EVALUATING THERAPEUTIC STIMULATION ELECTRODE CONFIGURATIONS BASED ON PHYSIOLOGICAL RESPONSES

• US 20090054946A1
• Filed: 08/20/2008
• Published: 02/26/2009
• Est. Priority Date: 08/20/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John L., Eggen, Michael D., Marshall, Mark T., Miyazawa, Gabriela C., Bourn, David Wayne
• Granted Patent: US 8,326,418 B2
• Time in Patent Office: Days
• US Class Current: 607/28
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A medical system comprises a plurality of electrodes; at least one sensor configured to output at least one signal based on at least one physiological parameter of a patient; and a processor. The processor is configured to control delivery of stimulation to the patient using a plurality of electrode configurations. Each of the electrode configurations comprises at least one of the plurality of electrodes. For each of the electrode configurations, the processor is configured to determine a first response of target tissue to the stimulation based on the signals, and a second response of non-target tissue to the stimulation based on the signals. The processor is also configured to select at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations. As examples, the target tissue may be a left ventricle or vagus nerve.

Claims

1. A medical system comprising:

a plurality of electrodes;

at least one sensor configured to output at least one signal based on at least one physiological parameter of a patient; and

a processor configured to;

control delivery of stimulation to the patient using a plurality of electrode configurations, wherein each of the electrode configurations comprises at least one of the plurality of electrodes,

for each of the electrode configurations, determine a first response of target tissue to the stimulation based on the signals, and a second response of non-target tissue to the stimulation based on the signals, and

select at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations.

2. The medical system of claim 1, further comprising at least one implantable medical lead, wherein the at least one implantable medical lead includes the plurality of electrodes.

3. The medical system of claim 2, wherein the at least one implantable medical lead comprises cardiac pacing leads, wherein the target tissue comprises tissue of the left ventricle of the patient and the non-target tissue comprises tissue of the phrenic nerve of the patient.

4. The medical system of claim 2, wherein the target tissue comprises tissue of the vagus nerve of the patient and the non-target tissue comprises muscle tissue of the patient adjacent to the vagus nerve.

5. The medical system of claim 2, further comprising an implantable medical device including a stimulation generator coupled to the implantable medical leads, wherein the processor controls the implantable medical device to deliver the stimulation to the patient using the plurality of electrode configurations.

6. The medical system of claim 1, wherein the at least one sensor includes:

a first sensor that outputs a first signal based on a first physiological parameter of the patient that indicates the first response of the target tissue; and

a second sensor that outputs a second signal based on a second physiological parameter of the patient that indicates the second response of the non-target tissue.

7. The medical system of claim 1, wherein the physiological parameters of the patient are selected from a group consisting of:

an electrocardiogram (ECG);

heart rate;

QRS width;

atrioventricular (AV) dissociation;

respiration rate;

respiratory volume;

core temperature;

diaphragmatic stimulation;

skeletal muscle activity;

blood oxygen level;

cardiac output;

blood pressure;

intercardiac pressure;

time derivative of intercardiac pressure (dP/dt);

electromyogram (EMG) parameters; and

an electroencephalogram (EEG) parameters.

8. The medical system of claim 1, wherein the first response of target tissue comprises a first capture threshold of target tissue and the second response of non-target tissue comprises a second capture threshold of non-target tissue.

9. The medical system of claim 8, wherein the first and second capture thresholds are selected from a group consisting of:

a stimulation waveform;

a stimulation amplitude;

a stimulation pulse width; and

a stimulation pulse frequency.

10. The medical system of claim 8, wherein determining the first and second responses for the electrode configurations includes determining that at least one of the first and second capture thresholds exceeds a maximum stimulation amplitude allowed by the medical system.

11. The medical system of claim 1, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations includes determining a value of a suitability index for each of the electrode configurations based on a ratio of the first second capture threshold to the second capture threshold for each of the electrode configurations.

12. The medical system of claim 1, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations comprises:

automatically selecting at least one electrode configuration of the plurality of electrode configurations; and

controlling delivery of stimulation to the patient using the at least one electrode configuration.

