Breathing therapy device and method

• US 8,412,331 B2
• Filed: 10/15/2004
• Issued: 04/02/2013
• 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:
  US10/966,474
• Publication Number:
  US 20050085868A1
• Time in Patent Office: 3,091 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 device and method is provided for electrically stimulating the diaphragm to control breathing while inhibiting respiratory drive. A stimulation phase is identified. The stimulation phase is a period of time within the breathing cycle in which stimulation will inhibit respiratory drive. The respiratory drive inhibition may be used in a number of applications including but not limited to: improving or remodeling the heart in heart failure patients, treating apnea, chronic obstructive pulmonary disorder (COPD), and hypertension.

Claims

1. A method for treating a breathing disorder in a patient breathing, intrinsically comprising:

providing a device comprising a control unit, a sensor and a signal generator, wherein said control unit receives information from said sensor and is programmed to cause said signal generator to generate an electrically stimulating signal to diaphragm and/or phrenic nerve tissue;

identifying the phases within an intrinsic breathing cycle of a patient, said phases comprising the inspiration, exhalation, and rest periods of the intrinsic breathing cycle of the patient utilizing said sensor;

delivering the electrically stimulating signal during the rest period of the intrinsic respiratory cycle of said patient; and

,

electrically stimulating the diaphragm or phrenic nerve tissue of the patient by delivering a burst or series of pulses as the electrically stimulating signal at a time of the rest period prior to the expected onset of the next breath when breathing is present, providing therapeutic stimulation such that diaphragm movement of the patient is controlled to thereby inhibit central respiratory drive to prevent the onset or to reduce frequency of a breathing disorder.

2. The method of claim 1 wherein the step of electrically stimulating further comprises providing electrical stimulation directed to stabilizing swings in levels done Or more blood gas wherein the stabilization of the swings reduces occurrence of a breathing disorder.

3. The method of claim 2 wherein the step of providing electrical stimulation directed to stabilizing swings in levels of one or more blood gas comprises:

preventing a fall in oxygen saturation to thereby reduce a possibility of an arousal occurring.

4. The method of claim 1 wherein the step of electrically stimulating comprises providing stimulation at a point that is about 90% of the total rest period length.

5. The method of claim 1 wherein the step of stimulating comprises providing stimulation at a point about 100 to 500 milliseconds prior to the end of the rest period.

6. The method of claim 1 further comprising providing a series of sequential stimulations subsequent to providing stimulation during an exhalation period.

7. The method of claim 1 wherein the step of electrically stimulating comprises further providing electrical stimulation to manipulate minute ventilation.

8. The method of claim 1 wherein the step of electrically stimulating comprises farther providing electrical stimulation to manipulate a duration of an exhalation cycle with respect to a duration of an inspiration cycle.

9. The method of claim 1 wherein the step of electrically stimulating comprises stimulating diaphragm and/or phrenic nerve tissue via one or more electrodes in contact with the tissue.

10. The method of claim 9 further comprising providing an implantable unit placed in electrical communication with the tissue.

11. The method of claim 1 wherein the step of identifying the phases within an intrinsic breathing cycle of a patient comprises identifying stimulation boundaries for earliest and latest periods of stimulation within the phase of the intrinsic breathing cycle.

12. The method of claim 11 wherein the earliest period of stimulation comprises a period following exhalation.

13. The method of claim 11 wherein the latest period of stimulation comprises a period prior to onset of a subsequent spontaneous breath.

14. The method of claim 1 further comprising normalizing the electrical stimulation during a period of normalization.

15. The method of claim 14 further comprising weaning the patient from the electrical stimulation until spontaneous breathing by the patient resumes.