U.S. patent application number 11/735194 was filed with the patent office on 2008-10-16 for apparatus and method for remote deflation of intragastric balloon.
This patent application is currently assigned to ALLERGAN, INC.. Invention is credited to Janel A. Birk.
Application Number | 20080255601 11/735194 |
Document ID | / |
Family ID | 39523333 |
Filed Date | 2008-10-16 |
United States Patent
Application |
20080255601 |
Kind Code |
A1 |
Birk; Janel A. |
October 16, 2008 |
Apparatus and method for remote deflation of intragastric
balloon
Abstract
An intragastric balloon and apparatus for remote deflation of
the balloon are disclosed. The apparatus for remote deflation
allows the physician to cause the valve of the intragastric balloon
to open without surgery using a remote control from outside of the
body. The remote deflation mechanism may be powered internally by a
battery or may be powered externally by induction. Additionally, a
deflation mechanism that causes the entire valve to be separated
from the intragastric balloon is disclosed.
Inventors: |
Birk; Janel A.; (Oxnard,
CA) |
Correspondence
Address: |
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE
CA
92612-1599
US
|
Assignee: |
ALLERGAN, INC.
Irvine
CA
|
Family ID: |
39523333 |
Appl. No.: |
11/735194 |
Filed: |
April 13, 2007 |
Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61F 2210/0014 20130101;
A61F 5/003 20130101; A61F 5/004 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. An inflatable intragastric balloon useful for facilitating
weight loss in a patient in need thereof and suitable for remote
deflation comprising: a shell for containing a volume of fluid
introduced therein; a valve for adjusting the volume of fluid in
said shell; a remotely-activated deflation mechanism for emptying
the volume of fluid in said shell; and a remote control for
communicating with said remotely-activated deflation mechanism from
outside the patient's body.
2. The intragastric balloon of claim 1, wherein said
remotely-activated deflation mechanism comprises a meltable sealing
plug.
3. The intragastric balloon of claim 1, wherein said
remotely-activated deflation mechanism comprises a shape memory
element, wherein application of heat to said shape memory element
causes said shape memory element to deform.
4. The intragastric balloon of claim 1 further comprising a quick
fill valve.
5. The intragastric balloon of claim 1, wherein said shell
comprises at least one of the following materials: diphenyl
silicone, PTFE, silicone-polyurethane elastomer, HDPE, LDPE, or
parylene coating.
6. The intragastric balloon of claim 3, wherein said shape memory
element comprises a shape memory alloy.
7. The intragastric balloon of claim 6, wherein said shape memory
element comprises NiTiNOL.
8. The intragastric balloon of claim 3, wherein said shape memory
element comprises a shape memory polymer.
9. The intragastric balloon of claim 1, wherein said
remotely-activated deflation mechanism further comprises a battery
for powering said remote deflation mechanism.
10. The intragastric balloon of claim 1, wherein said
remotely-activated deflation mechanism further comprises
microelectronics for controlling said remote deflation
mechanism.
11. The intragastric balloon of claim 1, wherein said
remotely-activated deflation mechanism is powered by induction from
outside the patient's body.
12. The intragastric balloon of claim 3, wherein said shape memory
element comprises a cutting wire, wherein application of heat to
said shape memory element causes said cutting wire to deform,
thereby forming an opening in said shell.
13. The intragastric balloon of claim 10, wherein said shape memory
element further comprises a plug proximate said cutting wire,
wherein upon application of heat, said cutting wire deforms to open
said plug.
14. The intragastric balloon of claim 3, wherein said shape memory
element comprises a spring and a plug detachably mounted thereto,
wherein upon application of heat said spring deforms to open said
plug.
15. The intragastric balloon of claim 3, wherein said shape memory
element comprises an actuator, and said remotely-activated
deflation mechanism comprises a spring collar and an obstruction
for holding said spring collar in a first position, and a slit
valve, wherein upon application of heat said actuator deforms to
eject said obstruction, thereby causing said spring collar to move
to a second position in which said slit valve opens.
16. The intragastric balloon of claim 1, wherein the valve is in a
self-contained capsule that may be ejected by a remotely-activated
deflation mechanism.
17. A method for the in vivo remote deflation and removal from a
mammalian body of an intragastric balloon containing a volume of
fluid therein comprising the steps of: remotely activating a
deflation mechanism to create an opening in the shell; allowing
normal intragastric movements to drain fluid from the balloon; and
allowing the deflated balloon to pass through the body.
Description
BACKGROUND OF INVENTION
[0001] 1. Field of the Invention
[0002] The present invention is directed to devices and methods
that enable remote deflation of intragastric balloons used for the
treatment of obesity, and in particular devices and methods that
enable an implanted intragastric balloon to be remotely deflated
while the device itself is in the stomach.
[0003] 2. Description of the Related Art
[0004] Intragastric balloons are well known in the art as a means
for treating obesity. 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 (sold under the
trademark BIB.RTM.). 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.
[0005] The BIB System, for example, consists of a silicone
elastomer intragastric balloon that is inserted into the stomach
and filled with fluid. Commercially available intragastric balloons
are filled with saline solution or air. The intragastric balloon
functions by filling the stomach and enhancing appetite control.
