Detecting and treatment of sleep apnea

• US 8,781,587 B2
• Filed: 01/19/2013
• Issued: 07/15/2014
• 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:
  US13/694,927
• Publication Number:
  US 20130197376A1
• Time in Patent Office: 542 Days
• Field of Search: None
• US Class Current: 607/35
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 device 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 device includes circuitry adapted to respond to a cardiac signal generated by the heart. Switching circuitry diverts passage of the heart signal through both a high impedance path and a substantially lower impedance path, and a differential amplifier processes the resulting signal pairs to ascertain the difference in magnitude between the two signals of each pair. An analyzer thereof determines changes in the patient'"'"'s ventilation, from which inordinately reduced patient ventilation is detected to assess possible occurrence of an episode of sleep apnea. If the analyzer denotes change of ventilation between otherwise regular respiratory cycles, an actual episode of sleep apnea is indicated. A stimulus generator responds to such indication to generate an appropriate electrical therapy for delivery to a preselected location in the patient'"'"'s body to induce ventilation so as to terminate the apnea episode.

Claims

1. A device for detecting sleep apnea in a patient, comprising an input circuit adapted to receive a cardiac electrical signal representing cardiac electrical activity from electrical energy generated by the patient'"'"'s own heart as the sole input to the input circuit, for processing the received cardiac electrical signal to detect changes in patient thoracic impedance therefrom, whereby the thoracic impedance changes are detected solely from cardiac electrical activity of the patient, and an analyzer responsive to the detected thoracic impedance changes to assess patient ventilation therefrom, so as to identify potential incidents of sleep apnea.

2. The device of claim 1, wherein said input circuit includes a switching circuit for diverting the received cardiac electrical signal through separate paths of high input impedance and of considerably lower impedance to produce two different signals, and a differential amplifier of said two different signals to detect changes in the patient'"'"'s thoracic impedance from the amplified difference therebetween.

3. The device of claim 2, wherein

said analyzer includes means for sensing consecutive respiration cycles from said assessed patient ventilation, and responsive thereto for establishing a predetermined escape interval of time between pairs of successive respiration cycles and for resetting said escape interval upon sensing each respiration cycle, so as to detect 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

means coupled to said analyzer for generating a therapeutic response to disrupt the apnea and thereby restore patient ventilation in response to said indication of an actual episode of sleep apnea.

4. The device of claim 2, further including:

a stimulator coupled to said analyzer for generating electrical stimulation therapy to restore adequate patient ventilation in response to the assessed patient ventilation being identified as inordinately reduced and thereby indicative of an actual episode of sleep apnea, and

an implantable electrical stimulus transmission system adapted to be coupled to said stimulator for delivering said electrical stimulation therapy to a preselected nerve of the patient in response to said actual episode of sleep apnea, for disrupting the apnea and thereby restoring patient ventilation.

5. The device of claim 4, including:

an electrical signal transmission system adapted to be coupled to said input circuit for delivering said cardiac electrical signal as the sole input thereto from a site of the patient'"'"'s body in the immediate vicinity of the site at which said electrical stimulation is to be delivered to said preselected nerve.

6. The device of claim 5, wherein:

at least one electrode is shared by said electrical signal transmission system and said electrical stimulus transmission system for use in both said sensing and said stimulation.

7. The device of claim 4 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),

said device includes means for 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

said implantable electrical stimulus transmission system is adapted to be coupled to said stimulator for delivering said electrical stimulation therapy in a manner according to which of said one type and said another type is present in said distinguished episode.

8. The device of claim 7, wherein:

said distinguishing means distinguishes an episode of CSA/CSR type from an episode of OSA type of sleep apnea disorder by determining whether ventilation is identified as completely absent or partly present, respectively.

9. The device of claim 7, wherein:

said distinguished episode is of CSA/CSR type, and

said stimulator is adapted to respond thereto by generating therapy for stimulating the patient'"'"'s phrenic nerve with electrical pulses in a pattern for diaphragmatic pacing to restore proper respiration.

