U.S. patent application number 17/550926 was filed with the patent office on 2022-09-08 for communication system with enhanced partial power source and method of manufacturing same.
This patent application is currently assigned to OTSUKA PHARMACEUTICAL CO., LTD.. The applicant listed for this patent is OTSUKA PHARMACEUTICAL CO., LTD.. Invention is credited to Robert AZEVEDO, Peter BJELETICH, Benedict COSTELLO, Robert DUCK, Jeremy FRANK, Hooman HAFEZI, Iliya PESIC, Eric SNYDER.
Application Number | 20220280061 17/550926 |
Document ID | / |
Family ID | 1000006359154 |
Filed Date | 2022-09-08 |
United States Patent
Application |
20220280061 |
Kind Code |
A1 |
FRANK; Jeremy ; et
al. |
September 8, 2022 |
COMMUNICATION SYSTEM WITH ENHANCED PARTIAL POWER SOURCE AND METHOD
OF MANUFACTURING SAME
Abstract
The system of the present invention includes a conductive
element, an electronic component, and a partial power source in the
form of dissimilar materials. Upon contact with a conducting fluid,
a voltage potential is created and the power source is completed,
which activates the system. The electronic component controls the
conductance between the dissimilar materials to produce a unique
current signature. The system can also measure the conditions of
the environment surrounding the system.
Inventors: |
FRANK; Jeremy; (San
Francisco, CA) ; BJELETICH; Peter; (Livermore,
CA) ; HAFEZI; Hooman; (Redwood City, CA) ;
AZEVEDO; Robert; (Albany, CA) ; DUCK; Robert;
(San Francisco, CA) ; PESIC; Iliya; (Saratoga,
CA) ; COSTELLO; Benedict; (Piedmont, CA) ;
SNYDER; Eric; (South San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
OTSUKA PHARMACEUTICAL CO., LTD. |
Tokyo |
|
JP |
|
|
Assignee: |
OTSUKA PHARMACEUTICAL CO.,
LTD.
TOKYO
JP
|
Family ID: |
1000006359154 |
Appl. No.: |
17/550926 |
Filed: |
December 14, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16689578 |
Nov 20, 2019 |
11229378 |
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17550926 |
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14308548 |
Jun 18, 2014 |
10517507 |
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16689578 |
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13180525 |
Jul 11, 2011 |
8802183 |
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14308548 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
H01M 2220/30 20130101;
A61B 5/0031 20130101; H01M 4/0402 20130101; Y10T 29/49002 20150115;
H01M 4/06 20130101; A61B 5/0028 20130101; A61B 5/14539 20130101;
A61B 2562/125 20130101; A61B 2560/0214 20130101; H01M 4/66
20130101; A61J 3/007 20130101; Y10T 156/1056 20150115; A61B 5/073
20130101; H01M 4/381 20130101; H01M 4/366 20130101; A61B 2562/12
20130101; A61B 5/6861 20130101; A61B 2562/162 20130101; H01Q 1/273
20130101; Y10T 29/49117 20150115; A61B 5/01 20130101; H01M 4/08
20130101; H01M 4/582 20130101; A61B 5/4839 20130101; H01M 6/34
20130101 |
International
Class: |
A61B 5/07 20060101
A61B005/07; A61B 5/00 20060101 A61B005/00; A61B 5/145 20060101
A61B005/145; H01Q 1/27 20060101 H01Q001/27; A61J 3/00 20060101
A61J003/00; H01M 4/04 20060101 H01M004/04; H01M 4/06 20060101
H01M004/06; H01M 4/08 20060101 H01M004/08; H01M 6/34 20060101
H01M006/34 |
Claims
1-20. (canceled)
21. A system comprising: a pharmaceutical formulation; and a device
configured to be ingested within a body of a living organism and to
produce a current through a conducting liquid that can be detected
external to the body, wherein the device includes a plurality of
materials disposed on a support structure, the plurality of
materials comprising: an anode material; a cathode material that is
dissimilar to the anode material, wherein the anode and cathode
materials are configured to generate a voltage when in contact with
the conducting liquid to enable the device to produce the current;
a transition material disposed between at least one of the anode
material and the support structure or the cathode material and the
support structure; and an adhesion material disposed between at
least one of the anode material and the support structure or the
cathode material and the support structure.
22. The system of claim 21, the system further comprising a
receiver configured to detect the current produced by the
device.
23. The system of claim 21, wherein the anode material comprises
Mg.
24. The system of claim 21, wherein the cathode material comprises
CuCl.
25. The system of claim 21, wherein the adhesion material comprises
gold.
26. The system of claim 21, wherein the adhesion material defines a
layer that is less than 100 microns thick.
27. The system of claim 21, wherein the adhesion material defines a
layer having an uneven surface configured to improve adhesion.
28. The system of claim 27, wherein the uneven surface defines a
plurality of holes.
29. The system of claim 28, wherein the plurality of holes are
spaced a predetermined distance away from all edges of the layer of
adhesion, such that every hole of the plurality of holes is covered
by at least some portion of either the anode material or the
cathode material.
30. The system of claim 21, wherein the support structure comprises
silicon.
31. The system of claim 21, wherein the transition material
comprises titanium.
32. The system of claim 21, wherein the device further comprises a
control device configured to alter conductance between the anode
and cathode material.
33. The system of claim 32, wherein the control device is further
configured to produce a unique current signature by controlling a
magnitude of the current.
34. The system of claim 32, wherein the control device comprises a
control module and a memory.
35. The system of claim 32, wherein the control device comprises a
clock.
36. The system of claim 32, wherein the control device is powered
on by the voltage generated by the anode and cathode material when
in contact with the conducting liquid.
37. The system of claim 32, wherein the control device comprises a
sensor module.
38. The system of claim 21, wherein the device further comprises a
membrane comprising a non-conducting material.
39. The system of claim 38, wherein the membrane is secured to the
support structure and surrounds the anode material, the cathode
material, the adhesion material and the transition material.
40. The system of claim 39, wherein the membrane is configured to
increase a length of the current to make the current more easily
detectable by a receiver.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 13/180,525, filed on Jul. 11, 2011 and entitled
"Communication System with Enhanced Partial Power and Method of
Manufacturing Same", which is related to U.S. patent application
Ser. No. 12/564,017, filed on Sep. 21, 2009 and entitled
"Communication System with Partial Power Source", published on Apr.
