Integrated diagnostic and therapeutic system and method for improving treatment of subject with complex and central sleep apnea

• US 8,545,416 B1
• Filed: 07/19/2007
• Issued: 10/01/2013
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Kayyali, Hani, Bishop, Dan, Kolkowski, Brian M.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/880,046
• Time in Patent Office: 2,266 Days
• Field of Search: 600529-543, 128/204.22, 128/204.23, 128/204.26
• US Class Current: 600/534
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0013 Medical image data A61B1/00011, A61B6/56, A61B8/56 take precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4815 Sleep quality
• 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 5/681 Wristwatch-type devices
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/06 : Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0875 : Connecting tubes
• CPC Class Codes: A61M 16/12 : by mixing different gases
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/0039 : in the inspiratory circuit
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2202/0225 : Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/8206 : battery-operated
• 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 2230/14 : Electro-oculogram [EOG]
• CPC Class Codes: A61M 2230/202 : partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/46 : Resistance or compliance of the lungs
• 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

Abstract

The present invention relates to an integrated sleep diagnosis and treatment device, and more particularly to an integrated apnea diagnosis and treatment device. The present invention additionally relates to methods of sleep diagnosis and treatment. The sleep disorder treatment system of the present invention can use a diagnosis device to perform various forms of analysis to determine or diagnose a subject'"'"'s sleeping disorder or symptoms of a subject'"'"'s sleep disorder, and using this analysis or diagnosis can with or in some embodiments without human intervention treat the subject either physically or chemically to improve the sleeping disorder or the symptoms of the sleeping disorder. The diagnostic part of the system can use many different types of sensors and methods for diagnosing the severity of the symptoms of or the sleep disorder itself. The treatment part of the system can use a device to physically or chemically treat the subject'"'"'s symptoms or sleep disorder itself.

Claims

1. A system for adjusting a positive airway pressure device comprising:

a data acquisition system comprising at least one sensor with an electrical signal, and a data acquisition box comprising at least one first electronic component for receiving the signal from the at least one sensor, and at least one second electronic component for re-transmitting the electrical signal or transmitting a processed signal based at least in part on the electrical signal from the at least one sensor, the at least one first electronic component and the at least one second electronic component being from a same or separate electronic modules; and

a PAP device separate and in a different enclosure from the data acquisition box, for treating a patient'"'"'s sleep apnea, the PAP device comprising an electrical connection for receiving the electrical signal or processed signal transmitted from the data acquisition box, and a controller for identifying central or complex sleep apneas from the signal or processed signal, differentiating the central or complex sleep apneas from obstructive apneas and hypopneas, and modifying treatment based on the identified central or complex sleep apneas.

2. The system of claim 1, wherein the data acquisition system comprising at least two sensors each having a signal, one being a respiratory effort belt and the other being a pulse oximeter, and the controller identifies central apneas when the pulse oximeter drops by 3% and the thoracic effort ceases based on the signals of the at least two sensors.

3. The system of claim 1, wherein the data acquisition system is used to train the PAP device during titration or adjustment so the PAP device correlates more robust or rich signal data collected with the data acquisition system with a more limited sensor data from the PAP device using the controller on the PAP device.

4. The system of claim 1, wherein the system further includes a second treatment device used to treat central or complex apneas and the PAP device and the second treatment device are titrated or adjusted at the same time.

5. The system of claim 4, wherein the second treatment device is selected from the group consisting of an O₂ tank or source, a CO₂ tank or source, a medication or chemical reservoir, a FES device and combinations thereof.

6. The system of claim 1, wherein the data acquisition system includes at least three sensors each with an electrical signal, the at least three sensors including a respiratory effort belt, a pulse oximetry sensor, and an airflow pressure sensor and the electrical signals from the at least three sensors are received by the PAP controller.

