flow-through channels within the stomach through which solid and
liquid flows. One way to look at such artificial intragastric
spaces is that they create a stomach-within-stomach.
[0028] For example, FIGS. 1-1C disclose a implant 20 configured as
a perforated tube 22 that is held in position within the biological
stomach, bypassing it and acting as a small, artificial stomach,
thereby decreasing the amount of food that is ingestible.
Perforations 24 allow ingress of digestive stomach juices. An
esophageal stent 26 is built into the tube 22 to anchor the
proximal end within the esophagus. A distal sleeve 28 of the tube
22 extends past the pyloric sphincter and empties directly into the
duodenum. Pyloric anchoring is achieved by the short duodenal
sleeve 28, which also reduces nutrient absorption within the
duodenum. To prevent the implant from migrating further down the
duodenum, a bulbous flange 30 attaches to the tube 22 close to the
distal sleeve 28. The bulbous flange 30 is too large to pass
through the pyloric sphincter. Desirably, the bulbous flange 30 is
molded with relatively thick walls to maintain its as-molded shape
without inflation, and may includes holes to allow stomach juices
to freely flow in and out.
[0029] At the locations where the tube 22 passes through the
esophageal and pyloric sphincters, longitudinal slits 32 formed in
the walls serve to allow compression of the sphincters and complete
closure/sealing. That is, the slits 32 permit the tube 22 to easily
buckle inward. Functionality of the slits 32 without damage to the
sphincters is dependent on the conformity/pliability and softness
of the material from which the tube 22 is manufactured. Desirably,
the tube 22 is made of a resilient material that springs outward in
the absence of sphincter closing forces, and thus the slits are in
substantially constant contact with the surrounding anatomical
walls which helps prevent leakage through the slits 32.
[0030] Some food will normally "leak" from the esophagus around the
bypassing tube 22 into the biological stomach, through the slits,
and/or around the esophageal stent 26. The leaked food will likely
be small particulate and liquid only, as larger boluses will be
naturally steered to and trapped within the tube 22.
[0031] Insertion and removal of the implant 20 is accomplished by
inserting into the esophagus, a thin-walled, lubricated Teflon tube
that is pre-loaded with the compressed implant 20. A distal end of
the insertion tube is positioned using visualization techniques
within the duodenum, at which point the implant 20 is held from
linear movement while the insertion tube is retracted. The
esophageal stent 26 anchors and locates the implant 20, and a small
amount of repositioning prior to deploying the stent may be
required as a final step of implanting the implant 20. To remove,
the stent 20 will be grabbed and constricted inward, whereupon the
rest of the implant 20 may be withdrawn without too much
difficulty.
[0032] FIG. 1C is an enlarged sectional view through an alternative
distal end configuration for the implant shown in FIG. 1. In this
embodiment, the duodenal sleeve 28 is replaced with a much shorter
tube enclosed within an enlargement 34, such as an inflated or
pillow-like structure. The enlargement 34 prevents migration of the
distal to back into the stomach. Although not shown, the short
flow-through tube may be extended as far as the sleeve 28 shown in
FIG. 1 to reduce the ability of the duodenum to absorb nutrients,
thus slowing digestion. In one embodiment, the short duodenal tube
and enlargement 34 extend only up to 5-10 cm into the duodenum.
[0033] Another so-called stomach-in-stomach implant 40 seen in FIG.
2 provides weight control in three ways--by stimulating the cardia,
by providing a stomach-in-stomach, and by providing a duodenal
sleeve. The implant 40 comprises an elongated tube 42 having a
length that permits it to extend in a curve as show generally from
the esophageal sphincter to the pylorus. A proximal shelf 44
surrounding an open proximal end of the tube 42 stabilizes the
implant at the esophageal sphincter, while a distal shelf 46
surrounding a distal opening accomplishes the same thing adjacent
at the pylorus. These shelves 44, 46 prevent migration back up the
esophagus and down the pylorus, respectively. Furthermore, the
upper shelf 44 rests firmly against the cardia walls, applying
pressure thereto and thereby triggering release of satiety-inducing
hormones, signaling the body to stop eating.
