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

• US 9,533,114 B1
• Filed: 08/26/2013
• Issued: 01/03/2017
• 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, Daniel, Kolkowski, Brian M
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/975,792
• Time in Patent Office: 1,226 Days
• US Class Current: 1/1
• 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 a first electronic component or connection for receiving the signal from the at least one sensor, and a second electronic component or connection 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 first electronic component or connection and the second electronic component or connection being from the same or separate electronic modules or parts; 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 apneas and hypopneas from the electrical signal or processed signal, differentiating the central apneas and hypopneas from obstructive apneas and hypopneas, and modifying treatment based on the identified central apneas and hypopneas.

2. The system of claim 1, wherein the data acquisition system comprising at least two sensors each having a signal, one being is respiratory effort belt and the other being a pulse oximeter, and the controller identifies central apneas when the pulse oximeter measurement drops by 3% and the thoracic effort ceases based no 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 an additional treatment device configured to treat central or complex apneas and the PAP device and the additional treatment device are configured to titrate or adjust at the same time.

5. The system of claim 4, wherein the additional 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 two sensors each with first and second electrical signals, the at least two sensors including a respiratory effort belt and a pulse oximetry sensor, and the first and second electrical signals from the at least two sensors are received by the PAP controller.

7. A system for treating adjusting a positive airway pressure (PAP) device and treating apneas and hyponeas comprising:

a data acquisition system comprising at least one sensor with an electrical signal, and a data interface for receiving the electrical signal from the at least one sensor, and a second electronic component or connection 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 first electronic component or connection and the second electronic component or connection being from the same or separate electronic modules or parts;

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 electrical signal or processed signal transmitted from the data acquisition system, a blower and a controller for identifying central apneas and hypopneas from the electrical signal or processed signal, differentiating the central apneas and hypopneas from obstructive apneas and hypopneas, and modifying treatment from the blower based on the identified central apneas and hypopneas; and

a chemical treatment device comprising one or more of an O₂ source, a CO₂ source or medication source either integral to or separate from the PAP device, and configured to modify the treatment.

8. The system of claim 7, wherein the chemical treatment device is a medication reservoir placed inline with the airflow of the PAP device and configured to deliver a nebulized medication or drug to the patient'"'"'s lungs.

9. The system of claim 7, wherein the data acquisition system is modular and after a limited period of time is detachable from the PAP device.

10. The system of claim 7, the airflow of the PAP device has a concentration of carbon dioxide, and wherein the chemical treatment is a CO₂ source configured to increase the concentration of carbon dioxide in the airflow being delivered to the patient with the PAP device.

11. The system of claim 7, the airflow of the PAP device has a concentration of oxygen, and wherein the chemical treatment is an O₂ source configured to increase the concentration of oxygen in the airflow being delivered to the patient with the PAP device.

12. The system of claim 7, wherein the at least one sensor comprises a pulse oximetry sensor and a respiratory effort belt, wherein the controller identifies central apneas, in part, when the pulse oximeter measurement drops by 3% and the respiratory effort measurement ceases based on the electrical signals of the pulse oximetry sensor and the respiratory effort belt.

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

applying a PAP device to a patient;

apply ing 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 a processing unit on the PAP device, or external to the PAP device; and

analyzing the electrical signal from said respiratory effort belt with the processing unit, in part, to identify central apneas and/or hypopneas, differentiating those central apneas and/or hypopneas from obstructive apneas and/or hypopneas, and

modifying a treatment with the PAP device based at least in part on the identified central sleep apneas.

14. The method of claim 13, wherein the respiratory effort belt is capable of wirelessly transmitting the electrical signal or a processed signal based in part on the signal to the processing unit.

15. The method of claim 13, wherein the electrical signal or processed signal from the respiratory effort belt is wirelessly transmitted at least in part to a remote location, and the PAP device is, in part, manually titrated by a clinician at least in part due to the wirelessly transmitted electrical signal or processed signal and the identified central sleep apneas and/or hypopneas by a clinician.

16. The method of claim 13, wherein the electrical signal or processed signal from the respiratory effort belt is transmitted at least in part to a remote location, and the PAP device is, in part, configured to be manually titrated by a clinician based at least in part due to the transmitted electrical signal or processed signal and the identified central sleep apneas and/or hypopneas.

17. The method of claim 15, wherein the PAP device is configured to be manually titrated by the clinician based on manual input to a device from the group consisting of a cell phone, a PDA or a cell phone to manually titrate the PAP device.

18. The method of claim 16, wherein the PAP device is configured to be manually titrated by the clinician based on manual input to a device from the group consisting of a cell phone, a PDA or a cell phone to manually titrate the PAP device.

19. The method of claim 15, wherein the electrical signal or processed signal is transmitted or re-transmitted via cell towers or satellite to the remote location.

20. The method of claim 16, wherein the electrical signal or processed signal is transmitted or re-transmitted via cell towers, land phone lines, satellite, radio frequencies or cable to the remote location.