Method of detecting sleep apnea and treatment thereof

• US 8,359,097 B2
• Filed: 01/25/2011
• Issued: 01/22/2013
• Est. Priority Date: 10/01/2001
• Status: Active Grant

• Current Assignee: Eckhard Alt, Maik Gollasch
• Original Assignee: Eckhard Alt, Maik Gollasch
• Inventors: Alt, Eckhard, Gollasch, Maik
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US12/931,152
• Publication Number:
  US 20110190642A1
• Time in Patent Office: 728 Days
• Field of Search: 607/3, 607/17, 607/18, 607/20, 607/35
• US Class Current: 607/20
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36128 Control systems

Abstract

A method is presented for evaluating whether an episode of sleep apnea is occurring in a patient suffering from chronic sleep apnea disorder, for delivery of appropriate therapy. The method, performed by an implantable device, includes sensing the patient'"'"'s EKG signal and using electrical energy generated by the heart to power subsequent signal processing. This signal is applied as the sole input to a differential signal processing circuit for passage through both a high impedance path and a substantially lower impedance path and amplification of the difference in magnitude between the resulting two signals, to determine changes in the patient'"'"'s thoracic impedance. Based on such changes, the presence or absence of patient ventilation is detected, to enable an assessment of whether an episode of sleep apnea is occurring. An actual episode of sleep apnea is deemed to have occurred if lack of ventilation exceeds a predetermined interval of time between otherwise regular respiratory cycles. If sleep apnea is indicated, the appropriate therapy is delivered by the device to induce ventilation and halt the apnea episode.

Claims

1. A method of detecting sleep apnea in a patient, which comprises the steps of:

sensing an EKG signal generated by the patient'"'"'s heart, amplifying the sensed EKG signal in separate paths of high input impedance and of considerably lower impedance to produce two different signals, and differentially amplifying said two signals to detect changes in the patient'"'"'s ventilation, to identify the absence of ventilation as a potential episode of sleep apnea.

2. The method of claim 1, including:

sensing consecutive respiration cycles from said detected changes of patient ventilation;

establishing a predetermined escape interval of time between pairs of successive respiration cycles and resetting said escape interval upon sensing each respiration cycle, for detecting a sustained absence of ventilation upon expiration of a said escape interval without having detected a next following respiration cycle, as indicative of an actual episode of sleep apnea; and

delivering electrical stimulation therapy to restore patient ventilation in response to said indication of an actual episode of sleep apnea.

3. The method of claim 2, including:

delivering said electrical stimulation therapy to the patient'"'"'s phrenic nerve in response to said indication of an actual episode of sleep apnea, to initiate diaphragmatic pacing and restoration of patient ventilation.

4. The method of claim 3, including:

sensing said EKG signal in the immediate vicinity of the site at which said electrical stimulation is to be applied to the phrenic nerve.

5. The method of claim 4, including:

using at least one of the same electrode for both said sensing and said stimulation.

6. The method of claim 2, wherein:

said episode of sleep apnea is of a type among central sleep apnea (CSA), Cheyne-Stokes Respiration (CSR)-induced apnea, and obstructive sleep apnea (OSA), and including;

distinguishing between an episode of CSA/CSR as constituting one type for treatment purposes and an episode of OSA as constituting another type for treatment purposes, and delivering said electrical stimulation therapy in a manner according to which of said one type and said another type is present in said episode.

7. The method of claim 6, including:

distinguishing an episode of CSA/CSR type from an episode of OSA type of sleep apnea disorder by sensing whether phrenic nerve signals are absent or present, respectively.

8. The method of claim 7, wherein:

said sleep apnea disorder is of CSA/CSR type, and

said therapy comprises stimulating the patient'"'"'s phrenic nerve with electrical pulses in a pattern to produce diaphragmatic pacing for restoration of proper respiration.

9. The method of claim 8, including:

applying said stimulation pulses to both sides of the phrenic nerve sufficiently removed from the site of the heart to avoid interference with heart function.

10. The method of claim 7, wherein:

said sleep apnea disorder is of OSA type, and

said therapy comprises stimulating muscle adjacent a projection of the soft palate from the throat of the patient in a stimulation pattern toward toning of said muscle to at least partially remove obstruction of the respiratory airway by the soft palate, and thereby restore more normal respiration.

11. The method of claim 1, including:

providing said separate paths by alternately shunting said high input impedance path with said considerably lower input impedance path at a relatively high switching rate predetermined to provide sufficient resolution to detect patient ventilation and said changes therein.

12. The method of claim 1, including:

sensing said EKG signal at a site of the patient'"'"'s body remote from the site of the patient'"'"'s heart.

13. An implantable device-implemented method of evaluating whether an episode of sleep apnea is occurring in a patient, said method comprising the steps of:

sensing the electrical signal generated by the patient'"'"'s heart with the implanted device,

processing the sensed electrical signal as the sole input to signal processing circuitry of the implanted device to acquire separate high and low input impedance signals therefrom, and differentially amplifying the high and low input impedance signals to determine ventilation of the patient to assess therefrom whether an episode of sleep apnea is occurring.

14. The device-implemented method of claim 13, including:

stimulating the patient'"'"'s phrenic nerve from the implanted device when the assessment indicates an episode of sleep apnea has commenced.

15. The device-implemented method of claim 13, wherein:

said processing of the sensed electrical signal includes continuously switching application thereof to a high input impedance path and a low input impedance path of said signal processing circuitry at a rate sufficiently rapid to detect patient ventilation and changes therein.

