U.S. patent application number 14/864277 was filed with the patent office on 2016-06-02 for communication system incorporated in a container.
The applicant listed for this patent is Proteus Digital Health, Inc.. Invention is credited to Hooman Hafezi, Zahedeh Hatamkhany, Patricia Johnson, David O'Reilly, Timothy Robertson, Mark Zdeblick.
Application Number | 20160155316 14/864277 |
Document ID | / |
Family ID | 48470324 |
Filed Date | 2016-06-02 |
United States Patent
Application |
20160155316 |
Kind Code |
A1 |
Hafezi; Hooman ; et
al. |
June 2, 2016 |
COMMUNICATION SYSTEM INCORPORATED IN A CONTAINER
Abstract
The system of the present invention includes a container and an
electronic component with a partial power source in the form of
dissimilar materials. The container includes a liquid. Upon contact
with the liquid, 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.
Inventors: |
Hafezi; Hooman; (Redwood
City, CA) ; O'Reilly; David; (Palo Alto, CA) ;
Johnson; Patricia; (San Carlos, CA) ; Hatamkhany;
Zahedeh; (San Mateo, CA) ; Robertson; Timothy;
(Belmont, CA) ; Zdeblick; Mark; (Portola Valley,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Proteus Digital Health, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
48470324 |
Appl. No.: |
14/864277 |
Filed: |
September 24, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13304274 |
Nov 23, 2011 |
9198608 |
|
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14864277 |
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Current U.S.
Class: |
340/539.11 |
Current CPC
Class: |
A61J 3/007 20130101;
H04B 2001/3894 20130101; A61B 2562/0214 20130101; G08B 21/18
20130101; A61B 5/14539 20130101; A61B 5/1473 20130101; A61B 5/073
20130101; B65D 41/02 20130101; A61B 5/4839 20130101; H04B 1/3888
20130101; A61B 5/01 20130101; H01Q 1/273 20130101; A61B 5/036
20130101 |
International
Class: |
G08B 21/18 20060101
G08B021/18; B65D 41/02 20060101 B65D041/02 |
Claims
1-22. (canceled)
23. A system for communication comprising: a container comprising a
liquid, the container defining an opening, wherein the container
comprises a cap to secure the opening of the container; and an
event indicator configured to transmit a first signal, wherein the
event indicator comprises a wireless transmitter configured to
transmit the first signal after the cap is removed from the
container, wherein the first signal comprises information
associated with activation of the event indicator; and an
ingestible indicator configured to transmit a second signal,
wherein the ingestible indicator is located within the container;
and wherein the ingestible indicator comprises a coating to prevent
interaction of the ingestible indicator with the liquid when the
ingestible indicator is located within the container.
24. The system of claim 23, wherein the event indicator is located
adjacent the opening of the container.
25. The system of claim 23, wherein the event indicator comprises
zinc, and wherein a voltage potential is produced when the event
indicator contacts air such that the voltage potential activates
the event indicator after the lid is removed, and wherein the event
indicator transmits a signal upon activation.
26. The system of claim 23, wherein the ingestible indicator
comprises: a support structure including a control module; and a
partial power source comprising: a first material physically
associated with the support structure; and a second material
physically associated with the support structure at a location
different from the location of the first material, such that the
first material and second material are electrically isolated from
each other and are configured to produce a voltage potential,
wherein the control module is configured to control conductance
between the first material and the second material when the partial
power source is completed by introducing an electrically conductive
liquid between the first material and the second material to
complete the partial power source.
27. The system of claim 26, wherein the ingestible indicator
produces a current signature that includes information encoded
therein using the control module.
28. The system of claim 27, wherein at least one of the event
indicator and the ingestible indicator is configured to communicate
with a receiver associated with a consumer's body.
29. The system of claim 23, wherein the ingestible indicator
transmits the second signal via transconduction to a receiver
secured to a consumer's body.
30. The system of claim 23, wherein the event indicator transmits
the first signal via transconduction to a receiver secured to a
consumer's body.
31. The system of claim 23, wherein the coating of the ingestible
indicator dissolves when in contact with a physiological fluid.
32. The system of claim 31, wherein the event indicator is
activated after the coating is dissolved.
