System and method for regulating cardiac triggered therapy to the brain

• US 8,041,418 B2
• Filed: 12/19/2005
• Issued: 10/18/2011
• Est. Priority Date: 12/17/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Giftakis, Jonathon E., Graves, Nina M.
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US11/311,200
• Publication Number:
  US 20060136006A1
• Time in Patent Office: 2,129 Days
• Field of Search: 600/544
• US Class Current: 600/544
• 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 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• 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 5/293 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• 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 1/37 : 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 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/39622 : Pacing therapy

Abstract

A medical device system includes a brain monitoring element, cardiac monitoring element, therapy module and a processor. The processor is configured to activate the therapy module upon detection of a cardiac event in the cardiac signal. The processor is further configured to monitor the brain signal and communicate to the therapy module to change the cardiac triggered therapeutic output to the brain based upon the brain monitoring. A method of treating a person with a neurological disorder is also provided.

Claims

1. A medical device system comprising:

(a) a brain monitoring element for sensing activity in the brain and outputting a brain signal;

(b) a cardiac monitoring element for sensing activity in the heart and outputting a cardiac signal;

(c) a therapy module for providing therapeutic output to a brain; and

(d) a processor in communication with the brain monitoring element, the cardiac monitoring element and the therapy module, the processor configured to perform the following;

(i) detecting a cardiac event in the cardiac signal;

(ii) activating the therapy module to provide the therapeutic output to the brain based on detecting a cardiac event;

(iii) monitoring the brain signal for an activity indicative of a nervous system disorder;

(iv) determining whether an activity indicative of a nervous system disorder has been detected in the brain signal within a specified period of time after detection of the cardiac event in the cardiac signal; and

(v) communicating to the therapy module to change the therapeutic output to the brain based upon the monitoring of the brain signal.

2. The medical device system of claim 1 wherein the therapeutic output is provided through the brain monitoring element.

3. The medical device system of claim 1 wherein monitoring the brain signal comprises execution of a neurological event detection algorithm that outputs an indication that a neurological event is occurring or is not occurring based on an evaluation of the brain signal.

4. The medical device of claim 3 wherein the step of detecting a neurological event further comprises detecting an end of the neurological event, and wherein communicating to the therapy module to change the therapeutic output to the brain comprises discontinuing the therapeutic output to the brain based upon the detecting the end of the neurological event.

5. The medical device of claim 1 further comprising a body implantable housing, the housing containing the therapy module and the processor.

6. The medical device system of claim 1 wherein the processor is further configured to discontinue the therapeutic output to the brain when the specified period of time has passed without detection of an activity indicative of a nervous system disorder in the brain signal.

7. The medical device system of claim 1 wherein the specified period of time is programmable.

8. The medical device system of claim 1 wherein the specified period of time is set at less than 10 minutes.

27. The medical device system of claim 6, wherein monitoring the brain signal comprises monitoring the brain signal for an activity indicative of a nervous system disorder, and wherein the processor is further configured to determine whether an activity indicative of a nervous system disorder has been detected in the brain signal within a specified period of time after detection of the cardiac event in the cardiac signal.

28. The medical device system of claim 27 wherein the processor is further configured to discontinue the therapeutic output to the brain when the specified period of time has passed without detection of an activity indicative of a nervous system disorder in the brain signal.

9. A medical device system comprising:

(a) a brain monitoring element for sensing activity in the brain and outputting a brain signal;

(b) a cardiac monitoring element for sensing activity in the heart and outputting a cardiac signal;

(c) a therapy module for providing therapeutic output to a brain; and

(d) a processor in communication with the brain monitoring element, the cardiac monitoring element and the therapy module, the processor configured to perform the following;

(i) detecting a cardiac event in the cardiac signal;

(ii) activating the therapy module to provide the therapeutic output to the brain based on detecting a cardiac event;

(iii) monitoring the brain signal; and

(iv) communicating to the therapy module to change the therapeutic output to the brain based upon the monitoring of the brain signal,

wherein monitoring the brain signal comprises execution of a neurological event detection algorithm that outputs an indication that a neurological event is occurring or is not occurring based on an evaluation of the brain signal, and

wherein the processor is further configured to determine when a period of time has passed after detection of the cardiac event in the cardiac signal without detection of a neurological event in the brain signal.