1, 2010 as U.S. Publication No. US2010-0081894A1, which is a
continuation-in-part application of U.S. patent application Ser.
No. 11/912,475 filed Jun. 23, 2008 and entitled "Pharma-Informatics
System", published on Nov. 20, 2008 as U.S. Publication No.
2008-0284599A1 which application is a 371 application of PCT
Application No. PCT/US06/16370 filed Apr. 28, 2006 and entitled
"Pharma-Informatics System"; which application pursuant to 35
U.S.C. .sctn. 119 (e), claims priority to the filing dates of: U.S.
Provisional Patent Application Ser. No. 60/676,145 filed Apr. 28,
2005 and entitled "Pharma-Informatics System"; U.S. Provisional
Patent Application Ser. No. 60/694,078, filed Jun. 24, 2005, and
entitled "Pharma-Informatics System"; U.S. Provisional Patent
Application Ser. No. 60/713,680 filed Sep. 1, 2005 and entitled
"Medical Diagnostic And Treatment Platform Using Near-Field
Wireless Communication Of Information Within A Patient's Body"; and
U.S. Provisional Patent Application Ser. No. 60/790,335 filed Apr.
7, 2006 and entitled "Pharma-Informatics System"; the disclosures
of which are herein incorporated by reference.
[0002] This application is related to the following US applications
filed concurrently herewith, the disclosures of which are
incorporated herein by reference: U.S. application Ser. No.
13/180,516, filed Jul. 11, 2011 entitled COMMUNICATION SYSTEM WITH
REMOTE ACTIVATION; U.S. application Ser. No. 13/180,498, filed Jul.
11, 2011, entitled COMMUNICATION SYSTEM WITH MULTIPLE TYPES OF
POWER; U.S. application Ser. No. 13/180,539, filed Jul. 11, 2011,
entitled COMMUNICATION SYSTEM USING AN IMPLANTABLE DEVICE; U.S.
application Ser. No. 13/180,538, filed Jul. 11, 2011, entitled
COMMUNICATION SYSTEM USING POLYPHARMACY CO-PACKAGED MEDICATION
DOSING UNIT; and U.S. application Ser. No. 13/180,507, filed Jul.
11, 2011, entitled COMMUNICATION SYSTEM INCORPORATED IN AN
INGESTIBLE PRODUCT.
FIELD
[0003] The present invention is related to communication systems
for detection of an event. More specifically, the present
disclosure includes a system that includes a device with various
power sources and communication schemes.
INTRODUCTION
[0004] Ingestible devices that include electronic circuitry have
been proposed for use in a variety of different medical
applications, including both diagnostic and therapeutic
applications. These devices typically require an internal power
supply for operation. Examples of such ingestible devices are
ingestible electronic capsules which collect data as they pass
through the body, and transmit the data to an external receiver
system. An example of this type of electronic capsule is an in-vivo
video camera. The swallowable capsule includes a camera system and
an optical system for imaging an area of interest onto the camera
system. The transmitter transmits the video output of the camera
system and the reception system receives the transmitted video
output. Other examples include an ingestible imaging device, which
has an internal and self-contained power source, which obtains
images from within body lumens or cavities. The electronic circuit
components of the device are enclosed by an inert indigestible
housing (e.g. glass housing) that passes through the body
internally. Other examples include an ingestible data recorder
capsule medical device. The electronic circuits of the disclosed
device (e.g. sensor, recorder, battery etc.) are housed in a
capsule made of inert materials.
[0005] In other examples, fragile radio frequency identification
(RFID) tags are used in drug ingestion monitoring applications. In
order for the RFID tags to be operational, each requires an
internal power supply. The RFID tags are antenna structures that
are configured to transmit a radio-frequency signal through the
body.
[0006] The problem these existing devices pose is that the power
source is internal to device and such power sources are costly to
produce and potentially harmful to the surrounding environment if
the power source leaks or is damaged. Additionally, having antennas
extending from the device is a concern as related to the antennas
getting damaged or causing a problem when the device is used
in-vivo. Therefore, what is needed is suitable system with
circuitry that eliminates the need for an internal power source and
antennas.
SUMMARY
[0007] The present disclosure includes a system for producing a
unique signature that indicates the occurrence of an event. The
system includes circuitry and components that can be placed within
certain environments that include a conducting fluid. One example
of such an environment is inside a container that houses the
conducting fluid, such as a sealed bag with a solution, which
includes an IV bag. Another example is within the body of a living
organism, such as an animal or a human. The systems are ingestible
and/or digestible or partially digestible. The system includes
dissimilar materials positioned on the framework such that when a
conducting fluid comes into contact with the dissimilar materials,
a voltage potential difference is created. The voltage potential
difference, and hence the voltage, is used to power up control
logic that is positioned within the framework. Ions or current
flows from the first dissimilar material to the second dissimilar
material via the control logic and then through the conducting
fluid to complete a circuit. The control logic controls the
conductance between the two dissimilar materials and, hence,
controls or modulates the conductance.
[0008] As the ingestible circuitry is made up of ingestible, and
even digestible, components, the ingestible circuitry results in
little, if any, unwanted side effects, even when employed in
chronic situations. Examples of the range of components that may be
included are: logic and/or memory elements; effectors; a signal
transmission element; and a passive element, such as a resistor or
inductor. The one or more components on the surface of the support
may be laid out in any convenient configuration. Where two or more
components are present on the surface of the solid support,
interconnects may be provided. All of the components and the
support of the ingestible circuitry are ingestible, and in certain
instances digestible or partially digestible. Furthermore, the
circuitry is manufactured according to a process to enhance
adhesion of the materials.
BRIEF DESCRIPTION OF THE FIGURES
[0009] FIG. 1 shows a pharmaceutical product with an event
indicator system according to the teaching of the present
invention, wherein the product and the event indicator system
combination are within the body.
[0010] FIG. 2A shows the pharmaceutical product of FIG. 1 with the
event indicator system on the exterior of the pharmaceutical
product.
[0011] FIG. 2B shows the pharmaceutical product of FIG. 1 with the
event indicator system positioned inside the pharmaceutical
product.
[0012] FIG. 3 is a block diagram representation of one aspect of
the event indicator system with dissimilar metals positioned on
opposite ends.
[0013] FIG. 4 is a block diagram representation of another aspect
of the event indicator system with dissimilar metals positioned on
the same end and separated by a non-conducting material.
