U.S. patent application number 12/877046 was filed with the patent office on 2012-03-08 for remotely adjustable gastric banding system.
This patent application is currently assigned to ALLERGAN, INC.. Invention is credited to Christian Y. Perron.
Application Number | 20120059216 12/877046 |
Document ID | / |
Family ID | 45771184 |
Filed Date | 2012-03-08 |
United States Patent
Application |
20120059216 |
Kind Code |
A1 |
Perron; Christian Y. |
March 8, 2012 |
REMOTELY ADJUSTABLE GASTRIC BANDING SYSTEM
Abstract
A fluid reservoir for use in a remotely adjustable gastric
banding system comprises a housing and a flexible reservoir pouch
positioned within the housing. The flexible reservoir pouch is
coupled to an inflatable portion of a gastric band via flexible
tubing. A pump coupled to the flexible reservoir pouch facilitates
filling and draining the inflatable portion of the gastric band.
The pump may be located within or outside of the housing. A
receiving coil may be coupled to the housing, and the receiving
coil forms a loop around the housing. The receiving coil receives
radio frequency signals to drive the pump. A circuit board may be
disposed in the housing for driving the pump to move the fluid
between the flexible reservoir pouch and the inflatable portion of
the gastric band. A portion of the circuit board may be a flexible
circuit board to allow the housing to flex.
Inventors: |
Perron; Christian Y.;
(Goleta, CA) |
Assignee: |
ALLERGAN, INC.
Irvine
CA
|
Family ID: |
45771184 |
Appl. No.: |
12/877046 |
Filed: |
September 7, 2010 |
Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61F 5/0056 20130101;
A61F 5/0059 20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. A fluid reservoir for connecting to a remotely adjustable
gastric banding system for the treatment of obesity, the fluid
reservoir comprising: a housing; a flexible reservoir pouch
positioned within the housing and coupled to an inflatable portion
of a gastric band via tubing, the flexible reservoir pouch for
storing a fluid for filling and draining the inflatable portion of
the gastric band; and a receiving coil coupled to the housing,
wherein the receiving coil forms a loop around the housing, and
wherein the receiving coil receives radio frequency signals from a
remote transmitter to drive a pump in the remotely adjustable
gastric banding system.
2. The fluid reservoir of claim 1, wherein the housing is
substantially cylindrical.
3. The fluid reservoir of claim 1, wherein the housing is at least
one of flexible, semi-flexible, rigid, or semi-rigid.
4. The fluid reservoir of claim 1, further comprising a coil
channel for looping the receiving coil around the housing.
5. The fluid reservoir of claim 4, wherein the coil channel extends
along the sides of the housing, substantially parallel to a central
axis of the housing.
6. The fluid reservoir of claim 1, wherein the loop formed by the
receiving coil defines a plane that is substantially parallel to a
surface of the patient's skin.
7. The fluid reservoir of claim 6, wherein the housing is sutured
to a muscle of a patient to facilitate maintaining the loop of the
receiving coil substantially parallel to the surface of the
patient's skin.
8. The fluid reservoir of claim 1, wherein the receiving coil is a
first receiving coil forming a first loop around the housing, the
fluid reservoir further comprising a second receiving coil forming
a second loop around the housing.
9. The fluid reservoir of claim 8, wherein the housing further
comprises a second coil channel for receiving the second receiving
coil.
10. The fluid reservoir of claim 9, wherein the first loop formed
by the first receiving coil is substantially perpendicular to the
second loop formed by the second receiving coil.
11. The fluid reservoir of claim 10, further comprising a center
tap circuit for adding the radio frequency energy received through
the first receiving coil and the second receiving coil when both
the first receiving coil and the second receiving coil receive the
radio frequency energy.
12. The fluid reservoir of claim 11, wherein the center tap circuit
comprises a first rectifying diode coupled between the first
receiving coil and a load so that current from the first receiving
coil is restricted to one direction.
13. The fluid reservoir of claim 12, wherein the center tap circuit
comprises a second rectifying diode coupled between the second
receiving coil and the load.
14. The fluid reservoir of claim 1, further comprising a pump
disposed within the housing to move fluid between the flexible
reservoir pouch and the inflatable portion of the gastric band,
wherein the pump receives energy from the radio frequency signals
received through the receiving coil.
