HK1190000A - Wireless energy sources for integrated circuits - Google Patents

Description

Wireless energy source for integrated circuit

Introduction to the design reside in

According to 35u.s.c. § 119(e), the present patent claims priority from the application date of U.S. provisional patent application No. 61/428,055, entitled WIRELESSENERGY SOURCES FOR INTEGRATED CIRCUITS, filed 11/29/2010, the disclosure of which is incorporated herein by reference.

The present disclosure generally relates to wireless energy sources for integrated circuits. More particularly, the present disclosure relates to a wireless energy source including energy harvesting and power management circuitry for wirelessly delivering power to an ingestible identifier including an integrated circuit.

In the context of ingestible identifiers, such as Ingestible Event Markers (IEMs), prescription drugs are effective treatments for many patients when taken correctly, e.g., according to instructions. However, studies have shown that on average about 50% of patients do not comply with the prescribed medication regimen. Low compliance rates with medication regimens result in a large number of hospitalizations and nursing home treatments each year. The latest estimates are that healthcare-related costs due to patient non-compliance are reaching $ 1000 billion per year in the united states alone.

Accordingly, identifiers, commonly referred to as event markers, have been developed that can incorporate pharmaceutical compositions with drug information functionality. These devices may be ingestible and/or digestible or partially digestible. The ingestible device includes electronic circuitry for a variety of different medical applications, including both diagnostic and therapeutic applications. Some ingestible devices, such as IEMs manufactured by proteus biomedical, inc. The energy source of these IEMs, when associated with a target site of the body, is activated by the presence of a predetermined specific stimulus on said target site, such as liquid (wet), time, pH, ionic strength, conductivity, presence of biomolecules (e.g. specific proteins or enzymes present in the stomach, small intestine, colon), blood, temperature, specific auxiliary agents (food ingredients such as fat, salt or sugar, or other drugs which are co-present in clinical relevance), bacteria in the stomach, pressure, light. The predetermined specific stimulus is a known stimulus for which the controlled activation identifier is designed or configured to respond by activation.

The communication propagated by the energized ingestible marker may be received by another device (e.g., a receiver) within or near the body, which may then record that the marker (e.g., a marker associated with one or more active agents and pharmaceutical compositions) has actually reached the target site.

The digestibility or partial digestibility of the internal energy source and circuitry makes it difficult to perform diagnostic tests on the circuitry or other components without energizing the ingestible identifier and/or without dissolving the device prior to its ultimate use and thus deploying and/or destroying the device. Accordingly, it would be advantageous to provide a wireless energy source to power an ingestible marker system in a wireless mode and perform diagnostic tests and verify the operation, presence and/or functionality of the ingestible marker prior to its ultimate use.

SUMMARY

In one aspect, a system includes a control device and a wireless energy source electrically coupled to the control device. The wireless energy source includes an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy into a potential difference to energize the control device.

In another aspect, a system includes a control device for changing conductivity, a wireless energy source electrically coupled to the control device, and a local power source. The wireless energy source includes an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy to a first potential difference to energize the control device. The local power source includes a first material electrically coupled to the control device and a second material electrically coupled to the control device and electrically isolated from the first material. The first material and the second material are selected to provide a second potential difference when in contact with the electrically conductive liquid. The control device changes the electrical conductivity between the first material and the second material such that the magnitude of the electrical current is changed to encode information.

In yet another aspect, a system includes a control device, a wireless energy source electrically coupled to the control device, and a power source electrically coupled to the control device. The wireless energy source includes an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy to a first potential difference to energize the control device. The power source is electrically coupled to the control device and provides a second potential difference to the control device.

Drawings

FIG. 1 illustrates one aspect of a system including a wireless energy source and a marker system for indicating the occurrence of an event.

Fig. 2 illustrates an aspect of a system including a wireless energy source similar to that of fig. 1 and a marker system for indicating the occurrence of an event.

Fig. 3 illustrates one aspect of a system including a wireless energy source similar to that of fig. 1 and 2 and a marker system for indicating the occurrence of an event.

Fig. 4 illustrates an aspect of a wireless energy source including an energy harvester configured to harvest electromagnetic energy from an environment in the form of optical radiation and power management circuitry.

Fig. 5 illustrates an aspect of a system employing an optical radiation-based energy harvesting technique.

Fig. 6 illustrates one aspect of a system employing an energy harvesting technique based on modulated optical radiation.

Fig. 7 is a schematic view of a vibration/motion system that may be employed in the vibrational energy harvester described herein in connection with fig. 8-11.

Fig. 8 illustrates an aspect of a system including a wireless energy source including an energy harvester including an electrostatic energy conversion element that converts vibrational/kinetic energy into electrical energy as described in connection with fig. 7.

Fig. 9 illustrates one aspect of a system including a wireless energy source including an energy harvester including a piezoelectric energy conversion element that converts vibrational/kinetic energy into electrical energy as described in connection with fig. 7.

Fig. 10 is a schematic diagram of a piezoelectric type capacitor element of a wireless energy source configured to operate according to the vibration/motion energy harvesting principle described in fig. 7.

Fig. 11 illustrates an aspect of a system including a wireless energy source including an energy harvester including an electromagnetic energy conversion element that converts vibrational/kinetic energy into electrical energy as described in connection with fig. 7.

Fig. 12 illustrates one aspect of a system including a wireless energy source including an energy harvester including an acoustic energy transducing element.

Fig. 13 illustrates an aspect of a system including a wireless energy source including an energy harvester including a radio frequency energy conversion element.

Fig. 14 illustrates one aspect of a system including a wireless energy source including an energy harvester including a thermoelectric energy conversion element.

FIG. 15 illustrates one aspect of a system including a wireless energy source including an energy harvester including a thermoelectric energy conversion element similar to that illustrated in connection with FIG. 14.

Fig. 16 illustrates an aspect of an ingestible product including a system for indicating the occurrence of an event, shown in the body.

Fig. 17A illustrates a pharmaceutical product shown with a system such as an ingestible event marker or an ion emitting module.

Fig. 17B illustrates a pharmaceutical product similar to the product of fig. 17A shown with a system such as an ingestible event marker or an identifiable transmission module.

FIG. 18 illustrates a more detailed diagram of one aspect of the system of FIGS. 17A and 17B.

FIG. 19 illustrates one aspect of a system including a sensor and in contact with a conductive fluid.

FIG. 20 is a block diagram display of the device described in connection with FIGS. 18 and 19.

Fig. 21 illustrates another aspect of the systems of fig. 17A and 17B, respectively, shown as systems in greater detail.

FIG. 22 illustrates one aspect of a system similar to that of FIG. 18, including a pH sensor module coupled to a material selected according to the particular type of sensing function being performed.

FIG. 23 is a schematic diagram of a pharmaceutical product supply chain management system.

FIG. 24 is a schematic diagram of a circuit that may represent various aspects.

Description of the invention

The present disclosure provides aspects of a system including a wireless energy source for energizing a marker to indicate an occurrence of an event. Further, as described below, the system may include other energy sources and may be activated in a variety of other modes. In one aspect, the wireless energy source may be activated in a wireless mode by an external source. Further, in another aspect, the system can be activated in a galvanic mode by a chemical reaction of the system's exposure to the conductive fluid.

In the wireless activation mode, the marker system may be activated by stimulation from an external source and/or an internal source, such as an Implantable Pulse Generator (IPG). The stimulation provides energy that can be harvested by a wireless energy source. The external stimulus may be provided by electromagnetic radiation in the form of light or Radio Frequency (RF), vibration, motion, and/or a heat source. In response to the stimulus, the system powers up and generates a signal that can be detected by external and/or internal devices to communicate information related to the system to such devices. In one aspect, the system operates to communicate information that may be used to perform diagnostic tests on the system, verify the operation of the system, detect the presence of the system, and/or determine the functionality of the system. In other aspects, the system operates to deliver a unique current signature associated with the system.

In the streaming electrical activation mode, the system is activated when the system is in contact with a conductive fluid. In instances where the system is used with a product intended for ingestion by a living organism, upon ingestion, the system comes into contact with the conductive body fluid and activates. In one aspect, the system includes dissimilar materials positioned on the frame such that a potential difference is created when the conductive fluid is in contact with the dissimilar materials. The potential difference and thus the voltage is used to power up or energize control logic located within the frame. The potential difference causes ions or current to flow from the first different material to the second different material via the control logic and then through the conductive fluid to complete the circuit. The control logic operates to control the conductivity between two different materials and thus control or modulate the conductivity. Furthermore, the control logic can encode information about the current characteristics.

Fig. 1 illustrates one aspect of a system 10 including a wireless energy source 11 and a marker system 16, the marker system 16 including a control device for indicating the occurrence of an event. The wireless energy source 11 energizes the control means in a wireless mode. The wireless energy source 11 comprises an energy harvester 12 to convert energy of one form received at its input into energy of another form at its output. In various aspects, the output energy is in the form of a potential difference. Optionally, the wireless energy source may include a power management circuit 14 (shown in phantom to indicate that it is optional) for providing energy suitable for operating the circuitry of the marker system 16. In one aspect, the system 10 may be a tag, such as an electronic tag associated with an item, for example, for identifying the item. The system 10 may be used in a variety of different applications, including as a component of an ingestible identifier, such as an IEM, for example, a pharmaceutical composition with medical information functionality. In one aspect, the marker system 16 comprises an in-vivo device that, when energized, operates to transmit information to an external system positioned outside the body. In one aspect, the in-vivo device is operative to transmit information ex-vivo only when the wireless energy source is energized by an external energy source positioned outside the body.

In the most general aspect to which fig. 1 relates, the system 10 does not contain a separate internal energy source, such as, for example, a local power source (described below), a battery, or an ultracapacitor, and only the potential (V) generated by the wireless energy source 11 from energy harvested by the energy harvester 12 as disclosed herein (V;)₁-V₂) To supply power.

In various aspects described in more detail below, the energy harvester 12 harvests energy from the environment using a variety of techniques including, but not limited to, electromagnetic radiation (e.g., light or RF radiation), vibration/motion, sound waves, heat. Such techniques may be implemented using a variety of technologies, such as, for example, micro-electro-mechanical systems (MEMS), electromagnetic, piezoelectric, thermoelectric (e.g., Seebeck (Seebeck) or Peltier (Peltier) effects), and others. Energy harvester 12 may be optimized to accommodate the particular energy harvesting technology implemented by system 10.

In some aspects, the input to the energy harvester 12 may be directly driven or stimulated by a dedicated source to produce a dc power source, such as a battery in the form of an electrical potential suitable for operating the circuitry of the identifier system 16, on the output of the energy harvester 12. In such aspects, the power management circuit 14 may be eliminated. In other aspects, the power management circuit 14 may be employed to provide a potential suitable for powering the circuitry of the identifier system 16 when the potential generated by the energy harvester 12 is not suitable for operating the circuitry of the identifier system 16. Power management circuit 14 may adapt its inputs to the energy harvester 12 implemented by system 10 and its outputs to a load, such as an identifier system 16. In various aspects, power management circuitry 14 may include some form of converter to convert the input voltage generated by energy harvester 12 to an electrical potential suitable for operating marker system 16. Although the converter may be implemented in different configurations, a DC-DC converter, charge pump, boost converter, and rectified AC-DC converter may be adapted for use with power management circuit 14. In addition, the power management circuit 14 may include voltage regulators, buffers, and control circuits, among others.

