Device and method for biasing lung volume

• US 7,970,475 B2
• Filed: 11/10/2005
• Issued: 06/28/2011
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Lee, Chang, Ligon, David, Tehrani, Amir J., Goodman, Amy Michelle, Province, Rose
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US11/271,726
• Publication Number:
  US 20060155341A1
• Time in Patent Office: 2,056 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 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/3614 based on impedance measurement

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 device for manipulating lung volume comprising

an electrode configured to stimulate tissue associated with respiration of a patient to cause a diaphragm response;

one or more sensors configured to be attached to or placed within the patient'"'"'s body and configured to sense respiration;

a control unit comprising;

a) a stimulator in electrical communication with the electrode and configured to supply an electrically stimulating signal to the tissue in response to the sensed respiration detected internally within the patient'"'"'s body, wherein the stimulator is configured to provide the electrically stimulating signal at least in part during an end of an exhalation period; and

b) a processor which is in communication with the sensor and which is programmed to identify a portion of a respiratory cycle, including an exhalation period and coordinate the electrically stimulating signal with the sensed respiration and which is further programmed to detect for a characteristic indicative of a disordered respiratory event from the sensed respiration,

wherein the processor is further programmed to compare the sensed respiration against a predetermined threshold and then provide the electrically stimulating signal at least in part during an end of an identified exhalation period when the characteristic is detected where the signal has a waveform which is provided in response to the sensed respiration such that an additional lung volume is created.

2. The device of claim 1 wherein the electrically stimulating signal is programmed to permit an intrinsic breath to occur during the stimulation signal.

3. The device of claim 1 wherein the stimulator is further programmed to additionally stimulate during an inspiration portion of an intrinsic breath of the patient to augment the inspiration portion and the processor is further programmed to identify an inspiration period and provide the electrically stimulating signal during an identified inspiration portion.

4. The device of claim 1 wherein the stimulator is further programmed to provide stimulation at least in part during a rest phase of an exhalation period and the processor is further programmed to identify a rest phase of an exhalation period and provide the electrically stimulating signal during an identified rest phase of an exhalation period.

5. The device of claim 1 wherein the stimulator is programmed to supply the electrically stimulating signal intermittently on a periodic basis.

6. The device of claim 1 wherein the stimulator is further programmed to provide a stimulation signal during a beginning of the exhalation period.

7. The device of claim 6 wherein the stimulator is further programmed to provide a stimulation signal during all of the respiratory cycle.

8. The device of claim 1 wherein the processor is further programmed to identify an intrinsic inspiration portion and the stimulator further comprises a stimulation timer configured to provide stimulation to increase inspiration duration with respect to an intrinsic inspiration duration.

9. A method for manipulating lung volume comprising the steps of:

sensing respiration and identifying a portion of the respiratory cycle, including an exhalation period, in a patient detected internally within the patient'"'"'s body via at least one electrode;

detecting via a processor for a characteristic indicative of a disordered respiratory event from the internally sensed respiration;

comparing the sensed respiration against a predetermined threshold; and

,

when the characteristic is detected, electrically stimulating tissue associated with respiration to a diaphragm at least in part during the end of an identified exhalation period, where a waveform of the stimulation for controlling respiration is provided in response to the sensed characteristic to create an additional lung capacity.

10. The method of claim 9 wherein the step of electrically stimulating further permits intrinsic respiration to occur.

11. The method of claim 9 wherein the step of identifying further comprises identifying an inspiration portion of a breath and the step of electrically stimulating further comprises stimulating at least in part during an identified inspiration portion of an intrinsic breath of a patient.

12. The method of claim 9 wherein the step of electrically stimulating further comprises stimulating at least during the beginning of an exhalation portion of an intrinsic breath of a patient.

13. The method of claim 9 wherein the step of identifying further comprises identifying a rest portion of the exhalation period of a breath and the step of electrically stimulating further comprises stimulating at least in part during an identified rest portion of the exhalation portion of the intrinsic breath of the patient.

14. The method of claim 9 wherein the step of electrically stimulating comprises stimulating for a duration greater than an intrinsic respiration cycle.

15. The method of claim 9 wherein the step of electrically stimulating comprises stimulating intermittently on a periodic basis.

16. The method of claim 9 wherein the step of electrically stimulating further comprises stimulating during all of a respiratory cycle.

17. The method of claim 9 further comprising electrically stimulating such that tidal volume or minute ventilation is reduced and a partial pressure of CO₂ is increased.

18. A method of treating a subject comprising:

providing an electrode configured to stimulate tissue associated with respiration of a subject to cause a diaphragm response and a stimulator in electrical communication with the electrode;

sensing respiration and identifying a portion of a respiratory cycle, including an exhalation period of a breath in the subject detected internally within the subject'"'"'s body;

detecting via a processor for a characteristic indicative of a disordered respiratory event from the internally sensed respiration;

comparing the sensed respiration against a predetermined threshold; and

,

when the characteristic is detected, electrically stimulating tissue associated with respiration of the diaphragm at least in part at the end of an identified exhalation period, where a waveform of the stimulation is provided in response to the sensed respiration to provide a relative increase in lung volume at an end portion of exhalation.

19. The method of claim 18 wherein the step of electrically stimulating further comprises stimulating to increase a tidal volume during an inspiration with respect to a normal intrinsic inspiration tidal volume so that there is a relative increase in lung volume at the end of exhalation.

20. The method of claim 18 wherein the step of identifying further comprises identifying a rest portion of the exhalation period of a respiratory cycle and the step of electrically stimulating further comprises stimulating during an identified rest period of a respiration cycle.

21. The method of claim 18 wherein the step of identifying further comprises identifying intrinsic inspiration and the step of electrically stimulating further comprises stimulating to increase an inspiration duration with respect to an intrinsic inspiration duration.

22. The method of claim 18 wherein the step of identifying further comprises identifying intrinsic inspiration and the step of electrically stimulating further comprises increasing the ratio of the inspiration duration to the exhalation duration with respect to an intrinsic inspiration duration and exhalation duration.