Method of improving sleep disordered breathing

• US 8,478,412 B2
• Filed: 10/30/2008
• Issued: 07/02/2013
• 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:
  US12/261,979
• Publication Number:
  US 20090118785A1
• Time in Patent Office: 1,706 Days
• Field of Search: 607/42
• US Class Current: 607/42
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A diaphragm pacing stimulatory method and a system to implement the method are provided to improve respiratory function and the quality of sleep in patients whose sleep is compromised by poor respiration. The diaphragm pacing method includes adaptations that make it particularly compatible with the onset of sleep and sustaining sleep. Embodiments of the method are operated independently of breathing effort the patient may make during sleep. Patients for whom the invention is appropriate include those with a neuromuscular disease, such as amyotrophic lateral sclerosis (ALS). System elements include an external electrical stimulator coupled to one or more implanted electrodes that stimulate diaphragm contraction. The system and method provide for a pacing of the diaphragm, improved breathing, and improved sleep. Features of improved sleep include longer sleep time, an increased amount of REM sleep, and fewer episodes of wakefulness and restlessness.

Claims

1. A method of improving sleep in a patient with a centrally mediated sleep disorder by using a system comprising an external stimulator and one or more electrodes configured for implantation in a diaphragm for stimulation of the diaphragm, the method comprising:

adapting stimulation parameters to support respiration during sleep,

stimulating the diaphragm in a therapeutic regimen with the one or more electrodes to support respiration after the onset of sleep, the regimen including the adapted stimulation parameters, the stimulation operating independently of any intrinsic respiratory effort of the patient, the stimulation comprising one or more stimulation pulses configured to initiate a breath and support the breath to completion; and

after implementing the therapeutic regimen, evaluating the patient again for presence of sleep disordered breathing by any one or more diagnostic criteria including morning headaches, daytime sleepiness, polysomnography (PSG) recordings consistent with disordered sleep, diaphragm electromyography (EMG) recordings during sleep consistent with disordered sleep, or pulmonary function test data consistent with disordered sleep.

2. The method of claim 1 comprising, prior to the adapting and stimulating steps, diagnosing the patient as having a neuromuscular disease.

3. The method of claim 2 further comprising diagnosing the patient as having amyotrophic lateral sclerosis (ALS).

4. The method of claim 1 comprising, prior to the adapting and stimulating steps, identifying the patient as being at risk for sleep disordered breathing.

5. The method of claim 4 wherein the patient at risk is any of an ICU patient or a post-surgical patient.

6. The method of claim 5 wherein the post-surgical patient at risk has undergone a bariatric procedure.

7. The method of claim 1 comprising, prior to the adapting and stimulating steps, identifying the patient as having an upper motor neuron dysfunction that results in temporary or permanent diaphragm paralysis.

8. The method of claim 1 comprising, prior to the adapting and stimulating steps, implanting one or more electrodes in the diaphragm of the patient.

9. The method of claim 1 comprising, prior to the adapting and stimulating steps, diagnosing the patient as having sleep-disordered breathing by any one or more criteria including morning headaches, daytime sleepiness, PSG recordings consistent with disordered sleep, diaphragm EMG recordings during sleep consistent with disordered sleep, or pulmonary function testing data consistent with disordered sleep.

10. The method of claim 9, in the event that sleep-disordered breathing is found, further comprising diagnosing the patient'"'"'s sleep sleep-disordered breathing as being centrally-mediated.

11. The method of claim 1 wherein adapting stimulation parameters includes determining any one or more of an appropriate time interval after the onset of sleep to lapse prior to initiating stimulation, a threshold level of stimulation sufficiently low so as to allow onset of sleep, a threshold level of stimulation sufficient to stimulate diaphragm contraction, or a threshold level sufficient to support breathing during sleep.

12. The method of claim 1 further comprising monitoring the EMG of the patient during the therapeutic regimen.

13. The method of claim 1, wherein stimulating the diaphragm in a therapeutic regimen after the onset of sleep comprises waiting for a period of time after the onset of sleep before initiating stimulation.

14. The method of claim 1, wherein stimulating the diaphragm in a therapeutic regimen comprises gradually ramping the stimulation over time to a reach a steady state level of stimulation.

15. The method of claim 1, wherein the stimulation is configured to elicit a fused contraction of the diaphragm.

16. The method of claim 1, wherein the stimulation comprises one or more stimulation pulses configured to increase inspiratory pressure in order to increase breath volume.

17. The method of claim 1, further comprising determining whether a predetermined sleep onset time has been reached.

18. A method of improving sleep in a patient with a centrally mediated sleep disorder by using a system comprising an external stimulator and one or more electrodes configured for implantation in a diaphragm for stimulation of the diaphragm, the method comprising:

adapting stimulation parameters to support respiration during sleep,

stimulating the diaphragm in a therapeutic regimen with the one or more electrodes to support respiration after the onset of sleep, the regimen including the adapted stimulation parameters, the stimulation operating independently of any intrinsic respiratory effort of the patient, the stimulation comprising one or more stimulation pulses configured to initiate a breath and support the breath to completion; and

in the event of a finding of continued presence of sleep-disordered breathing, revising the adapted stimulation parameters, and implementing a revised therapeutic regimen for the patient based on the revised parameters, the regimen comprising stimulating the diaphragm with the one or more electrodes to support respiration.

19. A method of improving sleep in a patient with a centrally mediated sleep disorder by using a system comprising an external stimulator and one or more electrodes configured for implantation in a diaphragm for stimulation of the diaphragm, the method comprising:

adapting stimulation parameters to support respiration during sleep,

stimulating the diaphragm in a therapeutic regimen with the one or more electrodes to support respiration after the onset of sleep, the regimen including the adapted stimulation parameters, the stimulation operating independently of any intrinsic respiratory effort of the patient, the stimulation comprising one or more stimulation pulses configured to initiate a breath and support the breath to completion; and

wherein the stimulating the diaphragm after onset of sleep comprises determining the onset of sleep by monitoring a level of one or more physiological parameters and determining when they fall below a threshold value, the parameters including any of a diaphragm EMG, an EEG, or body movement.

20. A method of improving sleep in a patient with a centrally mediated sleep disorder by using a system comprising an external stimulator and one or more electrodes configured for implantation in a diaphragm for stimulation of the diaphragm, the method comprising:

adapting stimulation parameters to support respiration during sleep,

stimulating the diaphragm in a therapeutic regimen with the one or more electrodes to support respiration after the onset of sleep, the regimen including the adapted stimulation parameters, the stimulation operating independently of any intrinsic respiratory effort of the patient, the stimulation comprising one or more stimulation pulses configured to initiate a breath and support the breath to completion; and

detecting the onset of sleep and adapting the stimulation parameters in response to the detection of the onset of sleep.