[0014] FIG. 5 shows ionic transfer or the current path through a
conducting fluid when the event indicator system of FIG. 3 is in
contact with conducting liquid and in an active state.
[0015] FIG. 5A shows an exploded view of the surface of dissimilar
materials of FIG. 5.
[0016] FIG. 5B shows the event indicator system of FIG. 5 with a pH
sensor unit.
[0017] FIG. 5C shows the event indicator system in accordance with
another aspect of the present invention.
[0018] FIG. 6 is a block diagram illustration of one aspect of the
control device used in the system of FIGS. 3 and 4.
[0019] FIG. 7 shows a cross sectional side view of the event
indicator system in accordance with the present invention.
[0020] FIG. 8 is an exploded view of two components of the event
indicator system of FIG. 7 in accordance with the present
invention.
[0021] FIG. 9 is an assembly process of a portion of the event
indicator system of FIG. 7 in accordance with the present
invention.
[0022] FIG. 10 shows a wafer with multiple event indicator systems
in accordance with the present invention.
[0023] FIG. 11 shows a non-conducting membrane sheet with holes for
receiving a device forming part of the event indicator system of
FIG. 7 in accordance with the present invention.
DETAILED DESCRIPTION
[0024] The present disclosure includes multiple aspects for
indicating the occurrence of an event. As described in more detail
below, a system of the present invention is used with a conducting
fluid to indicate the event marked by contact between the
conducting fluid and the system. For example, the system of the
present disclosure may be used with pharmaceutical product and the
event that is indicated is when the product is taken or ingested.
The term "ingested" or "ingest" or "ingesting" is understood to
mean any introduction of the system internal to the body. For
example, ingesting includes simply placing the system in the mouth
all the way to the descending colon. Thus, the term ingesting
refers to any instant in time when the system is introduced to an
environment that contains a conducting fluid. Another example would
be a situation when a non-conducting fluid is mixed with a
conducting fluid. In such a situation the system would be present
in the non-conduction fluid and when the two fluids are mixed, the
system comes into contact with the conducting fluid and the system
is activated. Yet another example would be the situation when the
presence of certain conducting fluids needed to be detected. In
such instances, the presence of the system, which would be
activated, within the conducting fluid could be detected and,
hence, the presence of the respective fluid would be detected.
[0025] Referring again to the instance where the system is used
with the product that is ingested by the living organism, when the
product that includes the system is taken or ingested, the device
comes into contact with the conducting liquid of the body. When the
system of the present invention comes into contact with the body
fluid, a voltage potential is created and the system is activated.
A portion of the power source is provided by the device, while
another portion of the power source is provided by the conducting
fluid, which is discussed in detail below.
[0026] Referring now to FIG. 1, an ingestible product 14 that
includes a system of the present invention is shown inside the
body. The product 14 is configured as an orally ingestible
pharmaceutical formulation in the form of a pill or capsule. Upon
ingestion, the pill moves to the stomach. Upon reaching the
stomach, the product 14 is in contact with stomach fluid 18 and
undergoes a chemical reaction with the various materials in the
stomach fluid 18, such as hydrochloric acid and other digestive
agents. The system of the present invention is discussed in
reference to a pharmaceutical environment. However, the scope of
the present invention is not limited thereby. The present invention
can be used in any environment where a conducting fluid is present
or becomes present through mixing of two or more components that
result in a conducting liquid.
[0027] Referring now to FIG. 2A, a pharmaceutical product 10,
similar to the product 14 of FIG. 1, is shown with a system 12,
such as an ingestible event marker or an ionic emission module. The
scope of the present invention is not limited by the shape or type
of the product 10. For example, it will be clear to one skilled in
the art that the product 10 can be a capsule, a time-release oral
dosage, a tablet, a gel cap, a sub-lingual tablet, or any oral
dosage product that can be combined with the system 12. In the
referenced aspect, the product 10 has the system 12 secured to the
exterior using known methods of securing micro-devices to the
exterior of pharmaceutical products. Example of methods for
securing the micro-device to the product is disclosed in U.S.
Provisional Application No. 61/142,849 filed on Jan. 1, 2009 and
entitled "HIGH-THROUGHPUT PRODUCTION OF INGESTIBLE EVENT MARKERS"
as well as U.S. Provisional Application No. 61/177,611 filed on May
12, 2009 and entitled "INGESTIBLE EVENT MARKERS COMPRISING AN
IDENTIFIER AND AN INGESTIBLE COMPONENT", the entire disclosure of
each is incorporated herein by reference. Once ingested, the system
12 comes into contact with body liquids and the system 12 is
activated. The system 12 uses the voltage potential difference to
power up and thereafter modulates conductance to create a unique
and identifiable current signature. Upon activation, the system 12
controls the conductance and, hence, current flow to produce the
current signature.
[0028] There are various reasons for delaying the activation of the
system 12. In order to delay the activation of the system 12, the
system 12 may be coated with a shielding material or protective
layer. The layer is dissolved over a period of time, thereby
allowing the system 12 to be activated when the product 10 has
reached a target location.
[0029] Referring now to FIG. 2B, a pharmaceutical product 20,
similar to the product 14 of FIG. 1, is shown with a system 22,
such as an ingestible event marker or an identifiable emission
module. The scope of the present invention is not limited by the
environment to which the system 22 is introduced. For example, the
system 22 can be enclosed in a capsule that is taken in addition
to/independently from the pharmaceutical product. The capsule may
be simply a carrier for the system 22 and may not contain any
product. Furthermore, the scope of the present invention is not
limited by the shape or type of product 20. For example, it will be
clear to one skilled in the art that the product 20 can be a
capsule, a time-release oral dosage, a tablet, a gel capsule, a
sub-lingual tablet, or any oral dosage product. In the referenced
aspect, the product 20 has the system 22 positioned inside or
secured to the interior of the product 20. In one aspect, the
system 22 is secured to the interior wall of the product 20. When
the system 22 is positioned inside a gel capsule, then the content
of the gel capsule is a non-conducting gel-liquid. On the other
hand, if the content of the gel capsule is a conducting gel-liquid,
then in an alternative aspect, the system 22 is coated with a
protective cover to prevent unwanted activation by the gel capsule
content. If the content of the capsule is a dry powder or
microspheres, then the system 22 is positioned or placed within the
capsule. If the product 20 is a tablet or hard pill, then the
system 22 is held in place inside the tablet. Once ingested, the
product 20 containing the system 22 is dissolved. The system 22
comes into contact with body liquids and the system 22 is
activated. Depending on the product 20, the system 22 may be
positioned in either a near-central or near-perimeter position
depending on the desired activation delay between the time of
initial ingestion and activation of the system 22. For example, a
central position for the system 22 means that it will take longer
for the system 22 to be in contact with the conducting liquid and,
hence, it will take longer for the system 22 to be activated.
