Therapy system including cardiac rhythm therapy and neurostimulation capabilities

• US 9,026,206 B2
• Filed: 10/30/2009
• Issued: 05/05/2015
• 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
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): OROPEZA, FRANCES P
• Application Number:
  US12/610,160
• Publication Number:
  US 20100114217A1
• Time in Patent Office: 2,013 Days
• Field of Search: 607/2, 607/4, 607/5, 607/6, 607/7, 607/9, 607/116, 607/119
• US Class Current: 607/9
• 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 for determining whether lead migration has occurred, the method comprising:

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

sensing a baseline physiological response from a patient to produce an electromyogram (EMG) waveform;

storing the baseline physiological response into memory, the baseline physiological response comprising a baseline characteristic of the EMG waveform;

sensing a physiological response from a patient to produce a EMG waveform at a subsequent time to the baseline physiological response;

comparing the physiological response to the baseline physiological response by comparing a characteristic of the EMG waveform produced at the subsequent time to the baseline characteristic of the EMG waveform;

detecting lead migration if the characteristic of the EMG waveform increased from the baseline EMG waveform characteristic; and

decreasing intensity of neurostimulation in response to detecting the lead migration.

2. The method of claim 1, wherein the delivery of the neurostimulation to the patient via the set of electrodes of the lead is withheld if the physiological response is not detected.

3. The method of claim 2, wherein the physiological response comprises a response of the muscle to the electrical signal.

4. The method of claim 3, wherein the physiological response indicates activity of a laryngeal muscle.

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

6. 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 response to the first frequency, and detecting the response when the second frequency of the physiological response is greater or equal to the first frequency.

7. The method of claim 1, wherein sensing the physiological response comprises sensing at least one of an electrical cardiac signal, an acoustic signal or a pressure signal, and the physiological response comprises an indication of cardiac capture.

8. The method of claim 7, wherein the physiological response indicates a depolarization of a heart of the patient caused by the electrical signal.

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

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

11. The method of claim 1, further comprising delivering cardiac rhythm therapy to a patient via a first set of electrodes of another lead electrically connected to a cardiac therapy module, wherein cardiac rhythm therapy comprises at least one of pacing, cardioversion or defibrillation therapy.

12. The method of claim 11, wherein the cardiac therapy module and neurostimulation therapy module are enclosed in separate outer housings that are separately implantable within the patient.

13. The method of claim 11, wherein the cardiac therapy module and neurostimulation therapy module are enclosed in a common outer housing of an implantable medical device.

14. A system comprising:

a lead comprising a set of electrodes;

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

a sensing module that senses a baseline physiological response to produce an electromyogram (EMG) waveform and a subsequent physiological signal to produce another EMG waveform of the patient;

a processor that stores the baseline physiological response comprising a baseline characteristic of the EMG waveform, compares the baseline characteristic of the EMG waveform and a characteristic of the EMG waveform produced subsequent to the baseline physiological response to determine the lead has migrated if the characteristic of the EMG waveform has increased from the baseline characteristic of the EMG waveform and controls the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on whether the lead has migrated.

15. The system of claim 14, further comprising a cardiac therapy module electrically connected to the set of electrodes of the lead, wherein the cardiac therapy module generates and delivers cardiac rhythm therapy to a heart of the patient via the set of electrodes wherein the sensing module senses the physiological response of the patient via the another set of electrodes.

16. The system of claim 14, wherein the sensing module senses the physiological response of the patient via the set of electrodes.

17. The system of claim 15, wherein the cardiac therapy module and the neurostimulation therapy module are enclosed within a common outer housing of an implantable medical device.

18. The system of claim 15, 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.

19. The system of claim 14, wherein the processor withholds the delivery of neurostimulation to the patient via the set of electrodes of the lead if the physiological response is not detected.

20. The system of claim 19, wherein the physiological response indicates muscle activity of the patient and the physiological response comprises a response of the muscle to the electrical signal.

21. The system of claim 19, wherein the processor detects the physiological response by at least comparing an amplitude of the physiological response to a threshold value, and detecting the physiological response when the amplitude is greater than or equal to the threshold value.

22. The system of claim 19, wherein the processor detects the physiological response by at least comparing a frequency of the physiological response to a threshold value, and detecting the physiological response when the frequency is greater or equal to the threshold value.

23. The system of claim 14, wherein the processor withholds the delivery of neurostimulation to the patient via the set of electrodes of the lead if the physiological response is detected.

24. The system of claim 14, wherein the set of electrodes of the lead are implanted proximate to a vagus nerve of the patient.

25. A system for determining whether lead migration has occurred, the system comprising:

a set of electrodes of a lead electrically connected to a neurostimulation therapy module;

means for sensing a baseline physiological response from a patient to produce an electromyogram (EMG) waveform, the baseline physiological response comprising a baseline characteristic of the EMG waveform;

means for storing the baseline physiological response into memory;

means for sensing a physiological response from a patient to produce an EMG waveform at a subsequent time to the baseline physiological response;

means for comparing the physiological response to the baseline physiological response by comparing a characteristic of the EMG waveform produced at the subsequent time to the baseline characteristic of the EMG waveform;

means for detecting lead migration if the characteristic of the EMG waveform increased from the baseline EMG waveform characteristic; and

means for decreasing intensity of neurostimulation if lead migration is detected.

26. The system of claim 25, wherein the means for controlling comprises means for withholding the delivery of the neurostimulation therapy to the patient via the set of electrodes of the lead if the physiological response is not detected.

27. The system of claim 26, wherein the means for sensing the physiological response 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.

28. The system of claim 25, wherein the means for controlling comprises means for controlling the neurostimulation therapy module to deliver neurostimulation therapy to the patient via the set of electrodes of the lead if the physiological response is not detected and to withhold the delivery neurostimulation therapy to the patient via the set of electrodes of the lead if the physiological response is detected.

29. The system of claim 28, wherein the means for sensing the physiological response comprises means for sensing an electrical cardiac signal, and the physiological response is indicative of cardiac capture.

30. A non-transitory 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 baseline physiological response of the patient to the electrical signal based on the physiological signal, the baseline physiological response comprising a characteristic of an electromyogram (EMG) signal;

store the characteristic of the EMG signal as a baseline physiological response;

detect a physiological response comprising a characteristic of the EMG signal at a time subsequent to the baseline physiological response;

determine the second lead has migrated if the characteristic of the EMG signal at the subsequent time increased from the baseline characteristic of the EMG signal; and

suspend the neurostimulation therapy module to selectively deliver neurostimulation to the patient based on determining whether the second lead has migrated.