Abstract: TTFields therapy is a proven approach for treating tumors using electric fields. This application describes systems and methods for measuring the temperature at the electrode elements of the transducer arrays that are used to apply the TTFields to a subject. A distal circuit is positioned adjacent to each transducer array, and the distal circuit interfaces with temperature sensors in the transducer array to obtain temperature readings. Those temperature readings are transmitted to a central hub. In some embodiments, temperature measurements from all of the distal circuits occur simultaneously.

Abstract: In one example, a method of monitoring a sustained activity of a human or animal subject for the purpose of determining a risk group includes detecting a physical activity signal from the subject, determining a magnitude of the detected physical activity signal, initiating a timer in response to determining the magnitude of the physical activity signal exceeding an activity level threshold, triggering storing at least one value associated with the physical activity signal only when the magnitude of the physical activity signal exceeds the activity level threshold and the timer is greater than a duration threshold, and determining, using the processor circuit, an indication of the subject's cardiovascular disease based on the stored value.

Abstract: A portable device for evaluating a physical strength is disclosed. The portable device includes a first sensor for sensing walking of a user; a second sensor for sensing heartbeat of the user; and a controller for: measuring a walking speed of the user using a sensed result of the first sensor; measuring a heart rate of the user using a sensed result of the second sensor; and evaluating a physical strength of the user using the measured heart rate when the walking speed of the user is changed by a specific speed or more by comparing a virtual heart rate calculated using the walking speed of the user with the measured heart rate.

Abstract: A cardiac rhythm management system provides an increase in pacing rate as a combination of responses to three characteristics of a relative-temperature signal: a dip, a positive slope, and a positive magnitude. The relative-temperature signal is the difference between a short-term and a long-term temperature average. A dip produces a limited and temporary rate increase having a first proportionality. A positive slope produces a rate increase with a second proportionality. A positive magnitude produces a rate increase with a third proportionality. The dip response seeds the slope response to provide a seamless and immediate rate transition after a dip. The cardiac rhythm management system limits and filters the sum of the rate increases to provide a sensor indicated rate, which is used to stimulate the heart.

Abstract: Devices and methods for improving cardiac efficiency involve measuring, patient-internally, an oxygen saturation parameter indicative of oxygen usage of myocardial tissue of the heart. A cardiac electrical therapy is adjusted to cause a change of the measured oxygen saturation parameter, and the adjusted cardiac electrical therapy is selected for delivery based on a changed oxygen saturation parameter indicative of an increase in cardiac efficiency.

Abstract: Implantable medical devices (IMD) configured for implantation within a recess formed in a cranium of a patient, as well as associated methods, are described. In some embodiments, the IMD includes a top external surface and another adjacent external surface, e.g., a side surface, which are oriented with respect to each other to define an acute angle. A connection module for an electrical lead or catheter may be included on the top external surface. Embodiments of the invention may facilitate implantation of an IMD within a recess formed in the cranium of a patient at a location remote to an incision made in the scalp of the patient.

Abstract: A leadless cardiac pacemaker comprises a hermetic housing, a power source disposed in the housing, at least two electrodes supported by the housing, a semiconductor temperature sensor disposed in the housing, and a controller disposed in the housing and configured to deliver energy from the power source to the electrodes to stimulate the heart based upon temperature information from the temperature sensor. In some embodiments, the sensor can be configured to sense temperature information within a predetermined range of less than 20 degrees C. The temperature sensor can be disposed in the housing but not bonded to the housing.

Abstract: A cardiac pacing system controls the progression of a cardiac disorder such as heart failure by delivering cardiac stress augmentation pacing to create or augment regional stress in the heart according to a delivery schedule programmed for a patient. Various events associated with the patient's conditions, activities, and other treatments may render the cardiac stress augmentation pacing risky or ineffective. The system detects such events before and during each cardiac stress augmentation pacing session and modifies the delivery schedule in response to the detection of each event to ensure patient safety and therapy efficiency.

Abstract: In a patient suffering from neural impairment, stimulation is provided to sensory surfaces of the face and/or neck, or more generally to areas of the body that stimulate the trigeminal nerve, while performing an activity intended to stimulate a brain function to be rehabilitated. The simulation may then be continued after the performance of the activity has ceased. It has been found that the patient's performance of the activity is then improved after stimulation has ceased. Moreover, it tends to improve to a greater extent, and/or for a longer time, when the post-activity stimulation is applied, as compared to when postactivity stimulation is not applied.