In one aspect, system 10 and/or marker system 16 may be fabricated on an Integrated Circuit (IC). In a particular aspect, the marker system 16 may include on-board Random Access Memory (RAM). Marker system 16 includes control logic that operates to modulate the voltage on capacitive plates positioned on the top surface of the IC relative to the substrate voltage of the IC, thereby modulating the information to be transmitted. The modulated voltage may be detected by a capacitively coupled reader (not shown). Thus, the marker system 16 operates to transmit information related to the system 10 when the wireless energy source 11 is activated by an external source. The information may be used to functionally test the system 10 and perform diagnostic tests as well as verify the operation of the system 10 and detect the presence of the system 10. In other aspects, the marker system 16 operates to communicate unique characteristics associated with the system 10.

Although described herein generally in connection with electrical potentials, the scope of the disclosed system is not so limited. In this regard, where the operation of the circuitry of identifier system 16 is dependent upon the delivery of a predetermined current rather than a predetermined potential, energy harvester 12 and/or power management circuit 14 may be designed and implemented to operate accordingly.

Fig. 2 illustrates an aspect of a system 20 including a wireless energy source 21 similar to the wireless energy source 11 of fig. 1 and a marker system 22 for indicating the occurrence of an event. The wireless energy source 21 energizes the control means in a wireless mode. The wireless energy source 21 comprises an energy harvester 12 to convert energy of one form received at its input into energy of another form at its output. In various aspects, the output energy is in the form of a potential difference. Optionally, the wireless energy source may include a power management circuit 14 (shown in phantom to indicate that it is optional) for providing energy suitable for operating the circuitry of the marker system 16. In the aspect concerned, the system 20 comprises a hybrid energy source comprising the wireless energy source 11 and a local power source in the marker system 22. The wireless energy source 11 is electrically coupled to the control device 24 to supply power to the circuitry of the marker system 22 independent of the local power source. In one aspect, the local power source may be activated in a galvanic mode when the local power source contacts a conductive fluid, which may include a conductive liquid, a gas, a mist, or any combination thereof. The wireless energy source 11 and the local power source may be activated individually or in combination. Thus, system 20 may operate in a wireless mode, a galvanic mode, or a combination thereof. The system 20 may be used in a variety of different applications, including as a component of an ingestible identifier, such as an IEM, for example, a pharmaceutical composition with medical information functionality.

The marker system 22 includes: a control device 24 for varying the conductivity; and a local power source comprising a first conductive material 26 electrically coupled to the control device 24 and a second conductive material 28 electrically coupled to the control device and electrically isolated from the first material 26. The first conductive material 26 and the second conductive material 28 are selected to provide a potential difference when in contact with a conductive fluid. The control device 24 changes the electrical conductivity between the first conductive material 26 and the second conductive material 28 such that the magnitude of the electrical current is changed to encode information. As described with reference to fig. 1, optionally, power management circuit 14 may be used to adapt its inputs to energy harvester 12 and its outputs to a load, such as an identifier system 22. Control device 24 includes control logic that can operate in a wireless mode or a galvanic mode to modulate the voltage on first conductive material 26 and second conductive material 28 to convey information. The modulated voltage may be detected by respective first and second capacitive coupling plates of a reader positioned outside of system 20. In one aspect, system 20 may include additional capacitive plates formed of similar or different conductive materials that operate to convey information related to system 20.

Fig. 3 illustrates one aspect of a system 30 including a wireless energy source 31 similar to the wireless energy sources 11, 21 of fig. 1 and 2 and a marker system 32 for indicating the occurrence of an event. The wireless energy source 31 energizes the control means in a wireless mode. The wireless energy source 31 comprises an energy harvester 12 to convert energy of one form received at its input into energy of another form at its output. In various aspects, the output energy is in the form of a potential difference. Optionally, the wireless energy source may include a power management circuit 14 (shown in phantom to indicate that it is optional) for providing energy suitable for operating the circuitry of the marker system 16. The system 30 may be used in a variety of different applications, including as a component of an ingestible identifier, such as an IEM, for example, a pharmaceutical composition with medical information functionality.

In the aspect concerned, the system 30 comprises a hybrid energy source comprising a wireless energy source 31 and an onboard power source 35, such as a microbattery or an ultracapacitor. The wireless energy source 31 is coupled to an on-board power source 35 and is operable to power the marker system 30 in a wireless mode. In one aspect, the microbattery may be a thin film integrated battery fabricated directly in an IC package in any shape or size. In another aspect, a thin film rechargeable battery or a supercapacitor can be designed and implemented to bridge the separation between the battery and a conventional capacitor. In a design implementation incorporating a rechargeable thin film microbattery or supercapacitor, the wireless energy source 31 may be used to charge or recharge the battery or supercapacitor. Thus, the wireless energy source 31 may be used to minimize energy loss from the on-board power supply 35.

The marker system 32 includes: a control device 34 for varying the conductivity; and a local power supply including a first capacitive plate 36 electrically coupled to the control device 34 and a second capacitive plate 38 electrically coupled to the control device and electrically isolated from the first capacitive plate 36. The control device 34 changes the conductivity between the first capacitive plate 36 and the second capacitive plate 38 such that the magnitude of the current is changed to encode information. The wireless energy source 31 is coupled to the control device 34 to supply power to the circuitry of the marker system 32 independently of or in conjunction with an onboard power source 35. As described with reference to fig. 1 and 2, optionally, the input of the power management circuit 14 may be adapted to the output of the energy harvester 12 and the output of the power management circuit 14 may be adapted to a load, such as the identifier system 32. Control device 34 includes control logic that operates to modulate the voltage on first conductive plate 36 and second conductive plate 38, thereby modulating the information to be transmitted. The voltage modulated onto the first and second conductive plates 36, 38 may be detected by the respective first and second capacitive coupling plates of the reader. First capacitor plate 36 and second capacitor plate 38 may be formed of similar or different materials.

In the aspect to which fig. 1-3 relate, the power management circuit 14 is shown in dashed lines to indicate that it is optional. Power management circuitry 14 may be used to condition, boost or adjust the energy harvested by energy harvester 12 to provide a source of dc power in the form of electrical potential, such as a battery, suitable for operating the circuitry of systems 16, 22, 32. It should be understood that any of the components or elements of the systems 16, 22, 32 may be used alone or in combination in other systems within the scope of the present disclosure.

In various aspects of the systems 10, 20, 30 described in connection with fig. 1-3, the circuitry of the energy harvester 12, the power management circuit 14, and the identifier systems 16, 22, 32 may be integrated into one or more ICs. In operation, when activated in a wireless or streaming mode, the system 10, 20, 30 operates to indicate the occurrence of an event. The information communicated may be the same, although different communication modes may be employed. In wireless mode, information may be transmitted as a series of pulses at a rate of 10-20Hz and may be phase modulated at 1 kHz. Information may be encoded using a variety of techniques, such as Binary Phase Shift Keying (BPSK), Frequency Modulation (FM), Amplitude Modulation (AM), on-off keying, and PSK with on-off keying. In a particular aspect, the systems 10, 20, 30 and/or the marker systems 16, 22, 32 may include onboard RAM. The information may include an identification number, information contained in onboard RAM (such as medication, date code), and date of manufacture. In one aspect, information may be communicated by modulating a voltage on a plate formed on a top surface of an IC relative to a substrate voltage of the IC. A capacitively coupled reader may be used to detect the modulated voltage (e.g., as shown in fig. 23, 24).

Further, any of the marker systems 16, 22, 32 described in connection with respective fig. 1-3 may be implemented to include in-vivo devices, such as IEMs that may be powered in multiple modes and communicate information to the outside of the body using multiple techniques. By way of example and not limitation, in one aspect, an IEM may be energized by generating an external (extracorporeal) potential and an internal (intracorporeal) potential at different points in time and responding to such external and internal potentials by communicating with at least one external device located intracorporeally or partially located intracorporeally or extracorporeally. In another aspect, the IEM may generate different levels of electrical potential through external and internal energization elements (e.g., energy harvesters including wireless energy sources, internal galvanic energy systems, micro-batteries, or super-capacitors), and communicate with external devices in response to such generated different levels of electrical potential. In another aspect, the IEM may generate energy from an external source and store the generated energy in, for example, a capacitor or a super capacitor, where the IEM may use the stored energy for communication with an external device after a delay. In yet another aspect, the IEM may be energized by external or internal sources located at different locations within the body, such as, for example, the esophagus, stomach, lower portion of the intestine, colon, etc. In another aspect, the IEM may selectively employ external energy and internal energy to communicate with different external devices at different points in time. In various aspects, the IEM may communicate with different external devices, such as a patch or other receiver placed in a watch, necklace, or external location. Examples of external devices that can communicate with IEMs are described in commonly assigned U.S. patent application publication No. 2010/0312188 (serial No. 12/673326) entitled "Body-Associated Receiver and Method" filed on 12/15 of 2009, U.S. patent application publication No. 2008/0284599 (serial No. 11/912475) entitled "pharmaceutical-information systems" filed on 28/4 of 2006, and U.S. patent application publication No. 2009/0227204 (serial No. 12/404184) entitled "pharmaceutical-information systems" filed on 3/13 of 2009, each of which is incorporated herein by reference in its entirety. In yet another aspect, when the IEM is powered on in any of the modes described above, the IEM may only receive control commands for its activation from any external device and/or internal device.

Fig. 4 illustrates one aspect of a wireless energy source 41 comprising an energy harvester 12 configured to harvest electromagnetic energy from an environment in the form of optical radiation and a power management circuit 14. Energy harvester 12 includes a light energy conversion element, such as a photodiode 42, configured to convert incident radiant electromagnetic energy in the form of light 44 photons into electrical energy. The particular photodiode 42 may be selected to optimally respond to the wavelength of the incident light 44, which may range from the visible spectrum to the invisible spectrum. As used herein, the term radiant electromagnetic energy refers to light in the visible spectrum or invisible spectrum in the frequency range from ultraviolet to infrared.

As shown in fig. 4, when light 44 strikes the P-N junction of the photodiode 42, a current or voltage is generated by the photodiode 42 depending on the mode of operation. In the aspect concerned, the photodiode 42 is reverse biased and a current i flows from the photodiode 42 into the charge pump 46 circuit that is proportional to the amount of light 44 striking the photodiode 42. The charge pump 46 may be implemented in a variety of configurations. Essentially, a charge pump is one type of DC-DC converter that uses a capacitor as an energy storage element to form a higher (boost) voltage power supply. The charge pump 46 circuit is relatively simple and capable of achieving high efficiencies (up to 90-95%), making it a satisfactory solution for boost applications.

The charge pump 46 utilizes some form of switching device to control the connection of the voltage to the capacitor. To generate higher voltages, the first stage involves connecting a capacitor across the voltage to charge the capacitor. In the second stage, the capacitor is disconnected from the original charging voltage and its negative terminal is reconnected to the original positive charging voltage. Since the capacitor holds the voltage stored across the capacitor (neglecting leakage effects), the positive terminal voltage is added to the original voltage, which effectively doubles the voltage. The pulse nature of the higher voltage output is typically smoothed by the use of an output capacitor. Accordingly, the charge pump 46 converts the current i generated by the photodiode 42 into the output voltage Vo. The charge pump 46 may have any suitable number of stages to raise the input voltage to any suitable level. The control circuit 49 controls the operation of the switching devices to coordinate the connection of the voltages to the capacitors of the charge pump 46 to produce an output voltage Vo suitable for operating the circuitry of the marker systems 16, 22, 32 of fig. 1-3.

The DC-DC converter may be a boost converter or a charge pump. To achieve high efficiency, most conventional DC-DC converters employ an external inductor. Since it is difficult to fabricate large value inductors with many windings using monolithic or planar microfabrication processes, the charge pump is easier to match integrated circuit implementation because capacitors are used instead of inductors. This enables efficient DC-DC conversion. Alternative configurations of DC-DC converters using switched capacitors are numerous. Such DC-DC converters include, but are not limited to, voltage doublers, Dickson charge pumps, cyclo-converters, and Fibonacci converters, among others.

