Abstract: Devices, systems and methods are described which control blood pressure, nervous system activity, and neurohormonal activity by activating baroreceptors. By selectively and controllably activating baroreceptors, the present invention reduces excessive blood pressure, sympathetic nervous system activity and neurohormonal activity, thereby minimizing their deleterious effects on a heart, vasculature and other organs and tissues. A baroreceptor activation device is positioned near a low-pressure baroreceptor, preferably in the venous system, heart, or pulmonary vasculature.

Abstract: Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive technique. An implantable baroreflex activation system includes a control system having an implantable housing, an electrical lead, attachable to the control system, and an electrode structure. The electrode structure is near one end of the electrical lead, and includes a monopolar electrode, a backing material having an effective surface area larger than the electrode, and a releasable pivotable interface to mate with an implant tool. The electrode is configured for implantation on an outer surface of a blood vessel and the control system is programmed to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.

Abstract: Systems and methods provide baroreflex activation to treat or reduce pain and/or to cause or enhance sedation or sleep. Methods involve activating the baroreflex system to provide pain reduction, sedation, improved sleep or some combination thereof. Systems include at least one baroreflex activation device, at least one sensor for sensing physiological activity of the patient, and a processor coupled with the baroreflex activation device(s) and the sensor(s) for processing sensed data received from the sensor and for activating the baroreflex activation device. In some embodiments, the system is fully implantable within a patient, such as in an intravascular, extravascular or intramural location.

Abstract: Devices and methods of use are described for identification, treatment, and/or management of heart failure and/or associated conditions. An exemplary device may include a first fluid status monitoring circuit configured to monitor a first fluid status indicator of a pulmonary fluid status associated with pulmonary edema, a second fluid status monitoring circuit configured to monitor a separate and different second fluid status indicator of a non-pulmonary fluid status, and a controller coupled to the first and second fluid status monitoring circuits, and a therapy circuit coupled to the controller. The controller is configured to use information about the first and second fluid status indicators to determine a therapy control signal to control a therapy, and the therapy circuit is configured to provide therapy in response to the therapy control signal to adjust at least one of the pulmonary fluid status or the non-pulmonary fluid status.

Abstract: Devices and methods for use of identification, treatment and/or management of heart failure and/or associated conditions. Methods may include providing a baroreflex therapy system, providing an implantable measurement device proximate a blood vessel of a patient, the implantable measurement device including a plurality of electrodes, determining an impedance of the blood vessel with the implantable measurement device over a time period of at least one cardiac cycle, generating at least one signal representative of a pressure waveform based on the impedance, activating, deactivating or otherwise modulating the baroreflex therapy system to deliver a therapy to treat heart failure based at least in part on the at least one signal representative of the pressure waveform.

Abstract: Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: A system for stimulating a baroreflex of a patient that includes a first light source with a first emitter for emitting a first light, the first emitter at a first location proximate a target tissue having baroreceptor cells, and a second light source including a second emitter and for emitting a second light, the second emitter at a second location proximate the target tissue. The system also includes a control circuit coupled to the first and the second light sources, the control circuit configured to activate the first and the second light sources such that the first light traverses a first pathway to arrive at and penetrate the first portion of the target tissue and the second light-like traverses a second pathway to arrive at and penetrate the second portion of the target tissue, thereby stimulating the baroreceptor cells and activating a baroreflex of the patient.

Abstract: A system for providing baroreflex stimulation comprises a sensor to detect a parameter and provide a signal indicative of the parameter and a baroreflex stimulator. The baroreflex stimulator includes a driver to provide a control signal adapted to deliver a baroreflex therapy and a controller to receive the signal indicative of the parameter and modulate the control signal based on the signal indicative of the parameter to change the baroreflex therapy from a first baroreflex therapy to a second baroreflex therapy.

Abstract: A real time, heart rate monitor and a hemodynamic monitoring system are operably integrated with the programmer system for an implantable hypertension treatment device. A series of tests are automatically performed to set programmable parameters for the implantable hypertension treatment device without clinician intervention. In one embodiment, a predetermined level of a dose-response evaluation is initiated for each test in the series. Preferably, the programmer system monitors the heart rate to determine whether a hemodynamic measurement should be initiated at all for a given test, as well as whether the hemodynamic measurement should be initiated earlier or later than a predetermined settling period for assessing the sympathetic nervous response to the test dose. In one embodiment, this determination is based on heart rate stability/instability.

Abstract: Devices and methods of use for identification, treatment and/or management of heart failure and/or associated conditions. An exemplary device may include a first sensor configured to monitor a parameter indicative of a fluid level in a pulmonary circulation of a patient, a second sensor configured to monitor a parameter indicative of a fluid level in a non-pulmonary circulation of a patient, and a control system coupled to the first sensor and second sensor. The control system is configured to provide a baroreflex therapy to the patient based at least in part on the parameter indicative of a fluid level in a pulmonary circulation and the parameter indicative of a fluid level in a non-pulmonary circulation. The baroreflex therapy adjusts at least one of the fluid level in the pulmonary circulation and the fluid level in the non-pulmonary circulation.