[0034] The tube 42 is highly flexible and includes a plurality of
positioning rings 48 attached thereto, preferably molded into the
side wall of the tube. The positioning rings 48 are also highly
flexible, so the entire structure can be compressed down into a
lubricated introduction tube. The positioning rings provide struts
that help maintain the curvature of the tube 42 within the stomach,
as shown--in other words, the tube 42 extends in a gradual arc from
the esophageal sphincter to the pylorus rather than taking the
shortest path. As such, there is preferably at least one
positioning ring 48, and more preferably two positioning rings, on
the inside curve of the tube 42 to maintain spacing from the lesser
curvature of the stomach. Likewise, there is preferably at least
one positioning ring 48, and more preferably two positioning rings,
on the outside curve of the tube 42 to maintain spacing from the
cardia region and greater curvature. Solids and liquids swallowed
by the patient enter the tube 42 through the proximal shelf 44 and
pass therethrough to exit through the distal shelf 46. Since the
tube 42 can hold much less volume than the stomach, smaller than
normal amounts of nutrients are able to be processed.
[0035] The tube 42 further includes a plurality of fluid transfer
perforations 50 that allow digestive juices to freely flow in and
out of the tube. Furthermore, peristaltic convolutions of the
stomach apply mechanical forces through the tube 42 walls,
desirably through the positioning rings 48, to help break down food
boluses. Some leakage of food exiting the esophagus into the
larger, biological stomach will likely occur, and leakage out
through the pylorus will also likely occur. However, most ingested
food will likely make its way through this channeling system.
[0036] An esophageal stent 52 connected to the proximal shelf 44
helps maintain the preferred position of the implant 40 within the
stomach. The stent 52 may be balloon- or self-expanding, and in the
illustrated embodiment comprises a helical coil of plastic wire.
The esophageal sphincter is allowed to close as normally as
possible, since the spiral plastic stent 52 is molded very thinly
in the area that passes centrally through the sphincter.
[0037] The satiety-inducing implant 40 also restricts caloric
intake through the duodenum, as the bottom segment is anchored via
an intermediate tether 54 by a duodenal sleeve 56 that lines the
upper duodenal wall. Such a duodenal sleeve 56 partially prevents
nutrient absorption by inhibiting or delaying the point at which
chyme from the stomach contacts the mucous membranes of the
intestine.
[0038] FIG. 3 illustrating a different stomach-spanning
intragastric obesity implant 60 having a cardia flange 62 and a
generally tubular antrum stent 64 connected by struts 66, while
FIG. 4 shows the implant by itself. The cardia flange 62 is a
flexible, flat partial conical ring that includes a central through
hole 68 centered at the esophageal sphincter through which food
passes. In the illustrated embodiment the cardia flange 62
comprises a braided wire mesh, such as from Nitinol covered with a
soft silicone. Likewise, the antrum stent 64 comprises a braided
wire mesh, such as from Nitinol covered with a soft silicone. It
should be noted that other configurations for the cardia flange 62
and the antrum stent 64 are contemplated; for instance, they may
alternatively be a solid silicone member with wire
reinforcements.
[0039] In the illustrated embodiment, the implant 60 further
comprises a duodenal stent 70 connected in series with the antrum
stent 64 at a narrow neck region 72. The combined somewhat
hourglass shape of the antrum stent 64, neck region 72, and
duodenal stent 70 is adapted to conform closely to the antrum,
pylorus and upper end of the duodenum. The duodenal stent 70 is
considered optional.
[0040] The struts 66 connecting the cardia flange 62 and antrum
stent 64 are preferably flexible enough to straighten out and be
passed transorally down an access tube, while also being somewhat
stiff to provide light pressure to both the cardia flange 62 and
antrum stent 64 on each end. In this way, the cardia flange 62
contacts and stimulates the cardia, and antrum stent 64 contacts
and stimulates the antrum, both helping to induce a feeling of
satiety. In a preferred embodiment there is no esophageal stent,
and the entire device resides below the esophageal sphincter. As
stated above, the duodenal stent 70 is optional and in a
configuration without it the implant 60 remains anchored in place
just by virtue of the stiffness of the struts 66 applying pressure
to both the cardia flange 62 and antrum stent 64.
[0041] In one embodiment, the central through hole 68 of the cardia
flange 62 is large enough to avoid impeding flow of food and liquid
into the stomach. Likewise, the antrum stent 64 and duodenal stent
70 may be sized to permit free flow of chime, or may be slightly
undersized so as to delay gastric emptying, and thus slow the
eating process. All of the tubular elements and the length of the
struts 66 may be custom sized to fit a variety of patients.