13. The medical system of claim 1, further comprising a user interface, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations includes:

presenting the first and second responses to a clinician via the user interface; and

receiving an input from the clinician via the user interface selecting at least one of the electrode configurations for delivery of stimulation to the patient.

14. The medical system of claim 13, wherein the first response of target tissue comprises a first capture threshold of target tissue and the second response of non-target tissue comprises a second capture threshold of non-target tissue.

15. The medical system of claim 1, further comprising a clinician programmer including the processor.

16. The medical system of claim 1, wherein the selected at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations include an electrode configuration comprising:

a first electrode segment configured as a first anode;

a second electrode segment configured as a cathode; and

a third electrode segment configured as a second anode, wherein the third electrode segment being opposite the first electrode segment relative to the second electrode segment.

17. The medical system of claim 1, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations comprises selecting at least one electrode configuration of the plurality of electrode configurations to optimize the physiological parameters of the patient.

18. A method for evaluating therapeutic stimulation of a plurality of electrode configurations comprising:

controlling delivery of stimulation to a patient using the plurality of electrode configurations;

for each of the electrode configurations, determining a first response of target tissue to the stimulation and a second response of non-target tissue to the stimulation based on at least one sensor signal, wherein the sensor signals are based on at least one physiological parameter of the patient; and

selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations.

19. The method of claim 18, wherein the plurality of electrode configurations include sets of at least one electrode included on at least one implantable medical lead.

20. The method of claim 19, wherein the at least one implantable medical lead are cardiac pacing leads, wherein the target tissue comprises the left ventricle of the patient and the non-target tissue comprises the phrenic nerve of the patient.

21. The method of claim 19, wherein the target tissue comprises the vagus nerve of the patient and the non-target tissue comprises a muscle of the patient adjacent to the vagus nerve.

22. The method of claim 19, further comprising controlling a stimulation generator coupled to the implantable medical leads to deliver the stimulation to the patient using the plurality of electrode configurations.

23. The method of claim 18, wherein the sensor signals are sent by at least one sensor including:

a first sensor that outputs a first signal based on a first physiological parameter of the patient that indicates capture of the target tissue; and

a second sensor that outputs a second signal based on a second physiological parameter of the patient that indicates capture of the non-target tissue.

24. The method of claim 18, wherein the physiological parameters of the patient are selected from a group consisting of:

an electrocardiogram (ECG);

heart rate;

QRS width;

atrioventricular (AV) dissociation;

respiration rate;

respiratory volume;

core temperature;

diaphragmatic stimulation;

skeletal muscle activity;

blood oxygen level;

cardiac output;

blood pressure;

intercardiac pressure;

time derivative of intercardiac pressure (dP/dt);

electromyogram (EMG) parameters; and

an electroencephalogram (EEG) parameters.

25. The method of claim 18, wherein the first and second responses are selected from a group consisting of:

a stimulation waveform;

a stimulation amplitude;

a stimulation pulse width; and

a stimulation pulse frequency.

26. The method of claim 18, wherein the first response comprises a first capture threshold and the second response comprises a second capture threshold, wherein determining the first and second responses for the electrode configurations includes determining that at least one of the first and second capture thresholds exceeds a maximum stimulation amplitude allowed by the method.

27. The method of claim 18, wherein the first response comprises a first capture threshold and the second response comprises a second capture threshold, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations includes determining a value of a suitability index for each of the electrode configurations based on a ratio of the first second capture threshold to the second capture threshold for each of the electrode configurations.

28. The method of claim 18, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations comprises:

automatically selecting at least one preferable electrode configuration of the plurality of electrode configurations; and

controlling delivery of stimulation to the patient using the at least one preferable electrode configuration.

29. The method of claim 18, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations includes:

presenting the first and second responses to a clinician via a user interface; and

receiving an input from the clinician via the user interface selecting at least one of the electrode configurations for delivery of stimulation to the patient.

30. The method of claim 18, wherein the selected at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations include an electrode configuration comprising:

a first electrode segment configured as a first anode;

a second electrode segment configured as a cathode; and

a third electrode segment configured as a second anode, wherein the third electrode segment being opposite the first electrode segment relative to the second electrode segment.

