Therapeutic diaphragm stimulation device and method

• US 8,140,164 B2
• Filed: 10/31/2007
• Issued: 03/20/2012
• 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., Province, Rose, Schwartz, Alan, Hillman, David, Eastwood, Peter, Ligon, David, Lee, Chang, Hoffmann, Drew, Goodman, Amy Michelle
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Alter, Alyssa M
• Application Number:
  US11/981,342
• Publication Number:
  US 20080167695A1
• Time in Patent Office: 1,602 Days
• Field of Search: 607/42, 600/529
• 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 for treating a variety of conditions, disorders or diseases with diaphragm/phrenic nerve stimulation is provided.

Claims

1. A method for providing therapeutic electrical stimulation to improve gas exchange in a patient, comprising:

identifying the patient having intrinsic respiration; and

,

applying electrical stimulation pulses targeted to diaphragm or phrenic nerve tissue of the patient at a stimulation frequency greater than a frequency of an intrinsic respiration rate at a pulse energy and frequency effective to induce a plurality of twitch contractions in the diaphragm which result in flow oscillations during a single intrinsic breath and where the flow oscillations are superimposed upon the intrinsic breath.

2. The method of claim 1 further comprising stiffening an airway of the patient prior to or while applying electrical stimulation pulses targeted to diaphragm or phrenic nerve tissue.

3. The method of claim 2 wherein stiffening an airway comprises applying an electrical stimulation to a hypoglossal nerve.

4. The method of claim 1 wherein identifying comprises identifying a patient having at least one indication selected from upper airway resistance syndrome, chronic obstructive pulmonary disease, asthma, lung injury, respiratory failure, heart failure, ventilatory instability, and sleep breathing disorders.

5. The method of claim 1 further comprising applying an electrical stimulation to open or preserve airway patency while applying electrical stimulation pulses targeted to diaphragm or phrenic nerve tissue.

6. The method of claim 1 whereby gas exchange in the patient is improved by increasing a ventilated surface area of alveoli or bronchioles in at least one lung of the patient.

7. The method of claim 1 wherein the stimulation frequency has a rate of between 10 to 150 times greater than the frequency of the intrinsic respiration rate.

8. The method of claim 1 wherein the stimulation frequency has a rate of between 15 to 50 times greater than the frequency of the intrinsic respiration rate.

9. The method of claim 1 wherein the stimulation pulses elicit non-physiologic flow characteristics from the diaphragm such that gas exchange in the patient is improved.

10. The method of claim 1 wherein applying electrical stimulation pulses contracts the diaphragm at a rate of between 3 to 15 contractions per second.

11. The method of claim 1 wherein the stimulation frequency elicits flow oscillations such that gas exchange in the patient is increased.

12. The method of claim 1 wherein applying electrical stimulation pulses further comprises normalizing or increasing a functional residual capacity of a lung volume.

13. The method of claim 1 wherein applying electrical stimulation pulses comprises applying the pulses transvenously to the diaphragm or phrenic nerve tissue.

14. The method of claim 1 wherein applying electrical stimulation pulses comprises applying the stimulation during an inspiration of the patient.

15. The method of claim 1 wherein applying electrical stimulation pulses comprises applying the stimulation during an exhalation of the patient.

16. The method of claim 1 wherein applying electrical stimulation comprises applying the stimulation at a frequency greater than a frequency of an intrinsic respiration rate whereby a functional residual capacity is sustained or increased.

17. The method of claim 16 further comprising entraining a respiration of the patient whereby the stimulation pulses are applied at a rate greater than or equal to the intrinsic respiration rate until a length of the intrinsic respiration rate is lengthened.

18. The method of claim 16 further comprising applying a deep inspiration therapy to the patient whereby the one or more breaths are stimulated to have an inspiration duration greater than an inspiration duration during intrinsic respiration.