33. The system of claim 23, wherein the event indicator is
activated when the event indicator comes into contact with the
liquid.
34. The system of claim 23, wherein the first signal comprises
information associated with a removal of the cap.
35. The system of claim 23, wherein the container comprises at
least one pair of sensors located on a surface of the container,
and wherein the at least one pair of sensors is configured to
detect a volume of liquid in the container.
36. The system of claim 35, wherein the at least one pair of
sensors comprises a pair of capacitive sensors.
37. A system for communication comprising: a container comprising a
liquid, the container defining an opening, wherein the container
comprises a cap to secure the opening of the container; and an
event indicator configured to transmit a first signal, wherein the
first signal comprises information associated with activation of
the event indicator; and an ingestible indicator configured to
transmit a second signal, wherein the ingestible indicator is
located within the container; and wherein the ingestible indicator
comprises a coating to prevent interaction of the ingestible
indicator with the liquid when the ingestible indicator is located
within the container; and a content sensor secured on a surface of
the container, the content sensor configured to transmit a third
signal comprising information associated with a volume of the
liquid in the container.
38. The system of claim 37, wherein the first signal from the event
indicator and the third signal from the content sensor are
transmitted to a receiver associated with a consumer of the liquid
of the container.
39. The system of claim 37, wherein the content sensor comprises a
capacitive sensor secured to the surface of the container, wherein
the capacitive sensor includes a pair of capacitive plates
positioned on the container to allow for detection of the
capacitance of the liquid of the container and wherein the
capacitive sensor is configured to transmit the third signal
indicating at least one change in the capacitance of the liquid of
the container.
40. The system of claim 39, wherein the capacitive sensor comprises
at least one pair of capacitive plates.
41. The system of claim 39, wherein the capacitive sensor comprises
conductive ink that forms a capacitive plate pair.
42. The system of claim 37, wherein the content sensor is secured
to an outside surface of the container.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 13/180,507 filed on Jul. 11, 2011 and entitled
"Communication System Incorporated in an Ingestible Product", which
is a continuation-in-part of U.S. Publication PCT/US20100081894A1
filed on Sep. 21, 2009 (U.S. patent application Ser. No.
12/564,017, now U.S. Pat. No. 7,978,064 and entitled "Communication
System with Partial Power Source") which is a continuation-in-part
application of U.S. patent application Ser. No. 11/912,475 filed
Jun. 23, 2008: which application is a 371 application of PCT
Application Serial No. PCT/US06/16370 filed Apr. 28, 2006; 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; U.S. Provisional Patent Application
Ser. No. 60/694,078 filed Jun. 24, 2005; U.S. Provisional Patent
Application Ser. No. 60/713,680 filed Sep. 1, 2005 and U.S.
Provisional Patent Application Ser. No. 60/790,335 filed Apr. 7,
2006; the disclosures of which are herein incorporated by
reference.
[0002] This application is related to the following US
applications, the disclosures of which are incorporate herein by
reference: U.S. application Ser. No. 13/180,516, filed Jul. 11,
2011 and entitled COMMUNICATION SYSTEM WITH REMOTE ACTIVATION; U.S.
application Ser. No. 13/180,525 filed on Jul. 11, 2011 and entitled
COMMUNICATION SYSTEM WITH ENHANCED PARTIAL POWER AND METHOD OF
MANUFACTURING SAME; U.S. application Ser. No. 13/180,498, filed
Jul. 11, 2011 and entitled COMMUNICATION SYSTEM WITH MULTIPLE TYPES
OF POWER; U.S. application Ser. No. 13/180,538, filed Jul. 11, 2011
and entitled COMMUNICATION SYSTEM USING POLYPHARMACY CO-PACKAGED
MEDICATION DOSING UNIT; U.S. application Ser. No. 13/180,539, filed
Jul. 11, 2011 and entitled COMMUNICATION SYSTEM USING AN
IMPLANTABLE DEVICE.
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 for association
with ingestible ingredients or products.
INTRODUCTION
[0004] Various devices and products are used for tracking food
consumption. Examples of such devices or products have typically
required human input or intervention in order to correlate the
information associated with the type of food taken, the timing of
consumption, and the amount of food consumed. Additionally, even if
collection of some information is automated, human input is needed
to match the information with the actual consumer so that there is
a direct connection between the information and the person that
consumed the food.
