U.S. patent application number 17/340791 was filed with the patent office on 2022-04-28 for methods, devices, and systems for obesity treatment.
This patent application is currently assigned to Fulfillium, Inc.. The applicant listed for this patent is Fulfillium, Inc.. Invention is credited to Richard D.Y. Chen, Reinhold H. Dauskardt, Craig A. Johanson, Christopher S. Jones, Marc B. Taub.
Application Number | 20220125612 17/340791 |
Document ID | / |
Family ID | 1000006075433 |
Filed Date | 2022-04-28 |
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United States Patent
Application |
20220125612 |
Kind Code |
A1 |
Chen; Richard D.Y. ; et
al. |
April 28, 2022 |
METHODS, DEVICES, AND SYSTEMS FOR OBESITY TREATMENT
Abstract
In one aspect, an obesity treatment device includes multiple
inflatable space-filling compartments and a valve system for
introducing fluid into each compartment, where the device forms,
upon filing the compartments, to a curved shape conforming to a
natural three-dimensional kidney shape of the stomach. In one
aspect, a method for deploying a gastric balloon structure in a
gastric cavity includes determining dimensions of the gastric
cavity in a feeding state, selecting a fill volume for each of a
number of isolated chambers of the balloon structure, and filling
each chamber while the balloon structure is in the gastric cavity.
In one aspect, a system for treating obesity includes a means for
conforming a flexible, space-filling structure to a natural kidney
shape of the gastric cavity, a means for maintaining at least two
isolated inflatable regions of the flexible, space-filling
structure, and a means for introducing fluid into each inflatable
region.
Inventors: |
Chen; Richard D.Y.; (Napa,
CA) ; Johanson; Craig A.; (Napa, CA) ; Jones;
Christopher S.; (Napa, CA) ; Dauskardt; Reinhold
H.; (Napa, CA) ; Taub; Marc B.; (Napa,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fulfillium, Inc. |
Napa |
CA |
US |
|
|
Assignee: |
Fulfillium, Inc.
Napa
CA
|
Family ID: |
1000006075433 |
Appl. No.: |
17/340791 |
Filed: |
June 7, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16199063 |
Nov 23, 2018 |
11026825 |
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17340791 |
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15231167 |
Aug 8, 2016 |
10179060 |
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16199063 |
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14971795 |
Dec 16, 2015 |
9445930 |
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15231167 |
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11282224 |
Nov 18, 2005 |
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14971795 |
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11170274 |
Jun 28, 2005 |
8070807 |
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11282224 |
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11122315 |
May 3, 2005 |
8066780 |
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11170274 |
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60629800 |
Nov 19, 2004 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/003 20130101;
A61B 5/076 20130101; A61F 2210/0061 20130101; A61F 2250/008
20130101; A61B 5/0028 20130101; A61N 1/372 20130101; A61B 5/746
20130101; A61F 5/0036 20130101; A61B 2560/0276 20130101; A61B
5/7282 20130101; A61B 5/686 20130101; G08B 21/18 20130101; A61F
2250/0003 20130101; A61F 2250/0002 20130101; A61N 1/08 20130101;
A61F 5/0046 20130101; A61F 2/12 20130101; A61F 5/0033 20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00; A61B 5/00 20060101 A61B005/00; A61F 2/12 20060101
A61F002/12; A61B 5/07 20060101 A61B005/07; A61N 1/372 20060101
A61N001/372; A61N 1/08 20060101 A61N001/08; G08B 21/18 20060101
G08B021/18 |
Claims
1. An improved implantable device having an exterior structure,
wherein the improvement comprises a system incorporated into said
exterior structure, which system emits a detectable wireless signal
upon breach of said exterior structure.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims the benefit
of priority from U.S. patent application Ser. No. 16/199,063, filed
Nov. 23, 2018, which is a continuation of and claims the benefit of
priority from U.S. patent application Ser. No. 15/231,167, filed
Aug. 8, 2016 (now U.S. Pat. No. 10,179,060), which is a
continuation of U.S. application Ser. No. 14/971,795, filed Dec.
16, 2015 (now U.S. Pat. No. 9,445,930), which is a continuation of
U.S. application Ser. No. 11/282,224, filed Nov. 18, 2005, which is
a continuation-in-part of U.S. application Ser. No. 11/170,274,
filed on Jun. 28, 2005 (now U.S. Pat. No. 8,070,807), which is a
continuation in-part of U.S. application Ser. No. 11/122,315, filed
on May 3, 2005 (now U.S. Pat. No. 8,066,780), and claims the
benefit under 35 USC .sctn. 119(e) of prior Provisional Application
No. 60/629,800, filed on Nov. 19, 2004. All above identified
applications are hereby incorporated by reference in their
entireties.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates generally to medical apparatus
and methods. More particularly, the present invention relates to
implantable devices and methods and systems for detecting their
malfunction or failure or impending malfunction or failure.
[0003] All implants of devices, especially those indicated for long
term use, in the human body are highly regulated and must meet
certain safety requirements. One such requirement is
biocompatibility of the materials used in the construction of the
device in the event they come into direct contact with body tissues
and fluids. Even if the material is biocompatible, the contact with
body tissues and fluid could result in diminished performance or
malfunction esp. in devices with electronic components. It is known
that when a device is implanted in the body, the materials forming
the cover and structural elements of the device degrade and fatigue
over time. It is also well known that excessive handling during
implantation or even normal, repetitive movements could stress the
structural integrity of the device. Failure of the structural
integrity of the device or its covering, which eventually happens,
causes the contents of the device, which heretofore were confined
in the interior of the device, to be in contact with the
surrounding tissues and their secretions. Therefore, it would be
desirable to detect or to predict such an event before any
potentially harmful contents come in contact with the surrounding
tissues, before tissue secretions leak into the interior of the
device resulting in malfunction, or before the content itself
suffers a malfunction.
[0004] Prosthetic devices implanted in numerous locations in the
body are prevalent in medical practice. Many of these prostheses
are designed to assume the structural shape of the body part yet
are soft and have similar flexibility to approximate the look and
feel of normal human tissue. A common use has been for
reconstructing the normal contour, improving the shape, and/or
enlarging the size of the human breast. The most common breast
prosthesis is a soft elastomeric container made of silicone rubber
which is filled or "inflated" with a liquid or gel, typically a
saline solution or a silicone gel, or a combination of such filling
materials. Typically such prostheses are surgically implanted to
fit underneath the skin of the body either between the chest wall
and the mammary gland or in place of the mammary gland following a
mastectomy. The ideal result after implantation is to achieve the
contours and tissue characteristics of a natural breast, and
prosthetic devices filled with silicone gel have been found to
produce the best cosmetic result. Hence, silicone gel breast
implants are the devices of choice in locations where they are
approved.
[0005] Degradation and fatigue of the silicone rubber container of
such breast implants, however, can lead to perforations, tears,
ruptures, and seam separations, resulting in the leakage of filling
materials to the surrounding tissues. Leakage from a saline filled
device is usually harmless as the solution, if uncontaminated, is
absorbed. Leakage from the preferred silicone gel filled device is
much more problematic. Bleeding of gel at the surface is believed
to contribute to the development of capsular contracture, a
scarring condition that compresses the implanted device from a
soft, natural profile into a rigid, spherical shape. More serious
is the migration of leaked silicone gel to other parts of the body
such as the lymph nodes and major organs where it becomes
unremovable. Consequently, silicone gel has been implicated in many
health problems including connective tissue diseases. This risk
increases with the length of time the device is implanted.
[0006] The problem is exacerbated by the fact that leakage of
silicone gel is not easily detected and the rupture of the device
cannot be predicted. Unlike saline filled devices where rupture and
leakage results in deflation over a short period of time and
readily discovered by the patient, silicone gel tends to leak
slowly and can go unnoticed for years. Often the rupture is
discovered only upon removal of the device for another reason. The
only noninvasive method currently sensitive enough to detect such
an event reliably is an MRI scan. To monitor the integrity of a
silicone gel device by regularly scheduled MRI scans is cost
prohibitive. Consequently, the use of silicone gel filled breast
prostheses is now highly restricted by regulatory authorities.
[0007] Gastric balloons are another type of implantable, inflatable
prosthesis which is subject to failure from breach of the wall.
Gastric balloons are typically introduced through the esophagus and
inflated in situ in order to occupy a significant volume within the
stomach. While gastric balloons are typically inflated with saline
or other non-toxic materials which are benign if released into the
stomach, the balloon structure itself is hazardous if accidentally
deflated since it can pass and cause obstruction of the pyloric
valve or the intestines distal to the pyloric valve. Any such
obstruction is a medical emergency.
