Device and method for biasing and stimulating respiration

• US 8,116,872 B2
• Filed: 10/31/2007
• Issued: 02/14/2012
• 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., Province, Rose, Ligon, David, Lee, Chang, Goodman, Amy Michelle
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US11/981,800
• Publication Number:
  US 20080208281A1
• Time in Patent Office: 1,567 Days
• Field of Search: 607/42, 607/117, 607/118
• 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 biasing lung volume by electrically stimulating tissue associated with the diaphragm or phrenic nerve at a low level.

Claims

1. A method of stimulating breathing in a subject having intrinsic breathing comprising the steps of:

sensing for a presence of a disordered breathing event during intrinsic breathing in the subject;

providing a first type of electrical stimulation comprising a first stimulation waveform to phrenic nerve or diaphragm tissue of the subject during a non-inspiratory portion of a respiration cycle to activate a diaphragm such that an upper airway of the subject is stiffened to inhibit collapse of the airway; and

,

providing a second type of electrical stimulation comprising a second stimulation waveform to activate the diaphragm such that

an inspiration is elicited.

2. The method of claim 1 wherein the first stimulation waveform biases the lung volume immediately prior to initiation of the inspiration elicited by the second stimulation waveform.

3. The method of claim 1 further comprising:

providing a plurality of second stimulation waveforms; and

providing a plurality of first stimulation waveforms during non-inspiratory portions betweens said plurality of second stimulation waveforms.

4. The method of claim 1 wherein providing a first type of electrical stimulation comprises providing the first type of electrical stimulation transvenously.

5. The method of claim 1 wherein sensing for a presence comprises sensing for the disordered breathing event indicative of central sleep apnea.

6. A respiration device comprising:

at least one electrode in communication with a phrenic nerve or diaphragm tissue of a subject;

an electrical stimulator in communication with the at least one electrode wherein the electrical stimulator is actuated to deliver stimulation to the tissue of the subject to thereby activate diaphragm muscle; and

,

a responsive device coupled to the electrical stimulator, the responsive device being programmed to actuate the electrical stimulator to deliver the stimulation comprising a first stimulation mode having a first stimulation waveform which biases lung volume such that an upper airway of the subject is stiffened to inhibit collapse of the airway at least during a non-inspiratory portion of a respiration cycle and a second stimulation mode which delivers a second stimulation waveform which elicits an inspiration.

7. The respiration device of claim 6 wherein the responsive device is programmed to actuate the electrical stimulator to provide a plurality of stimulations in the second mode with stimulation in the first mode between each of successive stimulations in the second mode.

8. The device of claim 6 wherein the at least one electrode is configured to deliver the stimulation transvenously.

9. A method of stimulating breathing in a subject having intrinsic breathing comprising the steps of:

sensing for a presence of intrinsic breathing in the subject;

providing electrical stimulation to phrenic nerve or diaphragm tissue of the subject to activate a diaphragm,

wherein the stimulation comprises a first stimulation waveform of a first type of stimulation and a second stimulation waveform of a second type of stimulation, and

wherein the first stimulation signal portion biases lung volume during a non-inspiratory portion of a respiration cycle such that an upper airway of the subject is stiffened to inhibit collapse of the airway and the second stimulation signal augments an intrinsic inspiration.

10. The method of claim 9 wherein the first stimulation waveform biases lung volume prior to augmenting inspiration with the second stimulation waveform.

11. The method of claim 9 wherein the step of providing electrical stimulation comprises:

providing a plurality of second stimulation waveforms during a corresponding plurality of intrinsic inspirations; and

providing a plurality of first stimulation waveforms during non-inspiratory portions between said plurality of second stimulation waveforms.

12. The method of claim 9 wherein providing electrical stimulation comprises providing the first stimulation waveform transvenously.

13. A respiration device comprising

at least one electrode in communication with a phrenic nerve or diaphragm tissue of a subject;

an electrical stimulator in communication with the at least one electrode wherein the electrical stimulator is actuated to deliver stimulation to the tissue of the subject to thereby activate diaphragm muscle; and

,

a responsive device coupled to the electrical stimulator, the responsive device being programmed to actuate the electrical stimulator to deliver the stimulation comprising a first stimulation mode having a first stimulation waveform which biases lung volume such that an upper airway of the subject is stiffened to inhibit collapse of the airway during a non-inspiratory portion of a respiration cycle and a second stimulation mode which delivers a second stimulation which augments an intrinsic inspiration.

14. The respiration device of claim 13 wherein the responsive device is programmed to actuate the electrical stimulator to provide a plurality of stimulations in the second mode with stimulation in the first mode between each of successive stimulations in the second mode.

15. The device of claim 13, wherein the at least one electrode is configured to deliver the stimulation transvenously.

16. A method of treating a breathing disorder in a subject having intrinsic breathing comprising:

sensing for a presence of intrinsic breathing in the subject;

detecting an onset of a disordered breathing event during the intrinsic breathing; and

,

providing a first electrical stimulation waveform to phrenic nerve or diaphragm tissue of the subject during a non-inspiratory portion of a respiration cycle to activate at least a portion of the diaphragm such that an upper airway of the subject is stiffened to inhibit collapse of the airway; and

,

providing a second electrical stimulation waveform whereby flow in the upper airway is normalized prior to the onset of the disordered breathing event.

17. The method of claim 16 wherein the step of providing a first electrical stimulation waveform comprises activating at least the portion of the diaphragm during non-REM sleep.

18. The method of claim 16 wherein the step of providing a first electrical stimulation waveform comprises activating at least the portion of the diaphragm during sleep transition.

19. The method of claim 16, wherein providing a first electrical stimulation waveform comprises providing the first electrical stimulation waveform transvenously.

20. The method of claim 16 wherein the breathing disorder comprises central sleep apnea.

21. A method of providing electrical stimulation to activate a diaphragm in a manner that avoids airway closure in a subject having intrinsic breathing comprising:

sensing for a presence of intrinsic breathing in the subject;

providing a first electrical stimulation waveform to phrenic nerve or diaphragm tissue of the subject during a non-inspiratory portion of a respiration cycle to activate a diaphragm and maintain patency of an upper airway; and

,

providing a second electrical stimulation waveform such that tidal volume is increased, and

wherein an inspiration duration is increased while maintaining peak flow at a level sufficient to avoid upper airway closure.

22. The method of claim 21, wherein providing a first electrical stimulation waveform comprises providing the first electrical stimulation waveform transvenously.

23. A method of treating a breathing disorder in a subject having intrinsic breathing comprising:

sensing for a presence of intrinsic breathing in the subject;

detecting an onset of a disordered breathing event during the intrinsic breathing;

providing a first electrical stimulation waveform to phrenic nerve or diaphragm tissue of the subject during a non-inspiratory portion of a respiration cycle to activate at least a portion of the diaphragm such that an upper airway of the subject is stiffened to inhibit collapse of the airway; and

,

providing a second electrical stimulation waveform whereby tidal volume is normalized prior to the onset of the disordered breathing event by stimulating the diaphragm to increase tidal volume while maintaining peak flow at or below an intrinsic peak flow level sufficient to avoid airway closure.

24. The method of claim 23 wherein the step of providing a first electrical stimulation waveform comprises activating the diaphragm during non-REM sleep.

25. The method of claim 23 wherein the step of providing a first electrical stimulation waveform comprises activating the diaphragm during sleep transition.

26. The method of claim 23 wherein the breathing disorder comprises central sleep apnea.

27. The method of claim 23, wherein providing a first electrical stimulation waveform comprises providing the first electrical stimulation waveform transvenously.