Systems and methods for using sensed pressure for neuro cardiac therapy

• US 9,393,417 B2
• Filed: 12/01/2011
• Issued: 07/19/2016
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Arcot-Krishnamurthy, Shantha, Maskara, Barun
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): Ramachandran, Vasuda
• Application Number:
  US13/309,328
• Publication Number:
  US 20120172741A1
• Time in Patent Office: 1,692 Days
• Field of Search: 600/534
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0823 Detecting or evaluating cough events
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A device embodiment is configured to deliver vagal stimulation therapy (VST) to a vagus nerve of a patient. The device embodiment includes a neural stimulator, an implantable pressure sensor, and a pressure analyzer. The neural stimulator is configured to deliver the VST to the vagus nerve in a cervical region of the patient. The implantable pressure sensor is configured to be implanted in the cervical region and to detect pressure changes in the cervical region caused by laryngeal vibrations. The pressure sensor is configured to generate sensed pressure values. The pressure analyzer is configured to analyze the sensed pressure values generated by the pressure sensor. The analyzer is configured to detect laryngeal vibrations or cough from the sensed pressure values.

Claims

1. A method, comprising:

delivering a vagal stimulation therapy (VST) to a vagus nerve of a patient, wherein delivering the VST includes delivering a therapeutically-effective intensity of neural stimulation to treat a condition, wherein the therapeutically-effective intensity of neural stimulation causes laryngeal vibrations;

performing a stimulation capture confirmation process multiple times and intermittently during delivery of the VST, wherein performing the stimulation capture confirmation process includes detecting laryngeal vibrations to determine whether the VST is capturing the vagus nerve, wherein detecting laryngeal vibrations includes detecting laryngeal vibrations when the VST does not cause cough and further includes;

sensing pressure using an implantable pressure sensor configured to sense pressure in a cervical region in the patient caused by the laryngeal vibrations, wherein sensing pressure includes sensing pressure a plurality of times to provide a plurality of sensed pressure values; and

analyzing variability of a plurality of the sensed pressure values to determine whether the VST causes laryngeal vibrations, including whether the VST causes laryngeal vibrations when the VST does not cause cough, and thereby determine whether the VST is capturing the vagus nerve; and

controlling the VST based on whether the VST is capturing the vagus nerve; and

detecting whether the VST is causing cough, including analyzing the variability of the plurality of the sensed pressure values to confirm the cough; and

maintaining the therapeutically-effective intensity of the neural stimulation for the VST during the stimulation capture confirmation process, including controlling the intensity based on the variability of the plurality of the sensed pressure values to avoid causing cough while capturing the vagus nerve.

2. The method of claim 1, wherein delivering the VST includes delivering the VST using an electrode in a blood vessel;

and sensing pressure includes sensing pressure using a pressure sensor in the blood vessel.

3. The method of claim 2, wherein the blood vessel is an internal jugular vein.

4. The method of claim 1, wherein delivering VST includes delivering a neuro cardio therapy (NCT) to treat a cardiovascular disease, wherein delivering NCT includes delivering NCT as a heart failure therapy or delivering NCT as a hypertension therapy.

5. The method of claim 1, further comprising analyzing the plurality of the sensed pressure values to detect a change in absolute pressure values, or detect a mean of the sensed pressure values.

6. The method of claim 5, wherein analyzing the variability of the plurality of the sensed pressure values includes determining a standard deviation or an Inter-Percentile Range of the sensed pressure values.

7. A method for detecting laryngeal vibrations and cough and controlling a vagal stimulation therapy (VST) to cause laryngeal vibrations and avoid cough, comprising:

delivering VST, wherein the VST includes a therapeutically-effective intensity of neural stimulation to treat a condition, and the therapeutically-effective intensity of neural stimulation causes laryngeal vibrations; and

performing a stimulation capture confirmation process multiple times and intermittently during delivery of the VST, wherein the stimulation capture confirmation process includes;

sensing pressure using an implantable pressure sensor configured to sense pressure changes in a cervical region of a patient caused by laryngeal vibrations when cough is not present and cause by laryngeal vibrations when cough is present, wherein sensing pressure includes sensing pressure a plurality of times to provide a plurality of sensed pressure values;

analyzing a variability of a plurality of the sensed pressure values to identify the laryngeal vibrations and to identify cough; and

controlling an intensity of the VST during the stimulation capture confirmation process based on the analyzed plurality of the sensed pressure values to cause laryngeal vibrations and avoid cough.