A voltage regulator 48 may optionally be coupled to the charge pump 46. The voltage regulator regulates the output voltage Vo of the charge pump 46 and generates a voltage V relative to the substrate₂Regulated output voltage V₁. Potential (V)₁-V₂) Suitable for operating the circuitry of any of the systems 16, 22, 32 of fig. 1-3. In various aspects, the charge pump 46 may be replaced with any suitable boost circuit, such as a boost regulator, flyback, step (boost) or forward converter. In other aspects, the charge pump 46 may be replaced with a DC-DC converter type booster circuit.

In one aspect, the photodiode 42 may be a conventional photodiode, a PIN photodiode, or a Complementary Metal Oxide Semiconductor (CMOS) PN diode. The photodiode may be a monolithic element fabricated using semiconductor materials such as silicon (Si), silicon nitride (SiNi), indium gallium arsenide (InGaAs), and other semiconductor materials. Although shown as a single component, the photodiode 42 may include multiple photodiodes connected in series and/or parallel depending on the particular design and implementation. In various aspects, the photodiode 42 may be implemented with a diode or a phototransistor. In other aspects, the photodiode 42 may be replaced with a photovoltaic cell that produces a voltage proportional to the incident light 44 that impinges on its surface. The charge pump 46 circuit may be used to raise the voltage output of the photovoltaic cells to a level suitable for operating the circuitry of the marker system 12, 22, 32.

In various aspects, the photodiode 42 may be integrated with the IC portion of the system 10, 20, 30; laminated on the surface of IC; or to the side edges of the IC or current path extensions. A light aperture may be formed on the system 10, 20, 30IC to allow incident light 44 to strike the P-N junction of the photodiode 42. The MEMS process may be used to shield other areas of the system 10, 20, 30 from incident light 44.

In the case where the underlying energy harvester 12 process employs optical radiation technology, a light source having a predetermined spectral composition and illumination level may be used to generate a light beam to impinge upon the photodiode 42 element of the energy harvester 12 in a precise manner such that the charge pump 46 directly produces the appropriate voltage output. Where the underlying energy harvester 12 process employs a vibration/motion technique, a source of vibration or motion energy may be used to drive the energy harvester 12. Likewise, where the underlying energy harvester 12 process employs thermal energy technology, a source of thermal energy may be used to create a temperature gradient that may be converted to an appropriate electrical potential. Similarly, where the following process of energy harvester 12 employs RF radiation techniques, a source of RF energy having a predetermined frequency and power level may be used to generate an electromagnetic beam to drive an input element of energy harvester 12, such as, for example, a coil or antenna. These and other techniques are described in more detail below.

Fig. 5 illustrates an aspect of a system 50 that employs an optical radiation-based energy harvesting technique. A light source 53, located remotely from the wireless energy source 51, includes a light emitting element 55 configured to emit light 54 at a predetermined wavelength and power level. The radiated light 54 is detected by a light energy conversion element of the energy harvester 12, such as a photodiode 52 similar to the photodiode 42 of fig. 4. In the aspect concerned, the photodiode 52 is reverse biased and a current i (or voltage, depending on the mode of operation) proportional to the amount of light 54 striking the photodiode 52 is converted to a potential (V1-V2) by the power management circuit 14 and stored in the capacitor 57.

The light-emitting element 55 can be a light-emitting diode (LED), a laser diode, a laser, or any source capable of generating radiant energy of light 54 at a wavelength (or frequency) and power level suitable for generating an appropriate current i through the photodiode 52. In various aspects, the light emitting elements 55 can be designed and implemented to generate light 54 of wavelengths in the visible spectrum and/or the invisible spectrum, including light 54 of wavelengths in the range from ultraviolet to infrared wavelengths. In one aspect, the light source 53 may be configured to radiate light at a single monochromatic wavelength. Those skilled in the art will appreciate that the light source 53 may include one or more light-emitting elements 55, and that the one or more light-emitting elements 55 may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum when energized by an electrical power source. In such aspects, the light source 53 may be configured to radiate light composed of a mixture of multiple monochromatic wavelengths.

The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is the portion of the electromagnetic spectrum that is visible to the human eye (e.g., detectable by the human eye) and may be referred to as visible light or simply light. A typical human eye may respond to wavelengths in air from about 380nm to about 750 nm. The visible spectrum is continuous and there are no distinct boundaries between one color and adjacent colors. The following ranges may be used as approximations of the color wavelengths:

purple: about 380nm to about 450 nm;

blue: about 450nm to about 495 nm;

green: about 495nm to about 570 nm;

yellow: about 570nm to about 590 nm;

orange: about 590nm to about 620 nm; and

red: about 620nm to about 750 nm.

The invisible spectrum (i.e., the non-luminescent spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (e.g., below about 380nm and above about 750 nm). The invisible spectrum cannot be detected by the human eye. Wavelengths greater than about 750nm are longer than the red visible spectrum and they become invisible infrared, microwave and radio electromagnetic radiation. Wavelengths less than about 380nm are shorter than the violet spectrum and they become invisible ultraviolet, x-ray and gamma ray electromagnetic radiation.

In various other aspects, the light emitting element 54 can be a source of radiant electromagnetic energy in the form of X-rays, microwaves, and radio waves. In such aspects, energy harvester 12 may be designed and implemented to be compatible with the particular type of radiant electromagnetic energy emitted by source 53.

Fig. 6 illustrates one aspect of a system 60 employing an energy harvesting technique based on modulated optical radiation. The light source 63, which is located remotely from the wireless energy source 61, includes a light emitting element 65 similar to the light emitting element 55 of fig. 5, which light emitting element 65 emits light 64 at a particular wavelength and power level. The light 64 is modulated by a switch 66 and radiated at the frequency of the control signal. The modulated light 64 is detected by a light energy conversion element, such as a photodiode 62 similar to the photodiode 52 of fig. 5. An Alternating Current (AC) current i (or voltage, depending on the mode of operation) proportional to the amount of light 64 striking the photodiode 62 is provided to an AC/DC converter 66, where the current i is converted to a potential (V1-V2) and stored in a capacitor 67. The frequency of the AC current i is substantially equal to the frequency of the control signal.

In one aspect, information may be communicated from the system 60 by modulating the photodiode 62 with light 64 modulated by a switch 66 and radiated at the frequency of the control signal. For example, when the system 60 is used as an ingestible identifier, such as, for example, an IEM or a component of a pharmaceutical composition with medical information functionality, information may be communicated from the system 60 by modulating the photodiode 62 with light 64 radiated to the photodiode 62 at the frequency of the control signal. In another aspect, a switch similar to switch 66 may be placed in series with photodiode 62 to modulate the photodiode with a control signal to communicate information from system 60.

Fig. 7 is a schematic view of a vibration/motion system 70 that may be employed in the vibrational energy harvester described herein in connection with fig. 8-11. The vibration/motion system 70 is a model for understanding the general concept of converting vibration or motion energy into electrical energy. Known sensor mechanisms for converting vibration/motion energy into electrical energy are electrostatic, piezoelectric or electromagnetic. In the electrostatic sensor, the polarization capacitor generates an AC voltage when the distance or overlap of the two electrodes of the polarization capacitor changes due to movement or vibration of one movable electrode relative to the other. In a piezoelectric sensor, a voltage is generated when vibration or movement causes a piezoelectric capacitor to deform. Finally, in an electromagnetic sensor, when the movable magnet moves relative to the coil causing a change in magnetic flux, an AC voltage is generated across (or an AC current is induced through) the coil.

Still referring to fig. 7, the vibration/motion system 70 includes a sensor inserted into an inertial frame 71. One part of the sensor is fixed to the frame 71 and the other part (if free) moves with the vibration/motion input. The frame 71 is coupled to a vibration source or motion source and the relative motion of the two parts of the sensor moves according to the law of inertia. The system 70 depicted in fig. 7 is resonated by attaching the movable body 72 to the spring 74. In other aspects, a non-resonant system that does not use springs may be employed. The vibration/motion system 70 based energy harvester can be considered a velocity damped bulk 72 spring 74 system, where Z (t) represents the motion of the bulk 72, d is the damper 76 coefficient due to air resistance, friction, and the like, K is the suspended spring 74 constant, m is the mobile 72, and y (t) is the amplitude of the frame 71 movement in the Z direction. In addition, there may be damping due to the conversion of mechanical energy by the generator 79 into electrical energy Vg to the load 79. It should be appreciated that electrical power can be maximized by equalizing the generator with parasitic damping.

Electrostatic and piezoelectric vibration/motion based energy harvesters can be fabricated using micromachining processes, such as MEMS processes. When large inductors (coils) with sufficient windings for efficient electromagnetic conversion are used, which are not necessarily compatible with monolithic or planar microfabrication processes, a combination of micromachining and machining techniques may be used to fabricate the electromagnetic energy harvesting device. Alternatively, small value inductors may be fabricated on an integrated circuit using the same process used to fabricate the transistors. The integrated inductor may be arranged in a spiral coil pattern with aluminum interconnects. The small size of the integrated inductor limits the inductance values achievable in the integrated coil. Another option is to use a "gyrator" which uses capacitors and active components to create an electrical behavior similar to an inductor.

Fig. 8 illustrates one aspect of a system 80 comprising a wireless energy source 81 as described in connection with fig. 7, the wireless energy source 81 comprising an energy harvester 12, the energy harvester 12 comprising an electrostatic energy conversion element that converts vibrational/kinetic energy into electrical energy. In the aspect of fig. 8, the electrostatic energy conversion elements of energy harvester 12 utilize electrostatic energy conversion technology to convert vibrational/kinetic energy into electrical energy. The energy harvester 12 sensor includes an inertial frame 84, the inertial frame 84 including the first electrode 82_aAnd a second electrode 82_bThe polarization capacitor 82. First capacitor electrode 82_aConnected to a movable element 86 (which is schematically shown as a spring having a spring constant K), the movable element 86 is free to move in response to a vibration/motion input y (t). First capacitor electrode 82_aIs denoted by z (t). Second electrode 82_bIs fixed to the frame 84 and does not move relative to the frame 84. When the first electrode 82_aAnd a second electrode 82_bResponsive to the first capacitor electrode 82_aWhen the motion z (t) or vibration changes, the polarization capacitor 82 generates an AC current i (t).

The AC/DC converter 86 of the power management circuit 14 converts the AC capacitor current i (t) to a potential suitable for operating the circuitry of the respective marker system 16, 22, 32 of fig. 1-3. The AC/DC converter includes a rectification circuit to rectify an AC input into a DC output. DC level shifters and voltage regulation circuits may also be included in the AC/DC converter 86 to provide potentials (V1-V2) appropriate for the marker systems 16, 22, 32. Although the AC/DC converter 86 may employ diodes in the rectifier portion, higher efficiency may be achieved by replacing the diodes with transistor switches, since the transistors have lower voltage drops and thus facilitate more efficient rectification. The capacitor 87 smoothes the output voltage and acts as an energy storage device.

