Method and apparatus for therapies of the cardiovascular and cardiorenal system

• US 8,897,879 B2
• Filed: 11/02/2012
• Issued: 11/25/2014
• Est. Priority Date: 11/04/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Karamanoglu, Mustafa, Splett, Vincent E
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/667,925
• Publication Number:
  US 20130116743A1
• Time in Patent Office: 753 Days
• Field of Search: 607/42, 607/123
• US Class Current: 607/42
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A system and method for controlling respiration depth or respiration rate is provided. A bipolar pair of a plurality of electrodes is selected in a location for stimulating a phrenic nerve. Electrical stimulation is delivered through a medical electrical lead electrode proximate phrenic nerve tissue. Modulating respiration is elicited in response to electrical stimulation of the phrenic nerve.

Claims

1. A method of controlling respiration depth or respiration rate through an implanted medical electrical lead having an electrode for pacing and sensing, the method comprising:

delivering electrical stimulation through an electrode proximate phrenic nerve tissue, and

eliciting modulating respiration in response to electrical stimulation of the phrenic nerve, the modulating respiration asynchronously modifies intrinsic respiration,

wherein glomerular filtration rate (GFR) is improved by about 10% compared to another GFR before any phrenic nerve stimulation has occurred.

2. The method of claim 1 wherein the modulating respiration overrides any intrinsic respiration.

3. The method of claim 1 wherein the electrical stimulation includes at least one stimulation parameter including one of current amplitude, voltage, frequency, and pulse width.

4. The method of claim 3 wherein the current amplitude is in the range of about 2 to about 20 milliampere (mA).

5. The method of claim 3 wherein the voltage is in the range of about 1 volts to about 8 volts.

6. The method of claim 3 wherein the frequency is in the range of about 20 to about 100 Hertz (Hz).

7. The method of claim 3 wherein the pulse width is in the range of about 20 to about 400 microseconds (μ

s).

8. The method of claim 2 wherein modulation respiration occurs involuntarily.

9. The method of claim 2, wherein a modulated strength of respiration is adjusted by about 10% of a total tidal volume as compared to total tidal volume before initiation of phrenic nerve stimulation.

10. The method of claim 2, wherein a modulated strength of respiration is adjusted by about 15% of a total tidal volume as determined before any phrenic nerve stimulation occurs in a patient.

11. The method of claim 1 wherein phrenic nerve stimulation is through transvenous phrenic nerve stimulation.

12. The method of claim 1 further comprising terminating phrenic nerve stimulation in response to detecting a predetermined terminating condition.

13. The method of claim 12 wherein the predetermined terminating condition is a cardiovascular physiological condition.

14. The method of claim 12 wherein the cardiovascular physiological condition is one of mean arterial blood pressure, and heart rate.

15. The method of claim 14 wherein the mean arterial blood pressure having a range of about 70 mmHg and about 110 mmHg.

16. The method of claim 14 wherein the heart rate having a range of about 40 beats per minute (BPM) and about 80 BPM.

17. The method of claim 12 wherein the predetermined terminating condition is saturation level of oxygen (SaO₂) in hemoglobin, wherein the SaO₂ is in the range of about 92% to about 100%.

18. The method of claim 12 wherein the predetermined condition is inadvertent capture of one of a heart and skeletal muscle.

19. The method of claim 12 wherein the predetermined condition is diaphragmatic fatigue.

20. The method of claim 12 wherein the predetermined condition is carbon dioxide (CO₂) tension in blood.

21. The method of claim 12 wherein the predetermined condition is one of a predetermined number of programmed breaths following an apnetic event, a breathing pattern, and a predetermined duration of the therapy.

22. The method of claim 12 wherein the predetermined condition is activated by a patient.

24. The method of claim 1, further comprising:

adjusting substantially a respiration depth during the inspiration.

25. The method of claim 1, further comprising:

adjusting substantially a respiration rate.

23. A method of controlling respiration depth or respiration rate through an implanted medical electrical lead having an electrode for pacing and sensing, the method comprising:

delivering electrical stimulation through an electrode proximate phrenic nerve tissue, and

eliciting modulating respiration in response to electrical stimulation of the phrenic nerve, the modulating respiration asynchronously modifies intrinsic respiration, wherein GFR is improved by about 15% compared to another GFR of before any phrenic nerve stimulation has occurred.