15. The fluid reservoir of claim 14, further comprising a circuit
board for driving the pump.
16. The fluid reservoir of claim 15, wherein at least a portion of
the circuit board comprises a flexible circuit board.
17. The fluid reservoir of claim 14, wherein the pump is a
piezoelectric pump comprising a piezo actuator.
18. The fluid reservoir of claim 14, wherein the pump is a
piezoelectric pump comprising a plurality of piezo actuators.
19. A fluid reservoir for a remotely adjustable gastric banding
system, the reservoir comprising: a housing; a flexible reservoir
pouch disposed in the housing; a pump disposed in the housing and
coupled to the flexible reservoir pouch via a valve, wherein the
pump moves a fluid in the flexible reservoir pouch between the
flexible reservoir pouch and an inflatable portion of a gastric
band; and a circuit board disposed in the housing for driving the
pump to move the fluid between the flexible reservoir pouch and the
inflatable portion of the gastric band.
20. The fluid reservoir of claim 19, further comprising a receiving
coil disposed in the housing, wherein the receiving coil receives
radio frequency energy for driving the pump.
21. The fluid reservoir of claim 19, wherein a receiving coil
located near a sternum of a patient receives radio frequency energy
for driving the pump.
22. The fluid reservoir of claim 19, further comprising a second
pump and a third pump, each of the pump, the second pump, and the
third pump comprising two piezoelectric actuators for moving the
fluid between the flexible reservoir pouch and the inflatable
portion of the gastric band.
23. A remotely adjustable gastric banding system for filling and
draining an inflatable portion of a gastric band, the system
comprising: a housing defining a fluid reservoir; a flexible
reservoir pouch disposed in the housing; a pump disposed in the
housing and coupled to the flexible reservoir pouch via a valve,
wherein the pump moves a fluid in the flexible reservoir pouch
between the flexible reservoir pouch and the inflatable portion of
the gastric band; a circuit board disposed in the housing for
driving the pump to move the fluid between the flexible reservoir
pouch and the inflatable portion of the gastric band; a coil
channel disposed along a periphery of the housing; and a receiving
coil disposed in the coil channel of the housing, wherein the
receiving coil forms a loop around the housing, and wherein the
receiving coil receives radio frequency signals from a remote
transmitter to drive the pump.
Description
FIELD
[0001] The present invention generally relates to medical systems
and apparatus and uses thereof for treating obesity and/or
obesity-related diseases, and more specifically, relates to gastric
banding systems that are remotely adjustable.
BACKGROUND
[0002] Adjustable gastric banding apparatus have provided an
effective and substantially less invasive alternative to gastric
bypass surgery and other conventional surgical weight loss
procedures. Despite the positive outcomes of invasive weight loss
procedures, such as gastric bypass surgery, it has been recognized
that sustained weight loss can be achieved through a
laparoscopically-placed gastric band, for example, the
LAP-BAND.RTM. (Allergan, Inc., Irvine, Calif.) gastric band or the
LAP-BAND AP.RTM. (Allergan, Inc., Irvine, Calif.) gastric band.
Generally, gastric bands are placed about the cardia, or upper
portion, of a patient's stomach forming a stoma that restricts the
food's passage into a lower portion of the stomach. When the stoma
is of an appropriate size that is restricted by a gastric band, the
food is held in the upper portion of the stomach provides a feeling
of satiety or fullness that discourages overeating. Unlike gastric
bypass procedures, gastric band apparatus are reversible and
require no permanent modification to the gastrointestinal
tract.
[0003] Over time, a stoma created by a gastric band may need
adjustment in order to maintain an appropriate size, which is
neither too restrictive nor too passive. Accordingly, prior art
gastric band systems provide a subcutaneous fluid access port
connected to an expandable or inflatable portion of the gastric
band. By adding fluid to or removing fluid from the inflatable
portion by means of a hypodermic needle inserted into the access
port, the effective size of the gastric band can be adjusted to
provide a tighter or looser constriction. Naturally, it would be
desirable to allow for non-invasive adjustment of gastric band
constriction, for example, without the use of a hypodermic
needle.
