System for treating sleep disordered breathing

• US 8,938,299 B2
• Filed: 11/19/2009
• Issued: 01/20/2015
• Est. Priority Date: 11/19/2008
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Christopherson, Mark A., Ni, Quan, Herbert, Timothy P., Rondoni, John
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Flory, Christopher A
• Application Number:
  US13/130,287
• Publication Number:
  US 20110264164A1
• Time in Patent Office: 1,888 Days
• Field of Search: 607/42, 600/529, 600/538, 600/546
• US Class Current: 607/42
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• 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 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/0803 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• 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
• CPC Class Codes: A61N 1/3615 : Intensity
• CPC Class Codes: A61N 1/36185 : Selection of the electrode configuration

Abstract

A system is disclosed for applying a treatment therapy for sleep disordered breathing. The system includes a sensing module configured to sense physiologic conditions and an implantable pulse generator in communication with the sensing module and including an automatic therapy manager. The automatic therapy manager operates in a first state to detect sleep indicative behavior, a second state to detect sleep disordered breathing behavior, and a third state to apply a nerve stimulation signal.

Claims

1. A system of applying a treatment therapy for sleep disordered breathing, comprising:

a sensing module including an array of sensors configured to sense physiologic conditions, the array including at least one of a body activity sensor, a body posture sensor, and a respiration sensor; and

an implantable pulse generator in communication with the sensing module and including an automatic therapy manager configured to operate in;

a first state to detect sleep indicative behavior by sensing physiologic conditions via at least the respective body activity sensor and body posture sensor;

a second state to monitor the sensed physiologic conditions to detect sleep disordered breathing behavior, wherein the therapy manager transitions into the second state when the detected sleep-indicative behavior meets a first criteria; and

a third state to apply a nerve stimulation signal, synchronous with inspiration, to an airway patency-related nerve, wherein the therapy manager transitions into the third state upon detecting, in the second state, sleep disordered breathing behavior exceeding a second criteria,

wherein the automatic therapy manager includes an inverse relationship sampling function configured, in cooperation with the sensing module, to perform sampling of physiologic conditions in the second state at intervals according to an inverse relationship between the amount of patient body activity and the frequency of sampling, such that upon sensing a higher degree of patient body activity that corresponds to a lower likelihood of detecting sleep, performing a lower frequency of sampling physiologic conditions and upon sensing a lower degree of patient body activity corresponding to higher likelihood of detecting sleep, performing a higher frequency of sampling physiologic conditions.

2. The system of claim 1, wherein the automatic therapy manager includes a suspension function configured, upon detecting the sleep disordered breathing behavior falling below the second criteria, to suspend the third state of operation and maintaining the respective first and second state of operation.

3. The system of claim 1, wherein the automatic therapy manager includes a bypass function configured, upon detecting a sleep state in the first state of operation, to bypass the second state of operation and immediately implement the third state of operation.

4. A system of applying a treatment therapy for sleep disordered breathing, comprising:

a sensing module including an array of sensors configured to sense physiologic conditions, the array including at least one of a body activity sensor, a body posture sensor, and a respiration sensor; and

an implantable pulse generator in communication with the sensing module and including an automatic therapy manager configured to operate in;

a first state to detect sleep indicative behavior by sensing physiologic conditions via at least the respective body activity sensor and body posture sensor;

a second state to monitor the sensed physiologic conditions to detect sleep disordered breathing behavior, wherein the therapy manager transitions into the second state when the detected sleep-indicative behavior meets a first criteria; and

a third state to apply a nerve stimulation signal, synchronous with inspiration, to an airway patency-related nerve, wherein the therapy manager transitions into the third state upon detecting, in the second state, sleep disordered breathing behavior exceeding a second criteria, wherein the detection of sleep disordered breathing behavior exceeding the second criteria includes detection of an occurrence of at least one obstructive sleep apnea event,

wherein the automatic therapy manager includes a periodic suspension function configured to;

periodically suspend the third state of operation while maintaining the respective first and second state of operation during the periodic suspensions;

detect whether the monitored sleep disordered breathing behavior exceeds the second criteria; and

implement at least one of maintaining suspension of the third state of operation if the monitored sleep disordered breathing behavior fails to meet the second criteria or resuming the third state of operation if the monitored sleep disordered breathing behavior meets or exceeds the second criteria,

wherein the periodic suspension function is configured to periodically suspend the third state of operation at a frequency and for a predetermined suspension time period,

wherein the frequency of suspending is inversely proportional to a severity score of the sleep disordered breathing behavior, such that upon a relatively higher severity score, a lower frequency of suspending occurs and upon a relatively lower severity score, a higher frequency of suspending occurs, wherein the severity score is based at least one of a quantity, duration, and intensity of obstructive sleep apneas within a given time period.

5. The system of claim 4, wherein the periodic suspension function is configured to automatically forego suspension of the third state of operation during an initial sleep stage of a daily sleep period.

6. The system of claim 4, wherein the periodic suspension function is configured to automatically forego suspension of the third state of operation for a daily sleep period upon detecting that the monitored sleep disordered breathing behavior substantially exceeds the second criteria.