Shock reduction using absolute calibrated tissue oxygen saturation and total hemoglobin volume fraction

• US 9,126,049 B2
• Filed: 06/10/2010
• Issued: 09/08/2015
• Est. Priority Date: 06/10/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kuhn, Jonathan L., Cinbis, Can, Anderson, David A., Carney, James K.
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): NGUYEN, HIEN NGOC
• Application Number:
  US12/797,781
• Publication Number:
  US 20100317946A1
• Time in Patent Office: 1,916 Days
• Field of Search: 600/324
• US Class Current: 1/1
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

An implantable medical device for detecting and treating an arrhythmia includes an optical sensor adapted for positioning adjacent to a blood-perfused tissue volume. In one embodiment for controlling arrhythmia therapies delivered by the device, the optical sensor is controlled to emit light in response to detecting an arrhythmia, detect light scattered by the volume of blood perfused tissue including measuring an optical sensor output signal corresponding to the intensity of scattered light for at least four spaced-apart wavelengths, and compute a volume-independent measure of tissue oxygen saturation from the detected light. The hemodynamic status of the arrhythmia is detected in response to the measure of tissue oxygen saturation.

Claims

1. A method, comprising:

sensing cardiac depolarization signals;

detecting an arrhythmia in response to the depolarization signals;

controlling an optical sensor to emit light in response to the detected arrhythmia;

detecting light scattered by a volume of blood perfused tissue wherein detecting light comprises measuring an optical sensor output signal corresponding to light attenuation of at least four spaced apart light wavelengths;

computing a measure of tissue oxygenation from the optical sensor output signal, wherein computing the measure of tissue oxygenation comprises;

computing a light attenuation for each of the at least four wavelengths;

computing a second derivative of the light attenuation with respect to two different wavelengths;

computing a measure of tissue oxygen saturation independent of total hemoglobin as a ratio of the second derivatives at the two different wavelengths;

computing a measure of total hemoglobin volume fraction using the second derivative of a selected one of the two different wavelengths;

detecting a hemodynamic status of the arrhythmia in response to the measure of tissue oxygenation, wherein the measure of tissue oxygenation is computed responsive to at least one of the measure of tissue oxygen saturation independent of total hemoglobin and the measure of total hemoglobin volume fraction;

computing the measure of tissue oxygenation as a weighted combination of the measure of oxygen saturation and the measure of total hemoglobin volume fraction;

determining if one of the measure of oxygen saturation and the measure of total hemoglobin volume fraction is out of a respective acceptable range; and

adjusting a weighting factor used to compute the weighted combination in response to one of the measures of oxygen saturation and total hemoglobin volume fraction being out of a respective acceptable range.

2. The method of claim 1, wherein detecting a hemodynamic status comprises:

detecting a hemodynamically unstable arrhythmia in response to a decreasing measure of tissue oxygen saturation;

enabling a shock therapy for treating the arrhythmia in response to detecting the hemodynamically unstable arrhythmia; and

withholding delivering of a shock therapy for treating the arrhythmia in response to not detecting the hemodynamic status as being unstable.

3. The method of claim 1, wherein the measure of total hemoglobin volume fraction is computed using the measure of tissue oxygen saturation.

4. The method of claim 1, further comprising:

determining a baseline measurement of tissue oxygenation prior to detecting the arrhythmia;

computing an onset measurement of tissue oxygenation corresponding to a time at which the arrhythmia is detected in response to the depolarization signals;

comparing the baseline measurement and the onset measurement; and

enabling a shock therapy in response to the onset measurement being less than the baseline measurement.

5. The method of claim 1, further comprising:

computing an onset measurement of tissue oxygenation corresponding to a time at which the arrhythmia is detected in response to the depolarization signals;

computing an episode measurement of tissue oxygenation at a time subsequent to arrhythmia detection;

comparing the onset measurement and the episode measurement; and

withholding a shock therapy in response to the comparison.

6. The method of claim 3 further comprising:

defining an acceptable measurement range for the measure of total hemoglobin volume fraction;

comparing the measure of total hemoglobin volume fraction to the acceptable measurement range; and

determining a quality of the measure of total hemoglobin volume fraction in response to the comparing.