[0004] A remotely adjustable gastric band is a medical device which
allows a healthcare worker to adjust a gastric band without
utilizing hypodermic needles to connect to an implanted access
port. A handheld controller may be used to send radio frequency
waves for powering and communicating with the implanted device. The
implanted device can fill or drain the gastric band as requested by
the healthcare worker via the handheld controller.
[0005] Birk, et al., U.S. Patent Pub. No. 2007/0265645, and Birk,
U.S. Patent Pub. No. 2007/0156013, which are commonly-assigned and
co-pending with the present application, are incorporated herein in
their entirety by this specific reference. Both of these
applications disclose certain approaches to implantable pumping
systems that may be relevant.
[0006] Some versions of remotely adjustable gastric band systems
may include a receiving coil for power induction to drive the pump.
However, the location and/or orientation of the receiving coil may
not provide desired power to the pump and/or other system
components. Furthermore, the presence of metallic objects near the
receiving coil may adversely affect the power provided to the
system.
[0007] Additionally, some attempts have been made to utilize a
remotely driven pump to inflate an inflatable portion of a gastric
band. For example, Hassler, Jr., et al., U.S. Patent Pub. Nos.
2006/0252982 and 2005/0288739; Hassler, Jr., U.S. Pat. No.
7,390,294, and U.S. Patent Pub. Nos. 2005/0267406 and 2005/0267500;
and Jordan, et al., U.S. Patent Pub. No. 2008/0108862 generally
disclose remote adjustment of a gastric band. However, the location
and/or position of the induction coils in these systems may not
provide the desired energy for the system.
[0008] Thus, there continues to be a need for more effective
remotely adjustable gastric banding systems, particularly for
systems that have more available power for driving the implantable
pump and/or other system components. Further, there is a need for
remotely adjustable gastric banding systems that have a more
effective electric coil for receiving transmitted energy.
SUMMARY
[0009] Generally described herein are remotely adjustable and
powered gastric banding systems. The apparatus and systems
described herein aid in facilitating obesity control and/or
treating obesity-related diseases while being non-invasive once
implanted.
[0010] In an embodiment, a fluid reservoir for use in the remotely
adjustable gastric banding system comprises a housing and a
flexible reservoir pouch positioned within the housing. The
flexible reservoir pouch is coupled to an inflatable portion of a
gastric band via flexible tubing. A pump coupled to the flexible
reservoir pouch facilitates filling and draining of the inflatable
portion of the gastric band.
[0011] In another embodiment, a receiving coil may be coupled to
the housing, and the receiving coil forms a loop around the
housing. For example, the receiving coil may be disposed in a coil
channel along the periphery of the housing. The receiving coil
receives radio frequency signals from a remote transmitter to drive
the pump coupled to the flexible reservoir pouch. Certain
embodiments may include two receiving coils disposed along the
periphery of the housing to facilitate enhanced energy reception by
the coils.
[0012] According to another embodiment, the pump may be disposed in
the housing and coupled to the flexible reservoir pouch via a
valve. Some embodiments include a plurality of pumps, each coupled
to the flexible reservoir pouch. The pumps move a fluid in the
flexible reservoir pouch between the flexible reservoir pouch and
the inflatable portion of the gastric band.
[0013] A circuit board may also be disposed in the housing for
driving the pump to move the fluid between the flexible reservoir
pouch and the inflatable portion of the gastric band. At least a
portion of the circuit board may be a flexible circuit board to
allow the housing to flex.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIGS. 1A and 1B illustrate a location of a gastric banding
system within a patient's body according to an embodiment of the
present invention.
[0015] FIG. 2A illustrates a sectional view of a fluid reservoir
with a receiving coil according to an embodiment of the present
invention.
[0016] FIG. 2B illustrates another sectional view of a fluid
reservoir with a receiving coil according to an embodiment of the
present invention.
[0017] FIG. 2C illustrates a sectional view of a fluid reservoir
with two receiving coils according to an embodiment of the present
invention.
[0018] FIG. 3 illustrates a center tap circuit for adding energy
received through two receiving coils according to an embodiment of
the present invention.
[0019] FIG. 4A illustrates a sectional view of a fluid reservoir
with pumps and a circuit board according to an embodiment of the
present invention.