Abstract: The temperature of a patient is a significant predictor of death in heart failure patients. Temperature provides a window into the physiology of the patient's underlying condition and may be used as an early marker for CHF exacerbations. The patient's temperature is taken to form a time series of temperature values. In accordance with some embodiments, the time series of temperature values is converted to the frequency domain by, for example, a discrete Fourier Transform. The frequency domain representation then is analyzed for a marker indicative of the worsening condition of the patient. In accordance with other embodiments, the patient's time series of temperature values is analyzed for a marker using, for example, Cosinor analysis. In yet other embodiments, both the time and frequency domain temperature data is analyzed for markers of the patient's worsening medical condition.

Abstract: Various aspects of the present disclosure are directed toward an implantable electrostimulation device, a plurality of sensing and pacing elements, and a fine wire lead extending in a sealed relationship from the electrostimulation device and to the plurality of sensing and pacing elements. The fine wire lead includes multiple discrete conductors and a drawn silica or glass fiber core, a polymer cladding on the drawn silica or glass fiber core, and a conductive metal cladding over the polymer cladding. Additionally, the fine wire lead simultaneously delivers different electrical signals or optical signals between the sensing and pacing elements and the electrostimulation device.

Abstract: A leadless cardiac pacemaker comprises a housing, a plurality of electrodes coupled to an outer surface of the housing, and a pulse delivery system hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse delivery system configured for sourcing energy internal to the housing, generating and delivering electrical pulses to the electrode plurality. The pacemaker further comprises a temperature sensor hermetically contained within the housing and adapted to sense temperature information, wherein the pacemaker can control electrical pulse delivery at least partly based on the temperature information.

Abstract: The invention relates to systems, devices, and methods for detecting infections associated with implantable medical devices. In an embodiment, the invention includes a method of detecting infection in a patient including measuring a physiological parameter using a chronically implanted sensor at a plurality of time points and evaluating the physiological parameter measurements to determine if infection is indicated. In an embodiment, the invention includes an implantable medical device including a first chronically implantable sensor configured to generate a first signal corresponding to a physiological parameter and a controller disposed within a housing, the controller configured to evaluate the first physiological parameter signal to determine if an infection is indicated. Other embodiments are also included herein.

Abstract: A leadless cardiac pacemaker comprises a hermetic housing, a power source disposed in the housing, at least two electrodes supported by the housing, a semiconductor temperature sensor disposed in the housing, and a controller disposed in the housing and configured to deliver energy from the power source to the electrodes to stimulate the heart based upon temperature information from the temperature sensor. In some embodiments, the sensor can be configured to sense temperature information within a predetermined range of less than 20 degrees C. The temperature sensor can be disposed in the housing but not bonded to the housing.

Abstract: A leadless cardiac pacemaker comprises a housing, a plurality of electrodes coupled to an outer surface of the housing, and a pulse delivery system hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse delivery system configured for sourcing energy internal to the housing, generating and delivering electrical pulses to the electrode plurality. The pacemaker further comprises a temperature sensor hermetically contained within the housing and adapted to sense temperature information, wherein the pacemaker can control electrical pulse delivery at least partly based on the temperature information.

Abstract: An external defibrillator having a battery; a capacitor electrically communicable with the battery; at least two electrodes electrically communicable with the capacitor and with the skin of a patient; a controller configured to charge the capacitor from the battery and to discharge the capacitor through the electrodes; and a support supporting the battery, capacitor, electrodes and controller in a deployment configuration, the defibrillator having a maximum weight per unit area in the deployment configuration of 0.1 lb/in2 and/or a maximum thickness of 1 inch. The support may be a waterproof housing.

Abstract: Systems, devices and methods for defining, identifying and utilizing composite parameter indices from health-related parameters are disclosed. One aspect is a programmable device having machine executable instructions for performing a method to assist with managing a patient's health. In various embodiments, a first set of at least two health-related parameters is acquired. A first composite parameter is generated using the first set of at least two health-related parameters. Other aspects and embodiments are provided herein.

