HK1196239B

HK1196239B - Communication system with remote activation

Info

Publication number: HK1196239B
Application number: HK14109909.5A
Authority: HK
Inventors: 杰弗里．伯克曼; 马克．J.．兹德伯雷科; 帕特丽夏．约翰逊; 霍曼．哈菲奇; 乔纳森．惠特灵顿
Original assignee: Otsuka Pharmaceutical Co., Ltd.
Priority date: 2011-07-11
Filing date: 2012-07-10
Publication date: 2017-02-17

Description

Communication system with remote activation

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a partial continuation of U.S. patent application No. 13/180,516, entitled "communication system with removal activation" filed on 7/11.2011 and published on 1/12.2012 as U.S. publication No. 2012/0007734a1, the application No. 13/180,516 is a partial continuation of U.S. patent application No. 12/564,017, entitled "communication system with partial power source" filed on 9/21.2009 and published on 4/1.2010 as U.S. publication No. 2010 0081894a1, the U.S. patent application No. 12/564,017 is a partial continuation of U.S. patent application No. 11/912,475, entitled "Pharma 2006-informacs system" filed on 6/23.2008 and published on 20.11.2008 as U.S. publication No. WO 2006-0289 a1, the application No. phakogaku system is a partial continuation of U.S. patent application No. 11/912,475, entitled "PCT/WO 11/912,475 8, filed on 11.11.2008-20.2008 and published as WO 11611/718.s. The 371 application of PCT application No. US06/16370, which was filed pursuant to 35u.s.c. § 119(e), claiming priority from the application dates of the following applications: U.S. provisional patent application No. 60/676,145 entitled "Pharma-information systems" filed on 28.4.2005; U.S. provisional patent application No. 60/694,078 entitled "Pharma-information systems" filed 24.6.2005; U.S. provisional patent application No. 60/713,680 entitled "medical diagnostic kit and treatment platform for Using near-field Wireless communication of information within application of application's body" filed on 9/1 2005; and U.S. provisional patent application No. 60/790,335 entitled "Pharma-information systems" filed on 7.4.2006; the disclosures of these applications are incorporated herein by reference.

This application is related to the following co-pending U.S. applications, the disclosures of which are incorporated herein by reference: 13/180,498, "COMMUNICATIONSYSTEMWITHMULTIPLESOURCESOFPOWER", published as U.S. publication No. 2012/0004520A1 on 5/1/2012; 13/180,539, "COMMUNICATIONSYSTEMUSINGANISMANTABLEDEVICES", published as U.S. publication No. 2012/0004527A1 on 5/1 of 2012; 13/180,525, U.S. application entitled "COMMUNICATIONSYSTEMWITHENHANCEDPARTALPOWERANDMETHODOMANUFACTURINGSAME", published as U.S. publication No. 2012/0116188A1 on 5/10 of 2012; 13/180,538, POLYPHARMACYCO-PACKAGEDMEDICATIONDOSINGUNITINCLUDINGCOMMUNICATIONSYSTEMTHEREFOR, which is published as US publication 2012/0024889A1 on 2/2012; and U.S. application No. 13/180,507, "COMMUNICATIONSYSTENCONPORORPOREDINANIGESTYLEPULACT", published 3, 15/2012 as U.S. publication No. 2012/0062379A 1.

Technical Field

The present invention relates to a communication system for detecting events. More specifically, the present disclosure includes a system including devices having various power and communication schemes.

Background

Ingestible devices that include electronic circuits have been proposed for use in a variety of different medical applications, including both diagnostic and therapeutic applications. These devices typically require an internal power supply for operation. An example of such an ingestible device is an ingestible electronic capsule that collects data as it passes through the body and sends the data to an external receiver system. An example of such an electronic capsule is an in vivo camera. The swallowable capsule includes a camera system and an optical system for imaging a region of interest onto the camera system. The transmitter transmits a video output of the camera system, and the receiving system receives the transmitted video output. Other examples include ingestible imaging devices that have an internal, self-contained power source and obtain images from within a body lumen or cavities. The electronic circuit components of the device are enclosed by an inert, non-digestible housing (e.g., a glass housing) that passes through the interior of the body. Other examples include ingestible data recorder capsule medical devices. The electronic circuitry (e.g., sensors, recorders, batteries, etc.) of the disclosed device is contained in a capsule made of an inert material.

In other examples, fragile Radio Frequency Identification (RFID) tags are used in drug intake monitoring applications. In order for the RFID tag to operate, each application/tag requires an internal power supply. An RFID tag is an antenna structure configured to transmit radio frequency signals through the body.

These prior devices pose problems in that the power supply is internal to the device, and such power supplies are bulky, costly to produce, and can be potentially harmful to the surrounding environment if the power supply leaks or is damaged. In addition, when the device is used in a living body, extending the antenna from the device is a concern related to the antenna being damaged or causing problems. Therefore, there is a need for a suitable system having a circuit that does not require an internal power supply and antenna.

Disclosure of Invention

The present disclosure includes a system for generating a unique signature indicative of an occurrence of an event. The system includes circuits and components that may be placed within certain environments that include electrically conductive fluids. One example of such an environment is within a container containing a conductive fluid, such as a sealed bag with a solution, including an IV bag. Another example is within the body of a living organism, such as an animal or human. The system is ingestible and/or digestible or partially digestible. The system includes a dissimilar material disposed on the frame such that when the conductive fluid comes into contact with the dissimilar material, a potential difference is created. The potential difference and thus the voltage is used to power up control logic disposed within the frame. Ions or current flow from the first dissimilar material to the second dissimilar material through the control logic and then through the conductive fluid to complete the circuit. The control logic controls the conductance between the two dissimilar materials and thus controls or modulates the conductance of the system.

Because the ingestible circuitry is made from ingestible and even digestible components, the ingestible circuitry produces few, if any, unwanted side effects, even when used over long periods of time. Examples of ranges of components that may be included are: logic and/or memory elements; an effector; a signal transmitting element; and passive components such as resistors or inductors. One or more components on the surface of the support may be arranged in any convenient configuration. Where there are two or more components on the surface of the solid support, an interconnect may be provided. All components and supports of the ingestible circuitry are ingestible and, in some instances, digestible or partially digestible.

Drawings

FIG. 1 illustrates a pharmaceutical product having an event indicator system according to the teachings of the present invention, wherein the product and event indicator system are combined within the body.

Fig. 2A illustrates the drug product of fig. 1 with an event indicator system on the exterior of the drug product.

Fig. 2B illustrates the drug product of fig. 1 with an event indicator system disposed inside the drug product.

Fig. 2C shows a capsule having an event indicator system disposed therein according to one aspect of the present invention.

Fig. 2D shows a capsule having an event indicator system disposed therein according to one aspect of the present invention.

Fig. 2E shows a capsule having an event indicator system disposed therein according to one aspect of the present invention.

Fig. 2F is an exploded view of the event indicator system.

FIG. 3 is a block diagram representation of one aspect of an event indicator system having dissimilar metals disposed on opposite ends.

FIG. 4 is a block diagram representation of another aspect of an event indicator system having dissimilar metals disposed on the same end and separated by a non-conductive material.

FIG. 5 illustrates the ion transfer or current path through the conductive fluid when the event indicator system of FIG. 3 is in contact with the conductive liquid and in an active state.

Fig. 5A shows an exploded view of the surface of the dissimilar material of fig. 5.

Fig. 5B shows the event indicator system of fig. 5 with a pH sensor unit.

FIG. 6 is a block diagram illustration of one aspect of a control device used in the systems of FIGS. 3 and 4.

Fig. 7 is a functional block diagram of a demodulation circuit that may be present in a receiver to perform coherent demodulation, according to an aspect.

Fig. 8 illustrates a functional block diagram of a beacon module within a receiver in accordance with an aspect.

Fig. 9 is a block diagram of different functional modules that may be present in a receiver according to one aspect.

Fig. 10 is a block diagram of a receiver in accordance with an aspect.

Fig. 11 provides a block diagram of a high frequency signal chain in a receiver according to one aspect.