Fig. 9 illustrates one aspect of a system 90 comprising a wireless energy source 91 as described in connection with fig. 7, the wireless energy source 91 comprising an energy harvester 12, the energy harvester 12 comprising a piezoelectric-to-electric energy conversion element that converts vibrational/kinetic energy into electrical energy. In the aspect of fig. 9 to which reference is made, the piezoelectric energy conversion element of the energy harvester 12 sensor mechanism utilizes piezoelectric energy conversion technology to convert vibrational/kinetic energy into electrical energy. The energy harvester 12 sensor includes an inertial frame 94, the inertial frame 94 including a first electrode 92_aAnd a second electrode 92_bThe piezoelectric capacitor 92. When piezoelectric capacitor 92 deforms in response to vibration/motion input y (t), piezoelectric sensor 92 generates AC voltage v (t). The power management circuit 14 includes an AC/DC converter 96 similar to the AC/DC converter 86 of fig. 8 to convert the AC voltage v (t) at its input to a potential at its output suitable for operating the circuitry of the respective marker systems 16, 22, 32 of fig. 1-3. The capacitor 97 smoothes the output voltage and acts as an energy storage device.

Fig. 10 is a schematic diagram of the piezoelectric type capacitor 100 elements of a wireless energy source configured to operate according to the vibration/motion energy harvesting principles described in fig. 7. The piezoelectric capacitor 100 includes: a body 102, the body 102 acting as an inertial frame; and a cantilever 104 having one end fixed to the body 102 and a second end free to move in response to the vibration/motion input y (t). The cantilever 104 may be designed and implemented to have a predetermined spring constant. The cantilever 104 includes a thin layer of piezoelectric material 106 formed on its surface. When the cantilever 104 moves in response to the vibration/motion input Y (t), the cross-electrode 108_aAnd 108_bGenerating an AC voltage v (t). May be passed through an AC/DC converter 86 similar to that of FIGS. 8 and 9, respectively,The AC/DC converter of 96 converts the AC voltage to an appropriate DC potential.

Fig. 11 illustrates an aspect of a system 110 comprising a wireless energy source 111 as described in connection with fig. 7, the wireless energy source 111 comprising an energy harvester 12, the energy harvester 12 comprising an electromagnetic energy converting element that converts vibrational/kinetic energy into electrical energy. In aspects related to fig. 11, the electromagnetic energy conversion elements of the energy harvester 12 sensor mechanism utilize electromagnetic energy conversion technology to convert vibrational/kinetic energy into electrical energy. The energy harvester 12 sensor includes an inertial frame 114 containing a fixed coil 112 (e.g., an inductor) and a movable magnet 114 (e.g., a magnet). The magnet 114 has a first end fixed to the spring element 116 and a free second end. When the movable magnet 114 moves relative to the fixed coil 112 and causes a change in magnetic flux, an AC current i (t) (or voltage, depending on the particular implementation) is generated by the coil 112. In other aspects, an AC voltage v (t) is generated across the coil 112 when the movable magnet 114 moves relative to the coil 112 and causes a change in magnetic flux. It should be appreciated that in other aspects, the magnet 114 may be fixed and the coil 112 may be movable.

An AC/DC converter 116, similar to the AC/DC converters 86, 96 of respective fig. 8 and 9, converts the AC current i (t) or voltage v (t) at its input to an electrical potential at its output suitable for operating the circuitry of the respective marker system 16, 22, 32 of fig. 1-3. The capacitor 117 smoothes the output voltage and acts as an energy storage device.

Fig. 12 illustrates one aspect of a system 120 comprising a wireless energy source 121, the wireless energy source 121 comprising an energy harvester 12, the energy harvester 12 comprising an acoustic energy transducing element. In the aspect of fig. 12 concerned, the acoustic energy transducing element of the energy harvester 12 sensor mechanism transduces acoustic energy into electrical energy. The piezoelectric transducer 128 is configured to detect the acoustic waves 127 generated by the acoustic source 122. The acoustic source 122 includes an oscillator and speaker 126. The oscillator 124 drives a speaker 126 at a predetermined frequency. Depending on the design and implementation of the system 120, the frequencies may be in the audible band or the ultrasonic band. The piezoelectric transducer 128 detects the acoustic wave 127 generated by the acoustic source 122. A voltage proportional to the acoustic pressure incident on the piezoelectric sensor 128 is generated across the piezoelectric sensor 128. The voltage is converted by the power management circuit 14 to a potential suitable for operating the circuitry of the respective marker system 16, 22, 32 of fig. 1-3. As described in connection with fig. 8, 9, and 11, the power management circuit 14 may be an AC/DC converter. The capacitor 129 smoothes the output voltage and acts as an energy storage device.

Fig. 13 illustrates one aspect of a system 130 comprising a wireless energy source 131, the wireless energy source 131 comprising an energy harvester 12, the energy harvester 12 comprising an RF energy converting element. In the aspect of fig. 13 concerned, the RF energy conversion elements of energy harvester 12 convert RF energy into electrical energy. Energy harvester 12 includes an antenna 132 to receive RF energy. The power management circuit 14 includes an RF converter 134 coupled to the input antenna 132. The RF converter 134 converts the RF radiation received by the input antenna 132 into a voltage Vo. The voltage Vo is provided to the voltage regulator 136 to regulate the output potential (V1-V2). A capacitor 138 is coupled to the output of the voltage regulator 136. Capacitor 138 smoothes the output voltage and acts as an energy storage device.

The RF source 133 is configured to generate an RF waveform. An oscillator 135 may be used to generate the frequency of the RF waveform. The output of the oscillator 135 is coupled to an amplifier 137, which amplifier 137 determines the power level of the RF waveform. The output of amplifier 137 is coupled to an output antenna 139, which output antenna 139 generates an electromagnetic beam to drive the input antenna 132 of energy harvester 12. In one aspect, the input antenna 132 may be an integrated circuit antenna.

Fig. 14 illustrates one aspect of a system 140 comprising a wireless energy source 141, the wireless energy source 141 comprising an energy harvester 12, the energy harvester 12 comprising a thermoelectric energy conversion element. In one aspect, the thermoelectric energy harvesting may be based on the Seebeck (Seebeck) effect. In other aspects, thermoelectric energy harvesting may be based on the Peltier (Peltier) effect. In the aspect of fig. 14, the thermoelectric energy conversion elements of the energy harvester 12 convert thermal energy to electrical energy. Energy harvester 12 includes a thermocouple 142, a junction that produces a voltage between two different metals that is related to the temperature difference. The thermocouple 142 may be used to convert thermal energy to electrical energy. Any junction of different metals will produce a temperature dependent potential. Thermocouples are junctions of specific alloys that have a predictable and reproducible relationship between temperature and voltage. Different alloys may be used for different temperature ranges. In case the measuring point is far away from the measured wireless energy harvester 12, the intermediate connection can be made by means of an extension line.

The power management circuit 14 includes a charge pump 144 similar to the charge pump 46 of fig. 4. The charge pump 144 boosts the voltage Vt generated by the junction of the thermocouple 142 and generates an output voltage Vo. The charge pump 144 may have any suitable number of stages to raise the input voltage to a suitable level. The control circuit 146 controls the operation of the switching device that controls the connection of the voltage to the capacitor of the charge pump 144 to generate the output voltage Vo. The output voltage Vo is provided to a voltage regulator 148 to regulate the output voltage V1 to a voltage suitable for operating the circuitry of the marker systems 16, 22, 32 of fig. 1-3. The capacitor 149 smoothes the output voltage and acts as an energy storage device. Any suitable heat source (e.g., hot or cold) may be used to drive the system 140.

Fig. 15 illustrates one aspect of a system 150 comprising a wireless energy source 151, the wireless energy source 151 comprising an energy harvester 12, the energy harvester 12 comprising a thermoelectric energy conversion element similar to that described in connection with fig. 14. In the aspect of fig. 15, the thermoelectric energy conversion elements of the energy harvester 12 convert thermal energy to electrical energy. Energy harvester 12 includes a thermopile 152, an electronic device that converts thermal energy to electrical energy. The thermopile 152 includes a plurality of thermocouples connected in series. In other aspects, the thermocouples may be connected in parallel. The thermopile 152 generates an output voltage Vt that is proportional to the local temperature difference or gradient.

The power management circuit 14 includes a charge pump 154 similar to the charge pump 144 of fig. 14. The charge pump 154 boosts the voltage Vt generated by the thermopile 152 and generates an output voltage Vo. The control circuit 156 controls the operation of the switching device that controls the connection of the voltage to the capacitor of the charge pump 154 to generate the output voltage Vo. The output voltage Vo is provided to a voltage regulator 158 to regulate the output voltage V1 to a voltage suitable for operating the circuitry of the marker systems 16, 22, 32 of fig. 1-3. The capacitor 159 smoothes the output voltage and acts as an energy storage device. Any suitable heat source (e.g., hot or cold) may be used to drive the system 150.

Having described various aspects of a system including a wireless energy source based on the principles of light energy, vibration/motion energy, acoustic energy, RF energy, and thermal energy conversion, the present disclosure now turns to one example application of the system 20 described in connection with fig. 2. Briefly, the system 20 of FIG. 2 includes a wireless energy source 21 and a marker system 22 for indicating the occurrence of an event. The system 20 includes a hybrid energy source that includes the wireless energy source 11 and a local power source in the marker system 22 that can be activated to indicate an event when the first and second conductive materials 26, 28 provide a potential difference upon contact with a conductive fluid (which can include a conductive liquid, gas, mist, or any combination thereof). In the aspect to which fig. 2 relates, the event may be flagged by activation of the wireless energy source 21 or by contact between the conductive fluid and the system 20, and more specifically by contact between the marker system 22 and the conductive fluid.

In one aspect, the system 20 may be used with a pharmaceutical product and the indicated event is when the product is taken or ingested. The term "ingested" or "ingestion" is understood to mean any introduction of the system 20 into the body. For example, being ingested involves simply placing the system 20 in the mouth up to the descending colon. Thus, the term being ingested refers to any instant 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 this case, the system 20 may be present in a non-conductive fluid, and when the two fluids are mixed, the system 20 contacts the conductive fluid and activates the system. Yet another example may be when it is desired to detect the presence of a particular conductive fluid. In such examples, the presence of the activated system 20 within the conductive fluid, and thus the presence of the corresponding fluid, may be detected.

Referring now to fig. 2 and 16, the system 20 is used with a product 164 ingested by a living organism. When the product 164 including the system 20 is ingested, the system 20 is in contact with the conductive body fluid. When the system 20 of the present disclosure comes into contact with a body fluid, an electrical potential is formed and the system 20 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, as described in detail below.

Referring now to fig. 16, one aspect of an ingestible product 164 that includes a system for indicating the occurrence of an event is shown in vivo. The system includes a wireless energy source that includes an energy harvester and power management circuitry as described above for delivering wireless power to the electronic components of the system. In the aspect concerned, the product 164 is configured as an orally ingestible pharmaceutical formulation in the form of a pill or capsule. Upon ingestion, the pill moves to the stomach. Upon reaching the stomach, the product 164 contacts the gastric fluid 168 and undergoes chemical reactions with various substances in the gastric fluid 168, such as hydrochloric acid and other digestive agents. The system is described with reference to a pharmaceutical environment. However, the scope of the present disclosure is not limited thereto. The product 164 and system according to the present disclosure may be used in any environment where a conductive liquid is present or becomes present by creating a mixture of two or more components of the conductive liquid.