[0042] As with the other embodiments, the implant 60 is implanted
transorally, across the gastro-esophageal (G-E) junction, during a
minimally invasive gastroendoscopic surgical procedure. The implant
60 may easily be compressed within a delivery tube and advanced
through the esophagus to be deployed within the stomach. The
Nitinol stents easily compress down to pass through the access
tube, with the stuts 66 therebetween. One sequence includes first
expelling the antrum stent 64, and duodenal stent 70 if included,
at the antrum, and gradually withdrawing the access tube to release
the struts 66 and then the cardia flange 62. Withdrawal through a
similar tube using a grabber is also contemplated.
[0043] It should also be stated that any of the embodiments
described herein may utilize materials that improve the efficacy of
the implant. For example, a number of elastomeric materials may be
used including, but not limited to, rubbers, fluorosilicones,
fluoroelastomers, thermoplastic elastomers, or any combinations
thereof. The materials are desirably selected so as to increase the
durability of the implant and facilitate implantation of at least
six months, and preferably more than 1 year.
[0044] Material selection may also improve the safety of the
implant. Some of the materials suggested herein, for example, may
allow for a thinner wall thickness and have a lower coefficient of
friction than the implant.
[0045] The implantable devices described herein will be subjected
to clinical testing in humans. The devices are intended to treat
obesity, which is variously defined by different medical
authorities. In general, the terms "overweight" and "obese" are
labels for ranges of weight that are greater than what is generally
considered healthy for a given height. The terms also identify
ranges of weight that have been shown to increase the likelihood of
certain diseases and other health problems. Applicants propose
implanting the devices as described herein into a clinical survey
group of obese patients in order to monitor weight loss.
[0046] The clinical studies will utilize the devices described
above in conjunction with the following parameters.
[0047] Materials: [0048] a. Silicone materials used include 3206
silicone for any shells, inflatable structures, or otherwise
flexible hollow structures. Any fill valves will be made from 4850
silicone with 6% BaSo.sub.4. Tubular structures or other flexible
conduits will be made from silicone rubber as defined by the Food
and Drug Administration (FDA) in the Code of Federal Regulations
(CFR) Title 21 Section 177.2600.
[0049] Purposes: [0050] i. the devices are for human implant,
[0051] ii. the devices are intended to occupy gastric space while
also applying intermittent pressure to various and continually
changing areas of the stomach; [0052] iii. the devices are intended
to stimulate feelings of satiety, thereby functioning as a
treatment for obesity.
[0053] General Implant Procedures: [0054] i. The device is intended
to be implanted transorally via endoscope into the corpus of the
stomach. [0055] ii. Implantation of the medical devices will occur
via endoscopy. [0056] iii. Nasal/Respiratory administration of
oxygen and isoflurane to be used during surgical procedures to
maintain anesthesia as necessary.
[0057] One exemplary implant procedure is listed below. [0058] i.
Perform preliminary endoscopy on the patient to examine the GI
tract and determine if there are any anatomical anomalies which may
affect the procedure and/or outcome of the study. [0059] ii. Insert
and introducer into the over-tube. [0060] iii. Insert a gastroscope
through the introducer inlet until the flexible portion of the
gastroscope is fully exited the distal end of the introducer.
[0061] iv. Leading under endoscopic vision, gently navigate the
gastroscope, followed by the introducer/over-tube, into the
stomach. [0062] v. Remove gastroscope and introducer while keeping
the over-tube in place. [0063] vi. OPTIONAL: Place the insufflation
cap on the over-tubes inlet, insert the gastroscope, and navigate
back to the stomach cavity. [0064] vii. OPTIONAL: Insufflate the
stomach with air/inert gas to provide greater endoscopic visual
working volume. [0065] viii. Collapse the gastric implant and
insert the lubricated implant into the over-tube, with inflation
catheter following if required. [0066] ix. Under endoscopic vision,
push the gastric implant down the over-tube with gastroscope until
visual confirmation of deployment of the device into the stomach
can be determined. [0067] x. Remove the guide-wire from the
inflation catheter is used. [0068] xi. If inflated: Inflate the
implant using a standard BioEnterics Intragastric Balloon System
("BIB System") Fill kit. [0069] xii. Using 50-60 cc increments,
inflate the volume to the desired fill volume. [0070] xiii. Remove
the inflation catheter via over-tube. [0071] xiv. Inspect the
gastric implant under endoscopic vision for valve leakage, and any
other potential anomalies. Record all observations. [0072] xv.