Fig. 12 provides a diagram of how a system including a signal receiver and an ingestible event marker may be used, according to one aspect.

Detailed Description

The present disclosure includes various aspects for indicating the occurrence of an event. As described in more detail below, the system of the present invention is used with a conductive fluid to indicate an event identified by contact between the conductive fluid and the system. For example, the system of the present disclosure may be used with a pharmaceutical product, and the indicated event is when the product is taken or ingested. The term "ingesting" is understood to mean introducing the system into the body in any way. For example, ingestion involves simply placing the system in the mouth up to the descending colon. Thus, the term ingestion relates to any time when the system is introduced into an environment containing a conductive fluid. Another example is when a non-conductive fluid is mixed with a conductive fluid. In such a case, the system is present in the non-conductive fluid and when the two fluids are mixed, the system comes into contact with the conductive fluid and the system is activated. Yet another example is when there is some conductive fluid that needs to be detected. In these examples, the presence of the system (which may be activated) within the electrically conductive fluid may be detected, and thus the presence of the corresponding fluid will be detected.

Referring again to the example of the use of the system with products ingested into living organisms, the device comes into contact with the body's conductive fluid when the product comprising the system is ingested or ingested. When the system of the invention comes into contact with a body fluid, an electrical potential is generated and the system is activated. One portion of the power source is provided by the device and another portion of the power source is provided by the conductive fluid, which is discussed in detail below.

Referring now to fig. 1, an ingestible product 14 comprising the system of the present invention is shown inside the body. The product 14 is configured as an orally ingestible pharmaceutical formulation in the form of a pill or capsule. After ingestion, the pill moves to the stomach. Upon reaching the stomach, the product 14 comes into contact with the gastric fluid 18 and undergoes chemical or electrochemical reactions with various substances in the gastric fluid 18 (e.g., hydrochloric acid and other digestants). The system of the present invention is discussed with reference to a pharmaceutical environment. However, the scope of the present invention is not limited thereto. The invention may be used in any environment, for example, outside the body, where a conductive fluid is present or has been made present by mixing two or more components that produce a conductive fluid.

Referring now to fig. 2A, a pharmaceutical product 10 is shown that is similar to the product 14 of fig. 1, having a system 12, such as an ingestible event marker or Ion Emission Module (IEM). The scope of the invention is not limited by the shape or type of product 10. For example, it will be clear to those skilled in the art that the product 10 may be a capsule, a sustained release oral dosage, a tablet, a gel capsule, a sublingual tablet, or any oral dosage product that may be combined with the system 12. In the mentioned aspects, the product 10 secures the system 12 to the outside using known methods of securing microdevices to the outside of pharmaceutical products. Examples of methods for securing a micro device to a product are disclosed in the following applications: united states provisional application No. 12/741,583 entitled "HIGH-throughput method for making information and method for works" filed on 5.1.2010, which was also filed on 5.1.2010 as PCT application No. PCT/US10/20142 and published on 15.7.2010 as WO 2010/080765; and united states provisional application No. 61/177,611 entitled "induction b leveen cam k er co m is a non-limiting and non-limiting method of providing a compound of formula i", filed on 12.5.2009, which was also filed on 10.5.2010 as PCT application No. PCT/US10/34186 and published on 18.11.2010 as WO2010/132331, the entire disclosure of each of which is incorporated herein by reference. Once ingested, the system 12 comes into contact with the body fluid and the system 12 is activated. The system 12 uses the potential difference to power up and thereafter modulates the conductance to produce a unique and identifiable current signature. Upon activation, the system 12 controls conductance and thus current flow to generate a current signature.

There are various reasons for delaying the activation of the system 12. To delay activation of the system 12, the system 12 may be coated with a shielding material or protective layer. The layer dissolves after a period of time, thereby allowing the system 12 to be activated when the product 10 has reached the target location.

Referring now to fig. 2B, a pharmaceutical product 20 similar to the product 14 of fig. 1 is shown having a system 22, such as an ingestible event marker or an identifiable transmission module. The scope of the present invention is not limited by the environment in which system 22 is introduced. For example, the system 22 may be enclosed in a capsule that is taken in addition to/independent of the pharmaceutical product. The capsule may simply be a carrier for the system 22 and may not contain any product. Moreover, the scope of the present invention is not limited by the shape or type of the product 20. For example, it will be clear to those skilled in the art that the product 20 may be a capsule, a sustained release oral dosage, a tablet, a gel capsule, a sublingual tablet, or any oral dosage product. In the mentioned aspect, the product 20 has the system 22 disposed inside the product 20 or secured to the inside of the product 20. In one aspect, the system 22 is secured to an interior wall of the product 20. When the system 22 is positioned inside a gel capsule, then the contents of the gel capsule are a non-conductive gel liquid. On the other hand, if the contents of the gel capsule are conductive gel liquids, in an alternative aspect, the system 22 is coated with a protective cover to prevent unwanted activation by the gel capsule contents. If the contents of the capsule are dry powders or microspheres, the system 22 is disposed or placed within the capsule. If the product 20 is a tablet or hard pill, the system 22 remains in place inside the tablet. Once ingested, the product 20 containing the system 22 disintegrates and/or dissolves. The system 22 is brought into contact with the body fluid and the system 22 is activated. Depending on the product 20, the system 22 may be positioned near the center or near the periphery depending on the desired activation delay between the initial ingestion and the activation time of the system 22. For example, a central location for the system 22 means that the system 22 will take longer to come into contact with the conductive liquid, and thus the system 22 will take longer to be activated. Therefore, it will take longer to detect the occurrence of an event.

Referring now to FIG. 2C, in accordance with one aspect of the present invention, a capsule 11 is shown having a cavity 11a therein. According to one aspect of the invention, the capsule 11 is shown as an empty capsule. Inside the cavity is a system 12A, which system 12A is similar to the system 12 of fig. 2A and the system 22 of fig. 2B. When the capsule 11 is introduced into or brought into contact with the conductive fluid, the capsule 11 cracks or disintegrates or dissolves to allow release of the system from the environment.

Referring now to fig. 2D, a capsule 11 is shown having a system 12a with a material 13 embedded in the cavity 11 a. The material 13 may be activated to expand and cause the capsule 11 to rupture. According to one aspect of the invention, the activation of material 13 is controlled by system 12 a. System for controlling a power supply12a (shown below in fig. 2E) receive a signal from an external source that may be located inside, on, or outside the body, and in response to the signal can activate material 13 to cause material 12 to expand. For example, according to one aspect of the present invention, material 13 is an electroactive material that is selected to be reactive to an electrical signal such that the properties change when exposed to an electrical potential or current. Electroactive materials or matrices include materials whose properties, such as physical size or solubility, change in response to an applied voltage or current. Examples of electroactive materials include: polyvinylidene fluoride (PVDF), perfluorosulfonic acid (Nafion (TM)), perfluorocarboxylic acid (Flemion (TM)), cellulose, salts (e.g., containing multivalent ions (e.g., Fe)³⁺) Salt) of a polymer matrix (e.g., polyethylene oxide or cellulose) or a protein. According to another aspect of the invention, the system 12a includes a plunger that releases a chemical or compound into the material 11a to cause a chemical reaction that causes the material 11a to expand.

Referring now to fig. 2E, the capsule 11 is shown in more detail with the system 12 a. The system 12a includes a unit 12b secured to the system 12 a. According to one aspect of the invention, the unit 12b includes a housing defining a cavity 12 c. In one example, the cavity 12c may be filled with a chemical or compound that is released into the cavity 11a when the cavity 11a is filled with the material 13 to initiate a reaction that causes the material 13 to expand. Referring now also to fig. 2F, in another example, the cavity 12c includes a solid object that acts as a needle or rod. The object is mechanically pushed out of the cavity 12c in the direction AA as shown. The object is then able to squeeze through the wall of the capsule 11 and cause the wall to puncture or rupture. This causes the system 12a to be separated from the capsule 11 and allows the system 12a to come into contact with the surrounding environment and be activated. Thus, unit 12b is able to control the activation of system 12 a.