[0020] FIG. 4B illustrates another sectional view of a fluid
reservoir with pumps and a circuit board according to an embodiment
of the present invention.
DETAILED DESCRIPTION
[0021] The present invention generally provides remotely adjustable
gastric banding systems, for example, for treatment of obesity and
obesity related conditions, as well as systems for controlling
inflation and deflation of gastric banding systems.
[0022] A remotely adjustable gastric band is a medical device which
allows a healthcare worker to adjust a gastric band without
utilizing hypodermic needles to connect to an implanted access
port. An external, handheld controller can be used to send radio
frequency signals for powering and communicating with the implanted
device. The implanted device can fill or drain the gastric band as
requested by the healthcare worker via the handheld controller. The
handheld controller may be a remote device configured to produce a
telemetric signal that controls the various components of the
gastric banding system.
[0023] The filling and draining of the band is accomplished by a
set of fluidic elements including pumps, valves, and sensors which
monitor and/or move fluid between the gastric band and a reservoir.
In accordance with various embodiments, different numbers, types,
and orientations of the fluidic elements may be utilized to obtain
the desired results. Any and/or all of these various components may
be configured to be controlled by a remote transmitter, such as a
handheld controller.
[0024] Turning now to FIGS. 1A-1B, in accordance with an
embodiment, a gastric banding system 100 includes a gastric band
105, a reservoir unit 108, an access port 114, and a receiving coil
116. The flexible tubing 106 connects the gastric band 105 and the
access port 114 to the reservoir unit 108. Each of the components
of the system 100 is implantable in a patient using conventional
surgical techniques. The reservoir unit 108 and the coil unit 116
may be used instead of or in addition to the conventional access
port 114. In various embodiments, as will be discussed further
below, the coil unit 116 may be incorporated into other components
of the gastric banding system 100.
[0025] The reservoir unit 108 may move precisely metered volumes of
fluid (e.g., saline, a drug, and/or combinations thereof) from the
reservoir unit 108 through the flexible tubing 106 into the gastric
band 105. The reservoir unit 108 may comprise a compressible
reservoir, such as an elastic polymer, a balloon, a rubber
container, a silicone container, a collapsible container, a
non-elastomeric container, a bellows, and combinations thereof that
are configured to contain the fluid. The gastric banding system 100
may include various pumps, motors, and the like that are configured
to facilitate filling or draining the gastric band 105 by moving
fluid between the reservoir unit 108 and the gastric band 105. The
various pumps, motors, and the like may be separate components of
the system 100, or they may be incorporated into existing
components. For example, the reservoir unit 108 may comprise pumps,
motors, and the like.
[0026] Moving the fluid into the gastric band 105 causes inflation
of at least one bladder, or inflatable member of the gastric band
105, and constricts around the cardia, or upper portion of the
stomach, forming a stoma that restricts the passage of food into a
lower portion of the stomach. This stoma may provide a patient with
a sensation of satiety or fullness that discourages overeating. In
contrast, moving the fluid out of at least one inflatable member of
the gastric band 105 contracts the pressure around the cardia and
allows a stoma to be at least partially released and regains the
patient's hunger sensation.
[0027] The receiving coil 116 receives radio frequency signals from
an external/remote handheld controller or transmitter to control
operation of the system 100. For example, the receiving coil 116
receives radio frequency energy to provide power to various system
components (e.g., a pump, a motor, a circuit board, and the like).
As noted above, and as will be discussed further below, the
receiving coil 116 may be located in or near other components of
the gastric banding system 100, such as in or near the reservoir
unit 108 or the access port 114.
[0028] Although "transmitter" may be used herein, it should be
understood that the remote transmitter may also be a wireless
receiver and/or transceiver operable to take readings from the
system 100 to determine the amount of fluid entering and/or exiting
the gastric band 105, and/or to send or receive other types of
information associated with the gastric banding system 100.
