Multimode device and method for controlling breathing

• US 8,160,711 B2
• Filed: 06/29/2006
• Issued: 04/17/2012
• 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, Lee, Chang, Province, Rose, Goodman, Amy Michelle
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US11/480,074
• Publication Number:
  US 20060247729A1
• Time in Patent Office: 2,119 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 therapeutic stimulating, augmenting, manipulating and/or controlling breathing, in combination with stimulation of auxiliary respiratory nerves or muscles including the upper airway tract, chest wall muscles or abdominal muscles. Stimulation may be provided, for example, to augment breathing or to prevent closing of the upper airway during therapeutic stimulation. Stimulation may be also provided to the Hypoglossal nerve during exhalation.

Claims

1. A device for manipulating breathing of a subject comprising:

a phrenic nerve and/or diaphragm tissue stimulation element comprising at least a first electrode;

an upper airway stimulation element comprising at least a second electrode;

a controller in communication with the first and second electrodes and programmed to supply a first stimulation signal through the first electrode during at least one existing breath to a phrenic nerve and/or diaphragm tissue to elicit a diaphragm response without initiating a new breath during a respiratory cycle of the subject having intrinsic respiration and to further supply a second stimulation signal through the second electrode during at least one existing breath to tissue associated with an upper airway of the subject during said respiratory cycle to elicit a response of an upper airway musculature; and

,

a sensor in communication with the controller, wherein the sensor is configured to detect at least one parameter of the respiratory cycle,

wherein the controller is further programmed to coordinate the first and second stimulation signals provided by the phrenic nerve and/or diaphragm tissue stimulation element and upper airway stimulation element with respect to each other to supply diaphragm stimulation and upper airway stimulation such that the breath is supplemented, and

wherein the controller is also programmed to adjust a waveform of the first stimulation signal in response to the sensed parameter of the respiratory cycle.

2. The device of claim 1 wherein the controller is further programmed to stimulate the upper airway via the upper airway stimulation element during a first respiratory cycle prior to inspiration of a next respiratory cycle.

3. The device of claim 2 wherein the controller is further programmed to stimulate the upper airway via the upper airway stimulation element during an exhalation cycle of a first respiratory cycle prior to inspiration of the next respiratory cycle.

4. The device of claim 3 wherein the controller is further programmed to provide the first stimulation signal via the phrenic nerve and/or diaphragm tissue stimulation element to stabilize an airway and a subsequent stimulation signal via the phrenic nerve and/or diaphragm tissue stimulation element.

5. The device of claim 4 wherein the controller is further programmed to provide an increased lung volume beyond a baseline via the phrenic nerve and/or diaphragm tissue stimulation element.

6. The device of claim 1 wherein the controller is further programmed to provide stimulation via the phrenic nerve and/or diaphragm tissue stimulation element to supplement an intrinsic breath of said next respiratory cycle.

7. The device of claim 1 wherein the controller is further programmed to increase a functional residual capacity of the subject by providing a stimulation via the phrenic nerve and/or diaphragm tissue stimulation element while stiffening the airway.

8. The device of claim 1 wherein the controller is further programmed to provide stimulation via the diaphragm stimulation element to augment or supplement a tidal volume of the intrinsic respiration of a subsequent respiratory cycle.

9. The device of claim 1 wherein the controller is further programmed to provide stimulation via the phrenic nerve and/or diaphragm tissue stimulation element to increase lung volume.

10. A device for manipulating breathing of a subject comprising:

a phrenic nerve and/or diaphragm tissue stimulation element comprising at least a first electrode;

an upper airway stimulation element comprising at least a second electrode;

a controller in communication with the first and second electrodes and programmed to supply a low-level stimulation signal through the first electrode during at least one existing breath to a phrenic nerve and/or diaphragm tissue of the subject having intrinsic respiration to elicit a diaphragm response without initiating a new breath and to further supply a stimulation signal through the second electrode during at least one existing breath to tissue associated with an upper airway of the subject to elicit a response of an upper airway musculature; and

,

a sensor in communication with the controller, wherein the sensor is configured to detect at least one parameter of the respiratory cycle,

wherein the controller is further programmed to coordinate the first and second stimulation signals provided by the phrenic nerve and/or diaphragm tissue stimulation element and upper airway stimulation element with respect to each other to supply diaphragm stimulation and upper airway stimulation such that the functional residual capacity is supplemented, and

wherein the controller is also programmed to adjust a waveform of the first stimulation signal in response to the sensed parameter of the respiratory cycle.

11. The device of claim 10 wherein the controller is further programmed to supply an electrical stimulation signal via the upper airway stimulation element during an exhalation portion of a first respiratory cycle prior to an inspiration portion of an inspiration portion of a next respiratory cycle.