According to one aspect of the invention, unit 12b includes a communication module capable of receiving, transmitting, or both. Thus, unit 12b may act as a secondary communication module, as discussed in detail below with respect to fig. 5 and element 75. According to one aspect of the invention, unit 12b may receive control signals from an external source. According to another aspect, unit 12b may transmit the signal to an external source. According to yet another aspect of the invention, unit 12b acts as a transceiver and is capable of receiving and transmitting signals to external devices. The unit 12b also communicates with other components of the system 12a, as discussed in detail below.

Referring now to fig. 3, in one aspect, the system 12 of fig. 2A and the system 22 of fig. 2B are shown in more detail as system 30. The system 30 may be used in conjunction with any pharmaceutical product, as mentioned above, to determine when a patient ingests the pharmaceutical product. As indicated above, the scope of the present invention is not limited by the environment and the products used with the system 30. For example, the system 30 may be placed within a capsule, and the capsule placed within a conductive liquid. The capsule then dissolves after a period of time and releases the system 30 into the conductive liquid. Thus, in one aspect, the capsule contains the system 30 without a product. Such capsules can then be used in any environment where a conductive liquid is present and with any product. For example, the capsule may be placed in a container filled with aviation fuel, saline, tomato sauce, motor oil, or any similar product. Additionally, the capsule containing the system 30 may be ingested at the same time as any pharmaceutical product is ingested in order to record the occurrence of an event, such as when the product was taken.

In the specific example of the system 30 in combination with a pharmaceutical product, the system 30 is activated as the product or pill is ingested. The system 30 controls the conductance to produce a unique current signature that is detected, thereby indicating that the pharmaceutical product has been taken. The system 30 comprises V_highAnd a resistor 31 connected to ground 52. The resistance element comprises a known quantity and represents V_highThe voltage drop to ground. This known quantity is used to determine the impedance of the surrounding environment, as noted with respect to FIG. 5 and cell 75a below.

The system 30 includes a frame 32. The frame 32 is a chassis for the system 30, and various components are attached to the frame 32, deposited on the frame 32, or secured to the frame 32. In this aspect of the system 30, the ingestible or digestible material 34 is physically associated with the framework 32. Material 34 may be chemically deposited on, evaporated onto, secured to, or built up on the frame, all of which may be referred to herein as "deposited" relative to frame 32. Material 34 is deposited on one side of frame 32. Materials of interest that may be used as material 34 include, but are not limited to: cu or CuI. Material 34 is deposited by physical vapor deposition, electrodeposition or plasma deposition, among other methods. Material 34 may be about 0.05 to about 500 μm thick, for example about 5 to about 100 μm thick. The shape is controlled by shadow mask deposition or photolithography and etching. Additionally, although only one zone is shown for depositing the material, each system 30 may contain two or more electrically unique zones where material 34 may be deposited, as desired.

On a different side, which is the opposite side as shown in fig. 3, another digestible material 36 is deposited such that the materials 34 and 36 are distinct and isolated from each other. Although not shown, the different side selected may be one that is adjacent to the side selected for material 34. The scope of the present invention is not limited by the selected side, and the term "different side" may mean any of a plurality of sides different from the first selected side. Further, although the shape of the system is shown as square, the shape may be any geometrically suitable shape. The materials 34 and 36 are selected such that they create a potential difference when the system 30 is in contact with a conductive liquid (e.g., a body fluid). Materials of interest for material 36 include, but are not limited to: mg, Zn or other electronegative metals. As shown above with respect to material 34, material 36 may be chemically deposited on, evaporated onto, secured to, or built up on the frame. Also, an adhesive layer may be necessary to help the material 36 (and, if desired, the material 34) adhere to the frame 32. Typical adhesion layers for material 36 are Ti, TiW, Cr or similar materials. The anode material and adhesion layer may be deposited by physical vapor deposition, electrodeposition or plasma deposition. Material 36 may be about 0.05 to about 500 μm thick, for example about 5 to about 100 μm thick. However, the scope of the present invention is not limited by the thickness of any material, nor by the type of process used to deposit or secure the material to the frame 32.

Materials 34 and 36 may be any pair of materials having different electrochemical potentials in accordance with the stated disclosure. Additionally, in aspects where the system 30 is used in vivo, the materials 34 and 36 may be vitamins that can be absorbed. More specifically, materials 34 and 36 may be made of any two materials suitable for the environment in which system 30 is to operate. For example, when used with an ingestible product, materials 34 and 36 are any pair of materials having different electrochemical potentials that are ingestible. One illustrative example includes the case when the system 30 is contacted with an ionic solution, such as stomach acid. Suitable materials are not limited to metals, and in certain aspects, pairs of materials are selected from metals and non-metals, for example, pairs consisting of a metal (e.g., Mg) and a salt (e.g., CuCl or CuI). As regards the active electrode material, any pair of substances (metal, salt or intercalation compound) with suitably different electrochemical potentials (voltages) and low interfacial resistance is suitable.

Materials and pairs 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., in order to enhance the electrical potential formed between the materials when they come into contact with the conductive liquid. In certain aspects, non-metals that can be used as dopants include, but are not limited to: sulfur, iodine, and the like. In another aspect, the materials are copper iodide (CuI) as the anode and magnesium (Mg) as the cathode. Aspects of the present invention use electrode materials that are harmless to the human body.

Thus, when system 30 is in contact with a conductive liquid, a current path is formed between materials 34 and 36 through the conductive liquid, an example of which is shown in FIG. 5. A control device 38 is secured to the frame 32 and electrically coupled to the materials 34 and 36. Control device 38 includes electronic circuitry, such as control logic, capable of controlling and changing the conductance between materials 34 and 36.

The potential developed between materials 34 and 36 provides power for operating the system as well as creating a flow of current through the conductive fluid and the system. In one aspect, the system operates in a direct current mode. In an alternative aspect, the system controls the direction of the current such that the direction of the current is reversed in a cyclic manner, similar to an alternating current. As the system reaches the conductive fluid or electrolyte, where the fluid or electrolyte components are provided by the physiological fluid (e.g., gastric acid), the path for current flow between materials 34 and 36 is completed outside of system 30; the current path through the system 30 is controlled by a control device 38. Completion of the current path allows current to flow, and a receiver (not shown) may in turn detect the presence of current and recognize that the system 30 has been activated and that a desired event is occurring or has occurred. Illustrative examples of such receivers are further described with respect to fig. 7-12, as described below.

In one aspect, the two materials 34 and 36 are functionally similar to the two electrodes required for a direct current power source (e.g., a battery). The conductive liquid serves as the electrolyte needed to complete the power supply. The completed power source described is defined by the electrochemical reaction between materials 34 and 36 of system 30 and is initiated by the body's fluids. The completed power source can be considered as a power source using ionic or conductive solutions such as gastric juices, blood or other body fluids and electrochemical conduction in some tissues. Additionally, the environment may be something other than the body, and the liquid may be any conductive liquid. For example, the conductive fluid may be saline or a metal-based coating.

In certain aspects, both materials are shielded from the surrounding environment by an additional layer of material. Thus, when the shield dissolves and the two dissimilar materials are exposed to the target site, an electrical potential is generated.

In certain aspects, the completed power source or power supply is comprised of an active electrode material, an electrolyte, and an inactive material (e.g., current collector, encapsulation, etc.). The active material is any pair of materials having different electrochemical potentials. Suitable materials are not limited to metals, and in certain aspects, the mating materials are selected from metals and non-metals, e.g., a pair consisting of a metal (e.g., Mg) and a salt (e.g., CuI). As regards the active electrode material, any pair of substances (metal, salt or intercalation compound) with suitably different electrochemical potentials (voltages) and low interfacial resistance is suitable.

A variety of different materials may be used as the material forming the electrodes. In certain aspects, the electrode material is selected to provide a voltage upon contact with a target physiological site (e.g., stomach) sufficient to drive the system of the identifier. In certain aspects, after the metal of the power source is contacted with the target physiological site, the voltage provided by the electrode material is 0.001V or greater, including 0.01V or greater, such as 0.1V or greater, such as 0.3V or greater; including 0.5 volts or higher; including 1.0 volt or higher, with voltages in certain aspects in the range of about 0.001 to about 10 volts, such as from about 0.01 to about 10 volts.