[0029] In accordance with various embodiments, the gastric banding
system 100 allows for a remotely controlled adjustment without
needles, non-invasively, by using the remote transmitter. A
conventional access port 114 may be included as part of system 100
in order to provide alternate filling and draining capabilities,
for example, to provide a fail-safe alternative in case the
non-invasive functionality (e.g., motor, electronics, driving
mechanism) becomes inoperative and/or ineffective. The access port
114 may be used to extract fluid from the system in case of an
emergency or as a safety measure. However, non-invasively filling
and draining the gastric band 105 using the reservoir unit 108
represents advantages over gastric banding systems that only use
standard access ports. The access port 114 may further be used to
prime the system with a desired amount of fluid upon
implantation.
[0030] When compared to conventional gastric banding systems having
standard access ports which exclusively require syringe access, the
presently described systems and apparatus offer several benefits.
First, for conventional access ports located under a thick layer of
fatty tissue, which is generally the case as the devices are
typically used to treat obesity, the access port can be difficult
to locate. The present systems reduce or eliminate the need for
port location as the use of the remote transmitter removes the
necessity of adjustment using a syringe.
[0031] In various embodiments, the access port 114 may be
incorporated into other system components in order to provide for
backup and/or emergency filling and draining of the gastric band
(e.g., when the remote filling and draining functionalities are
ineffective or unresponsive). For example, an implantable pump may
incorporate the access port 114 and may be implanted at a location
similar to where the access port 114 may be implanted. Such an
implantable pump may be referred to as a gastric restrictive
implantable pump. The implantable pump may further include fluidics
(e.g., pumps and valves) and associated electronics. In some
embodiments, the receiving coil 116 for power induction may be
included within the implantable pump housing. However, the size of
the implantable pump housing, the depth of the implantable pump
(e.g., up to four or more inches), and the presence of metal within
the housing may affect the ability to achieve specific power
requirements.
[0032] According to various embodiments, components of the gastric
banding system 100 may be placed in their respective positions
within a patient 101 using common surgical techniques. The surgical
techniques may be similar to those used in the placement of
conventional gastric banding systems. For example, the gastric band
105 may be placed around the stomach using laparoscopic techniques,
as known to those of skill in the art.
[0033] Like a conventional access port, various components of the
gastric banding system 100 may be sutured onto the rectus muscle
sheath 102 or any other conveniently accessible muscle. For
example, the access port 114 and/or the reservoir unit 108 may be
sutured to the rectus muscle sheath 102. The rectus muscle sheath
102 provides a secure surface on which to attach the access port
114 under a layer of fat 103 that separates the patient's skin 104
from the muscle 102.
[0034] The receiving coil unit 116 may be located near the sternum
of the patient 101, and a wire 117 may electronically couple the
receiving coil unit 116 to the reservoir unit 108. In an
embodiment, the reservoir unit 108 is located in the peritoneal
cavity of the patient 101. In other embodiments, the components of
the system 100 may be positioned in other locations in the patient
101 to facilitate filling or draining of the gastric band 105. For
example, in an embodiment, the access port 114 may be incorporated
into the reservoir unit 108, such that the reservoir unit 108 may
be implanted on the rectus muscle sheath.
[0035] Turning to FIGS. 2A-2C, in various embodiments, the
reservoir unit 108 comprises a housing 209 that is generally and/or
substantially cylindrical in shape. Other shapes may be used
without departing from the scope of the present invention. The
housing 209 may be flexible, semi-flexible, semi-rigid, and/or
rigid. A reservoir, such as a flexible reservoir pouch 210 is
disposed in the housing 209. The flexible reservoir pouch 210 may
be a compressible pouch, an elastic polymer, a balloon, a rubber
container, a silicon container, and/or combinations thereof.
Further, the flexible reservoir pouch 210 may be formed in the
shape of a donut, a circle, an ellipse, a rectangle, and
combinations thereof.
[0036] In an embodiment, the coil 116 may be implemented at the
level of the reservoir unit 108, for example, by winding the coil
116 around the reservoir unit 108. The housing 209 of the reservoir
unit 108 may comprise a coil channel 272 that receives the coil 116
and orients the coil 116 in a loop around the reservoir unit 108.
The coil channel 272 may extend along the sides of the housing 209,
extend parallel to a central axis of the housing 209, and/or extend
around/along the periphery of the housing 209.