Referring now to fig. 17A, a pharmaceutical product 170 is shown having a system 172, such as an IEM or also referred to as an ion emitting module. In the aspects involved, the system 172 is similar to the system 20 of fig. 2. In other aspects, the systems 10 and 30 of fig. 1 and 3, respectively, may replace the system 20 of fig. 2. Any such system 10, 20, 30 may include one or more of the wireless energy sources 51, 61, 81, 91, 111, 121, 131, 141, 151 of fig. 4-6, 8-9, and 11-15, respectively, described herein for activating the system 172 in a wireless mode. For the sake of brevity and clarity, however, only the system 20 of fig. 2 in combination with a pharmaceutical product will be described in detail. The scope of the present disclosure is not limited to the shape or type of the product 170. For example, one skilled in the art understands that product 170 can be a capsule, a sustained release oral dose, a tablet, a gel capsule, a sublingual tablet, or any oral dose product that can be combined with system 172. In the aspect concerned, the product 170 has a system 172, said system 172 being fixed to the outside by known methods of fixing microdevices to the outside of pharmaceutical products. Examples OF methods for securing a microdevice to a product are disclosed in U.S. provisional patent application No. 61/142,849 entitled "HIGH-THROUGHPUT product OF information EVENT MARKERS" filed on 6.1.2009 and U.S. provisional patent application No. 61/177,611 entitled "information methods AN IDENTIFIER AND AN information compositions" filed on 12.5.2009, each OF which is incorporated herein by reference in its entirety. Once ingested, the system 172 comes into contact with the body fluid and activates the system 172. In the streaming mode, the system 172 utilizes the potential difference to energize and then modulate the conductivity to form a unique and identifiable current signature. When activated, the system 172 controls conductivity and thus current to produce a current signature.

The system 172 includes a wireless energy source comprising any of the wireless energy harvester and the power management circuit according to any of the various aspects described herein. Thus, the system 172 may be energized by the wireless energy source without utilizing the conductive fluid to activate the system 172.

In one aspect, activation of the system 172 may be delayed for various reasons. To delay activation of the system 172, the system 172 may be coated with a shielding material or protective layer. The layer dissolves over a period of time, thereby allowing activation of the system 172 when the product 170 has reached the target location.

Referring now to fig. 17B, a pharmaceutical product 174 similar to the product 170 of fig. 17A is shown with a system 176, such as an IEM or identifiable emission module. The system 176 of fig. 17B is similar to the system 20 of fig. 2. In other aspects, the systems 10 and 30 of fig. 1 and 3, respectively, may replace the system 20 of fig. 2. Any such system 10, 20, 30 may include a wireless energy source as described herein. The scope of the present disclosure is not limited to the environment in which the system 176 is introduced. For example, the system 176 may be enclosed in a capsule that is administered in addition to/independent of the pharmaceutical product. The capsule may simply be a carrier for the system 176 and may not contain any product. Moreover, the scope of the present disclosure is not limited to the shape or type of the product 174. For example, one skilled in the art will appreciate that product 174 may be a capsule, a sustained release oral dose, a tablet, a gel capsule, a sublingual tablet, or any oral dose product. In a related aspect, product 174 has a system 176 positioned within product 174 or secured to the interior of product 174. In one aspect, system 176 is secured to an inner wall of product 176. When the system 176 is positioned within a gel capsule, 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 fluids, in an alternative aspect, the system 176 is coated with a protective layer to prevent the gel capsule contents from causing unwanted activation. If the contents of the capsule are dry powders or microspheres, system 176 is positioned or placed within the capsule. If product 174 is a tablet or hard pill, system 176 remains in place within the tablet. Once ingested, the product 174 containing the system 176 is dissolved. The system 176 contacts the body fluid and activates the system 176. Depending on the product 174, the system 176 may be positioned near the center or near the periphery depending on the desired activation delay between the initial intake time and the activation of the system 176. For example, a central location for system 176 means that system 176 takes longer to contact the conductive liquid and therefore takes longer to activate system 176. Therefore, it takes longer to detect the occurrence of an event.

The system 176 includes a wireless energy source (e.g., 51, 61, 81, 91, 111, 121, 131, 141, 151 of fig. 4-6, 8-9, and 11-15, respectively) comprising any of the wireless energy harvester and the power management circuit according to any of the various aspects described herein. Thus, the system 176 may be energized by the wireless energy source without activating the system 176 with a conductive fluid. For energy harvesting, capsules, sustained release oral doses, tablets, hard pills, gel capsules, sublingual tablets or any oral dosage product, non-conductive gel solutions, protective layer coatings, dry powders or microspheres may be selected so that they are compatible with the energy harvesting mechanism used. Specifically, for product 174, when system 176 is an optical system similar to systems 41, 50, and 60 of respective fig. 4-6, optically transparent apertures may be provided in product 174 to allow system 176 to function properly. It should be appreciated that optically transparent apertures may not be required if the product 174 is coated with an optically transparent gel or other coating.

Referring now to fig. 18, in one aspect, the systems 172 and 176 of fig. 17A and 17B, respectively, are shown in more detail as system 180. As described above, the system 180 may be used in association with any pharmaceutical product to determine when a patient is taking the pharmaceutical product. As noted above, the scope of the present disclosure is not limited to environments and products for use with system 180. For example, the system may be activated in a wireless mode by a wireless energy source, in a galvanic mode by placing the system 180 in the capsule and placing the capsule in a conductive fluid, or by a combination thereof. The capsule then dissolves over time and releases the system 180 into the conductive fluid. Thus, in one aspect, the capsule contains system 180 and no product. This capsule can then be used in any environment where an electrically conductive fluid is present and with any product. For example, the capsule may be dropped into a container filled with aviation fuel, saline, tomato sauce, motor oil, or any similar product. In addition, the capsule containing system 180 may be ingested at the same time any pharmaceutical product is ingested to record the occurrence of an event, such as when the product was taken.

As described above with reference to fig. 17A, 17B, the system 180 includes a wireless energy source that includes any of the wireless energy harvester and power management circuits described herein. Thus, the system 180 can be powered in a wireless mode by the wireless energy source without activating the system 180 in a galvanic mode by exposing the system to a conductive fluid. Alternatively, the system 180 may be energized in a galvanic mode by merely exposing the system 180 to a conductive fluid or may be energized in both a wireless mode and a galvanic mode. In other aspects, the system 180 can be activated in a combination of wireless mode and galvanic mode. When system 180 is activated in wireless mode, system 180 operates to communicate information related to system 180. The information may be used to diagnose the system 180, verify its operation, detect its presence, and test its functionality. In other aspects, the system operates to communicate unique features associated with the system 180.

In the particular example of the system 180 being combined with a pharmaceutical product, the system 180 is activated in a galvanic mode when the product or pill is ingested. The system 180 controls the conductivity to produce a unique current signature that is detected, thereby indicating that the drug product has been administered. When activated in the wireless mode, the system controls the modulation of the capacitive plates to produce a unique voltage signature detected in connection with the system 180.

In one aspect, the system 180 includes a frame 182. Frame 182 is the chassis of system 180 and the various components are attached to, deposited on, or secured to frame 182. In the present aspect of the system 180, the digestible material 184 is physically associated with the framework 182. The material 184 may be chemically deposited, evaporated, fixed, or built up on the frame, all referred to herein as "deposited" relative to the frame 182. Material 184 is deposited on one side of frame 182. Materials of interest that can be used as the material 184 include, but are not limited to: cu or Cul. The material 184 is deposited by physical vapor deposition, electrodeposition or plasma deposition, among other schemes. The material 184 may be about 0.05 μm to about 500 μm thick, such as from about 5 μm to about 100 μm thick. The shape is controlled by shadow mask deposition or photolithography and etching. Further, while only one area for depositing material is shown, each system 180 may contain two or more electrically distinct areas where material 184 may be deposited, as desired.

Another digestible material 186 is deposited on a different one of the opposite sides as shown in fig. 18 such that the materials 184 and 186 are different. Although not shown, the different side selected may be the side immediately adjacent to the side selected as material 184. The scope of the present disclosure is not limited to the selected side, and the term "different side" may mean any of a plurality of sides that are different from the first selected side. Further, while the shape of the system is shown as square, the shape may be any geometrically suitable shape. Materials 184 and 186 are selected such that a potential difference is created when system 180 is contacted by a conductive liquid, such as a body fluid. Materials of interest for material 186 include, but are not limited to: mg, Zn or other electronegative metals. As noted above with respect to material 184, material 186 may be chemically deposited, evaporated, affixed, or built up on the frame. In addition, an adhesive layer may be required to help adhere material 186 (and material 184 (when needed)) to frame 182. Typical adhesion layers for material 186 are Ti, TiW, Cr, or similar materials. The anode material and adhesion layer may be deposited by physical vapor deposition, electrodeposition, or plasma deposition. The material 186 may be from about 0.05 μm to about 500 μm thick, such as from about 5 μm to about 100 μm thick. However, the scope of the present disclosure is not limited to any material thickness and type of process used to deposit or secure the material to the frame 182.

Materials 184 and 186 may be any pair of materials having different electrochemical potentials in accordance with the illustrated disclosure. Further, in aspects where system 180 is used in vivo, materials 184 and 186 may be absorbable vitamins. More specifically, materials 184 and 186 may be made of any two materials suitable for the environment in which system 180 operates. For example, when used with an ingestible product, materials 184 and 186 are any pair of ingestible materials having different electrochemical potentials. Illustrative examples include when system 180 is exposed to an ionic solution such as gastric acid. Suitable materials are not limited to metals, and in particular aspects, pairs of materials are selected from metals and non-metals, for example, pairs consisting of a metal (such as Mg) and a salt (such as CuCl or Cul). For the active electrode material, any pair of substances-metals, salts or intercalation compounds-with suitably different electrochemical potentials (voltages) and low interfacial resistances is suitable.

Materials of interest and pairs of materials include, but are not limited to, the materials listed in table 1 below. In one aspect, one or both of the metals may be doped, e.g., non-metallic, to increase the potential formed between the materials when they are in contact with the conductive liquid. Non-metals that may be used as dopants in particular aspects include, but are not limited to: sulfur, iodine, and the like. In another aspect, the materials are copper iodide (Cul) as the anode and magnesium (Mg) as the cathode. Aspects of the present disclosure use electrode materials that are harmless to the human body.

Thus, when the system 180 contacts a conductive fluid, a current path is formed through the conductive fluid between the materials 184 and 186 (an example is shown in fig. 19). A control device 188 is secured to frame 182 and electrically coupled to materials 184 and 186. Control device 188 includes electronic circuitry, such as control logic capable of controlling and changing the conductivity between materials 184 and 186.

The resulting electrical potential between materials 184 and 186 provides the power for operating the system as well as generating an electrical current through the conductive fluid and system 180. In one aspect, system 180 operates in a dc mode. In an alternative aspect, the system 180 controls the direction of the current such that the direction of the current is reversed in a cyclic manner, similar to alternating current. When the system reaches the conducting fluid or electrolyte (where the fluid or electrolyte component is provided by physiological fluid, such as gastric acid), the current path between materials 184 and 186 is completed outside of the system 180; the current path through the system 180 is controlled by a control device 188. Completion of the current path allows current to flow, which in turn a receiver (not shown) can detect the presence of current and confirm that the system 180 has been activated and that the desired event is occurring or has occurred.

In one aspect, the two materials 184 and 186 function similarly to the two electrodes required for a direct current power source (such as a battery). The conductive liquid serves as the electrolyte needed to complete the power supply. The completed power source depicted is defined by the physicochemical reactions between the materials 184 and 186 of the system 180 and the surrounding bodily fluids. The completed power source can be viewed as a power source employing reverse electrolysis in ionic or conductive solutions such as gastric juices, blood or other body fluids, and some tissues. Further, the environment may be an environment other than the body and the liquid may be any conductive liquid. For example, the conductive fluid may be a saline or metal-based paint.

In a particular aspect, the two materials 184 and 186 are shielded from the surrounding environment by an additional layer of material. Thus, when the shield dissolves and the two different materials are exposed to the target site, an electrical potential is generated.

In a particular aspect, the complete power source or power supply is one made of active electrode material, electrolyte, and inactive material (such as current collector, package). The active material is any pair of materials having different electrochemical potentials. Suitable materials are not limited to metals, and in particular aspects, pairs of materials are selected from metals and non-metals, for example, pairs consisting of a metal (such as Mg) and a salt (such as cui). For the active electrode material, any pair of substances-metals, salts or intercalation compounds-with suitably different electrochemical potentials (voltages) and low interfacial resistances is suitable.