Abstract: A tissue stimulation device includes an electrode array having at least four independently switchable electrodes. In one embodiment, the electrode array comprises a flexible base to which the electrodes are fixed that flexes to encompass at least a portion of an artery or other elongate biological structure. The electrodes are electrically coupled to and energized by a signal generator coupled to a control system. In one embodiment, the array of electrodes are configured such that a suitable signal pattern for stimulation pulses between or among a set of the switchable electrodes may be determined without having to reposition the electrode assembly by using a series of signal patterns activating different combinations of switchable electrodes in response to sub-stimulation test signals to determine a signal pattern that provides suitable patient response. In another embodiment, the array of electrodes includes an array of selectively activatable multi-polar electrodes.

Abstract: The present invention comprises a medical device having a baroreflex stimulator to generate a stimulation signal, the stimulation signal being adapted to stimulate a baroreflex, and a controller to communicate with the baroreflex stimulator and implement a baroreflex stimulus regimen to vary an intensity of the baroreflex stimulation provided by the stimulation signal to maintain stimulation efficacy.

Abstract: Devices and methods of use are described for identification, treatment, and/or management of heart failure and/or associated conditions. An exemplary system may include a baroreflex activation device configured to be implantable proximate a blood vessel of a patient, a measurement device configured to be implantable proximate a blood vessel, and a control system coupled to the baroreflex activation device and the measurement device and in communication with a blood pressure sensing means. The control system is programmed to automatically determine pressure waveform data from the measurement device over a time period of at least a portion of one cardiac cycle, determine a patient physiological parameter based on the pressure waveform data, and compare the patient physiological parameter to a blood pressure measurement taken from the blood pressure sensing means.

Abstract: The present invention provides systems, devices, and methods for using the same for activating (stimulating) the baroreflex system of a patient using a baroreflex activation system with incrementally changing therapy intensity by sensing/monitoring/interpreting sensed data.

Abstract: Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. An intravascularly implantable medical device may include a sleeve formed at least in part of an expandable member configured to be movably attachable about at least a portion of an outer surface of an expandable intravascular stent, and one or more electrodes disposed on the sleeve and coupled to a control system and configured to selectively activate baroreceptors within a wall of a vessel when the expandable intravascular stent is implanted within the vessel.

Abstract: A method of determining one or more physiological parameter of a patient by providing a plurality of implantable electrodes proximate a blood vessel of the patient, applying a measurement signal through the plurality of electrodes, the measurement signal having a known parameter, obtaining a resultant signal through the plurality of electrodes, the resultant signal having a resultant parameter, calculating vascular impedance based on the measurement signal and the resultant signal, and calculating a physiological parameter based on the vascular impedance. In some embodiments, the physiological parameter is utilized to modify a therapy signal controlling therapy delivered to the patient.

Abstract: Systems and methods provide baroreflex activation to treat or reduce pain and/or to cause or enhance sedation or sleep. Methods involve activating the baroreflex system to provide pain reduction, sedation, improved sleep or some combination thereof. Systems include at least one baroreflex activation device, at least one sensor for sensing physiological activity of the patient, and a processor coupled with the baroreflex activation device(s) and the sensor(s) for processing sensed data received from the sensor and for activating the baroreflex activation device. In some embodiments, the system is fully implantable within a patient, such as in an intravascular, extravascular or intramural location.

Abstract: A method of determining one or more physiological parameter of a patient by providing a plurality of implantable electrodes proximate a blood vessel of the patient, applying a measurement signal through the plurality of electrodes, the measurement signal having a known parameter, obtaining a resultant signal through the plurality of electrodes, the resultant signal having a resultant parameter, calculating vascular impedance based on the measurement signal and the resultant signal, and calculating a physiological parameter based on the vascular impedance. In some embodiments, the physiological parameter is utilized to modify a therapy signal controlling therapy delivered to the patient.

Abstract: Systems and methods provide baroreflex activation to treat or reduce pain and/or to cause or enhance sedation or sleep. Methods involve activating the baroreflex system to provide pain reduction, sedation, improved sleep or some combination thereof. Systems include at least one baroreflex activation device, at least one sensor for sensing physiological activity of the patient, and a processor coupled with the baroreflex activation device(s) and the sensor(s) for processing sensed data received from the sensor and for activating the baroreflex activation device. In some embodiments, the system is fully implantable within a patient, such as in an intravascular, extravascular or intramural location.

Abstract: Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive technique. An implantable baroreflex activation system includes a control system having an implantable housing, an electrical lead, attachable to the control system, and an electrode structure. The electrode structure is near one end of the electrical lead, and includes a monopolar electrode, a backing material having an effective surface area larger than the electrode, and a releasable pivotable interface to mate with an implant tool. The electrode is configured for implantation on an outer surface of a blood vessel and the control system is programmed to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.