[0037] In various embodiments, the coil 116 is wound around the
periphery of the reservoir unit 108 so as to be near the surface of
the housing 209. In such a configuration, less of the material of
the housing 209 would interfere with the induction between the coil
116 and the external transmitter. Further, locating the coil 116
near the periphery of the housing 209 would place the coil 116
nearer the transmitter to increase the power made available to the
system 100.
[0038] Where the coil 116 forms a single loop around the reservoir
unit 108, more power will be induced into the system 100 when the
coil 116 is parallel to the skin surface 104 of the patient 101,
compared to the coil 116 being perpendicular to the skin surface
104. In an embodiment, the reservoir unit 108 may be sutured in
place to properly orient the coil 116 with respect to the skin
surface 104, for example, so that the loop formed by the coil 116
is substantially parallel to the skin surface 104.
[0039] Other embodiments account for the situation where the coil
116 may be perpendicular to the skin surface 104. For example, with
particular reference to FIG. 2C, and in accordance with an
embodiment, the coil 116 may form one loop around the housing 209
through the coil channels 272, and a second coil 218 may form a
second loop around the housing 209 and through coil channels 273.
The coils 116 and 218 may be substantially perpendicular to each
other, so that if one coil is oriented perpendicularly with respect
to the skin surface 104, the other coil would be substantially
parallel to the skin surface 104, allowing the parallel coil to
pick up the RF energy from the transmitter.
[0040] In other embodiments, both of the coils 116 and 218 may pick
up RF energy from the transmitter, for example, where neither of
the coils 116 and 218 are perpendicular to the skin surface 104. As
such, the energy picked up from both of the coils 116 and 218 would
need to be added.
[0041] With reference to FIG. 3, and in accordance with an
embodiment, the energy from the coils 116 and 218 may be added
through a circuit, such as a center tap 375. A resistor (R1) 379
and a capacitor (C1) 378 may represent the load of the system 100.
A rectifying diode 376 is coupled to the coil 116, and a rectifying
diode 377 is coupled to the second coil 218. The rectifying diodes
376 and 377 restrict the flow of current from the coils 116 and 218
to one direction into the capacitor 378 and the resistor 379. In
various embodiments, depending on the orientation of the coils 116
and 218, the center tap 375 may result in half-wave rectification.
It should be understood that other circuits and/or components may
be utilized to facilitate transferring inducted energy from the
coils 116 and 218 to the components of the system 100 that utilize
the energy, and that such other circuits and/or components are
within the scope of the present invention.
[0042] In accordance with various embodiments, circuitry, such as
the center tap circuit 375 may be located in or near the reservoir
unit 108. In other embodiments, the circuitry may be located in or
near other components of the system 100, such as in or near the
access port 114.
[0043] Where the coils 116 and 218 are looped around the reservoir
unit 108, in an embodiment, tuning capacitors may also be located
in or near the reservoir unit 108. The tuning capacitors may
facilitate adjusting the resonant frequency of the system, and
locating the tuning capacitors closer to the coils 116 and 218
advantageously results in proper adjustment of the resonant
frequency. For example, locating the tuning capacitors further away
from the coils 116 and 218 may result in greater parasitic
capacitance.
[0044] Further, in accordance with various embodiments, it may be
desirable to reduce the distance between the skin surface 104 and
the coils 116 and 218 which are looped around the reservoir unit
108. For example, the RF coupling between the transmitter and the
coils 116 and 218 is inversely proportional to the distance between
the coils 116 and 218 and the transmitter by a power of
approximately 3. In other words, the closer the coils 116 and 218
are to the skin surface 104, the more RF energy may be received by
the coils 116 and 218, resulting in more power for the system 100.
Therefore, in various embodiments, the coils 116 and 218 are
advantageously located near the skin surface 104.
[0045] Configurations of the system 100 according to embodiments of
the present invention remedy deficiencies in prior art systems
where the prior induction coils may be located in a manner that
reception by the coils is poor. On the other hand, embodiments of
the present invention increase energy reception by the coils 116
and 218 due to the advantageous location and configuration of the
coils 116 and 218.
