SYSTEM AND METHOD FOR REGULATING CARDIAC TRIGGERED THERAPY TO THE BRAIN

• US 20070239230A1
• Filed: 04/27/2007
• Published: 10/11/2007
• Est. Priority Date: 12/17/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David, Giftakis, Jonathon, Graves, Nina
• Application Number:
  US11/741,126
• Publication Number:
  US 20070239230A1
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/384 Recording apparatus or displays specially adapted therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• 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 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3702 : Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3706 : Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37514 : Brain implants
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3962 : in combination with another heart therapy

Abstract

An implantable neurostimulator device for implantation in a head of a patient includes a housing adapted to be implanted beneath a patient'"'"'s scalp, a cardiac monitoring element, a therapy module, and a processor. The processor is configured to activate the therapy module to deliver a therapeutic output to treat a neurological event upon detection of a cardiac event in a cardiac signal. In some embodiments, the device may comprise a brain monitoring element. In some embodiments, the processor may be configured to receive and monitor a brain signal from the brain monitoring element and change the therapeutic output based upon the brain signal.

Claims

1. An implantable neurostimulator device for implantation in a head of a patient, the device comprising:

a biocompatible housing adapted to be implanted beneath a patient'"'"'s scalp;

a cardiac monitoring element at least partially supported by the housing, the cardiac monitoring element adapted to sense cardiac activity to generate a cardiac signal;

a processor at least partially supported by the housing, the processor adapted to receive the cardiac signal from the cardiac monitoring element and detect a cardiac event in the cardiac signal; and

a therapy module at least partially supported by the housing, the therapy module adapted to deliver a therapeutic output to a brain of the patient when a cardiac event is detected by the processor.

2. The device of claim 1 wherein the housing is adapted to be fixed to a cranial bone.

3. The device of claim 1 wherein the housing is adapted to be at least partially disposed in a recess formed in a cranial bone.

4. The device of claim 1 wherein the housing is adapted to be implanted between a cranium and a scalp of the patient.

5. The device of claim 1 wherein the housing comprises an overmold that at least partially encloses the cardiac monitoring element.

6. The device of claim 1 wherein the cardiac monitoring element is an acoustic sensor coupled to the housing to sense cardiac activity.

7. The device of claim 6 wherein the acoustic sensor senses heart sounds to generate the cardiac signal.

8. The device of claim 7 wherein the cardiac signal generated is a function of an intensity of the sensed heart sounds.

9. The device of claim 8 wherein detection of the cardiac event occurs when the intensity of the sensed heart sounds changes by a threshold amount.

10. The device of claim 7 wherein the cardiac signal generated is a function of the timing of heart sounds.

11. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a heart rate change greater than a threshold amount.

12. The device of claim 11 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a heart rate that changes by more than a threshold amount within a predefined time window.

13. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a heart rate exceeding a threshold rate.

14. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a measured heart rate variability that falls outside of a defined range.

15. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a measured QT interval variability that falls outside of a defined range.

16. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a rate-corrected QT interval (“

QT_C”

) that falls outside of a defined range.

17. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a sinus arrest episode.

18. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a syncope episode.

19. The device of claim 18 wherein the syncope episode includes a sudden drop in heart rate.

20. The device of claim 10 wherein detection of the cardiac event occurs when the timing of heart sounds indicates a detected arrhythmia.

21. The device of claim 7 wherein the heart sounds sensed by the acoustic sensor are applied to a low-pass filter prior to generating the cardiac signal.

22. The device of claim 21 wherein the low-pass filter limits signals to less than 4 Hz.

23. The device of claim 1 wherein the cardiac monitoring element is a blood pressure sensor coupled to the housing to sense cardiac activity.

24. The device of claim 23 wherein detection of the cardiac event occurs when the sensed blood pressure changes by more than a threshold amount.

25. The device of claim 24 wherein detection of the cardiac event occurs when the sensed blood pressure changes by more than a threshold amount within a predefined time window.

26. The device of claim 23 wherein detection of the cardiac event occurs when the sensed blood pressure exceeds a threshold level.

27. The device of claim 23 wherein the blood pressure sensor employs a capacitive sensor to measure blood pressure.

28. The device of claim 23 wherein the blood pressure sensor employs a strain gauge sensor to measure blood pressure.

29. The device of claim 1 wherein the cardiac monitoring element is an oxygen saturation sensor coupled to the housing to sense cardiac activity.

30. The device of claim 29 wherein detection of the cardiac event occurs when the oxygen saturation level changes by more than a threshold amount.