Therefore, it will take longer for the occurrence of the event to
be detected.
[0030] Referring now to FIG. 3, in one aspect, the systems 12 and
22 of FIGS. 2A and 2B, respectively, are shown in more detail as
system 30. The system 30 can be used in association with any
pharmaceutical product, as mentioned above, to determine when a
patient takes the pharmaceutical product. As indicated above, the
scope of the present invention is not limited by the environment
and the product that is used with the system 30. For example, the
system 30 may be placed within a capsule and the capsule is placed
within the conducting liquid. The capsule would then dissolve over
a period of time and release the system 30 into the conducting
liquid. Thus, in one aspect, the capsule would contain the system
30 and no product. Such a capsule may then be used in any
environment where a conducting liquid is present and with any
product. For example, the capsule may be dropped into a container
filled with jet fuel, salt water, tomato sauce, motor oil, or any
similar product. Additionally, the capsule containing the system 30
may be ingested at the same time that any pharmaceutical product is
ingested in order to record the occurrence of the event, such as
when the product was taken.
[0031] In the specific example of the system 30 combined with the
pharmaceutical product, as the product or pill is ingested, the
system 30 is activated. The system 30 controls conductance to
produce a unique current signature that is detected, thereby
signifying that the pharmaceutical product has been taken. The
system 30 includes a framework 32. The framework 32 is a chassis
for the system 30 and multiple components are attached to,
deposited upon, or secured to the framework 32. In this aspect of
the system 30, a digestible material 34 is physically associated
with the framework 32. The material 34 may be chemically deposited
on, evaporated onto, secured to, or built-up on the framework all
of which may be referred to herein as "deposit" with respect to the
framework 32. The material 34 is deposited on one side of the
framework 32. The materials of interest that can be used as
material 34 include, but are not limited to: Cu or CuI. The
material 34 is deposited by physical vapor deposition,
electrodeposition, or plasma deposition, among other protocols. The
material 34 may be from about 0.05 to about 500 .mu.m thick, such
as from about 5 to about 100 .mu.m thick. The shape is controlled
by shadow mask deposition, or photolithography and etching.
Additionally, even though only one region is shown for depositing
the material, each system 30 may contain two or more electrically
unique regions where the material 34 may be deposited, as desired.
The various methods for depositing the materials onto the framework
32 are discussed in greater detail with respect to FIGS. 7-9
below.
[0032] At a different side, which is the opposite side as shown in
FIG. 3, another digestible material 36 is deposited, such that
materials 34 and 36 are dissimilar. Although not shown, the
different side selected may be the side next to the side selected
for the material 34, The scope of the present invention is not
limited by the side selected and the term "different side" can mean
any of the multiple sides that are different from the first
selected side. Furthermore, even though the shape of the system is
shown as a square, the shape maybe any geometrically suitable
shape. Material 34 and 36 are selected such that they produce a
voltage potential difference when the system 30 is in contact with
conducting liquid, such as body fluids. The materials of interest
for material 36 include, but are not limited to: Mg, Zn, or other
electronegative metals. As indicated above with respect to the
material 34, the material 36 may be chemically deposited on,
evaporated onto, secured to, or built-up on the framework. Also, an
adhesion layer may be necessary to help the material 36 (as well as
material 34 when needed) to adhere to the framework 32. Typical
adhesion layers for the material 36 are Ti, TiW, Cr or similar
material. Anode material and the adhesion layer may be deposited by
physical vapor deposition, electrodeposition or plasma deposition.
The material 36 may be from about 0.05 to about 500 .mu.m thick,
such as from about 5 to about 100 .mu.m thick. However, the scope
of the present invention is not limited by the thickness of any of
the materials nor by the type of process used to deposit or secure
the materials to the framework 32.
[0033] According to the disclosure set forth, the materials 34 and
36 can be any pair of materials with different electrochemical
potentials. Additionally, in the aspects wherein the system 30 is
used in-vivo, the materials 34 and 36 may be vitamins that can be
absorbed. More specifically, the materials 34 and 36 can be made of
any two materials appropriate for the environment in which the
system 30 will be operating. For example, when used with an
ingestible product, the materials 34 and 36 are any pair of
materials with different electrochemical potentials that are
ingestible. An illustrative example includes the instance when the
system 30 is in contact with an ionic solution, such as stomach
acids. Suitable materials are not restricted to metals, and in
certain aspects the paired materials are chosen from metals and
non-metals, e.g., a pair made up of a metal (such as Mg) and a salt
(such as CuCl or CuI). With respect to the active electrode
materials, any pairing of substances--metals, salts, or
intercalation compounds--with suitably different electrochemical
potentials (voltage) and low interfacial resistance are
suitable.
[0034] Materials and pairings of interest include, but are not
limited to, those reported in Table 1 below. In one aspect, one or
both of the metals may be doped with a non-metal, e.g., to enhance
the voltage potential created between the materials as they come
into contact with a conducting liquid. Non-metals that may be used
as doping agents in certain aspects include, but are not limited
to: sulfur, iodine and the like. In another aspect, the materials
are copper iodine (CuI) as the anode and magnesium (Mg) as the
cathode. Aspects of the present invention use electrode materials
that are not harmful to the human body.
TABLE-US-00001 TABLE 1 Anode Cathode Metals Magnesium, Zinc Sodium,
Lithium Iron Salts Copper salts: iodide, chloride, bromide,
sulfate, formate, (other anions possible) Fe.sup.3+ salts: e.g.
orthophosphate, pyrophosphate, (other anions possible) Oxygen or
Hydrogen ion (H+) on platinum, gold or other catalytic surfaces
Intercalation Graphite with Li, Vanadium oxide compounds K, Ca, Na,
Mg Manganese oxide
[0035] Thus, when the system 30 is in contact with the conducting
liquid, a current path, an example is shown in FIG. 5, is formed
through the conducting liquid between material 34 and 36. A control
device 38 is secured to the framework 32 and electrically coupled
to the materials 34 and 36. The control device 38 includes
electronic circuitry, for example control logic that is capable of
controlling and altering the conductance between the materials 34
and 36.