[0005] Given that there are so many different variables and types
of information to track, the known systems do not provide an
accurate means for tracking food consumption because of the need to
rely upon human entry of data. Therefore, what is needed is a
system and method for automating the tracking of food consumption,
including timing of consumption, quantity of consumption, and
identity of the consumer along with other information such as when
a container is opened.
SUMMARY
[0006] The present disclosure includes a system for automation of
the monitoring and tracking of consumption of food products. The
system includes a container with a sensor that can communicate to a
receiver. The container also includes sensors that measure the
amount of food consumed and information related to the timing of
the intent to consume as well as the timing of the consumption. The
information can also be used to determine the identity of the
consumer by using an ingestible device that produces a unique
signature once inside the consumer's body.
BRIEF DESCRIPTION OF THE FIGURES
[0007] FIG. 1 shows an event indicator system in communication with
an implanted device in according to the teaching of the present
invention.
[0008] FIG. 2A shows the pharmaceutical product of FIG. 1 with the
event indicator system on the exterior of the pharmaceutical
product in accordance with the teachings of the present
invention.
[0009] FIG. 2B shows the pharmaceutical product of FIG. 1 with the
event indicator system positioned inside the pharmaceutical product
in accordance with the teachings of the present invention.
[0010] FIG. 3 is a block diagram representation of one aspect of
the event indicator system with dissimilar metals positioned on
opposite ends in accordance with the teachings of the present
invention.
[0011] 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 in
accordance with the teachings of the present invention.
[0012] 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 in accordance
with the teachings of the present invention.
[0013] FIG. 5A shows an exploded view of the surface of dissimilar
materials of FIG. 5, in accordance with the teachings of the
present invention.
[0014] FIG. 5B shows the event indicator system of FIG. 5 with a pH
sensor unit, in accordance with the teachings of the present
invention.
[0015] FIG. 6 is a block diagram illustration of one aspect of the
control device used in the system of FIGS. 3 and 4, in accordance
with the teachings of the present invention.
[0016] FIG. 7 shows a container for liquids with an event indicator
in accordance with the teachings of the present invention.
[0017] FIG. 8 shows a container for liquids with an event indicator
and volume sensor in accordance with the teachings of the present
invention.
[0018] FIG. 9 is a process for collecting and correlating the
information to automate tracking of food consumption by a
consumer.
DETAILED DESCRIPTION
[0019] The present invention discloses an apparatus that is part of
a system. The apparatus that includes a container and a sensor, as
discussed in detail below. In accordance with one aspect of the
present invention, the sensor is air activated. In accordance with
another aspect of the present invention the sensor is activated
upon contact with a conduction liquid or fluid, such as a drink or
physiological fluid. The container can also measure the quantity
food in the container and includes multiple aspects for indicating
the occurrence of an event.
[0020] As described in more detail below, the 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.
[0021] 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.
[0022] Referring now to FIG. 1, an ingestible capsule 14 that
includes a system of the present invention is shown inside the
body. The capsule 14 is configured as an orally ingestible
pharmaceutical formulation in the form of a pill or capsule. Upon
ingestion, the capsule 14 moves to the stomach. Upon reaching the
stomach, the capsule 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.
[0023] Referring now to FIG. 2A, a pharmaceutical product 10,
similar to the capsule 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.
[0024] Additionally, the system 12 of the present invention may be
ingested without a pharmaceutical product via a carrier capsule
that includes only the system with no other active agent. In
accordance with another aspect of the present invention, the system
12 may be used as part of a food product or an ingredient in a food
product. For example, the system 12 is coated with a protective
material as discussed in detail below. The system 12 is then
included is the food product similar to any ingredient. Thus,
ingestion of that food product may be tracked automatically, which
is often useful in setting where knowing the exact food take and
time of ingestion is needed, for example when a person has a
special diet or is receiving care at a hospital as a patient or
in-patient.
