Implantable medical device crosstalk evaluation and mitigation

• US 9,775,987 B2
• Filed: 01/30/2009
• Issued: 10/03/2017
• Est. Priority Date: 10/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Donofrio, William T., Burnes, John E., Krause, Paul G., Arne, Gerald P., Peichel, David J., Zhou, Xiaohong, Reinke, James D., Davis, Timothy
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US12/362,792
• Publication Number:
  US 20100114208A1
• Time in Patent Office: 3,168 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/39624 Pain reduction therapy

Abstract

Electrical crosstalk between two implantable medical devices or two different therapy modules of a common implantable medical device may be evaluated, and, in some examples, mitigated. In some examples, one of the implantable medical devices or therapy modules delivers electrical stimulation to a nonmyocardial tissue site or a nonvascular cardiac tissue site, and the other implantable medical device or therapy module delivers cardiac rhythm management therapy to a heart of the patient.

Claims

1. A method comprising:

determining a noise characteristic of a first electrical signal sensed by a first implantable medical device (IMD) while a second IMD is delivering a second electrical signal to a tissue site within a patient, wherein the first and second IMDs are implanted within the patient;

comparing the noise characteristic of the first electrical signal to a threshold value, wherein comparing the noise characteristic to the threshold value comprises determining whether the noise characteristic is greater than or equal to the threshold value; and

in response to determining the noise characteristic of the first electrical signal is greater than or equal to the threshold value, modifying at least one of a stimulation parameter with which the second IMD generates electrical stimulation that is delivered to the tissue site or a sensing parameter with which the first IMD senses the first electrical signal based on the comparison.

2. The method of claim 1, wherein the tissue site comprises at least one of a nonmyocardial tissue site or a nonvascular cardiac tissue site.

3. The method of claim 1, wherein the tissue site comprises at least one of an extravascular tissue site or the tissue site proximate to a nerve of the patient.

4. The method of claim 1, wherein the first implantable medical device delivers at least one of pacing, cardioversion or defibrillation therapy to a heart of the patient.

5. The method of claim 1, wherein the second implantable medical device delivers at least one of pacing, cardioversion or defibrillation therapy to the tissue site.

6. The method of claim 1, wherein determining the noise characteristic of the first electrical signal comprises determining a value indicative of a difference between an amplitude of the first electrical signal and a sensing threshold of the first implantable medical device.

7. The method of claim 1, wherein determining the noise characteristic of the first electrical signal comprises:

suspending delivery of the second electrical signal by the second implantable medical device (IMD);

sensing a third electrical signal with the first IMD;

activating the delivery of the second electrical signal by the second IMD;

sensing the first electrical signal with the first IMD while second IMD delivers the second electrical signal to the tissue site; and

determining a difference between at least one signal characteristic of the first and third electrical signals.

8. The method of claim 7, wherein determining the difference between at least one signal characteristic of the first and third electrical signals comprises:

determining a first value indicative of a difference between a first amplitude of the first electrical signal and a sensing threshold of the first implantable medical device (IMD);

determining a second value indicative of a difference between a second amplitude of the third electrical signal and the sensing threshold of the first IMD; and

determining the difference between the first and second values.

9. The method of claim 8, wherein comparing the noise characteristic of the first electrical signal to the threshold value comprises determining whether the difference between the first and second values is greater than or equal to the threshold value.

10. The method of claim 9, wherein the threshold value is less than the sensing threshold of the first implantable medical device.

11. The method of claim 10, wherein the threshold value is about 25 percent (%) to about 50% of the sensing threshold of the first implantable medical device.

12. The method of claim 7, wherein determining the difference between at least one signal characteristic of the first and third electrical signals comprises determining the difference between at least one signal characteristic of the first and third electrical signals during a quiet segment of a cardiac cycle of a heart of the patient.

13. The method of claim 7, wherein determining the difference between at least one signal characteristic of the first and third electrical signals comprises determining a difference between one or more frequency band characteristics of the first and third electrical signals.

14. The method of claim 1, wherein determining the noise characteristic of the first electrical signal comprises determining a first characteristic of the first electrical signal sensed by the first implantable medical device (IMD) at a first time and modifying the at least one of the stimulation parameter or the sensing parameter comprises modifying at least one stimulation parameter, the method further comprising:

delivering a third electrical signal to the tissue site via the second IMD according to the at least one modified stimulation parameter;

determining a second characteristic of a fourth electrical signal sensed by the first IMD at a second time while the second IMD is delivering the third electrical signal; and

determining an electrical noise status based on the second characteristic.

