Abstract: Compositions, systems and methods that allow for the detection of the actual physical delivery of a pharmaceutical agent to a body are provided. Embodiments of the compositions include an identifier and an active agent. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.

Abstract: A system according to one embodiment includes a Radio Frequency Identification (RFID) tag, the RFID tag having a housing; an interface configured for detachable coupling to a connector that is coupleable or coupled to an external module having at least one of a battery and a remote sensor; a controller for processing data derived from an output of the remote sensor; a memory for storing the data derived from an output of the remote sensor and/or the processed data; and an antenna coupled to the controller for enabling backscatter communication.

Abstract: Acoustic tags have been used for years in fisheries research to study survival and behavior of fish in various aquatic environments. The described techniques, devices and systems enhance the ability of researchers to understand the effect on fish mortality by predators through an acoustic tag that includes a digestible fuse. When the implanted acoustic tag comes in contact with the digestive fluids in a predator's stomach, the fuse coating is dissolved causing the fuse to disintegrate and result in an open circuit. The open circuit in turn signals the electronics in the acoustic tag that the tagged fish has been consumed. In response, the electronics alter the tag transmit signal to indicate that predation has occurred.

Abstract: Techniques and systems for monitoring cardiac arrhythmias and delivering electrical stimulation therapy using a subcutaneous implantable cardioverter defibrillator (SICD) and a leadless pacing device (LPD) are described. For example, the SICD may detect a tachyarrhythmia within a first electrical signal from a heart and determine, based on the tachyarrhythmia, to deliver anti-tachyarrhythmia shock therapy to the patient to treat the detected arrhythmia. The LPD may receive communication from the SICD requesting the LPD deliver anti-tachycardia pacing to the heart and determine, based on a second electrical signal from the heart sensed by the LPD, whether to deliver anti-tachycardia pacing (ATP) to the heart. In this manner, the SICD and LPD may communicate to coordinate ATP and/or cardioversion/defibrillation therapy. In another example, the LPD may be configured to deliver post-shock pacing after detecting delivery of anti-tachyarrhythmia shock therapy.

Abstract: A system for the control of an implant (32) in a body (11), comprising first (10, 20) and second parts (12) which communicate with each other. The first part (10, 20) is adapted for implantation and for control of and communication with the medical implant (32), and the second part (12) is adapted to be worn on the outside of the body (11) in contact with the body and to receive control commands from a user and to transmit them to the first part (10, 20). The body (11) is used as a conductor for communication between the first (10, 20) and the second (12) parts. The second part (12) is adapted to receive and recognize voice control commands from a user and to transform them into signals which are transmitted to the first part (10, 20) via the body (11).

Abstract: A device which is introduced into the intestinal tract of a living organism and which operates autonomously therein, adapted to obtain data using a sensor apparatus (such as an imaging device), and process the data using an onboard processor core. In one embodiment, the processor core comprises a RISC core with an extension instruction set, the extension instructions of which are specifically selected to optimize the data processing, as well as reducing the power consumption of an integrated circuit of which the core is part (such as by way of reducing gate count in the integrated circuit through elimination of unnecessary core functions).

Abstract: An improved endoscopic device which is introduced into, for example, the intestinal tract of a living organism and which operates autonomously therein, adapted to obtain and store or transmit one or more types of data such as visual image data, laser autofluorescence data, pressure data, or ultrasonic waveform data. In one embodiment, the device includes one or more pressure sensing apparatus configured to enable measurement of pressure resulting from, for instance, peristaltic contractions within the intestinal tract, including transmission of pressure data as a function of time off of the device via a wireless interface while the device is within the intestinal tract.

Abstract: A method of storing information relating, to a medical implant device having a number of implant elements includes receiving a first image, the first image showing a surgical site and the medical implant device, creating a second image using the first image and a stored list of possible implant elements, the second image showing the surgical site and the medical implant device with a number of labels associated therewith, wherein each of the labels is associated with a respective one of the implant elements and indicates one of the possible implant. elements from the stored list, and storing the second image on an transponder device structured to be attached to the medical implant device or at a medically appropriate site on or within a patient's body.

Abstract: An implantable neurostimulator system adapted to provide therapy for various neurological disorders is capable of varying therapy delivery strategies based on the context, physiological or otherwise, into which the therapy is to be delivered. Responsive and scheduled therapies can be varied depending on various sensor measurements, calculations, inferences, and device states (including elapsed times and times of day) to deliver an appropriate course of therapy under the circumstances.