Referring again to fig. 3, materials 34 and 36 provide an electrical potential to activate control device 38. Once the control device 38 is activated or powered up, the control device 38 may change the conductance between the materials 34 and 36 in a unique manner. By varying the conductance between the materials 34 and 36, the control device 38 is able to control the magnitude of the current passing through the conductive liquid surrounding the system 30. This produces a unique current signature that can be detected and measured by a receiver (not shown), which can be placed inside or outside the body. In addition to controlling the magnitude of the current path between the materials, a non-conductive material, film or "skirt" is used to increase the "length" of the current path, thus serving to strengthen the conductance path, as disclosed In U.S. patent application No. 12/238,345 entitled "In-body device with virtual bipolar amplification" filed on 25.9.2008, which was published as 2009-0082645a1 on 26.3.2009, which is incorporated herein by reference In its entirety. Alternatively, throughout the disclosure, the terms "non-conductive material", "membrane", and "skirt" may be used interchangeably with the term "current path extender" without affecting the scope of the inventive aspects and claims herein. Skirts, partially shown at 35 and 37, respectively, may be associated with the frame 32, e.g., fastened to the frame 32. Various shapes and configurations of the skirt are contemplated as falling within the scope of the present invention. For example, the system 30 may be wholly or partially surrounded by a skirt, and the skirt may be disposed along a central axis of the system 30 or eccentrically with respect to the central axis. Accordingly, the scope of the invention as claimed herein is not limited by the shape or size of the skirt. Further, in other aspects, the materials 34 and 36 may be separated by a skirt that is disposed in any defined region between the materials 34 and 36.

Referring now to FIG. 4, in another aspect, the system 12 of FIG. 2A and the system 22 of FIG. 2B are shown in more detail as system 40. The system 40 includes a frame 42. The frame 42 is similar to the frame 32 of fig. 3. In this aspect of the system 40, the digestible or dissolvable material 44 is deposited on a portion of one side of the frame 42. At a different portion of the same side of frame 42, another digestible material 46 is deposited, such that materials 44 and 46 are dissimilar. More specifically, materials 44 and 46 are selected such that they form a potential difference when in contact with a conductive liquid (e.g., a bodily fluid). Thus, when system 40 is in contact and/or partial contact with the conductive liquid, a current path is then formed through the conductive liquid between materials 44 and 46, an example of which is shown in FIG. 5. A control device 48 is secured to the frame 42 and electrically coupled to the materials 44 and 46. Control device 48 includes electronic circuitry capable of controlling a portion of the electrically conductive path between materials 44 and 46. The materials 44 and 46 are separated by a non-conductive skirt 49. Various examples of skirts 49 are disclosed in the following applications: united states provisional application No. 61/173,511 entitled "highlyrelibeleingestribeleveleetmaktanbersanctmethodsofusinggsame" filed on 28.4.2009, which was also filed on 27.2010 as PCT application No. PCT/US10/32590 and published on 11.2010 as WO 2010/129288; united states provisional application No. 61/173,564 entitled "ingelbleeve system for providing a signal to a user at 28/4/2009," which was also filed at 27/2010 as PCT application No. PCT/US10/32590 and published at 11/2010 as WO 2010/129288; and U.S. application No. 12/238,345 entitled "IN-bodyviewvitriolipidemignamplification" filed on 25/9/2008, which was published as U.S. publication No. 2009-0082645a1 on 26/3/2009; the entire disclosure of each of the foregoing is incorporated herein by reference.

Once the control device 48 is activated or powered up, the control device 48 may change the conductance between the materials 44 and 46. Thus, the control device 48 is capable of controlling the magnitude of the current passing through the conductive liquid surrounding the system 40. As shown above with respect to system 30, a unique current signature associated with system 40 may be detected by a receiver (not shown) to indicate activation of system 40. Illustrative examples of receivers are found in fig. 7-12, as described below. To increase the "length" of the current path, the size and/or characteristics of the skirt 49 are changed. The longer the current path, the easier it is for the receiver to detect the current.

Referring now to fig. 5, the system 30 of fig. 3 is shown in an activated state and in contact with a conductive liquid. The system 30 is grounded through a ground contact 52. For example, when the system 30 is in contact with a conductive fluid, the conductive fluid provides a ground. The system 30 also includes a sensor module 74, which is described in more detail with respect to FIG. 6. Ion or current paths 50 are formed between material 34 to material 36 and through the conductive fluid in contact with system 30. The potential developed between materials 34 and 36 is developed by a chemical reaction between material 34/36 and the conductive fluid.

The system 30 further comprises a unit 75. The unit 75 includes aspects that enable communication functionality, and may function as any of a receiver, transmitter, or transceiver, in accordance with various aspects of the present invention. Thus, another device external to system 30 (e.g., a cell phone, an implantable device, a device attached to the body of the user, or a device placed under the skin of the user) may communicate to system 30, from system 30, or both, e.g., through unit 75. Cell 75 is also electrically connected to materials 34 and 36. According to one aspect of the invention, any device external to system 30 may utilize the flow of electrical current through the environment surrounding system 30 to communicate with unit 75 or control module 38. For example, a patch or receiver attached to the user's body, a cell phone or device being held by the user, or an implantable device, are examples of devices that can generate a current signature through the user's body. The current signature may include information encoded therein. The current signature is detected by system 30 using unit 75 or control module 38 and decoded to allow communication to system 30 from a device external to system 30. Thus, the external device may send a signal wirelessly or through a transconductance to the active unit 75 of the control system 30.

According to one aspect of the invention, unit 75 may also measure the ambient environment, either directly or through sensor module 74, to determine whether system 30 should be deactivated due to adverse environmental conditions. For example, the unit 75 may comprise an impedance measurement unit 75a, the impedance measurement unit 75a being capable of measuring the impedance of the environment surrounding the system 30. Unit 75a measures impedance by transmitting or applying a voltage to one output terminal (e.g., material 34). The unit 75a then measures the impedance (using the resistor 31 of fig. 3). With a known amount of resistance and a known voltage, unit 75a is able to determine the impedance of the surrounding environment. The signal received at the receiver is proportional to the current output of the system 30. If a variable resistance (e.g., resistance 31) is added at the output terminals of system 30, the current output of system 30 will be proportional to 1/(R + Z), where R is the value of the variable resistor and Z is the local impedance of the solution or gastric environment surrounding system 30. Thus, the detected signal will be equal to:

Vreceievd=k/(R+Z)

the system 30 may be designed with variable resistors that cycle between 2 or more levels during transmission. This results in a received signal that will vary according to the above equation. When detected, the signal is used to generate a linear curve to match:

1/Vrceived relative R

And determining the slope and intercept. The slope will have a value of 1/k and the intercept will have a value of Z/k. This allows both k and the local impedance of the system 30 to be determined independently of the actual voltage or current obtained from the system 30, since the value of the variable resistor is known from the design parameters.

Impedance measurements can be used to monitor the hydration status of the patient, the presence of drugs, gastrointestinal motility/fluctuations, stomach transit time, the presence of certain types of tissue (tumors), or bleeding. Impedance measurements are also useful diagnostic tools for monitoring the performance of the system 30. For example, if the impedance of the surrounding environment prevents effective communication, the system 30 may be deactivated or activation delayed. According to one aspect of the invention, unit 75 sends a signal to control device 38. In response, control device 38 may change the conductance, and thus the impedance, between materials 34 and 36 to reduce the rate of chemical reaction between materials 34 and 36 and the surrounding environment, and thereby cause system 30 to reach a deactivated mode, state, or condition. In this way, despite some chemical reaction, it is low enough to conserve power of the system 30 for later use, while still allowing sensing and measurement operations of the nearby environment.

If the conditions of the environment change to become favorable for communication, as determined by the measurement of the environment, unit 75 sends a signal to control device 38 to change the conductance between materials 34 and 36 to allow communication with the current signature of system 30. Thus, if the system 30 has been deactivated and the impedance of the environment is suitable for communication, the system 30 may be activated again.