[0008] The problem is not limited to inflatable devices. Many
implanted devices, e.g., cardiac pacemakers, contain electronic
circuits and have insulated wires or leads that sense or deliver
signals at certain points in the body. For example, the covering or
insulation could deteriorate over time or tear in response to
normal body movements. Body fluids from the surrounding could then
leak into the circuitry, either as a liquid or vapor, causing
disruption of signals. Or the lead could break at any point or
detach from the connector to the device. Another class of implanted
devices involves a closed vessel system conveying fluids leading
from a part of the device or a part of the body to another part of
the body, such as a shunt conveying blood or cerebrospinal fluid.
The catheter or reservoir in the system could tear or break leading
to the leakage of material out of the catheter to an unintended
part of the body or leakage of body fluids into the catheter
causing contamination. Yet another class of devices, which depend
on solid objects for function or structural support, could fail
from fracture or dislocation. These fractures can start as a
hairline from repeated mechanical stress from use and progress to a
complete fracture. Dislocations start with a loosening of the
structure(s) holding an object in place and progress to a complete
dislocation.
[0009] For these reasons, it would be desirable to provide
apparatus and methods to detect or predict an actual or potential
wall breach which can lead to leakage of the filling contents of
breast implants, gastric balloons, catheters, reservoirs, and the
like or an actual or potential disruption of an electronic circuit
in cardiac pacemakers or neurostimulators or the like or an actual
or potential stress fracture or dislocation in the case of solid
components in prosthetic devices or the like. It would desirable
further to monitor remotely the structural integrity and presumed
functional status of a device without activating the function after
device implantation in the case of cardiac defibrillators or
without directly applying stress to the monitored part in the case
of solid components. Prompt removal of such devices upon breach or
imminent breach would avert most, if not all, of the ensuing
problems including catastrophes. The methods and apparatus will
preferably be adaptable for use in any structural design of the
device without adversely affecting its structure or, in the case of
breast implants, the final cosmetic result, and further be
applicable to solid and rigid body implants containing electronic
components such as pacemaker and defibrillator canisters and leads
and to solid body implants such as prosthetic heart valves or
orthopedic devices. It would be further desirable if the breach or
imminent breach of the device were detectable to the patient in an
easy, rapid, and reliable fashion outside of a medical facility or
at home. Additionally, it would be beneficial if the system were
able to monitor the device non-invasively on a frequent basis over
the life of the device without incurring significant additional
cost for each diagnostic event. At least some of these objectives
will be met by the inventions described hereinafter.
2. Description of the Background Art
[0010] Leakage detection is described in U.S. Pat. No. 6,826,948
and published applications US 2004/0122526 and US 2004/0122527.
Breast implants and methods for their use are described in U.S.
Pat. Nos. 6,755,861; 5,383,929; 4,790,848; 4,773,909; 4,651,717;
4,472,226; and 3,934,274; and in U.S. PubL Appln. 2003/163197.
Gastric balloons and methods for their use in treating obesity are
described in U.S. Pat. Nos. 6,746,460; 6,736,793; 6,733,512;
6,656,194; 6,579,301; 6,454,785; 5,993,473; 5,259,399; 5,234,454;
5,084,061; 4,908,011; 4,899,747; 4,739,758; 4,723,893; 4,694,827;
4,648,383; 4,607,618; 4,501,264; 4,485,805; 4,416,267; 4,246,893;
4,133,315; 3,055,371; and 3,046,988 and in the following
publications: US 2005/0137636; US 2004/0215300; US 2004/0186503; US
2004/0186502; US 2004/0162593; US 2004/0106899; US 2004/0059289; US
2003/0171768; US 2002/0099430; US 2002/0055757; WO 03/095015;
W088/00027; W087/00034; WO83/02888; EP 0103481; EP0246999;
GB2090747; and GB2139902.
BRIEF SUMMARY OF THE INVENTION
[0011] The present invention provides systems and methods for
detecting partial or complete breach in the exterior wall of an
implantable device, such as an inflatable, implantable prosthesis
of the type where a wall at least partially surrounds a fluid
medium, liquid or air, in one or more inflatable compartments. The
walls of inflatable devices will usually be non-rigid, either
elastic or non-elastic. Other implantable devices subject to
exterior structure breach include metal and plastic (polymer)
devices which may comprise rigid-walled casings or housings, such
as pacemakers, implantable defibrillators, neurostimulators,
insulin pumps, reservoirs, devices having flexible housings such as
elastomeric reservoirs containing with naturally collected or
pre-filled fluids or insulation or other coverings formed over the
electrically conductive core of electrical leads, electrical
connectors (e.g., plugs), and the like. Implantable devices subject
to stress fracture in solid functional components include
artificial joints, prosthetic heart valves, and the like. These and
other devices may contain potentially bioincompatible materials,
such as batteries, circuitry, synthetic chemicals, and the like.
While the implementation of these systems and methods will be
described in detail in connection with inflatable devices such as
breast implants and gastric balloons and with solid core devices
such as electrical leads, it will be appreciated that the
principles may be applied to other inflatable prostheses, such as
penile implants, to vessel systems containing or conveying fluids,
to electronic and other devices having solid internal structural or
functional components. The systems of the present invention are
incorporated into at least a portion of the wall of the wall or
covering of the inflatable prosthesis or other device or coupled to
the electronic circuitry or embedded in the solid component itself
and provide for or enable the emission or transmission of a
detectable radio-frequency or other electronic signal upon breach
or partial breach of the wall or the structural integrity of the
component. As used hereinafter, the term "breach" will refer to any
partial or full penetration of the structure of the wall or
covering as well as to other mechanical disruption of a solid part
of the device which could initiate or lead to the contact of
materials inside the wall or covering or the solid component itself
with tissues or body fluids outside the device. Such breach
signifies a compromise or a threatening compromise to the integrity
of the device.
[0012] The signal emission system of the present invention
preferably comprises a signaling circuit having one or more
components which become exposed to an exterior or interior
environment surrounding or within the prosthesis or other
implantable device upon breach or partial breach of the wall or
covering, wherein such exposure enables, disables, energizes,
and/or changes a signal which is emitted by the system. In
particular, the breach may act like a switch to close or open a
region within the signaling circuit to cause, enable, disable, or
alter the signal emission. Alternatively, the exposure of the
circuit and/or internal structure to the interior or exterior
environment may result in a change in impedance, capacitance,
inductance or other detectable circuit characteristics that can
trigger or modify the signal emitted.
[0013] In a first embodiment, the component of the signaling
circuit will generate electrical current when exposed to a body
fluid and/or an interior medium within the device upon breach or
failure of the exterior structure. Body fluids such as blood,
cerebrospinal fluid, lymph fluid, and the like, are naturally
conductive, i.e., contain electrolytes. The interior medium, such
as an inflation medium, can be selected to be electrically
conductive, e.g., comprise or consist of saline or other
biologically compatible electrolytes and salt solutions. In such
cases, the generated electrical current can power an unpowered
transmission component to emit the signal. Alternatively, the power
can alter a signal which has already been continuously or
periodically emitted by the signaling circuit. In the latter case,
the signaling circuit may require a separate source of energy, such
as a battery or circuit components which are placed on the exterior
or interior of the wall so that they are always exposed to fluids
to provide for current generation.
[0014] Alternatively, the circuit components may include
spaced-apart conductors which are electrically coupled to the
signaling circuit to "close" the signaling circuit to permit
current flow when exposed to a body fluid and/or device contents by
a wall breach. Alternatively, the circuit may be altered, enabled
or otherwise modified by a sufficient flow of electrolytes to
enable, interpret, disrupt, or modify a signal emission. The
circuit components may include spaced apart conductors which are
coupled to the signaling circuit to detect a change in resistance,
capacitance, impedance, or voltage. Since the breach could be small
and intermittent as it starts, it can be difficult to detect as a
flow but the cumulative gain or loss of the electrolytes from the
contents or surrounding body fluids could cause a change in the
resistance, capacitance, or impedance across the conductors.
Alternatively, the detection circuit is closed and the contact of
the contents or the body fluids with the conductors could cause a
break, disruption, or change in the functioning of the circuit. In
the exemplary embodiments described below, the conductors may
comprise meshes, films, or other relatively large surface areas
covering most or all of the wall so that breach at any point in the
wall will provide the intended electrically conductive bridging
between the conductors. The coupling of the conductors may also
cause, alter, or enable a signal emission to alert the patient of
the breach or potential breach. The spaced-apart conductors can
have anyone of a variety of shapes or configurations, continuous
configurations, such as plates and films, or discontinuous
configurations, such as lattices, meshes, and the like, can be
placed in various locations, preferably near interior portions of
the device where body fluids will pool to enhance sensitivity and
reliability of the detection.
