Abstract: Methods and devices for monitoring and/or treating patients comprise a switch to automatically start-up the device when the device contacts tissue. By automatically starting up the device, the device may be installed without the clinician and/or user turning on the device, such that the device can be easy to use. In many embodiments, the device comprises startup circuitry with very low current and/or power consumption, for example less than 100 pA. The startup circuitry can detect tissue contact and turn on circuitry that is used to monitor or treat the patient.

Abstract: Methods and apparatus combine patient measurement data with demographic or physiological data of the patient to determine an output that can be used to diagnose and treat the patient. A customized output can be determined based the demographics of the patient, physiological data of the patient, and data of a population of patients. In another aspect, patient measurement data is used to predict an impending cardiac event, such as acute decompensated heart failure. At least one personalized value is determined for the patient, and a patient event prediction output is generated based at least in part on the personalized value and the measurement data. For example, bioimpedance data may be used to establish a baseline impedance specific to the patient, and the patient event prediction output generated based in part on the relationship of ongoing impedance measurements to the baseline impedance. Multivariate prediction models may enhance prediction accuracy.

Abstract: Methods and apparatus to determine the presence of and track functional chronotropic incompetence (hereinafter “CI”) in an in-home setting under conditions of daily living. The functional CI of the patient may be determined with one or more of a profile of measured patient heart rates, a measured maximum patient heart rate, or a peak of the heart rate profile. The functional CI of the patient may be determined with the measured heart rate profile, in which the measured heart rate profile may correspond to heart rates substantially less than the maximum heart rate of the patient, such that the heart rate can be safely measured when the patient is remote from a health care provider. The functional CI of the patient may be determined based a peak of the remotely measured heart rate profile, for example a peak corresponding to the mode of the heart rate distribution profile.

Abstract: A device to measure tissue impedance comprises drive circuitry coupled to calibration circuitry, such that a calibration signal from the calibration circuitry corresponds to the current delivered through the tissue. Measurement circuitry can be coupled to measurement electrodes and the calibration circuitry, such that the tissue impedance can be determined in response to the measured calibration signal from the calibration circuitry and the measured tissue impedance signal from the measurement electrodes. Processor circuitry comprising a tangible medium can be configured to determine a complex tissue impedance in response to the calibration signal and the tissue impedance signal. The processor can be configured to select a frequency for the drive current, and the amount of drive current at increased frequencies may exceed a safety threshold for the drive current at lower frequencies.

Abstract: An adherent device is configured to adhere to the skin of the patient with an adherent patch, for example breathable tape, coupled to at least four electrodes. The device comprises impedance circuitry coupled to the at least four electrodes and configured to measure respiration of the patient to detect sleep apnea and/or hypopnea. The impedance circuitry may be used to measure hydration of the patient. An accelerometer can be mechanically coupled to the adherent patch such that the accelerometer can be coupled to and move with the skin of the patient. Electrocardiogram circuitry to generate an electrocardiogram signal may be coupled to at least two of the at least four electrodes to detect the sleep apnea and/or hypopnea.

Abstract: Systems and methods of detecting an impending cardiac decompensation of a patient measure an electrocardiogram signal of the patient. An incidence of cardiac arrhythmias is determined from the electrocardiogram signal. A risk of impending decompensation is determined in response to the incidence of cardiac arrhythmias. In many embodiments, the impending decompensation can be detected early enough to avoid, or at least delay, the impending decompensation, such that patient trauma and/or expensive ICU care can be avoided. Although embodiments make specific reference to monitoring electrocardiogram and other physiological signals with an adherent patch, the system methods and devices are applicable to many applications in which physiological monitoring is used, for example wireless physiological monitoring with implanted sensors for extended periods.

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: A respiratory monitoring system is provided. A measuring system is provided that includes, (i) an adherent device configured to be coupled to a patient, the adherent device including a plurality of sensors that monitor respiratory status, at least one of the sensors configured to monitor the patient's respiration, and (ii) a wireless communication device coupled to the plurality of sensors and configured to transfer patient data directly or indirectly from the plurality of sensors to a remote monitoring system. A remote monitoring system is coupled to the wireless communication device.

Abstract: An adherent patient device is configured to adhere to the skin of the patient and measure electrocardiogram data, impedance data, accelerometer data, blood oxygen data and temperature data. The adherent device can communicate wirelessly with gateways and a local processor system, such that the patient can wander about the hospital and update the monitoring station with the patient data when the patient is ambulatory. The local processor system can be configured to customize alerts for the patient, for example to notify automatically a specialist in response to a special condition of the patient. The adherent device may comprise a unique adherent device identifier such that the customized alert can be sent based on the unique device identifier. Each of the gateways can be carried and may comprise a unique gateway identifier, such that the unique device identifier and the unique gateway identifier can be used to locate the ambulatory patient.

Abstract: An adherent device to monitor a patient for an extended period comprises a breathable tape. The breathable tape comprises a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient. At least one electrode is affixed to the breathable tape and capable of electrically coupling to a skin of the patient. A printed circuit board is connected to the breathable tape to support the printed circuit board with the breathable tape when the tape is adhered to the patient. Electronic components electrically are connected to the printed circuit board and coupled to the at least one electrode to measure physiologic signals of the patient. A breathable cover and/or an electronics housing is disposed over the circuit board and electronic components and connected to at least one of the electronics components, the printed circuit board or the breathable tape.

