SYSTEMS AND METHODS FOR TREATING DYSPNEA, INCLUDING VIA ELECTRICAL AFFERENT SIGNAL BLOCKING

• US 20100070004A1
• Filed: 08/07/2009
• Published: 03/18/2010
• Est. Priority Date: 08/11/2008
• Status: Active Grant

• Current Assignee: Cibiem, Inc.
• Original Assignee: Concept Medical Inc.
• Inventors: Elliott, Lynn S., Hlavka, Edwin J.
• Granted Patent: US 9,089,700 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

Systems and methods for treating a patient with dyspnea are disclosed. A method in accordance with a particular embodiment includes identifying the patient as suffering from dyspnea, and, based at least in part on identifying the patient as suffering from dyspnea, implanting an electrical signal delivery element within the patient in signal communication with an afferent neural pathway of a carotid body chemoreceptor. The method can further include at least reducing dyspneic sensations in the patient by directing an electrical signal from the electrical signal delivery element to the neural pathway to at least partially block afferent signals from the chemoreceptor.

Claims

1. A method for treating a patient, comprising:

identifying the patient as suffering from dyspnea;

based at least in part on identifying the patient as suffering from dyspnea, implanting an electrical signal delivery element within the patient in signal communication with an afferent neural pathway of a carotid body chemoreceptor; and

at least reducing dyspneic sensations in the patient, or increasing an exercise capacity of the patient, or both, by directing an electrical signal from the electrical signal delivery element to the neural pathway to at least partially block afferent signals from the chemoreceptor.

2. The method of claim 1, further comprising;

automatically enabling delivery of the electrical signal during normal waking hours;

automatically disabling delivery of the electrical signal during normal sleeping hours;

directing the electrical signal only when both (a) the delivery of the electrical signal is enabled, and (b) the patient initiates a concurrent request for signal delivery; and

preventing delivery of the electrical signal when (c) the delivery of the electrical signal is enabled, even if (d) the patient initiates a concurrent request for signal delivery.

3. The method of claim 1 wherein directing the electrical signal includes directing the electrical signal while the patient is exercising.

4. The method of claim 3, further comprising increasing the patient'"'"'s level of exercise while the electrical signal is directed to the neural pathway, relative to the patient'"'"'s exercise level when the electrical signal is not directed to the neural pathway.

5. The method of claim 1, further comprising increasing the patient'"'"'s activity level while the electrical signal is directed to the neural pathway, relative to the patient'"'"'s activity level when the electrical signal is not directed to the neural pathway.

6. The method of claim 1, further comprising controlling delivery of the electrical signal to the neural pathway in response to receiving an input.

7. The method of claim 6 wherein the input includes a time input.

8. The method of claim 7 wherein controlling delivery of the electrical signal includes directing the electrical signal during normal waking hours and halting the electrical signal during normal sleeping hours.

9. The method of claim 7 wherein controlling delivery of the electrical signal includes directing the electrical signal during a first predetermined period of time and halting the electrical signal during a second predetermined period of time.

10. The method of claim 7 wherein controlling delivery of the electrical signal includes directing the electrical signal for a predetermined cumulative maximum period of time per day.

11. The method of claim 7 wherein controlling delivery of the electrical signal includes preventing the initiation of the electrical signal for a predetermined period of time after the previous initiation of the electrical signal.

12. The method of claim 6 wherein receiving an input includes receiving an input corresponding to a patient activity level.

13. The method of claim 12 wherein the input includes an accelerometer input.

14. The method of claim 12 wherein the input includes a heart rate input.

15. The method of claim 12 wherein controlling delivery of the electrical signal includes:

directing the signal or increasing an inhibitory effect of the signal on the afferent neural pathway in response to an increase in patent activity level; and

halting the signal or decreasing an inhibitory effect of the signal on the afferent neural pathway in response to a decrease in patent activity level

16. The method of claim 6 wherein the input includes a manual patient input.

17. The method of claim 1, further comprising providing a patient alert in response to a detected condition.

18. The method of claim 17 wherein providing a patient alert includes providing a patient alert in response to a detected pulmonary condition.

19. The method of claim 18 wherein providing a patient alert includes providing a patient alert in response to a detected patient breathing rate.

20. The method of claim 18 wherein providing a patient alert includes providing a patient alert in response to a detected patient blood oxygen level.

21. The method of claim 17, further comprising controlling delivery of the electrical signal in response to the detected condition.

22. The method of claim 1, further comprising;

automatically enabling delivery of the electrical signal when the patient is in a first state; and

automatically disabling delivery of the electrical signal when the patient is in a second state different than the first state.

23. The method of claim 22 wherein the first state corresponds to a first patient blood oxygen level, and wherein the second state corresponds to a second blood oxygen level lower than the first.

24. The method of claim 22, further comprising automatically directing the electrical signal in response to an indication that delivery of the electrical signal is enabled.

25. The method of claim 22, further comprising only directing the electrical signal in response to (a) an indication that delivery of the electrical signal is enabled, and (b) a concurrent patient request for signal delivery.