[0015] Alternatively, the detection and signaling circuit may
comprise at least two conductors coupled to a third conductor which
is part of the functional circuitry or is embedded in the solid
component of the device or is the solid component itself. In the
event any of the conductors, and the third, functional conductor in
particular, is fractured, even intermittently, a circuit is broken
thereby causing a signal alteration by the signaling circuit to
alert the patient of the breach or potential breach. The detecting
conductors can have any one of a variety of shapes or
configurations, including continuous configurations, such as plates
and films, or discontinuous configurations, such as lattices,
meshes, braids, fabrics, and the like, and can be placed in various
locations, preferably spanning parts of the device where fractures
are prone in order to enhance sensitivity and reliability of the
detection. More than one of these couplings could be made in any
configuration or location on a device to determine the site of the
breach.
[0016] The signaling circuit can be active or passive. In a
preferred embodiment, the signaling circuit will comprise a passive
transponder and antenna which are adapted to be powered and
interrogated by an external reader. Such transponder circuitry may
conveniently be provided by using common radio frequency
identification (RFID) circuitry where the transponder and tuned
antenna are disposed on or within a protected area in the
prosthesis and connected to remaining portions of the signaling
circuit. Passively powered circuitry is particularly preferred in
devices with on board batteries where the amount of energy stored
in the battery generally determines the functional product life.
The antenna and transponder could be located in close proximity to
the detection circuitry or placed elsewhere in the device or
another part of the body. For example, by connecting the
transponder circuitry to "open" conductors which is closed in the
presence of body fluids and/or inflation medium, the signal emitted
by the transponder upon interrogation by an external reader may be
altered. Thus, the patient or medical professional may interrogate
the prosthesis and determine whether or not the prosthesis remains
intact or the threat of an impending breach exists. This is a
particularly preferred approach since it allows the user to
determine that the transponder circuitry is functional even when a
breach has not occurred.
[0017] The present invention further provides methods for signaling
breach of a wall or covering of an inflatable prosthesis,
electronic prosthesis, solid prosthesis, electrical cable, or the
like. Usually, signaling comprises generating an emission by
closing a signaling circuit when the wall or part of the device is
at least partially breached. Usually a flow of electrolytes occurs
when the wall or part of the device is at least partially breached,
thereby closing the signaling circuit. To detect a near complete or
complete fracture in solid components, generating an emission may
comprise opening a signaling circuit when the wall, covering, or
other part is substantially breached or generating an electrical
current when the part is substantially breached. The particular
signaling circuits and transmission modes have been described above
in connection with the methods of the present invention.
[0018] The signaling system of the present invention can be
designed to function using any one of a variety of algorithms to
notify the patient in a simple, unequivocal fashion. For example,
in a toggle algorithm, the transmitter is either on in the static
state or preferably off in order to reduce the need for power. Upon
direct contact between the conductors and the body fluids and or
device contents, the now closed circuit cause the transmitter to
turn the signal off or preferably on to be able to send a wireless
signal on a continuous basis. The wireless signal or lack thereof
depending on the algorithm is recognized by the detector to notify
the patient that the integrity of the device is compromised.
[0019] Alternatively, the algorithm could be based on time,
amplitude, frequency, or some other parameter. For example, the
transmitter may send a wireless signal at a predetermined time
interval in its static state. The detector recognizes the length of
the interval as normal and the existence of the signal as the
system in working order. Upon direct contact with the body fluids
or device contents by the probes, the transmitter is enabled to
send the same signal at different time intervals or a different
signal, which is recognized by the detector to notify the patient
that the integrity of the device is compromised. The lack of a
signal is recognized by the detector to notify the patient of a
detection system malfunction and potential compromise of the
integrity of the device.
[0020] Optionally, more than one probe or more than one type of
probe may be placed internally in different parts or components in
the device so that the particular part or component which failed
may be identified based on which probe was activated. The
transmitter would send different signals for the receiver to
display the source of the failure.
[0021] The internal probe could be of any shape and is disposed in
the interior or preferably in the wall or covering of the device.
The preferred configuration is a fine lattice or continuous film of
the detection material embedded in the wall or in between layers of
the wall covering the entire device, thereby conforming to the
shape of the device. Such a configuration optimizes the performance
of the system in detecting failures early. As the site of the tear
or rupture cannot be predicted, the probe would be unlikely to miss
detecting the breach by covering the entire device.
[0022] Compromise of the device typically starts with a somewhat
linear split or tear in surface of the device wall or covering from
mechanical fatigue or handling damage. As the split propagates, it
will expose more and more lines of the lattice or area of the film
to the body fluids and or device contents. Consequently, as the
size and seriousness of the breach increases, the probability of
detection increases. Embedding the detection material in the
covering such as the wall of the balloon further enables detection
before a full breach of the entire thickness of the device
wall.
[0023] The detection material could be any metal, polymer, fiber,
ingredient, or combination thereof, with or without any coating
that can generate an electrical charge or enable flow of electric
current when in contact with the body fluids or device contents.
For example, an electrical charge could be generated from a
non-toxic chemical reaction when the lattice exposed underneath a
tear comes in contact with the body secretions. Flow of electric
current could be enabled when two ends of an electric circuit
hitherto physically separated by electrically non-conductive
material in the covering or a structural element of the device are
in contact with electrolytes in the body secretions when the
electrically nonconductive material is compromised. For example, a
charged lattice is embedded in the wall separated by silicone
rubber from the ground probe on the external surface of the device.
When the lattice is exposed to the electrolytes in the body fluids
in the event of a tear, the circuit is closed. Alternatively, the
lattice and ground could be separate from each other but interlaced
in the wall of the device. Preferred materials include
non-corrosive, biocompatible metals and elastomers, inks, or the
like which contain electrically conductive particles.
[0024] The transmitter can be a simple wireless signal generator
triggered by an electric current or preferably a transponder using
the well-established RFID technology, i.e., produces a wireless
signal when triggered by an interrogating signal. The electric
charge generated or the electric current enabled by the probe in
contact with the body fluids or device contents changes the logic
state thereby enabling the transmitter to emit or causes it to emit
a wireless signal. Typically, the transponder is powered by the
interrogating radio frequency signal so that no power source of its
own is required. Alternatively, the transmitter could be powered by
a micro battery or by the electrical power generated by a chemical
reaction. For protection from degradation by an acidic and
electrolyte solution and become potentially toxic, the transmitter
or transponder circuit is encased in a highly resistant material,
such as silicone rubber or stainless steel. The transmitter or
transponder circuit can be placed on the exterior, embedded in the
wall, or preferably in the interior of the device for shielding
from chemical degradation and mechanical stress. It can be placed
in any orientation, preferably in the plane where the antenna is
most sensitive and the transmitter is most effective in sending and
receiving signals through body tissue overlying the device.
[0025] The wireless signal from the transmitter is recognized by a
separate detector, typically external to the body. The detector
could be simply a receiver tuned to the transmitter's signal or,
preferably, a combination of both a transmitter of a signal to
interrogate the transponder and a receiver to distinguish the
different signals from the transponder. The detector is preferably
powered by batteries and portable enough to be worn on a wristband,
necklace, or belt or can be placed conveniently near a place where
the patient spends most of his time. Upon receiving a signal that a
breach has occurred, the detector will alert the patient to seek
medical assistance or alert medical professionals directly through
other devices, such as Bluetooth linked to an autodial telephone.
The alarm could be auditory, such as beeping sounds, visual, such
as flashing LED's or a LCD display, sensory, such as vibrations, or
preferably a combination of any or all of the above.
[0026] Optionally, the detector could have different auditory,
visual, sensory, or different combinations to identify the source
of the detected breach, especially with more than one probe or more
than one type of probe. For example, LED's of different colors or
different sounds could be used. The alarm could further indicate
the seriousness of the breach. For example, when multiple probes
detect a breach, the volume of the alarm would increase to a higher
level.
[0027] In the case of electronic implantable devices, such as
pacemakers and defibrillators, the devices will be subject to
failure due to intrusion of body fluids through breaches,
particularly at the seams and lead connections. Thus, the detector
circuit components described above could be located within the
device canister near those seams and connectors at risk of failure
so that initial penetration of fluids could be detected before
sufficient amount of fluids, liquid or vapor, has entered to cause
failure of the device.
[0028] In the case of electrical leads used in electronic
stimulation devices, a breach in the insulation and a breach in the
conductor can both be detected. The embodiments described above are
particularly suitable for detecting a breach in the covering
insulation from wear and tear. Usually this breach will precede and
can serve as a sentry for a breach in the conductor. A breach in
the conductor without a breach in the insulation can be detected by
a closed circuit formed by two conducting probes, one coupled to
the conductor near its proximal end and the other at its distal
end. Any fracture or disruption of the current flow in the
conductor, whether made of a metal, elastomer, or gel, between the
two points will result in "opening" the circuit. An opening will
change the logic state of the detection circuit and enable the
transmitter to emit or causes it to emit a wireless signal. The
detection and transmitting circuitry could be attached to any part
of the lead or is in its own separate housing connected to the lead
by the conducting probes. Thus, the detection and transmitting
circuitry could be placed in a preferred orientation where normal
body movements would not cause any sharp angles in the conductors
and an area away from sites where wear and tear are more prone.