15. The method of claim 14, wherein modifying the stimulation parameter comprises modifying a first value of a first stimulation parameter and determining the electrical noise status based on the second characteristic comprises comparing the second characteristic to the threshold value, the method further comprising modifying a second value of a second stimulation parameter with which the second implantable medical device generates the electrical stimulation in response to determining the second characteristic is greater than or equal to the threshold value, wherein the first and second stimulation parameters are different.

16. The method of claim 14, wherein determining the electrical noise status based on the second characteristic comprises comparing the second characteristic to the threshold value, the method further comprising modifying the at least one stimulation parameter in response to determining the second characteristic is greater than or equal to the threshold value.

17. The method of claim 14, wherein determining the electrical noise status based on the second characteristic comprises comparing the second characteristic to the threshold value, the method further comprising adjusting the delivery of electrical stimulation by the second implantable medical device in response to determining the second characteristic is greater than or equal to the threshold value.

18. The method of claim 17, wherein adjusting the delivery of electrical stimulation by the second implantable medical device (IMD) comprises suspending the delivery of electrical stimulation by the second IMD.

19. The method of claim 1, further comprising generating and storing an interference indication in response to determining the noise characteristic is greater than or equal to the threshold value.

20. The method of claim 1, wherein the stimulation parameter comprises at least one of a current amplitude, a voltage amplitude, a pulse width, a pulse rate, a frequency, a duty cycle or an electrode combination.

21. The method of claim 1, wherein the sensing parameter comprises at least one of a sensing threshold value, an amplifier gain, a sensing vector, filter characteristic, or a type of physiological parameter of the patient that is sensed by the first implantable medical device.

22. The method of claim 21, wherein the filter characteristic comprises a type of filter applied by the first implantable medical device to the sensed first electrical signal.

23. The method of claim 1, further comprising presenting a waveform indicative of the first electrical signal on a display of a device.

24. The method of claim 1, wherein the threshold value comprises a first threshold value, the method further comprising:

determining whether the noise characteristic is greater than or equal to a second threshold value that is different than the first threshold value in response to determining the noise characteristic is greater than or equal to the first threshold value;

generating a first category indication in response to determining the noise characteristic is not greater than or equal to the second threshold value; and

generating a second category indication in response to determining the noise characteristic is greater than or equal to the second threshold value.

25. The method of claim 1, wherein determining the noise characteristic of the first electrical signal sensed by the first implantable medical device (IMD) comprises determining the noise characteristic of the first electrical signal sensed by the first IMD during a quiet segment of a cardiac cycle of a heart of the patient.

26. The method of claim 1, wherein the second electrical signal comprises an intensity that is lower than an activation threshold of tissue of the patient.

27. The method of claim 1, wherein modifying the at least one of the stimulation parameter with which the second implantable medical device (IMD) generates electrical stimulation that is delivered to the tissue site or the sensing parameter with which the first IMD senses the first electrical signal based on the comparison comprises modifying the stimulation parameter.

28. The method of claim 1, wherein modifying the at least one of the stimulation parameter with which the second implantable medical device (IMD) generates electrical stimulation that is delivered to the tissue site or the sensing parameter with which the first IMD senses the first electrical signal based on the comparison comprises modifying the sensing parameter.

29. A system comprising:

a first implantable medical device (IMD) configured to sense a first electrical signal within a patient;

a second IMD configured to deliver a second electrical signal to a tissue site within the patient, wherein the first IMD is configured to sense the first electrical signal while the second IMD delivers the second electrical signal to the patient; and

a processor configured to determine a noise characteristic of the first electrical signal, compare the noise characteristic to a threshold value by at least determining whether the noise characteristic is greater than or equal to the threshold value, and configured to, in response to determining the noise characteristic of the first electrical signal is greater than or equal to the threshold value, modify at least one of a stimulation parameter with which the second IMD generates electrical stimulation therapy or a sensing parameter with which the first IMD senses the first electrical signal based on the comparison.

30. The system of claim 29, wherein the first implantable medical device is configured to deliver at least one of pacing, cardioversion or defibrillation therapy to a heart of the patient.