Referring now to fig. 5A, fig. 5A shows an exploded view of the surface of material 34. In one aspect, the surface of material 34 is not flat, but rather is an irregular surface. The irregular surface increases the surface area of the material and thus the area that comes into contact with the conductive fluid. In one aspect, at the surface of material 34, there is an electrochemical reaction between material 34 and the surrounding conductive fluid, such that matter is exchanged with the conductive fluid. The term "species" as used herein includes any ionic or non-ionic species that may be added to or removed from a conductive fluid as part of an electrochemical reaction occurring on material 34. One example includes an example where the material is CuCl and the CuCl is converted to Cu metal (solid) and Cl "is released into solution when in contact with a conductive fluid. The flow of positive ions into the conductive fluid is depicted by current path 50. The negative ions flow in the opposite direction. In a similar manner, there is an electrochemical reaction involving material 36 that causes the release or removal of ions from the conductive fluid. In this example, the release of negative ions at the material 34 and the release of positive ions through the material 36 are related to each other by the flow of current controlled by the control device 38. The reaction rate and hence the ion emission rate or current is controlled by the control means 38. The control device 38 can increase or decrease the rate of ion flow by changing its internal conductance, which changes the impedance and thus the current flow and reaction rate at the materials 34 and 36. By controlling the rate of reaction, the system 30 can encode information in the flow of ions. Thus, the system 30 utilizes ion emission or flow to encode information.

The control device 38 can vary the duration of the ion flow or current while keeping the magnitude of the current or ion flow near constant, similar to when the frequency is modulated and the amplitude is constant. Also, the control device 38 may vary the level of ion flow rate or the magnitude of current flow while keeping the duration nearly constant. Thus, with various combinations of changes in duration and rate or magnitude of change, the control device 38 encodes information in the current or current flow. For example, control device 38 may use, but is not limited to, any of the following techniques, including binary Phase Shift Keying (PSK), frequency modulation, amplitude modulation, on-off keying, and PSK with on-off keying.

As indicated above, various aspects disclosed herein (e.g., the system 30 of fig. 3 and the system 40 of fig. 4) include an electronic component 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, integrated circuits, inductors, resistors, and sensors for measuring various parameters. Each component may be secured to the frame and/or another component. The components on the surface of the support may be arranged in any convenient configuration. Where there are two or more components on the surface of the solid support, an interconnect may be provided.

As indicated above, the system (e.g., control devices 30 and 40) controls the conductance between the dissimilar materials and thus the rate of ion flow or current flow. By varying the conductance in a particular way, the system is able to encode information in the ion flow and current signature. The ion flow or current signature is used to uniquely identify a particular system. In addition, the systems 30 and 40 are capable of generating a variety of different unique patterns or signatures, thus providing additional information. For example, a second current signature based on a second conductance change pattern may be used to provide additional information, which may be related to the physical environment. To further illustrate, the first current signature may be a current state that maintains a very low current state of an oscillator on the chip, and the second current signature may be a current state that is at least ten times greater than a current state associated with the first current signature.

Referring now to FIG. 6, a block diagram representation of control device 38 is shown. The control device 38 includes a control module 62, a counter or clock 64, and a memory 66. Additionally, the apparatus 38 is shown to include a sensor module 72 and a sensor module 74, the sensor module 74 being referenced in FIG. 5. Control module 62 has an input 68 electrically coupled to material 34 and an output 70 electrically coupled to material 36. The control module 62, clock 64, memory 66 and sensor module 72/74 also have power inputs (some not shown). When system 30 is in contact with the conductive fluid, the power for each of these components is supplied by the electrical potential generated by the chemical reaction between materials 34 and 36 and the conductive fluid. The control module 62 controls the conductance through logic that varies the overall impedance of the system 30. The control module 62 is electrically coupled to a clock 64. Clock 64 provides clock cycles to control module 62. Based on the programmed characteristics of control module 62, control module 62 changes the conductance characteristics between materials 34 and 36 when a certain number of clock cycles have elapsed. This cycle is repeated and the control device 38 generates a unique current signature characteristic. The control module 62 is also electrically coupled to a memory 66. Both clock 64 and memory 66 are powered by the potential developed between materials 34 and 36.

The control module 62 is also electrically coupled to and in communication with the sensor modules 72 and 74. In the illustrated aspect, the sensor module 72 is part of the control device 38 and the sensor module 74 is a separate component. In alternative aspects, either of the sensor modules 72 and 74 may be used without the other, and the scope of the present invention is not limited by the structural or functional location of the sensor module 72 or 74. In addition, any of the components of the system 30 may be moved, combined, or rearranged, functionally or structurally, without limiting the scope of the invention as claimed. It is therefore possible to have a single structure, for example a processor, designed to perform the functions of all the following modules: a control module 62, a clock 64, a memory 66, and a sensor module 72 or 74. On the other hand, it is also within the scope of the invention to have each of these functional components located in a separate structure that is electrically linked and capable of communication.

Referring again to FIG. 6, the sensor module 72 or 74 may include any of the following sensors: temperature, pressure, pH and conductivity. In one aspect, the sensor module 72 or 74 collects information from the environment and communicates analog information to the control module 62. The control module then converts the analog information to digital information and encodes the digital information in the current flow or in the rate of mass transfer that produces the flow of ions. In another aspect, the sensor module 72 or 74 collects information from the environment and converts analog information to digital information, which is then communicated to the control module 62. In the aspect shown in FIG. 5, sensor module 74 is shown electrically coupled to materials 34 and 36 and control device 38. In another aspect, as shown in FIG. 6, sensor module 74 is electrically coupled to control device 38 at connection 78. The connection 78 serves as both a power supply source for the sensor module 74 and a communication channel between the sensor module 74 and the control device 38.

Referring now to FIG. 5B, system 30 includes a pH sensor module 76 connected to material 39, the pH sensor module 76 being selected according to the particular type of sensing function being performed. The pH sensor module 76 is also connected to the control device 38. Material 39 is electrically isolated from material 34 by a non-conductive barrier layer 55. In one aspect, material 39 is platinum. In operation, the pH sensor module 76 utilizes the potential difference between the materials 34/36. The pH sensor module 76 measures the potential difference between material 34 and material 39 and records the value for later comparison. pH sensor module 76 also measures the potential difference between material 39 and material 36 and records the value for later comparison. The pH sensor module 76 uses the potential value to calculate the pH value of the surrounding environment. The pH sensor module 76 provides information to the control device 38. The control device 38 varies the rate of mass transfer and current flow that produces ion transfer to encode pH-related information in the ion transfer that can be detected by a receiver (not shown). Thus, the system 30 can determine and provide information related to the pH value to a source external to the environment.

As indicated above, the control device 38 may be pre-programmed to output a predefined current signature. In another aspect, the system may include a receiver system that may receive programming information when the system is activated. In another aspect (not shown), the switch 64 and the memory 66 may be combined into one device.

Examples of sources outside the environment include various receivers and the like. In one example of a receiver (sometimes referred to herein as a "signal receiver"), two or more different demodulation protocols may be employed to decode a given received signal. In some examples, both coherent and differential coherent demodulation protocols may be employed. Fig. 7 provides a functional block diagram of how a receiver may implement a coherent demodulation protocol in accordance with an aspect of the present invention. It should be noted that only a portion of the receiver is shown in fig. 7. Fig. 7 illustrates the process of mixing down the signal to baseband once the carrier frequency (and carrier signal mixed down to the carrier offset) is determined. Carrier signal 2221 is mixed with second carrier signal 2222 at mixer 2223. A narrow low pass filter 2220 with the appropriate bandwidth is applied to reduce the effect of the out-of-bound noise. Demodulation occurs at block 2225 in accordance with the coherent demodulation scheme of the present invention. The unwrapped phase of the complex signal is determined 2230. A selective third mixer stage may be applied in which the phase evolution is used to estimate the frequency difference between the calculated carrier frequency and the true carrier frequency. The structure of the data packet is then used at block 2240 to determine the start of the coding region of the BPSK signal. The start boundary of a data packet is determined primarily using the presence of a sync header, which appears as an FM edge in the amplitude signal of the complex demodulated signal. Once the start point of the data packet is determined, the signal is rotated at the IQ plane and standard bit identification at block 2250 and finally decoded at block 2260.

