Measurement of patient physiological parameters

• US 8,116,873 B2
• Filed: 12/29/2008
• Issued: 02/14/2012
• Est. Priority Date: 12/28/2007
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Anderson, Russell Eugene, Yared, Nadim, Stroebel, John Charles, Kieval, Robert S., Check, Steve, Lovett, Eric
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US12/345,558
• Publication Number:
  US 20090198302A1
• Time in Patent Office: 1,142 Days
• Field of Search: 600/436, 600/547, 600/345
• US Class Current: 607/44
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

A method of determining one or more physiological parameter of a patient by providing a plurality of implantable electrodes proximate a blood vessel of the patient, applying a measurement signal through the plurality of electrodes, the measurement signal having a known parameter, obtaining a resultant signal through the plurality of electrodes, the resultant signal having a resultant parameter, calculating vascular impedance based on the measurement signal and the resultant signal, and calculating a physiological parameter based on the vascular impedance. In some embodiments, the physiological parameter is utilized to modify a therapy signal controlling therapy delivered to the patient.

Claims

1. A method of determining a physiological parameter of a patient, comprising:

applying a measurement signal through a plurality of electrodes implanted in contact with a wall of a blood vessel of the patient, the measurement signal having a known parameter;

obtaining a resultant signal through the plurality of electrodes, the resultant signal having a resultant parameter;

calculating impedance of the blood vessel based on the measurement signal and the resultant signal; and

determining a physiological parameter based on the impedance of the blood vessel.

2. The method of claim 1, wherein the plurality of electrodes are implanted intravascularly.

3. The method of claim 1, wherein the plurality of electrodes are implanted extravascularly.

4. The method of claim 1, wherein calculating a physiological parameter comprises calculating a parameter selected from the group consisting of blood pressure, heart rate, respiration, activity, posture, and sleep state.

5. The method of claim 1, further comprising:

providing a second plurality of electrodes, wherein the second plurality of electrodes are configured to obtain a resultant signal from the measurement signal applied to the first plurality of electrodes.

6. The method of claim 1, wherein the plurality of electrodes are implanted apart from one another along a longitudinal axis of the blood vessel.

7. The method of claim 1, wherein the plurality of electrodes are implanted at different locations about a circumference of the blood vessel.

8. The method of claim 1, further comprising providing a controller configured for applying the measurement signal, calculateing the impedance of the wall of the blood vessel, and determining the physiological parameter.

9. A system, comprising:

at least one pair of electrodes adapted to be implanted in contact with a wall of blood vessel of a patient; and

a controller communicably coupled to the pair of electrodes, the controller configured to calculate the impedance of the blood vessel based on a measured signal from the pair of electrodes, and determine a physiological parameter of a patient based on the calculated impedance.

10. The system of claim 9, further comprising a baroreflex modulation device configured to electrically activate a baroreceptor.

11. The system of claim 10, wherein the pair of electrodes are integrated with the baroreflex modulation device.

12. The system of claim 9, wherein the controller is configured to calculate impedance of the blood vessel by applying a measurement signal having a known parameter through the electrodes and receive a resultant signal having a resultant parameter through the electrodes.

13. The system of claim 12, further comprising a second pair of electrodes adapted to be implanted proximate the blood vessel, wherein one pair of electrodes is configured to transmit the measurement signal, and one pair of electrodes is configured to receive the resultant signal.

14. An implantable baroreflex therapy system for providing real-time feedback of physiological parameters comprising:

an implantable baroreflex modulation device including one or more therapy electrodes adapted to be positioned implanted in contact with a wall of a blood vessel, the baroreflex modulation device configured to electrically activate a baroreceptor; and

a control system operably coupled to the baroreflex modulation device, the control system configured to transmit a therapy signal having a known parameter to the baroreflex modulation device, wherein the one or more therapy electrodes are configured to monitor a resultant signal indicative of a parameter that correlates to the known parameter of the therapy signal, the control system being configured to calculate the impedance of the blood vessel based on the known parameter and the resultant parameter, determine one or more patient physiological parameters based on the calculated impedance, and modify the therapy signal based on the one or more patient physiological parameters.

15. The implantable baroreflex therapy system of claim 14, further comprising a plurality of measurement electrodes operably coupled to the baroreflex modulation device and the control system, the measurement electrodes configured to monitor the resultant signal.

16. The implantable baroreflex therapy system of claim 15, wherein the plurality of measurement electrodes are separate from, but proximate to the baroreflex modulation device.

17. The implantable baroreflex therapy system of claim 14, wherein the known parameter of the therapy signal is a constant current and the resultant parameter is voltage.

18. The implantable baroreflex therapy system of claim 14, wherein the known parameter of the therapy signal is a constant voltage and the resultant parameter is current.

19. The implantable baroreflex therapy system of claim 14, wherein the baroreflex modulation device includes two electrodes configured to be oriented about 180 degrees apart from each other along the longitudinal axis of the blood vessel proximate which the baroreflex modulation device is positioned.

20. A method of providing therapy having real-time feedback, comprising:

providing a baroreflex modulation device including a therapy electrode, the baroreflex modulation device configured to electrically activate a baroreceptor;

providing one or more measurement electrodes;

providing instructions, comprising;

implanting the baroreflex modulation device proximate a blood vessel;

implanting the one or more measurement electrodes in contact with a wall of the blood vessel;

transmitting a therapy signal from a control system to the therapy electrode of the baroreflex modulation device, the therapy signal having at least one known parameter;

monitoring a resultant signal with the one or more measurement electrodes, the resultant signal having a resultant parameter;

calculating the impedance of the blood vessel based on the known parameter and the resultant parameter;

determining one or more physiological parameters based on the impedance of the blood vessel; and

adjusting the therapy signal based on the one or more physiological parameters.

21. The method of claim 20, wherein the one or more measurement electrodes are integrated with the baroreflex modulation device.

22. The method of claim 20, wherein the physiological parameter is selected from the group consisting of blood pressure, heart rate, respiration, activity, posture, and sleep state.

23. A method, comprising:

providing a baroreflex modulation device including two or more electrodes, the baroreflex modulation device configured to electrically activate a baroreceptor;

providing a control system operably coupled to the baroreflex modulation device; and

providing instructions recorded on a tangible medium on how to provide real-time feedback of a physiological parameter of a patient undergoing baroreflex therapy, the instructions including;

implanting the baroreflex modulation device such that the two or more electrodes are in contact with a wall of a blood vessel;

delivering a therapy signal having a known parameter to at least one of the two or more electrodes;

monitoring with the at least one of the two or more electrodes a resultant signal having a resultant parameter as the therapy signal is being delivered;

calculating with the control system an impedance of the blood vessel based on the known parameter and the resultant parameter;

determining one or more patient parameters based on the calculated impedance; and

modifying the therapy signal based on the one or more patient parameters.

24. A kit for a baroreflex therapy system, comprising:

a baroreflex modulation device including two or more electrodes, the baroreflex modulation device configured to electrically activate a baroreceptor;

a control system operably coupleable to the baroreflex modulation device; and

instructions recorded on a non-transitory tangible medium for operating the system so as to provide real-time feedback of a physiological parameter of a patient undergoing baroreflex therapy, the instructions including;

instructions to program the control system to deliver a therapy signal having a known parameter to the patient through at least one of the two or more electrodes of the baroreflex modulation device and to cause the control system to monitor with at least one of the two or more electrodes a resultant signal having a resultant parameter, calculating with the control system an impedance of the blood vessel based on the known parameter and the resultant parameter, determining one or more patient parameters based on the calculated impedance, and modifying the therapy signal based on the one or more patient parameters.