Abstract: A method includes monitoring an indicator of fluid volume of a patient via a sensor device, and setting an initial fluid volume removal prescription for a blood fluid removal session based on the monitored indicator of fluid volume. The method may further include transmitting data regarding the indicator of fluid volume from the implantable sensor device to fluid removal device. The system includes a blood fluid removal device and control electronics configured to set the initial fluid removal volume and rate prescription. In some embodiments, the fluid removal device sets or calculated the initial fluid volume removal prescription based on the data received from the implantable sensor. The indicator of fluid volume may be an indicator of tissue fluid volume or an indicator of blood fluid volume.

Abstract: The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can also be associated with food and communicate data about ingestion of food material to a receiver.

Abstract: The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can be used in a variety of different applications, including as components of ingestible identifiers, such as may be found in ingestible event markers, e.g., pharma-informatics enabled pharmaceutical compositions.

Abstract: The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can also measure the conditions of the environment surrounding the system.

Abstract: The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can also measure the conditions of the environment surrounding the system.

Abstract: The system of the present invention includes an implantable device that can detect high and low frequency current signature. The implantable device can communicate with a communication device that includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, the communication device is activated.

Abstract: A sensor inserting device includes a device main body and a push handle for moving a detector of a sensor and an insertion needle, with the sensor held coupled to the insertion needle, into the body of a patient. A transmitter, for processing a signal from the sensor, is set in the device main body. A cable, allowing transmission of a signal between the sensor and the transmitter, is connected to the sensor (12) and the transmitter.

Abstract: Virtual dipole signal amplification for in-body devices, such as implantable and ingestible devices, is provided. Aspects of the in-body deployable antennas of the invention include antennas configured to go from a first configuration to a second configuration following placement in a living body, e.g., via ingestion or implantation. Embodiments of the in-body devices are configured to emit a detectable signal upon contact with a target physiological site. Also provided are methods of making and using the devices of the invention.

Abstract: Power sources that enable in-body devices, such as implantable and ingestible devices, are provided. Aspects of the in-body power sources of the invention include a solid support, a first high surface area electrode and a second electrode. Embodiments of the in-power sources are configured to emit a detectable signal upon contact with a target physiological site. Also provided are methods of making and using the power sources of the invention.

Abstract: Methods, systems and compositions that allow for treating a patient according to a patient customized therapeutic regimen are provided. Embodiments of the invention include obtaining dosage administration information from a patient and using the same to tailor a therapeutic regimen for the patient. Embodiments of the invention further include preparing and forwarding to the patient physical pharmaceutical dosages based on the customized therapeutic regimen.

Abstract: A method for diagnosing constipation comprising the steps of providing an ingestible capsule (20) having a given density and a pH sensor (22) and a temperature sensor (24), having a subject ingest the capsule, recording pH measurements from the pH sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject, transmitting the pH measurements to a processor (19) outside of the gastrointestinal tract of the subject, recording temperature measurements from the temperature sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject, transmitting the temperature measurements to a processor (19) outside of the gastrointestinal tract of the subject, determining transit time of the capsule between a first location in the gastrointestinal tract of the subject and a second location in the gastrointestinal tract of the subject as a function of the pH measurements and the temperature measurements, pro

Abstract: Controlled activation identifiers for use in ingestible compositions, such as pharma-informatics enabled compositions, are provided. The identifiers include a controlled activation element that provides for activation of the identifier in response to the presence of a predetermined stimulus at a target site of interest. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.

Abstract: A gas measurement device for measuring at least one gas in the stomach of a mammal, the device comprises a housing for being located in the mammal's stomach and providing at least one gas sensor for detecting the gas. The housing is impermeable to liquid within the stomach. The device may also comprise a controller disposed within the housing and which is electrically coupled to the at least one gas sensor. The controller is arranged to periodically process an output from the gas sensor(s) to provide data indicative of the amount of the gas within the stomach. The controller can include a wireless transmitter for transmitting the data to a remotely located receiving device disposed exterior to the mammal.

Abstract: This disclosure describes antenna structures for use with implantable medical devices (IMDs). The IMD may include a housing that hermetically encloses electronic components of the IMD and a fixation mechanism that attaches the IMD to a target location within a patient, such as a wall of a vessel. The fixation mechanism may function as a radiating element of an antenna of the IMD. The fixation mechanism may be attached to a housing of the IMD with two different members. One member may be an anchoring structure that mechanically anchors the fixation mechanism to the housing. The second member may be a connector that electrically connects the fixation mechanism to the housing such that the fixation mechanism is configured to transmit and/or receive communication signals with other implantable or external devices.

