Method and apparatus for determination of physiological parameters using cervical impedance

• US 9,814,395 B2
• Filed: 08/07/2012
• Issued: 11/14/2017
• Est. Priority Date: 08/10/2011
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E., Ternes, David J., Maskara, Barun, Arcot-Krishnamurthy, Shantha, Hincapie Ordonez, Juan Gabriel, Vanderlinde, Scott
• Primary Examiner(s): Weston, Tiffany
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US13/568,887
• Publication Number:
  US 20130041269A1
• Time in Patent Office: 1,925 Days
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 5/6877 Nerve
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

Implanted electrodes can be used to deliver electrical stimulation signals to areas near blood vessels, nerves, or other internal body locations. In an example, an electrode can be implanted in a cervical location and can be used to measure dimensional changes in an artery using impedance plethysmography. Measured artery dimensional changes can be used to determine one or more physiological parameters associated with a patient'"'"'s health status, such as pulse transit time, relative pulse pressure, or aterial compliance, among others. These parameters can be used to monitor a patient health status or to modulate a patient'"'"'s therapy, among other uses. In some examples, an electrode configured to deliver an electrostimulation signal to nerve tissue can be used to provide non-neurostimulating electrical stimulation plethysmography signals near a blood vessel.

Claims

1. An apparatus, comprising:

an electrode configured to be extravascularly implanted, the extravascularly-implanted electrode adapted for encircling extravascular nerve tissue near a blood vessel without encircling the blood vessel;

an electrical energy delivery circuit configured to be coupled to the extravascularly-implanted electrode and configured to;

provide an electrical test signal directed from the extravascularly-implanted electrode to a location internal to a patient body and near the blood vessel when the electrode encircles the extravascular nerve tissue without encircling the blood vessel; and

provide an electrostimulation signal directed from the extravascularly-implanted electrode toward the extravascular nerve tissue when the electrode encircles the extravascular nerve tissue without encircling the blood vessel;

a detector circuit configured to receive an electrical response signal in response to the electrical test signal; and

a signal processor circuit, coupled to the electrical energy delivery circuit and the detector circuit, the signal processor circuit configured to;

determine a vessel dimension of the blood vessel near the extravascularly-implanted electrode using the received electrical response signal;

compare the determined vessel dimension to a reference vessel dimension to determine a vessel dimension change; and

output an indication of the determined vessel dimension change.

2. The apparatus of claim 1, wherein the electrical energy delivery circuit is configured to provide the electrical test signal to the extravascular nerve tissue, wherein the extravascular nerve tissue includes a vagus nerve in a cervical region near the blood vessel including a carotid artery.

3. The apparatus of claim 2, wherein the electrical energy delivery circuit is configured to provide the electrical test signal as a non-neurostimulating electrical test signal.

4. The apparatus of claim 2, wherein the electrical energy delivery circuit is configured to provide a series of non-neurostimulating electrical test signals;

wherein the detector circuit is configured to receive a corresponding series of electrical response signals in response to the series of non-neurostimulating electrical test signals; and

wherein the signal processor circuit is configured to determine the vessel dimension change of the blood vessel near the extravascularly-implanted electrode using the series of received electrical response signals.

5. The apparatus of claim 1, further comprising an electrode;

wherein the electrical energy delivery circuit is configured to provide a neurostimulating therapy signal to the electrode; and

wherein the electrical energy delivery circuit is further configured to provide a non-neurostimulating test signal to the same electrode.

6. The apparatus of claim 1, wherein the electrical energy delivery circuit is configured to provide a neurostimulating therapy signal directed from the extravascularly-implanted electrode toward a vagus nerve;

and

wherein the electrical energy delivery circuit is configured to provide the electrical test signal as a portion of the neurostimulating therapy signal.

7. The apparatus of claim 1, wherein the electrical energy delivery circuit is configured to provide a signal waveform comprising a first neurostimulating therapy signal pulse phase and a second non-neurostimulating signal pulse phase incapable of stimulating the nerve tissue.

8. The apparatus of claim 1, wherein the signal processor circuit is further configured to:

determine a pulse transit time using information about the vessel dimension change; and

output information about a patient health status using the pulse transit time.

9. The apparatus of claim 8, wherein the signal processor circuit is further configured to:

trend the pulse transit time over multiple cardiac cycles; and

output the information about a patient health status using information about the trended pulse transit time.

