System and method for regulating cardiopulmonary triggered therapy to the brain

• US 8,068,911 B2
• Filed: 04/27/2007
• Issued: 11/29/2011
• Est. Priority Date: 12/17/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L, Giftakis, Jonathon E, Graves, Nina M.
• Primary Examiner(s): Bertram; Eric D.
• Application Number:
  US11/741,109
• Publication Number:
  US 20080033490A1
• Time in Patent Office: 1,677 Days
• Field of Search: 607/45
• US Class Current: 607/45
• 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 5/291 for electroencephalography [EEG]
• 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 5/4094 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 housing, the housing at least partially supporting a therapy module and a processor, and a respiratory monitoring element coupled to the processor. The processor is configured to activate the therapy module upon detection of a respiratory event in a respiratory signal. In some embodiments, the system may further comprise a brain monitoring element, and the processor may be configured to monitor a brain signal and change the therapeutic output based upon the brain signal.

Claims

1. An implantable medical device system for implantation in a patient, the system comprising:

a biocompatible housing adapted to be implanted in a patient;

a brain monitoring element adapted to sense activity in a brain of the patient and generate a brain signal;

a respiratory monitoring element, the respiratory monitoring element adapted to sense respiratory activity and generate a respiratory signal, the respiratory monitoring element comprising a sensor stub;

a therapy module at least partially supported by the housing, the therapy module adapted to deliver a therapeutic output to the brain of the patient when a respiratory event is detected in the respiratory signal; and

a processor at least partially supported by the housing, the processor configured to

receive the respiratory signal from the respiratory monitoring element and detect a respiratory event in the respiratory signal,

activate the therapy module to deliver the therapeutic output to the brain based on detecting a respiratory event in the respiratory signal;

receive the brain signal from the brain monitoring element and detect a neurological event in the brain signal;

determine whether a neurological event has been detected in the brain signal within a specified period of time after detection of the respiratory event; and

change the therapeutic output delivered by the therapy module based on the sensed brain activity that occurs following a detected respiratory event.

2. The medical device system of claim 1 wherein the sensor stub comprises a proximal end and a distal end, the proximal end being coupled to the housing, the sensor stub having an electrode disposed proximate the sensor stub distal end.

3. The medical device system of claim 2 wherein the respiratory monitoring element is adapted to sense respiratory activity along the sensor stub substantially between the electrode and the housing.

4. The medical device system of claim 3 wherein the respiratory activity is sensed by measuring a transthoracic impedance between the electrode and the housing.

5. The medical device system of claim 4 wherein the respiratory signal comprises an output of the measured transthoracic impedance applied to a low-pass filter (LPF).

6. The medical device system of claim 5 wherein the LPF is a passband filter from about 0.05 Hz to 0.8 Hz.

7. The medical device system of claim 3 wherein the respiratory event is detected in the respiratory signal when a respiration rate exceeds a predefined threshold.

8. The medical device system of claim 3 wherein the respiratory event is detected in the respiratory signal when a tidal volume exceeds a predefined threshold.

9. The medical device system of claim 3 wherein the respiratory event is detected in the respiratory signal when a minute ventilation exceeds a predefined threshold.

10. The medical device system of claim 3 wherein the respiratory event is detected in the respiratory signal when an apnea event occurs.

11. The medical device system of claim 2 wherein the sensor stub is less than about 10 inches long.

12. The medical device system of claim 11 wherein the distal end of the sensor stub extends 1 to 5 inches from the housing.

13. The medical device system of claim 2 wherein the sensor stub is adapted for placement outside a heart of the patient.

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

15. The medical device system of claim 14 wherein the therapy module is adapted to be coupled to a first lead for delivering electrical stimulation to the brain of the patient.

16. The medical device system of claim 15 wherein a single lead functions as both the first lead for delivering electrical stimulation to the brain of the patient, and as the brain monitoring element for sensing brain signals from the brain of the patient.

17. The medical device system of claim 15 wherein the brain monitoring element comprises a cranially implantable lead.

18. The medical device system of claim 15 wherein the processor is configured to terminate the therapeutic output delivered by the therapy module when the brain signal does not indicate a neurological event within the specified period of time after detecting the respiratory event.

19. The medical device system of claim 15 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.

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

21. The medical device system of claim 20 wherein the therapy module is adapted to be coupled to a drug delivery pump for delivering drug therapy to the brain of the patient.