31. The device of claim 30 wherein detection of the cardiac event occurs when the oxygen saturation level changes by more than a threshold amount within a predefined time window.

32. The device of claim 29 wherein detection of the cardiac event occurs when the oxygen saturation level exceeds a threshold level.

33. The device of claim 29 wherein the oxygen saturation sensor employs a reflectance oximeter to measure oxygen saturation level.

34. The device of claim 1 wherein the therapeutic output delivered by the therapy module includes electrical stimulation.

35. The device of claim 34 wherein the therapy module is adapted to be coupled to a first lead for delivering electrical stimulation to the brain of the patient.

36. The device of claim 35 wherein the therapy module is coupled to a second lead, the second lead being adapted to sense brain signals from the brain of the patient, and wherein the processor is adapted to change the therapeutic output delivered by the therapy module based on the sensed brain signals.

37. The device of claim 36 wherein a single lead functions as both the first lead and the second lead.

38. The device of claim 35 wherein the coupling between the therapy module and the first lead is selected from the group consisting of conductive coupling, magnetic coupling, and radio frequency coupling.

39. The device of claim 1 wherein the therapeutic output delivered by the therapy module includes drug delivery.

40. The device of claim 39 wherein the therapy module is adapted to be coupled to a drug delivery pump for delivering drug therapy to the brain of the patient.

41. The device of claim 40 wherein the therapy module is electrically coupled to a lead for sensing brain signals from the brain of the patient, and wherein the processor is adapted to change the therapeutic output delivered by the therapy module based on the sensed brain signals.

42. An implantable neurostimulator device for implantation in a head of a patient, the device comprising:

a biocompatible housing adapted to be implanted beneath a patient'"'"'s scalp;

a processor at least partially supported by the housing, the processor being adapted to receive a cardiac signal from a remote cardiac monitoring element, the remote cardiac monitoring element adapted to sense cardiac activity and to generate and transmit a cardiac signal to the processor, the processor being adapted to detect a cardiac event in the cardiac signal; and

a therapy module at least partially supported by the housing, the therapy module adapted to deliver a therapeutic output to a brain of the patient when the cardiac event is detected by the processor.

43. The device of claim 42 wherein the remote cardiac monitoring element is an implantable loop recorder for sensing electrical heart activity.

44. The device of claim 43 wherein the processor is adapted to receive analog cardiac signals from the remote cardiac monitoring element.

45. The device of claim 43 wherein the processor is adapted to receive digital event information from the remote cardiac monitoring element.

46. The device of claim 42 wherein the remote cardiac monitoring element is a cardiac vest worn by the patient, the vest being adapted for sensing electrical heart activity.

47. The device of claim 42 wherein the remote cardiac monitoring element is a patch worn by the patient, the patch being adapted for sensing ECG information.

48. The device of claim 42 wherein the remote cardiac monitoring element is an acoustic sensor for sensing heart sounds.

49. The device of claim 42 wherein the remote cardiac monitoring element is a blood pressure sensor for sensing blood pressure levels in the patient.

50. The device of claim 42 wherein the remote cardiac monitoring element is an oxygen saturation sensor for sensing oxygen saturation levels in the patient.

51. The device of claim 42 wherein the therapy module is electrically coupled to a lead for sensing brain signals from the brain of the patient, and wherein the processor is adapted to change the therapeutic output delivered by the therapy module based on the sensed brain signals.

52. A neurostimulator system comprising:

a cardiac monitoring element adapted to sense cardiac activity and to generate and transmit a cardiac signal;

a biocompatible housing adapted to be implanted beneath a patient'"'"'s scalp;

a processor at least partially supported by the housing, the processor being adapted to receive the cardiac signal from the cardiac monitoring element and to detect a cardiac event in the cardiac signal; and

a therapy module at least partially supported by the housing, the therapy module adapted to deliver a therapeutic output to a brain of the patient when the cardiac event is detected by the processor.

53. The system of claim 52 comprising an electrode operatively coupled to the therapy module, the electrode being adapted to deliver electrical stimulation therapy to the patient'"'"'s brain in response to a detected cardiac event.

54. The system of claim 53 wherein the electrode is further adapted to sense brain signals from the patient'"'"'s brain.

55. The system of claim 54 wherein the processor is adapted to change the therapeutic output delivered by the therapy module based on the sensed brain signals.

56. The system of claim 55 wherein the therapeutic output delivered by the therapy module is dependent upon sensed brain signals for a period following a detected cardiac event.