A variety of different materials may be used as the material forming the electrodes. In a particular aspect, the electrode material is selected to provide a voltage sufficient to drive the system of the marker when contacting the target physiological site (e.g., the stomach). In particular aspects, the voltage provided by the electrode material when the metal of the power source is in contact with the target physiological site is 0.001V or more, including 0.01V or more, such as 0.1V or more, for example 0.3V or more, including 0.5V or more and including 1.0V or more, wherein in particular aspects the voltage ranges from about 0.001V to about 10V, such as from about 0.01V to about 10V.

Referring again to fig. 18, materials 184 and 186 provide the electrical potential to activate control device 188. Upon activation or energization of the control device 188, the control device 188 may change the electrical conductivity between the first material 184 and the second material 186 in a unique manner. By varying the electrical conductivity between the first material 184 and the second material 186, the control device 38 is able to control the magnitude of the electrical current passing through the conductive liquid surrounding the system 180. This results in a unique current signature that can be detected and measured by a receiver (not shown) located either in vivo or in vitro. IN addition to controlling the size of the current path between the materials, the non-conductive material, film or "skirt" also serves to increase the "length" of the current path and thus the conductive path, as disclosed IN U.S. patent application No. 12/238,345 entitled "IN-BODY DEVICE WITH VIRTUAL medical amplitude location," filed on month 25 of 2008, the entire contents of which are incorporated herein by reference. Alternatively, throughout the disclosure herein, the terms "non-conductive material", "film" and "side edge" may be interchanged with the term "current path extender" without affecting the scope or the present aspect and claims herein. The side edges, shown at 185 and 187, respectively, may be associated with the frame 182, e.g., secured to the frame 182. Various shapes and configurations of the side edges are considered to be within the scope of the present disclosure. For example, the system 180 may be completely or partially surrounded by a skirt and the skirt may be positioned along a central axis of the system 180 or off-center with respect to the central axis. Accordingly, the scope of the present disclosure as claimed herein is not limited to the shape or size of the edges. Further, in other aspects, the materials 184 and 186 can be separated by one side edge positioned in any defined area between the materials 184 and 186.

In addition to the components described above, the system 180 also includes a wireless energy source 183 for activating the system 180 in a wireless mode. As previously described, the system 183 may be powered in a wireless mode, a galvanic mode, or a combination thereof. In the aspects involved, the wireless energy source 183 is similar to the wireless energy source 21 and more specifically to the wireless energy source 41 of fig. 4. In other aspects, the wireless energy source 183 may be implemented as any of the wireless energy sources 51, 61, 81, 91, 111, 121, 131, 141, 151 of fig. 4-6, 8-9, and 11-15, respectively.

Thus, as previously described, the wireless energy source 183 includes an energy harvester and power management circuitry configured to harvest energy from the environment using optical radiation techniques, as described in connection with fig. 4. The energy harvester includes a photodiode configured to convert incident radiant electromagnetic energy in the form of photons into electrical energy. The particular photodiode can be selected to optimally respond to the wavelength of incident light, which can range from the visible spectrum to the invisible spectrum. As used herein, the term radiant electromagnetic energy refers to light in the visible spectrum or invisible spectrum in the frequency range from ultraviolet to infrared. The charge pump DC-DC converter steps up the voltage level to be suitable for operating the control device 188 and activating the system in wireless mode. Once activated, control device 188 modulates the voltage across the capacitor plate element formed by first material 184 and second material 186 to convey information related to system 180. The modulated voltage may be detected by a capacitively coupled reader (not shown).

Referring now to fig. 19, a system 190 similar to the system 180 of fig. 18 (with the addition of sensor 199 elements coupled to a control device) is shown in an activated state and in contact with a conductive liquid. The system 180 is grounded through a ground contact 194. The system 180 also includes a sensor module 199, which will be described in more detail in conjunction with FIG. 20. An ion or current path 192 is established between the first material 184 to the second material 186 and through the conductive fluid of the contact system 180. The electrical potential formed between the first and second materials 184, 186 is formed by a chemical reaction between the first and second materials 184/186 and the conductive fluid. The surface of the first material 184 is not planar but is an irregular surface. The irregular surface increases the surface area of the material and thus the area in contact with the conductive fluid.

In one aspect, on the surface of the first material 184, there is a chemical reaction between the material 184 and the surrounding conductive fluid such that the mass is released into the conductive fluid. The term plastid as used herein refers to protons and neutrons that form a substance. One example includes an example where the material is CuCl, which becomes Cu (solid) and Cl-in solution when contacted with a conductive fluid. The flow of ions to the conductive fluid is represented by ion path 192. Similarly, there is a chemical reaction between the second material 186 and the surrounding conductive fluid and ions are trapped by the second material 186. The release of ions from the first material 184 and the capture of ions by the second material 186 are collectively referred to as ion exchange. The rate of ion exchange and hence the ion emission rate or flow is controlled by control device 188. The control device 188 may increase or decrease the rate of ion flow by changing the electrical conductivity (changing the impedance) between the first material 184 and the second material 186. By controlling ion exchange, system 180 can encode information during ion exchange. Thus, system 180 utilizes ion emission to encode information in ion exchange.

The control device 188 can change the duration of the fixed ion exchange rate or current magnitude while keeping the rate or magnitude near constant, similar to the case where the frequency is modulated and the amplitude is constant. In addition, the control device 188 may vary the ion exchange rate or level of current magnitude while maintaining the duration approximately constant. Thus, with various combinations of changes in duration and rates or magnitudes of change, the control device 188 encodes information in the current or ion exchange. For example, control device 188 may use, but is not limited to, any of binary Phase Shift Keying (PSK), Frequency Modulation (FM), Amplitude Modulation (AM), on-off keying, and PSK with on-off keying.

As noted above, various aspects disclosed herein, such as the system 180 of fig. 18, include an electronic component as part of the control device 188. Components that may be present include, but are not limited to: logic and/or memory components, integrated circuits, inductors, resistors, and sensors for measuring various parameters. Each component may be fixed to the frame and/or another component. The components on the surface of the stent may be arranged in any convenient configuration. Where two or more components are present on the surface of the solid support, an interconnect may be provided.

As noted above, the system 180 controls the conductivity between different materials and, thus, the rate or current of ion exchange. By varying the conductivity in a particular way, the system is able to encode information in the ion exchange and current characteristics. Ion exchange or current signatures are used to uniquely identify a particular system. In addition, the system 180 is able to generate various unique exchanges or features and thus provide additional information. For example, a second current characteristic based on a second conductivity change pattern may be used to provide additional information, which may be related to the physical environment. Further illustrated, the first current characteristic may be a current state that maintains an ultra-low current state of an oscillator on the chip, and the second current characteristic may be a current state at least ten times higher than a current state associated with the first current characteristic.

FIG. 20 is a block diagram display of the device 188 described in connection with FIGS. 18 and 19. The device 188 includes a control module 201, a counter or clock 202, and a memory 203. Further, device 188 is shown to include sensor module 206 as well as sensor module 199 referred to in fig. 19. The control module 201 has an input 204 electrically coupled to the first material 184 (fig. 18, 19) and an output 205 electrically coupled to the second material 186 (fig. 18, 19). The control module 201, clock 202, memory 203 and sensor module 206/199 also have power inputs (some not shown). In one aspect, when the system 190 contacts the electrically conductive fluid, the power for each of these components is supplied by the electrical potential generated by the chemical reaction between the first and second materials 184, 186 and the electrically conductive fluid. In another aspect, power for each of these components is supplied by the potential generated by the wireless energy source. The control module 201 controls the conductivity by logic that changes the overall impedance of the system 190. Control module 201 is electrically coupled to clock 202. Clock 204 provides clock cycles to control module 201. Based on the programmed characteristic of the control module 201, the control module 201 changes the conductivity characteristic between the first material 184 and the second material 186 when a set number of clock cycles have elapsed. This cycle is repeated and the unique current signature characteristic is thereby generated by the control device 188. The control module 201 is also electrically coupled to a memory 203. Both the clock 202 and the memory 203 are powered by the potential formed between the first material 184 and the second material 186.

Further, control module 201 is electrically coupled to sensor modules 206 and 199 and is in communication with sensor modules 206 and 199. In the illustrated aspect, the sensor module 206 is part of the control device 188 and the sensor module 199 is a separate component. In an alternative aspect, one of the sensor modules 206 and 199 may be used separately from the other. However, the scope of the present disclosure is not limited to the structural or functional location of the sensor module 206 or 199. Further, any components of the system 190 may be moved, combined, or repositioned functionally or structurally without limiting the scope of the present disclosure. Thus, there may be a single structure, such as a processor, designed to perform the functions of all of the following modules: control module 201, clock 202, memory 203, and sensor module 206 or 199. On the other hand, it is also within the scope of the present disclosure to have each of these functional components located in a separate structure that is electrically connected and capable of communication.

Referring again to fig. 20, the sensor module 206 or 199 may include any of the following sensors: temperature, pressure, pH and conductivity. In one aspect, the sensor module 206 or 199 collects information from the environment and transmits analog information to the control module 201. The control module then converts the analog information to digital information and the digital information is encoded in the current or transfer rate of the mass that produces the ion stream. In another aspect, the sensor module 206 or 199 collects information from the environment and converts analog information to digital information and then transmits the digital information to the control module 201. In the aspect illustrated in fig. 20, sensor module 199 is shown electrically coupled to first and second materials 184, 186 and control device 188. In another aspect, as shown in FIG. 20, sensor module 199 is electrically coupled to control device 188 at connection 204. Connection 204 serves as both a source for powering sensor module 199 and a communication channel between sensor module 199 and control device 188.

Referring now to fig. 21, in another aspect, the systems 170 and 174 of fig. 17A and 17B, respectively, are shown in more detail as system 210. The system 210 includes a frame 212. Frame 212 is similar to frame 182 of fig. 18. In this aspect of the system 210, a digestible or soluble first material 214 is deposited on a portion of one side of the framework 212. Another digestible second material 216 is deposited on a different portion of the same side of the frame 212 such that the first material 214 is different from the second material 216. More specifically, materials 214 and 216 are selected such that a potential difference is formed when they contact a conductive liquid (such as a body fluid). Thus, when the system 210 is in contact and/or partial contact with the conductive liquid, the current path 192 (an example of which is shown in fig. 19) is formed through the conductive liquid between the first material 214 and the second material 216. A control 218 is secured to the frame 212 and electrically coupled to the first material 214 and the second material 216. The control device 218 includes electronic circuitry capable of controlling a portion of the conductive path between the first material 214 and the second material 216. The first material 214 is separated from the second material 216 by a non-conductive side edge 219. Various examples of skirts 219 are disclosed IN U.S. provisional patent application No. 61/173,511 entitled "high sensitive adjustable envelope EVENT MARKERS AND method of USING SAME" filed on 28.4.2009, U.S. provisional patent application No. 61/173,564 entitled "envelope EVENT MARKERSHAVING SIGNAL AMPLIFIERS method suite AN ACTIVE AGENT" filed on 28.4.2009, and U.S. patent application No. 12/238,345 entitled "IN-BODY DEVICE WITH virtualol signalidentification" filed on 25.9.2008, each of the complete disclosures being incorporated herein by reference IN its entirety).