10. The apparatus of claim 1, wherein the signal processor circuit is further configured to:

determine a relative pulse pressure using information about the vessel dimension change; and

output information about a patient health status using the relative pulse pressure.

11. The apparatus of claim 10, wherein the signal processor circuit is further configured to:

trend the relative pulse pressure over multiple cardiac cycles; and

output the information about a patient health status using information about the trended relative pulse pressure.

12. The apparatus of claim 1, wherein the signal processor circuit is further configured to determine at least one of an arterial compliance, an autonomic status, a cardiac contractility, a pulmonary vein distension, a respiratory effort, a respiratory disturbance, or a fluid status using the determined change in the vessel dimension;

and

output information about a patient health status using the at least one of an arterial compliance, an autonomic status, a cardiac contractility, a pulmonary vein distension, a respiratory effort, a respiratory disturbance, or a fluid status.

13. The apparatus of claim 1, wherein the signal processor circuit is configured to determine a radial vessel dimension change of the blood vessel.

14. The apparatus of claim 1, wherein the electrical energy delivery circuit is configured to provide the electrical test signal in response to a signal provided by a physiological sensor comprising at least one of:

a posture sensor;

a heart rate sensor;

a respiration rate sensor;

a respiratory phase sensor;

a patient physical activity level sensor;

or an arrhythmia sensor.

15. The apparatus of claim 1, wherein the signal processor circuit is configured to provide the output indication in response to a signal provided by a physiological sensor comprising at least one of:

a posture sensor;

a heart rate sensor;

a respiration rate sensor;

a respiratory phase sensor;

a patient physical activity level sensor;

or an arrhythmia sensor.

16. A method of using an extravascularly-implanted electrode positioned at an extravascular nerve tissue, the method comprising:

providing an electrical test signal directed from the extravascularly-implanted electrode to a location internal to a patient body and near a blood vessel, the extravascularly-implanted electrode encircling the extravascular nerve tissue without encircling the blood vessel;

receiving an electrical response signal in response to the electrical test signal;

measuring, using a processor circuit, a vessel dimension of the blood vessel near the extravascularly-implanted electrode using the received electrical response signal;

comparing, using a processor circuit, the measured vessel dimension to a reference vessel dimension to determine a vessel dimension change;

outputting an indication of the determined vessel dimension change; and

providing an electrostimulation signal directed from the extravascularly-implanted electrode toward the extravascular nerve tissue.

17. The method of claim 16, wherein the providing the electrical test signal includes providing the electrical test signal to the extravascular nerve tissue, wherein the extravascular nerve tissue includes a vagus nerve in a cervical region near the blood vessel including a carotid artery.

18. The method of claim 16, further comprising:

providing a neurostimulating therapy signal directed from the extravascularly-implanted electrode to a vagus nerve; and

providing the electrical test signal as a portion of the neurostimulating therapy signal.

19. The method of claim 16, further comprising:

determining at least one of a pulse transit time or a relative pulse pressure using the information about the vessel dimension change; and

outputting information about a patient health status using the at least one of the pulse transit time or the relative pulse pressure.

20. An apparatus, comprising:

an electrode configured to be extravascularly implanted in a cervical region, the extravascularly-implanted electrode adapted for encircling a vagus nerve near a carotid artery without encircling the carotid artery;

an electrical energy delivery circuit configured to be coupled to the extravascularly-implanted electrode and configured to;

provide a non-neurostimulating electrical test signal using the extravascularly-implanted electrode when the electrode encircles the vagus nerve without encircling the carotid artery; and

provide a neurostimulating signal directed from the extravascularly-implanted electrode toward the vagus nerve when the electrode encircles the vagus nerve without encircling the carotid artery;

a detector circuit configured to receive an electrical response signal in response to the non-neurostimulating electrical test signal; and

a signal processor circuit, coupled to the electrical energy delivery circuit and the detector circuit, the signal processor circuit configured to;

determine a radial blood vessel dimension of the carotid artery near the extravascularly-implanted electrode using the received electrical response signal;

compare the determined radial blood vessel dimension to a reference radial blood vessel dimension to determine a radial blood vessel dimension change;

determine at least one of a pulse transit time or a relative pulse pressure using information about the radial blood vessel dimension change; and

output information about a patient health status using the at least one of the pulse transit time or the relative pulse pressure.