[0036] The voltage potential created between the materials 34 and
36 provides the power for operating the system as well as produces
the current flow through the conducting fluid and the system. In
one aspect, the system operates in direct current mode. In an
alternative aspect, the system controls the direction of the
current so that the direction of current is reversed in a cyclic
manner, similar to alternating current. As the system reaches the
conducting fluid or the electrolyte, where the fluid or electrolyte
component is provided by a physiological fluid, e.g., stomach acid,
the path for current flow between the materials 34 and 36 is
completed external to the system 30; the current path through the
system 30 is controlled by the control device 38. Completion of the
current path allows for the current to flow and in turn a receiver,
not shown, can detect the presence of the current and recognize
that the system 30 has been activate and the desired event is
occurring or has occurred.
[0037] In one aspect, the two materials 34 and 36 are similar in
function to the two electrodes needed for a direct current power
source, such as a battery. The conducting liquid acts as the
electrolyte needed to complete the power source. The completed
power source described is defined by the electrochemical reaction
between the materials 34 and 36 of the system 30 and enabled by the
fluids of the body. The completed power source may be viewed as a
power source that exploits electrochemical conduction in an ionic
or a conducting solution such as gastric fluid, blood, or other
bodily fluids and some tissues. Additionally, the environment may
be something other than a body and the liquid may be any conducting
liquid. For example, the conducting fluid may be salt water or a
metallic based paint.
[0038] In certain aspects, these two materials are shielded from
the surrounding environment by an additional layer of material.
Accordingly, when the shield is dissolved and the two dissimilar
materials are exposed to the target site, a voltage potential is
generated.
[0039] In certain aspects, the complete power source or supply is
one that is made up of active electrode materials, electrolytes,
and inactive materials, such as current collectors, packaging, etc.
The active materials are any pair of materials with different
electrochemical potentials. Suitable materials are not restricted
to metals, and in certain aspects the paired materials are chosen
from metals and nonmetals, e.g., a pair made up of a metal (such as
Mg) and a salt (such as CuI). With respect to the active electrode
materials, any pairing of substances--metals, salts, or
intercalation compounds--with suitably different electrochemical
potentials (voltage) and low interfacial resistance are
suitable.
[0040] A variety of different materials may be employed as the
materials that form the electrodes. In certain aspects, electrode
materials are chosen to provide for a voltage upon contact with the
target physiological site, e.g., the stomach, sufficient to drive
the system of the identifier. In certain aspects, the voltage
provided by the electrode materials upon contact of the metals of
the power source with the target physiological site is 0.001 V or
higher, including 0.01 V or higher, such as 0.1 V or higher, e.g.,
0.3 V or higher, including 0.5 volts or higher, and including 1.0
volts or higher, where in certain aspects, the voltage ranges from
about 0.001 to about 10 volts, such as from about 0.01 to about 10
V.
[0041] Referring again to FIG. 3, the materials 34 and 36 provide
the voltage potential to activate the control device 38. Once the
control device 38 is activated or powered up, the control device 38
can alter conductance between the materials 34 and 36 in a unique
manner. By altering the conductance between materials 34 and 36,
the control device 38 is capable of controlling the magnitude of
the current through the conducting liquid that surrounds the system
30. This produces a unique current signature that can be detected
and measured by a receiver (not shown), which can be positioned
internal or external to the body. In addition to controlling the
magnitude of the current path between the materials, non-conducting
materials, membrane, or "skirt" are used to increase the "length"
of the current path and, hence, act to boost the conductance path,
as disclosed in the U.S. patent application Ser. No. 12/238,345
entitled, "In-Body Device with Virtual Dipole Signal Amplification"
filed Sep. 25, 2008, the entire content of which is incorporated
herein by reference. Alternatively, throughout the disclosure
herein, the terms "non-conducting material", "membrane", and
"skirt" are used interchangeably with the term "current path
extender" without impacting the scope or the present aspects and
the claims herein. The skirt, shown in portion at 35 and 37,
respectively, may be associated with, e.g., secured to, the
framework 32. Various shapes and configurations for the skirt are
contemplated as within the scope of the present invention. For
example, the system 30 may be surrounded entirely or partially by
the skirt and the skirt maybe positioned along a central axis of
the system 30 or off-center relative to a central axis. Thus, the
scope of the present invention as claimed herein is not limited by
the shape or size of the skirt. Furthermore, in other aspects, the
materials 34 and 36 may be separated by one skirt that is
positioned in any defined region between the materials 34 and
36.
[0042] Referring now to FIG. 4, in another aspect, the systems 12
and 22 of FIGS. 2A and 2B, respectively, are shown in more detail
as system 40. The system 40 includes a framework 42. The framework
42 is similar to the framework 32 of FIG. 3. In this aspect of the
system 40, a digestible or dissolvable material 44 is deposited on
a portion of one side of the framework 42. At a different portion
of the same side of the framework 42, another digestible material
46 is deposited, such that materials 44 and 46 are dissimilar. More
specifically, material 44 and 46 are selected such that they form a
voltage potential difference when in contact with a conducting
liquid, such as body fluids. Thus, when the system 40 is in contact
with and/or partially in contact with the conducting liquid, then a
current path, an example is shown in FIG. 5, is formed through the
conducting liquid between material 44 and 46. A control device 48
is secured to the framework 42 and electrically coupled to the
materials 44 and 46. The control device 48 includes electronic
circuitry that is capable of controlling part of the conductance
path between the materials 44 and 46. The materials 44 and 46 are
separated by a non-conducting skirt 49. Various examples of the
skirt 49 are disclosed in U.S. Provisional Application No.
61/173,511 filed on Apr. 28, 2009 and entitled "HIGHLY RELIABLE
INGESTIBLE EVENT MARKERS AND METHODS OF USING SAME" and U.S.
Provisional Application No. 61/173,564 filed on Apr. 28, 2009 and
entitled "INGESTIBLE EVENT MARKERS HAVING SIGNAL AMPLIFIERS THAT
COMPRISE AN ACTIVE AGENT"; as well as U.S. application Ser. No.