[0029] In the case where electrical leads are coupled to another
conductor such as the connector outside the canister containing the
functioning hardware and software, the principles and methods can
detect detachment of the lead. In this embodiment, one probe is
electrically coupled to the male and another probe to the female
side of the connection. When the lead is detached from the
connector, the circuit is thereby "opened" and detected as a
breach.
[0030] In the case of solid devices, such as artificial joints or
heart valves, the conductors are embedded in the device components
prone to failure. The detection and transmitting circuitry could
also be embedded in the device or placed in an area away from sites
where wear and tear are more prone or signal transmission could be
adversely affected.
[0031] In one aspect, the present disclosure provides improved
gastric balloons and methods for their deployment and use. The
balloons may have an overall volume or displacement selected to
leave a residual volume in the proximal area of the stomach in the
range from 10 ml to 100 ml, usually from 20 ml to 40 ml. As
discussed in detail below in some embodiments, the volume may be
adjustable to optimize treatment on individual patients. The
gastric balloons may be designed to conform to the natural shape of
the gastric cavity while maintaining the normal function of the
stomach. The balloon may have a crescent or "kidney" shape to align
the balloon wall against the greater and lesser curvatures of the
stomach, an oval cross section to conform to the shape of the
cavity in the sagittal plane, and delineate a space proximally for
the collection of ingested food and another space distally for
active digestion.
[0032] In one aspect, the gastric balloons include at least two
principal structural components. The first principal structural
component is an expandable scaffold which helps define a shape
conforming to a gastric cavity, typically a crescent or "kidney"
shape, when expanded. The scaffold may be self-expanding, e.g.
formed from a shape memory metal or shape memory polymer, or may be
inflatable with an incompressible fluid, such as saline, water,
oil, gel, or other liquid, gel, slurry, solution, or the like. Use
of an incompressible inflation or filling fluid can help rigidify
the scaffold so that it maintains its shape for extended periods
when implanted in the stomach. The expanded shape and side of the
scaffold by itself or together with an intact portion of the device
may form an object that is too large in all orientations, even when
compressed in peristalsis, to permit the device to pass the
pylorus.
[0033] The second principal structural component may include one or
more inflatable or otherwise expandable space-occupying structures
or compartments which are secured to the interior and/or exterior
of the expandable scaffold. The space-filling structures or
compartments assume a space-filling configuration when inflated or
otherwise filled or expanded, typically being inflated or filled at
least partly with a compressible fluid, typically a gas such as
air. Such filling or inflation of the scaffold and/or the
space-filling compartment(s) may be accomplished from an external
pressurized fluid source, but certain gaseous inflation media can
be generated in situ within the component by chemical reactions
induced by mixing reactants or otherwise initiating a gas-producing
chemical reaction. In some cases, the scaffold may form all or a
portion of the space-filling structure or compartment.
[0034] The gastric balloons, as described herein, may comprise two
or more walls or layers or lamina of materials to improve the
durability of the device by optimizing the performance
characteristics of different materials. This is desirable because
the maximal thickness of the entire device in its deflated state
such that it can be passed uneventfully through the esophagus is
limited and is useful even for a simple, single compartment
balloon. Typically, the outermost layer is made of materials, such
as silicone rubber, selected primarily for their biocompatibility
in the stomach and resistance to an acidic environment and the
innermost layer is made of materials selected primarily for their
resistance to structural fatigue and permeability to the filling
fluid. In addition, use of multiple layers allows the layers to be
formed from different materials having different properties, to
enhance the performance characteristics of the entire balloon
structure. The inner layers could have biocompatibility of a
shorter duration than the outermost layer. It may be desirable to
enhance the durability further by embedding other structural
elements in the layers, such as a mesh made of metal, polymer, or
high strength fibers, such as Kevlar.RTM.. In the simplest
embodiment, the two layers are either bonded together to function
as a single wall or left unbonded such that the layers could slide
by each other except at certain attachment points.
[0035] Optionally, a variety of structural elements may reside in
between the outermost and innermost layers. For support, the mesh
of high strength fibers, polymer, or metal could constitute another
layer in of itself instead of being embedded in the layers.
Alternatively, the mesh forms or is a component of the expandable
scaffold. One or more layers of materials selected for the optimal
balance of biocompatibility, impermeability, rigidity, durability
among other criteria could be added to enhance the structural
performance characteristics of the device further.
[0036] The inflatable compartment(s) may be inflated with
compressible fluids (gases), incompressible fluids (liquids), or in
some cases mixtures of gases and liquids. When multiple inflatable
compartments are used, each compartment may be inflated with the
same or different gas(es), liquid(s), and/or mixtures thereof. The
use of gas and liquid for gastric balloon inflation has a number of
advantages. A principal benefit is the ability to control buoyancy
and weight distribution within the balloon, e.g., by filling most
of the compartments with a gas and distributing the non-gas
inflation medium in other compartments throughout the balloon, the
risk of concentrated pressure points against the stomach is
reduced. Second, by properly controlling the ratio of air or other
gas to saline or other liquid, the gastric balloon can be provided
with a desired buoyancy and mass within the stomach. Typically, the
ratio of air:liquid can be in the range from 2:1 to 10:1, more
preferably within the range from 3:1 to 6:1. Such ratios can
provide effective densities relative to water at a specific gravity
in the range from 0.09 to 0.5, usually from 0.17 to 0.33, depending
on the total volume occupied by the device. Typically, the weight
of the filled balloon is in the range from 50 gm to 500 gm, usually
being from 50 gm to 450 gm. The use of gastric balloons which are
light and less dense will reduce the risk that the balloons will
cause abrasion, pressure induced lesions, shearing lesions, or
other trauma when implanted in the stomach for extended periods of
time.
[0037] Optionally, gastric balloons may include at least one
separately inflatable or otherwise expandable external bladder
formed over an exterior surface of the balloon. The external
bladder(s) can be separately inflatable from both the scaffold and
the space-filling compartment(s) although they may be attached to
or share common walls with either or both of these other principal
structural components. The bladder may be positioned on the
exterior of the balloon so that it can control either or both of
the shape and buoyancy of the balloon as a whole. Typically, the
bladder will be inflated at least partly with a compressible gas,
typically air or other biocompatible gas. Often, the balloon will
be underfilled, i.e., filled with a volume that does not distend or
increase the wall tension beyond that of the unfilled bladder.
[0038] The expandable scaffold, the inflatable space-filling
compartment(s) or structures, and optionally the inflatable
bladder(s) may be joined together in the overall gastric balloon
structure in a variety of ways. Typically, each component may be
separately formed and joined by adhesives, bonding, or by other
non-penetrating fasteners, or by other means. Alternatively, all or
a portion of these principal structural components may be formed by
co-extrusion to provide the desired inflatable volumes.
[0039] The external bladder(s) may also be formed from elastic
and/or inelastic materials, such as silicone rubber and
polyethylene terephthalate film (Mylar.RTM.), respectively, so that
they can be inflated at the end of the procedure to properly
position the gastric balloon within the stomach and to provide for
proper sizing of the balloon within the stomach. In an illustrated
embodiment, the gastric balloon includes one space-filling
compartment and one external bladder for each of the four channels
formed by the inflatable scaffold, but the number of compartments
and/or bladders may differ from the number of channels.
[0040] Some embodiments include at least two or more
inflatable-space-filling compartments and in some cases may also
include one or more inflatable external bladders. The inflation of
multiple inflatable compartments and external bladders may be
accomplished in a variety of ways. Most simply, each inflatable
compartment and inflatable external bladder (if any) could be
connected to an independent inflation tube which can be
disconnected after inflation. The use of multiple independent
inflation tubes allows each inflatable compartment and external
bladder to be selectively and independently filled, further
allowing filling at different pressures, with different inflation
fluids, and the like. The use of multiple inflation tubes, however,
is not generally preferred since the tubes, collectively, can have
rather a large cross section, and such multiple tubes may interfere
with device deployment.
[0041] The multiple inflatable compartments and external bladders
of certain embodiments may be filled through a single inflation
tube in at least two ways. First, by connecting the inflatable
compartments and external bladders in series, for example using a
series of one-way valves, inflation through a first inflatable
compartment (or external bladder) can sequentially fill additional
compartments and bladders in the series as the pressure in each
compartment raises and in turn begins to fill the next compartment
or bladder in series.
