Device and method for gradually controlling breathing

• US 7,979,128 B2
• Filed: 11/10/2005
• Issued: 07/12/2011
• 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
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US11/271,264
• Publication Number:
  US 20060149334A1
• Time in Patent Office: 2,070 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

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 of manipulating breathing comprising:

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

sensing respiration via a sensor and identifying one or more portions of one or more respiratory cycles including first, second and subsequent intrinsic respiratory cycles by the patient detected internally within the patient'"'"'s body;

determining via a processor in communication with the sensor when the sensed respiration is a disordered event;

when the disordered event is detected, applying electrical stimulation during a first selected intrinsic inspiration cycle at a first delay from an onset of the first intrinsic inspiration cycle;

further applying the electrical stimulation during a second intrinsic inspiration cycle at a second delay from an onset of the second intrinsic cycle; and

,

further applying the electrical stimulation during one or more subsequent intrinsic breaths such that each stimulation is applied with a delay from an onset of each subsequent intrinsic breath such that the delay in each subsequent breath reduces from a previous delay until the stimulation is synchronous with a start of each subsequent intrinsic inspiration

wherein the electrical stimulation is provided to tissue associated with the diaphragm of the patient at least in part during the intrinsic inspiration cycle in accordance with the electrical stimulation protocol until the sensed respiration has reached a normalized respiration such that ventilatory stability is improved.

2. The method of claim 1 wherein further applying the electrical stimulation during one or more subsequent intrinsic breaths comprises stimulating the tissue with the stimulator to provide a sequence of augmented intrinsic inspirations.

3. The method of claim 1 wherein further applying the electrical stimulation during one or more subsequent intrinsic breaths comprises providing multiple stimulations at a respiratory rate greater than or equal to an intrinsic respiratory rate.

4. The method of claim 1 wherein further applying the electrical stimulation during one or more subsequent intrinsic breaths comprises providing multiple stimulations configured to provide a minute ventilation approximately greater than or equal to an intrinsic minute ventilation.

5. The method of claim 1 wherein the identified one or more portions of the one or more respiratory cycles includes an exhalation portion, and the further applying the electrical stimulation during one or more subsequent intrinsic breaths comprises providing at least one of said plurality of stimulations during exhalation.

6. The method of claim 5 wherein the identified one or more portions of the one or more respiratory cycles includes a rest portion of an exhalation cycle, and the providing at least one of said plurality of stimulations during exhalation comprises stimulating during a rest phase portion of an exhalation cycle.

7. The method of claim 5 wherein providing at least one of said plurality of stimulations during exhalation comprises stimulating to elicit a breath during an exhalation cycle of an intrinsic respiration cycle.

8. A breathing stabilizer device for manipulating breathing comprising:

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

an electrode configured to be implanted to stimulate tissue associated with a phrenic nerve or diaphragm of a patient to cause a diaphragm response, wherein the stimulator is in electrical communication with the 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 to identify one or more portions of one or more respiratory cycles including an onset of a first, second and subsequent intrinsic breath internally within a patient'"'"'s body; and

a stimulation timer programmed to cause stimulation to occur during a respiratory cycle and to further stimulate breathing at a first respiratory rate greater than or equal to an intrinsic respiratory rate,

wherein the stimulation timer is further programmed to initiate the stimulation upon detection of a respiratory disorder, where the stimulation is applied during a first selected intrinsic breath at a first delay from an onset of the first intrinsic breath, and where the stimulation is applied during a second intrinsic breath at a second delay from an onset of the second intrinsic breath such that the second delay is shorter than the first delay, and

wherein the stimulation is further applied during one or more subsequent intrinsic breaths with each stimulation being applied at a delay from an onset of each subsequent intrinsic breath such that the delay in each subsequent intrinsic breath is shorter than a previous delay until the stimulation applied is synchronous with an onset of each subsequent intrinsic breath.

9. The device of claim 8 wherein the identified one or more portions of the one or more respiratory cycles includes an inspiration portion, and the stimulator is configured to provide stimulation during an inspiration portion of the intrinsic breaths.

10. The device of claim 9 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 breaths.

11. The device of claim 8 wherein the stimulator is programmed with an electrical stimulation protocol directed to entraining breathing of a patient.

12. The device of claim 8 wherein the identified one or more portions of the one or more respiratory cycles includes an exhalation portion, and the stimulator is further programmed to cause stimulation to occur during an exhalation portion of the respiratory cycles.

13. The device of claim 8 wherein the stimulator is configured to stimulate to elicit a sequence of augmented intrinsic inspirations.

14. The device of claim 8 wherein the stimulator is configured to entrain breathing with a sequence of a plurality of stimulations at respiratory rate greater than or equal to an intrinsic respiratory rate.

15. The device of claim 8 wherein the electrical stimulation protocol is further configured to approximately provide a sensed peak flow less than or equal to a peak flow of an intrinsic breath.

16. The device of claim 8 wherein the identified one or more portions of the one or more respiratory cycles includes an inspiration portion, and the stimulator is configured to apply the stimulation to occur at least in part during an inspiration portion of the intrinsic breaths of the patient.