10. The device of claim 7, wherein:

said distinguished episode is of OSA type, and

said stimulus transmission system is adapted to respond thereto by applying stimulation pulses to one of a glossopharyngeal nerve and a hypoglossus nerve whereby to move the soft palate from blockage of the patient'"'"'s airway.

11. The device of claim 7, wherein:

said distinguished episode is of OSA type, and said stimulus transmission system is adapted to respond by applying stimulation pulses to a preselected nerve directly associated with muscle of the patient'"'"'s soft palate.

12. The device of claim 4, wherein:

said preselected nerve is one of the patient'"'"'s phrenic nerve and a nerve associated with muscle of the soft palate in the patient'"'"'s throat, according to the type of sleep apnea present in said actual episode.

13. The device of claim 4, wherein said preselected nerve is a phrenic nerve.

14. The device of claim 4, wherein said preselected nerve is a glossopharyngeal nerve.

15. The device of claim 4, wherein said preselected nerve is a hypoglossus nerve.

16. The device of claim 2, wherein:

said switching circuit provides said separate paths by alternately switching the received cardiac electrical signal between said high input impedance path and said considerably lower input impedance path at a relatively high switching rate selected for sufficient resolution to enable said differential amplification to detect patient thoracic impedance and changes therein.

17. The device of claim 2, including:

an electrical signal transmission system adapted to be coupled to said input circuit for delivering said cardiac electrical signal as said sole input thereto from a site of the patient'"'"'s body remote from the site of the patient'"'"'s heart.

18. The device of claim 1, wherein said device is implantable, said input circuit is adapted to acquire separate high and low input impedance signals from its sole input, and to differentially amplify the high and low input impedance signals to detect said thoracic impedance changes.

19. The implantable device of claim 18, including:

a stimulator responsive to the assessment of patient ventilation by said analyzer for generating electrical therapy adapted to stimulate a predetermined nerve of the patient when the assessment indicates an episode of sleep apnea has commenced, for terminating said episode and thereby restoring adequate ventilation by the patient.

20. The device of claim 1, wherein said analyzer includes means responsive to assessment of patient ventilation from the detected changes in thoracic impedance for identifying a time interval of predetermined sustained length without adequate ventilation as indicative that the patient is experiencing onset of an actual episode of sleep apnea.

21. The device of claim 20, wherein the input circuit processing of the cardiac electrical signal is performed to detect dynamic impedance changes for evaluation by said analyzer of patient ventilatory status therefrom.

22. The device of claim 20, wherein said analyzer includes means for distinguishing between sleep apnea of CSA/CSR type and sleep apnea of OSA type.

23. The device of claim 20, wherein said analyzer is adapted to determine from the detected impedance changes the patient ventilatory status including number of breaths by the patient and depth of each breath corresponding with its tidal volume, whereby to enable threshold detection of ventilation as well as detection of a total absence of breathing.

24. The device of claim 1, further comprising means responsive to identification of an incident of sleep apnea for generating a predetermined therapeutic response to the patient to disrupt the apnea and thereby restore adequate ventilation by the patient.

25. The device of claim 24, wherein said analyzer includes means responsive to said assessment of patient ventilation for distinguishing between apnea of OSA type and CSA/CSR type, and wherein said generating means comprises a generator of predetermined electrical stimuli according to which of the identified types of apnea is occurring, for application to a selected nerve of the patient as said therapeutic response.

26. The device of claim 25, wherein said electrical stimuli are predetermined for application to at least one of a glossopharyngeal nerve and a hypoglossus nerve as said selected nerve of the patient to disrupt sleep apnea of OSA type.

27. The device of claim 25, wherein said electrical stimuli are predetermined for application to a phrenic nerve as said selected nerve of the patient to disrupt sleep apnea of CSA/CSR type.