THERAPY SYSTEM INCLUDING CARDIAC RHYTHM THERAPY AND NEUROSTIMULATION CAPABILITIES

• US 20100114217A1
• Filed: 10/30/2009
• Published: 05/06/2010
• Est. Priority Date: 10/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Krause, Paul G., Scheiner, Avram
• Granted Patent: US 9,026,206 B2
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• 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 1/36521 the parameter being derived from measurement of an electrical impedance

Abstract

An implantable medical system that includes a cardiac therapy module and a neurostimulation therapy module may identify when neurostimulation electrodes have migrated toward a patient'"'"'s heart. In some examples, the system may determine whether the neurostimulation electrodes have migrated toward the patient'"'"'s heart based on a physiological response to an electrical signal delivered to the patient via the neurostimulation electrodes. In addition, in some examples, the system may determine whether the neurostimulation electrodes have migrated toward the patient'"'"'s heart based on an electrical cardiac signal sensed via the neurostimulation electrodes.

Claims

1. A method comprising:

delivering cardiac rhythm therapy to a patient via a first set of electrodes of a first lead electrically connected to a cardiac therapy module;

delivering an electrical signal to a tissue site within a patient via a second set of electrodes of a second lead electrically connected to a neurostimulation therapy module;

sensing a physiological signal;

detecting a physiological response of the patient to the electrical signal based on the physiological signal; and

controlling the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response.

2. The method of claim 1, wherein controlling the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response comprises controlling the neurostimulation therapy module to deliver neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is detected and controlling the neurostimulation therapy module to withhold the delivery neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is not detected.

3. The method of claim 2, wherein sensing the physiological signal comprises sensing an electrical nerve signal generated by a nerve of the patient and the physiological response comprises a response of the nerve to the electrical signal.

4. The method of claim 2, wherein sensing the physiological signal comprises sensing the physiological signal indicative of muscle activity of the patient and the physiological response comprises a response of the muscle to the electrical signal.

5. The method of claim 4, wherein the physiological signal indicates activity of a laryngeal muscle.

6. The method of claim 2, wherein detecting the physiological response comprises comparing an amplitude of the physiological signal to a threshold value, and detecting the response when the amplitude is greater than or equal to the threshold value.

7. The method of claim 2, wherein delivering the electrical signal to the tissue site comprises delivering the electrical signal having a first frequency, and wherein detecting the physiological response comprises comparing a second frequency of the physiological signal to the first frequency, and detecting the response when the second frequency of the physiological signal is greater or equal to the first frequency.

8. The method of claim 1, wherein controlling the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response comprises controlling the neurostimulation therapy module to deliver neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is not detected and controlling the neurostimulation therapy module to withhold the delivery neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is detected.

9. The method of claim 8, wherein sensing the physiological signal comprises sensing at least one of an electrical cardiac signal, an acoustic signal or a pressure signal, and the physiological response indicates cardiac capture.

10. The method of claim 9, wherein the physiological response indicates a depolarization of a heart of the patient caused by the electrical signal.

11. The method of claim 9, wherein the physiological signal comprises at least one of an electrocardiogram or an electrogram, and the physiological response comprises at least one of an R-wave or a P-wave.

12. The method of claim 1, wherein the second lead is implanted proximate to nonmyocardial tissue or nonvascular cardiac tissue of the patient.

13. The method of claim 1, wherein the second lead is implanted within vasculature of the patient.

14. The method of claim 1, wherein the cardiac rhythm therapy comprises at least one of pacing, cardioversion or defibrillation therapy.

15. The method of claim 1, wherein the cardiac therapy module and neurostimulation therapy module are enclosed in separate outer housings that are separately implantable within the patient.

16. The method of claim 1, wherein the cardiac therapy module and neurostimulation therapy module are enclosed in a common outer housing of an implantable medical device.

17. A system comprising:

a first lead comprising a first set of electrodes;

a second lead comprising a second set of electrodes;

a cardiac therapy module electrically connected to the first set of electrodes of the first lead, wherein the cardiac therapy module generates and delivers cardiac rhythm therapy to a heart of the patient via the first set of electrodes;

a neurostimulation therapy module electrically connected to the second set of electrodes of the second lead, wherein neurostimulation therapy module generates and delivers an electrical signal to a tissue site within the patient via the second set of electrodes;

a sensing module that senses a physiological signal of the patient;

a processor that detects a physiological response of the patient to the electrical signal based on the physiological signal and controls the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response.