[0025] In accordance with another example of the present invention,
the system 12 may be combined with an ingredient commonly used in
making food. For example, the system 12 may be secured to salt in a
manner similar to the way the system 12 is secured to a
pharmaceutical product, as discussed below. Then as the ingredient
with the system 12 is mixed into the food, the food will include
the system which will become activated upon ingestion.
[0026] In accordance with various aspects of the present invention,
when the system 12 is combined with food and ingested there are
various approaches to activation of the system 12. In accordance
with one aspect of the present invention, the system 12 may be
coated with a material that breaks and releases the system 12 as
the food is being masticated, e.g. chewed or squashed. In
accordance with another aspect of the present invention, the
coating material may be reactive to saliva and when in contact with
saliva will dissolve or disintegrate and release the system 12.
Conducting fluids associated with saliva may activate the system
12. In accordance with yet another aspect of the present invention,
the coating material may be reactive to stomach acids and dissolve
or disintegrate upon contact with the stomach fluids to release the
system 12. In accordance with another aspect of the present
invention, the coating material may be made of material that
resists breaking or dissolving when masticated or exposed to
saliva, such as the beads found in drinks. In accordance with
another aspect of the present invention, the coating material may
be intentionally destroyed or broken apart when distributed or
mixed in with a food, such as when bread is mixed and prepared for
a food (e.g. pizza dough).
[0027] Continuing with FIG. 2A, in the shown 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
or an ingestible ingredient, for example food or ingredients of
food. 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 or an
ingestible product/ingredient 20, similar to the capsule 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 or ingestible ingredient. 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 food product or
ingredient, 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.
[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 on
platinum, gold or other catalytic surfaces Intercalation Graphite
with Vanadium oxide compounds Li, K, Ca, Manganese oxide Na, Mg
[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 physical chemical reaction
between the materials 34 and 36 of the system 30 and the
surrounding fluids of the body. The completed power source may be
viewed as a power source that exploits reverse electrolysis 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 non-metals, 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 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 between material 34 to material 36
and 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] The system 30 also includes a unit 75. The unit 75 includes
communication functions and in accordance with the various aspects
of the present invention can act as any of the following: a
receiver, a transmitter, or a transceiver. Thus, another device
that is external to the system 30, such as a cell phone, an
implanted device, a device attached to the user's body, or a device
placed under the user's skin can communicate with the system 30
through the unit 75. The unit 75 is also electrically connected to
the materials 34 and 36. In accordance with one aspect of the
present invention, any device that is external to the system 30 may
communicate with either the unit 75 or the control module 38 using
current flow through the environment surrounding the system 30. For
example, a patch or receiver that is attached to the user's body, a
cell phone or device being held by the user, or an implanted
device, any of which can generate a current signature through the
user's body. The current signature can include information that is
encoded therein. The current signature is detected by the system
30, using the unit 75 or the control module 38, and decoded to
allow communication to the system 30 from the device external to
system 30. Accordingly, the external device can send a signal to
the unit 75, either wirelessly or through transconduction, that
controls the activation of the system 30.
[0046] Referring now to FIG. 5A shows an exploded view of the
surface of the material 34. 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 released into the conducting fluid. The
term "mass" as used herein refers to protons and neutrons that form
a substance. One example includes the instant where the material is
CuCl and when in contact with the conducting fluid, CuCl becomes Cu
(solid) and Cl.sup.- in 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 between the material 36 and the
surrounding conducting fluid. In this example, the release of
negative ions at the material 34 and release of positive ion by the
material 36 is collectively referred to as the ionic exchange. The
rate of ionic exchange and, hence the ionic emission rate or flow,
is controlled by the control device 38. The control device 38 can
increase or decrease the rate of ion flow by altering the
conductance, which alters the impedance, between the materials 34
and 36. Through controlling the ion exchange, the system 30 can
encode information in the ionic exchange process. Thus, the system
30 uses ionic emission to encode information in the ionic
exchange.
[0047] The control device 38 can vary the duration of a fixed ionic
exchange rate or current flow magnitude while keeping the rate or
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 exchange 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 flow or the ionic exchange. For example, the control device
38 may use, but is not limited to any of the following techniques
namely, 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 system 30 and 40,
control the conductance between the dissimilar materials and,
hence, the rate of ionic exchange or the current flow. Through
altering the conductance in a specific manner the system is capable
of encoding information in the ionic exchange and the current
signature. The ionic exchange 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 exchanges
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 control device 30 includes a
control module 62, a counter or clock 64, and a memory 66.
