Cvrx, Inc.

Barologics, Inc.

Dimitrios Georgakopoulos

Eric G Lovett

Nadim Yared

Molly Wade

Ivana Stojanovic

Devices, systems and methods for non-invasive modulation of the baroreflex system of a patient. In embodiments, the present disclosure may be used to measure and monitor baroreflex function for diagnostic purposes in patients acutely or chronically to inform and guide medical treatment, assess disease severity, or assess morbidity/mortality risk. In embodiments, the present disclosure may be used to provide non-invasive baroreflex activation therapy acutely or chronically to treat a variety of disease conditions through rebalancing of the sympathetic and parasympathetic limbs of the autonomic nervous system and their connections to higher brain centers.

External baroreflex activation for assessment and treatment

Methods and systems for stimulating nerve fibers to treat a condition in a patient are disclosed herein. Such methods can include stimulating, via an electrode device, afferent fibers associated with baroreceptors and/or a carotid sinus nerve of a patient; sensing a heart rate of the patient; and adjusting a stimulation frequency of the afferent fibers based on the sensed heart rate. The heart rate can be indicative of an activity level of the patient, and an increase in the sensed heart rate can cause an increase in the stimulation frequency.

Carotid sinus nerve stimulation

A method for stimulating nerve fibers to treat a condition in a patient first involves identifying carotid sinus nerve afferent fibers in a first side of the patient's neck and identifying cardiac-specific vagal nerve afferent fibers in the first side of the patient's neck. The method further involves placing a first multipolar electrode device around the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers. Finally, the method involves stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers, using the first multipolar electrode device. This method may be performed on a second side of the neck as well.

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.

Devices and methods for treatment of heart failure and associated conditions

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.

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.

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.

Devices and methods of use are described for detecting and treating an undesirable level of fluid in a pulmonary circulation of a patient. An exemplary system may include an implantable baroreflex activation device including an electrode configured to be implanted proximate a baroreptor within a patient, an implantable sensor configured to provide an indication of a fluid level within the patient, and a control system coupled to the baroreflex activation device and the sensor. The control system may be programmed to automatically detect a level of a fluid in a pulmonary circulation of the patient with the sensor and upon detecting an undesirable level of the fluid in the pulmonary circulation, delivering a therapy via the electrode of the baroreflex activation device to reduce the level of fluid in the pulmonary circulation.

Devices and methods of use identification, treatment, and/or management of heart failure and/or associated conditions. Methods may include providing a baroreflex therapy system including a blood pressure sensor and a heart rate sensor, providing an implantable measurement device proximate a blood vessel of a patient, the implantable measurement device including an electrode, providing a control system coupled to the baroreflex therapy system and the implantable measurement device, the control system programmed to automatically determine an impedance of the blood vessel with the implantable measurement device over a time period of at least one cardiac cycle, determine arterial stiffness of the blood vessel based on the impedance, determine blood pressure and heart rate, and activate, deactivate or otherwise modulate the baroreflex therapy system to deliver a baroreflex therapy based on the blood pressure, heart rate and arterial stiffness.

Growing community of inventors

Maple Grove, MN, United States of America

Dimitrios Georgakopoulos