# US 12,109,416 B2 · Carotid sinus nerve stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,416 B2 - Document ID: US12109416B2 - Status: Granted - Kind: B2 - Application number: 17/156,896 - Filed: 2021-01-25 - Published: 2021-07-08 - Granted: 2024-10-08 - Earliest claimed: 2018-04-25 - Assignees: Barologics, Inc. - Applicants: Barologics, Inc. - Inventors: Dimitrios Georgakopoulos; Molly Wade - Web page: https://patentgrep.com/patent/US12109416B2 ## CPC - A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)} - A61B 5/0006: {ECG or EEG signals} - A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition - A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287) - A61N 1/0556: {Cuff electrodes} - A61N 1/36057: {adapted for stimulating afferent nerves} - A61N 1/36117: {for treating hypertension} - A61N 1/36135: {using physiological parameters} - A61N 1/36157: {Current (A61N1/3616 takes precedence)} - A61N 1/36171: {Frequency} - A61N 1/36175: {Pulse width or duty cycle} - A61N 1/36178: {Burst or pulse train parameters} - A61B 5/02108: {from analysis of pulse wave characteristics} - A61B 5/024: Measuring pulse rate or heart rate - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract 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. ## Claims ### Claim 1 A method for stimulating nerve fibers to treat a condition in a patient, the method comprising: identifying carotid sinus nerve afferent fibers in a first side of a patient's neck; identifying cardiac-specific vagal nerve afferent fibers in the first side of the patient's neck; placing a first multipolar electrode device around the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers; stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers, using the first multipolar electrode device; sensing a heart rate indicative of an activity level of the patient; and adjusting stimulation frequency of the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers based on the sensed heart rate, wherein an increase in the sensed heart rate causes an increase in the stimulation frequency. ### Claim 2 (depends on 1) The method of claim 1, wherein stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers comprises sending a stimulation signal from a pulse generator implanted in the patient through a first lead to the first multipolar electrode device. ### Claim 3 (depends on 1) The method of claim 1, wherein identifying the carotid sinus nerve afferent fibers comprises identifying a nerve plexus near the carotid sinus. ### Claim 4 (depends on 1) The method of claim 1, further comprising: identifying carotid sinus nerve afferent fibers in a second side of the patient's neck; identifying cardiac-specific vagal nerve afferent fibers in the second side of the patient's neck; placing a second multipolar electrode device around the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers in the second side; and stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers in the second side, using the second multipolar electrode device. ### Claim 5 (depends on 4) The method of claim 4, wherein stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers comprises: sending a first stimulation signal from a pulse generator implanted in the patient through a first lead to the first multipolar electrode device; and sending a second stimulation signal from a pulse generator implanted in the patient through a second lead to the second multipolar electrode device. ### Claim 6 (depends on 1) The method of claim 1, wherein the multipolar electrode device is a hexapolar electrode. ### Claim 7 (depends on 1) The method of claim 1, wherein stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers comprises providing a stimulation signal with parameters in the ranges of 1-25 mA amplitude, 0.06-5 ms pulse widths and 1-5000 Hz frequency. ### Claim 8 (depends on 7) The method of claim 7, wherein stimulation is at a frequency of between 80 Hz and 120 Hz. ### Claim 9 (depends on 1) The method of claim 1, wherein adjusting the one or more parameters of stimulation comprises increasing a frequency of the stimulation if the sensed heart rate is above a first predefined threshold and/or decreasing the frequency of the stimulation if the sensed heart rate is below a second predefined threshold. ### Claim 10 (depends on 1) The method of claim 1, wherein sensing the heart rate comprises using data selected from the group consisting of an electrocardiogram, a blood pressure waveform, a phonocardiograph and an arterial distension waveform. ### Claim 11 (depends on 1) The method of claim 1, further comprising timing the stimulating by delivering all of a pulse train of the stimulation during a diastolic phase of the patient's heartbeat. ### Claim 12 (depends on 1) The method of claim 1, wherein stimulating the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers comprises selectively stimulating only afferent nerve fibers and not stimulating efferent nerve fibers. ### Claim 13 (depends on 1) The method of claim 1, wherein the sensed heart rate is a first sensed heart rate, the method further comprising: