U.S. patent application number 12/270607 was filed with the patent office on 2009-07-02 for gastric space occupier systems and methods of use.
Invention is credited to Daniel J. Balbierz, David Cole, Samuel T. Crews, John Lunsford, Andrew Smith, Bretton Swope.
Application Number | 20090171383 12/270607 |
Document ID | / |
Family ID | 40799426 |
Filed Date | 2009-07-02 |
United States Patent
Application |
20090171383 |
Kind Code |
A1 |
Cole; David ; et
al. |
July 2, 2009 |
GASTRIC SPACE OCCUPIER SYSTEMS AND METHODS OF USE
Abstract
Systems for controlling obesity utilize a number of space
occupiers positioned in the stomach to reduce the effective volume
of the stomach. Such arrangements provides sufficient stomach
volume consumption to induce weight loss, but enable use of space
occupiers that are proportioned to minimize the threat of
obstruction even if they should migrate into the intestine. In
general, numerous small volume space occupiers are placed in the
stomach such that the total volume equals or exceeds the single
volume of prior art single unit space occupiers. However, each
individual space occupier is proportioned so that it will pass
without obstruction if it moves into the intestine.
Inventors: |
Cole; David; (San Mateo,
CA) ; Crews; Samuel T.; (Woodside, CA) ;
Swope; Bretton; (Gaithersburg, MD) ; Smith;
Andrew; (San Francisco, CA) ; Lunsford; John;
(San Carlos, CA) ; Balbierz; Daniel J.; (Redwood
City, CA) |
Correspondence
Address: |
King & Spalding LLP
P.O. Box 889
Belmont
CA
94002-0889
US
|
Family ID: |
40799426 |
Appl. No.: |
12/270607 |
Filed: |
November 13, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61018405 |
Dec 31, 2007 |
|
|
|
Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61F 5/0036 20130101;
A61F 5/003 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1. A gastric space occupier, comprising: a tubular balloon having a
tubular wall comprising an outer tubular layer and an inner layer
tubular disposed within the outer tubular layer, the inner and
outer tubular layers having a space therebetween, the wall defining
an elongate lumen extending through the balloon; and a fluid in the
space between the inner and outer tubular layers.
2. The gastric space occupier of claim 1, wherein the inner and
outer tubular layers are slidable relative to one another in
opposite directions.
3. The gastric space occupier of claim 2, wherein the inner and
outer tubular layers are slidable from a first arrangement in which
the inner tubular layer is disposed within the outer tubular layer,
and a second arrangement in which the outer tubular layer is
disposed within the inner tubular layer.
4. The gastric space occupier of claim 3, wherein the inner and
outer tubular layers are movable between the first and second
arrangements in response to radially inward pressure against an
outer surface of the tubular balloon.
5. The gastric space occupier of claim 1, wherein the tubular wall
is formed of an elongate tube having first and second ends, the
first and second ends sealed together to form the tubular inner and
outer layers and the space between the inner and outer tubular
layers.
6. The gastric space occupier of claim 1, further including a valve
fluidly coupled to the space.
7. The gastric space occupier of claim 1, wherein the gastric space
occupier includes a plurality of the tubular balloons.
8. A method of treating obesity in a patient, comprising: placing a
tubular balloon into a stomach, the tubular balloon including a
tubular wall comprising an outer tubular layer and an inner layer
tubular disposed within the outer tubular layer, and a space
between the inner and outer tubular layers; filling the space
between the inner and outer tubular layers with a fluid such that
the fluid is contained within the tubular wall.
9. The method of claim 8, wherein the method further includes; in
the event the tubular balloon advances from the stomach into
contact with walls of a lumen of the stomach or intestine that is
sufficiently narrow to impart radially inward pressure against the
tubular balloon, allowing the inner and outer tubular layers to
slide relative to one another in the opposite directions, causing
the tubular balloon to move proximally within the stomach.