26. The method of claim 1 wherein the carotid body chemoreceptor is one of two carotid body chemoreceptors spaced apart laterally on opposite sides of the patient'"'"'s midline, and wherein implanting the signal delivery device includes implanting the signal delivery device unilaterally to be in signal communication with the afferent neural pathway of one of the carotid body chemoreceptors.

27. The method of claim 26, further comprising resecting the afferent neural pathway of the contralateral chemoreceptor.

28. The method of claim 1 wherein the carotid body chemoreceptor is one of two carotid body chemoreceptors spaced apart laterally on opposite sides of the patient'"'"'s midline, and wherein implanting the signal delivery device includes implanting one or more signal delivery devices to be in signal communication with afferent neural pathways of both the carotid chemoreceptors.

29. The method of claim 1, further comprising positioning the electrical signal delivery device to direct signals preferentially to chemoreceptor neurons over baroreceptor neurons.

30. The method of claim 29, further comprising electrically insulating structures neighboring the afferent neural pathway from effects of the signal.

31. The method of claim 1, further comprising:

assessing a baroreceptor function level of the patient;

if the patient'"'"'s sensitivity to loss of barosense function has a first level, positioning the electrical signal delivery device to direct signals preferentially to chemoreceptor neurons over baroreceptor neurons; and

if the patient'"'"'s sensitivity to loss of barosense function has a second level less than the first, positioning the electrical signal delivery device to direct signals without preference to affecting chemoreceptor neurons over baroreceptor neurons.

32. The method of claim 1 wherein directing an electrical signal from the electrical signal delivery element to the neural pathway includes directing the signal to a portion of the pathway at or superior to the patient'"'"'s carotid body.

33. The method of claim 32 wherein directing an electrical signal from the electrical signal delivery element to the neural pathway includes directing the signal to a portion of the pathway no greater than 5 centimeters superior to the patient'"'"'s carotid body

34. The method of claim 1 wherein directing an electrical signal includes directing a varying electrical signal at a frequency of from about 1 KHz to about 10 KHz, a pulse width of from about 10 microseconds to about 100 microseconds, and a pulse amplitude of up to about 12 volts or up to about 10 milliamps.

35. The method of claim 1, further comprising varying a degree to which the afferent signals are blocked by varying an amplitude of the electrical signal.

36. The method of claim 1, further comprising:

halting the signal;

identifying a persistence period occurring after the signal is halted and during which dyspneic symptoms remain at least reduced; and

based at least in part on identifying the persistence period, directing additional signals in accordance with a duty cycle having quiescent periods selected to be less than the persistence period.

37. A method for treating a patient, comprising:

using a non-invasive, physiological-functioning screening procedure, assessing the patient'"'"'s suitability for a dyspnea treatment regimen; and

based at least in part on a positive result from the screening procedure, engaging the patient in the treatment regimen.

38. The method of claim 37 wherein assessing the patient'"'"'s suitability for a dyspnea treatment regimen includes:

directing the patient to breathe a gas having an elevated oxygen content compared to standard air; and

receiving an indication from the patient identifying a change or lack of change in dyspneic symptoms, exercise capacity, or both.

39. The method of claim 38 wherein the gas is at least 30% oxygen.

40. The method of claim 38 wherein the gas is at least 50% oxygen.

41. The method of claim 38 wherein the gas is approximately 100% oxygen.

42. The method of claim 37 wherein engaging the patient in a treatment regimen includes at least reducing dyspneic sensations in the patient by directing an electrical signal from the electrical signal delivery element to the neural pathway to at least partially block afferent signals from the chemoreceptor.

43. The method of claim 42 wherein using a non-invasive, physiological-functioning screening procedure includes assessing a baroreceptor function level of the patient, and wherein the method further comprises:

if the patient'"'"'s sensitivity to loss of barosense function has a first level, positioning the electrical signal delivery device to direct signals preferentially to chemoreceptor neurons over baroreceptor neurons; and

if the patient'"'"'s sensitivity to loss of barosense function has a second level less than the first, positioning the electrical signal delivery device to direct signals without preference to affecting chemoreceptor neurons over baroreceptor neurons.

44. A system for treating a patient, comprising:

an implantable electrical signal delivery element configured to direct electrical signals to a patient'"'"'s neural pathway;

a power source coupled to the signal delivery element;

an oxygen sensor configured to transmit a signal corresponding to the patient'"'"'s blood oxygen level; and

a controller coupled to the power source and the oxygen sensor, the controller being programmed with instructions that, when executed;

direct an inhibitory electrical signal to the signal delivery element when the oxygen sensor indicates a blood oxygen level above a first threshold; and

cease directing the inhibitory signal when the oxygen sensor indicates a blood oxygen level below a second threshold.

45. The system of claim 44 wherein the first and second thresholds are the same.

46. The system of claim 44 wherein the first threshold has a value in the range of from about 89% to about 93%.

47. The system of claim 44 wherein the second threshold has a value in the range of from about 93% to about 89%.

48. The system of claim 44 wherein the power source is implantable within the patient.

49. The system of claim 44 wherein the power source is an external power source.

50. The system of claim 44 wherein the signal delivery element includes a cuff electrode.

51. The system of claim 44 wherein the signal delivery element includes an elongated lead having a plurality of axially spaced-apart ring contacts.