Placement of the intragastric balloon is non-surgical, usually
requiring no more than 20-30 minutes. The procedure is performed
gastroscopically in an outpatient setting, typically using local
anesthesia and sedation. Placement is temporary, and intragastric
balloons are typically removed after six months.
[0006] Most intragastric balloons utilized for this purpose 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.
Clinical results with these devices show that for many obese
patients, the intragastric balloons significantly help to control
appetite and accomplish weight loss.
[0007] Intragastric balloons typically are implanted for a finite
period of time, usually lasting approximately six months. This time
period may be shortened by a treating physician who wishes to alter
the patient's treatment and remove the balloon prior to the six
month period. In any event, at some point after the balloon has
been surgically placed in the stomach, it will become desirable to
remove the balloon from the stomach. One of the means of removing
the balloon is to deflate it by puncturing the balloon, and either
aspirating the contents of the balloon or allowing the fluid to
pass into the patient's stomach. This means of removing saline from
the balloon requires surgical intervention, through the use of a
gastroscopic instrument. When the balloon is deflated in this
manner, the balloon itself may be surgically removed using the
gastroscopic instrument.
[0008] Alternatively, if the balloon is left in place beyond its
designed lifetime, the acids present in a patient's stomach may
erode the balloon to the point where it self-deflates. When this
occurs, the deflated balloon may pass naturally through the
patient's digestive system and be expelled through the bowel.
[0009] Those experienced in the art will readily appreciate that
manipulating the balloon in situ in order to deflate the balloon
can be difficult. This is because the balloon is slippery and
positionally unstable. The usually spherical or ellipsoidal
intragastric balloons may readily rotate in the stomach, making it
difficult for a surgeon to manipulate the balloon in order to find
a deflation valve, or to safely puncture the balloon using a
surgical instrument.
[0010] It may become desirable, then, particularly when the balloon
is to be removed from the body, to cause the deflation of the
balloon remotely without surgical intervention.
[0011] Therefore, the present invention is directed at overcoming
the problems associated with the prior art systems. These and other
objects of the present invention will become apparent from the
further disclosure to be made in the detailed descriptions given
below.
SUMMARY OF THE INVENTION
[0012] The present invention addresses the above-described problems
by providing apparatuses and methods for the remote deflation of an
intragastric balloon. The present invention allows a physician to
remotely deflate an intragastric balloon from outside the body,
utilizing a remote control that triggers the deflation with an
activation signal.
[0013] In one preferred embodiment, the apparatus of the present
invention includes a meltable wax plug that melts to cause the
opening of a valve. Upon receipt of an activation signal sent by
the physician from a remote control outside the body, the
microelectronics contained in the valve assembly cause the
temperature of heating element(s) contained within the valve to
melt the wax plug. Once the wax plug has melted, thus causing the
balloon valve to open, the normal movements of the stomach cause
the fluid contained within the balloon to empty from the balloon,
causing deflation. The patient is able to then pass the
balloon.
[0014] In another preferred embodiment, the apparatus of the
present invention includes a remote deflation valve having a shape
memory element spring that holds a plug in place, thus sealing the
valve of the intragastric balloon. The shape memory element spring
may be heated remotely by induction, or the deflation mechanism may
include microelectronics to cause heating of the spring. As the
spring changes shape as a result of the application of heat, it
removes the plug, thus causing the balloon to unseal. The fluid
contained in the balloon may then flow freely out of the balloon,
thus causing the balloon to deflate. The patient is then able to
safely pass the deflated balloon.
[0015] According to yet another embodiment of the present
invention, the intragastric balloon includes a remote deflation
mechanism with a shape memory element actuator, a spring collar, an
obstruction that holds the spring collar in place and a slit valve.
As with the other embodiments disclosed, the shape memory element
actuator may be heated remotely by induction or may alternatively
include microelectronics and heating elements contained within the
deflation mechanism. When the deflation mechanism is activated, the
actuator pushes the obstruction out of the valve, thus allowing the
spring collar to contract. The contraction of the spring collar
causes the slit valve to open, which allows fluid contained in the
balloon to flow out of the balloon and drain accordingly. The
patient is then able to pass the deflated balloon.
[0016] In another preferred embodiment of the present invention, a
shape memory element "cutting wire" is employed in the remote
deflation mechanism. In this embodiment, when heat is applied to
the shape memory alloy wire contained within a remote deflation
valve, the wire changes shape, causing the wire to cut through a
wax (or other suitable material, e.g. plastic or polymer) plug that
seals the valve. Once the wax plug has been cut from the valve,
fluid is able to freely flow through the valve, thus allowing the
balloon to drain and pass from the body.
[0017] In still yet another preferred embodiment of the present
invention, the remote deflation mechanism of the intragastric
balloon includes a wire that surrounds the valve. The wire is used
to break the bond between the valve and the balloon. When the bond
between balloon and the valve is broken, the valve separates from
the balloon, and fluid flows freely from the balloon. This
preferred embodiment has the added benefit that the balloon and
valve assembly may pass through the body separately, thus allowing
passage to occur more easily, as the device is in two separate
pieces. These and various other aspects of the invention, and its
advantages, will be discussed in more detail below.
