System and method for diaphragm stimulation

• US 8,200,336 B2
• Filed: 10/15/2004
• Issued: 06/12/2012
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Tehrani, Amir J., Ligon, David
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US10/966,472
• Publication Number:
  US 20050085867A1
• Time in Patent Office: 2,797 Days
• Field of Search: 607/42
• 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 stimulation device is provided that stimulates breathing to manipulate blood gas concentrations such as SaO₂ or PCO₂ and thereby treat underlying causes of breathing disorders and heart failure progression. A programmable device is provided for setting diaphragm stimulation waveforms that adjust minute ventilation about a predetermined baseline value. Normal breathing of the subject is observed to establish a baseline reference minute ventilation, and the device is programmed to produce stimulation waveforms that may provide either a decrease or an increase in the patients minute ventilation. The minute ventilation of the subject may be decreased or increased from the baseline level by decreasing or increasing a parameter that changes minute ventilators.

Claims

1. A system having an electrical stimulation device for treating a subject comprising:

an electrode configured to be implanted and electrically coupled to tissue of a subject;

a sensing device adapted to measure a respiration of the subject during a respiration cycle;

a signal source coupled to the electrode configured to provide an electrical signal to tissue of the subject through the electrode wherein the electrical stimulation device is configured to electrically stimulate phrenic nerve or diaphragm tissue to cause a contraction of at least a portion of a diaphragm and,

a control unit in communication with said signal source and sensing device,

wherein the signal source is in communication with the sensing device and wherein the control unit is programmed to cause the signal source to generate a first stimulation signal correlated to a respiratory parameter of the subject and which is delivered by the signal source during spontaneous respiration by the subject at a level and a period effective to maintain contraction of the diaphragm to provide a therapeutically significant lung volume change and to modify negative intrapleural pressure around lungs of the subject during at least a portion of an exhalation period of the respiration cycle, said control unit is further programmed to compare sensed respiration parameters before and after delivery of said stimulation, and programmed to adjust a subsequent stimulation signal in amplitude and/or frequency if needed to cause a diaphragm movement.

2. The system of claim 1 wherein the control unit is programmed for the device to deliver the first or subsequent stimulation signal during a non-inspiratory portion of the subject'"'"'s respiration cycle.

3. The system of claim 1 wherein said at least a portion of the exhalation period comprises the end of the subject'"'"'s respiration cycle.

4. The system of claim 1 wherein the control unit is programmed for the device to deliver the first or subsequent stimulation signal configured to increase a minimum lung volume, wherein said signal source is adapted to provide an electrical signal comprising a burst or series of pulses.

5. The system of claim 1 wherein the signal source is configured to deliver a stimulation signal configured to cause a movement of a diaphragm having a normal respiratory function to thereby modify negative intrapleural pressure.

6. The system of claim 1 wherein the control unit is further programmed to cause the device to deliver a stimulation configured to provide a continuous low level enhanced negative intrapleural pressure.

7. The system of claim 1 wherein the control unit is further programmed to cause the device to deliver said stimulation signal for an entire exhalation cycle until the onset of a subsequent inspiration cycle.

8. The system of claim 7 wherein the control unit is programmed to cause the device to deliver the stimulation signal during inspiration and the entire exhalation cycle of the respiration cycle.

9. The system of claim 1 wherein the control unit is programmed to cause the device to deliver an electrical stimulation signal during an inspiratory portion of the subject'"'"'s respiration cycle.

10. The system of claim 9 wherein the control unit is further programmed to deliver a first type of stimulation during and inspiration portion of a respiration cycle and a second type of stimulation during a non-inspiratory portion of the subject'"'"'s respiration cycle.

11. The system of claim 1 wherein the signal is configured to cause a diaphragm movement to additionally provide a therapeutically significant lung volume change during at least a non-inspiratory portion of the subject'"'"'s respiration cycle.