10. The method of claim 8, wherein filling the space includes
filling the space prior to placing the tubular balloon into the
stomach.
11. The method of claim 8, wherein filling the space includes
filling the space after placing the tubular balloon into the
stomach.
12. The method of claim 8, wherein the method includes placing a
plurality of the tubular balloons into the stomach.
13. The method of claim 12, further including monitoring a rate of
weight loss by the patent, and removing at least one tubular
balloons from the stomach to decrease the rate of weight loss.
14. The method of claim 8, further including monitoring a rate of
weight loss by the patent, and placing additional tubular balloons
into the stomach to increase the rate of weight loss.
15. The method of claim 8, wherein the tubular balloon reduces the
effective volume of the stomach by an amount sufficient to cause
the patient to lose weight.
16. A gastric space occupier system comprising: an elongate member
having first and second end portions, the elongate member movable
between a first generally streamlined position in which the
elongate member is shaped for passage through the esophagus into
the stomach, and a second position in which the elongate member is
incapable of passage from the stomach into the intestine; and a
fastener positioned to couple the first and second end portions
together to retain the elongate member in the second position.
17. The gastric space occupier system of claim 16, wherein first
and second end portions have first and second ends, respectively,
and wherein the fastener is positioned to couple the first end to
the second end.
18. The gastric space occupier system of claim 17, wherein the
elongate member in the second position bounds a central
opening.
19. The gastric space occupier system of claim 18, wherein the
elongate member in the second position has a generally annular
shape.
20. The gastric space occupier system of claim 18, wherein the
elongate member in the second position defines a generally
triangular shape.
21. The gastric space occupier system of claim 20, wherein the
elongate member includes a pair of bend regions, and wherein the
elongate member is bendable at the bend regions to move the
elongate member from the first position to the second position.
22. The gastric space occupier system of claim 17, further
including an element coupled to the first end and slidably coupled
to the second end such that application of tension to the element
moves the first end towards the second end.
23. The gastric space occupier system of claim 16, further
including a plurality of the elongate members independently
introducible through the esophagus into the stomach, and each
movable to a second position incapable of passage from the stomach
into the intestine.
24. A method of treating obesity in a patient, comprising:
introducing an elongate member in a streamlined first position
through an esophagus into a stomach; moving first and second end
portions of the elongate member relatively towards one another to
position the elongate member in a second position in which the
elongate member is incapable of passage from the stomach into the
intestine; and coupling the first and second end portions together
to retain the elongate member in the second position.
25. The method according to claim 23, wherein the method further
includes: placing a plurality of the elongate members in the second
position in the stomach.
26. The method according to claim 25, wherein the elongate members
reduce the effective volume of the stomach by an amount sufficient
to cause the patient to lose weight.
27. A method of treating obesity in a patient using a gastric
implant, comprising: introducing a plurality of gastric balloons
within the stomach, each gastric balloon having a volume in the
range of approximately 50-200 cc, wherein the plurality of gastric
balloons reduce the effective volume of the stomach by an amount
sufficient to cause the patient to lose weight.
28. The method of claim 27, wherein each gastric balloon has a
volume in the range of approximately 75-125 cc.
29. The method of claim 27, further including monitoring a rate of
weight loss by the patent, and removing at least one gastric
balloon from the stomach to decrease the rate of weight loss.
30. The method of claim 27, further including monitoring a rate of
weight loss by the patent, and placing additional gastric balloons
into the stomach to increase the rate of weight loss.
31. The method of claim 27, wherein the gastric balloons
collectively occupy at least approximately 300 cc of stomach
volume.
Description
PRIORITY
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/018,405, filed Dec. 31, 2007, which is
incorporated herein by reference.
TECHNICAL FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
implants for inducing weight loss in patients, and specifically to
devices and methods for reducing the effective volume of a
patient's stomach.