Abstract: Multi-directional transmitters for in-body devices, such as implantable and ingestible devices, are provided. Aspects of the in-body multi-direction transmitters of the invention include signal transmitters configured to transmit an identifying signal in at least two different directions in an x-y plane. Embodiments of the in-body devices are configured to emit a detectable signal upon contact with a target physiological site. Also provided are methods of making and using the devices of the invention.

Abstract: An endoscopic capsule has a biocompatible capsule housing that contains at least one sensor device for acquiring medical data. The sensor is arranged on an outer surface of the housing, and has a first electrode produced of an acid-resistant noble metal, and a second electrode produced of silver. An electrical voltage is applied between the first and second electrodes, and a change in an electrical variable is measured between the first and second electrodes when ammonia is present. The endoscopic capsule allows screening of gastric acid and the tissue of the stomach lining for Helicobacter pylori in a manner that is gentle for the patient.

Abstract: An electrolytic biosensor for use in intracorporeal leak detection may be incorporated into a surgical drain that is installed post-operatively at the site of a wound. The electrolytic biosensor may be used to monitor drain effluent flowing through the surgical drain by measuring a fluid conductivity of the drain effluent. Certain changes, patterns, or responses of the so measured fluid conductivity values may be indicative of a physiological condition of the wound. For example, when the wound is a gastrointestinal anastomosis, the fluid conductivity values measured with the electrolytic biosensor may be used to characterize a fluid integrity of the gastrointestinal anastomosis. An electrolytic biosensor system may include an application that records conductivity data and provides notifications, such as a patient alarm, when a leak is detected.

Abstract: Systems and methods described herein use near field communications to locate a radiating transponder, such as a pill swallowed by a patient. The system can be triggered to turn on and transmit an amplitude shift keyed waveform (or other type of waveform) to a set of antennas attached to, coupled with, or near the patient at roughly known locations. The magnetic field emitted by the transponder can be measured by the receiving antennas, for example, using principles of mutual inductance. The differential phase and/or time shifts between the antennas can contain sufficient information to find the location of the transponder and optionally its orientation relative to body coordinates. The system can display the location and/or orientation of the transponder and may optionally provide other information about the movement, flow, or other characteristics of pill to assist clinicians with diagnosis.

Abstract: A method of communicating with an ingestible capsule includes detecting the location of the ingestible capsule, focusing a multi-sensor acoustic array on the ingestible capsule, and communicating an acoustic information exchange with the ingestible capsule via the multi-sensor acoustic array. The ingestible capsule includes a sensor that receives a stimulus inside the gastrointestinal tract of an animal, a bidirectional acoustic information communications module that transmits an acoustic information signal containing information from the sensor, and an acoustically transmissive encapsulation that substantially encloses the sensor and communications module, wherein the acoustically transmissive encapsulation is of ingestible size. The multi-sensor array includes a plurality of acoustic transducers that receive an acoustic signal from a movable device, and a plurality of delays, wherein each delay is coupled to a corresponding acoustic transducer.

Abstract: An injectable detecting device is provided for use in physiological monitoring. The device includes a plurality of sensors axially spaced along a body that provide an indication of at least one physiological event of a patient, a monitoring unit within the body coupled to the plurality of sensors configured to receive data from the plurality of sensors and create processed patient data, a power source within the body coupled to the monitoring unit, and a communication antenna external to the body coupled to the monitoring unit configured to transfer data to/from other devices.

Abstract: An endocapsule has a measurement chamber therein containing a sensor that detects at least one metabolic product of a specific bacterium in a hollow organ of a human or animal gastrointestinal tract. The endocapsule is introduced into the hollow organ wherein detection of the at least one metabolic product takes place.

Abstract: Devices and methods useful for non-invasively measuring and indicating a rate of fluid flow are disclosed. In one embodiment, a sensor housing adapted to received fluid flow therethrough is provided. A radio frequency tag and a masking element can be disposed in the sensor housing. The masking element and the radio frequency tag can be configured to move relative to one another. The relative positions or movement can alter the response of the radio frequency tag to a wireless signal (which can be emitted from an external reading device, for example) and thereby indicate a rate of fluid flowing through the housing. For example, in some embodiments, the masking element can selectively cover at least part of the radio frequency tag in correspondence to the flow rate, which can change a characteristic of the radio frequency tag's response to the wireless signal.

Abstract: Device, system and method for in-vivo detection of H. pylori. For example, an in-vivo device includes a housing, a reference electrode disposed on the housing, and a working electrode disposed on the housing in close proximity to the reference electrode. The working electrode is coated by litography or screen printing with salt such that substantially no current passes between the working electrode and the reference electrode. The in-vivo device further includes a measuring device for measuring current, impedance, and/or resistance between the working and the reference electrodes, and a transmitter for transmitting the measurements. Presence of ammonia, which is a byproduct of H. pylori, causes increase in current and thus decrease in impedance or resistance between the reference electrode and the working electrode; thereby measurements of current, impedance, and/or resistance indicate on presence or absence of H. pylori.