Additionally, the 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] In certain aspects, the ingestible circuitry includes a
coating layer. 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. 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.
[0057] Referring now to FIG. 7, a container 100 is shown that
includes an event indicator 102. The container 100 holds liquid 110
that can be consumed by a consumer. The scope of the present
invention is not limited by the type of consumable liquid within
container 100. In accordance with one aspect of the present
invention, the indicator 102 is placed at or near the opening of
the container 100, such that as the liquid 110 is poured and comes
into contact with the event indicator 102, the presence of the
liquid 110 activates the indicator 102. As long as the liquid 110
is in contact with the indicator 102, such as while the liquid 100
is being poured, the indicator 102 remains active. Once activated,
the indicator 102 communicates with a detector or receiver device
120. Thus, the device 120 can record the timing of the activation
of the indicator 102.
[0058] In accordance with another aspect of the present invention,
the indicator 102 can be activated by coming into contact with the
consumer's mouth and is activated upon contact with the
physiological fluids of the consumer, such as saliva. Once
activated the indicator 102 communicates with the device 120, which
may be positioned on or secured to the consumer's body or skin or
part of the clothing worn by the consumer that is in contact with
the consumer's skin. Thus, the device 120 could communicate with
the indicator 102 through the consumer's body using transconduction
or wirelessly through the air.
[0059] In accordance with other aspects of the present invention,
additional indicators, such as an ingestible indicator 130 that
includes a coating material 130a and a unit 130b, is present or
included in the liquid 110. In accordance with one aspects of the
present invention, the indicator 130 is similar to the indicator
102. Based on the various aspects of the present invention, the
indicator 130 may be different from the indicator 102. In
accordance with one aspects of the present invention, the coating
130a of the indicator 130 is designed to react with physiological
fluids, such as stomach acids, and dissolve. Once the coating 130a
is dissolved inside the consumer's body, the indicator 130 is
activated and communicates with the device 120 using
transconduction as indicated above. The scope of the present
invention is not limited by the number of indicators 130 that are
included in the liquid 110.
[0060] In accordance with another aspect of the present invention,
the indicator 102 includes a zinc-air activated type battery. Thus,
as a cap 104 is secured onto the container, the cap 104 isolates
the indicator 102 from the air. Thus, the indicator 102 is
activated when the cap 104 is removed and the indicator 102 is
exposed to the air. Once activated, information is then sent to the
device 120 to indicate that the container 100 is open and the
liquid 110 is ready to be consumed or dispensed. Thus, when the
consumer ingests or drinks the liquid 110, the indicator 130 is
activated and additional information is sent to the device 120. The
correlation between the information from the indicator 102 and the
indicator 130 determines if the consumer actually consumed the
liquid 110 as well as the delay between opening the container 100
and consuming the liquid 110.
[0061] In accordance with another aspect of the present invention,
the liquid 110 is non-conducting and thus the coating 130a is
removed and only the unit 130b of the indicator 130 is
included.
[0062] Referring now to FIG. 8, a container 200 is shown similar to
the container 100 that includes an event indicator 202 and an
ingestible indicator 230. The container 200 holds liquid 210 that
can be consumed. The scope of the present invention is not limited
by the type of consumable liquid within container 200. The
container 200 also includes sensors 300 (e.g. 300a-c) and 302 (e.g.
302a-c). In accordance with one aspect of the present invention,
the sensors 300 and 302 include conductive ink that forms a
capacitive plate pair. In accordance with another aspect of the
present invention, the sensor 300 and 302 are made of traditional
conduction material to form a capacitive pair. The sensor 300 forms
one side of a capacitive coupler and the sensor 302 is the other
side. For example the sensors 300a and 302a are one capacitive
pair. The sensors 300 and 302 are secured to or positioned on the
outside of the container 200. The sensor 300 and 302, in accordance
with one aspect of the present invention, form a sensor for
detection of change in content of the container 200. As the liquid
210 is removed, the capacitive characteristics between the sensors
300 and 302 changes. This change indicates the volume of liquid
removed from the container 200. For example, the capacitance
between the sensors 300a and 302a is different compared to the
sensors 300b and 302b due to the type of material separating the
sensors 300 and 302. In one instance it is air, in another it is
the liquid 210, respectively. The sensors 300 and 302 can be
positioned more or less proximal and the scope of the present
invention is not limited by the relative distance separating the
sensors 300 and 302. The more sensor pairs 300 and 302 that are
included, the more accurate the measurement of the volume
dispensed. This information can be communicated to a device
220.