[0018] In another embodiment, the valve could be contained in a
cylindrical capsule (taking the shape of a large pill, for example)
that fits within a collared opening of the balloon shell to create
a seal. The collared opening could include a spring or other such
mechanism that would retain the size and shape of the collar. When
the remote deflation mechanism is activated, the spring is
released, thereby opening the collar and ejecting the cylindrical
capsule from the balloon, rendering two separate components that
could then easily pass through the gastrointestinal track.
Alternatively, the collared opening could include a heating
element, which when the remote deflation mechanism is activated,
would cause the seal between the capsule and the collar to break,
thereby ejecting the cylindrical capsule from the balloon. As yet a
further alternative, the cylindrical capsule could contain a
mechanism such as a spring (a torsional spring, for example), that
retains the shape and size of the capsule, holding the capsule in
place within the collared opening of the balloon shell. When the
remote deflation mechanism is activated, the torsional spring
collapses, causing the capsule to be ejected from the balloon.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is an elevated side view of an intragastric balloon
of the present invention.
[0020] FIG. 2a is a side cut-away view of a remote deflation valve
according to one embodiment of the present invention, which shows
the valve in the "closed" position.
[0021] FIG. 2b is a side cut-away view of the remote deflation
valve of FIG. 2a shown in the "open" position.
[0022] FIG. 3a is a side cut-away view of a remote deflation valve
according to a further embodiment of the present invention, which
shows the valve in the "closed" position.
[0023] FIG. 3b is a side cut-away view of the remote deflation
valve of FIG. 3a shown in the "open" position.
[0024] FIG. 4a is a side view of a remote deflation valve according
to yet a further embodiment of the present invention, which shows
the valve in the "closed" position.
[0025] FIG. 4b is a side cut-away view of the remote deflation
valve of FIG. 4a shown in the "open" position.
[0026] FIG. 5a is a side view of the remote deflation valve of FIG.
4a which shows the valve in the "closed" position.
[0027] FIG. 5b is a side view of the remote deflation valve of FIG.
4b shown in the "open" position.
[0028] FIG. 6a is a side cut-away view of a remote deflation valve
according to still a further embodiment of the present invention,
which shows the valve in the "closed" position.
[0029] FIG. 6b is a side cut-away view of the remote deflation
valve of FIG. 6a shown in the "open" position.
[0030] FIGS. 7a and 7b show a top view of an embodiment of the wire
cutting mechanism of the remote deflation valve of FIGS. 6a and
6b.
[0031] FIGS. 7c and 7d show a further embodiment of the wire
cutting mechanism of the remote deflation valve of FIGS. 6a and
6b.
[0032] FIG. 8a shows an elevated side view of an intragastric
balloon of the present invention with a deflation mechanism
surrounding the valve prior to the deflation mechanism being
activated.
[0033] FIG. 8b shows an elevated side view of FIG. 8a after the
deflation mechanism has been activated.
[0034] FIG. 9 is a front view of a remote control for activating a
remote deflation valve according to the present invention.
[0035] FIG. 10a is a side cut-away view of a remote-deflating
intragastric balloon according to still a further embodiment of the
present invention, which shows the balloon in the "closed"
position.
[0036] FIG. 10b is a side cut-away view of the remote-deflating
intragastric balloon of FIG. 10a shown in the "open" position.
[0037] FIG. 11 is a side cut-away view of a remote-deflating
intragastric balloon according to still a further embodiment of the
present invention, which shows the balloon in the "closed"
position.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0038] The present invention is directed to a method and device for
remotely deflating an intragastric balloon without requiring
surgical intervention.
[0039] Referring to FIGS. 1-2b, the intragastric balloon according
to one preferred embodiment of the present invention is shown. The
intragastric balloon 10 includes a shell 12, fill valve 14, and
remote deflation valve 16.
[0040] During implantation, an un-inflated balloon 10 may be
positioned in the stomach in a desired location. Once the balloon
is positioned, it may be inflated using fill valve 14, and those
experienced in the art will appreciate that there are several
different methods for inflating the balloon, such as disclosed in
commonly assigned International Application Number PCT U.S.
03/19414, entitled "Two Way Slit Valve", the disclosure of which is
incorporated in its entirety herein by reference.
[0041] After implantation, it may become desirable to remove the
balloon. In order to remove the balloon it must first be deflated.
Once deflated, the balloon may be allowed to naturally pass through
the body upon deflation, or alternatively the balloon may be
surgically removed using a minimally invasive gastroscopic
procedure. The present invention is designed such that the deflated
intragastric balloon and integrated remote deflation valve may
naturally pass through the human body.
[0042] Referring to FIGS. 2a and 2b, a preferred embodiment of the
remote deflation valve of the present invention is shown. Remote
deflation valve 16 is comprised of sealing plug 30, heating
element(s) 31, microelectronic control 32 and power source 33. The
power source 33 may be a battery, capacitor, induction coil,
kinetic energy creation by body motion stored onto a capacitor,
fuel cell, power source powered by chemistry of the body, or a
power source powered by temperature change. The sealing plug 30 is
preferably formed of suitable medical-grade wax, such as paraffin,
or may also be a lower temperature melt polymer. Any type of
suitable medical-grade wax, such as paraffin, may be used for
sealing plug 30.
