Breathing therapy device and method

• US 20050085868A1
• Filed: 10/15/2004
• Published: 04/21/2005
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Ligon, David, Tehrani, Amir J.
• Granted Patent: US 8,412,331 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36132 using patient feedback

Abstract

A device and method is provided for electrically stimulating the diaphragm to control breathing while inhibiting respiratory drive. A stimulation phase is identified. The stimulation phase is a period of time within the breathing cycle in which stimulation will inhibit respiratory drive. The respiratory drive inhibition may be used in a number of applications including but not limited to: improving or remodeling the heart in heart failure patients, treating apnea, chronic obstructive pulmonary disorder (COPD), and hypertension.

Claims

1. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing and inhibit central respiratory drive.

2. The respiration stimulation device of claim 1 further comprising a sensor configured to sense at least one respiratory parameter and to determine a rest phase for a respiratory cycle of a subject from the respiratory parameter.

3. The respiration stimulation device of claim 1 further comprising a sensor configured to sense at least one respiration parameter and to determine a stimulation phase from the at least one respiratory parameter wherein the stimulation phase is selected for stimulation to inhibit central respiratory drive.

4. The respiration stimulation device of claim 1 further comprising a sensor configured to sense at least one respiration parameter and to determine a stimulation phase from the at least one respiratory parameter wherein the stimulation phase is selected for stimulation to reduce a rest period length with respect to a baseline rest period length.

5. The respiration stimulation device of claim 1 wherein the signal source is configured to deliver a stimulation signal that approximately maintains a baseline tidal volume.

6. The respiration stimulation device of claim 5 wherein the signal source is further configured to deliver a stimulation signal that increases a rest period of a respiration cycle with respect to a baseline rest period.

7. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing; and

a sensor configured to sense at least one respiration parameter and to determine a stimulation phase from the at least one respiratory parameter wherein the stimulation phase is selected for stimulation to reduce a rest period length with respect to a baseline rest period length.

8. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing, to deliver a stimulation signal that approximately maintains a baseline tidal volume, and to deliver a stimulation signal that increases a rest period of a respiration cycle with respect to a baseline rest period.

9. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control an exhalation portion of a respiratory cycle.

10. The device of claim 9 wherein the signal source is configured to deliver a stimulation signal during an exhalation portion of a respiratory cycle.

11. The device of claim 10 wherein the signal source is configured to deliver a stimulation signal comprising a plurality of stimulation pulses reducing in amplitude.

12. The device of claim 9 wherein the signal source is configured to deliver a stimulation signal configured to extend a duration of the exhalation portion of a respiratory cycle.

13. A breathing therapy device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing for at least a period of time to reduce a load on a heart of a patient.

14. The breathing therapy device of claim 13 wherein the signal source is configured to deliver a stimulation signal to control breathing to increase blood oxygen saturation levels.

15. A hypertension therapy device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing to increase a combined length of an inspiration phase and an exhalation phase of a respiratory cycle.

16. The hypertension therapy device of claim 15 wherein the signal source is configured to deliver a stimulation signal wherein a resulting breathing rate is less than about 20 breaths per minute.

17. The hypertension therapy device of claim 15 wherein the signal source is configured to deliver a stimulation signal wherein a resulting breathing rate is less than about 10 breaths per minute.

18. The hypertension therapy device of claim 15 wherein the signal source is configured to deliver a stimulation signal wherein a resulting breathing rate is between about 4 and 8 breaths per minute.

19. A chronic obstructive pulmonary disease therapy device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing to reduce the concentration of carbon dioxide in blood of a patient.

20. A chronic obstructive pulmonary disease therapy device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing to increase a length of an expiration portion of a respiratory cycle.

21. An breathing disorder therapy device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing and inhibit central respiratory drive prior to the onset of a breathing disorder.

22. An apnea therapy device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing during an apnea event at a lower minute ventilation with respect to a baseline normal minute ventilation.

23. A method of controlling breathing of a subject comprising the steps of:

providing at least one electrode configured to be coupled to tissue of a subject; and

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue; and

stimulating the tissue to inhibit respiratory drive and to provide therapy to the subject by controlling breathing.

24. The method of claim 23 further comprising the steps of:

sensing at least one respiratory parameter and determining a baseline rest phase for a respiratory cycle of a subject from the at least one respiratory parameter.

25. The method of claim 24 further comprising the step of stimulating the tissue to control breathing to reduce a length of a rest phase with respect to the baseline rest phase.

26. The method of claim 25 wherein the step of delivering a stimulation signal further comprises delivering a stimulation signal that approximately maintains a baseline tidal volume.

27. The method of claim 23 further comprising the steps of:

sensing at least one respiratory parameter and determining a stimulation phase from the at least one respiratory parameter wherein the stimulation phase is selected for stimulation to inhibit central respiratory drive.

28. A method for controlling respiration comprising:

sensing at least one respiration parameter and determining a stimulation phase from the at least one respiratory parameter to provide stimulation to reduce a rest period length with respect to a baseline rest period length; and

delivering electrical stimulation to tissue of a patient during the stimulation phase to control movement of a diaphragm and breathing of a patient.

29. A method of controlling breathing comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient to approximately maintain a baseline tidal volume, and to increases a rest period of a respiration cycle with respect to a baseline rest period.

30. A method of controlling breathing comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient to control an exhalation portion of a respiratory cycle.

31. The method of claim 30 wherein electrically stimulating the tissue comprised delivering a stimulation signal during an exhalation portion of a respiratory cycle.

32. The method of claim 31 wherein the step of delivering a stimulation signal comprising delivering a plurality of stimulation pulses tapering in amplitude.

33. The method of claim 30 further comprising the step of delivering a stimulation signal configured to extend a duration of the exhalation portion of a respiratory cycle.

34. A method of treating heart failure patients comprising the step of:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient for at least a period of time to control breathing and reduce a load on a heart of a patient.

35. The method of claim 34 wherein the step of controlling diaphragm movement further comprises controlling breathing to increase blood oxygen saturation levels.

36. A method for treating hypertension comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient for at least a period of time to increase a combined length of an inspiration phase and an exhalation phase of a at least one respiratory cycle.

37. The method of claim 36 further comprising controlling breathing rate wherein the breathing rate is less than about 20 breaths per minute.

38. The method of claim 36 further comprising controlling breathing rate wherein the breathing rate is less than about 10 breaths per minute.

39. The method of claim 36 further comprising controlling breathing rate wherein the breathing rate is between about 4 and 8 breaths per minute.

40. A method for treating chronic obstructive pulmonary disease comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient for at least a period of time to reduce the concentration of carbon dioxide in blood of a patient.

41. A method for treating chronic obstructive pulmonary disease therapy device comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient for at least a period of time to control breathing to increase a length of an expiration portion of a respiratory cycle.

42. A method for treating a breathing disorder comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient to inhibit central respiratory drive prior to the onset of a breathing disorder.

43. A method for treating apnea comprising:

controlling diaphragm movement of the patient by electrically stimulating tissue of the patient for at least a period of time to control breathing during an apnea event to provide a lower minute ventilation with respect to a baseline normal minute ventilation.