Abstract: Embodiments of the invention are related to an implantable medical system, amongst other things. In an embodiment, the invention includes a processor, an electrical sensor, and a temperature sensor. The processor is configured to monitor myocardial electrical activity with input from the electrical sensor; identify myocardial electrical activity indicative of an arrhythmia, measure temperature of blood in the coronary venous system with input from the temperature sensor; determine if the arrhythmia is hemodynamically stable or hemodynamically unstable based on the temperature of blood in the coronary venous system, and initiate high-voltage shock therapy if the arrhythmia is hemodynamically unstable. Other embodiments are also included herein.

Abstract: A cardiac stimulator has an implantable cardiac lead that carries a temperature sensitive element with a surface thereof in contact with biological matter. The temperature sensitive element emits a temperature signal corresponding to the temperature of biological matter, such as blood, in contact with the surface of the temperature sensitive element. Processing circuitry receives the temperature signal and determines a variability thereof within a selected time interval. A status signal is emitted dependent on this variability.

Abstract: An apparatus comprises an implantable cardiac signal sensing circuit that provides an electrical cardiac signal representative of cardiac activity of a subject, an implantable therapy circuit that delivers electrical pacing stimulation energy to a heart of a subject, and a controller circuit. The controller circuit includes a chronotropic incompetence detection circuit that initiates pacing of an atrium of the subject at a rate higher than a device-indicated rate or a sensed intrinsic rate, monitor the AV interval, initiates an increase in the pacing rate while continuing the monitoring of the AV interval, calculates a change in AV intervals between a highest paced rate used in the monitoring and a lowest paced rate used in the monitoring, and indicates that the AV intervals are evidence of chronotropic incompetence when the calculated change in the AV intervals exceeds a specified threshold AV interval change value.

Abstract: A system and method for predicting and avoiding a seizure in a patient. The system and method includes use of an implanted surface acoustic wave probe and coupled RF antenna to monitor temperature of the patient's brain, critical changes in the temperature characteristic of a precursor to the seizure. The system can activate an implanted cooling unit which can avoid or minimize a seizure in the patient.

Abstract: A leadless cardiac pacemaker comprises a housing, a plurality of electrodes coupled to an outer surface of the housing, and a pulse delivery system hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse delivery system configured for sourcing energy internal to the housing, generating and delivering electrical pulses to the electrode plurality. The pacemaker further comprises a temperature sensor hermetically contained within the housing and adapted to sense temperature information, wherein the pacemaker can control electrical pulse delivery at least partly based on the temperature information.

Abstract: A method and apparatus for verifying a determined cardiac event in a medical device based on detected variation in hemodynamic status that includes a plurality of sensors sensing cardiac signals, and a physiologic sensor sensing physiologic signals to generate a plurality of variation index samples corresponding to the sensed signals. A microprocessor detects a cardiac event in response to the sensed cardiac signals, computes a variation index trend associated with a predetermined number of variation index samples of the plurality of variation index samples, determines whether the sensed cardiac signals are associated with noise in response to the computed variation index, and confirms the determined cardiac event in response to the sensed cardiac signals not being associated with noise.

Abstract: A leadless cardiac pacemaker comprises a housing, a plurality of electrodes coupled to an outer surface of the housing, and a pulse delivery system hermetically contained within the housing and electrically coupled to the electrode plurality, the pulse delivery system configured for sourcing energy internal to the housing, generating and delivering electrical pulses to the electrode plurality. The pacemaker further comprises an activity sensor hermetically contained within the housing and adapted to sense activity and a processor hermetically contained within the housing and communicatively coupled to the pulse delivery system, the activity sensor, and the electrode plurality, the processor configured to control electrical pulse delivery at least partly based on the sensed activity.

Abstract: In some embodiments, an implantable medical device (IMD) system may include one or more of the following elements: (a) an oxygen sensor for measuring oxygen extraction from blood flowing through a coronary sinus of a patient's heart, (b) an oxygen signal generated by the oxygen sensor, (c) an IMD coupled to the oxygen sensor, wherein the IMD is configured to output pacing pulses as a function of the oxygen signal, and (d) an atrial and a ventricular pacing lead coupled to the IMD to deliver the pacing pulses to the patient's heart, wherein the IMD generates the pacing pulses as a function of the oxygen signal, wherein the pacing pulses are adjusted by the IMD as a function of the oxygen signal, wherein the IMD is configured to adjust the pacing pulses to increase oxygen in the blood flow through the coronary sinus.