[0042] In one aspect, a selective valve system can be accessed and
controlled by a single inflation tube in order to independently and
selectively inflate each of the inflatable compartments and
external bladders (if any). Such selective valving system may be
constructed in any of at least several ways. For example, an
inflation tube having a lateral inflation port near its distal end
can be disposed between two, three, or more one-way valves opening
into respective inflatable compartments and external bladders. By
rotating the inflation tube, the inflation port on the tube can be
aligned with one of the one-way valves at a time, thus permitting
inflation of the respective compartment or bladder to a desired
pressure and with a desired inflation fluid, including liquid
inflation fluids, gaseous inflation fluids, and mixtures thereof.
The rotatable and selectable inflation tube could be removable.
Alternatively, at least a portion of the inflation tube could be
permanently mounted within the gastric balloon structure, allowing
an external portion of the inflation tube to be removably coupled
to the internal portion to deliver the inflation fluids.
[0043] In addition to rotatably selectable inflation tubes, the
inflation tube could be axially positionable to access linearly
spaced-apart one-way valve structures, each of which is connected
to a different inflatable compartment or external bladder.
[0044] As a still further alternative, a single inflation tube
could be rotatably mounted and have several inflation ports along
its lengths. Each of the inflation ports could be disposed near
one, two, or more different one-way valves communicating with
different inflatable compartments and/or external bladders.
[0045] The one-way valves may permit inflation by introducing an
inflation medium at a pressure sufficiently high to open the
one-way valve and permit flow into the associated inflatable
compartment or external bladder. Upon removing the pressurized
inflation source, the one-way valve closes and remains sealed in
response to the increased pressure within the inflatable
compartment or external bladder.
[0046] The inflation tube(s) may be removable from the connected
component after the component or multiple components have been
inflated. Thus, as described in more detail below, the gastric
balloon may be delivered to the stomach in a deflated, low profile
configuration, typically through a gastroscope or other
transesophageal delivery device. Once in place, the inflatable
components may be inflated, filled, or otherwise expanded in situ
to a desired volume and buoyancy typically by delivering the
inflation media through the inflation tubes.
[0047] Once the desired inflation size is reached, the inflation
tubes may be detached from each of the compartments allowing
self-sealing so that the inflation medium remains contained for
extended periods of time. To ensure the containment of the medium,
valves may be placed in series for any one or more of the
inflatable component(s) and/or bladder(s). Other expansion
protocols are described elsewhere herein. In particular, component,
compartment, or portion of the balloon may be inflated in situ by
inducing a gas-generating reduction within the balloon. The
reactant(s) may be present in the balloon prior to introduction to
the patient or may be introduced using the connecting tubes after
introduction to the stomach.
[0048] Although one illustrated embodiment includes four channels
in the inflatable scaffold, it will be appreciated that the present
disclosure covers gastric balloon structures having only a single
passage or channel formed within the scaffold with a single
space-filling compartment and single external bladder. Embodiments
with two channels, space-filling compartments and external bladders
as well as three channels, three space-filling compartments, and
three external bladders, as well as even higher numbers will also
be within the scope of the present specification.
[0049] The dimensions of the scaffold, space-filling compartment(s)
or structure(s), external bladder(s), and/or isolated inflation
chambers within any or all of these components, may be selected
such that the collective volume or physical dimensions of the
chambers remaining inflated after deflation of any single chamber
(or limited number of chambers) is sufficient to prevent passage of
the balloon through the pyloric valve. Usually, the volume(s) will
be such that at least two inflatable components and/or chambers
within said components could deflate without risk of the
"diminished" balloon passing through the pyloric valve, preferably
at least three could deflate, and often at least four or more
chambers could deflate. The precise volume(s) necessary to prevent
passage of the partially deflated balloon structure through the
pyloric valve and may vary from individual to individual. A
preferred remaining residual inflated volume may be at least about
75 ml, preferably at least about 100 ml and still more preferably
at least about 200 ml. After partial deflation, the balloon should
have a dimension along any axis or its cross axis of at least 2 cm,
preferably at least 4 cm, and most preferably at least 5 cm.
[0050] In one aspect, the present specification relates to methods
for treating obesity in a patient. The methods may comprise
introducing a gastric balloon structure to the patient's stomach.
An inflatable scaffold which forms part of the balloon may be
filled with an incompressible fluid to provide a fixed support
geometry. At least a portion of a separate space-filling
compartment may be filled at least partly with a compressible
fluid, typically a gas such as air, nitrogen, or the like, within
the remainder (if any) being filled with an incompressible
material, such as a liquid, gel, slurry, or the like. In this way,
the buoyancy of the balloon may be controlled within the limits
described above.
[0051] The methods of the present specification may include
determining the size of the gastric cavity and selecting a gastric
balloon of proper size prior to introducing the balloon to the
stomach. Such size determination may comprise visually examining
the gastric cavity, typically under direct observation using a
gastroscope, but alternatively using fluoroscopy, ultrasound, x-ray
or CAT scanning, or any other available imaging method. An estimate
of the dimensions of the stomach and the size of the device can be
made by direct observation of the interior of the stomach
immediately prior to deployment. Alternatively, the dimensions of
the feeding stomach, which is generally larger than the resting
stomach, and the size of the device will be determined at an
earlier session where the patient has consumed or swallowed a
biocompatible filling medium, e.g., water, contrast medium, food,
etc. A sufficient amount of filling medium will be consumed so that
the imaging technique can detect full relaxation of the stomach
during feeding and estimate its dimensions and size.
[0052] Introducing may include passing the gastric balloon in a
deflated configuration into the stomach through the same
gastroscope. Alternatively, the deflated balloon could be
introduced into the gastric cavity via an attachment to an
orogastric or nasogastric tube. The balloon may be oriented so that
the scaffold will open with curved geometry conforming to the curve
of the gastric cavity. The scaffold may be released from constraint
to self-expand or will be filled through a removable inflation tube
attached to the scaffold, where the inflation tube may be removed
after filling. The scaffold may then be sealed or be self-sealing
upon detachment of the filling tube(s) to prevent loss of the
inflating liquid medium. Similarly, the space-filling
compartment(s) may also be filled through one or more inflation
tube(s) removably attached to the compartment(s), where the tube(s)
are removed after the compartment(s) have been filled with the
desired medium, for example a mixture of liquid and gas sources.
Further, the external bladder(s) may be filled through one or more
inflation tube(s) generally as described above for both the
scaffold and the space-filling compartment(s).
[0053] After all the principal structural components of the gastric
balloon have been inflated or otherwise expanded and the associated
inflation tubes released, any other anchors or tethers attached to
the balloon may also be released, leaving the balloon free to
"float" within the patient's stomach. By properly selecting the
ratio of liquid inflation medium to gas inflation medium, as
discussed above, the weight, distribution, and the buoyancy of the
gastric balloon may be such that the balloon rests within the
stomach without exerting undue pressure at any particular point,
thus reducing the risk of abrasions or other trauma to the stomach
lining. The inflated gastric balloon may be left in place for
extended periods of time, typically as long as weeks, months, or
even years.
[0054] After the balloon has been inflated and left in place, it
may become desirable to adjust the size and/or buoyancy of the
balloon for purposes of patient comfort, efficacy, or other
reasons. To perform such adjustments, the balloon may be
transesophageally accessed, typically using a gastroscope with
suitable working tools introduced therethrough. For example, the
balloon may be grasped with graspers and inflation tubes may be
suitably attached or docked to inflation ports on the balloon
structure. For example, the inflation ports may be located near the
end of the gastric balloon structure which is oriented toward the
top of the stomach so that they are readily accessed through the
gastroscope. After attachment with the inflation tube, the
inflation medium can be introduced and/or extracted, depending on
whether the particular structural component is to be enlarged,
deflated, or have a buoyancy adjustment. Optionally, an incising
instrument could be introduced through the gastroscope to penetrate
and deflate any filled compartment to reduce the overall volume of
the device and improve accommodation of the device. Typically,
these compartments are small to allow minor adjustments without
jeopardizing the integrity of the device itself.
[0055] In addition to adjusting the size and/or buoyancy of the
gastric balloon, it may become desirable or necessary to remove the
balloon completely. To effect such removal, the balloon may be
accessed transesophageally, typically using a gastroscope. The
balloon may first be grasped or secured using a grasping tool.
Then, one or more surfaces of the balloon may be penetrated or
breached in order to release the contents of the balloon into the
stomach. The contents may be biocompatible gasses or liquids so
that release into the stomach will not be a concern. After the
contents of the compartments have been released, the balloon may
then be pulled through the patient's esophagus, for example by
pulling with the grasping tool. It may be possible to pull the
deflated gastric balloon through the working channel of the
gastroscope, but more often the balloon will simply be withdrawn
through the esophagus as the gastroscope is withdrawn. Optionally,
a sheath or other protective cover may be placed over the deflated
balloon in order to reduce the risk of trauma or injury to the
esophagus upon withdrawal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0056] FIG. 1 illustrates a gastric balloon having the wall breach
detections system of the present invention incorporated
therein.
[0057] FIG. 2 illustrates a breast implant having the wall breach
detection system of the present invention incorporated therein.