18. The system of claim 17, wherein the sensing module senses the physiological signal of the patient via the first set of electrodes.

19. The system of claim 17, wherein the sensing module senses the physiological signal of the patient via the second set of electrodes.

20. The system of claim 17, wherein the cardiac therapy module and the neurostimulation therapy module are enclosed within a common outer housing of an implantable medical device.

21. The system of claim 17, further comprising a first implantable medical device (IMD) comprising a first outer housing enclosing the cardiac therapy module and a second IMD comprising a second outer housing enclosing the neurostimulation therapy module, wherein the first and second outer housings are physically separate from each other and separately implantable within the patient.

22. The system of claim 17, wherein the processor controls the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response by at least controlling the neurostimulation therapy module to deliver neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is detected and controlling the neurostimulation therapy module to withhold the delivery neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is not detected.

23. The system of claim 22, wherein the physiological signal comprises an electrical nerve signal generated by a nerve of the patient, and the physiological response comprises a response of the nerve to the electrical signal.

24. The system of claim 22, wherein the physiological signal indicates muscle activity of the patient and the physiological response comprises a response of the muscle to the electrical signal.

25. The system of claim 22, wherein the processor detects the physiological response by at least comparing an amplitude of the physiological signal to a threshold value, and detecting the physiological response when the amplitude is greater than or equal to the threshold value.

26. The system of claim 22, wherein the processor detects the physiological response by at least comparing a frequency of the physiological signal to a threshold value, and detecting the physiological response when the frequency is greater or equal to the threshold value.

27. The system of claim 17, wherein the processor controls the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response by at least controlling the neurostimulation therapy module to deliver neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is not detected and controlling the neurostimulation therapy module to withhold the delivery neurostimulation to the patient via the second set of electrodes of the second lead if the physiological response is detected.

28. The system of claim 27, wherein the physiological signal comprises at least one of an electrical cardiac signal, an acoustic signal or a pressure signal, and the physiological response indicates cardiac capture.

29. The system of claim 28, wherein the physiological signal comprises at least one of an electrocardiogram or an electrogram, and the physiological response comprises at least one of an R-wave or a P-wave.

30. The system of claim 17, wherein the second set of electrodes of the second lead are implanted proximate to a vagus nerve of the patient.

31. A system comprising:

means for delivering cardiac rhythm therapy to a patient via a first set of electrodes of a first lead;

means for delivering an electrical signal to a tissue site within a patient via a second set of electrodes of a second lead;

means for sensing a physiological signal;

means for detecting a physiological response of the patient to the electrical signal based on the physiological signal; and

means for controlling the means for delivering the electrical signal to deliver neurostimulation therapy to the patient based on the detected physiological response.

32. The system of claim 31, wherein the means for controlling the means for delivering the electrical signal comprises means for controlling the means for delivering the electrical signal to deliver neurostimulation therapy to the patient via the second set of electrodes of the second lead if the physiological response is detected and means for controlling the means for delivering the electrical signal to withhold the delivery neurostimulation therapy to the patient via the second set of electrodes of the second lead if the physiological response is not detected.

33. The system of claim 32, wherein the means for sensing the physiological signal comprises means for sensing an electrical nerve signal indicative of activity of a nerve of the patient or an electrical muscle signal indicative of muscle activity of the patient.

34. The system of claim 31, wherein the means for controlling the means for delivering the electrical signal comprises means for controlling the means for delivering the electrical signal to deliver neurostimulation therapy to the patient via the second set of electrodes of the second lead if the physiological response is not detected and means for controlling the means for delivering the electrical signal to withhold the delivery neurostimulation therapy to the patient via the second set of electrodes of the second lead if the physiological response is detected.

35. The system of claim 34, wherein the means for sensing the physiological signal comprises means for sensing an electrical cardiac signal, and the physiological response is indicative of cardiac capture.

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

control a cardiac therapy module to deliver cardiac rhythm therapy to a patient via a first set of electrodes of a first lead electrically connected to the cardiac therapy module;

control a neurostimulation therapy module to deliver an electrical signal to a tissue site within a patient via a second set of electrodes of a second lead electrically connected to the neurostimulation therapy module;

control a sensing module to sense a physiological signal;

detect a physiological response of the patient to the electrical signal based on the physiological signal; and

control the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on the detected physiological response.