Abstract: Methods and systems for diagnosing disorders, including, for example, disordered breathing, involve sensing one or more of a blood chemistry parameter and/or an expired gas parameter, such as expired respiratory gas concentration, blood gas concentration, and blood pH. Diagnosis of the disorder may be performed by a medical device, such as a respiratory therapy device or a cardiac therapy device, based on implantably detected blood gas/pH concentration/level or externally detected expired respiratory gas concentration. Cardiac and respiratory therapies for addressing the disorder may be adjusted based on the detected parameters.

Abstract: A method and apparatus for verifying a determined cardiac event in a medical device based on detected variation in hemodynamic status that includes a physiologic sensor sensing physiologic signals to generate a plurality of variation index samples corresponding to the sensed signals, and a microprocessor computing a variation index trend associated with a predetermined number of variation index samples of the plurality of variation index samples, determining whether deviations of the predetermined number of variation index samples over predetermined sampling windows are less than a deviation threshold, and determining, in response to the deviations being less than the deviation threshold, a corrected variation index trend in response to the changes in the variation index trend during the predetermined sampling windows.

Abstract: A method for decreasing responsiveness or decreasing resistance to airflow of airways involves the transfer of energy to or from the airway walls to prevent or reduce airway constriction and other symptoms of lung diseases. The treatment reduces the ability of the airways to contract during an acute narrowing of the airways, reduces mucus plugging of the airways, and/or increases the airway diameter. The methods according to the present invention provide a longer duration and/or more effective treatment for lung diseases than currently used drug treatments, and obviate patient compliance issues.

Abstract: A cardiac pacing system controls the progression of a cardiac disorder such as heart failure by delivering cardiac stress augmentation pacing to create or augment regional stress in the heart according to a delivery schedule programmed for a patient. Various events associated with the patient's conditions, activities, and other treatments may render the cardiac stress augmentation pacing risky or ineffective. The system detects such events before and during each cardiac stress augmentation pacing session and modifies the delivery schedule in response to the detection of each event to ensure patient safety and therapy efficiency.

Abstract: An IV pole mountable, therapeutic infusate processing device is incorporated into a hypothermia system to receive therapeutic fluid(s), such as normal saline, peritioneal dialysis solution, or other crystalloid solution, to heat such therapeutic fluid(s) a few degrees centigrade above normal body temperature and to direct the resulting heated infusate to and through a selected anatomical portion of a patients body to raise the temperature of that body portion so as to affect any cancerous or other tumors that may be located therein. The processing device is provided with touch screen controls and visual indicators to facilitate its proper use; while the system further includes temperature and pressure sensors to monitor the hyperthermia processing to insure patient safety.

Abstract: Methods and systems for performing pacing interval optimization are provided. One or more optimum pacing interval is determined for each of a plurality of different ranges of heart rate, different levels of autonomic tone, different body temperature ranges, or combinations thereof. The information (e.g., measures of hemodynamic response) collected to perform pacing interval optimization can be collected and stored in a table over disjoint periods of time. Such measures of hemodynamic performance are preferably relative measures, but can alternatively be absolute measures.

Abstract: Systems including an implantable receiver-stimulator and an implantable controller-transmitter are used for leadless electrical stimulation of body tissues. Cardiac pacing and arrhythmia control is accomplished with one or more implantable receiver-stimulators and an external or implantable controller-transmitter. Systems are implanted by testing external or implantable devices at different tissue sites, observing physiologic and device responses, and selecting sites with preferred performance for implanting the systems. In these systems, a controller-transmitter is activated at a remote tissue location to transmit/deliver acoustic energy through the body to a receiver-stimulator at a target tissue location. The receiver-stimulator converts the acoustic energy to electrical energy for electrical stimulation of the body tissue. The tissue locations(s) can be optimized by moving either or both of the controller-transmitter and the receiver-stimulator to determine the best patient and device responses.