26. A stimulator system comprising:

a phrenic nerve tissue electrode and a physiological electrode, spatially separated from one another and all coupled to an implantable pulse generator, the implantable pulse generator comprising;

delivering electrical stimulation through an electrode proximate phrenic nerve tissue, the delivery of electrical stimulation is timed without sensed respiration data, wherein glomerular filtration rate (GFR) is improved by about 10% compared to another GFR before any phrenic nerve stimulation has occurred.

27. A stimulator system comprising:

a phrenic nerve tissue electrode and a physiological electrode, spatially separated from one another and all coupled to an implantable pulse generator, the implantable pulse generator comprising;

means for delivering electrical stimulation through an electrode proximate phrenic nerve tissue, and

means for eliciting modulating respiration in response to electrical stimulation of the phrenic nerve, the modulating respiration asynchronously modifies intrinsic respiration, wherein glomerular filtration rate (GFR) is improved by about 10% compared to another GFR before any phrenic nerve stimulation has occurred.

28. A method of controlling respiration depth or respiration rate through an implanted medical electrical lead having an electrode for pacing and sensing, the method comprising:

delivering electrical stimulation through an electrode proximate phrenic nerve tissue, the delivery of electrical stimulation is timed without sensed respiration data;

determining whether a termination condition is detected; and

terminating phrenic nerve stimulation in response to detecting the termination condition.

29. A method of controlling respiration depth or respiration rate through an implanted electrical lead having an electrode for pacing and sensing, the method comprising:

determining whether to initiate stimulation of the phrenic nerve based on a predetermined initiation event;

in response to determining whether to initiate stimulation, delivering electrical stimulation through an electrode proximate phrenic nerve tissue,

eliciting modulating respiration in response to electrical stimulation of the phrenic nerve, the modulating respiration asynchronously modifies intrinsic respiration;

detecting a cardiovascular parameter within a predetermined range; and

terminating electrical stimulation in response to detecting the cardiovascular parameter within the predetermined range wherein glomerular filtration rate (GFR) is improved by about 10% compared to another GFR before any phrenic nerve stimulation has occurred.

30. The method of claim 29 wherein the initiation event is selected from the group consisting of immediately upon enabling stimulation, on a periodic basis, upon user activation, upon user command, or in response to a change in a physiological parameter.

31. The method of claim 30 wherein the physiological parameter is selected from the group consisting of blood pressure, heart rate, pH of arterial blood, and SaO₂.

32. The method of claim 30 wherein the physiological parameter is an arterial blood pressure that exceeds a range of 70 to 110 mmHg.

33. The method of claim 30 wherein the physiological parameter is a resting heart rate which falls outside a range of 40 to 80 beats per minute.

34. The method of claim 30 wherein the physiological parameter is a pH of arterial blood which falls outside a predetermined normal range for a patient.

35. The method of claim 30 wherein the physiological parameter is a pH of arterial blood which falls outside a range of about 7.35 to about 7.45.

36. The method of claim 30 wherein the physiological parameter is a SaO₂ which falls outside of a range of about 92% to about 100%.

37. The method of claim 29 wherein terminating stimulation of the phrenic nerve occurs when the pH of arterial blood falls within a predetermined normal range for a patient.

38. The method of claim 29 wherein terminating stimulation of the phrenic nerve occurs when the pH of arterial blood is within the range of about 7.35 to about 7.45.

39. A neurostimulator system comprising:

a pulse generator;

a medical electrical lead having one or more electrodes, the medical electrical lead connected to the pulse generator;

means for stimulating phrenic nerve tissue;

modulating respiration in response to stimulating phrenic nerve stimulation; and

means for terminating phrenic nerve stimulation without using respiration data, wherein glomerular filtration rate (GFR) is improved by about 10% compared to another GFR before any phrenic nerve stimulation has occurred.

40. The stimulator system of claim 39 wherein terminating phrenic nerve stimulation is in response to detecting one of pH of arterial blood and SaO₂.

41. A method of controlling ventilation depth or ventilation rate through an implanted electrical lead having an electrode for pacing and sensing, the method comprising:

determining whether to initiate stimulation of the phrenic nerve based on a predetermined initiation event;

in response to determining whether to initiate stimulation, delivering electrical stimulation through an electrode proximate phrenic nerve tissue,

eliciting modulating ventilation in response to electrical stimulation of the phrenic nerve, the modulating ventilation asynchronously modifies intrinsic ventilation;

detecting a cardiovascular parameter within a predetermined range; and

terminating electrical stimulation in response to detecting the cardiovascular parameter,

wherein glomerular filtration rate (GFR) is improved by about 10% compared to another GFR before any phrenic nerve stimulation has occurred.