BACKGROUND
[0003] Prior art treatments for obesity range from diet and
medication to highly invasive surgical procedures. Some of the more
successful surgical procedures are the vertical banded gastroplexy
or the proximal gastric pouch with a Roux-en-Y anastomosis.
However, known complications are present with each of these
procedures. More successful and less invasive options are
desired.
[0004] A less invasive prior art treatment for obesity includes
implantation of a gastric space occupier delivered into the stomach
via the esophagus. The space occupier is an obstructive device--it
prevents overeating by occupying volume within the stomach.
Although implantation of a space occupier is less invasive than
other surgical procedures, complications do exist. In particular,
because space occupiers are typically fluid filled balloons,
rupture of balloons can and does occur. A punctured balloon can
migrate into the intestines, potentially causing life-threatening
intestinal obstruction. Some prior systems attempt to avoid the
risk of migration by anchoring space occupiers within the stomach,
but these systems tend to nevertheless detach from the stomach
wall, resulting in migration. A space occupier which does not pose
the treat of obstruction is highly desirable. However, the size of
space occupier necessary for weight loss makes a single unit space
occupier design difficult.
[0005] Additionally, the stomach is a dynamic organ capable of
adapting to changes--including those associated with positioning of
a space occupier. Given the adaptive nature of the stomach, space
occupiers do not adequately provide for long term weight loss. It
would be advantageous to have a system which could accommodate such
adaptations, thus allowing for long term weight loss.
[0006] The present application describes space occupier designs
that minimize risk of obstruction, as well as methods for using the
designs in a manner that addresses stomach adaptations and/or
changes to the amount of volume consumption needed for a given
patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 schematically shows a cross-section view of a
stomach, with a plurality of space occupiers positioned within the
stomach;
[0008] FIG. 2 is similar to FIG. 1, and shows one of the space
occupiers deflated and passing through the intestine;
[0009] FIG. 3 is similar to FIG. 1 and illustrates use of a second
type of space occupier;
[0010] FIG. 4A is a side elevation view of an alternative to the
space occupier of FIG. 3;
[0011] FIG. 4B is a cross-section view taken along the plane
designated 4B-4B in FIG. 4A;
[0012] FIGS. 5 and 6 are cross-section views of the space occupier
of FIG. 4A, in which FIG. 5 shows the space occupier in an
insertion position and FIG. 6 shows locking of the space occupier
into an expanded position;
[0013] FIG. 7 is a side elevation view of yet another embodiment of
a space occupier;
[0014] FIG. 8 is similar to FIG. 1, and illustrates the ability of
the space occupier of FIG. 7 to shoot upwardly when it migrates
into contact with the pyloric sphincter;
[0015] FIGS. 9A and 9B illustrate steps in the manufacture of the
space occupier of FIG. 7.
DETAILED DESCRIPTION
[0016] The disclosed embodiments address the shortcomings of prior
art space occupier technologies. In preferred modes of use, the
disclosed systems utilize a number of space occupiers positioned in
the stomach. Such an arrangement provides sufficient stomach volume
consumption to induce weight loss, but enables use of space
occupiers that are proportioned to minimize the threat of
obstruction even if they should migrate into the intestine. In
general, numerous small volume space occupiers are placed in the
stomach such that the total volume equals or exceeds the single
volume of known space occupiers. However, each individual space
occupier is proportioned so that it will pass without obstruction
if it moves into the intestine. The devices are capable of being
inserted transorally, but once in the stomach the space occupiers
are expanded or otherwise changed into a shape or size which
prevents migration into the intestinal tract. Because they are
smaller than known space occupiers, additional individual units may
be introduced into the stomach to increase the rate of weight loss
or to accommodate changes in the stomach size.