[0043] At the time the physician desires to deflate the balloon,
the patient may be brought into the physician's office in an
outpatient setting. In order to open deflation valve 16, the
physician activates the valve opening mechanism remotely and from
outside the body, using a remote control 100 such as that depicted
in FIG. 9. The physician holds remote control 100 near the stomach
of the patient, and upon depression of button 101, remote control
100 sends an activation signal, which my be comprised of radio
waves, sonic waves, or any other waves suitable for transmitting a
small activation signal through the tissue of the abdominal cavity
to the implanted balloon.
[0044] Microelectronic control 32 has an antenna (not shown) for
receiving the activation signal from remote control 100. Upon
receiving the activation signal, microelectronic control uses power
from power source 33 to begin increasing the temperature of the
heating element(s) 31. A metal film heating element, utilizing
metals (such as nichrome, stainless steel, copper, gold, etc.) can
be used for heating element(s) 31. As the temperature of the
heating element(s) 31 begins to increase, the sealing plug 30
begins to melt. Ideally, the melting point of the sealing plug will
be slightly above the temperatures in the stomach to ensure that
the valve stays closed in its normal operating environment.
[0045] As the sealing plug begins to melt, it is expelled into the
stomach and/or collects on wicking surfaces 34, which may be
composed of a contoured reservoir. Ideally the wax will melt and be
expelled into the stomach for rapid quench cooling and passage
through the intestines. The collection of the wax or other sealing
material on wicking surfaces 34 prevents it from clogging
capillaries 35 and allows the fluid contained within intragastric
balloon 10 to flow out of the balloon. Once the sealing plug is
completely melted and been expelled into the stomach and/or
collected on wicking surfaces 34, capillaries 35 allow the free
flow of the fluid contained inside the balloon through valve
opening 36 (FIG. 2b). Through the normal movements and contraction
of the stomach walls, the balloon will drain of the fluid contained
inside and shrink down to a size that is passable through the body.
The microelectronics, heating element, and power source are safely
contained within the valve structure such that they do not present
any danger to the patient.
[0046] In addition to performing the function of controlling the
heating element for the melting of the sealing plug, the
microelectronic control 32 may communicate with the remote control
100 to confirm that the deflation mechanism has been activated.
Following receipt of a confirmation signal, the physician and
patient may then track the progress of the passing of the
device.
[0047] Referring to FIGS. 3a and 3b, another preferred embodiment
of the remote deflation valve of the present invention is shown.
Remote deflation valve 26 is comprised of a shape memory spring 41,
plug 42, and capillaries 43. While NiTiNOL is the preferred
material for the spring utilized in the present invention, any
number of shape memory alloys or polymers, or spring materials,
including steels (such as stainless steel, chromium, titanium,
etc.), may be used.
[0048] As with the valve mechanism discussed in the previous
embodiment, at the time the physician desires to deflate the
balloon, the patient may be brought into the physician's office in
an outpatient setting.
[0049] In order to open deflation valve 26, the physician activates
the deflation mechanism from outside the body, using a remote
control (not shown). The spring may be heated remotely by induction
from the remote control, or may alternatively include
microelectronics for receiving an activation signal and controlling
heating elements similar to those described in the previous
embodiment.
[0050] Irrespective of the method of activation, when the spring 41
is heated, it contracts, pulling the plug 42 out of its resting
place and into reservoir 44. This causes channel 45 to open, thus
allowing the fluid contained in the balloon to flow through the
capillaries 43 and open channel 45, out of the balloon. FIG. 3b
shows the valve mechanism in its open position. Because of pressure
normally exerted on the balloon by the stomach, the fluid contained
therein will flow freely through the capillaries and open channel
and into the stomach, thus causing the balloon to deflate. The
deflated intragastric balloon is then allowed to pass out of the
body.
[0051] As an alternative to having a shape memory spring
permanently fixed to a plug, the spring may be detachably fixed to
a plug comprised of wax or some other similar biodegradable
material. In this way, when the spring is heated and changes shape,
it may be used to eject the biodegradable plug into the stomach,
thus allowing the balloon to drain. The deflated intragastric
balloon would then be allowed to pass out of the body.
[0052] Referring to FIGS. 4a, 4b, 5a, and 5b, another preferred
embodiment of a remote deflation valve of the present invention is
shown. FIGS. 4a and 4b show a cutaway side view of remote deflation
valve 56, while FIGS. 5a and 5b show the same valve in a side view.
Remote deflation valve 56 is comprised of a shape memory actuator
61, obstruction 62, slit valve 63 and spring collar 64. As
previously discussed, while NiTiNOL is the preferred material for
the actuator of the present invention, any number of shape memory
alloys or polymers may be used.
[0053] In order to open deflation valve 56, the physician activates
the valve opening mechanism remotely and from outside the body,
using remote control 100. The actuator 61 may be heated remotely by
induction or alternatively the remote deflation valve may include
microelectronics and heating elements.
[0054] Irrespective of the method of activation, the actuator 61,
when activated, pushes obstruction 62 out of the valve opening.