[0058] FIG. 3 illustrates a multi-layer wall structure useful for
the prostheses of the present invention.
[0059] FIG. 4 illustrates a passive transponder system which may be
utilized in the wall breach detection systems of the present
invention.
[0060] FIG. 5 illustrates a hand-held interrogation unit useful
with the systems of the present invention.
[0061] FIGS. 6A through 6I illustrate leads and connectors used in
electronic stimulators having the covering breach detection system
of the present invention incorporated therein.
[0062] FIG. 7 illustrates solid device components having the wall
breach detection system of the present invention incorporated
therein.
[0063] FIG. 8 is a side view of an example gastric balloon, shown
deployed in a stomach.
[0064] FIG. 9 is a cross-sectional view taken along line 9-9 in
FIG. 8.
[0065] FIG. 10 is a top view of the gastric balloon of FIG. 8,
illustrating the inflation ports or nipples.
[0066] FIGS. 11A and 11B illustrate use of example tools introduced
through a gastroscope for inflating and deflating a gastric
balloon, respectively.
[0067] FIGS. 12A through 12E illustrate a complete deployment
protocol according to example methods described herein.
[0068] FIGS. 13A through 13C are enlarged, peeled-back,
cross-sectional views of a portion of the multi-layered wall of an
example gastric balloon constructed in different
configurations.
[0069] FIG. 14 illustrates another example gastric balloon
geometry.
[0070] FIG. 15A illustrates a first embodiment of a self-expanding
scaffold for the balloon geometry of FIG. 14.
[0071] FIG. 15B illustrates a second embodiment of a self-expanding
scaffold geometry for a balloon having the geometry of FIG. 14.
[0072] FIG. 15C illustrates an example inflatable scaffold suitable
for use with a balloon having the geometry of FIG. 14.
[0073] FIG. 15D is a cross-sectional view taken along line 15D-15D
of FIG. 15C.
[0074] FIG. 15E illustrates an example gastric balloon including a
pair of inflatable space-filling compartments contained by an
external sheath.
[0075] FIG. 15F illustrates an example gastric balloon having two
inflatable space-filling compartments joined together by a spine
structure.
[0076] FIGS. 16-18 are flow diagrams illustrating several valving
systems suitable for inflating gastric balloons having multiple
inflatable compartments and optionally internal bladders.
[0077] FIG. 19 illustrates an exemplary structure for valving
according to FIG. 16.
[0078] FIGS. 20A-20C illustrate an exemplary structure for valving
according to FIG. 18.
DETAILED DESCRIPTION OF THE INVENTION
[0079] Referring now to FIG. 1, the gastric balloon 100 includes
two electric probes. Probe 130 is on the external surface in
contact with the surrounding tissues, body fluids, and contents of
the stomach. Probes 130 and 110 can have any of a variety of shapes
or configurations, including circular plates, lattices, films, and
the like, cover all or a portion of the balloon or other device.
Probe 110, shown here in a lattice configuration, provides the
second probe incorporated in the wall of the balloon. The probe
material could be any metal, polymer, fiber, or combination
thereof, with or without any coating that can generate an
electrical charge or enable flow of electric current when in
contact with the stomach contents. The probes are connected
electronically to the wireless transmitter 140, but are separated
from each other by at least one layer of non-conductive material in
the balloon wall. The transmitter can be a simple wireless signal
generator triggered by an electric current or preferably is an
unpowered transponder using well-established RFID technology which
produces a wireless signal in response to an interrogating signal.
In the intact state when the wall is not breached, components 130,
110, and 140 comprise an open electrical circuit and the
transmitter is inactive, disabled, or enabled to transmit a base
signal.
[0080] Referring now to FIG. 2, a breast implant 200 may be
similarly formed with a lattice 210 formed within the breast wall,
an external electrically conductive probe 230 formed on or over the
exterior surface of the implant, and a transmitter 240 connected to
both the lattice and exterior probe. In the case of breast implants
filled with low conductivity materials, such as silicone gel, it
may be desirable to provide conductive materials to enhance
conductivity upon leakage.
[0081] As magnified in FIG. 3, the second internal probe comprises
both a fine lattice 110 and a thin film configuration 112 in the
wall of the balloon in between, at the minimum two layers, an
outermost layer 102 and innermost layer 104. The second internal
probe can be also disposed in any enclosed space in the device (not
shown). In the configuration described in FIG. 1, probes 130 and
110 and transponder 140 represent one open circuit and probes 130
and 112 and transponder 140 represent a second open circuit. Each
open circuit is available to power or enable the transmitter or may
enable the transponder to alter a base signal.
[0082] After the balloon is deployed in the stomach, the external
probe 130 is in contact with the surrounding tissue and body fluids
and stomach contents. Upon a breach in the integrity of the wall,
such as a tear in the outermost layer 102, the leakage of
physiologic fluid or stomach contents with electrolytes into the
tear forms a salt bridge that closes the circuit formed probes 130
and 112 and transponder 140. Once the circuit is closed, a toggle
is switched in the transponder, which will be enabled to transmit a
"layer 102 breach" signal. Tears through layer 106 in the balloon
wall will allow leakage of physiologic fluid or stomach contents
with electrolytes into the tear forming a salt bridge that closes
the circuit formed probes 130 and 110 and transmitter 140. Closing
this circuit switches another toggle in the transponder, which will
be enabled to transmit a "layer 106 breach" signal.
[0083] The preferred radiofrequency identification circuit is shown
schematically in FIG. 4. The circuit comprises a transmitter
component 300 which includes transponder circuitry 302, typically
formed as an integrated circuit, and a tuned antenna-capacitor
circuit 304. An interrogator reader 310 comprises circuitry 312
including the power supply (typically a battery) demodulator
circuitry, decoder circuitry, and the like. An antenna 314 is tuned
so that it can communicate wirelessly with the antenna 304 of the
transponder 300. Operation of this circuitry is generally
conventional and provides for energizing, demodulating, and
decoding signals between the external and implanted components. The
transponder circuitry, however, will be modified so that the
conductive elements implanted in the wall, such as film 320 and
lattice 330 may enable or alter the signal emitted by the
transponder when the conductive elements are bridged by body fluids
or inflation medium. In the preferred embodiments described above,
electrical coupling of the conductors 320 and 330 will alter the
signal that is produced by the transponder 302. In that way, the
patient or other user will be able to interrogate the transponder
and receive a base or "normal" response signal when no wall breach
has occurred. In the event of a wall breach, the signal emitted by
the transponder will be altered so that the breach will be made
evident.
[0084] An exemplary reader module 120 is shown in FIG. 5 and
includes LEDs to indicate normal or "on" function, failure, and
emergency failure. An audible the alarm 126 could also be provided
to alert with beeping sounds, or sensory, such as vibrations, or
preferably a combination of any or all of the above. Optionally,
the detector could have different auditory, visual, sensory, or
different combinations to identify the source of the detected
breach, especially with more than one chemical substance used. The
alarm could further indicate the seriousness of the breach. For
example, when breaches are detected, the volume of the alarm would
increase to a higher level.
[0085] Referring now to FIG. 6A, an electrical lead 600 with a
functional conductor 650 which is useful for cardiac or neuro
stimulators may be similarly formed with an electrically conductive
lattice 610 embedded within an insulating covering 605, an external
electrically conductive cable coil 630 attached to the exterior
surface of the implant, and a transmitter 640 connected to both the
lattice 610 and external coil 630. As shown in the cross section
FIG. 6B, the lattice 610 is preferably formed coaxial to the
conductor 650 and separated from the conductor and the surrounding
environment by inner and outer annular portions of the cover 605.
The cross section of FIG. 6C shows conductive probes 610 and 620 in
lattice form both embedded in the covering. The cross section of
FIG. 6D shows a plurality of conducting probes 610 and 620 which
are embedded coaxially in the insulating covering 605. In this
embodiment, a current flow enabled by electrolytes between external
probe 630 and 610 or 620 or the functional conductor 650 could
indicate the extent of the breach. An alternative configuration is
shown as lead 601 in FIG. 6E and FIG. 6F with two functional
conductors 650a and 650b connected at their ends but electrically
isolated from each other along their length so that each can serve
as a backup for the other. In this configuration, the probes 610
and 620 do not have to be separated from but are in contact with
the functional conductors.
[0086] In the case of detecting a breach of the functional
conductor, a lead 602 is shown with two electrically conductive
probes 660 and 670 coupled to two ends of the functional conductor
650, as shown in FIG. 6G.
[0087] In the case where the functional conductor 650 is connected
to another functional electrical conductor 680, as shown in FIG.