Abstract: Devices and methods useful for non-invasively measuring and indicating a rate of fluid flow are disclosed. In one embodiment, a sensor housing adapted to received fluid flow therethrough is provided. A radio frequency tag and a masking element can be disposed in the sensor housing. The masking element and the radio frequency tag can be configured to move relative to one another. The relative positions or movement can alter the response of the radio frequency tag to a wireless signal (which can be emitted from an external reading device, for example) and thereby indicate a rate of fluid flowing through the housing. For example, in some embodiments, the masking element can selectively cover at least part of the radio frequency tag in correspondence to the flow rate, which can change a characteristic of the radio frequency tag's response to the wireless signal.

Abstract: Methods, systems, and apparatuses for an ingestible sensor device are described. The ingestible sensor devices may be swallowed by an animal to diagnose one or more conditions of the animal. The ingestible sensor device may include a sensor configured to receive a stimulus inside the gastrointestinal tract of an animal, wherein the sensor is configured to output a signal having a characteristic proportional to the received stimulus. The ingestible sensor device may further include a communications module that transmits a signal modulated with the sensor output signal and a housing configured to have a size that is swallowable, wherein the housing substantially encloses the sensor and communications module.

Abstract: Virtual dipole signal amplification for in-body devices, such as implantable and ingestible devices, is provided. Aspects of the in-body deployable antennas of the invention include antennas configured to go from a first configuration to a second configuration following placement in a living body, e.g., via ingestion or implantation. Embodiments of the in-body devices are configured to emit a detectable signal upon contact with a target physiological site. Also provided are methods of making and using the devices of the invention.

Abstract: A method of monitoring a patient's compliance with a medication program includes transmitting a first signal from an electronic ingestible medication delivery device located within a patient's body, the signal including information about a physiological parameter of the patient. The signal is detected with an electronic reader located outside the patient's body. A second signal is provided to the reader from a different source than the delivery device. The second signal includes information about the same physiological parameter of the patient. Related systems are also described.

Abstract: Ingestible event marker systems that include an ingestible event marker (i.e., an IEM) and a personal signal receiver are provided. Embodiments of the IEM include an identifier, which may or may not be present in a physiologically acceptable carrier. The identifier is characterized by being activated upon contact with a target internal physiological site of a body, such as digestive tract internal target site. The personal signal receiver is configured to be associated with a physiological location, e.g., inside of or on the body, and to receive a signal the IEM. During use, the IEM broadcasts a signal which is received by the personal signal receiver.

Abstract: An apparatus for obtaining EEG data includes a signal processing component for receiving EEG signals from each of a plurality of electrodes and a data output component. The signal processing component is arranged to convert respective EEG signals in real time to a reduced data set and provide the reduced data set to the data output component.

Abstract: A capsule system comprising a first capsule (16) configured to be ingested by a subject, a second capsule (18) configured to be ingested by the subject separately from the first capsule, the first capsule having an electromagnetic element (29, 30) and a sensor (22, 23) for sensing a physiological parameter of a gastrointestinal tract of the subject, the second capsule having a magnetic element (29, 30) and a sensor (22, 23) for sensing a physiological parameter of the gastrointestinal tract of the subject, the first capsule and the second capsule having an active state wherein a magnetic force is selectively provided between the first and second capsules attracting the first and second capsules while the capsules are within the gastrointestinal tract of the subject and having an inactive state wherein the magnetic force is absent, and a control (26/32) configured to selectively place the capsules in the active state from the inactive state while the capsules are within the gastrointestinal tract of the subjec

Abstract: A sensor system including an implantable sensor and an external transceiver. Aspects of the sensor system may provide improved implantation and antenna orientation of the implanted sensor. The sensor may include a sensor antenna, the transceiver may include a transceiver antenna. In some embodiments, the sensor antenna and/or transceiver antenna may include a first set of coils oriented in a first plane and a second set of coils oriented in a second plane that is different than the first plane. In some embodiments, the sensor may have a geometry that will prevent or reduce movement and/or rotation of the implanted sensor. For instance, in some embodiments, the sensor may be enclosed in silicon that contains antenna coils and/or include wings, a fluid filled sack, a swelling material, an expansion material, and/or arms.