Abstract: The temperature of a patient is a significant predictor of death in heart failure patients. Temperature provides a window into the physiology of the patient's underlying condition and may be used as an early marker for CHF exacerbations. The patient's temperature is taken to form a time series of temperature values. In accordance with some embodiments, the time series of temperature values is converted to the frequency domain by, for example, a discrete Fourier Transform. The frequency domain representation then is analyzed for a marker indicative of the worsening condition of the patient. In accordance with other embodiments, the patient's time series of temperature values is analyzed for a marker using, for example, Cosinor analysis. In yet other embodiments, both the time and frequency domain temperature data is analyzed for markers of the patient's worsening medical condition.

Abstract: An implantable heart stimulating device for indicating congestive heart failure (CHF) has a processor, an activity sensor that generates an activity signal indicative of a patient's activity, and a blood temperature sensor that measures blood temperature inside the heart of the patient and generates a temperature signal indicative of the measured temperature. From the activity signal and the temperature signal, the processor identifies a characteristic dip in the temperature signal related to a predetermined increase in the activity signal. The processor determines a CHF indicator value indicating the degree of CHF based on the magnitude of the temperature sensor dip for at least two increased activity levels.

Abstract: An implantable medical device such as a cardiac pacemaker or implantable cardioverter/defibrillator with the capability of storing body temperature measurements taken periodically and/or when triggered by particular events.

Abstract: Methods of cardiac pacing involve sensing left ventricular electrical rhythms, sensing left ventricular blood flow rate, and sensing a coronary vein blood temperature. The methods further involve modifying delivery of synchronized electrical signals to the patient's heart based at least in part on the sensed coronary vein blood temperature and sensed left ventricular flow rate.

Abstract: A cardiac stimulation device and method monitor and store discrepancies in sensor indicated rates determined from two or more sensors generating signals related to metabolic demand. One feature included in the present invention is a sensor cross-check record that stores the time, duration and sensor indicated rates whenever individual sensor indicated rates differ by more than a discrepancy threshold. This record allows a clinician to monitor an abnormal patient condition or determine if a sensor is not functioning properly or is programmed sub-optimally. Another feature provided by the present invention is a sensor cross-check histogram in which sensor indicated rate differences are stored. Histogram data aids the clinician in selecting programmable operating parameters that control the calculation of sensor indicated rates and the rate response of the cardiac stimulation device.

Abstract: A lead system is provided including a coronary sinus lead extending from a proximal end to a distal end, where the lead includes at least one thermal sensor, or optionally, a thermistor. The thermal sensor is positionable within a coronary sinus of a heart when the coronary sinus lead is implanted in the heart to measure the temperature of a myocardium. The method includes coupling at least one thermal sensor with the implantable lead, including coupling a first thermal sensor and a second thermal sensor with the lead, placing the implantable lead and at least one thermal sensor within a coronary sinus of a heart and positioning the first thermal sensor within the coronary sinus, and positioning the second thermal sensor within a right atrium of a heart. The method further includes coupling the implantable lead with the implantable electrical stimulation source, and measuring a myocardium temperature.

Abstract: A plurality of sensors are disposed in and around the heart of a patient to collect data such as various electrical parameters, pressure parameters and temperature parameters. The data collected via the sensors may be organized and stored according to cardiac rhythm type. The organization of data according to cardiac rhythm type allows the patient's physician to be better able to monitor how the various parameters are related to the various cardiac rhythm types. In a typical embodiment, one or more of the sensors may be deployed on a single lead implanted in the heart.

Abstract: An implanted heart monitor includes sensors that measure various aspects of the heart failure patient's heart. A remote heart monitoring system connects the implanted heart monitor to a care provider, such as a physician. The data provided by the implanted heart monitor permits the care provider to obtain valuable data on the heart in order to make health care decisions affecting the heart failure patient's treatment. In many cases, the measurement of core body temperature and other patient data will enable the care provider to alter the patient's treatment to address the patient's condition. The implanted heart monitor can communicate over a wireless communication link with an external monitor. The implanted heart monitor may be implemented as part of a pacing device (i.e., pace maker) or may be a separate unit devoted to monitoring functions. The external monitor communicates with a monitoring station over a communication link.