When control 218 is activated or powered in either wireless mode or galvanic mode, control 228 may change the conductivity between material 214 and material 216. Thus, the control 218 is able to control the magnitude of the current passing through the conductive liquid surrounding the system 210. As described with respect to system 180 of fig. 18, a unique current signature associated with system 210 may be detected by a receiver (not shown) to indicate activation of system 210. To increase the length of the current path, the side edges 219 are sized. The longer the current path, the easier it is for the receiver to detect the current.

In addition to the above components, the system 210 further comprises a wireless energy source 213 for activating the system 210 in a wireless mode. As previously described, the system 210 may be powered in a wireless mode, a galvanic mode, or a combination thereof. In the aspects concerned, the wireless energy source 213 is similar to the wireless energy source 21 of fig. 2 and more particularly to the wireless energy source 41 of fig. 4. In other aspects, the wireless energy source 213 may be implemented as any of the wireless energy sources 51, 61, 81, 91, 111, 121, 131, 141, 151 of fig. 4-6, 8-9, and 11-15, respectively. Thus, as previously described, the wireless energy source 213 includes an energy harvester and power management circuitry configured to harvest energy from the environment using optical radiation techniques, as described in connection with fig. 4. The energy harvester includes a photodiode configured to convert incident radiant electromagnetic energy in the form of photons into electrical energy. The particular photodiode can be selected to optimally respond to the wavelength of incident light, which can range from the visible spectrum to the invisible spectrum. As used herein, the term radiant electromagnetic energy refers to light in the visible spectrum or invisible spectrum in the frequency range from ultraviolet to infrared. The charge pump DC-DC converter steps up the voltage level to be suitable for the operation control 218 and activates the system in wireless mode. Once activated, the control device 218 modulates the voltage across the capacitive plate element formed by the first material 214 and the second material 216 to convey information related to the system 210. The modulated voltage may be detected by a capacitively coupled reader (not shown).

Referring now to fig. 22, a system 220 similar to the system 180 of fig. 18 includes a pH sensor module 221 connected to a material 229, the material 229 being selected according to the particular type of sensing function being performed. The pH sensor module 221 is also connected to the control device 228. Material 229 is electrically isolated from material 224 by non-conductive barrier 223. In one aspect, material 229 is platinum. In operation, the pH sensor module 221 utilizes the potential difference between the materials 224/226. The pH sensor module 221 measures the potential difference between material 224 and material 229 and records the value for subsequent comparison. The pH sensor module 221 also measures the potential difference between the material 229 and the material 226 and records the value for subsequent comparison. The pH sensor module 221 uses the potential value to calculate the pH value of the surrounding environment. The pH sensor module 221 provides this information to the control device 228. The control device 228 varies the transfer rate and current of the mass that produces the ion transfer to encode information related to pH in the ion transfer, which can be detected by a receiver (not shown). Thus, the system 220 can determine and provide information related to the pH to a source outside the environment.

As noted above, the control device 228 may be programmed in advance to output a predefined current signature. In another aspect, a system may include a receiving system that may receive programming information when the system is activated. In another aspect (not shown), the clock 202 and memory 203 of fig. 20 may be combined into one device.

In addition to the above components, the system 220 also includes a wireless energy source 231 for activating the system 220 in a wireless mode. As previously described, the system 220 may be powered in a wireless mode, a galvanic mode, or a combination thereof. In the aspects concerned, the wireless energy source 231 is similar to the wireless energy source 21 of fig. 2 and more particularly to the wireless energy source 41 of fig. 4. In other aspects, the wireless energy source 231 may be implemented as any of the wireless energy sources 51, 61, 81, 91, 111, 121, 131, 141, 151 of fig. 4-6, 8-9, and 11-15, respectively. Thus, as previously described, the wireless energy source 231 includes an energy harvester and power management circuitry configured to harvest energy from the environment using optical radiation techniques, as described in connection with fig. 4. The energy harvester includes a photodiode configured to convert incident radiant electromagnetic energy in the form of photons into electrical energy. The particular photodiode can be selected to optimally respond to the wavelength of incident light, which can range from the visible spectrum to the invisible spectrum. As used herein, the term radiant electromagnetic energy refers to light in the visible spectrum or invisible spectrum in the frequency range from ultraviolet to infrared. The charge pump DC-DC converter steps up the voltage level to be suitable for the operation control 228 and activates the system in wireless mode. Once activated, the control device 228 modulates the voltage across the capacitive plate element formed by the first material 229 and the second material 224 to convey information related to the system 220. The modulated voltage may be detected by a capacitively coupled reader (not shown).

In addition to the components described above, the system 220 may also include one or other electronic components. Electrical components of interest include, but are not limited to: additional logic and/or memory elements, for example in the form of integrated circuits; a power conditioning device, such as a battery, fuel cell or capacitor; a sensor, an actuator; signal transmission elements, for example in the form of antennas, electrodes, coils; passive components such as inductors, resistors.

Fig. 23 is a schematic diagram of a pharmaceutical product 237 supply chain management system 230. The supply chain management system 230 is designed to manage a supply of a pharmaceutical product 237, the pharmaceutical product 237 including a system 239 (such as an IEM or ion emission module), the system 239 including a wireless energy source according to aspects of the wireless energy source described herein. System 239 is representative of systems 180, 190, 188, 210, 220 of respective fig. 18-22. In the aspects involved, the pharmaceutical product 237 includes a wireless energy source similar to the wireless energy source 21 of fig. 2, and more particularly similar to the wireless energy source 41 of fig. 4. In other aspects, the wireless energy source may be implemented as any of the wireless energy sources 51, 61, 81, 91, 111, 121, 131, 141, 151 of fig. 4-6, 8-9, and 11-15, respectively.

The supply chain management system 230 is used to probe the drug product 237 in a wireless mode to power the system 239 and perform diagnostic tests, verify the operation, detect the presence, and determine the functionality of the drug product 237 in the supply chain. In other aspects, when powered on, the system 239 operates to communicate a unique current signature associated with the drug product 237 to the computer system 236 to determine the effectiveness or ineffectiveness of the drug product 237 based on the communicated information.

In various aspects, the supply management system 230 includes an optical energy source 232, such as, for example, a laser capable of generating an optical beam 234 to activate a wireless energy source and detection system 239. When energized, includes a first capacitive plate 238_aAnd a second capacitor plate 238_bDetects the information transmitted by the system 239. Capacitor plate 238_a、238_bThe detected information is provided to the computer system 236, and the computer system 236 determines the validity or invalidity of the pharmaceutical product 237. In this way, various supply chain or other requirements may be fulfilled.

Products include, for example, IV bags, syringes, IEMs, and similar devices as disclosed and described below: PCT patent application No. PCT/US1886/016370, published as WO/1886/116718; PCT patent application No. PCT/US1887/082S63, published as WO/1888/0S 2136; PCT patent application No. PCT/US1887/02422S, published as WO/1888/063626; PCT patent application No. PCT/US1887/0222S7, published as WO/1888/066617; PCT patent application No. PCT/US1888/0S284S, published as WO/1888/09S 183; PCT patent application No. PCT/US1888/0S3999, published as WO/1888/101107; PCT patent application No. PCT/US1888/0S6296, published as WO/1888/112S 77; PCT patent application No. PCT/US1888/0S6299, published as WO/1888/112S 78; PCT patent application No. PCT/US1888/0777S3, published as WO 1889/042812; PCT patent application No. PCT/US 09/S3721; PCT patent application No. PCT/US1887/01SS47, published as WO 1888/008281; and U.S. provisional patent application No. 61/142,849; 61/142,861, respectively; 61/177,611, respectively; 61/173,564 No. C; each of the above applications is incorporated by reference herein in its entirety. Such products may generally be designed and implemented to include conductive materials/components and a wireless energy source. Detection of the conductive material/components of the product by the capacitive plates may indicate the presence of the correct configuration of the conductive components of the product. Alternatively, failure to communicatively couple upon probing may indicate a product failure, such as one or more of conductive material missing, misconfigured.

As shown, the IEM, such as the system 239 configured with excipients within the drug product 237, is fully encapsulated and checked via optical energy source 232 detection to ensure, for example, that the IEM is still functional and functions untouched or possibly contactable, and optical detection is used to energize the IEM and capacitive coupling to detect information conveyed by the IEM through the non-contact capacitive plates. First detection capacitor plate 238_aA first metal or material coupled to one side of the frame of the IEM, and a second probe capacitor plate 238_bA second metal or material on the other side of the frame coupled to the IEM. For example, the pharmaceutical product 237 may be coated with something to keep it stable and this coating may be a non-conductive material. Various ways of capacitively coupling the system 237 may be implemented, such as metal, metal pads. As shown in FIG. 23, first capacitive plate 238_aAnd a second capacitor plate 238_bCapacitively coupled to corresponding first and second materials formed on the frame of the system 237.

FIG. 24 is a schematic diagram of a circuit 250 that may represent various aspects. First capacitor plate 238_aAnd a second capacitor plate 238_bCoupled to the input of sense amplifier 252. The output of the amplifier 252 is provided to the computer system 236. When in the first capacitor plate 238_aAnd a second capacitor plate 238_bWith the introduction of the pharmaceutical product 237, an optical energy source 232 (fig. 23), such as a laser, for example, energizes a system 239 with a beam 234. The controller then modulates the voltage on the first material and the second material of the system 239. The modulated voltage 254 is provided by the capacitive plates 238a, 238_bDetects, is amplified by the amplifier 252, and is provided to the computer system 236, which computer system 236 can perform diagnostic tests on the system 239, verify the operation of the system 239, detect the presence of the system 239 in the drug product 237, and test the functionality of the system 239 in the supply chain. In other aspects, the computer system 236 receives unique current signatures associated with the drug product 237. In general, the computer system 236 determines the validity or invalidity of the drug product 237 based on information communicated during the probing process.

In various aspects, the capacitive coupling device may be used with any device designed and implemented with a wireless energy source, such as an IEM or similar device, which may be a DC source device modified for interoperability, such as a device equipped with a rectifier to provide a stable voltage on a chip, whose impedance may be modulated.

In various aspects, the capacitive plate 238_aAnd 238_bVarious structural components and other devices (e.g., tubular structures having capacitive plates) may be integrated or otherwise associated. One or more pharmaceutical products 237 having an IEM or similar device can be introduced via automated means, e.g., manually, and the IEM detected by a capacitive plate in the tube when the wireless energy source of the system 239 is energized by the detection source 232 (fig. 23).

In one aspect, a method of testing a pharmaceutical product 237 having a first conductive region and a second conductive region is provided. The pharmaceutical product 237 is introduced into the capacitive coupling device. The wireless energy source within the system 239 of the pharmaceutical product 237 is detected by the source to energize the system 239. A first capacitive plate of a capacitive coupling device is capacitively coupled to a first conductive region of the system 239 and a second capacitive plate of the capacitive coupling device is capacitively coupled to a second conductive region of the system 239. The computer system 236 is coupled to the capacitive device. The computer system 236 includes data storage elements to store data related to information stored in the system 239.

In various aspects, other devices and/or components may be associated. In one example, a programmable device may be communicatively associated with a capacitive coupling device to receive, transmit data and/or information generated by the capacitive coupling device. Continuing with the above description, once all or a portion of the quantity of the pharmaceutical product 237 has been "read" by the capacitive coupling device, the capacitive coupling device may communicate, e.g., wirelessly, wiredly, to the computer system 236, which computer system 236 may include a database and display device for further storage, display, manipulation. In this way, a single datum, multiple data, a large number of dates may be processed for various purposes. One of these purposes may be: for example, drugs are tracked in supply chain applications during manufacturing processes such as tablet compression or other processes, during pharmaceutical validation processes, during dispensing processes. Various processes may be supplemented, incorporated. One such example is verification by read number. If valid (e.g., readable), the tablet is acceptable. If not, the tablet is rejected.