31. The method of claim 18, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations comprises selecting at least one electrode configuration of the plurality of electrode configurations to optimize the physiological parameters of the patient.

32. A computer-readable medium comprising instructions that cause a programmable processor to:

control delivery of stimulation to a patient using a plurality of electrode configurations;

for each of the electrode configurations, determine a first response of target tissue to the stimulation and a second response of non-target tissue to the stimulation based on at least one sensor signal, wherein the sensor signals are based on at least one physiological parameter of the patient; and

select at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations.

33. The computer-readable medium of claim 32, wherein the plurality of electrode configurations include sets of at least one electrode included on at least one implantable medical lead.

34. The computer-readable medium of claim 33, wherein the at least one implantable medical lead are cardiac pacing leads, wherein the target tissue comprises the left ventricle of the patient and the non-target tissue comprises the phrenic nerve of the patient.

35. The computer-readable medium of claim 33, wherein the target tissue comprises the vagus nerve of the patient and the non-target tissue comprises a muscle of the patient adjacent to the vagus nerve.

36. The computer-readable medium of claim 33, comprising further instructions that cause the programmable processor to control a stimulation generator coupled to the implantable medical leads to deliver the stimulation to the patient using the plurality of electrode configurations.

37. The computer-readable medium of claim 32, wherein the sensor signals are sent by at least one sensor including:

a first sensor that outputs a first signal based on a first physiological parameter of the patient that indicates capture of the target tissue; and

a second sensor that outputs a second signal based on a second physiological parameter of the patient that indicates capture of the non-target tissue.

38. The computer-readable medium of claim 32, wherein the physiological parameters of the patient are selected from a group consisting of:

an electrocardiogram (ECG);

heart rate;

QRS width;

atrioventricular (AV) dissociation;

respiration rate;

respiratory volume;

core temperature;

diaphragmatic stimulation;

skeletal muscle activity;

blood oxygen level;

cardiac output;

blood pressure;

intercardiac pressure;

time derivative of intercardiac pressure (dP/dt);

electromyogram (EMG) parameters; and

an electroencephalogram (EEG) parameters.

39. The computer-readable medium of claim 32, wherein the first and second capture thresholds are selected from a group consisting of:

a stimulation waveform;

a stimulation amplitude;

a stimulation pulse width; and

a stimulation pulse frequency.

40. The computer-readable medium of claim 32, wherein the first response comprises a first capture threshold and the second response comprises a second capture threshold, wherein determining the first and second responses for the electrode configurations includes determining that at least one of the first and second capture thresholds exceeds a maximum stimulation amplitude allowed by the computer-readable medium.

41. The computer-readable medium of claim 32, wherein the first response comprises a first capture threshold and the second response comprises a second capture threshold, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second capture responses for the electrode configurations includes determining a value of a suitability index for each of the electrode configurations based on a ratio of the first second capture threshold to the second capture threshold for each of the electrode configurations.

42. The computer-readable medium of claim 32, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations comprises:

automatically selecting at least one preferable electrode configuration of the plurality of electrode configurations; and

controlling delivery of stimulation to the patient using the at least one preferable electrode configuration.

43. The computer-readable medium of claim 32, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations includes:

presenting the first and second responses to a clinician via a user interface; and

receiving an input from the clinician via the user interface selecting at least one of the electrode configurations for delivery of stimulation to the patient.

44. The computer-readable medium of claim 32, wherein the selected at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations include an electrode configuration comprising:

a first electrode segment configured as a first anode;

a second electrode segment configured as a cathode; and

a third electrode segment configured as a second anode, wherein the third electrode segment being opposite the first electrode segment relative to the second electrode segment.

45. The computer-readable medium of claim 32, wherein selecting at least one of the electrode configurations for delivery of stimulation to the patient based on the first and second responses for the electrode configurations comprises selecting at least one electrode configuration of the plurality of electrode configurations to optimize the physiological parameters of the patient.

46. A medical device comprising:

a means for delivering stimulation therapy to a patient using a plurality of electrode configurations; and

a means for evaluating the relative suitability of the of the electrode configurations for delivering stimulation therapy to target tissue of the patient.