10. The medical device system of claim 9 wherein the processor is further configured to discontinue the therapeutic output to the brain when the period of time has passed without detection of a neurological event in the brain signal.

11. The medical device system of claim 9 wherein the period of time is programmable.

12. The medical device system of claim 9 wherein the period of time is set at less than 10 minutes.

13. The medical device system of claim 9 wherein the period of time is set at less than 5 minutes.

14. The medical device system of claim 9 wherein the period of time is set at less than 2 minutes.

15. A medical device system comprising:

(a) a brain monitoring element for sensing activity in the brain and outputting a brain signal;

(b) a cardiac monitoring element for sensing activity in the heart and outputting a cardiac signal;

(c) therapy means for providing therapeutic output to a brain; and

(d) control means in communication with the brain monitoring element, the cardiac monitoring element and the therapy means, the control means comprising;

(i) cardiac detection means for detecting a cardiac event and providing a cardiac detection output;

(ii) activation means for activating the therapy module to provide therapy to the brain based upon the cardiac detection output;

(iii) brain monitor means for evaluating the brain signal for an activity indicative of a nervous system disorder and providing a brain monitoring output;

(iv) determination means for determining whether an activity indicative of a nervous system disorder has been detected in the brain signal within a specified period of time after detection of the cardiac event in the cardiac signal; and

(v) communication means for informing the therapy module to change the therapy to the brain based upon the brain monitoring output.

16. A method of treating a patient with a neurological disorder comprising:

(a) monitoring a cardiac signal from a heart of a patient;

(b) monitoring a brain signal from a brain of the patient for an activity indicative of the neurological disorder;

(c) detecting a cardiac event in the cardiac signal with a processor configured to receive the cardiac signal and detect the cardiac event;

(d) providing a therapy to the brain based upon the detecting a cardiac event in the cardiac signal;

(e) determining whether an activity indicative of the neurological disorder has been detected in the brain signal within a specified period of time after detection of the cardiac event in the cardiac signal; and

(f) changing the therapy to the brain based on the monitoring the brain signal.

17. The method of claim 16 wherein providing a therapy to the brain comprises electrical stimulation.

18. The method of claim 16 wherein providing a therapy to the brain comprises delivering a drug or biologic to the brain.

19. The method of claim 16 wherein monitoring the brain signal comprises detecting a neurological event.

20. The method of claim 19 wherein detecting a neurological event further comprises detecting an end of the neurological event, and wherein changing the therapy to the brain comprises discontinuing the therapy to the brain based upon the detecting the end of the neurological event.

21. The method of claim 16, wherein the processor configured to receive the cardiac signal and detect the cardiac event is incorporated in an implantable medical device.

22. The method of claim 16, wherein the processor configured to receive the cardiac signal and detect the cardiac event is incorporated in a clinician device external to the patient.

23. A method of treating a patient with a neurological disorder comprising:

(a) monitoring a cardiac signal from a heart of a patient;

(b) monitoring a brain signal from a brain of the patient, wherein monitoring the brain signal comprises detecting a neurological event;

(c) detecting a cardiac event in the cardiac signal with a processor configured to receive the cardiac signal and detect the cardiac event;

(d) providing a therapy to the brain based upon the detecting a cardiac event in the cardiac signal;

(e) changing the therapy to the brain based on the monitoring the brain signal; and

(f) determining when a period of time has passed after detecting a cardiac event without the detection of a neurological event.

24. The method of claim 23 wherein changing the therapy to the brain comprises discontinuing the therapy to the brain based upon the determination of claim 23.

25. The method of claim 23 further comprising programming the period of time.

26. A medical device system comprising:

(a) a brain monitoring element for sensing activity in the brain and outputting a brain signal;

(b) a cardiac monitoring element for sensing activity in the heart and outputting a cardiac signal;

(c) a therapy module for providing therapeutic output to a brain; and

(d) a processor in communication with the brain monitoring element, the cardiac monitoring element and the therapy module, the processor configured to perform the following;

(i) detecting a cardiac event in the cardiac signal;

(ii) activating the therapy module to provide the therapeutic output to the brain based on detecting a cardiac event;

(iii) initiating monitoring the brain signal after detecting the cardiac event; and

(iv) communicating to the therapy module to change the therapeutic output to the brain based upon the monitoring of the brain signal.