Demand-based system for treating breathing disorders

• US 8,348,941 B2
• Filed: 10/13/2005
• Issued: 01/08/2013
• 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.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US11/249,718
• Publication Number:
  US 20060036294A1
• Time in Patent Office: 2,644 Days
• Field of Search: 607/42, 600/529
• US Class Current: 606/42
• 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 are provided for managing the treatment of a patient with respiratory disorders or symptoms. Respiratory parameters are sensed and recorded and communicated to an external device to provide information to a patient and/or provider for further treatment or diagnosis. Also respiratory disorders such as apnea or hypoventilation may be treated by electrically stimulating the diaphragm muscle or phrenic nerve in response to a sensed respiratory parameter or characteristic.

Claims

1. A method of treating sleep disordered breathing in a patient comprising the steps of:

identifying a breathing disorder in the patient;

providing at least one electrical stimulation to diaphragm or phrenic nerve tissue to manipulate the diaphragm such that the breathing of the patient is adjusted to thereby mitigate the breathing disorder, wherein the at least one electrical stimulation is applied as one or more bursts, each burst comprising a series of pulses, monitoring a respiration parameter of the patient sensing for normalized breathing for a first monitoring period;

further providing at least one electrical stimulation to diaphragm or phrenic nerve tissue if breathing is not as desired or ceasing the at least one electrical stimulation if the breathing is as desired;

further monitoring the respiration parameter if the breathing is not as desired for the presence of the breathing disorder during at least a second monitoring period which is longer than the first monitoring period sensing for normalized breathing; and

if the breathing is still not as desired for the presence of the breathing disorder during the at least a second monitoring period, providing a third or more monitoring periods, each longer than the previous period and further providing at least one electrical stimulation if the breathing is not as desired or ceasing the at least one electrical stimulation if the breathing is as desired.

2. The method of claim 1 wherein the step of providing at least one electrical stimulation comprises providing stimulation effective to adjust a parameter selected from the group consisting of a rate of a respiratory cycle, a slope of inspiration, a slope of exhalation, controlling fast exhalation, and a tidal volume.

3. The method of claim 1 wherein the step of providing at least one electrical stimulation comprises providing a stimulation configured to manipulate the duration of an exhalation or inspiration portion of a respiration cycle.

4. The method of claim 1 wherein the step of providing at least one electrical stimulation comprises providing a stimulation configured to manipulate a ratio of the duration of an exhalation portion of a respiration cycle with respect to an inspiration portion of the respiration cycle.

5. The method of claim 1 further comprising monitoring for the additional presence of a breathing disorder following the ceasing of the at least one electrical stimulation.

6. The method of claim 1 wherein the step of providing at least one electrical stimulation comprises stimulating during an inspiration cycle of an intrinsic breath of a patient.

7. The method of claim 6 wherein the step of providing at least one electrical stimulation comprises providing stimulation to normalize tidal volume or increase tidal volume of a breath with respect to a baseline normal tidal volume.

8. The method of claim 1 wherein the step of providing at least one electrical stimulation comprises initiating a respiratory cycle and controlling respiration of said patient.

9. The method of claim 1 further comprising the step of sensing at least one respiration parameter and coordinating the stimulation with the at least one sensed respiration parameter wherein the step of coordinating the stimulation comprises synchronizing stimulation with a portion of an intrinsic breath or synchronizing with said sensed parameter.

10. The method of claim 1 wherein at least one burst of said stimulation is provided during an entire inspiration portion of a respiration cycle to regulate the inspiration and exhalation morphology of said patient.

11. The method of claim 1 further comprising sensing at least one indicator preceding sleep disordered breathing.

12. The method of claim 11 wherein the step of sensing at least one indicator comprises sensing a tidal volume correlated signal of a patient below a predetermined threshold.

13. The method of claim 11 wherein the step of sensing at least one indicator preceding sleep disordered breathing comprises sensing an arrhythmic breathing characteristic.

14. The method of claim 11 wherein the step of sensing at least one indicator preceding sleep disordered breathing comprises sensing an attenuated EMG.

15. The method of claim 11 wherein the step of sensing at least on indicator preceding sleep disordered breathing comprises sensing an out of phase EMG.

16. The method of claim 1 further comprising modifying the duration of the bursts, or frequency, amplitude, or width of the pulses within the bursts to control the respiration of said patient.

17. The method of claim 1 further comprising following said first monitoring period further monitoring for intrinsic breathing, if the breathing is outside the intrinsic level, stimulating with adjusted parameters of stimulation to bring the breathing into an appropriate breathing range.