31. The system of claim 29, wherein the second implantable medical device is configured to deliver at least one of pacing, cardioversion or defibrillation therapy to a heart of the patient.

32. The system of claim 29, wherein the tissue site comprises at least one of a nonmyocardial tissue site or a nonvascular cardiac tissue site within the patient.

33. The system of claim 29, further comprising a medical device programmer that comprises the processor.

34. The system of claim 33, wherein the medical device programmer comprises a display, and the processor is configured to present a waveform indicative of the first electrical signal on the display.

35. The system of claim 29, wherein the first implantable medical device comprises the processor.

36. The system of claim 29, wherein the second implantable medical device comprises the processor.

37. The system of claim 29, wherein the processor is configured to determine the noise characteristic of the first electrical signal by at least determining a value indicative of a difference between an amplitude of the first electrical signal and a sensing threshold of the first implantable medical device.

38. The system of claim 29, wherein the processor is configured to determine the noise characteristic of the first electrical signal by at least controlling the second implantable medical device (IMD) to suspend delivery of the second electrical signal, controlling the first IMD to sense a third electrical signal, controlling the second IMD to deliver the second electrical signal to the patient after the first IMD senses the third electrical signal, controlling the first IMD to sense the first electrical signal, and determining a difference between at least one signal characteristic of the first and third electrical signals.

39. The system of claim 38, wherein the processor is configured to determine the difference between at least one signal characteristic of the first and third electrical signals by at least determining a first value indicative of a difference between a first amplitude of the first electrical signal and a sensing threshold of the first implantable medical device (IMD), determining a second value indicative of a difference between a second amplitude of the third electrical signal and the sensing threshold of the first IMD, and determining the difference between the first and second values.

40. The system of claim 39, wherein the processor is configured to compare the noise characteristic of the first electrical signal to the threshold value by at least determining whether the difference between the first and second values is greater than or equal to the threshold value.

41. The system of claim 40, wherein the threshold value is less than the sensing threshold of the first implantable medical device.

42. The system of claim 38, wherein the processor is configured to determine the difference between at least one signal characteristic of the first and third electrical signals comprises by at least determining a difference between one or more frequency band characteristics of the first and third electrical signals.

43. The system of claim 29, wherein the noise characteristic of the first electrical signal comprises at least one of a mean or median peak-to-peak amplitude, a greatest peak-to-peak amplitude, or a root means square amplitude, a greatest peak-to-peak amplitude over a predetermined period of time, or a predetermined percentage of the greatest peak-to-peak amplitude.

44. The system of claim 29, wherein the processor is configured to determine the noise characteristic of the first electrical signal by at least determining a first characteristic of the first electrical signal at a first time, and is configured to modify the at least one of the stimulation parameter or the sensing parameter by at least modifying the stimulation parameter, wherein the processor is configured to control the second implantable medical device (IMD) to deliver a third electrical signal to the patient according to the at least one modified stimulation parameter, determine a second characteristic of a fourth electrical signal sensed by the first IMD at a second time after the first time while the second IMD is delivering the third electrical signal, and determine whether a second characteristic signal is greater than or equal to the threshold value.

45. The system of claim 44, wherein the processor is configured to modify at least one stimulation parameter by at least modifying a first value of a first stimulation parameter value, and wherein the processor is configured to modify a second value of a second stimulation parameter with which the second implantable medical device generates the electrical stimulation in response to determining the second characteristic is greater than or equal to the threshold value, wherein the first and second stimulation parameters are different.

46. The system of claim 44, wherein the processor is configured to control the second implantable medical device to suspend the delivery of electrical stimulation if in response to determining the second characteristic is greater than or equal to the threshold value.

47. The system of claim 29, wherein the threshold value comprises a first threshold value, wherein the processor is configured to determine whether the noise characteristic is greater than or equal to a second threshold value that is different than the first threshold value in response to determining the noise characteristic is greater than or equal to the first threshold value, generate a first category indication in response to determining the noise characteristic is not greater than or equal to the second threshold value, and generate a second category indication in response to determining the noise characteristic is greater than or equal to the second threshold value.

48. The system of claim 29, wherein the first implantable medical device is configured to sense the first electrical signal during a quiet segment of a cardiac cycle of a heart of the patient.

49. The system of claim 29, wherein the second electrical signal comprises intensity that is lower than an activation threshold of tissue of the patient.