In addition to demodulation, the through-body communication module may include a forward error correction module that provides additional gain to combat interference from other unwanted signals and noise. Forward error correction function modules of interest include those described in PCT application No. PCT/US2007/024225, published as WO2008/063626, the disclosure of which is incorporated herein by reference. In some examples, the forward error correction module may employ any convenient protocol such as Reed-Solomon (Reed-Solomon), gray (Golay), Hamming (Hamming), BCH, and Turbo (Turbo) protocols to identify and correct (within bounds) decoding errors.

In another example, the receiver includes a beacon module, as shown in the functional block diagram of fig. 8. The scheme outlined in fig. 8 outlines one technique for identifying valid beacons. The incoming signal 2360 represents a signal that is received by the electrodes, bandpass filtered (e.g., from 10KHz to 34 KHz) by a high frequency signaling chain that includes a carrier frequency, and converted from analog to digital. The signal 2360 is then decimated at block 2361 and the signal 2360 is mixed at a nominal drive frequency (e.g., 12.5KHz, 20KHz, etc.) at mixer 2362. The resulting signal is decimated at block 2364 and low pass filtered (e.g., 5 KHzBW) at block 2365 to produce a carrier signal, signal 2369, that is mixed down to the carrier offset. Signal 2369 is further processed by block 2367 (fast fourier transform and then detection of the two strongest peaks) to provide a true carrier frequency signal 2368. This protocol allows the carrier frequency of the transmitted beacon to be accurately determined.

Fig. 9 provides a functional block diagram of integrated circuit components of a signal receiver in accordance with an aspect of the present invention. In fig. 9, receiver 2700 includes electrode input 2710. Electrically coupled to the electrode input 2710 are a trans-body conductive communication module 2720 and a physiological sensing module 2730. In one aspect, the through body conductive communication module 2720 is implemented as a High Frequency (HF) signal chain and the physiological sensing module 2730 is implemented as a Low Frequency (LF) signal chain. Also shown are a CMOS temperature sensing module 2740 (for detecting ambient temperature) and a 3-axis accelerometer 2750. Receiver 2700 also includes a processing engine 2760 (e.g., a microcontroller and digital signal processor), non-volatile memory 2770 (for data storage), and wireless communication module 2780 (for sending data to another device, such as in a data upload action).

Fig. 10 provides a more detailed block diagram of circuitry configured to implement the functional block diagram of the receiver depicted in fig. 9, in accordance with an aspect of the present invention. In fig. 10, receiver 2800 includes electrodes e1, e2, and e3 (2811, 2812, and 2813), which electrodes e1, e2, and e3 (2811, 2812, and 2813), for example, receive signals transmitted by IEM conductivity and/or sense physiological parameters or biomarkers of interest. Signals received by electrodes 2811, 2812, and 2813 are multiplexed by multiplexer 2820, which multiplexer 2820 is electrically coupled to the electrodes.

Multiplexer 2820 is electrically coupled to both high band pass filter 2830 and low band pass filter 2840. The high frequency signal chain and the low frequency signal chain provide programmable gain to cover a desired level or range. In this particular aspect, the high band pass filter 2830 passes frequencies in the 10KHz to 34KHz band, while filtering out noise from out-of-band frequencies. This high frequency band may vary and may include, for example, the range of 3KHz to 300 KHz. The passed frequency is then amplified by amplifier 2832 and then converted to a digital signal by converter 2834 for input into high power processor 2880 (shown as a DSP), which high power processor 2880 is electrically coupled to the high frequency signal chain. The low band pass filter 2840 is shown passing lower frequencies in the range of 0.5Hz to 150Hz, while filtering out-of-band frequencies. The frequency bands may vary and may include, for example, frequencies below 300Hz, such as below 200Hz, including below 150 Hz. The passed frequency signal is amplified by an amplifier 2842. Also shown is accelerometer 2850, which is electrically coupled to second multiplexer 2860. Multiplexer 2860 multiplexes the signal from the accelerometer with the amplified signal from amplifier 2842. The multiplexed signal is then converted to a digital signal by a converter 2864, which converter 2864 is also electrically coupled to a low power processor 2870. In one aspect, a digital accelerometer (e.g., manufactured by analog devices, inc.) may be implemented in place of accelerometer 2850. Various advantages may be realized by using a digital accelerometer. For example, because the digital accelerometer generates signals that are already in digital format, the digital accelerometer may bypass the converter 2864 and be electrically coupled to the low power microcontroller 2870 — in which case the multiplexer 2860 would no longer be required. Also, the digital signal may be configured to turn itself on when motion is detected, thereby further conserving power. Additionally, a sequential step count may be implemented. The digital accelerometer may include a FIFO buffer to help control the flow of data sent to the low power processor 2870. For example, data may be buffered in a FIFO until full, at which time the processor may be triggered to wake up from an idle state and receive the data. For example, low power processor 2870 may be an MSP430 microcontroller from texas instruments. Low power processor 2870 of receiver 2800 maintains an idle state, which, as stated previously, requires minimal current consumption, e.g., 10.mu.a or less, or 1.mu.a or less. For example, high power processor 2880 may be a VC5509 digital signal processor from texas instruments, inc. The high power processor 2880 performs signal processing actions during the active state. As stated previously, these actions require a greater amount of current than the idle state, such as 30.mu.a or more current, such as 50.mu.a or more, and may include actions such as scanning conductively transmitted signals, processing conductively transmitted signals upon receipt, obtaining and/or processing physiological data, for example.

Also shown in fig. 10 is flash memory 2890, which is electrically coupled to high power processor 2880. In one aspect, flash memory 2890 may be electrically coupled to low power processor 2870, which may provide better power efficiency. The wireless communication element 2895 is shown electrically coupled to the high power processor 2880 and may comprise, for example, a bluetooth. In one aspect, the wireless communication element 2895 is electrically coupled to the high power processor 2880. In another aspect, the wireless communication element 2895 is electrically coupled to the high power processor 2880 and the low power processor 2870. Further, the wireless communication element 2895 may be implemented with its own power supply so that it can be turned on and off independently of the other components of the receiver, e.g., by a microprocessor.

The following paragraphs provide example configurations of the receiver component shown in fig. 10 during various states of the receiver, in the case of an idle state, for example, in accordance with an aspect of the present invention. It should be understood that alternative configurations may be implemented depending on the desired application. For example, in the idle state, the receiver draws the least current. Receiver 2800 is configured such that low power processor 2870 is in an inactive state (e.g., idle state) and high power processor 2880 is in an inactive state (e.g., idle state), and circuit blocks related to peripheral circuits and their power supplies required during various active states remain off (e.g., wireless communication module 2895 and analog front end). For example, a low power processor may have a 32KHz oscillator active and may consume a few. mu.A current or less, including 0.5.mu.A or less. In the idle state, low power processor 2870 may, for example, wait for a signal to transition to an active state. The signal may be external, such as an interrupt, or generated internally by one of the device's peripherals, such as a timer. During the idle state of the high power processor, the high power processor may, for example, turn off the 32KHz clock crystal. For example, a high power processor may wait for a signal to transition to an active state. When the receiver is in the sniff state, the low power processor 2870 is in an idle state and the high power processor 2880 is in an idle state. In addition, circuit blocks related to the analog front end (including the a/D converter) required for the sniff function are turned on (in other words, high frequency signal chain). As stated previously, the beacon signal module may implement various types of sniff signals to achieve low power efficiency. Upon detection of the transmitted signal, a higher power demodulation and decoding state may be entered. When the receiver is in the demodulation and decoding state, the low power processor 2870 is in the active state and the high power processor 2880 is in the active state. For example, the high power processor 2880 may run from a 12MHz or nearby crystal oscillator with a PLL based clock multiplier that gives the device a 108MHz clock speed. For example, during the active state, the low power processor 2870 may turn off the internal R-C oscillator in the range of 1MHz to 20MHz and consume power in the range of 250 to 300uA/MHz clock speeds. The active state allows processing and any transmission that may follow. The required transmission may trigger the wireless communication module to cycle from off to on.