7. The method of claim 1, wherein detecting a hemodynamic status comprises:

determining a baseline measurement of tissue oxygenation prior to detecting the arrhythmia;

defining a threshold in response to the baseline measurement; and

comparing the measure of tissue oxygenation to the threshold.

8. The method of claim 3, further comprising computing a tissue oxygenation index as a function of the measure of tissue oxygen saturation and the measure of total hemoglobin volume fraction.

9. The method of claim 1, further comprising:

sensing a signal corresponding to a patient position; and

detecting the hemodynamic status in response to the measure of tissue oxygenation and the signal corresponding to the patient position.

10. The method of claim 1, further comprising:

storing a state table relating the tissue oxygenation measurement to a cardiac status; and

determining an absolute value of the tissue oxygenation measurement and a trended value of the tissue oxygenation measurement, wherein detecting a hemodynamic status comprises determining a cardiac status stored in the state table corresponding to the absolute value and the trended value.

22. The method of claim 1, further comprising:

enabling a pulse generator to deliver local stimulation to excitable tissue via electrodes adjacent the optical sensor to increase tissue oxygen consumption when light is being detected by the optical sensor.

23. The method of claim 1, further comprising:

storing a state table relating a plurality of combinations of oxygen saturation independent of total hemoglobin and total hemoglobin volume fraction to a cardiac status; and

determining a cardiac rhythm status from the state table using the measure of oxygen saturation independent of total hemoglobin and the measure of total hemoglobin volume fraction determined in response to detecting the arrhythmia.

24. The method of claim 23, further comprising:

determining an onset measure of each of the oxygen saturation independent of total hemoglobin and the total hemoglobin volume fraction at an onset of the detected arrhythmia;

determining at least one later measure of each of the oxygen saturation independent of total hemoglobin and the total hemoglobin volume fraction;

determining a trend of each of the oxygen saturation independent of total hemoglobin and the total hemoglobin volume fraction in response to the onset measures and the later measures;

classifying the trends according to the state table classifications,; and

determining the cardiac rhythm status from the state table in response to the trends, wherein the state combinations include trends in the measure of oxygen saturation independent of total hemoglobin and trends in the measure of total hemoglobin volume fraction.

11. An implantable medical device, comprising:

a cardiac electrode for sensing cardiac depolarization signals;

an optical sensor for providing a signal corresponding to light attenuation by a volume of blood perfused tissue;

a control module coupled to the optical sensor controlling the light emitted by the optical sensor;

a monitoring module receiving an optical sensor output signal and measuring light attenuation for at least four spaced-apart light wavelengths; and

a processor coupled to the cardiac electrode and the monitoring module, the processor being configured to;

detect an arrhythmia in response to the depolarization signals,

compute a tissue oxygenation measurement in response to detecting the arrhythmia,

compute an attenuation for each of the at least four wavelengths of detected light,

compute a second derivative of the light attenuation with respect to two different wavelengths,

compute a measure of tissue oxygen saturation independent of total hemoglobin as a ratio of the second derivatives at the two different wavelengths,

compute a measure of total hemoglobin volume fraction using the second derivative of a selected one of the two different wavelengths;

detect a hemodynamic status of the arrhythmia in response to the measure of tissue oxygenation, wherein the measure of tissue oxygenation is computed responsive to at least one of the measure of tissue oxygen saturation independent of total hemoglobin and the measure of total hemoglobin volume fraction;

determine an attenuation for each of the at least four wavelengths at an episode onset time point of the arrhythmia detection;

determine an onset measurement at the episode onset time point based on a weighted combination of the tissue oxygen saturation and the total hemoglobin volume fraction for the time of the arrhythmia detection;

determine if one of the measure of oxygen saturation and the measure of total hemoglobin volume fraction is out of a respective acceptable range; and

adjust a weighting factor used to compute the weighted combination in response to one of the measures of oxygen saturation and total hemoglobin volume fraction being out of a respective acceptable range.

12. The device of claim 11, further comprising a therapy delivery module coupled to the electrode to deliver shock therapy for treating the arrhythmia, wherein the processor is further configured to detect the hemodynamic status as unstable in response to a decreasing measure of tissue oxygenation and to enable the therapy delivery module to deliver the shock therapy in response to detecting the unstable hemodynamic status, and withhold delivery of a shock therapy by the therapy delivery module in response to not detecting the hemodynamic status as unstable.