12. The device of claim 10 wherein the controller is further programmed to provide the low-level stimulation signal via the phrenic nerve and/or diaphragm tissue stimulation element to stabilize an airway and a subsequent stimulation signal via the phrenic nerve and/or diaphragm tissue stimulation element to elicit a breath.

13. A device for manipulating breathing of a subject comprising:

a phrenic nerve and/or diaphragm tissue stimulation element comprising at least a first electrode;

an auxiliary stimulation element comprising at least a second electrode;

a controller in communication with the first and second electrodes and programmed to supply a stimulation signal through the first electrode during at least one existing breath to a phrenic nerve and/or diaphragm tissue of the subject having intrinsic respiration to elicit a diaphragm response without initiating a new breath during a respiratory cycle of the subject and to further supply a stimulation signal through the second electrode during at least one existing breath to tissue associated with an auxiliary musculature associated with the subject'"'"'s respiratory system during said respiratory cycle to elicit an auxiliary response of the auxiliary musculature; and

,

a sensor in communication with the controller, wherein the sensor is configured to detect at least one parameter of the respiratory cycle,

wherein the controller is further programmed to coordinate the first and second stimulation signals provided by the phrenic nerve and/or diaphragm tissue stimulation element and auxiliary stimulation element with respect to each other to supply diaphragm stimulation and auxiliary stimulation such that the breath is augmented, and

wherein the controller is also programmed to adjust a waveform of the first stimulation signal in response to the sensed parameter of the respiratory cycle.

14. A method for manipulating breathing of a subject comprising the steps of:

providing a phrenic nerve and/or diaphragm tissue stimulation element comprising at least a first electrode and an upper airway stimulation element comprising at least a second electrode;

monitoring a respiratory parameter of the subject;

supplying a first stimulation signal through the first electrode during an existing breath to a phrenic nerve and/or diaphragm tissue of the subject to elicit a diaphragm response without initiating a new breath during intrinsic respiration of the subject, wherein the first stimulation signal has a waveform which elicits the diaphragm response and which is adjusted in response to the monitored respiratory parameter;

supplying a second stimulation signal through the second electrode during the existing breath to tissue associated with an upper airway of the subject to elicit a response of an upper airway musculature; and

coordinating the first and second stimulation signals respectively provided by the diaphragm stimulation element and upper airway stimulation element to avoid upper airway collapse during diaphragm stimulation such that the breath is supplemented.

15. A method for manipulating breathing of a subject comprising the steps of:

providing a phrenic nerve and/or diaphragm tissue stimulation element comprising at least a first electrode and an upper airway stimulation element comprising at least a second electrode;

monitoring a respiratory parameter of the subject;

supplying a first stimulation signal through the first electrode during an existing breath to a phrenic nerve and/or diaphragm tissue of the subject to elicit a diaphragm response without initiating a new breath during intrinsic respiration of the subject, wherein the first stimulation signal has a waveform which elicits the diaphragm response and which is adjusted in response to the monitored respiratory parameter;

supplying a second stimulation signal through the second electrode during the existing breath to tissue associated with an upper airway of the subject to elicit a response of an upper airway musculature; and

stimulating the upper airway musculature during an exhalation cycle of a first respiratory cycle prior to an inspiration portion of a next respiratory cycle.

16. The method of claim 15 wherein the step of supplying a first stimulation signal comprises eliciting the diaphragm response by augmenting an intrinsic breath.

17. The method of claim 16 wherein the step of augmenting an intrinsic breath comprises augmenting the breath during said next respiration cycle.

18. The method of claim 15 wherein the step of supplying a first stimulation signal comprises eliciting the diaphragm response by providing a lung volume bias stimulation without eliciting a respiratory cycle.

19. A method for manipulating breathing of a subject comprising the steps of:

providing a phrenic nerve and/or diaphragm tissue stimulation element comprising at least a first electrode and an auxiliary stimulation element comprising at least a second electrode;

monitoring a respiratory parameter of the subject;

supplying a first stimulation signal through the first electrode during an existing breath to a phrenic nerve and/or diaphragm tissue to elicit a diaphragm response without initiating a new breath during a respiratory cycle of the subject having intrinsic respiration, wherein the first stimulation signal has a waveform which elicits the diaphragm response and which is adjusted in response to the monitored respiratory parameter;

supplying a second stimulation signal through the second electrode during the existing breath to tissue associated with an auxiliary musculature associated with the subject'"'"'s respiratory system during said respiratory cycle to elicit an auxiliary response of an auxiliary musculature; and

coordinating the first and second stimulation signals respectively provided by the diaphragm stimulation element and auxiliary stimulation element with respect to each other such that the breath is augmented.

20. The method for manipulating breathing of claim 19 wherein the step of coordinating the first and second stimulation signals comprises coordinating the diaphragm stimulation with one or more of upper airway stimulation, chest wall stimulation and abdominal stimulation.