Abstract: An adherent device to monitor a patient comprises an adhesive patch to adhere to a skin of the patient. At least four electrodes are connected to the patch and capable of electrically coupling to the patient. Impedance circuitry is coupled to the at least four electrodes to measure a hydration signal of the patient. Electrocardiogram circuitry is coupled to at least two of the at least four electrodes to measure an electrocardiogram signal of the patient. An accelerometer can be mechanically coupled to the adhesive patch to generate a signal in response to at least one of an activity or a position of the patient.

Abstract: Methods and apparatus to determine the presence of and track functional chronotropic incompetence (hereinafter “CI”) in an in-home setting under conditions of daily living. The functional CI of the patient may be determined with one or more of a profile of measured patient heart rates, a measured maximum patient heart rate, or a peak of the heart rate profile. The functional CI of the patient may be determined with the measured heart rate profile, in which the measured heart rate profile may correspond to heart rates substantially less than the maximum heart rate of the patient, such that the heart rate can be safely measured when the patient is remote from a health care provider. The functional CI of the patient may be determined based a peak of the remotely measured heart rate profile, for example a peak corresponding to the mode of the heart rate distribution profile.

Abstract: Systems and methods of detecting an impending cardiac decompensation of a patient measure at least two of an electrocardiogram signal of the patient, a hydration signal of the patient, a respiration signal of the patient or an activity signal of the patient. The at least two of the electrocardiogram signal, the hydration signal, the respiration signal or the activity signal are combined with an algorithm to detect the impending cardiac decompensation.

Abstract: Methods and apparatus combine patient measurement data with demographic or physiological data of the patient to determine an output that can be used to diagnose and treat the patient. A customized output can be determined based the demographics of the patient, physiological data of the patient, and data of a population of patients. In another aspect, patient measurement data is used to predict an impending cardiac event, such as acute decompensated heart failure. At least one personalized value is determined for the patient, and a patient event prediction output is generated based at least in part on the personalized value and the measurement data. For example, bioimpedance data may be used to establish a baseline impedance specific to the patient, and the patient event prediction output generated based in part on the relationship of ongoing impedance measurements to the baseline impedance. Multivariate prediction models may enhance prediction accuracy.

Abstract: Systems and methods of detecting an impending cardiac decompensation of a patient measure an electrocardiogram signal of the patient. An incidence of cardiac arrhythmias is determined from the electrocardiogram signal. A risk of impending decompensation is determined in response to the incidence of cardiac arrhythmias. In many embodiments, the impending decompensation can be detected early enough to avoid, or at least delay, the impending decompensation, such that patient trauma and/or expensive ICU care can be avoided. Although embodiments make specific reference to monitoring electrocardiogram and other physiological signals with an adherent patch, the system methods and devices are applicable to many applications in which physiological monitoring is used, for example wireless physiological monitoring with implanted sensors for extended periods.

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 adherent device is configured to adhere to the skin of the patient with an adherent patch, for example breathable tape, coupled to at least four electrodes. The device comprises impedance circuitry coupled to the at least four electrodes and configured to measure respiration of the patient to detect sleep apnea and/or hypopnea. The impedance circuitry may be used to measure hydration of the patient. An accelerometer can be mechanically coupled to the adherent patch such that the accelerometer can be coupled to and move with the skin of the patient. Electrocardiogram circuitry to generate an electrocardiogram signal may be coupled to at least two of the at least four electrodes to detect the sleep apnea and/or hypopnea.

Abstract: A device to measure tissue impedance comprises drive circuitry coupled to calibration circuitry, such that a calibration signal from the calibration circuitry corresponds to the current delivered through the tissue. Measurement circuitry can be coupled to measurement electrodes and the calibration circuitry, such that the tissue impedance can be determined in response to the measured calibration signal from the calibration circuitry and the measured tissue impedance signal from the measurement electrodes. Processor circuitry comprising a tangible medium can be configured to determine a complex tissue impedance in response to the calibration signal and the tissue impedance signal. The processor can be configured to select a frequency for the drive current, and the amount of drive current at increased frequencies may exceed a safety threshold for the drive current at lower frequencies.

Abstract: An adherent device comprises an adhesive patch with at least two electrodes and an accelerometer. The accelerometer can be used to determine an orientation of the at least two measurement electrodes on a patient. By determining the orientation of the electrodes of the patch on the patient, physiologic measurements with the at least two electrodes can be adjusted and/or corrected in response to the orientation of the patch on the patient. The adherent patch and/or electrodes can be replaced with a second adherent patch and/or electrodes, and the orientation of the second adherent patch and/or electrodes can be determined with the accelerometer or a second accelerometer. The determined orientation of the second patch and/or electrodes on the patient can be used to correct measurements made with the second adherent patch and/or electrodes.

Abstract: An adherent device to monitor a tissue hydration of a patient comprises an adhesive patch to adhere to a skin of the patient. At least four electrodes are connected to the patch and capable of electrically coupling to the patient. Impedance circuitry is coupled to the at least four electrodes to measure a tissue resistance of the patient, where the circuitry is configured to determine the tissue hydration in response to tissue resistance. The circuitry may comprise a processor system and the tissue resistance may correspond to a change in patient body fluid. The impedance circuitry is configured to measure the hydration signal using at least one low measurement frequency, which may be in the range of 0 to 10 kHz. Multiple measurement frequencies may be used and the hydration signal may include a tissue reactance measurement.