When in place, obstruction 62 serves to prevent the slit valve 63
from opening by causing spring collar 64 to be held in its open
position, as shown in FIGS. 4a and 5a. Once the obstruction 62 is
removed from the valve opening, spring collar 64, which is located
below the slit valve 63, contracts. The contraction of spring
collar 64 causes the slit valve 63 to be opened, as shown in FIG.
4b and 5b. With the slit valve 63 now open, the fluid contained in
the balloon may flow through channel 65 and out through the slit
valve opening 66. Again, because the intragastric balloon is under
pressure, and due to the normal movements of the stomach, the fluid
contained therein will flow freely through open slit valve 63 and
into the stomach, thus causing the balloon to deflate. The deflated
intragastric balloon is then allowed to pass out of the body.
[0055] Referring to FIGS. 6a and 6b, an interior cutaway view of
another preferred embodiment of the remote deflation valve of the
present invention is shown. Remote deflation valve 76 is comprised
of a shape memory alloy cutting wire mechanism 81, sealing plug 82,
and capillary 83. NiTiNOL is used in this preferred embodiment,
however, any number of suitable shape memory alloys may be
used.
[0056] As with the previous embodiments discussed, in order to open
valve 76, the physician activates the valve opening mechanism
remotely and from outside the body, using remote control 100 (FIG.
9). In this embodiment, the remote deflation valve 76 includes
microelectronics (not shown), a battery or other power source (not
shown) and heating element(s) 85 (FIGS. 7a-7d) for heating the
shape memory alloy cutting wire 84 (FIGS. 7a-7d). As with the
previous embodiments discussed, however, the shape memory alloy
cutting wire may be heated by induction.
[0057] FIGS. 7a, 7b, 7c, and 7d show top views of the cutting wire
mechanism 84. As heat is applied by the heating elements, the shape
memory element begins to change shape. FIG. 7a shows the shape
memory element cutting wire 84 prior to the application of heat.
Prior to the application of heat, the shape memory element cutting
wire 84 is in a curved L-shape, with the curved portion resting
around the outside of wax plug 82. As an alternative to the
L-shaped shape memory element cutting wire 84 of FIG. 7a, the
cutting wire may also be in a loop shape that completely encircles
the wax plug, as is shown in FIG. 7c.
[0058] In this embodiment, the shape memory element cutting wire
mechanism 81 is activated by a signal received from remote control
100 (FIG. 9). Upon receiving the activation signal, the
microelectronic control (not shown) uses power from the power
source (not shown) to begin increasing the temperature of heating
element(s) 85. As the shape memory element cutting wire 84 begins
to change shape as a result of the application of heat, it slices
through the sealing plug 82. FIGS. 7b and 7d show the shape memory
alloy cutting wire 84 in its post-heat application deformed shape,
having cut through the sealing plug 82. FIG. 7a shows a shape
memory alloy cutting wire in an L-shaped configuration, while FIG.
7c shows a shape memory alloy cutting wire in a loop shaped
configuration.
[0059] With the sealing plug 82 having been severed from the valve,
the capillary 83 (FIG. 6b) is now open to allow fluid contained
within the intragastric balloon to escape the balloon. Again,
because the intragastric balloon is under pressure and due to the
normal movements of the stomach, the fluid contained in the balloon
will flow freely through the capillary and into the stomach, thus
causing the balloon to deflate. The deflated intragastric balloon
is then allowed to pass out of the body.
[0060] Referring to FIGS. 8a and 8b, another preferred embodiment
of an intragastric balloon of the present invention incorporating a
remote deflation mechanism is shown. Intragastric balloon 90 is
comprised of shell 97, valve 91, valve/balloon bond 92, heating
elements 93, cutting wire 94, microelectronic control 95, and power
source 96.
[0061] Rather than using a remote deflation mechanism to open the
valve of the intragastric balloon, the embodiment of the present
invention shown in FIGS. 8a and 8b utilizes a deflation mechanism
for separating the entire valve from the remaining portion of the
balloon.
[0062] Similar to the procedures described above, at the time the
physician desires to deflate the balloon, the patient may be
brought into the physician's office in an outpatient setting. In
order to cause the intragastric balloon 90 to deflate, the
physician activates the valve opening mechanism remotely and from
outside the body, using a remote control 100 (FIG. 9). The
physician holds remote control 100 near the stomach of the patient,
and upon depression of a button, remote control 100 sends an
activation signal to the microelectronic control 95.
[0063] Microelectronic control 95 has an antenna (not shown) for
receiving the activation signal from remote control 100. Upon
receiving the activation signal, microelectronic control uses power
from power source 96 to begin increasing the temperature of heating
element(s) 93. Similar to the embodiments discussed above that
incorporate heating elements, metal film heating elements utilizing
materials such as nichrome, stainless steel, copper, gold, or other
such materials, can be used for heating element(s) 93. As the
temperature of heating element(s) 93 begin to increase, the
temperature of cutting wire 94 also begins to increase. The
increased temperature of the cutting wire causes the valve/balloon
bond 92 to deteriorate, resulting in separation of the valve 91
from shell 97.