Abstract: A body implantable system employs a lead system having at least one electrode and at least one thermal sensor at a distal end. The lead system is implanted within a patient's heart in a coronary vein of the left ventricle. The thermal sensor can be attached to a catheter that is disposed within an open lumen of the lead system. The thermal sensor senses a coronary vein temperature. The coronary vein temperature can be measured at a detector/energy delivery system and used as an activity indicator to adaptively control pacing rate. The measured coronary vein temperature can be also used with a left ventricular flow measurement to determine hemodynamic efficiency of the heart. A detected change in hemodynamic efficiency can be used by the detector/energy delivery system to modify the delivery of electrical pulses to the lead system.

Abstract: A technique and apparatus therefor adapted to treat in situ specified tissue, especially a malignant tumor, use being made of electrodes implanted in the tissue at spaced positions. Applied across the electrodes is a voltage causing a current to flow through the tissue to be treated. This current in one embodiment of the invention produces an electrochemical reaction yielding multiple reaction products, some of which are cytotoxic agents destructive of cancer cells, the voltage being regulated to optimize the yield of those agents having the greatest efficacy. In another embodiment, fed to the tissue is one or more reagents which when current flows through the tissue react with the material of an electrode to yield a cytotoxic agent in situ. Alternatively, the surface of the electrode can serve as a catalyst for the formation of the cytotoxic agents.

Abstract: A medical implantable device that includes a temperature sensor circuit and a control circuit coupled to the temperature sensor circuit to control non-therapy operation of the medical implantable device in response to temperature measurements obtained by the temperature sensor circuit.

Abstract: An implantable medical device such as a cardiac pacemaker or implantable cardioverter/defibrillator with the capability of storing body temperature measurements taken periodically and/or when triggered by particular events.

Abstract: A body implantable system employs a lead system having at least one electrode and at least one thermal sensor at a distal end. The lead system is implanted within a patient's heart in a coronary vein of the left ventricle. The thermal sensor can be attached to a catheter that is disposed within an open lumen of the lead system. The thermal sensor senses a coronary vein temperature. The coronary vein temperature can be measured at a detector/energy delivery system and used as an activity indicator to adaptively control pacing rate. The measured coronary vein temperature can be also used with a left ventricular flow measurement to determine hemodynamic efficiency of the heart. A detected change in hemodynamic efficiency can be used by the detector/energy delivery system to modify the delivery of electrical pulses to the lead system.

Abstract: An implantable medical device such as a cardiac pacemaker or implantable cardioverter/defibrillator with the capability of storing body temperature measurements taken periodically and/or when triggered by particular events.

Abstract: A rate responsive pacemaker is provided having the capability of automatically adjusting the lower rate limit (LRL) for sleep, or nighttime. The pacemaker has a temperature sensor for determining patient blood temperature, and processes patient blood temperature data to obtain an average daily low value of nighttime blood temperature. The pacemaker monitors blood temperature to determine a drop below a threshold which is coupled to the average daily low value, as well as when the rate of temperature change exceeds a predetermined limit, these two coincident conditions suggesting onset of nighttime and/or sleep. Lower rate limit is decremented, preferably by a predetermined amount at onset of nighttime, and is automatically incremented when patient blood temperature and/or time of day indicate the end of nighttime.

Abstract: An improved arm sling is provided comprising a first elongated member and a second elongated member being joined together, a first curved member extending from the first elongated member and a second curved member extending from the second elongated member, the first curved member for engaging the neck of a user, and the second curved member for supporting an injured arm of the user. The method of using the improved arm sling according to the present invention comprises the steps of connecting the two elongated members, positioning the first curved member around the neck of a user, and supporting an injured arm of the user on the second curved member. The present invention has the advantages of being adjustable in length and being usable on either a right or a left arm.

Abstract: A method and apparatus for minimizing the potential for injury due to operation of a body-implantable device during explant manipulation thereof. In one embodiment of the invention, a body-implantable device is provided with a temperature sensor and associated monitor circuit which issues a deactivation signal when the sensed temperature falls below a predetermined threshold level. Provision is made for subsequent reactivation of the device if it is determined, for example, that sensor failure has led to spurious deactivation of the device.

Abstract: An apparatus for determining a physical condition in a living subject by determining peripheral resistance to flow is wherein peripheral resistance to flow is determined by measuring changes in the pressure drop characteristic in an artery during diastole. The pressure drop characteristic can be determined by measuring absolute pressure, relative pressure or dimensional changes in the artery during diastole. The apparatus can advantageously be used in a rate-responsive heart stimulator.