Granted Patent B2

US 12,508,425 · App. 18/050,751 · Granted Dec 30, 2025

Inventors: Randal C. Schulhauser (Phoenix, AZ); Richard J. O'Brien (Hugo, MN); Scott R. Stanslaski (Shoreview, MN); Mark P. Ashby (Laguna Niguel, CA); Avram Scheiner (Vadnais Heights, MN); Becky L. Dolan (Chisago, MN); William Valls, Jr. (Chandler, AZ); David J. Miller (Austin, TX); Varun Umesh Kashyap (Irvine, CA); Peter N. Braido (Linwood, MN); Lilian Kornet (Eijsden, NL)

Assignee: Covidien LP

A61N1/36053A61N1/0558A61N1/36135

Abstract

Claims (36)

1 . A system comprising:

a first lead configured to be positioned in or beside a left internal jugular vein (IJV) of a patient to deliver a first stimulation signal to a first vagus nerve on a first side of a neck, the first lead including one or more first segmented electrodes positioned on a distal portion of the first lead and one or more first anchoring mechanisms;

a second lead configured to be positioned in or beside a right IJV of the patient to deliver a second stimulation signal to a second vagus nerve on a second side of a neck, the second side being different than the first side, the second lead including one or more second segmented electrodes positioned on a distal portion of the second lead and one or more second anchoring mechanisms; and

circuitry configured to be coupled to the first lead and the second lead, the circuitry being configured to deliver electrical energy to the first lead to deliver the first stimulation signal and the second lead to deliver the second stimulation signal to provide bilateral stimulation to the first vagus nerve and the second vagus nerve,

wherein the circuitry is further configured to:

sense at least one of a first signal via one or more of the first segmented electrodes and a second signal via one or more of the second segmented electrodes,

detect an inflammatory cytokine level of the patient based on at least one of the first sensed signal or the second sensed signal,

determine a start of an inflammatory time window that corresponds to an onset of a stroke or traumatic brain injury (TBI), and an end of the inflammatory time window based on the detected inflammatory cytokine level, and

deliver the electrical energy to at least one of the first lead or the second lead during the inflammatory time window in response to determining the start of the inflammatory time window.

2 . The system of claim 1 , wherein the first and second segmented electrodes include a plurality of electrode segments, and wherein the circuitry is configured to deliver the electrical energy to selected electrode segments to steer current associated with the first and second stimulation signals.

3 . The system of claim 1 , wherein the one or more first anchoring mechanisms are positioned proximally on the first lead with respect to the one or more first segmented electrodes and the one or more second anchoring mechanisms positioned proximally on the second lead with respect to the one or more second segmented electrodes.

4 . The system of claim 1 , wherein the circuitry is further configured to deliver the electrical energy alternatively to the first lead and the second lead during the inflammatory time window.

5 . A system of comprising:

a first lead configured to be positioned in or beside a left internal jugular vein (IJV) of a patient to deliver a first stimulation signal to a first vagus nerve on a first side of a neck, the first lead including one or more first segmented electrodes positioned on a distal portion of the first lead and one or more first anchoring mechanisms;

a second lead configured to be positioned in or beside a right IJV of the patient to deliver a second stimulation signal to a second vagus nerve on a second side of a neck, the second side being different than the first side, the second lead including one or more second segmented electrodes positioned on a distal portion of the second lead and one or more second anchoring mechanisms;

circuitry configured to be coupled to the first lead and the second lead, the circuitry being configured to deliver electrical energy to the first lead to deliver the first stimulation signal and the second lead to deliver the second stimulation signal to provide bilateral stimulation to the first vagus nerve and the second vagus nerve; and

one or more accelerometers configured to detect motion of a laryngeal muscle of the patient, the one or more accelerometers being configured to be coupled to the circuitry;

wherein the circuitry is further configured to:

sense at least one of a first signal via one or more of the first segmented electrodes and a second signal via one or more of the second segmented electrodes,

detect an inflammatory cytokine level of the patient based on at least one of the first sensed signal or the second sensed signal,

determine a start of an inflammatory time window that corresponds to an onset of a stroke or traumatic brain injury (TBI), and an end of the inflammatory time window based on the detected inflammatory cytokine level,

determine laryngeal activity of the patient based on the detected motion of the laryngeal muscle, and

adjust delivery of the electrical energy to at least one of the first lead and the second lead based on the determined laryngeal activity of the patient.

6 . An implantable medical device comprising:

stimulation circuitry configured to be coupled to a first lead and a second lead and configured to deliver first stimulation signals to a first vagus nerve on a first side of a neck via the first lead and deliver second stimulation signals to a second vagus nerve on a second side of the neck via the second lead;

telemetry circuitry configured to be coupled to a sensor device and configured to receive physiological parameter data from the sensor device, the sensor device configured to be implanted above shoulders of a patient; and

processing circuitry configured to:

determine an inflammatory cytokine level of the patient based on the received physiological parameter data;

determine a start of an inflammatory time window that corresponds to an onset of a stroke or traumatic brain injury (TBI), and an end of the inflammatory time window based on the determined inflammatory cytokine level; and

cause the stimulation circuitry to deliver the first stimulation signals and the second stimulation signals during the inflammatory time window.

7 . The implantable medical device of claim 6 , wherein the processing circuitry is further configured to:

determine a trigger value of the patient based on the detected physiological parameter data; and

cause the stimulation circuitry to adjust delivery of the first stimulation signals and the second stimulation signals based on the determined trigger value being greater than or equal to a trigger value threshold.

8 . The implantable medical device of claim 7 , wherein the trigger value is one or more of a stroke/TBI recovery score, a stroke/TBI score, a cardiac ischemia score, or brain ischemia score of the patient based on detected parameter data of the patient.

9 . The implantable medical device of claim 6 , wherein the detected physiological parameter data includes one or more of an electroencephalography (EEG), an electrocardiogram (ECG), accelerometry data, impedance data, or compound action potential data.

10 . The implantable medical device of claim 6 , wherein the processing circuitry is further configured to cause the stimulation circuitry to deliver the first stimulation signals and the second stimulation signals alternatively.

Assignments (4)

Continuity (1)

References Cited (118)