6H, a lead 603 is shown with a transmitter 640 with two probes, 660
and 670. Probe 660 is coupled to the functional conductor 650 and
670 to the other functional conductor 680, in this embodiment an
electrical connector. One or both of the probes 660 and 670 are
attached after the connection is made. Both probes 660 and 670 can
be embedded in the functional conductor connection housing in
either the male or female side, as shown in FIG. 6I. In this
embodiment of a female connector 604, functional conductor 650
passes through and is electrically coupled to functional conductor
680. In this embodiment as electrically isolated rings inside the
female connector 604, probe 670 is coupled to 680 and probes 660a
and 660b coupled to 650. Such a configuration would enable
detection of a partial detachment of the male member 649 when the
circuit between 670 and 660b is closed but that between 660a and
660b is open and a possible complete lead detachment when all the
detection circuits are open. The placement and physical length of
the probes 660a and 660b would determine the amount of detachment
necessary to open the circuit and enable the system to signal a
breach.
[0088] While the leads and connectors incorporating the detection
system are illustrated independently above, they may be configured
independent to each other in a device system or together in any
combination using one or more common detecting or signaling
circuits.
[0089] Referring now to FIG. 7, two solid prosthetic device forms
are shown. Cylindrical shaped 701 and a flat triangular shaped 702
are shown with a transmitter 740, an electrically conductive
lattice 710, and an external electrically conductive probe 730.
701a and 702a are cross sections of each respectively. Any wear and
tear or fracture deep to the lattice 710 is detected as a breach.
It can be appreciated that the principle can be applied to a solid
object of any shape. In the case of an object holding other parts
of the device in place or within a range of motion (not shown),
such as functioning like a ligamentous or cartilaginous structure
in the body, respectively, detecting a breach of the object would
indicate a potential dislocation of the other parts.
[0090] Referring now to FIGS. 8 and 9, a gastric balloon 10, in
some embodiments, comprises an inflatable scaffold structure 12,
four inflatable space-filling compartments 14, and four inflatable
external bladders 16. Referring in particular to FIG. 9, the
inflatable scaffold 12 has a X-shaped cross-section and defines
four generally axially oriented channels or quadrants, each of
which receives one of the four inflatable space-filling
compartments 14. The four inflatable external bladders 16 are
mounted over the inflatable space-filling compartments 14, and the
balloon 10 includes an upper cage 18 and lower cage structure 20
which permit grasping of the balloon using grasping tools, as will
be described in more detail below. In its deployed configuration,
the gastric balloon 10 has a crescent or curved shape which
conforms to the interior shape of a gastric cavity, with the upper
cage structure 18 oriented toward the esophagus E, the lower cage
structure 20 oriented toward the pyloric valve PV.
[0091] Referring now to FIG. 10, the inflatable scaffold structure
12 is provided with at least one inflation port or nipple 22 while
the inflatable space-filling compartments 14 are provided with a
separate port 24 and the inflatable external bladders are provided
with a separate inflation port 26. Although not illustrated, the
scaffold, internal components, and external bladders could have
isolated, inflatable volumes therein, each of which would be
attached to a separate inflation tube. By "subdividing" the volume
of the various principal structural components, the risk of
accidental deflation of the balloon is further reduced.
[0092] As illustrated in 11A, after the gastric balloon 10 is
introduced in its deflated configuration into the gastric cavity,
the inflatable structural components could be inflated using a
single inflation tube 30 introduced through the gastroscope G, or
orogastrically or nasogastrically by itself or using an orogastric
or nasogastric tube. For example, the upper cage 18 can be held by
a grasper 32 which can selectively hold and release the gastric
balloon 12 during inflation and subsequent deployment. Shown in
FIG. 11A, inflation tube 30 can be selectively coupled to any one
of the inflation ports 22, 24, or 26, and the desired inflation
medium introduced therethrough. Inflation tube 30 will be suitable
for delivering either liquid or gas inflation media, typically
including saline, water, contrast medium, gels, slurries, air,
nitrogen, and the like.
[0093] In some embodiments, the inflatable scaffold structure 12
will be inflated entirely with a liquid or other incompressible
medium, such as a gel, slurry, or the like. In contrast, the
inflatable space-filling compartments 14 may at least partly be
inflated with air or other gas. Often, however, the inflatable
space-filling compartments will inflated with a mixture of gas and
liquid in order to control the buoyancy of the balloon 12. Finally,
the external bladders 16 may be inflated with gas in order to
provide a relatively soft outer surface which can reduce trauma and
abrasion.
[0094] The various structural compartments of the balloon may be
made from the same or different materials. In some embodiments, the
inflatable scaffold structure 12 will be formed from a
non-distensible (non-stretching) material so that it may be
inflated to become a relatively rigid structure. Alternatively, or
additionally, the structures may be formed from stiffer materials
and/or be reinforced to increase the rigidity when inflated.
[0095] In contrast, the inflatable space-filling compartments 14
and the inflatable bladders 16 may be formed in whole or in part
from softer elastomeric materials in order to allow inflation
flexibility, both in terms of size and density of the combined
inflation media. The elastic nature of the external bladders allows
the peripheral dimensions of the gastric balloon to be adjusted
over a significant range by merely controlling inflation volume.
Elastic inflatable space-filling compartments can allow the amount
of space occupied in the interior of the balloon to be adjusted,
for example to adjust the amount of volume filled by the balloons
within the quadrants defined by the scaffold structure 12.
Alternatively, the volume of incompressible fluid introduced into
non-elastic structures may be sufficient to control the volume
being occupied.
[0096] As an alternative to using a single inflation tube, each of
the inflation ports 22, 24, and 26 could be pre-attached to
separate inflation tubes. In such cases, after inflation of each
structural component is completed, the necessary inflation tube
could then be withdrawn through the gastroscope G, leaving the
gastric balloon 10 in place.
[0097] Referring now to FIG. 11B, the balloon 10 can be deflated
while grasping the tip 18 of the balloon with grasper 32 through
gastroscope G using a blade structure 40 introduced through the
gastroscope. The blade structure 40 may be used to make one or more
penetrations or breaches within each of the inflatable components
of the gastric balloon, including the inflatable scaffold, the
inflatable space-filling compartment(s), and the inflatable
external bladder(s)
[0098] Referring now to FIGS. 12A-5E, gastric balloon 10 may be
introduced to a patient's stomach S using a gastroscope G
introduced through the esophagus E in a conventional manner
Standard procedures for preparing and introducing the gastroscope
are employed, including checking for ulcerations in the esophagus
and performing further examination if warranted.
[0099] After introducing the gastroscope G, the size of the gastric
cavity within stomach S can be estimated and a balloon of an
appropriate size selected. The balloon 10 is then also introduced
through the esophagus E (orogastrically or nasogastrically) using
an appropriate catheter or optionally using the inflation tube(s)
which will be used to inflate the balloon. After the entire balloon
is confirmed to be in the stomach at a proper orientation,
typically using the gastroscope G, the various components of the
balloon 10 may be inflated as shown in FIGS. 12C and 12D. First,
the inflation tube 32 attached to the port which is coupled to the
scaffold 12 is inflated, typically using saline or other
incompressible liquid until the scaffold structure becomes
relatively rigid, as shown in FIG. 12C. During this inflation, the
balloon 10 is held by at least an inflation tube 32 and may
optionally be held by additional inflation tube(s) and/or a grasper
32.
[0100] After the scaffold 12 has been inflated, an additional
syringe is used to inflate the space-filling compartments through a
second inflation tube 33, as shown in FIG. 12D. The space-filling
compartments, again, will typically be inflated with a combination
of saline or other liquid and air or other gas in order to achieve
the desired density of the inflation medium therein. The external
bladders 16 will be inflated in a similar manner, typically using
air or other gas inflation medium only.
[0101] When it is desired to remove the gastric balloon 10, the
balloon may be deflated as previously discussed and removed through
the esophagus using a grasper 32 passing through the gastroscope G,
as shown in FIG. 12E. Typically, the balloon will be pulled out
using both the gastroscope and the grasper 32.
[0102] As illustrated in FIG. 13A, the wall of a gastric balloon as
described herein includes at the minimum an outermost layer 1302
and innermost layer 1304. The layers may be manufactured by either
dipping a mold successively into solutions of different materials
that dry and cure or by successive precision injections of
materials into a mold. Typically, the outermost layer 1302 is made
of one or more materials, such as silicone rubber, selected
primarily for their non-abrasiveness, biocompatibility in the
stomach, and resistance to an acidic environment. Typically, the
innermost layer 1304 is made of materials selected primarily for
their resistance to structural fatigue and impermeability to the
filling fluid. The inner layer 1304 could have biocompatibility of
a shorter duration than the outermost layer. The two layers are
either bonded together to function as a single wall or left
unbonded such that the layers could slide by each other except at
certain attachment points.