[0064] Once the valve/balloon bond 92 is broken and the valve is
separated from the shell, fluid contained inside the balloon freely
flows through the opening 98 that is created by the separation of
the two portions. Through the normal movements and contraction of
the stomach walls, the balloon will drain of the fluid contained
inside and shrink down to a size that is passable through the human
body. The microelectronics, heating element(s) and power source are
safely contained within the valve structure such that they do not
present any danger to the patient. Because the entire intragastric
balloon may now be in two separate pieces--an empty shell and a
self-contained valve assembly--the passing of the balloon and valve
is facilitated.
[0065] As with the previous embodiments described, in addition to
performing the function of controlling the heating elements, the
microelectronic control 95 may communicate with the remote control
100 to confirm that the deflation mechanism has been activated.
Following receipt of a confirmation signal, the physician and
patient may then track the progress of the passing of the
device.
[0066] Referring to FIGS. 10a and 10b, another preferred embodiment
of an intragastric balloon of the present invention incorporating a
remote deflation mechanism is shown. Intragastric balloon 109 is
comprised of shell 110 and valve capsule 111. Valve capsule 111 is
comprised of valve 112, shape memory torsional spring 113, and
combined microelectronic control and power source 115. FIG. 10a
also shows adjustment tool 121 for adjusting the volume of the
intragastric balloon 109.
[0067] Rather than using a remote deflation mechanism to open the
valve of the intragastric balloon, the embodiment of the present
invention shown in FIGS. 10a and 10b utilizes a deflation mechanism
for separating the entire valve capsule from the remaining portion
of the balloon. When inflated, the valve capsule 111 is held
tightly in the balloon collar 114 by pressure exerted by shape
memory torsional spring 113, creating a seal between the valve
capsule and the balloon collar.
[0068] Similar to the various procedures described above, at the
time the physician desires to deflate the balloon, the patient may
be brought into the physician's office in an outpatient setting. In
order cause the intragastric balloon 109 to deflate, the physician
activates the valve opening mechanism remotely and from outside the
body, using a remote control 100 (FIG. 9). The physician holds
remote control 100 near the stomach of the patient, and upon
depression of a button, remote control 100 sends an activation
signal to the combined microelectronic control and power source
115.
[0069] Combined microelectronic control and power supply 115 has an
antenna (not shown) for receiving the activation signal from remote
control 100. Upon receiving the activation signal, combined
microelectronic control and power source uses power to begin
increasing the temperature of heating element(s) (not shown) that
are connected to the torsional spring 113. Similar to the
embodiments discussed above that incorporate heating elements,
metal film heating elements utilizing materials such as nichrome,
stainless steel, copper, gold, or other such materials, can be used
for the heating element(s). As the temperature of the heating
element(s) begin to increase, the temperature of shape memory
torsional spring 113 also begins to increase, thereby causing the
spring to deform and reduce in diameter. As the diameter decreases,
the seal between valve capsule 111 and balloon collar 114 is
broken.
[0070] Once the seal between the balloon collar 114 and valve
capsule 111 is broken and the valve capsule is separated from the
shell, fluid contained inside the balloon freely flows through the
opening 116 (FIG. 10b) that is created by the separation of the two
portions. Through the normal movements and contraction of the
stomach walls, the balloon will drain of the fluid contained inside
and shrink down to a size that is passable through the human body.
The combined microelectronic control and power supply and heating
element(s) are safely contained within the valve capsule such that
they do not present any danger to the patient. Because the entire
intragastric balloon may now be in two separate pieces--an empty
shell and a self-contained valve capsule--the passing of the
balloon and valve is facilitated.
[0071] As with the previous embodiments described, in addition to
performing the function of controlling the heating elements, the
combined microelectronic control and power supply 115 may
communicate with the remote control 100 to confirm that the
deflation mechanism has been activated. Following receipt of a
confirmation signal, the physician and patient may then track the
progress of the passing of the device.
[0072] Referring to FIG. 11, another preferred embodiment of an
intragastric balloon of the present invention incorporating a
remote deflation mechanism is shown. Intragastric balloon 129 is
comprised of shell 130 and valve capsule 131. Valve capsule 131 is
comprised of valve 132, and combined microelectronic control and
power source 135. Shell 130 is comprised of a collar 136, heating
element 137, and shape memory cutting element 138. FIG. 11 also
shows adjustment tool 141 for adjusting the volume of the
intragastric balloon 129.
[0073] As with several of the other embodiments previously
discussed, rather than using a remote deflation mechanism to open
the valve of the intragastric balloon, the embodiment of the
present invention shown in FIG. 11 utilizes a deflation mechanism
for separating the entire valve capsule from the remaining portion
of the balloon. When inflated, the valve capsule 131 is held
tightly in the balloon collar 114 by pressure exerted by shape
memory element 138, creating a seal between the valve capsule and
the balloon collar.
[0074] Similar to the various procedures described above, at the
time the physician desires to deflate the balloon, the patient may
be brought into the physician's office in an outpatient setting. In
order cause the intragastric balloon 129 to deflate, the physician
activates the valve opening mechanism remotely and from outside the
body, using a remote control 100 (FIG. 9). The physician holds
remote control 100 near the stomach of the patient, and upon
depression of a button, remote control 100 sends an activation
signal to the combined microelectronic control and power source
135.