22. The medical device system of claim 21 wherein the brain monitoring element comprises a cranially implantable lead.

23. The medical device system of claim 1 wherein the distal end of the sensor stub is adapted to be implanted in a thoracic area of the patient.

24. The medical device system of claim 23 wherein the housing is adapted to be implanted in the thoracic area of the patient.

25. An implantable medical device system for implantation in a patient, the device comprising:

a biocompatible housing adapted to be implanted in a patient;

a respiratory monitoring element adapted to sense respiratory activity and generate a respiratory signal, the respiratory monitoring element comprising an electrode;

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

a therapy module at least partially supported by the housing, the therapy module adapted to deliver a therapeutic output when a respiratory event is detected by the processor; and

a lead coupled to the therapy module for delivering the therapeutic output to a brain of the patient, the electrode being an integrated electrode at least partially supported by and disposed along the lead.

26. The medical device system of claim 25 wherein the respiratory monitoring element is adapted to sense respiratory activity substantially between the integrated electrode and the housing.

27. The medical device system of claim 26 wherein the respiratory event is detected in the respiratory signal when a respiration rate exceeds a predefined threshold.

28. The medical device system of claim 26 wherein the respiratory event is detected in the respiratory signal when a tidal volume exceeds a predefined threshold.

29. The medical device system of claim 26 wherein the respiratory event is detected in the respiratory signal when a minute ventilation exceeds a predefined threshold.

30. The medical device system of claim 26 wherein the respiratory event is detected in the respiratory signal when an apnea event occurs.

31. The medical device system of claim 25 wherein the respiratory activity is sensed by measuring transthoracic impedance between the integrated electrode and the housing.

32. The medical device system of claim 31 wherein the respiratory signal comprises an output of the measured transthoracic impedance applied to a low-pass filter (LPF).

33. The medical device system of claim 32 wherein the LPF is a passband filter from about 0.05 Hz to 0.8 Hz.

34. The medical device system of claim 26 wherein the integrated electrode is disposed along the lead less than about 10 inches from the housing.

35. The medical device system of claim 25 wherein the integrated electrode is disposed along the lead about 1 to 5 inches from the housing.

36. The medical device system of claim 25 wherein the therapeutic output delivered by the therapy module includes electrical stimulation.

37. The medical device system of claim 36 wherein the processor is configured to receive a brain signal from the brain of the patient and determine whether a neurological event has been detected in the brain signal within a predetermined period after detection of a respiratory event, and wherein the processor is configured to change the therapeutic output delivered by the therapy module based on the brain signal.

38. The medical device system of claim 37 wherein the brain signal is communicated to the processor via the lead.

39. The medical device system of claim 37 wherein the lead comprises a cranially implantable electrode for delivering the therapeutic output to the brain, and for sensing brain activity and generating the brain signal.

40. The medical device system of claim 37 wherein the processor is configured to terminate the therapeutic output delivered by the therapy module when the brain signal does not indicate a neurological event within the predetermined period after detecting the respiratory event.

41. A medical device system, comprising:

a biocompatible housing adapted to be implanted in a patient;

a brain monitoring element adapted to sense activity in a brain of the patient and generate a brain signal;

a respiratory monitoring element adapted to sense respiratory activity and generate a respiratory signal, the respiratory monitoring element comprising a sensor stub;

therapy means for providing a therapeutic output to the brain of the patient; and

a processor configured to receive the respiratory signal from the respiratory monitoring element, detect a respiratory event in the respiratory signal, activate the therapy means to provide the therapeutic output to the brain upon detection of a respiratory event, receive the brain signal from the brain monitoring element, detect a neurological event in the brain signal, determine whether a neurological event has been detected within a specified period of time after detection of the respiratory event, and change the therapeutic output provided by the therapy means based on the brain signal.

42. The medical device system of claim 41, wherein the sensor stub comprises a proximal end and a distal end, wherein the proximal end is coupled to the housing, the sensor stub further comprising an electrode at least partially supported by the distal end.

43. The medical device system of claim 42, wherein the respiratory monitoring element is adapted to sense respiratory activity along the sensor stub substantially between the electrode and the housing.

44. The medical device system of claim 41, wherein the brain monitoring element comprises a cranially implantable lead and the therapeutic output comprises electrical stimulation.

45. The medical device system of claim 44, wherein the therapeutic output is provided via the brain monitoring element.

46. The medical device system of claim 41, wherein the therapeutic output comprises a drug delivery.