13. The device of claim 11, wherein the measure of total hemoglobin volume fraction is computed using the measure of tissue oxygen saturation.

14. The device of claim 11, further comprising a therapy delivery module coupled to the electrode for delivering a shock therapy to a patient, wherein the processor is further configured to determine a baseline measurement of tissue oxygenation prior to detecting the arrhythmia, compute an onset measurement of tissue oxygenation corresponding to a time at which the arrhythmia is detected in response to the depolarization signals, compare the baseline measurement and the onset measurement, and enable the therapy delivery module to deliver shock therapy in response to the onset measurement being less than the baseline measurement.

15. The device of claim 11, further comprising a therapy delivery module coupled to the electrode for delivering a shock therapy to a patient, wherein the processor is further configured to determine an onset measurement of tissue oxygenation corresponding to a time at which the arrhythmia is detected in response to the depolarization signals, compute an episode measurement of tissue oxygenation corresponding to a time subsequent to the arrhythmia being detected in response to the depolarization signals, compare the onset measurement and the episode measurement and enable the therapy delivery module to deliver a shock therapy in response to the episode measurement being less than the onset measurement.

16. The device of claim 13, further comprising a memory storing an acceptable measurement range for the measure of total hemoglobin volume fraction, wherein the processor is further configured to compare the measure of total hemoglobin volume fraction to the acceptable measurement range, and determine a quality of the measure of total hemoglobin volume fraction and the measure of tissue oxygen saturation in response to the comparing.

17. The device of claim 11, further comprising a memory for storing a threshold, wherein the processor is further configured to determine a baseline measurement of tissue oxygenation prior to detecting the arrhythmia, compute a threshold in response to the baseline measurement and store the threshold in the memory;

and compare the measure of tissue oxygenation to the threshold.

18. The device of claim 13, wherein analyzing the measure of tissue oxygen saturation and the measure of total hemoglobin volume fraction comprises computing a tissue oxygenation index as a function of the measure of tissue oxygen saturation and the measure of total hemoglobin volume fraction.

19. The device of claim 11, further comprising a sensor coupled to the processor to sense a signal corresponding to a patient position, wherein the processor is further configured to detect the hemodynamic status in response to the measure of tissue oxygenation and the signal corresponding to the patient position.

20. The device of claim 11, further comprising a memory storing a state table relating the tissue oxygenation measurement to a cardiac status, wherein the processor is further configured to determine an absolute value of the tissue oxygenation measurement and a trended value of the tissue oxygenation measurement, and detect the hemodynamic status by determining a cardiac status stored in the state table corresponding to the absolute value and the trended value.

21. A non-transitory computer readable medium having computer executable instructions for performing a method comprising:

sensing cardiac depolarization signals;

detecting an arrhythmia in response to the depolarization signals;

controlling an optical sensor to emit light in response to the detected arrhythmia;

detecting light scattered by a volume of blood perfused tissue wherein detecting light comprises measuring an optical sensor output signal corresponding to light attenuation of at least four spaced apart light wavelengths;

computing a measure of tissue oxygenation from the optical sensor output signal, wherein computing the measure of tissue oxygenation comprises;

computing a light attenuation for each of the at least four wavelengths;

computing a second derivative of the light attenuation with respect to two different wavelengths;

computing a measure of tissue oxygen saturation independent of total hemoglobin as a ratio of the second derivatives at the two different wavelengths;

computing a measure of total hemoglobin volume fraction using the second derivative of a selected one of the two different wavelengths; and

detecting a hemodynamic status of the arrhythmia in response to the measure of tissue oxygenation, wherein the measure of tissue oxygenation is computed responsive to at least one of the measure of tissue oxygen saturation independent of total hemoglobin and the measure of total hemoglobin volume fraction;

determine an attenuation for each of the at least four wavelengths at an episode onset time point of the arrhythmia detection;

determine an onset measurement at the episode onset time point based on a weighted combination of the tissue oxygen saturation and the total hemoglobin volume fraction for the time of the arrhythmia detection;

determining if one of the measure of oxygen saturation and the measure of total hemoglobin volume fraction is out of a respective acceptable range; and

adjusting a weighting factor used to compute the weighted combination in response to one of the measures of oxygen saturation and total hemoglobin volume fraction being out of a respective acceptable range.