[0046] As noted above, in various embodiments, a pump may be
located in or near the access port 114. In other embodiments, and
with reference to FIGS. 4A-4B, a pump or pumps 481 may be located
within the reservoir unit 108. Further, other components of the
system 100 may be located within or near the reservoir unit 108 to
facilitate simpler implantation of the system 100. Where other
components are contained within the reservoir unit 108, the
reservoir housing 209 may be semi-flexible, semi-rigid, and/or
rigid. In various embodiments, currently existing access ports may
be coupled to the reservoir unit 108 resulting in simpler and less
expensive incorporation of the reservoir unit 108 into existing
gastric banding systems.
[0047] In an embodiment, where the pumps 481 are located within the
reservoir unit 108, the coil 116 may also be located within or
around the reservoir unit 108, as discussed above. However, as
illustrated in FIG. 1A, the coil 116 may be located near the
sternum to facilitate increased power inducted through the coil
116. Although the pumps 481 may be described herein as being
located within the reservoir unit 108, it should also be understood
that various embodiments of the invention include systems 100 where
the reservoir unit 108, the pumps 481, and/or other components may
be located in or near the access port 114 to facilitate simpler
implantation of the system 100.
[0048] With continued reference to FIGS. 4A-4B, various embodiments
of the present invention include a pump or pumps 481 disposed in
the housing 209 of the reservoir unit 108. The valves 482 couple
the pumps 481 to the flexible reservoir pouch 210. The pumps 481
are also coupled to the tubing 106 to facilitate moving fluid
between the flexible reservoir pouch 210 and the inflatable portion
of the gastric band 105. The pumps 481 are coupled to a circuit
board 483, such as a flexible circuit board, which drives the pumps
481. In an embodiment, the flexible reservoir pouch 210 comprises a
flaccid reservoir on top of fluidic and electronic elements such as
the pumps 481, the valves 482, and the circuit board 483. The
flexible reservoir pouch 210 adds flexibility to the reservoir unit
108, for example, in the cross-sectional plane.
[0049] The circuit board 483 may include various circuits for
driving the gastric banding system 100. For example, the circuit
board 483 may include the center tap circuit 375 for adding the
signals received through the coils 116 and 218.
[0050] The pumps 481 operate on the fluid in the flexible reservoir
pouch 210 to facilitate moving the fluid between the flexible
reservoir pouch 210 and the inflatable portion of the gastric band
105. In an embodiment, the pumps 481 comprise piezoelectric pumps.
Further in an embodiment, each pump 481 may comprise two or more
piezoelectric actuators to increase pumping capability without
adding additional pumps. For example, in an embodiment, six
piezoelectric actuators may be utilized to provide the desired
pumping capability, but these six actuators may be included in only
three pumps 481 which allows for a reduced amount of space needed
in the housing 209 for the pumps 481. In other embodiments, more or
fewer pumps 481 or piezoelectric actuators may be utilized
depending on the designed pumping capacity. Additionally, other
types of pumps may be utilized without departing from the scope of
the present invention.
[0051] In various embodiments, the circuit board 483 may comprise a
flexible circuit board. The entire circuit board 483 may be a
flexible circuit board, or only portions of the circuit board 483
may comprise a flexible circuit board. In an embodiment, the center
of the circuit board 483 is a flexible circuit board to allow the
reservoir unit 108 to flex in the middle of the unit 108.
[0052] As noted above, the coil 116 may be looped around the
reservoir unit 108, or the coil 116 may be located near the sternum
of the patient 101, or in another advantageously determined
location. Locating the coil 116 around the periphery of the
reservoir unit 108 may allow the coil 116 to have a larger area for
increased power transfer. However, locating the coil 116 near the
sternum may allow the coil 116 to be nearer the skin surface 104 to
also allow for increased power transfer. Thus, depending on the
patient 101 and/or other variables, some embodiments comprise the
coil 116 near the sternum, and other embodiments comprise the coil
116 near the reservoir unit 108. Locating the coil 116 near the
reservoir unit 108 as opposed to near the access port 114 reduces
the amount of metallic elements near the coil 116, which in turn
increases the amount of RF energy available to be absorbed by the
coil 116. Locating the coil 116 near the reservoir unit 108 also
reduces the length of the wiring utilized to couple the coil 116 to
the pumps 481, thereby advantageously reducing the possibility that
these wires will fail.
