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

• US 9,138,580 B2
• Filed: 04/23/2013
• Issued: 09/22/2015
• 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): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US13/868,848
• Publication Number:
  US 20130238053A1
• Time in Patent Office: 882 Days
• Field of Search: None
• US Class Current: 1/1
• 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 to entrain breathing in a patient, the method comprising repetitively applying low-levels of physiologically normal stimulation to establish a baseline automatic function, wherein the low-levels of physiologically normal stimulation are applied below the patient'"'"'s movement and sensory threshold to establish an automatic baseline pacing level while the patient is asleep.

2. The method of claim 1, further comprising implanting one or more electrodes in the patient'"'"'s diaphragm, wherein the low-levels of physiologically normal stimulation are applied through the one or more electrodes.

3. The method of claim 2, wherein the one or more electrodes are configured for permanent placement in the patient'"'"'s diaphragm.

4. The method of claim 2, wherein the one or more electrodes are configured for temporary placement in the patient'"'"'s diaphragm.

5. The method of claim 1, wherein the patient is suffering from daytime hypoventilation.

6. The method of claim 1, wherein the patient is suffering from temporarily compromised breathing.

7. The method of claim 6, wherein the temporarily compromised breathing is the result of respiratory arrest.

8. The method of claim 1, wherein the low-levels of physiologically normal stimulation are applied while the patient is sleeping.

9. The method of claim 1, further comprising stimulating the patient'"'"'s diaphragm above the movement threshold while the patient is asleep after the automatic baseline pacing level is established.

10. The method of claim 9, further comprising stimulating the patient'"'"'s diaphragm while the patient is awake to establish an automatic breathing mechanism.

11. The method of claim 10, further comprising evaluating the patient'"'"'s diaphragm by EMG to determine the effectiveness of the establishment of the automatic breathing mechanism.

12. A method of entraining breathing in a patient, the method comprising:

identifying a patient suffering from or at risk of daytime hypoventilation;

stimulating the patient'"'"'s diaphragm by applying stimulation below the patient'"'"'s movement and sensory threshold to establish an automatic baseline pacing level;

stimulating the patient'"'"'s diaphragm by applying stimulation above the patient'"'"'s movement threshold after the automatic baseline pacing level has been established; and

establishing an automatic breathing mechanism.

13. The method of claim 12, wherein the stimulation below the patient'"'"'s movement and sensory threshold is applied while the patient is sleeping.

14. The method of claim 12, wherein the stimulation above the patient'"'"'s movement threshold is applied while the patient is sleeping.

15. A method of entraining breathing in a patient, the method comprising:

stimulating the patient'"'"'s diaphragm while the patient is asleep by applying stimulation below the patient'"'"'s movement and sensory threshold to establish an automatic baseline pacing level;

stimulating the patient'"'"'s diaphragm while the patient is asleep by applying stimulation above the patient'"'"'s movement threshold after the automatic baseline pacing level has been established; and

establishing an automatic breathing mechanism.

16. The method of claim 15, further comprising stimulating the patient'"'"'s diaphragm while the patient is awake by applying stimulation above the patient'"'"'s movement threshold after the automatic baseline pacing level has been established.