Abstract: Devices and a system for detection of blood within in-vivo fluids are provided. A device comprises a housing that includes a gap. The gap has at least one opening through which in-vivo fluids may enter and/or exit the gap. The device further comprises an illumination source for illuminating the in-vivo fluids in the gap, a light detector for detecting light which passes through the in-vivo fluids in the gap, and flexible fins disposed on the housing in the vicinity of the gap's opening for covering the opening when the fins are folded and for pumping fluids into and out of the opening by repeated closure and opening of the opening by the fins, due to repeated peristaltic waves. This pumping effect may lead to continuous flow of fluids into and out of the opening and thus into and out of the gap of the device.

Abstract: Systems, devices, and methods are described for providing, among other things, devices operable to acquire intestinal microbial flora samples, to map intestinal microbial flora, to identify microbes present in an individual's digestive tract, to delivery intestinal microbial flora compositions, to register a microbial flora collection events, to register microbial flora-seeding events, or the like.

Abstract: Systems, devices, and methods are described for providing, among other things, devices operable to acquire intestinal microbial flora samples, to map intestinal microbial flora, to identify microbes present in an individual's digestive tract, to delivery intestinal microbial flora compositions, to register a microbial flora collection events, to register microbial flora-seeding events, or the like.

Abstract: A method for monitoring data in a clinical environment comprises receiving information indicative of a number of ambulatory sensing systems in a measurement environment comprising a plurality of ambulatory sensing systems. The method also comprises establishing a communication scheme associated with the measurement environment based on the number of ambulatory sensing systems in the measurement environment. The method further comprises providing, to each ambulatory sensing system, information indicative of the established communication scheme. The method also comprises configuring, in a central data module associated with the measurement environment, parameters for communicating with each respective ambulatory sensing system in accordance with the established control scheme.

Abstract: A method, an apparatus and an article of manufacture for enabling communication between at least two computer applications that is observable to a user. The method includes obtaining a description of functions for each of the at least two computer applications, comparing the description of functions for each of the at least two computer applications, generating a dialog between the at least two applications based on the comparing of the description of functions for each of the at least two computer applications, and making the dialog available to a user.

Abstract: A system includes a capsule body having a casing introduced into a subject to perform, in liquid, examination of or treatment on the interior of the subject, the casing containing a permanent magnet, a mass of the casing excluding the magnet being set to be less than a product of a volume of the casing and a density of the liquid; a magnetic field generator that generates a magnetic attraction for the magnet to guide the capsule body; and a magnetic field generation device that controls the magnetic field generator to generate the magnetic attraction by setting a maximum value of the generated magnetic attraction vertically upward to the capsule body, to be equal to a maximum value of the generated magnetic attraction vertically downward to the capsule body, and by setting the maximum values to be less than a value obtained by multiplying a mass of the magnet by a gravitational acceleration.

Abstract: In one aspect, containment devices are provided that include a microchip element having one or more containment reservoirs that are configured to be electrically activated to open; an electronic printed circuit board (PCB) or a silicon substrate positioned adjacent to the microchip element; one or more electronic components associated with the microchip element or the PCB/silicon substrate; and a first inductive coupling device associated with the microchip element or the PCB/silicon substrate, wherein the first inductive coupling device is in operable communication with the one or more electronic components. In another aspect, implantable drug delivery devices are provided that include a body housing at least one drug payload for actively controlled release, wherein the ratio of the volume of the at least one drug payload to the total volume of the implantable drug delivery device is from about 75 ?L/cc to about 150 ?L/cc.

Abstract: The current technology is relevant to a system having an implantable medical device, where the system is configured to identify a patient condition comprising cardiac dysynchrony, configured to notify a clinical user of the identified condition and configured to identify a therapy appropriate for the identified condition.

Abstract: In vivo devices, systems and methods for in vivo immunoassay include inserting into a patient's body lumen an in vivo diagnostic device comprising a housing. The housing of the device comprises a chamber, and a chromatography strip for immunoassay of a body lumen substance. The housing may further comprise a casing for the chromatography strip. The casing may comprise a first opening to allow entrance of in vivo liquids into the casing and a second opening into the chamber. The housing may further comprise a sensor to sense a property of the chromatography strip. Following insertion of the device into the patient's body, a sample is collected and the immunoassay is performed in vivo in areas of pathological lesions for a predetermined period of time. An in vivo image may be acquired or other data such as colorimetric or intensity data may be obtained from the chromatography strip.

Abstract: Controlling the interaction between an external device and an implanted device, including a method of controlling interaction between an external device and an implanted device, the method including at least the steps of: establishing communications between the implanted device and the external device; the external device determining an identification of the implant and comparing the identification with identifications in a stored list; if the device matches one of said identifications, then using a corresponding set of operating parameters to interact with said implant; and otherwise, not interacting with said device.