[0075] Combined microelectronic control and power supply 135 has an
antenna (not shown) for receiving the activation signal from remote
control 100. Upon receiving the activation signal, combined
microelectronic control and power source uses power to begin
increasing the temperature of heating element(s) 137 that are
connected to the shape memory cutting element 138. Similar to the
embodiments discussed above that incorporate heating elements,
metal film heating elements utilizing materials such as nichrome,
stainless steel, copper, gold, or other such materials, can be used
for the heating element(s). As the temperature of the heating
element(s) begin to increase, the temperature of shape memory
cutting element 138 also begins to increase, thereby causing the
cutting element to cut through the balloon collar 136. With the
balloon collar 136 completely cut, the seal between valve capsule
131 and balloon collar 136 is broken.
[0076] Once the seal between the balloon collar 136 and valve
capsule 131 is broken and the valve capsule is separated from the
shell, fluid contained inside the balloon freely flows through the
opening that is created by the separation of the two portions.
Through the normal movements and contraction of the stomach walls,
the balloon will drain of the fluid contained inside and shrink
down to a size that is passable through the human body. The
combined microelectronic control and power supply and heating
element(s) are safely contained within the valve capsule such that
they do not present any danger to the patient. Because the entire
intragastric balloon may now be in two separate pieces--an empty
shell and a self-contained valve capsule--the passing of the
balloon and valve is facilitated. As an alternative to the cutting
mechanism described herein, the remote deflation mechanism may be
comprised of a mechanical system (such as a torsional spring)
contained within the collar which holds the valve capsule in place
until the balloon deflation mechanism is initiated.
[0077] As with the previous embodiments described, in addition to
performing the function of controlling the heating elements, the
combined microelectronic control and power supply 135 may
communicate with the remote control 100 to confirm that the
deflation mechanism has been activated. Following receipt of a
confirmation signal, the physician and patient may then track the
progress of the passing of the device.
[0078] To ensure the device of the present invention will pass
easily, the intragastric balloon of the present invention may be
constructed of a very thin, highly acid-resistant shell material.
In addition, the intragastric balloon may be shaped to encourage
collapse into a bullet shape for smooth passage through the
intestines. This shape may be created by pre-formed convolutions in
the shell that would expand into a substantially spherical or
ellipsoidal shape when inflated, but would retract into its small
collapsed shape when the remote deflation mechanism was
triggered.
[0079] The remote control will take the form of a handheld control
unit that may feature an LCD display and/or similar type of display
and a control panel, such as a keyboard or touchscreen, to operate
the device. The remote control may feature a series of menus that
allow an operator to program (or read/determine) the
microelectronics to contain in memory important information such as
the intragastric balloon's size, patient's name, implanting
physician, and the date it was implanted. The remote control may
communicate with the sensor via telemetry through radiowaves. The
FDA and globally recognized communications band (WMTS 402-405 Mhz)
may be used in some embodiments, and an authentication process
(e.g., digital handshake signal, PIN verification, or other similar
verification process) can be used to ensure that the device cannot
be accidentally accessed or controlled by another control mechanism
other than the remote control. The telemetry control signal can be
sent from approximately a foot or possibly a greater distance from
the patient and will typically not require the patient to disrobe
to query the sensor or to change its parameters. The remote control
is preferably able to read and write information to the
microelectronics contained in the intragastric balloon. The remote
control may also be password controlled to prevent unauthorized
personnel from querying the device. The display of the remote
control, which may include visual and audio outputs, typically will
display or output the sensed parameter of the remote deflation
valve's condition or physical parameter whether this parameter is
"open", "closed", or any other physical parameter that the remote
control is adjusted to monitor.
EXAMPLES
[0080] The following examples describe various procedures using the
method and device of the present invention.
Example 1
Remote Deflation of an Intragastric Balloon Containing a Sealing
Plug
[0081] In this example, the patient is an overweight male who has
previously had an intragastric balloon inserted into his stomach.
The intragastric balloon has been implanted for a full course of
treatment for six months, and the surgeon is prepared to remove the
balloon.
[0082] The removal of the balloon is performed in an outpatient
setting at the doctor's office. Reference is made to FIGS. 2a and
2b for the remote deflation valve utilized in this example.
[0083] In order to open deflation valve 16, the physician activates
the remote deflation mechanism from outside the body using a remote
control 100, such as that depicted in FIG. 9. The physician holds
remote control 100 near the stomach of the patient, and upon
depression of a button, remote control 100 sends an activation
signal through the patient's tissue to the microelectronic control
32.
[0084] Upon receiving the activation signal, microelectronic
control 32 uses power from a battery 33 to begin increasing the
temperature of heating element(s) 31. As the temperature of heating
element(s) 31 begins to increase, the wax plug 30 begins to
melt.