[0017] The disclosed embodiments are preferably formed using
materials such as silicone that are capable of withstanding the
acidic environment of the stomach, and they are sufficiently soft
and appropriately shaped to be atraumatic to the tissue of the
stomach. Numerous embodiments are conceivable, a few of which are
shown herein. FIG. 1 shows a first embodiment of a space occupier
system in which a number of fluid filled space occupiers 10 are
transorally passed into the stomach. Ideally the volume of each
individual balloon is between 50-200 cc, but preferably between 75
and 125 cc. By placing two or more balloons of this size into the
stomach, adequate stomach volume is taken up such that weight loss
occurs. In some embodiments, the collective volume occupied by the
collection of space occupiers can be 300 cc or more (e.g. in a
range between approximately 300 cc and 700 cc).
[0018] Each space occupier has a deflated or compressed position
allowing its insertion into the stomach via the esophagus as shown.
The system may be provided with instruments that facilitate
implantation, such as an overtube positionable in the esophagus
(through which the space occupiers are passed), and instruments for
advancing the space occupiers through the overtube or directly
through the esophagus. Such instruments might include push tools
that push the space occupiers through the esophagus or overtube, or
graspers or alternative instruments that can be used to carry space
occupiers through the esophagus or overtube.
[0019] Once a space occupier is positioned in the stomach, fluid
(e.g. liquid, gas, gel) is introduced into the space occupier
through a valve 12. In one example, an inflation tube 14 is coupled
to the valve prior to introduction of the space occupier into the
stomach, and is subsequently detached from the space occupier
following inflation. Inflation tube is coupled to a fluid source 16
such as a fluid-filled syringe or canister. The space occupiers are
shown as spherical but may be any shape that will resist passage
into the digestive tract when filled with fluid, but that will
readily pass into the digestive tract, as shown in FIG. 2, when the
fluid is released such as through rupture.
[0020] The number of space occupier units implanted at any given
time is selected to give a target stomach volume consumption
selected to yield the desired weight loss results. Additional units
may be added, or some units removed, during the course of weight
loss treatment to increase or decrease the total volume consumption
and the corresponding rate of weight loss and/or to respond to
adaptive changes in the stomach's volume.
[0021] FIG. 3 illustrates use of an alternate form of space
occupier 10a that need not be inflatable but that is positioned in
a first streamlined shape 18a for insertion into the stomach and is
then manipulated into a different, less streamlined shape 18b that
will resist passage into the digestive tract. In this embodiment,
the space occupier 10a is an elongate band 20 having a locking
feature that joins the ends of the band to form a cylindrical
element or oval shaped element. In one configuration, the locking
feature includes a tab 22 on one end and a receptacle 24 on the
other end for receiving the tab in locking engagement.
[0022] The FIG. 3 embodiment may be constructed to form a wide
variety of alternate shapes beyond a cylindrical or oval shape. For
example, FIG. 4A shows a modification to the FIG. 3 embodiment in
which the ends of band 20a are coupled together to form a space
occupier 10b having a triangular shape. Band 20a may have a
circular cross-section as shown in FIG. 4B to give the space
occupier a smooth exterior surface. Suitable diameters for the band
range from 0.25-1 inches, or more preferably 0.5-0.75 inches.
[0023] As shown in FIG. 5, the band 20a may formed to include
predetermined bend locations 26 formed using, for example, weakened
or thinned regions of band material. In the illustrated embodiment,
bend locations are formed by forming v-shaped hinges into the band
material.
[0024] For implantation, the band is positioned in its
linear/streamlined configuration and introduced into the stomach as
shown in FIG. 3. Overtubes, pushers, graspers etc may be used to
facilitate instruction of the band into the stomach as indicated in
connection with the FIG. 1 embodiment.