[0103] Referring now to FIG. 13B, it may be desirable to enhance
the durability further by incorporating other structural elements
in the layers, such as a mesh 1306 made of metal, polymer, or high
strength fibers, such as Kevlar, or the scaffold (not shown). The
mesh could constitute a separate layer as illustrated in FIG. 13B
or instead, could be embedded in one of the layers of material, as
shown embedded in layer 1304 in FIG. 13C. A mesh 1306 could inhibit
the propagation of a tear in the layers. Many of these materials
are radio-opaque which enables imaging clearly the entire shape of
the device using plain diagnostic X-ray radiography.
[0104] As illustrated in FIGS. 13B and 13C, in addition to layers
of 1302 and 1306, one or more layers, 1308 and 1310, of materials
selected for the optimal balance of biocompatibility,
impermeability, rigidity, shear resistance among other criteria
could be added to enhance the structural performance
characteristics of the device further.
[0105] FIG. 14 illustrates an alternative crescent-shaped balloon
geometry suitable for use in the gastric balloons of the present
invention. Gastric balloon 1400 has a generally flat or truncated
upper surface 1402 which is positioned adjacent to the esophagus E.
A lower end 1404 is also generally flat or truncated. These flat
ends 1402 and 1404 are distinguishable from the more tapered ends
of the prior gastric balloon embodiments. Although illustrated
schematically as a single unit or structure, it will be appreciated
that the balloon 1400 will usually comprise multiple independently
inflatable space-filling compartments and optionally further
comprise external inflatable bladders. The geometry shown in FIG.
14 is intended to illustrate the peripheral shape of the device
including all components.
[0106] Referring now to FIGS. 15A-F, gastric balloon structures
having the geometry of balloon 1400 in FIG. 14 may be deployed
using a number of different expandable scaffolds. For example, as
shown in FIG. 15A, the balloon structure 1400 may include an
external "exo-skeleton" 1510 comprising a spine 1512 and a
plurality of ribs 1514 extending laterally from the spine. The
spine 1512 and ribs 1514 may be made from elastic components, such
as nickel titanium alloys or other super elastic materials,
permitting them to be folded and compressed to a small width for
introduction. The scaffold will then be deployed by releasing the
scaffold from constraint after it has been positioned within the
stomach.
[0107] The balloon 1400 may also be mated with an end cap 1520. The
end cap 1520 may include, for example, a plurality of interlaced
panels which can be folded down to a low profile configuration for
delivery. The panels may be composed of elastic polymers, shape
memory metals, shape memory polymers, or the like. The use of end
caps 1520 is particularly useful when the balloon will itself
comprise a single compartment. The end cap will prevent accidental
passage of the balloon through the pylorus even upon rapid
deflation of the balloon.
[0108] The balloon 1400 may also be mated to an inflatable scaffold
1530, which may be conveniently formed into the shape of a saddle,
as shown in FIGS. 15C and 15D. The balloon 1400 may comprise one,
two, or more separate inflatable compartments. Each of these
compartments, as well as the inflatable scaffold 1530, may require
separate inflation, preferably using one of the valving mechanisms
described below. The inflatable scaffold 1530 could have other
configurations as well, such as being in the form of a lattice with
a central inflatable spine and multiple arms disposed laterally
outwardly about the remainder of the balloon 1400.
[0109] Referring now to FIGS. 15E and 15F, the balloon 1400 may
comprise first and second internal inflatable compartments 1540 and
1542 having an external sheath or exoskeleton 1544. The sheath 1544
may be, for example, a non-distensible outer tubular structure
having the desired crescent geometry, with the inflatable
compartments 1540 and 1542 disposed therein. Alternatively, the
exoskeleton could comprise a mesh, fabric, or other flexible
containment member which holds the separate inflatable compartments
1540 and 1542 in place relative to each other. At least a portion
of the exoskeleton 1544 could be made to be non-collapsible in
order to prevent accidental passage of the balloon through the
pyloric valve in case of unintended deflation of both of the
inflatable compartments 1540 and 1542.
[0110] The compartments 1540 and 1542 could also be held together
by a spine element 1550, as shown in FIG. 15F. The balloons would
be attached to the spine, optionally by heat sealing or adhesives,
usually one or more fasteners 1552, such as adhesive straps, are
provided about the periphery of the inflatable compartments 1540
and 1542 to hold them together after deployment. The spine 1550 can
also optionally be used to receive and deploy inflation tubes, as
described in more detail below.
[0111] Each of the balloons 1400 described above may be provided
with a valve mechanism or assembly to permit selective inflation
with liquid fluids, gaseous fluids, or a combination thereof. If
only a single inflatable compartment is utilized, the valving
mechanism could be simply a one-way valve having a connector for
releasably connecting to an inflation tube. For example, the
inflation tube could be connected to the connector on the valve
prior to introduction of the balloon in the patient's stomach.
After introduction, the inflation medium could be introduced
through the tube, and the tube detached and removed after inflation
is complete. Optionally, the inflation tube could be introduced
later for reinflation of the balloon if desired.
[0112] When two or more inflatable compartments, and optionally
external bladders, are provided, the valve assemblies of the
present invention may provide for selectively delivering inflation
medium to individual inflation ports on each of the inflatable
compartments, external bladders, and optionally inflatable
scaffolds. Inflation valves may include a one-way valve structure,
such as a flap valve or a duckbill valve. The valves associated
with each compartment can be arranged to permit manipulation of an
associated inflation tube so that the valve is in line with an
inflation port on the inflation tube to permit delivery of
inflation medium.
[0113] In FIG. 16, for example, a first one-way valve 1600 can be
mounted on a wall of a first balloon compartment and a second
one-way valve 1602 can be mounted on the wall of a second balloon
compartment. By then arranging the two valves in opposite
directions along a common axis, an inflation tube 1604 having a
rotatable inflation port 1606 can be disposed between the two
valves. Then by turning the inflation tube, the first valve 1600 or
the second valve 1602 may be selected to deliver inflation medium
through the single inflation tube 1604.
[0114] Alternatively, as shown in FIG. 17, a first inflation valve
1610, a second inflation valve 1612, and a third inflation valve
1614, each of which is associated with a respective balloon
compartment, may be axially arranged so that a single inflation
tube 1616 may be translated to successfully access each of the
one-way valves 1610. In this way, each of the associated balloon
compartments may be selectively inflated and reinflated by simply
axially translating the inflation tube 1616.
[0115] As a further alternative, as shown in FIG. 18, a single
inflation tube 320 having multiple inflation ports 1622, 1624, and
1626 may be disposed next to a linear array of balloon compartments
and one-way inflation valves 1630, 1632, and 1634. In this way,
instead of axially translating the inflation tube 1620, the valves
can be selected by rotating the tube so that only a single
inflation port is aligned with a single one-way valve at one
time.
[0116] It will be appreciated that the above-described valve
mechanisms and assemblies may be constructed in a wide variety of
ways using a wide variety of one-way valve structures. For the
purposes of the present invention, it is desirable only that the
valve structures permit selective introduction of an inflation
medium to individual balloon compartments using a single inflation
tube. It will also be appreciated that more than one valve may be
used in series (not shown) in place of a single valve to reduce
further the potential for leakage of the filling media.
[0117] A first specific structure for implementing the inflation
assembly of FIG. 16 is shown in FIG. 19. The inflation tube 1604
having inflation port 1606 is disposed between a wall 1650 of a
first balloon and a wall 1652 of a second balloon. The first
one-way valve 1600 is positioned through the first wall 1650, and
the second one-way valve 1602 is positioned through the second wall
1652. Those valves are shown as duckbill valves. As shown in FIG.
19, the port 1606 is aligned with the first one-way valve 1600 so
that introduction of a pressurized inflation medium through lumen
1605 of the inflation tube 1604 will open the duckbill valve and
allow inflation medium to enter the first balloon. By then rotating
the inflation tube 1650 by 180.degree. so that it is aligned with
the second valve 1602, inflation medium can be similarly delivered
to the second balloon.
[0118] A specific valve system constructed generally as shown in
FIG. 18 is shown in FIGS. 20A-20C. The inflation tube 1620 is
rotatably disposed within an outer tube 1660 which passes between
walls 1662 and 1664 of first and second inflatable compartments,
respectively. The distal-most one-way valve 1634 is disposed in a
first radial direction on the outer tube 1660, and the next inner
one-way valve 1632 is offset by 90.degree.. The ports 1662 and 1664
on the inflation tube 1620 (FIGS. 20B and 20C not illustrated) will
be arranged so that in a first rotational position one port 1662 is
aligned with one-way valve 1632 and in a second rotational
position, a second port 1664 is aligned with one-way valve 1634. At
no time, however, is more than one inflation port aligned with more
than one one-way valve on the outer tube 1660. Thus, by rotating
inflation tube 1620, individual inflatable compartments can be
inflated.
[0119] While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. Therefore, the above description
should not be taken as limiting the scope of the invention which is
defined by the appended claims.
* * * * *