12. The system of claim 1 wherein the control unit is further programmed to generate the, first and/or subsequent stimulation signal which increases minute ventilation relative to a minute ventilation of un-stimulated respiration.

13. The system of claim 12 wherein the control unit is further programmed to cause the device to generate the first and/or subsequent stimulation signal which increases the minute ventilation by varying a combination of a respiratory rate and a tidal volume of the subject.

14. The system of claim 1 wherein the control unit is further programmed to cause the device to generate the first and/or subsequent stimulation signal which decreases minute ventilation relative to a minute ventilation of un-stimulated respiration.

15. The system of claim 14 wherein the control unit is further programmed to cause the device to generate the first and/or subsequent stimulation signal which decreases the minute ventilation by varying a combination of a respiratory rate and a tidal volume of the subject.

16. The system of claim 1 wherein the control unit is further programmed to cause the device to generate the first and/or subsequent stimulation signal which manipulates gas exchange wherein a level of SaO₂ or PCO₂ is increased.

17. A method of treating a subject comprising the steps of:

providing a device comprising a control unit, a stimulator having at least one implantable electrode capable of sensing respiratory parameters and delivering an electrical stimulation signal, and a signal source;

determining a respiratory parameter of a respiratory cycle of the subject utilizing said device;

modifying the respiratory parameter of the patient by electrically stimulating phrenic nerve or diaphragm tissue of the patient with a first stimulation signal comprising a burst or series of pulses delivered from the signal source via the electrode during spontaneous respiration by the subject to cause contraction of at least a portion of a diaphragm during at least a portion of exhalation at a level and a period effective to maintain contraction of the diaphragm and provide a modified negative intrapleural pressure and a therapeutically significant lung volume change; and

determining whether or not the therapeutically significant lung volume change has occurred to determine whether or not a second adjusted stimulation signal is needed.

18. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises modifying minute ventilation and further increasing a minimum lung volume of the subject.

19. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises stimulating to provide a continuous low level enhanced negative intrapleural pressure.

20. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises modifying intrapleural pressure for an entire exhalation cycle.

21. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises modifying minute ventilation for a duration including an inspiration cycle.

22. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises treating the patient having a disease state characterized at least in part by a gas exchange problem at a lower resting lung volume.

23. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises treating the patient with a breathing disorder.

24. The method of treating a patient of claim 23 wherein the step of treating the patient with a breathing disorder comprises treating the patient with sleep apnea.

25. The method of treating a patient of claim 23 wherein the step of treating the patient with a breathing disorder comprises treating the patient with obstructive sleep apnea.

26. The method of treating a patient of claim 23 wherein the step of treating the patient with a breathing disorder comprises treating the patient with hyperventilation.

27. The method of treating a patient of claim 23 wherein the step of treating the patient with a breathing disorder comprises treating the patient with hypoventilation.

28. The method of treating a patient of claim 23 wherein the step of treating the patient with a breathing disorder comprises treating the patient with partial apnea.

29. The method of treating a patient of claim 23 wherein the step of treating the patient with a breathing disorder comprises treating a heart failure patient.

30. The method of treating a patient of claim 17 wherein the step of modifying a respiratory parameter comprises providing stimulation to cause a diaphragm movement to provide a therapeutically significant lung volume change during at least a portion of a non-inspiratory period of the patient'"'"'s respiration cycle.

31. The method of treating a patient of claim 17 wherein further electrically stimulating the diaphragm comprises applying the first and/or subsequent signal to vary a combination of a respiratory rate and a tidal volume such that a minute ventilation is increased relative to a minute ventilation of un-stimulated respiration.

32. The method of treating a patient of claim 17 wherein further electrically stimulating the diaphragm comprises applying the first and/or subsequent signal to vary a combination of a respiratory rate and a tidal volume such that a minute ventilation is decreased relative to a minute ventilation of un-stimulated respiration.

33. The method of claim 17 wherein modifying a respiratory parameter comprises manipulating gas exchange wherein a level of SaO₂ or PCO₂ is increased.