System and method for diaphragm stimulation

• US 20050085867A1
• Filed: 10/15/2004
• Published: 04/21/2005
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Ligon, David, Tehrani, Amir J.
• Granted Patent: US 8,200,336 B2
• Time in Patent Office: Days
• 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 stimulation device is provided that stimulates breathing to manipulate blood gas concentrations such as SaO₂ or PCO₂ and thereby treat underlying causes of breathing disorders and heart failure progression. A programmable device is provided for setting diaphragm stimulation waveforms that adjust minute ventilation about a predetermined baseline value. Normal breathing of the subject is observed to establish a baseline reference minute ventilation, and the device is programmed to produce stimulation waveforms that may provide either a decrease or an increase in the patients minute ventilation. The minute ventilation of the subject may be decreased or increased from the baseline level by decreasing or increasing a parameter that changes minute ventilators.

Claims

1. A system for diaphragm stimulation comprising:

a programmable stimulation device for stimulating a diaphragm;

a flow sensor configured to sense a respiratory tidal volume;

a programmer configured to be coupled to said flow sensor and to said programmable stimulation device; and

wherein said programmable stimulation device is programmed by said programmer to provide a stimulation waveform to said diaphragm corresponding to a normal respiratory tidal volume sensed by said flow sensor.

2. The system of claim 1, wherein said programmable stimulation device is programmed by said programmer to provide a stimulation waveform to said diaphragm corresponding to respiratory tidal volume that is less than said normal tidal volume.

3. The system of claim 1, wherein said programmable stimulation device is programmed by said programmer to provide a stimulation waveform to said diaphragm corresponding to respiratory tidal volume that is greater than said normal tidal volume.

4. The system of claim 1, further comprising a gas sensor configured to be coupled to said programmer.

5. The system of claim 1, wherein said programmable stimulation device is programmed by said programmer to provide a stimulation waveform to said diaphragm corresponding to a normal inspiration duration associated with a normal respiratory rate.

6. The system of claim 1, wherein said programmable stimulation device is programmed by said programmer to provide a stimulation waveform to said diaphragm corresponding to an inspiration duration associated with a decreased respiratory rate.

7. The system of claim 1, wherein said programmable stimulation device is programmed by said programmer to provide a stimulation waveform to said diaphragm corresponding to an inspiration duration associated with an increased respiratory rate.

8. A system for diaphragm stimulation comprising:

a programmable stimulation device configured to stimulate a diaphragm, wherein said programmable stimulation device is programmed to deliver a stimulation waveform to said diaphragm during exhalation.

9. The system of claim 8, wherein said stimulation waveform comprises an inspiration stimulus and an exhalation bias waveform.

10. The system of claim 9, wherein said exhalation bias waveform comprises a negative ramp.

11. A method for providing a decreased minute ventilation in a subject with a programmable stimulation device coupled to a diaphragm, said method comprising:

observing a normal tidal volume and a normal respiratory rate of said subject;

determining stimulation waveform parameters for producing a normal respiratory rate and a decreased tidal volume in said subject;

storing said stimulation waveform parameters in said programmable device; and

applying a waveform stimulus to said diaphragm wherein said waveform stimulus is characterized by said stimulation waveform parameters.

12. A method for providing an increased minute ventilation in a subject with a programmable stimulation device coupled to a diaphragm, said method comprising:

observing a normal tidal volume and a normal respiratory rate of said subject;

determining stimulation waveform parameters for producing a normal respiratory rate and an increased tidal volume in said subject;

storing said stimulation waveform parameters in said programmable device; and

applying a waveform stimulus to said diaphragm wherein said waveform stimulus is characterized by said stimulation waveform parameters.

13. A method for providing an increased minute ventilation in a subject with a programmable stimulation device coupled to a diaphragm, said method comprising:

observing a normal tidal volume and a normal respiratory rate of said subject;

determining stimulation waveform parameters for producing an increased respiratory rate and a normal tidal volume in said subject;

storing said stimulation waveform parameters in said programmable device; and

applying a waveform stimulus to said diaphragm wherein said waveform stimulus is characterized by said stimulation waveform parameters.

14. A method for providing a decreased minute ventilation in a subject with a programmable stimulation device coupled to a diaphragm, said method comprising:

observing a normal tidal volume and a normal respiratory rate of said subject;

determining stimulation waveform parameters for producing a decreased respiratory rate and a normal tidal volume in said subject;

storing said stimulation waveform parameters in said programmable device; and

applying a waveform stimulus to said diaphragm wherein said waveform stimulus is characterized by said stimulation waveform parameters.

15. A method for establishing a baseline minute ventilation for a subject with an implanted programmable diaphragm stimulation device, said method comprising:

attaching a flow sensor to said subject;

observing a normal tidal volume and a normal respiratory rate;

measuring and storing data concerning the respiration of said subject; and

determining a normal inspiration duration.

16. The method of claim 15, wherein said observing a normal tidal volume and normal respiratory rate of said subject comprises interacting with said subject while said subject is in a waking state.

17. The method of claim 15, wherein said observing a normal tidal volume and normal respiratory rate of said subject comprises observing said subject while said subject is in a sleeping state.

18. The method of claim 15, further comprising collecting respiratory gas composition data.

19. The method of claim 15, wherein said determining a normal inspiration duration comprises calculating an average.

20. The method of claim 15, further comprising collecting blood gas composition data.

21. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing;

wherein the signal source is configured to control at least one parameter corresponding to minute ventilation to change minute ventilation with respect to a baseline minute ventilation.

22. The device of claim 21, wherein the signal source is configured to increase minute ventilation with respect to the baseline minute ventilation.

23. The device of claim 21, wherein the signal source is configured to decrease minute ventilation with respect to the baseline minute ventilation.

24. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing;

wherein the signal source is configured to control at least one respiration parameter to manipulate a subject'"'"'s blood PCO₂ level.

25. A respiration stimulation device comprising:

at least one electrode configured to be coupled to tissue of a subject;

a signal source coupled to the electrode and configured to deliver a stimulation signal to the tissue to control breathing;

wherein the signal source is configured to control at least one respiration parameter to manipulate a subject'"'"'s blood SaO₂ level.