7. A titration system including a positive airway pressure device comprising:

a data acquisition system comprising at least a pulse oximeter and a respiratory effort belt, each with an electrical signal for application to a patient, and a data acquisition box comprising at least one first electronic component for receiving the signals, and at least one second electronic component for re-transmitting the electrical signal or transmitting a processed signal based at least in part on the electrical signals from the pulse oximeter and the respiratory effort belt, the at least one first electronic component and the at least one second electronic component being from a same or separate electronic modules; and

a PAP device separate from the data acquisition system for treating a patient'"'"'s sleep apnea, the PAP device comprising an electrical connection for receiving the signals or processed signal transmitted from the data acquisition system, and a controller for titrating or modifying a patient'"'"'s treatment with the PAP device based on diagnostic central or complex sleep apneas identified from the signal or processed signal;

wherein the data acquisition system is used for a limited period of time to program or titrate the PAP device and is used to train the PAP device during titration so the PAP device correlates more robust or rich signal data collected with the data acquisition system with a more limited sensor data from the PAP device using the controller on the PAP device.

8. The titration system of claim 7, wherein the data acquisition system and PAP device communicate wirelessly with a remote location and permanent changes to the settings on the PAP device must be approved by a clinician or technician at a remote location before those changes take effect.

9. The titration system of claim 7, wherein the data acquisition system is modular and after the limited period of time can be detached from the PAP system.

10. The titration system of claim 7, wherein the data acquisition system includes at least one third electronic component for wirelessly transmitting a signal or a processed signal based at least in part on the signals from the pulse oximeter and the respiratory effort belt, the at least one first electronic component, the at least one second electronic component, and the at least one third electronic component being from a same or separate electronic modules, and the PAP device further includes a receiver or transceiver for receiving the wirelessly transmitted signal from the data acquisition system.

11. The titration system of claim 7, wherein the PAP device includes a source of carbon dioxide for delivery to the patient.

12. The titration system of claim 7, wherein the PAP device includes a source of oxygen for delivery to the patient.

13. The titration system of claim 7, wherein the the PAP device controller identifies central apneas when the pulse oximeter drops by 3% and the thoracic effort ceases based on the signals of the at least two sensors.

14. The titration system of claim 7, wherein the system further includes a second treatment device used to treat central or complex apneas and the PAP device and the second treatment device are titrated or adjusted at the same time.

15. The titration system of claim 14, wherein the second treatment device is selected from the group consisting of an O₂ tank or source, a CO₂ tank or source, a medication or chemical reservoir, a FES device and combinations thereof.

16. A method for determining between central apneas and obstructive apneas comprising the steps of:

applying a PAP device comprising a processing unit to a patient;

applying a respiratory effort belt, capable of outputting an electrical signal, to the patient;

detecting respiratory effort of the patient with the respiratory effort belt,

transmitting the electrical signal from the respiratory effort belt to the processing unit on the PAP device; and

analyzing the electrical signal from said respiratory effort belt with the processing unit on the PAP device to identify central and/or complex sleep apneas, differentiating those central apneas from obstructive apneas and hypopneas, and modify a treatment with the PAP device based at least in part on the identified central and/or complex sleep apneas.

17. The method of claim 16, wherein the respiratory effort belt is capable of wirelessly transmitting the signal or a processed signal based in part on the signal to the PAP device.

18. The method of claim 16, wherein the respiratory effort belt is capable of wirelessly transmitting the signal or a processed signal based in part on the signal to a remote location, and the PAP device is manually titrated through at least in part wireless communication from the remote location based at least in part on the identified central and/or complex sleep apneas.

19. The method of claim 18, wherein the method includes the steps of:

viewing the patient using a video sensor with a signal comprising an image of the subject; and

transmitting the signal comprising an image of the subject from the video sensor or a processed signal comprising an image of the subject from the video sensor to the remote location.

20. The method of claim 18, wherein the PAP device is titrated through at least in part wireless communication at least in part from the remote location based at least in part on the identified central and/or complex sleep apneas over a duration of at least two sessions.