[0053] Various embodiments of the present invention provide for
modular design of gastric banding system 100. For example, the
reservoir unit 108 may contain components that allow a remotely
adjustable gastric banding system to be utilized in connection with
access ports that are currently used in existing gastric banding
systems. Thus, a physician may have the option of implanting an
existing system or a system 100 according to embodiments of the
present invention depending on the circumstances of a particular
implantation procedure.
[0054] Unless otherwise indicated, all numbers expressing
quantities of ingredients, volumes of fluids, and so forth used in
the specification and claims are to be understood as being modified
in all instances by the term "about." Accordingly, unless indicated
to the contrary, the numerical parameters set forth in the
specification and attached claims are approximations that may vary
depending upon the desired properties sought to be obtained by the
present invention. At the very least, and not as an attempt to
limit the application of the doctrine of equivalents to the scope
of the claims, each numerical parameter should at least be
construed in light of the number of reported significant digits and
by applying ordinary rounding techniques. Notwithstanding that the
numerical ranges and parameters setting forth the broad scope of
the invention are approximations, the numerical values set forth in
the specific examples are reported as precisely as possible. Any
numerical value, however, inherently contains certain errors
necessarily resulting from the standard deviation found in their
respective testing measurements.
[0055] The terms "a," "an," "the" and similar referents used in the
context of describing the invention (especially in the context of
the following claims) are to be construed to cover both the
singular and the plural, unless otherwise indicated herein or
clearly contradicted by context. Recitation of ranges of values
herein is merely intended to serve as a shorthand method of
referring individually to each separate value falling within the
range. Unless otherwise indicated herein, each individual value is
incorporated into the specification as if it were individually
recited herein. All methods described herein can be performed in
any suitable order unless otherwise indicated herein or otherwise
clearly contradicted by context. The use of any and all examples,
or exemplary language (e.g., "such as") provided herein is intended
merely to better illuminate the invention and does not pose a
limitation on the scope of the invention otherwise claimed. No
language in the specification should be construed as indicating any
non-claimed element essential to the practice of the invention.
[0056] Groupings of alternative elements or embodiments of the
invention disclosed herein are not to be construed as limitations.
Each group member may be referred to and claimed individually or in
any combination with other members of the group or other elements
found herein. It is anticipated that one or more members of a group
may be included in, or deleted from, a group for reasons of
convenience and/or patentability. When any such inclusion or
deletion occurs, the specification is deemed to contain the group
as modified thus fulfilling the written description of all Markush
groups used in the appended claims.
[0057] Certain embodiments of this invention are described herein,
including the best mode known to the inventor for carrying out the
invention. Of course, variations on these described embodiments
will become apparent to those of ordinary skill in the art upon
reading the foregoing description. The inventor expects skilled
artisans to employ such variations as appropriate, and the inventor
intends for the invention to be practiced otherwise than
specifically described herein. Accordingly, this invention includes
all modifications and equivalents of the subject matter recited in
the claims appended hereto as permitted by applicable law.
Moreover, any combination of the above-described elements in all
possible variations thereof is encompassed by the invention unless
otherwise indicated herein or otherwise clearly contradicted by
context.
[0058] Furthermore, certain references have been made to patents
and printed publications throughout this specification. Each of the
above-cited references and printed publications are individually
incorporated herein by reference in their entirety.
[0059] Specific embodiments disclosed herein may be further limited
in the claims using "consisting of" and/or "consisting essentially
of" language. When used in the claims, whether as filed or added
per amendment, the transition term "consisting of" excludes any
element, step, or ingredient not specified in the claims. The
transition term "consisting essentially of" limits the scope of a
claim to the specified materials or steps and those that do not
materially affect the basic and novel characteristic(s).
Embodiments of the invention so claimed are inherently or expressly
described and enabled herein.
[0060] In closing, it is to be understood that the embodiments of
the invention disclosed herein are illustrative of the principles
of the present invention. Other modifications that may be employed
are within the scope of the invention. Thus, by way of example, but
not of limitation, alternative configurations of the present
invention may be utilized in accordance with the teachings herein.
Accordingly, the present invention is not limited to that precisely
as shown and described.
* * * * *