sensing a second heart rate of the patient; and adjusting the stimulation frequency based on the second sensed heart rate. ### Claim 14 (depends on 1) The method of claim 1, wherein the activity level comprises sitting, standing, or walking. ### Claim 15 (depends on 1) The method of claim 1, wherein the stimulation frequency corresponds to a number of electrical impulses. ### Claim 16 (depends on 1) The method of claim 1, wherein adjusting the stimulation frequency comprises adjusting the stimulation frequency such that the number of electrical impulses is constant per cardiac cycle. ### Claim 17 An implantable system for stimulating nerve fibers to treat a condition in a patient, the system comprising: a pulse generator; a first multipolar electrode device configured to wrap around carotid sinus nerve afferent fibers and cardiac-specific vagal nerve afferent fibers in a first side of a patient's neck; a first lead attached at one end to the pulse generator and at an opposite end to the first multipolar electrode device; and a computing device wirelessly connected to the pulse generator and configured to: receive a sensed heart rate from an electrocardiogram sensor, wherein the sensed heart rate is indicative of an activity level of the patient; transmit stimulation frequency to the pulse generator, wherein an increase in the sensed heart rate causes an increase in the stimulation frequency; time a stimulation of the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers to the sensed heart rate; and adjust stimulation of the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers based on the stimulation frequency. ### Claim 18 (depends on 17) The system of claim 17, wherein the first multipolar electrode device is a hexapolar electrode. ### Claim 19 (depends on 17) The system of claim 17, wherein the first multipolar electrode device is flexible and has two flaps connected along one edge and open along an opposite edge, wherein the open opposite edge is configured to admit the carotid sinus nerve afferent fibers and cardiac-specific vagal nerve afferent fibers. ### Claim 20 (depends on 17) The system of claim 17, further comprising: a second multipolar electrode device configured to wrap around carotid sinus nerve afferent fibers and cardiac-specific vagal nerve afferent fibers in a second side of the patient's neck; and a second lead attached at one end to the pulse generator and at an opposite end to the second multipolar electrode device. ### Claim 21 (depends on 20) The system of claim 20, wherein the system comprises the electrocardiogram sensor, the system further comprising: a third lead attached at one end to the pulse generator and at an opposite end to the electrocardiogram sensor. ### Claim 22 (depends on 21) The system of claim 21, wherein the electrocardiogram sensor comprises: a paddle-shaped substrate; and multiple electrodes positioned along the paddle-shaped substrate. ### Claim 23 (depends on 17) The system of claim 17, wherein the first multipolar electrode device is configured to selectively stimulate the carotid sinus nerve afferent fibers and the cardiac-specific vagal nerve afferent fibers and to not stimulate efferent nerve fibers. ### Claim 24 (depends on 17) The system of claim 17, wherein timing the stimulation comprises: delivering 25 percent of a pulse train of the stimulation at the onset of a sensed signal corresponding to a systolic phase of the patient's heartbeat; and delivering a remaining 75 percent of the pulse train during a diastolic phase of the patient's heartbeat. ### Claim 25 (depends on 17) The system of claim 17, wherein the stimulation frequency corresponds to a number of electrical impulses. ### Claim 26 (depends on 17) The system of claim 17, wherein adjusting stimulation comprises maintaining a number of electrical impulses per cardiac cycle. ### Claim 27 An implantable system for stimulating nerve fibers to treat a condition in a patient, the system comprising: a pulse generator; a multipolar electrode device configured to stimulate afferent fibers associated with baroreceptors and/or a carotid sinus nerve of a patient; a lead attached and operably coupled to the pulse generator and first multipolar electrode device; and a computing device connected to the pulse generator and configured to: provide a first stimulation via the multipolar electrode device; after providing the stimulation, receive a sensed heart rate from the patient, wherein the sensed heart rate is indicative of an activity level of the patient; transmit, to the pulse generator, a stimulation frequency correlated to the sensed heart rate, such that an increase in the sensed heart rate causes an increase in the stimulation frequency; and provide a second stimulation based on the stimulation parameter. ### Claim 28 (depends on 27) The system of claim 27, wherein the stimulation frequency corresponds to a number of electrical impulses. ### Claim 29 (depends on 27) The system of claim 27, wherein providing the second stimulation comprises maintaining a number of electrical impulses per cardiac cycle.