50. The system of claim 29, wherein the processor is configured to generate and store an interference indication in response to determining the noise characteristic is greater than or equal to the threshold value.

51. The system of claim 50, wherein the processor is configured to generate the interference indication by at least changing a property of the interference indication based on the difference between the noise characteristic of the first electrical signal and the threshold value.

52. The system of claim 51, wherein the property comprises at least one of an intensity of a visible characteristic of the interference indication, an audible characteristic of the interference indication or a somatosensory characteristic of the interference indication.

53. The system of claim 29, wherein the stimulation parameter comprises at least one of a current amplitude, a voltage amplitude, a pulse width, a pulse rate, a frequency, a duty cycle or an electrode combination.

54. The system of claim 29, wherein the sensing parameter comprises at least one of a sensing threshold value, an amplifier gain, a sensing vector, filter characteristic, or a type of physiological parameter of the patient that is sensed by the first implantable medical device.

55. The system of claim 54, wherein the filter characteristic comprises a type of filter applied by the first implantable medical device to the sensed first electrical signal.

56. A system comprising:

means for determining a noise characteristic of a first electrical signal sensed by a first implantable medical device (IMD) while a second IMD is delivering a second electrical signal to a tissue site within a patient, wherein the first and second IMDs are implanted within the patient;

means for comparing the noise characteristic of the first electrical signal to a threshold value by at least determining whether the noise characteristic is greater than or equal to the threshold value; and

means for modifying at least one of a stimulation parameter with which the second IMD generates electrical stimulation that is delivered to the tissue site or a sensing parameter with which the first IMD senses the first electrical signal based on the comparison and in response to the means for comparing determining the noise characteristic of the first electrical signal is greater than or equal to the threshold value.

57. The system of claim 56, wherein the means for determining the noise characteristic of the first electrical signal comprises:

means for suspending delivery of the second electrical signal by the second implantable medical device (IMD);

means for sensing a third electrical signal with the first IMD;

means for activating the delivery of the second electrical signal by the second IMD;

means for sensing the first electrical signal with the first IMD while second IMD delivers the second electrical signal to the tissue site; and

means for determining a difference between at least one signal characteristic of the first and third electrical signals.

58. The system of claim 56, wherein the means for determining the noise characteristic of the first electrical signal comprises means for determining a value indicative of a difference between a first amplitude of the first electrical signal and a sensing threshold of the first implantable medical device.

59. A non-transitory computer-readable storage medium comprising instructions that cause a programmable processor to:

determine a noise characteristic of a first electrical signal sensed by a first implantable medical device (IMD) while a second IMD is delivering a second electrical signal to a tissue site within a patient, wherein the first and second IMDs are implanted within the patient;

compare the noise characteristic of the first electrical signal to a threshold value by at least determining whether the noise characteristic is greater than or equal to the threshold value; and

modify at least one of a stimulation parameter with which the second IMD generates electrical stimulation that is delivered to the tissue site or a sensing parameter with which the first IMD senses the first electrical signal based on the comparison and in response to determining the noise characteristic of the first electrical signal is greater than or equal to the threshold value.

60. The non-transitory computer-readable storage medium of claim 59, wherein the instructions cause the processor to determine the noise characteristic of the first electrical signal by at least controlling the second implantable medical device (IMD) to suspend the delivery of the second electrical signal, control the first IMD to sense a third electrical signal, activate the delivery of the second electrical signal by the second IMD, control the first IMD to sense the first electrical signal with the first IMD while second IMD delivers the second electrical signal to the tissue site, and determine a difference between at least one signal characteristic of the first and third electrical signals.

61. A method comprising evaluating crosstalk between a first implantable medical device (IMD) implanted within a patient and a second IMD implanted within the patient with an external device, wherein the external device:

determines a characteristic of a first electrical signal sensed by the first IMD while a second IMD is delivering a second electrical signal to a tissue site within a patient;

compares the characteristic of the first electrical signal to a threshold value, wherein comparing the characteristic to the threshold value comprises determining whether the characteristic is greater than or equal to the threshold value; and

modifies at least one of a stimulation parameter with which the second IMD generates electrical stimulation that is delivered to the tissue site or a sensing parameter with which the first IMD senses the first electrical signal in response to determining the noise characteristic of the first electrical signal is greater than or equal to the threshold value.