System and method for moderating a therapy delivered during sleep using physiologic data acquired during non-sleep

• US 7,757,690 B2
• Filed: 09/13/2004
• Issued: 07/20/2010
• Est. Priority Date: 09/18/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E., Hartley, Jesse W., Lee, Kent, Ni, Quan
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Morales; Jon-Eric C.
• Application Number:
  US10/939,711
• Publication Number:
  US 20050080461A1
• Time in Patent Office: 2,136 Days
• Field of Search: None
• US Class Current: 128/204.18
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/398 Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/686 : Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61M 16/024 : including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/10 : Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 2016/0021 : with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 : in the inspiratory circuit
• CPC Class Codes: A61M 2016/0042 : in the expiratory circuit
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 : Electroencephalographic signals
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3629 : in combination with non-electric therapy
• CPC Class Codes: A61N 1/36514 : controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36535 : controlled by body position or posture
• CPC Class Codes: A61N 1/36592 : controlled by the heart rate variability
• CPC Class Codes: A61N 1/37 : Monitoring; Protecting

Abstract

Systems and methods provide for gathering of patient related data during non-sleep periods and modulating a therapy delivered to the patient during sleep using the gathered data. Data associated with a patient is gathered while the patient is awake. A therapy delivered to the patient during patient sleep is adjusted using the acquired data. The therapy delivered to the patient may include one or more of a respiratory therapy, such as a positive airway pressure (xPAP) therapy, a sleep disordered breathing therapy, a cardiac rhythm management therapy, such as a cardiac overdrive pacing therapy, a medication therapy, or a drug delivery therapy. The therapy delivered to the patient may be optimized using the acquired data.

Claims

1. A method, comprising:

acquiring data associated with a patient while the patient is awake, the data comprising respiration data indicative of a respiratory disorder; and

adjusting a therapy delivered by a patient-external device to the patient during patient sleep, the adjustment based at least in part on the acquired data including the respiration data indicative of the respiratory disorder, the therapy comprising one or both of a respiratory therapy and a therapy to treat a sleep-related respiratory disorder associated with the respiratory disorder.

2. The method of claim 1, wherein the therapy comprises a positive airway pressure therapy.

3. The method of claim 1, wherein the therapy comprises a sleep disordered breathing therapy.

4. The method of claim 1, wherein the acquired data is acquired by an implantable cardiac rhythm management device.

5. The method of claim 1, wherein the therapy comprises a medication use or delivery therapy.

6. The method of claim 1, wherein adjusting the therapy comprises performing therapy titration using the acquired data.

7. The method of claim 1, further comprising detecting a pathological condition using the acquired data, and adjusting the therapy in response to the detected pathological condition.

8. The method of claim 1, wherein the acquired respiratory data indicative of the respiratory disorder is indicative of Cheyne-Stokes patterned breathing.

9. The method of claim 1, wherein the acquired data indicative of the respiratory disorder comprises one or more of breathing pattern data, breathing rate data, and transthoracic impedance data.

10. The method of claim 1, wherein the acquired data further comprises one or more of heart rate data, heart rate variability data, PR interval data, and cardiac arrhythmia data, and the therapy adjustment is further based on the acquired one or more of heart rate data, heart rate variability data, PR interval data, and cardiac arrhythmia data.

11. The method of claim 1, wherein the acquired data further comprises patient activity data, and the therapy adjustment is further based on the patient activity data.

12. The method of claim 1, wherein the respiratory disorder of the acquired respiratory data comprises a respiratory condition that occurs during non-sleep periods and results from the sleep-related respiratory disorder.

13. The method of claim 1, wherein the acquired data further comprises contextual data impacting the patient, and the therapy adjustment is further based on the contextual data impacting the patient.

14. The method of claim 1, wherein the acquired data indicates one or more of a rate of change of a respiratory condition associated with the respiratory disorder and an effect of the therapy in addressing the sleep-related respiratory disorder.

15. The method of claim 1, wherein the acquired data further comprises autonomic nervous system activity data, and the therapy adjustment is further based on the autonomic nervous activity data.

16. The method of claim 1, wherein the acquired data further comprises medication use data, and the therapy adjustment is further based on the medication use data.

17. The method of claim 1, wherein the acquired data further comprises one or both of blood pressure data and blood oxygen level data, and the therapy adjustment is further based on the one or both of blood pressure data or blood oxygen data.

18. A system, comprising:

a data acquisition unit configured to acquire respiration data indicative of a respiratory disorder associated with a patient while the patient is awake; and

a patient-external therapy delivery system configured to adjust a therapy delivered to the patient during patient sleep using the acquired respiration data indicative of the respiratory disorder, the therapy comprising one or both of a respiratory therapy and a therapy to treat a sleep-related respiratory disorder associated with the respiratory disorder.

19. The system of claim 18, wherein the data acquisition unit is further configured for implantation and to patient-internally monitor electrical cardiac activity of the patient.

20. The system of claim 18, wherein the data acquisition unit is further configured for implantation, to monitor electrical cardiac activity of the patient, and to deliver an electrical cardiac therapy to the patient.

21. The system of claim 18, wherein the therapy delivery system comprises a positive airway pressure device.

22. The system of claim 18, wherein the data acquisition unit is an implantable cardiac rhythm management device and the therapy delivery system comprises a positive airway pressure device.

23. The system of claim 18, wherein the therapy delivery system comprises a patient management system configured to communicate medication use data to the patient.

24. The system of claim 18, wherein the therapy delivery system comprises a drug delivery system.

25. The system of claim 18, wherein the data acquisition unit comprises one or more sensors for detecting a pathological condition, and wherein the acquired respiration data comprises a pathological respiration condition associated with the respiratory disorder.

26. The system of claim 18, wherein the data acquisition unit comprises a cardiac rhythm management device.

27. The system of claim 18, wherein the data acquisition unit comprises a respiratory therapy delivery device.

28. A system, comprising:

means for acquiring data associated with a patient while the patient is awake, the data comprising respiration data indicative of a respiratory disorder; and

means for adjusting a therapy delivered by a patient-external device to the patient during patient sleep, the adjustment based at least in part on the acquired data including the respiration data indicative of the respiratory disorder, the therapy comprising one or both of a respiratory therapy and a therapy to treat a sleep-related respiratory disorder associated with the respiratory disorder.