25. An implantable medical device, comprising:

a cardiac electrode for sensing cardiac depolarization signals;

an optical sensor configured to produce a signal corresponding to light attenuation by a volume of blood perfused tissue;

a control module coupled to the optical sensor and configured to control the light emitted by the optical sensor;

a monitoring module coupled to the optical sensor and configured to receive an optical sensor output signal and determine light attenuation for at least four spaced-apart light wavelengths; and

a processor electrically coupled to the cardiac electrode and the monitoring module and configured to receive the cardiac electrical signal, the processor being configured to;

detect an arrhythmia in response to the cardiac electrical signal,

determine an attenuation for each of the at least four wavelengths at an episode onset time point of the arrhythmia detection;

determine a second derivative of the attenuation with respect to each of two different wavelengths of the four wavelengths for the episode onset time point of the arrhythmia detection;

determine a tissue oxygen saturation independent of total hemoglobin based on a ratio of the two second derivatives determined with respect to each of the two different wavelengths for the episode onset time point;

determine a total hemoglobin volume fraction based on a selected one of the two second derivatives determined for the episode onset time point;

establish a first weighting factor applied to the tissue oxygen saturation and a second weighting factor applied to the total hemoglobin volume fraction;

determine an onset measurement at the episode onset time point based on a weighted combination of the tissue oxygen saturation and the total hemoglobin volume fraction for the time of the arrhythmia detection using the established first and second weighting factors;

compare the onset measurement to an onset detection threshold,

detect a hemodynamically unstable status of the detected arrhythmia in response to the onset measurement being less than the onset detection threshold;

determine if one of the tissue oxygen saturation and the total hemoglobin volume fraction is out of a respective acceptable range; and

adjust one of the first weighting factor and the second weighting factor used to compute the weighted combination in response to one of the tissue oxygen saturation and the total hemoglobin volume fraction being out of the respective acceptable range.

27. The device of claim 25, further comprising a sensor coupled to the processor to sense a signal corresponding to a patient position, wherein the processor is further configured to detect the hemodynamic status in response to the measure of tissue oxygenation and the signal corresponding to the patient position.

28. The device of claim 25, further comprising a memory storing a state table relating the tissue oxygenation measurement to a cardiac status, wherein the processor is further configured to determine an absolute value of the tissue oxygenation measurement and a trended value of the tissue oxygenation measurement, and detect the hemodynamic status by determining a cardiac status stored in the state table corresponding to the absolute value and the trended value.

29. The device of claim 25, further comprising a therapy delivery module coupled to the electrode to deliver shock therapy for treating the detected arrhythmia.

26. A method, comprising:

sensing cardiac depolarization signals;

detecting an arrhythmia in response to the depolarization signals;

controlling an optical sensor to emit light in response to the detected arrhythmia;

detecting light scattered by a volume of blood perfused tissue wherein detecting light comprises measuring an optical sensor output signal corresponding to light attenuation of at least four spaced apart light wavelengths;

computing a measure of tissue oxygenation from the optical sensor output signal, wherein computing the measure of tissue oxygenation comprises;

computing a light attenuation for each of the at least four wavelengths;

computing a second derivative of the light attenuation with respect to two different wavelengths;

computing a measure of tissue oxygen saturation independent of total hemoglobin as a ratio of the second derivatives at the two different wavelengths;

computing a measure of total hemoglobin volume fraction using the second derivative of a selected one of the two different wavelengths;

computing the measure of tissue oxygenation as a weighted combination of the measure of oxygen saturation and the measure of total hemoglobin volume fraction;

determining if one of the measure of oxygen saturation and the measure of total hemoglobin volume fraction is out of a respective acceptable range;

adjusting a weighting factor used to compute the weighted combination in response to one of the measures of oxygen saturation and total hemoglobin volume fraction being out of a respective acceptable range; and

detecting a hemodynamic status of the arrhythmia in response to the measure of tissue oxygenation.