[0063] In accordance with various aspects of the present invention,
using the timing of activation of the indicator 202 and the
activation of the indicator 230, as well as the information from
sensor 300 and 302 information, the system can determine the volume
of liquid consumed as well as the timing of the consumption of the
content, such as the liquid 210, relative to the timing of opening
the container 200 and the timing of dispensing the content of the
container 200.
[0064] In accordance with another aspect of the present invention,
as the consumer holds the container 200 and is wearing the device
220, then a transconduction signal is used to communicate
information from the container 200 to the device 220. Furthermore,
as indicated above, the sensor 200, based on the various aspects of
the present invention, may be any of the sensor types, similar to
sensor 100 of FIG. 7.
[0065] In accordance with the teachings of the present invention,
there are various sources of information associated with the same
container. For example: when a container is opened is one source of
information; when a container is gripped or held by a consumer in
one source of information; when the content of the container is
dispensed is one source of information; when the container is in
contact with the consumer's mouth is one source of information;
when the content is ingested is one source of information; how much
of the content is ingested is another source of the information;
and the identity of the consumer is another source of information.
Depending on the various aspects of the present invention, the
information may be received by the device, such as the device 120
or device 220, wirelessly or through the consumer's body using
transconduction.
[0066] In accordance with the present invention, if one consumer
grips a container of the present invention, a signal is sent to
device. The container includes sensors, such as sensors 300 and 302
of FIG. 8, that can be activated using a zinc-air battery or
activated using a partial power source that is activated upon
contact with moisture on the skin. This sensor can be protected
from damage and activation by having a protective covering, such as
a peel off label or similar covering. The next source of
information is produced by having the lid or cap of the container
is removed. Depending on the power source of the sensor located
near the opening of the container, the information is either
produced the moment the lid is removed or when the consumer's mouth
comes into contact with the sensor located at the opening of the
container. As the liquid is dispensed, the sensors, such as sensors
300 or 302, on the container detect changes in capacitance and pass
that information to the device; the information can be sent through
a wireless communication approach or through the user's body using
transconduction by encoding the information in the current
signature that the device detects. Another source of information is
determining if the consumer ingested the content of the container
and this is detected as a current signature from the ingestible
sensors, such as sensors 130 or 230 that were ingested with the
food.
[0067] Referring now to FIG. 9, a flow process 900 is shown for
collecting and correlating the information associated with the
container, such as container 100 of FIG. 7 or container 200 of FIG.
8, to allow for automation of tracking food consumption by a
consumer of the food. In accordance with the scope of the present
invention, the information produces by the various sensors and
indicators are uniquely associated with the container. Thus, if
there were two containers sending information to the same device,
the device can distinguish between the source of the information
based on uniqueness of the information. The process 900 start at
step 902. At step 910 a detector or receiver device, such as the
device 120 or device 220, determines if there is any signal coming
from an active indicator/sensor/capacitor pair, such as indicators
102, 202, 130, 230, 300 and 302. If there is information being send
from any activate indicator/sensor/capacitor pair, then at step 912
the device stores the information including time and date
associated with the information. Furthermore, the information may
include identifying information about the product, which is also
stored. If there is no active activate indicator/sensor/capacitor
pair, then the process 900 waits at step 910. In accordance with
one aspect of the present invention, the device may enter a sleep
mode to conserve power is there is no active activate
indicator/sensor/capacitor pair detected for a defined period of
time. At step 914 the process 900 determines if the information
collected is associated with the same container or a different
container. If the information is associated with the same
container, such as container 100, then at step 916 the device
compares the time and date information with the other information
recorded and outputs, at step 920, some correlated data about the
container 100 or stored the correlated data. The process 900 then
returns to step 914 to determine if there is new information or
additional information about the same container to then correlated
further. If the information is for a different container, then at
step 918 the information is stored by the device until additional
information is gathered from another active
indicator/sensor/capacitor pair for the same container.