When the receiver is in the collect ECG and accelerometer states, circuit blocks associated with the accelerometer and/or ECG signal conditioning chain are turned on. High power processor 2880 is in an idle state during collection and is in an active state during processing and transmission (e.g., running from a 12MHz or nearby crystal oscillator with a PLL-based clock multiplier that gives device 108MHz clock speed). The low power processor 2870 is in an active state during this state, and may turn off the internal R-C oscillator in the range of 1MHz to 20MHz and consume power in the range of 250 to 300uA/MHz clock speeds.

The low power processor (e.g., MSP shown in fig. 10) and the high power processor (e.g., DSP shown in fig. 10) may communicate with each other using any convenient communication protocol. In some examples, these two elements, when present, communicate with each other via a serial peripheral interface bus (hereinafter "SPI bus"). The following description describes signaling and messaging schemes implemented to allow high and low power processors to communicate and send messages back and forth along an SPI bus. For the following description of communication between processors, "LPP" and "HPP" are used instead of "low power processor" and "high power processor", respectively, to remain consistent with fig. 10. However, this discussion may be applicable to other processors besides the processor shown in FIG. 10.

Fig. 11 provides a diagram of a block diagram of hardware in a receiver according to an aspect of the invention in relation to a high frequency signal chain. In fig. 11, receiver 2900 includes a receiver probe (e.g., in the form of electrodes 2911, 2912, and 2913) electrically coupled to multiplexer 2920. A high pass filter 2930 and a low pass filter 2940 are also shown to provide a band pass filter that eliminates any out of band frequencies. In the illustrated aspect, a 10KHz to 34KHz bandpass is provided to pass carrier signals that fall within the frequency band. Example carrier frequencies may include, but are not limited to, 12.5KHz and 20 KHz. One or more carriers may be present. In addition, receiver 2900 includes an analog-to-digital converter 2950, for example, sampled at 500 KHz. The digital signal may thereafter be processed by the DSP. In this aspect, a DMA to DSP unit 2960 is shown, which sends the digital signals to a dedicated memory for the DSP. Direct memory access provides the benefit of allowing the rest of the DSP to remain in a low power mode.

An example of a system including a receiver is shown in fig. 12. In fig. 12, system 3500 includes a drug composition 3510, which drug composition 3510 includes an ingestible device, such as an ingestible event marker "IEM". Also present in system 3500 is a signal receiver 3520. Signal receiver 3520 is configured to detect signals emitted from the identifiers of IEM 3510. The signal receiver 3520 also includes physiological sensing capabilities, such as ECG and motion sensing capabilities. The signal receiver 3520 is configured to transmit data to an external device or PDA3530 (e.g., a smart phone or other wireless communication enabled device) of the patient, which in turn transmits data to a server 3540, or PDA 3530. The server 3540 may be configured as needed, for example, to provide permissions for the patient. For example, the server 3540 may be configured to allow the home caregiver 3550 to participate in a patient's treatment regimen, e.g., via an interface (e.g., a web interface) that allows the home caregiver 3550 to monitor alarms and trends generated by the server 3540, and provide back support to the patient, as indicated by arrow 3560. The server 3540 may also be configured to provide responses directly to the patient, e.g., in the form of patient alerts, patient incentives, etc., which are relayed to the patient via the PDA3530, as indicated by arrow 3565. The server 3540 may also interact with a health care professional (e.g., RN, physician) 3555 that may use data processing algorithms to obtain patient health and fitness metrics, such as health index summaries, alerts, cross-patient benchmarks, etc., and provide informed clinical communication and support back to the patient, as indicated by arrow 3580.

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 integrated circuits; a power conditioning device, such as a battery, fuel cell, or capacitor; sensors, actuators, etc.; a signal transmitting element, for example in the form of an antenna, electrode, coil, etc.; passive components such as inductors, resistors, etc.

In certain aspects, the ingestible circuitry comprises a coating. The purpose of the coating may vary, for example, to protect the circuit, chip and/or battery or any component during processing, during storage or even during ingestion. In these examples, a coating on top of the circuitry may be included. Also of interest are coatings designed to protect the ingestible circuitry during storage but dissolve immediately during use. For example, a coating that dissolves upon contact with an aqueous fluid (e.g., gastric fluid) or a conductive fluid as mentioned above. Also of interest are protective treatment coatings that are used to allow the use of treatment steps that would otherwise damage certain components of the device. For example, in the production of chips with dissimilar materials deposited on the top and bottom, the product needs to be diced. However, the dicing process may scratch away the dissimilar materials and may also involve liquids that may cause the dissimilar materials to fall off or dissolve. In these examples, a protective coating on the material may be employed that prevents mechanical or liquid contact with the component during processing. Another use of the dissolvable coating may be provided to delay activation of the device. For example, a coating that is placed on a dissimilar material and takes a specific period of time (e.g., five minutes) to dissolve upon contact with gastric fluid may be employed. The coating may also be an environmentally sensitive coating, such as a temperature or pH sensitive coating, or other chemically sensitive coating that provides for dissolution in a controlled fashion and allows activation of the device when desired. Coatings that persist in the stomach but dissolve in the intestinal tract are also of interest, for example, where delayed activation is required until the device leaves the stomach. Examples of such coatings are polymers that are insoluble at low pH but become soluble at higher pH. Also of interest are pharmaceutical formulation protective coatings, e.g., gelatin capsule liquid protective coatings, which prevent the activation of the circuit by the liquid of the gelatin capsule.

The identifier of interest includes two dissimilar electrochemical materials that function similarly to the electrodes (e.g., anode and cathode) of the power source. References to electrodes or anodes or cathodes are used herein only as illustrative examples. The scope of the present invention is not limited by the name used, but includes the aspect of creating an electrical potential between two dissimilar materials. Thus, when referring to an electrode, an anode or a cathode, reference is intended to the electrical potential formed between two dissimilar materials.

When the material is exposed and brought into contact with a body fluid, such as stomach acid or other types of fluids (alone or in combination with a dry conductive medium precursor), a potential difference, i.e., a voltage, is generated between the electrodes due to the respective oxidation and reduction reactions to which the two electrode materials are subjected. And thus voltaic cells or batteries may be produced. Thus, in aspects of the invention, such power supply is configured such that when the two dissimilar materials are exposed to a target site (e.g., stomach, digestive tract, etc.), a voltage is generated.

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 cell. Non-metals that may be used as dopants in certain aspects include, but are not limited to: sulfur, iodine, and the like.

It is to be understood that this disclosure is not limited to particular embodiments or aspects described herein, 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.

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 stated ranges include one or both of the stated limits, ranges excluding either or both of those included limits are also included in the invention.

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.

Notwithstanding the claims, the invention also makes reference to the following clauses:

1. a device for communication, the device comprising circuitry and components that function in a conductive fluid, the device being ingestible and/or digestible, the device comprising:

a communication unit, the communication unit comprising:

a support structure;

a partial power source having a first material deposited onto the support structure; and

a second material deposited onto the support structure and electrically isolated from the first material, wherein the first material and the second material are selected to have a potential difference when in contact with a conductive fluid to provide power to activate the device;

a control module associated with the support structure and electrically connected to the first and second materials for controlling conductance between the first and second materials such that a change in conductance between the first and second materials changes a current signature of the device and thereby encodes information in the current signature; and

a unit in communication with the control module and associated with the support structure to at least receive signals from or send signals to an external source.

2. The apparatus of clause 1, further comprising a sealed housing defining a cavity, wherein the communication unit is disposed within the cavity.

3. The device of clause 2, further comprising a release material within the cavity, wherein the unit generates a release command to cause the release material to expand and open the sealed housing.