[0025] Once the band has been passed into the stomach, the ends of
the band are brought together to form the band into a shape that
will be unable to pass into the intestinal tract (such a shape may
be referred to herein as a "non-passable shape"). Various tools or
actuators may be used for this purpose. In one example shown in
FIG. 5, a tether 28 is coupled to tab 22 and threaded through the
receptacle 24 and also through a pusher tube 30. To couple the ends
of the band 20a, tether 28 is withdrawn while pusher tube 30 is
pushed against the band 20a as shown in FIG. 6, causing the tab 22
to pass into and become engaged in the receptacle 24. The tether 28
and pusher 30 are proportioned such that their proximal ends may be
manipulated in this manner from outside the body. If the tab should
become disengaged, the band will return to the streamlined shape
and thus will be able to pass through the intestinal tract without
harm to the patient.
[0026] As with the FIG. 1 embodiment, multiple units of the space
occupier 10a, 10b are preferably used at one time to achieve a
desired collective volume consumption within the stomach, such as
that described in connection with the FIG. 1 embodiment. The number
of units placed in the stomach may be decreased or increased as
needed to achieve the target weight loss.
[0027] FIG. 7 illustrates yet another embodiment of a gastric space
occupier 10c having a shape that inhibits passage of the space
occupier into the digestive tract. Space occupier 10c is a tubular
balloon. The balloon has inner and outer walls 32a, 32b, and a
fluid between the inner and outer walls. A lumen 34 extends
longitudinally through the tubular balloon.
[0028] The construction of the space occupier 10c is similar to
that of a children's' toy known as a "water snake". In particular,
the space occupier is configured such that squeezing the outer
surface at one end will "squirt" the space occupier away from the
point of compression by causing the layer of wall lining the lumen
34 to roll to the outside of the balloon while the layer of wall
lining the outer surface of the balloon rolls into the lumen as
indicated by arrows in FIG. 7. This feature aids in preventing the
device from passing into the digestive tract. In particular, should
the device begin to migrate into the digestive tract, its
distal-facing end will be compressed or squeezed as it descends
into the pyloric antrum and/or abuts the pyloric sphincter. In
response to this compression, the device walls will propel the
device away from the pyloric sphincter as shown in FIG. 8
[0029] FIGS. 9A and 9B illustrate steps of manufacturing the space
occupier 10c. Referring to FIG. 9A, a tube 36 having lumen 34 is
provided. Tube 36 may have a uniform diameter, and it can be formed
of a thin-walled extrusion of silicone, urethane, or other suitable
material. The ends 40 of the tube are everted and brought together
on the exterior of the tube, thus giving the tube a double-layer
wall. Fluid is introduced into the space 38 between the layers 32a,
32b of the wall. A seal 42 is applied to seal the ends 40 together
and to seal the fluid within the space 38. Seal 42 may include a
valve, allowing the fluid to be introduced in situ as described
with respect to the FIG. 1 embodiment. Alternatively, the seal may
be provided without a valve. This embodiment may be used as a
single unit, or multiple units may be implanted in the stomach.
[0030] As with previously described embodiments, obesity using the
space occupier 10c may involve placing a single space occupier or
multiple space occupiers within the stomach to achieve a desired
collective volume consumption within the stomach, such as that
described in connection with the FIG. 1 embodiment. As with the
previous embodiments, the overall and/or rate of weight loss is
monitored, and the number of units may be decreased or increased as
needed to achieve the target weight loss or rate of weight loss.
The space occupiers 10c may be passed through an endogastric
overtube or introduced into the stomach by some other means.
[0031] The disclosed space occupiers and associated systems may be
provided with instructions for use instructing the user to utilize
the space occupiers according to the various steps described
herein.
[0032] It should be recognized that a number of variations of the
above-identified embodiments will be obvious to one of ordinary
skill in the art in view of the foregoing description. Moreover,
various features of the disclosed embodiments may be combined in a
variety of ways. Accordingly, the invention is not to be limited by
those specific embodiments and methods of the present invention
shown and described herein. Rather, the scope of the invention is
to be defined by the following claims and their equivalents.
[0033] Any and all prior patents and applications referred to
herein, including for purposes of priority, are fully incorporated
by reference.
* * * * *