In another aspect, the pharmaceutical product has an IC chip (such as IEM) with side edges, such as, for example, side edges 185, 187 of a system 180 such as shown in fig. 18 and 19. In one example, the pill is coated with a non-conductive coating or a completely impermeable coating (as shown), and the pill itself comprises a non-conductive drug powder. For example, a region such as a tapered region comprises a conductive material, e.g., small particles or granules mixed with other pharmaceutical materials, excipients, placebo materials, such that the region converts to a conductive region. For example, graphite and other conductive materials, such as one of ten, five of ten, may be used to make the region conductive. Other materials and compositions are also possible, such as a gel or liquid capsule having conductive particles therein. Thus, at sufficiently high frequencies, the conductive particles may short together. One skilled in the art will appreciate that the conductive material may comprise a variety of materials and form factors, as well as combinations thereof, such as different sized particles, wires, metal films, filaments.

In various aspects, the conductive particles can be integrated or formed via a variety of methods and ratios. In one example, an IEM or similar device is embedded in or otherwise mechanically associated with a "doughnut" powder, and the holes formed therein are filled with or otherwise associated with conductive particles to form conductive regions. The size, area, volume, location, or other parameters of the conductive regions may be varied within the scope that the functionality described herein may be performed.

In a particular aspect, the close proximity between the capacitive coupling device and the IEM or similar device may facilitate or improve privacy aspects. In a particular aspect, a particular related device may include, for example, a circuit having an open schottky diode in parallel with a CMOS transistor that is timed to turn on and off. Other circuit designs and modifications are possible.

In a particular aspect, the ingestible circuitry includes a coating. The purpose of this coating layer may vary, for example for protecting the circuit, chip and/or battery or any component during handling, during storage or even during ingestion. In such an example, a coating on top of the circuitry may be included. Coatings designed to protect the ingestible circuitry during storage but which dissolve immediately during use are also of interest. For example, coatings that dissolve upon contact with aqueous fluids (e.g., gastric fluids) or electrically conductive fluids as referred to above. Protective treatment coatings that allow the use of treatment steps that may damage certain components of the device are also of interest. For example, in the production of chips with different materials deposited on the top and bottom, the product must be cut. The cutting process may scrape away different materials and may also involve liquids that may cause the different materials to drain or dissolve. In such instances, a protective coating may be employed on the material that prevents mechanical or liquid contact with the component during processing. Another purpose of the dissolvable coating may be to delay activation of the device. For example, coatings on different materials and that take a specific period of time (e.g., five minutes) to dissolve when in 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 dissolution in a controlled manner and allows activation of the device when desired. Coatings that survive in the stomach but dissolve in the intestinal tract are also of interest, for example coatings where it is desirable 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 high pH. Pharmaceutical formulation protective coatings are also of interest, such as gelatin capsule liquid protective coatings that prevent the circuit from being activated by the liquid of the gelatin capsule. When an optical wireless energy source is provided, the coating may be optically transparent or optically transparent apertures may be formed in the coating to allow optical radiation to reach the photodiode assembly of the wireless energy source.

The marker of interest comprises two different electrochemical materials that function like the electrodes (e.g., anode and cathode) of the power source. The electrodes or anodes or cathodes mentioned herein are only illustrative examples. The scope of the present disclosure is not limited to the indicia used, but includes aspects in which an electrical potential is formed between two different materials. Thus, when referring to an electrode, an anode or a cathode, it is intended to refer to the potential developed between two different materials.

When the material is exposed and contacted with a body fluid, such as stomach acid or other type of fluid (alone or in combination with dried conductive medium precursors), a potential difference, i.e., a voltage, is generated between the electrodes due to the respective oxidation and reduction reactions that occur with the two electrode materials. Voltaic cells or batteries may be produced. Thus, in aspects of the present disclosure, such a power source is configured such that a voltage is generated when two different materials are exposed to a target site (e.g., stomach, alimentary tract).

In particular aspects, one or both of the metals can be incorporated, for example, into a non-metal to increase the voltage output of the battery. Non-metals that may be used as dopants in particular aspects include, but are not limited to: sulfur, iodine, and the like.

Although the claims are included, the invention is also defined by the following clauses:

1. a system, comprising:

a control device; and

a wireless energy source electrically coupled to the control device, the wireless energy source comprising an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy into a potential difference to energize the control device.

2. The system of clause 1, wherein the energy harvester comprises one or more of the following:

a light energy conversion element that receives light energy at an input of the energy harvester and converts the light energy into electrical energy,

a vibration/motion energy conversion element receiving vibration/motion energy at an input of the energy harvester and converting the vibration/motion energy into electrical energy,

an acoustic energy conversion element that receives acoustic energy at an input of the energy harvester and converts the acoustic energy into electrical energy,

comprising a radio frequency energy conversion element receiving radio frequency energy at an input of the energy harvester and converting the radio frequency energy into electrical energy,

a thermal energy conversion element that receives thermal energy at the input of the energy harvester and converts the thermal energy to electrical energy.

3. The system of clause 1 or 2, further comprising a power management circuit coupled to the energy harvester to convert the electrical energy from the energy harvester to an electrical potential difference suitable to energize the control device.

4. The system of any of the preceding clauses further comprising an in-vivo device operative to transmit information to an external system positioned outside the body.

5. The system of clause 4, wherein the in-vivo device is operative to transmit information ex vivo only when the wireless energy source is energized by an external energy source positioned outside the body.

6. The system of any of the preceding clauses wherein the electrical conductivity is modified.

7. The system of any of the preceding clauses further comprising a local power source.

8. The system of clause 7, wherein the local power source comprises:

a first material electrically coupled to the control device; and

a second material electrically coupled to the control device and electrically isolated from the first material.

9. The system of clause 8, wherein the first material and the second material are selected to provide a second potential difference when in contact with a conductive liquid.

10. The system of clauses 8 or 9, wherein the control device changes the electrical conductivity between the first material and the second material such that the magnitude of the electrical current is changed to encode information.

11. The system of any of the preceding clauses wherein when the control device is energized by the wireless energy source, the control device changes the first potential difference between the first material and the second material such that a magnitude of the first voltage is changed to encode information.

12. The system of any of the preceding clauses further comprising one or more of the following elements:

a charge pump coupled to the energy harvester,

a DC-DC converter coupled to the energy harvester,

an AC-DC converter coupled to the energy harvester.

13. The system of any of the preceding clauses further comprising a power source electrically coupled to the control device, the power source providing a second potential difference to the control device.

14. The system of clause 13, wherein the power source is one or more of the following:

a thin-film integrated battery, comprising a thin-film electrode,

a super capacitor, a power supply and a power supply,

a thin film integrated rechargeable battery.

15. The system of any one of the preceding clauses wherein the system is ingestible.

16. The system of clause 15, further comprising a pharmaceutical product.

17. The system of any of the preceding clauses which is activatable upon contact with a conductive body fluid.

18. The system of any of the preceding clauses further comprising a protective coating that is dissolvable by bodily fluids and that may comprise a conductive or non-conductive material.

19. The system of any of the preceding clauses, comprising a frame having a first ingestible material and a second ingestible material disposed thereon, wherein upon contact with a bodily fluid, an electrical potential difference is generated between the two ingestible materials, thereby forming an electrical current path between the two ingestible materials.

20. The system of clause 20, wherein the magnitude of the current is controlled by varying the electrical conductivity between the first ingestible material and the second ingestible material.

21. The system of any of the preceding clauses further comprising a current path extension device.

22. The system of any one of the preceding clauses further comprising a pH sensor.

23. A pharmaceutical product supply chain management system comprising the system of any one of the preceding clauses.

24. A capacitive coupling device for testing a system as in any one of the preceding clauses including a pharmaceutical product.

25. A method of testing a pharmaceutical product comprising the steps of associating the product with a system as described in any of clauses 1-23 and introducing the system into a capacitive coupling device.

26. Use of the system of any of the preceding clauses 1-23 for indicating the occurrence of an in vivo event.

Claims (22)

1. A system, comprising:

a control device; and

a wireless energy source electrically coupled to the control device, the wireless energy source comprising an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy into a potential difference to energize the control device.

2. The system of claim 1, wherein the energy harvester comprises a light energy conversion element to receive light energy at an input of the energy harvester and convert the light energy into electrical energy.

3. The system of claim 1, wherein the energy harvester comprises a vibration/motion energy conversion element to receive vibration/motion energy at an input of the energy harvester and convert the vibration/motion energy to electrical energy.

4. The system of claim 1, wherein the energy harvester comprises an acoustic energy conversion element to receive acoustic energy at an input of the energy harvester and convert the acoustic energy into electrical energy.

5. The system of claim 1, wherein the energy harvester comprises a radio frequency energy conversion element to receive radio frequency energy at an input of the energy harvester and convert the radio frequency energy to electrical energy.

6. The system of claim 1, wherein the energy harvester comprises a thermal energy conversion element to receive thermal energy at an input of the energy harvester and convert the thermal energy to electrical energy.

7. The system of claim 1, further comprising a power management circuit coupled to the energy harvester to convert the electrical energy from the energy harvester to an electrical potential difference suitable to energize the control device.

8. The system of claim 1, comprising an in-vivo device operative to transmit information to an external system positioned outside the body.

9. The system of claim 8, wherein the in-vivo device is operative to transmit information ex vivo only when the wireless energy source is energized by an external energy source positioned outside the body.

10. A system, comprising:

a control device for varying the conductivity;

a wireless energy source electrically coupled to the control device, the wireless energy source comprising an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy to a first potential difference to energize the control device; and

a local power supply, comprising:

a first material electrically coupled to the control device; and

a second material electrically coupled to the control device and electrically isolated from the first material;

wherein the first material and the second material are selected to provide a second potential difference when in contact with a conductive liquid;

wherein the control device changes the electrical conductivity between the first material and the second material such that the magnitude of the electrical current is changed to encode information.

11. The system of claim 10, wherein when the control device is energized by the wireless energy source, the control device changes a first potential difference between the first material and the second material such that a magnitude of a first voltage changes to encode information.

12. The system of claim 10, wherein the energy harvester comprises a light energy conversion element to receive light energy at an input of the energy harvester and convert the light energy into electrical energy.

13. The system of claim 10, comprising a charge pump coupled to the energy harvester to convert the electrical energy from the energy harvester to the first potential difference suitable to energize the control device.

14. The system of claim 10, comprising a DC-DC converter coupled to the energy harvester to convert the electrical energy from the energy harvester to the first potential difference suitable to energize the control device.

15. The system of claim 10, comprising an AC-DC converter coupled to the energy harvester to convert the electrical energy from the energy harvester to the first potential difference suitable to energize the control device.

16. A system, comprising:

a control device;

a wireless energy source electrically coupled to the control device, the wireless energy source comprising an energy harvester to receive energy in a form at an input of the energy harvester and convert the energy to a first potential difference to energize the control device; and

a power source electrically coupled to the control device, the power source providing a second potential difference to the control device.

17. The system of claim 16, wherein the power source is a thin film integrated battery.

18. The system of claim 16, wherein the power source is a supercapacitor.

19. The system of claim 16, wherein the power source is a thin film integrated rechargeable battery.

20. The system of claim 16, comprising a charge pump coupled to the energy harvester to convert the electrical energy from the energy harvester to the first potential difference suitable to energize the control device.

21. The system of claim 16, comprising a DC-DC converter coupled to the energy harvester to convert the electrical energy from the energy harvester to the first potential difference suitable to energize the control device.

22. The system of claim 16, comprising an AC-DC converter coupled to the energy harvester to convert the electrical energy from the energy harvester to the first potential difference suitable to energize the control device.