Wireless closed-loop and system to detect and treat sleep apnea

• US 9,498,627 B2
• Filed: 01/15/2014
• Issued: 11/22/2016
• Est. Priority Date: 01/15/2014
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Rosenberg, Stuart, Keiser, Melanie Goodman, Venkatesan, Lalit, Theret, Didier
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/156,181
• Publication Number:
  US 20150196766A1
• Time in Patent Office: 1,042 Days
• Field of Search: 607/42
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• 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: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• 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 1/36139 with automatic adjustment

Abstract

A wireless implantable system is provided that is externally powered and comprises of a closed-loop feedback for treating both patients with obstructive and central sleep apnea. A method is provided for treating sleep apnea using an implantable device. The method comprises sensing an inspiration (IN) signal representative of inspiration experienced by a patient from a respiratory surrogate signal and sensing a respiratory effort (RE) signal representative of an amount of effort exerted by the patient during respiration. The method also comprises analyzing the inspiration signal relative to an IN baseline, that corresponds to normal respiratory behavior, to identify an IN indicator, analyzing the RE signal relative to an RE baseline, that corresponds to a normal amount of respiratory exerted by the patient, to identify an RE indicator, declaring a central sleep apnea (CSA) state or an obstructive sleep apnea (OSA) state based on the IN and RE indicators, and delivering at least one of a CSA therapy when the CSA state is declared or an OSA therapy when the OSA state is declared.

Claims

1. A method for treating sleep apnea using an implantable device, the method comprising:

sensing an inspiration (IN) signal representative of inspiration experienced by a patient from a respiratory surrogate signal;

sensing a respiratory effort (RE) signal representative of an amount of effort exerted by the patient during respiration;

analyzing the inspiration signal relative to an IN baseline, that corresponds to normal respiratory behavior;

analyzing the RE signal relative to an RE baseline, that corresponds to a normal amount of respiratory effort exerted by the patient;

declaring a central sleep apnea (CSA) state when the inspiration signal is less than the IN baseline and the RE signal is less than the RE baseline or an obstructive sleep apnea (OSA) state when the when the inspiration signal is less than the IN baseline and the RE signal is greater than the RE baseline; and

delivering at least one of a CSA therapy when the CSA state is declared or an OSA therapy when the OSA state is declared.

2. The method of claim 1, wherein the delivering includes delivering at least one of a nerve stimulation or a muscle stimulation configured to induce breathing.

3. The method of claim 1, wherein the CSA therapy includes targeting nerve stimulation at a phrenic nerve when the declaring declares the CSA state.

4. The method of claim 1, wherein the OSA therapy includes targeting nerve stimulation at a hypoglossal nerve when the declaring declares the OSA state.

5. The method of claim 1, wherein the CSA therapy includes targeting muscle stimulation at a diaphragm when the declaring declares the CSA state.

6. The method of claim 1, wherein the OSA therapy includes targeting muscle stimulation at oropharyngeal muscles when the declaring declares the OSA state.

7. The method of claim 1, wherein the sensing includes sensing at least one of a blood pressure or a blood oxygen saturation as an indirect measure of respiration.

8. The method of claim 7, wherein the therapy is delivered upon detection of a change or cessation of respiratory-related blood pressure oscillations in a pulmonary artery.

9. The method of claim 7, wherein the therapy is delivered upon detection of reduced oxygen saturation in a pulmonary arterial blood or superior vena cava.

10. The method of claim 1, wherein the sensing comprises receiving a surrogate pulmonary artery blood pressure (PABP) signal that changes over respiratory cycles, the surrogate PABP signal including an indication of a magnitude and a period of the inspiration.

11. The method of claim 1, wherein the sensing further comprises low pass filtering the PABP signal with a cutoff at a predefined frequency to generate a low pass filtered PABP signal that increases and decreases in magnitude in accordance with changes in inspiration over a respiratory cycle.

12. A system for treating sleep apnea, comprising:

sensors configured to sense inspiration and output an inspiration (IN) signal, representative of inspiration experienced by a patient, as a respiratory surrogate signal, the sensors further configured to sense a respiratory effort (RE) and output an RE signal representative of an amount of effort exerted by the patient during respiration;

an analysis circuit module configured to analyze the IN signals relative to an IN baseline, that corresponds to normal respiratory behavior;

the analysis circuit module configured to analyze the RE signal relative to an RE baseline, that corresponds to a normal amount of respiratory effort exerted by the patient;

a therapy circuit module configured to declare a central sleep apnea (CSA) state when the inspiration signal is less than the IN baseline and the RE signal is less than the RE baseline or an obstructive sleep apnea (OSA) state when the inspiration signal is less than the IN baseline and the RE signal is greater than the RE baseline; and

an implantable device configured to deliver at least one of a CSA therapy when the CSA state is declared or an OSA therapy when the OSA state is declared.

13. The system of claim 12, wherein the implantable device includes a lead positioned proximate to nerves or muscle of interest, the lead having electrode configured to deliver at least one of a nerve stimulation or a muscle stimulation configured to induce breathing.

14. The system of claim 12, wherein the therapy circuit module targets nerve stimulation at a phrenic nerve when the declaring declares the CSA state.

15. The system of claim 12, wherein the therapy circuit module targets nerve stimulation at a hypoglossal nerve when the declaring declares the OSA state.

16. The system of claim 12, wherein the therapy circuit module targets muscle stimulation at a diaphragm when the declaring declares the CSA state.

17. The system of claim 12, wherein the therapy circuit module targets muscle stimulation at oropharyngeal muscles when the declaring declares the OSA state.

18. The system of claim 12, wherein the sensors further comprise at least one of an implantable blood pressure sensor or an implantable blood oxygen saturation sensor configured to generate the IN signal as the respiratory surrogate signal.

19. The system of claim 12, wherein the sensors include a pulmonary pressure sensor configured to output a pulmonary artery blood pressure (PABP) signal as the IN signal, further comprising a low pass filter configured to remove a high frequency component from the PABP signal to produce a lowpass PABP signal as the IN signal.

20. The system of claim 12, wherein the analysis circuit module is configured to receive, as the IN signal, a surrogate positive airway pressure (PABP) signal that changes over respiratory cycles, the analysis circuit module configured to declare the CSA state or OSA state when at least one of a peak to peak magnitude or a period of the inspiration fails to satisfy at least one of a predetermined inspiration magnitude or period thresholds.

21. The system of claim 12, wherein the sensors further comprise a galvanic sensor configured to sense the RE signal representative of the amount of effort exerted by the patient during respiration.

22. The system of claim 12, further comprising an external device that includes the analysis and therapy circuit modules, the external device having inputs configured to receive the IN and RE signals from the sensors, the external device coupled to an antenna configured to communicate with the implantable device.

23. The system of claim 12, further comprising an external device that includes the analysis and therapy circuit modules, wherein the sensors are implantable in the patient, the external device coupled to an antenna configured to communicate with the sensors to receive at least one of the IN or RE signals.

24. The system of claim 12, further comprising first and second antenna are configured to be located in a bed or pillow of the patient proximate to a torso and head of the patient.