16. The device-implemented method of claim 13, including:

sensing said heart signals at a site of the body removed from the location of the heart.

17. The device-implemented method of claim 13, including:

detecting changes in the patient'"'"'s ventilation as determined, and identifying an absence of ventilation as a potential episode of sleep apnea.

18. The device-implemented method of claim 17, including:

sensing consecutive respiration cycles from said detected changes in patient ventilation;

establishing a predetermined escape interval of time between pairs of successive respiration cycles and resetting said escape interval upon sensing each respiration cycle;

detecting a sustained absence of ventilation upon expiration of a said escape interval without having detected a next following respiration cycle, as indicative of an actual episode of sleep apnea; and

delivering electrical stimulation therapy to restore patient ventilation in response to said indication of an actual episode of sleep apnea.

19. The device-implemented method of claim 18, including:

delivering said electrical stimulation therapy to the patient'"'"'s phrenic nerve in response to said indication of an actual episode of sleep apnea, to initiate diaphragmatic pacing and restoration of patient ventilation.

20. The device-implemented method of claim 19, including:

sensing said heart signals in the immediate vicinity of the site at which said electrical stimulation is to be applied to the phrenic nerve.

21. The device-implemented method of claim 20, including:

using at least one of the same electrode of said device for both said heart signal sensing and said phrenic nerve stimulation.

22. The device-implemented method of claim 18, wherein:

said episode of sleep apnea is of a type among central sleep apnea (CSA), Cheyne-Stokes Respiration (CSR)-induced apnea, and obstructive sleep apnea (OSA), and including;

distinguishing between an episode of CSA/CSR as constituting one type for treatment purposes and an episode of OSA as constituting another type for treatment purposes, and delivering said electrical stimulation therapy in a manner according to which of said one type and said another type is present in said episode.

23. The device-implemented method of claim 22, including:

distinguishing an episode of CSA/CSR type from an episode of OSA type of sleep apnea disorder by sensing whether phrenic nerve signals are absent or present, respectively.

24. The device-implemented method of claim 23, wherein:

said sleep apnea disorder is of CSA/CSR type, and

said therapy comprises stimulating the patient'"'"'s phrenic nerve with electrical pulses in a pattern to produce diaphragmatic pacing for restoration of normal patient respiration.

25. The device-implemented method of claim 20, including:

applying said stimulation pulses to both sides of the phrenic nerve sufficiently removed from the site of the heart to avoid interference with heart function.

26. The device-implemented method of claim 23, wherein:

said sleep apnea disorder is of OSA type, and

said therapy comprises stimulating muscle adjacent a projection of the soft palate from the throat of the patient in a stimulation pattern toward toning of said muscle to at least partially remove obstruction of the respiratory airway by the soft palate, and thereby restore normal patient respiration.

27. The device-implemented method of claim 17, including:

providing separate paths of high input impedance and of considerably lower impedance of said signal processing circuitry to acquire said separate signals in pairs from the sensed electrical signal generated by the patient'"'"'s heart; and

alternately shunting said high input impedance path with said considerably lower input impedance path at a relatively high switching rate predetermined to provide sufficient resolution to detect patient ventilation and said changes therein.

28. The device-implemented method of claim 13, including:

detecting changes in the patient'"'"'s ventilation as determined to confirm onset of an actual episode of sleep apnea, including;

analyzing said ventilation changes to detect successive respiratory cycles therefrom, and establishing an escape interval of time of sufficient sustained length between successive respiratory cycles to determine expiration of an escape interval without having detected the next respiratory cycle as signifying a lack of ventilation indicative of an actual episode of sleep apnea.

29. The device-implemented method of claim 28, including:

delivering electrical stimulation therapy to the patient'"'"'s phrenic nerve from the device in response to said indicated actual episode of sleep apnea, to induce resumption of normal ventilation by the patient.

30. The device-implemented method of claim 29, including

alternately sensing the patient'"'"'s heart signal and delivering the stimulation therapy at substantially the same site, remote from the patient'"'"'s heart, and

ceasing delivery of the stimulation therapy upon resumption of normal ventilation.

31. An implantable device-implemented method of detecting sleep apnea in a patient for delivery of therapy to disrupt the detected sleep apnea, which comprises the steps of:

sensing the patient'"'"'s EKG signal,

alternately applying the sensed signal to a high input impedance path and a considerably lower input impedance path continuously at a relatively rapid switching rate for sufficient resolution to detect patient ventilation and changes therein, and to produce consecutive pairs of signals of different amplitude, and

determining the difference in amplitude between signals of each of said signal pairs by differential processing thereof to detect patient ventilation and changes therein, including the presence or absence of ventilation, to identify commencement of an episode of sleep apnea.

32. The device-implemented method of claim 31, including:

confirming onset of an actual episode of sleep apnea by analyzing said ventilation changes to detect successive respiratory cycles therefrom, establishing an escape interval of time of sufficient sustained length between successive respiratory cycles to determine expiration of an escape interval without having detected the next respiratory cycle as signifying a lack of ventilation indicative of an actual episode of sleep apnea.

33. The device-implemented method of claim 32, including:

delivering electrical stimulation therapy to the patient'"'"'s phrenic nerve from the device in response to said detected actual episode of sleep apnea, to induce resumption of patient ventilation.

34. The device-implemented method of claim 33, including

sensing the EKG signal and delivering the stimulation therapy at substantially the same site, remote from the patient'"'"'s heart.