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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: 1000001733048
Appl. No.: 14/864277
Filed: September 24, 2015


Related U.S. Patent Documents

Application NumberFiling DatePatent Number
13304274Nov 23, 20119198608
14864277

Current U.S. Class: 340/539.11
Current CPC Class: B65D 41/02 20130101; G08B 21/18 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.

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