Integrated diagnostic and therapeutic PAP system

• US 10,543,328 B1
• Filed: 11/18/2016
• Issued: 01/28/2020
• 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:
  US15/355,189
• Time in Patent Office: 1,166 Days
• Field of Search: 600529-543
• 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 PAP device adapted to treat a patient'"'"'s sleep apnea,

a data acquisition system comprising

at least one sensor adapted to generate a first electrical signal,

a data acquisition box comprising a first electronic component or connection adapted to connect the at least one sensor and receiving the first electrical signal from the at least one sensor, and a second electronic component or connection adapted to receive a second electrical signal based on a PAP sensor within the PAP device, wherein the PAP device adapted to be separate and in a different enclosure from the data acquisition box, and

a processor adapted to identify central apneas and hypopneas from the first and second electrical signals, to differentiate the central apneas and hypopneas from obstructive apneas and hypopneas, and to modify treatment of the PAP device based on the identified central apneas and hypopneas.

2. The system of claim 1, wherein the data acquisition system comprises at least two sensors, each of the at least two sensors adapted to generate an electrical signal, the at least two sensors including a respiratory effort belt and a pulse oximeter, and the processor is adapted to identify central apneas when the pulse oximeter measurement drops by at least 3% and the thoracic effort ceases based on the electrical signals of the at least two sensors.

3. The system of claim 1, wherein the data acquisition system is adapted to train the PAP device during titration or adjustment so that 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 a processor on the PAP device.

4. The system of claim 1, wherein the processor is further adapted to modify a treatment of an additional treatment device configured to treat central or complex apneas.

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 functional electrical stimulation device and combinations thereof.

6. The system of claim 1, wherein the data acquisition system is adapted to receive the first and second electrical signals from at least two sensors, the at least two sensors including a respiratory effort belt and a flow or pressure sensor, and the first and second electrical signals from the at least two sensors are received by the processor.

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

a PAP device adapted to treat a patient'"'"'s sleep apnea; and

a data acquisition system comprising

at least one sensor adapted to generate a first electrical signal, and

a data acquisition box comprising a first electronic component or connection adapted to connect the at least one sensor and receiving the first electrical signal from the at least one sensor, and a second electronic component or connection adapted to receive a second electrical signal based on a PAP sensor within the PAP device, wherein the PAP device adapted to be separate and in a different enclosure from the data acquisition box;

a processor adapted to identify central apneas and hypopneas from the first and second electrical signals, to differentiate the central apneas and hypopneas from obstructive apneas and hypopneas, and to modify treatment by the PAP device based on the identified central apneas and hypopneas; and

a chemical treatment device comprising one or more of an O₂ source, a CO₂ source, and/or a medication source, the chemical treatment device adapted to be either integral to or separate from the PAP device, and the processor being further adapted to modify a treatment by the chemical treatment device.

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 processor 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. The system of claim 7, wherein the processor is further adapted to modify a treatment of an additional treatment device configured to treat central or complex apneas, the additional treatment device being a function electrical stimulation device.

14. A method of treating a sleep-related breathing disorder comprising steps of:

attaching a first sensor to a subject sleeping at home or at a facility remote from a sleep analysis lab and receiving PAP or CPAP therapy;

concurrently providing therapy to the subject with a PAP or CPAP device;

connecting, before or after attaching the first sensor to the subject, the first sensor to a data acquisition system, the data acquisition system comprising a data acquisition box, which is separate from the PAP or CPAP device and adapted to receive a first electrical signal from the first sensor;

collecting data from the first sensor attached to the subject during a time period while the subject attempts to sleep;

collecting during the time period and transmitting a second electrical signal from a second sensor integrated into the PAP or CPAP device to the data acquisition system, the device adapted to deliver a flow of pressurized gas to the subject; and

adjusting or titrating the flow of the pressurized gas delivered by the PAP or CPAP device using at least part of the data from both the first and second sensor signals to identify central apneas and hypopneas and differentiate the central apneas and hypopneas from obstructive apneas and hypopneas to improve therapy to the subject utilizing the PAP or CPAP after the time period when data is no longer collected from the first sensor.

15. The method of claim 14, wherein the data acquisition box and the PAP or CPAP device each have a wireless RF connection and the data from the second integrated sensor is transmitted wirelessly directly from the PAP or CPAP device to the data acquisition box in real time.

16. The method of claim 14, with the further step wherein the data from the first and second sensors is at least in part transmitted from the data acquisition system by cellular service, land lines or the internet to a remote data storage station for review remotely by medical personnel, and the medical personnel provides a command signal transmitted by cellular service, land lines or the internet for titrating or adjusting the PAP or CPAP device automatically if necessary to adjust the flow or by communicating with an individual near the subject or with the subject to adjust the PAP or CPAP device.

17. The method of claim 14, wherein the steps of the method is used to adjust or titrate the PAP or CPAP device to better identify and distinguish between obstructive, central and complex sleep apneas and the PAP or CPAP device is adjusted, titrated or discontinued based on this analysis after the time period when data is no longer collected from the first sensor.

18. The method of claim 14, wherein the data acquisition system comprises the first sensor and a third sensor, the first and third sensors adapted to generate electrical signals including a respiratory effort belt sensor, and a pulse oximetry sensor, and the second sensor integrated into the PAP or CPAP device is a flow or pressure sensor, wherein the PAP or CPAP device is adjusted or titrated using, in part, data from the first, second and third sensors to improve therapy to the subject utilizing the PAP or CPAP after the time period when data is no longer collected from the first and third sensors.

19. The method of claim 14, wherein the PAP or CPAP device is automatically titrated or adjusted based on physiological signals that are specific to the subject being treated for improved treatment after the time period when data is no longer collected from the first sensor.

20. The method of claim 14, further comprising the step of modifying a treatment of an additional treatment device configured to treat central or complex apneas based at least in part on the data from the first and second electrical signals, 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 functional electrical stimulation device and combinations thereof.