12/238,345 filed Sep. 25, 2008 and entitled "IN-BODY DEVICE WITH
VIRTUAL DIPOLE SIGNAL AMPLIFICATION"; the entire disclosure of each
is incorporated herein by reference.
[0043] Once the control device 48 is activated or powered up, the
control device 48 can alter conductance between the materials 44
and 46. Thus, the control device 48 is capable of controlling the
magnitude of the current through the conducting liquid that
surrounds the system 40. As indicated above with respect to system
30, a unique current signature that is associated with the system
40 can be detected by a receiver (not shown) to mark the activation
of the system 40. In order to increase the "length" of the current
path the size of the skirt 49 is altered. The longer the current
path, the easier it may be for the receiver to detect the
current.
[0044] Referring now to FIG. 5, the system 30 of FIG. 3 is shown in
an activated state and in contact with conducting liquid. The
system 30 is grounded through ground contact 52. For example, when
the system 30 is in contact with a conducting fluid, the conducting
fluid provides the ground. The system 30 also includes a sensor
module 74, which is described in greater detail with respect to
FIG. 6. Ion or current paths 50 extend between material 34 to
material 36 and flow through the conducting fluid in contact with
the system 30. The voltage potential created between the material
34 and 36 is created through chemical reactions between materials
34/36 and the conducting fluid.
[0045] If the conditions of the environment change to become
favorable to communication, as determined by the measurements of
the environment, then the unit 75 sends a signal to the control
device 38 to alter the conductance between the materials 34 and 36
to allow for communication using the current signature of the
system 30. Thus, if the system 30 has been deactivated and the
impedance of the environment is suitable for communication, then
the system 30 can be activated again.
[0046] Referring now to FIG. 5A, this shows an exploded view of the
surface of the material 34. In one aspect, the surface of the
material 34 is not planar, but rather an irregular surface. The
irregular surface increases the surface area of the material and,
hence, the area that comes in contact with the conducting fluid. In
one aspect, at the surface of the material 34, there is an
electrochemical reaction between the material 34 and the
surrounding conducting fluid such that mass is exchanged with the
conducting fluid. The term "mass" as used here includes any ionic
or non-ionic species that may be added or removed from the
conductive fluid as part of the electrochemical reactions occurring
on material 34. One example includes the instant where the material
is CuCl and when in contact with the conducting fluid, CuCl is
converted to Cu metal (solid) and Cl-- is released into the
solution. The flow of positive ions into the conducting fluid is
depicted by the current path 50. Negative ions flow in the opposite
direction. In a similar manner, there is an electrochemical
reaction involving the material 36 that results in ions released or
removed from the conducting fluid. In this example, the release of
negative ions at the material 34 and release of positive ions by
the material 36 are related to each other through the current flow
that is controlled by the control device 38. The rate of reaction
and hence the ionic emission rate or current, is controlled by the
control device 38. The control device 38 can increase or decrease
the rate of ion flow by altering its internal conductance, which
alters the impedance, and therefore the current flow and reaction
rates at the materials 34 and 36. Through controlling the reaction
rates, the system 30 can encode information in the ionic flow.
Thus, the system 30 encodes information using ionic emission or
flow.
[0047] The control device 38 can vary the duration of ionic flow or
current while keeping the current or ionic flow magnitude near
constant, similar to when the frequency is modulated and the
amplitude is constant. Also, the control device 38 can vary the
level of the ionic flow rate or the magnitude of the current flow
while keeping the duration near constant. Thus, using various
combinations of changes in duration and altering the rate or
magnitude, the control device 38 encodes information in the current
or the ionic flow. For example, the control device 38 may use, but
is not limited to any of the following techniques, including Binary
Phase-Shift Keying (PSK), Frequency modulation, Amplitude
modulation, on-off keying, and PSK with on-off keying.
[0048] As indicated above, the various aspects disclosed herein,
such as systems 30 and 40 of FIGS. 3 and 4, respectively, include
electronic components as part of the control device 38 or the
control device 48. Components that may be present include but are
not limited to: logic and/or memory elements, an integrated
circuit, an inductor, a resistor, and sensors for measuring various
parameters. Each component may be secured to the framework and/or
to another component. The components on the surface of the support
may be laid out in any convenient configuration. Where two or more
components are present on the surface of the solid support,
interconnects may be provided.
[0049] As indicated above, the system, such as control devices 30
and 40, control the conductance between the dissimilar materials
and, hence, the rate of ionic flow or current. Through altering the
conductance in a specific manner the system is capable of encoding
information in the ionic flow and the current signature. The ionic
flow or the current signature is used to uniquely identify the
specific system. Additionally, the systems 30 and 40 are capable of
producing various different unique patterns or signatures and,
thus, provide additional information. For example, a second current
signature based on a second conductance alteration pattern may be
used to provide additional information, which information may be
related to the physical environment. To further illustrate, a first
current signature may be a very low current state that maintains an
oscillator on the chip and a second current signature may be a
current state at least a factor of ten higher than the current
state associated with the first current signature.
[0050] Referring now to FIG. 6, a block diagram representation of
the control device 38 is shown. The device 30 includes a control
module 62, a counter or clock 64, and a memory 66. Additionally,
the control device 38 is shown to include a sensor module 72 as
well as the sensor module 74, which was referenced in FIG. 5. The
control module 62 has an input 68 electrically coupled to the
material 34 and an output 70 electrically coupled to the material
36. The control module 62, the clock 64, the memory 66, and the
sensor modules 72/74 also have power inputs (some not shown). The
power for each of these components is supplied by the voltage
potential produced by the chemical reaction between materials 34
and 36 and the conducting fluid, when the system 30 is in contact
with the conducting fluid. The control module 62 controls the
conductance through logic that alters the overall impedance of the
system 30. The control module 62 is electrically coupled to the
clock 64. The clock 64 provides a clock cycle to the control module
62. Based upon the programmed characteristics of the control module
62, when a set number of clock cycles have passed, the control
module 62 alters the conductance characteristics between materials
34 and 36. This cycle is repeated and thereby the control device 38
produces a unique current signature characteristic. The control
module 62 is also electrically coupled to the memory 66. Both the
clock 64 and the memory 66 are powered by the voltage potential
created between the materials 34 and 36.