[0068] 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.
[0069] 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.
[0070] 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.
[0071] In accordance with the various aspects of the present
invention, the system of the present invention can be inside
specific food products (e.g. a granola bar), with one of the data
encoded and communicated by the system being the caloric content of
the food or other relevant dietary information e.g. fiber sugar
content, fat type and content etc. This would help people on a diet
monitor their daily intakes, get incentives for staying on-diet
etc. Also, the system is co-ingested with food, using on-board
sensing to measure food release into the stomach e.g. fat content.
Also, an instrumented cup that detects when the system of the
present invention has been dropped into the cup and whether the
user or person took a drink (similar to inhaler product), and how
much they drank. For example, the sensors 300 and 302 of FIG. 8
would indicated how much of the content of the container 200 was
removed based on the change in capacitance between the various
sensors 300 and 302 as explained above. An advantage of this aspect
of the present invention is that it would automate the process of
tracking food or regular supplements consumption.
[0072] In accordance with other aspects of the present invention,
chemical markers can incorporate certain marker species into the
food (e.g. salt, low-or-high pH, protein, and lipid). When
ingested, a marker species is released into stomach environment.
With the sensing capability, the system of the present invention
can detect chemical-binding receptors on the surface or by coating
on the system that reacts with a chemically-active coating (e.g. a
coating such as a specific-ion-conducting glass membrane that
allows only the desired marker species to penetrate). Co-ingest the
system with the food, and use the system to measure/detect the
presence of the "marker species". The system that is ingestible and
masticable can contain a detector capable of measuring
endocanabinoids. (see paper DiPatrizio et al, "Endocannabinoid
signal in the gut controls dietary fat intake" for example
reference, the entire disclose of which is incorporated herein by
reference). When the signal is detected--a sign that high fat food
intake has occurred--the user or patient is instructed via phone to
take a prescription (also RIS-enabled) to disrupt the
endocannabinoid signal, thus reducing the craving for more high fat
foods.
[0073] In accordance with another aspect of the present invention,
the system is detectable when the skirt is not present. In
accordance with another aspect of the present invention, the
ingestible sensors are safe to bite, for example by thinning the
silicon. In accordance with another aspect of the present
invention, several of the systems of the present invention are
placed in the food so that if some get damaged during mastication
the others are still functional. Thus, the systems could be
distributed throughout the food, so that the number of systems
detected gives an indication of the quantity of food consumed.
Additionally, another aspect of the present invention teaches that
the system of the present invention can be surrounded with gummy
material and laminated between polymer layers that are soluble at
low pH, but not in neutral pH (saliva). Furthermore, by reversing
the coating, the opposite effect is achieved in accordance with
another aspect of the present invention. First coat/laminate the
system of the present invention with a pH sensitive polymer and
then insert it inside gummy bites to help survive in the mouth.
Thus, the system of the present invention is inside a gummy-bear
like protective layer, and may be reduced in size, such as
skirt-less or flexible skirt. The protective layer may consist of
multilayers or may have a density or solubility gradient such that
the material nearest the system is only slowly soluble and likely
to be swallowed due to slippery surface, rounded shape and very
small size. The system, according to another aspect of the present
invention, would have a circuit modification that, in addition to
probing the local impedance, has a feedback to postpone activation
while the local impedance is high. This allows time for the
remaining layer(s) to dissolve. The system is activated or turns on
as soon as liquid penetrates through, but cannot send sufficient
signal strength for detection, the high current and battery layer
depletion is postponed until the impedance drops sufficiently.
Thus, the system according to this aspect of the present invention,
for example, is put into pre-measured meal and snack types to read
out what was consumed.
[0074] It is to be understood that this invention is not limited to
particular aspects or aspects described, 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.
[0075] 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.
[0076] 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.
[0077] 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.
[0078] 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.
[0079] 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.
[0080] 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.
[0081] 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.
* * * * *