[0085] As the wax begins to melt, it collects on wicking surfaces
34. The collection of the wax on wicking surfaces 34 prevents the
wax from clogging capillaries 35 and allows the fluid contained
within intragastric balloon 10 to flow out of the balloon. Once the
wax is melted and collected on wicking surfaces 34, capillaries 35
allow the free flow of the fluid contained inside the balloon
through valve opening 36. In addition, once the wax is melted, the
microelectronic control 32 sends a confirmation signal to the
remote control 100, informing the doctor and patient that the
deflation device has been activated.
[0086] Through the normal movements and contraction of the stomach
walls, the balloon drains of the saline contained inside and
shrinks down to a size that is passable through the human body. The
microelectronics, heating elements, and battery are safely
contained within the valve structure such that they do not present
any danger to the patient.
[0087] Having received the confirmation signal, the patient may now
leave the doctor's office and return home. The patient tracks the
passage of the intragastric balloon and informs the doctor when it
has passed.
Example 2
Remote Deflation of an Intragastric Balloon Containing a Separable
Valve
[0088] In this example, the patient is an overweight female who has
previously had an intragastric balloon implanted. After
implantation the patient has experienced significant undesired side
effects resulting from the implantation, including nausea,
vomiting, and general abdominal discomfort. Therefore, the patient
desires to have the remote deflation mechanism activated, thus
allowing the balloon to be passed.
[0089] As with the first example, the balloon removal is performed
in an outpatient setting at the doctor's office. Reference is made
to FIGS. 8a and 8b for the remote deflation mechanism utilized in
this example.
[0090] In order to cause the intragastric balloon 90 to deflate,
the physician activates the remote deflation mechanism using a
remote control 100, such as that depicted in FIG. 9. The physician
positions remote control 100 near the stomach of the patient, and
upon depression of a button, remote control 100 sends an activation
signal through the tissue of the abdominal cavity to the
microelectronic control 95.
[0091] Microelectronic control 95 has an antenna for receiving the
activation signal from remote control 100. Upon receiving the
activation signal, microelectronic control uses power from battery
96 to begin increasing the temperature of heating element(s) 93. As
the temperature of heating element(s) 93 begins to increase, the
temperature of cutting wire 94 also begins to increase. The
increased temperature of the cutting wire causes the valve/balloon
bond 92 to deteriorate, resulting in separation of the valve 91
from shell 97.
[0092] As the valve/balloon bond 92 breaks and separates from the
shell, the normal movements of the stomach cause the fluid
contained inside the balloon to freely flow through the opening 98.
The normal movements and contraction of the stomach walls cause the
intragastric balloon to completely drain of the fluid contained
inside and shrink down to a size that is passable through the human
body. The microelectronics, heating elements and battery are safely
contained within the valve structure such that they do not present
any danger to the patient. Because the entire intragastric balloon
may now comprise two separate pieces, the passing of the balloon
and valve is facilitated.
[0093] Once the valve/balloon bond has been broken, the
microelectronic control 95 sends a confirmation signal to remote
control 100 to confirm that the deflation mechanism has been
activated. Following receipt of a confirmation signal by the remote
control, the procedure is complete and the patient can return home
and wait until the shell and valve assembly pass through the
system. The patient tracks the passage of the intragastric balloon
and informs the doctor when its has passed.
[0094] Although the invention has been described and illustrated
with a certain degree of particularity, it is understood that the
present disclosure has been made only by way of example, and that
numerous changes in the combination and arrangement of parts can be
resorted to by those skilled in the art without departing from the
spirit and scope of the invention, as hereinafter claimed.
Example 3
Remote Deflation of an Intragastric Balloon Containing a Valve
Capsule
[0095] In this example, the patient is an overweight male who has
previously had an intragastric balloon inserted into his stomach.
The intragastric balloon has been implanted for a full course of
treatment for six months, and the surgeon is prepared to remove the
balloon.
[0096] The removal of the balloon is performed in an outpatient
setting at the doctor's office. Reference is made to FIGS. 10a and
10b for the remote deflation valve utilized in this example.
[0097] In order to deflate balloon 109, the physician activates the
remote deflation mechanism from outside the body using a remote
control 100, such as that depicted in FIG. 9. The physician holds
remote control 100 near the stomach of the patient, and upon
depression of a button, remote control 100 sends an activation
signal through the patient's tissue to the combined microelectronic
control and power source 115.
[0098] Upon receiving the activation signal, the combined
microelectronic control and power source 115 uses power to begin
increasing the temperature of heating element(s) (not shown) that
are connected to the torsional spring 113. As the temperature of
the heating element(s) begin to increase, the temperature of shape
memory torsional spring 113 also begins to increase, thereby
causing the spring to deform and reduce in diameter. As the
diameter decreases, the seal between valve capsule 111 and balloon
collar 114 is broken. The valve capsule is separated from the
shell, and fluid contained inside the balloon freely flows through
the opening 116 (FIG. 10b) that is created by the separation of the
two portions.
[0099] Through the normal movements and contraction of the stomach
walls, the balloon drains of the saline contained inside and
shrinks down to a size that is passable through the human body. The
combined microelectronics control and power supply and heating
element(s) are safely contained within the valve capsule such that
they do not present any danger to the patient.
[0100] Having received the confirmation signal, the patient may now
leave the doctor's office and return home. The patient tracks the
passage of the intragastric balloon and informs the doctor when it
has passed.
* * * * *