[0051] The control module 62 is also electrically coupled to and in
communication with the sensor modules 72 and 74. In the aspect
shown, the sensor module 72 is part of the control device 38 and
the sensor module 74 is a separate component. In alternative
aspects, either one of the sensor modules 72 and 74 can be used
without the other and the scope of the present invention is not
limited by the structural or functional location of the sensor
modules 72 or 74. Additionally, any component of the system 30 may
be functionally or structurally moved, combined, or repositioned
without limiting the scope of the present invention as claimed.
Thus, it is possible to have one single structure, for example a
processor, which is designed to perform the functions of all of the
following modules: the control module 62, the clock 64, the memory
66, and the sensor module 72 or 74. On the other hand, it is also
within the scope of the present invention to have each of these
functional components located in independent structures that are
linked electrically and able to communicate.
[0052] Referring again to FIG. 6, the sensor modules 72 or 74 can
include any of the following sensors: temperature, pressure, pH
level, and conductivity. In one aspect, the sensor modules 72 or 74
gather information from the environment and communicate the analog
information to the control module 62. The control module then
converts the analog information to digital information and the
digital information is encoded in the current flow or the rate of
the transfer of mass that produces the ionic flow. In another
aspect, the sensor modules 72 or 74 gather information from the
environment and convert the analog information to digital
information and then communicate the digital information to control
module 62. In the aspect shown in FIG. 5, the sensor modules 74 is
shown as being electrically coupled to the material 34 and 36 as
well as the control device 38. In another aspect, as shown in FIG.
6, the sensor module 74 is electrically coupled to the control
device 38 at connection 78. The connection 78 acts as both a source
for power supply to the sensor module 74 and a communication
channel between the sensor module 74 and the control device 38.
[0053] Referring now to FIG. 5B, the system 30 includes a pH sensor
module 76 connected to a material 39, which is selected in
accordance with the specific type of sensing function being
performed. The pH sensor module 76 is also connected to the control
device 38. The material 39 is electrically isolated from the
material 34 by a non-conductive barrier 55. In one aspect, the
material 39 is platinum. In operation, the pH sensor module 76 uses
the voltage potential difference between the materials 34/36. The
pH sensor module 76 measures the voltage potential difference
between the material 34 and the material 39 and records that value
for later comparison. The pH sensor module 76 also measures the
voltage potential difference between the material 39 and the
material 36 and records that value for later comparison. The pH
sensor module 76 calculates the pH level of the surrounding
environment using the voltage potential values. The pH sensor
module 76 provides that information to the control device 38. The
control device 38 varies the rate of the transfer of mass that
produces the ionic transfer and the current flow to encode the
information relevant to the pH level in the ionic transfer, which
can be detected by a receiver (not shown). Thus, the system 30 can
determine and provide the information related to the pH level to a
source external to the environment.
[0054] As indicated above, the control device 38 can be programmed
in advance to output a pre-defined current signature. In another
aspect, the system can include a receiver system that can receive
programming information when the system is activated. In another
aspect, not shown, the switch 64 and the memory 66 can be combined
into one device.
[0055] In addition to the above components, the system 30 may also
include one or other electronic components. Electrical components
of interest include, but are not limited to: additional logic
and/or memory elements, e.g., in the form of an integrated circuit;
a power regulation device, e.g., battery, fuel cell or capacitor; a
sensor, a stimulator, etc.; a signal transmission element, e.g., in
the form of an antenna, electrode, coil, etc.; a passive element,
e.g., an inductor, resistor, etc.
[0056] Referring now to FIG. 5C, the system 30 is shown with the
skirt portions 35 and 37 secured to the framework 32, as discussed
in detail below. In accordance with one aspect of the present
invention, the material 34 and the material 36 extend beyond the
framework 32 onto the skirt portions 35 and 37. In another example
in accordance with the present invention, the materials 34 and 36
can extend to the edge of the skirt portions 35 and 37. The
increase in the area of the materials 34 and 36 results in an
increase in the power supplied.
[0057] Referring now to FIG. 7, a cross-sectional view is shown of
the system 30 with a first material region 34a and a second
material region 36a on the framework 32. The first material region
34a includes an adhering material 86. The adhering material 86 can
be any material selected to adhere and hold onto a first material
region 88, which material region 88 is made of CuCl in accordance
with one aspect of the present invention as discussed above with
respect to the first material 34. The second material region 36a
includes a transition metal 96 that is made of any transition
metal, for example titanium in accordance with one aspect of the
present invention. The second material region 36a also includes a
second material region 98, which is made of magnesium (Mg) in
accordance with one aspect of the present invention as discussed
above with respect to the second material 36.
[0058] Referring now to FIG. 8, an exploded view of the material 86
and the material region 88 is shown. The material 86 is made of a
non-reactive and conducting material, for example gold. To enhance
the adhesion properties of the material 86 to the material region
88, the material 86 has an unfinished or rough surface. The
material 86 is deposited onto the framework 32. Additionally,
according to one aspect of the present invention, the material 86
defines a plurality of holes 87 spaced a distance DD from the edge
of the framework 32 corresponding to the edge of the material 86.
The distance DD is the minimum distance that is needed to separate
the holes 87 from the edge of the material 86 and allow all the of
the holes 87 to fall within a boundary 89 so that the edge of the
material region 88 is not positioned over any hole; this design
enhances the adhesion property and characteristics of the material
86 to the material region 88.
[0059] Referring now to FIG. 9, a process of securing the metal 96
to the framework 32 is shown. Initially the metal 96 is deposited
onto the framework 32. Then the metal 86 with the framework 32 is
heated. Then the surface of the metal 96 is cleaned using, for
example, an ion gun cleaner. Then the magnesium is deposited onto
the cleaned surface of the metal 86 to form the material region
98.
[0060] In accordance with another aspect of the present invention,
a plurality of frameworks 32, as shown in FIG. 1, are built on a
wafer 100, as shown in the top view illustration of FIG. 10. The
wafer 100 can include any number of frameworks 32. Once the wafer
100 is complete, then each complete framework 32 is cut from the
wafer 100 and inserted or press fitted or placed into an opening
112 of FIG. 11 of a sheet 110 to produce the system 12, 22, 30, or
40 as shown and discussed about in accordance with the various
aspects of the present invention. The opening 112 is matingly cut
to the shape of the framework 32. The sheet 110 is then passed
through a punch press (not shown) that punches out each of systems
12, 22, 30, or 40 as noted.