4. The apparatus of any of clauses 2 or 3, wherein the means comprises: a mechanism extending outwardly from the unit to penetrate a wall portion of the sealed housing and allow the communication unit to be separated from the sealed housing.

5. The device of any of clauses 1-4, wherein the unit comprises a lever that is mechanically activated to puncture a wall portion of the sealed housing and cause the sealed housing to open and allow the communication unit to come into contact with the conductive fluid.

6. The apparatus of any of clauses 1-5, wherein the unit measures a characteristic associated with an environment directly surrounding the communication unit.

7. The apparatus of any of clauses 1-6, further comprising a release device secured to the support structure and in communication with the unit, wherein the release device receives a release command from the unit and causes the apparatus to be exposed to the conductive fluid in response to the signal.

8. The apparatus of any of clauses 2-7, wherein the cavity comprises a material in communication with the release device, and the release device causes the material to expand within the cavity such that the sealed housing splits open.

9. The apparatus of clause 7, wherein the release device comprises an expandable material that expands within the cavity to cause the sealed housing to rupture.

10. The apparatus of clause 7, wherein the release device includes a lever that mechanically extends from the release device within the cavity of the sealed housing to urge the sealed housing apart.

11. The device of any of clauses 1-10, wherein after the device makes contact with the conductive fluid, a signal received at the unit is sent to the control module, and the control module reduces the power generated by the device by changing the conductance between the first material and the second material.

12. The apparatus of any of clauses 1-11, wherein the means sends information associated with an environment of the apparatus to an external source.

13. The device of any of clauses 1-12, wherein the unit comprises an impedance measurement unit coupled to the first material at one output and to the second material at another output to measure the impedance of the surrounding environment and control the device.

14. The device of clause 13, wherein the unit sends an impedance signal to the control module, and the control module changes the conductance between the first material and the second material upon receiving the impedance signal, preferably wherein the measurement unit sends the impedance signal to the control module to indicate to the control module that the impedance of the ambient environment is below a specified value and the device can be activated.

15. The device of any of the preceding clauses wherein the unit receives a deactivation signal from an external source and communicates information to the control module such that the control module changes the conductance between the first and second materials so as to prevent the generation of a current flow between the first and second materials and thereby deactivate the device.

16. The device of any of the preceding clauses, further comprising a sealed housing defining a cavity, wherein the communication unit is disposed within the cavity and further comprises an electroactive matrix within the cavity, wherein the unit generates a voltage to cause the electroactive matrix to expand and open the sealed housing.

17. The device of any of the preceding clauses further comprising a pharmaceutical product.

18. The device of clause 17, wherein information is encoded in the current signature upon ingestion of the drug product and/or activation of the device and/or contact of the drug product with a conductive fluid.

19. A system comprising the apparatus of any of clauses 1-18 and a receiver for receiving a communication from the apparatus.

20. Use of a device or system according to any of the preceding clauses for indicating when a patient has taken a medication.

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 were incorporated by reference herein to disclose and describe the methods and/or materials in connection with which the publications were 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. In addition, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

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. Thus, 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.

As will be readily apparent to those skilled in the art upon reading this disclosure, each of the individual aspects described and illustrated herein has discrete components and features that 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 disclosure. Any recited method may be carried out in the order of events recited, or in any other order that is logically possible.

Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be 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.

Thus, the foregoing merely illustrates the principles of the invention. It will thus 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 as well as equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. Accordingly, the scope of the present invention is not intended to be limited to the exemplary aspects shown and described herein. Rather, the scope and spirit of the invention is embodied by the appended claims.

Claims

1. An apparatus for communication, the apparatus comprising:

a first communication unit, comprising:

a support structure;

a partial power supply, comprising:

a first material deposited onto the support structure; and

a control module associated with the support structure and electrically connected to the first and second materials and configured to control conductance between the first and second materials, wherein a change in conductance between the first and second materials changes a current signature when the first and second materials are in contact with the conductive fluid to thereby encode information in the current signature;

a second communication unit in communication with the control module and associated with the support structure to at least receive signals from or send signals to an external source;

a sealed housing defining a cavity, wherein the first communication unit and the second communication unit are disposed within the cavity; and

a release material within the cavity, wherein the second communication unit generates a release command to cause the release material to expand and open the sealed housing to release the first communication unit into the conductive fluid to activate the partial power source and thereby activate the device.

2. The apparatus of claim 1, wherein the second communication unit comprises: a mechanism extending outwardly from the second communication unit to penetrate a wall portion of the hermetic case to allow the first communication unit to be separated from the hermetic case.

3. An apparatus for communication, the apparatus comprising:

a first communication unit, comprising:

a support structure;

a partial power supply, comprising:

a first material deposited onto the support structure; and

a second communication unit in communication with the control module and associated with the support structure to at least receive or send signals from or to an external source, wherein the second communication unit comprises a lever that is mechanically activated to puncture a wall portion of a sealed housing and cause the sealed housing to open and allow the first communication unit to come into contact with the conductive fluid; and

the sealed housing defining a cavity, wherein the second communication unit is disposed within the cavity to release the first communication unit into the conductive fluid to activate the partial power source and activate the device.

4. An apparatus for communication, the apparatus comprising:

a first communication unit, comprising:

a support structure;

a partial power supply, comprising:

a first material deposited onto the support structure; and

a second communication unit in communication with the control module and associated with the support structure to at least receive signals from or send signals to an external source, wherein the second communication unit measures at least one characteristic associated with an environment directly surrounding the first communication unit; and

a release device secured to the support structure and in communication with the second communication unit, wherein the second communication unit is configured to provide a release command to the release device, and wherein the release device is configured to cause the apparatus to be exposed to the conductive fluid in response to the release command to release the first communication unit into the conductive fluid to activate the portion of the power source and thereby activate the apparatus.

5. The apparatus of claim 4, further comprising a sealed housing defining a cavity, wherein the first communication unit and the second communication unit are disposed within the cavity, and wherein the cavity comprises a material in communication with the release device, and upon receiving the release command the release device causes the material to expand within the cavity such that the sealed housing ruptures thereby causing the apparatus to be exposed to the conductive fluid.

6. The apparatus of claim 4, further comprising a sealed housing defining a cavity, wherein the first communication unit and the second communication unit are disposed within the cavity, and wherein the release device comprises an expandable material that expands within the cavity causing the sealed housing to rupture upon receipt of the release command causing the apparatus to be exposed to the conductive fluid.

7. The apparatus of claim 4, further comprising a sealed housing defining a cavity, wherein the first communication unit and the second communication unit are disposed within the cavity, and wherein the release device comprises a rod mechanically extending from the release device within the cavity of the sealed housing, the rod causing the sealed housing to split and the apparatus to be exposed to the conductive fluid when the release command is received.

8. An apparatus for communication, the apparatus comprising:

a first communication unit, comprising:

a support structure;

a partial power supply, comprising:

a first material deposited onto the support structure; and

a second communication unit in communication with the control module and associated with the support structure to at least receive signals from or send signals to an external source; and

a sealed housing defining a cavity, wherein the first and second communication units are disposed within the cavity, and further comprising an electroactive matrix within the cavity, wherein the second communication unit generates a voltage to cause the electroactive matrix to expand and open the sealed housing to release the first communication unit into the electrically conductive fluid to activate the partial power source and thereby activate the device.

9. An apparatus for communication, the apparatus comprising:

a first communication unit, comprising:

a support structure;

a partial power supply, comprising:

a first material deposited onto the support structure; and

a control module associated with the support structure and electrically connected to the first and second materials and configured to control conductance between the first and second materials, wherein a change in conductance between the first and second materials changes a current signature when the first and second materials are in contact with the conductive fluid to thereby encode information in the current signature; and

a second communication unit comprising an impedance measurement device configured to measure impedance of an environment surrounding the apparatus, the second communication unit in communication with the control module and associated with the support structure to at least receive signals from or transmit signals to an external source, wherein, after the apparatus contacts the conductive fluid, the second communication unit transmits a control signal to the control module in response to the measured impedance to adjust the conductance to deactivate or delay activation of the apparatus.