Device and method for controlling breathing

• US 20060149334A1
• Filed: 11/10/2005
• Published: 07/06/2006
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Province, Rose, Lee, Chang, Ligon, David, Tehrani, Amir J., Goodman, Amy Michelle
• Granted Patent: US 7,979,128 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

Abstract

A device and method is provided for controlling breathing of a subject by electrically stimulating tissue associated with the diaphragm or phrenic nerve of the subject.

Claims

1. A method for controlling breathing comprising the steps of:

providing an electrical stimulator including an implanted electrode, wherein the electrical stimulator is configured to provide electrical stimulation to tissue associated with the respiratory tract to cause a diaphragm response,

stimulating the tissue with the electrical stimulator during a portion of a respiratory cycle after an inspiration cycle, before onset of a subsequent respiration and continuing stimulation at a first respiratory rate greater than or equal to an intrinsic respiratory rate.

2. The method of claim 1 further comprising the step of stimulating at a decreased respiratory rate slower than the first rate after stimulating at the first rate.

3. The method of claim 1 wherein the step of stimulating the tissue with the electrical stimulator comprises providing stimulation at least in part during an inspiration portion of an intrinsic breath.

7. The method of claim 1 further comprising the step of stimulating for a plurality of breaths to control rate of breathing.

8. The method of claim 7 further comprising the step of stimulating at a low level for at least a portion of a period between inspiration cycles of a plurality of respiration cycles.

4. The method of claim 4 wherein the step of providing stimulation at least in part during an inspiration portion comprises stimulating during an inspiration portion of a first breath at a first delay after onset of the first breath and stimulating during an inspiration portion of a subsequent breath at a second delay after onset of the subsequent breath wherein the first delay is greater than the second delay.

5. The method of claim 4 further comprising the step of stimulating for a plurality of breaths to control rate of breathing.

6. The method of claim 5 further comprising the step of stimulating at a low level for at least a portion of a period between inspiration cycles of a plurality of respiration cycles.

9. A method for controlling breathing comprising the steps of:

providing an electrical stimulator including an implanted electrode, wherein the electrical stimulator is configured to provide electrical stimulation to tissue associated with the respiratory tract to cause a diaphragm response,

stimulating the tissue with the electrical stimulator at least in part during an inspiration cycle of an intrinsic breath with stimulation to provide an resulting breath; and

subsequently stimulating breathing to elicit a paced breath having at least one desired stimulation parameter.

10. The method of claim 9 further comprising the step of providing a low level of stimulation for at least a portion of a period between a plurality of respiration cycles.

11. The method of claim 9 wherein the step of stimulating breathing to elicit a paced breath comprises stimulating at a rate greater than or equal to an intrinsic respiration rate.

12. A method of manipulating breathing comprising:

providing an implantable stimulator programmed with an electrical stimulation protocol directed to improving ventilatory stability of a patient; and

electrically stimulating tissue associated with the diaphragm of the patient in accordance with the electrical stimulation protocol to improve ventilatory stability associated with airway obstruction, wherein the step of electrically stimulating comprises stimulating breathing at least in part during an intrinsic inspiration cycle when tidal volume is below an intrinsic tidal volume to normalize tidal volume.

13. A method of manipulating breathing comprising:

providing a stimulator programmed with an electrical stimulation protocol directed to improving ventilatory stability of a patient; and

electrically stimulating tissue associated with the diaphragm of the patient in accordance with the electrical stimulation protocol to improve ventilatory stability, wherein the step of stimulating to improve ventilatory stability comprises stimulating at a rate greater than or equal to an intrinsic rate and controlling at least one respiration parameter to control breathing to provide desired respiration.

14. The method of claim 13 wherein the step of controlling breathing to provide desired respiration comprises stimulating breathing to produce a desired respiration waveform.

15. The method of claim 13 wherein the step of controlling breathing to provide desired respiration comprises stimulating breathing to produce a desired tidal volume.

16. The method of claim 13 wherein the step of controlling breathing to provide desired respiration comprises stimulating breathing to produce a desired air flow.

17. The method of claim 13 wherein the step of controlling breathing to provide desired respiration comprises stimulating breathing to produce desired minute ventilation.

18. A device for manipulating breathing comprising:

a breathing stabilizer comprising;

an electrical stimulator programmed with an electrical stimulation protocol directed to controlling breathing of a patient;

an implantable electrode configured to be implanted to stimulate tissue associated with a respiratory tract of a patient to cause a diaphragm response, wherein the stimulator is in electrical communication with the implantable electrode to thereby supply an electrically stimulating signal to the tissue according to the electrical stimulation protocol;

an intrinsic breathing detector configured to detect an intrinsic breath; and

a stimulation timer configured to cause stimulation to occur during an exhalation portion of a respiratory cycle and to further stimulate breathing at a first respiratory rate greater than or equal to an intrinsic respiratory rate.

19. The device of claim 18 wherein the stimulator is configured to provide stimulation during an inspiration portion of an intrinsic breath.

20. The device of claim 19 wherein the stimulator is further configured to increase the rate of stimulation to a second respiratory rate after providing stimulation during the inspiration portion of the intrinsic breath.

21. The device of claim 18 wherein the stimulator is programmed with an electrical stimulation protocol directed to entraining breathing of a patient.

23. The device of claim 18 further comprising a low level stimulator.

22. The device of claim 28 further comprising:

a stimulation timer configured to initiate stimulation during a first intrinsic breath at a first delay from the first intrinsic breath and to initiate stimulation during a subsequent intrinsic breath at a second delay from the first breath.

24. A device for improving ventilatory stability comprising:

an electrical stimulator;

an electrical stimulation protocol directed to improving ventilatory stability associated with obstructive respiratory events of a patient and programmed into the electrical stimulator, wherein the electrical stimulation protocol is configured to augment an intrinsic breath with stimulation to provide an augmented breath;

an implantable electrode configured to be implanted to stimulate tissue associated with a respiratory tract of a patient to cause a diaphragm response, wherein the stimulator is in electrical communication with the implantable electrode to supply an electrically stimulating signal to the tissue according to the electrical stimulation protocol; and

a detector configured to detect a decrease in tidal volume associated with a possible obstructive respiratory event wherein the stimulator is configured to stimulate breathing when tidal volume is below an intrinsic tidal volume to normalize tidal volume.

25. The device of claim 24 further comprising a low level stimulator.