[0061] In certain aspects, the ingestible circuitry includes a
coating layer. In accordance with one aspect of the present
invention, the protective coating may be applied to the wafer 100
using a spinning process prior to removal of the framework 32 from
the wafer 100 of FIG. 10. In accordance with another aspect of the
present invention, the protective coating may be applied to the
system, for example the system 30, after being punched out or cut
out from the sheet 110 of FIG. 11. The purpose of this coating
layer can vary, e.g., to protect the circuitry, the chip and/or the
battery, or any components during processing, during storage, or
even during ingestion. In such instances, a coating on top of the
circuitry may be included. Also of interest are coatings that are
designed to protect the ingestible circuitry during storage, but
dissolve immediately during use. For example, coatings that
dissolve upon contact with an aqueous fluid, e.g. stomach fluid, or
the conducting fluid as referenced above. Also of interest are
protective processing coatings that are employed to allow the use
of processing steps that would otherwise damage certain components
of the device. For example, in aspects where a chip with dissimilar
material deposited on the top and bottom is produced, the product
needs to be diced. However, the dicing process can scratch off the
dissimilar material, and also there might be liquid involved which
would cause the dissimilar materials to discharge or dissolve. In
such instances, a protective coating on the materials prevents
mechanical or liquid contact with the component during processing
can be employed.
[0062] Another purpose of the dissolvable coatings may be to delay
activation of the device. For example, the coating that sits on the
dissimilar material and takes a certain period of time, e.g., five
minutes, to dissolve upon contact with stomach fluid may be
employed. The coating can also be an environmentally sensitive
coating, e.g.; a temperature or pH sensitive coating, or other
chemically sensitive coating that provides for dissolution in a
controlled fashion and allows one to activate the device when
desired. Coatings that survive the stomach but dissolve in the
intestine are also of interest, e.g., where one desires to delay
activation until the device leaves the stomach. An example of such
a coating is a polymer that is insoluble at low pH, but becomes
soluble at a higher pH. Also of interest are pharmaceutical
formulation protective coatings, e.g., a gel cap liquid protective
coating that prevents the circuit from being activated by liquid of
the gel cap.
[0063] Identifiers of interest include two dissimilar
electrochemical materials, which act similar to the electrodes
(e.g., anode and cathode) of a power source. The reference to an
electrode or anode or cathode are used here merely as illustrative
examples. The scope of the present invention is not limited by the
label used and includes the aspect wherein the voltage potential is
created between two dissimilar materials. Thus, when reference is
made to an electrode, anode, or cathode it is intended as a
reference to a voltage potential created between two dissimilar
materials.
[0064] When the materials are exposed and come into contact with
the body fluid, such as stomach acid or other types of fluid
(either alone or in combination with a dried conductive medium
precursor), a potential difference, that is, a voltage, is
generated between the electrodes as a result of the respective
oxidation and reduction reactions incurred to the two electrode
materials. A voltaic cell, or battery, can thereby be produced.
Accordingly, in aspects of the invention, such power supplies are
configured such that when the two dissimilar materials are exposed
to the target site, e.g., the stomach, the digestive tract, etc., a
voltage is generated.
[0065] In certain aspects, one or both of the metals may be doped
with a non-metal, e.g., to enhance the voltage output of the
battery. Non-metals that may be used as doping agents in certain
aspects include, but are not limited to: sulfur, iodine and the
like.
[0066] It is to be understood that this invention is not limited to
particular embodiments or aspects described and, as such, may vary.
It is also to be understood that the terminology used herein is for
the purpose of describing particular aspects only, and is not
intended to be limiting, since the scope of the present invention
will be limited only by the appended claims.
[0067] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range and any other stated or intervening
value in that stated range, is encompassed within the invention.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges and are also
encompassed within the invention, subject to any specifically
excluded limit in the stated range. Where the stated range includes
one or both of the limits, ranges excluding either or both of those
included limits are also included in the invention.
[0068] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
any methods and materials similar or equivalent to those described
herein can also be used in the practice or testing of the present
invention, representative illustrative methods and materials are
now described.
[0069] All publications and patents cited in this specification are
herein incorporated by reference as if each individual publication
or patent were specifically and individually indicated to be
incorporated by reference and are incorporated herein by reference
to disclose and describe the methods and/or materials in connection
with which the publications are cited. The citation of any
publication is for its disclosure prior to the filing date and
should not be construed as an admission that the present invention
is not entitled to antedate such publication by virtue of prior
invention. Further, the dates of publication provided may be
different from the actual publication dates which may need to be
independently confirmed.
[0070] It is noted that, as used herein and in the appended claims,
the singular forms "a", "an", and "the" include plural referents
unless the context clearly dictates otherwise. It is further noted
that the claims may be drafted to exclude any optional element. As
such, this statement is intended to serve as antecedent basis for
use of such exclusive terminology as "solely," "only" and the like
in connection with the recitation of claim elements, or use of a
"negative" limitation.
[0071] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual aspects described
and illustrated herein has discrete components and features which
may be readily separated from or combined with the features of any
of the other several aspects without departing from the scope or
spirit of the present invention. Any recited method can be carried
out in the order of events recited or in any other order which is
logically possible.
[0072] Although the foregoing invention has been described in some
detail by way of illustration and example for purposes of clarity
of understanding, it is readily apparent to those of ordinary skill
in the art in light of the teachings of this invention that certain
changes and modifications may be made thereto without departing
from the spirit or scope of the appended claims.
[0073] Accordingly, the preceding merely illustrates the principles
of the invention. It will be appreciated that those skilled in the
art will be able to devise various arrangements which, although not
explicitly described or shown herein, embody the principles of the
invention and are included within its spirit and scope.
Furthermore, all examples and conditional language recited herein
are principally intended to aid the reader in understanding the
principles of the invention and the concepts contributed by the
inventors to furthering the art, and are to be construed as being
without limitation to such specifically recited examples and
conditions. Moreover, all statements herein reciting principles,
aspects, and aspects of the invention as well as specific examples
thereof, are intended to encompass both structural and functional
equivalents thereof. Additionally, it is intended that such
equivalents include both currently known equivalents and
equivalents developed in the future, i.e., any elements developed
that perform the same function, regardless of structure. The scope
of the present invention, therefore, is not intended to be limited
to the exemplary aspects shown and described herein. Rather, the
scope and spirit of present invention is embodied by the appended
claims.
* * * * *