Remove the gastroscope from over-tube. [0073] xvi. Remove the
over-tube from the patient.
[0074] End Point Criteria:
[0075] Weight Loss
[0076] Comprehensive Metabolic Panel (CMP)
[0077] HbA1C
[0078] Lipid Panel
[0079] Tissue Samples/Response
[0080] Unless otherwise indicated, all numbers expressing
quantities of ingredients, properties such as molecular weight,
reaction conditions, and so forth used in the specification and
claims are to be understood as being modified in all instances by
the term "about." Accordingly, unless indicated to the contrary,
the numerical parameters set forth in the specification and
attached claims are approximations that may vary depending upon the
desired properties sought to be obtained. At the very least, and
not as an attempt to limit the application of the doctrine of
equivalents to the scope of the claims, each numerical parameter
should at least be construed in light of the number of reported
significant digits and by applying ordinary rounding
techniques.
[0081] Notwithstanding that the numerical ranges and parameters
setting forth the broad scope of the disclosure are approximations,
the numerical values set forth in the specific examples are
reported as precisely as possible. Any numerical value, however,
inherently contains certain errors necessarily resulting from the
standard deviation found in their respective testing
measurements.
[0082] The terms "a," "an," "the" and similar referents used in the
context of describing the invention (especially in the context of
the following claims) are to be construed to cover both the
singular and the plural, unless otherwise indicated herein or
clearly contradicted by context. Recitation of ranges of values
herein is merely intended to serve as a shorthand method of
referring individually to each separate value falling within the
range. Unless otherwise indicated herein, each individual value is
incorporated into the specification as if it were individually
recited herein. All methods described herein can be performed in
any suitable order unless otherwise indicated herein or otherwise
clearly contradicted by context. The use of any and all examples,
or exemplary language (e.g., "such as") provided herein is intended
merely to better illuminate the invention and does not pose a
limitation on the scope of the invention otherwise claimed. No
language in the specification should be construed as indicating any
non-claimed element essential to the practice of the invention.
[0083] Groupings of alternative elements or embodiments of the
invention disclosed herein are not to be construed as limitations.
Each group member may be referred to and claimed individually or in
any combination with other members of the group or other elements
found herein. It is anticipated that one or more members of a group
may be included in, or deleted from, a group for reasons of
convenience and/or patentability. When any such inclusion or
deletion occurs, the specification is deemed to contain the group
as modified thus fulfilling the written description of all Markush
groups used in the appended claims.
[0084] Certain embodiments are described herein, including the best
mode known to the inventors for carrying out the invention. Of
course, variations on these described embodiments will become
apparent to those of ordinary skill in the art upon reading the
foregoing description. The inventor expects skilled artisans to
employ such variations as appropriate, and the inventors intend for
the invention to be practiced otherwise than specifically described
herein. Accordingly, this invention includes all modifications and
equivalents of the subject matter recited in the claims appended
hereto as permitted by applicable law. Moreover, any combination of
the above-described elements in all possible variations thereof is
encompassed by the invention unless otherwise indicated herein or
otherwise clearly contradicted by context.
[0085] Furthermore, references may have been made to patents and
printed publications in this specification. Each of the above-cited
references and printed publications are individually incorporated
herein by reference in their entirety.
[0086] Specific embodiments disclosed herein may be further limited
in the claims using "consisting of" or "consisting essentially of"
language. When used in the claims, whether as filed or added per
amendment, the transition term "consisting of" excludes any
element, step, or ingredient not specified in the claims. The
transition term "consisting essentially of" limits the scope of a
claim to the specified materials or steps and those that do not
materially affect the basic and novel characteristic(s).
Embodiments of the invention so claimed are inherently or expressly
described and enabled herein.
[0087] In closing, it is to be understood that the embodiments of
the invention disclosed herein are illustrative of the principles
of the present invention. Other modifications that may be employed
are within the scope of the invention. Thus, by way of example, but
not of limitation, alternative configurations of the present
invention may be utilized in accordance with the teachings herein.
Accordingly, the present invention is not limited to that precisely
as shown and described.
* * * * *