Device and method of neuromodulation to effect a functionally restorative adaption of the neuromuscular system

• US 8,428,726 B2
• Filed: 01/20/2010
• Issued: 04/23/2013
• Est. Priority Date: 10/30/2007
• Status: Active Grant

• Current Assignee: Synapse Biomedical Inc.
• Original Assignee: Synapse Biomedical Inc.
• Inventors: Ignagni, Anthony R., Onders, Raymond P.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US12/690,410
• Publication Number:
  US 20100198296A1
• Time in Patent Office: 1,189 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 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

Described herein are methods and systems for improving or adapting a breathing pattern of a patient with disordered breathing toward a more helpful state, as well as systems and devices for adapting breathing. These methods and systems may be used for improving sleep in patients with sleep disordered breathing and a system by which to implement devices for performing these methods.

Claims

1. A method for adapting a breathing pattern of a patient with disordered breathing toward a more healthful state to improve sleep, the method comprising:

implanting a neurostimulatory device in a diaphragm of the patient;

stimulating the diaphragm with the neurostimulatory device to establish an automatic, reflexive, or synchronized breathing mechanism;

evaluating the patient'"'"'s diaphragm by electromyographic (EMG) methodology to determine an effectiveness of establishment of the automatic, reflexive, or synchronized breathing mechanism;

evaluating the patient by polysomnographic (PSG) methodology to assess diminishment of sleep disordered breathing; and

using one or more of the evaluation by EMG methodology and the evaluation by PSG methodology to adapt the breathing pattern of the patient by modulating the stimulation of the diaphragm.

2. The method of claim 1 further comprising determining onset of sleep.

3. The method of claim 2, wherein determining onset of sleep includes monitoring a level of one or more physiological parameters.

4. The method of claim 3 further comprising determining when the level of one or more physiological parameters falls below a threshold value.

5. The method of claim 4, wherein the one or more physiological parameters is selected from the group consisting of a diaphragm EMG, an EEG and body movement.

6. The method of claim 1 further comprising:

determining a movement threshold intensity, wherein the movement threshold intensity is a stimulation intensity when diaphragm movement is visualized or palpated; and

waiting for a predetermined sleep onset time before ramping the stimulation intensity up to a movement threshold intensity.

7. A method for adapting a breathing pattern of a patient with disordered breathing toward a more healthful state to improve sleep, the method comprising:

implanting a neurostimulatory device in a diaphragm of the patient;

stimulating the diaphragm with the neurostimulatory device to establish an automatic, reflexive, or synchronized breathing mechanism;

evaluating the patient'"'"'s diaphragm by electromyographic (EMG) methodology to determine an effectiveness of establishment of the automatic, reflexive, or synchronized breathing mechanism;

using the evaluation by EMG methodology to adapt the breathing pattern of the patient by modulating the stimulation of the diaphragm;

determining onset of sleep;

determining a sensory threshold intensity, wherein the sensory threshold intensity is a stimulation intensity where the patient first senses that stimulation is being applied; and

ramping the stimulation intensity up to the sensory threshold intensity before onset of sleep.

8. The method of claim 7 further comprising:

determining a movement threshold intensity, wherein the movement threshold intensity is the stimulation intensity when diaphragm movement is visualized or palpated; and

ramping the stimulation intensity up to the movement threshold intensity after onset of sleep.

9. The method of claim 8 further comprising synchronizing the patient'"'"'s natural breathing rate with a rate being paced by an electronic signal generator.

10. The method of claim 9 further comprising:

determining a function threshold intensity, wherein the functional threshold intensity is a stimulation intensity that elicits inspiration at a level that is sufficient to functionally ventilate the patient during sleep; and

ramping the stimulation intensity up to the function threshold intensity after the patient'"'"'s breathing rate is synchronized with the rate being paced by the electronic signal generator.

11. The method of claim 10 wherein ramping up stimulation intensity comprises increasing pulse duration.

12. The method of claim 10 wherein ramping up stimulation intensity comprises increasing pulse intensity.

13. The method of claim 10 wherein ramping up stimulation intensity comprises increasing pulse duration and pulse intensity.

14. The method of claim 10 further comprising detecting an apneic event, wherein the apneic event occurs when at least about 10 seconds has elapsed since the previous inspiration.

15. The method of claim 14 further comprising delivering stimulation at the functional threshold intensity upon the detection of the apneic event.

16. A method for adapting a breathing pattern of a patient with disordered breathing toward a more healthful state to improve sleep, the method comprising:

implanting a neurostimulatory device in a diaphragm of the patient;

stimulating the diaphragm with the neurostimulatory device to establish an automatic, reflexive, or synchronized breathing mechanism;

evaluating the patient'"'"'s diaphragm by electromyographic (EMG) methodology to determine an effectiveness of establishment of the automatic, reflexive, or synchronized breathing mechanism;

using the evaluation by EMG methodology to adapt the breathing pattern of the patient by modulating the stimulation of the diaphragm;

determining a movement threshold intensity, wherein the movement threshold intensity is a stimulation intensity when diaphragm movement is visualized or palpated; and

waiting for a predetermined sleep onset time before ramping the stimulation intensity up to a movement threshold intensity, wherein the predetermined sleep onset time is selected from the group consisting of approximately 5 minutes, 10 minutes, 20 minutes and 30 minutes.

17. A method for adapting a breathing pattern of a patient with disordered breathing toward a more healthful state to improve sleep, the method comprising:

initiating a sleep onset process prior to onset of sleep, wherein the sleep onset process comprises ramping a stimulation to a first level that does not exceed a level at which sleep is interrupted;

determining onset of sleep;

stimulating a diaphragm of the patient in a therapeutic regime after onset of sleep by gradually ramping the stimulation over time to reach a steady state level of stimulation to establish an automatic, reflexive, or synchronized breathing mechanism;

evaluating the patient'"'"'s diaphragm by electromyographic (EMG) methodology to determine an effectiveness of establishment of the automatic, reflexive, or synchronized breathing mechanism; and

using the evaluation by EMG methodology to adapt the breathing pattern of the patient by modulating the stimulation of the diaphragm.

18. A method for adapting a breathing pattern of a patient with disordered breathing toward a more healthful state to improve sleep, the method comprising:

initiating a sleep onset process prior to onset of sleep, wherein the sleep onset process comprises ramping a diaphragm stimulation to a first level that does not exceed a level at which sleep is interrupted;

determining onset of sleep; and

stimulating a diaphragm of the patient in a therapeutic regime after onset of sleep by gradually ramping the stimulation over time to reach a steady state level of stimulation.