Integrated sleep diagnostic and therapeutic system and method

• US 7,942,824 B1
• Filed: 07/19/2007
• Issued: 05/17/2011
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Kayyali, Hani, Kolkowski, Brian M., Bishop, Dan
• Primary Examiner(s): Lacyk; John P
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US11/879,934
• Time in Patent Office: 1,398 Days
• Field of Search: 600/481, 600/483, 600/484, 600500-503, 600/300, 600529-543, 12820421-20423, 128/204.26
• US Class Current: 600/538
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/296 for 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 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• 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 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0051 with alarm devices
• 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 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 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• 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 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• 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 2230/208 : pH-value
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/50 : Temperature
• 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 sleep-related breathing disorder treatment system comprising:

a portable data acquisition system comprising patient interface box further comprising at least one sensor having a signal, the sensor for determining a physiological characteristic of a subject, and at least one electronic component for receiving the signal and retransmitting the signal from the at least one sensor or transmitting a signal based at least in part on the signal from the at least one sensor to a separate PAP or CPAP device; and

the PAP or CPAP device for treating the subject'"'"'s sleep related breathing disorder, the PAP or CPAP device comprising an electrical component for receiving the retransmitted or transmitted signal and a nasal cannula or mask for delivering a gas for treating the subject'"'"'s sleep related breathing disorder

wherein the PAP or CPAP device is titrated or adjusted based on at least in part the retransmitted or transmitted signal and the titration or adjustment is also based at least in part on training data representative of physiological signals that are specific to that subject, derived from data collected from two or more days of use of the sleep-related breathing disorder treatment system.

2. The system of claim 1, wherein the signal is transmitted or retransmitted wirelessly.

3. The system of claim 1, wherein the signal is transmitted or retransmitted via USB.

4. The system of claim 1, wherein the data acquisition system further includes at least one additional sensor, the additional sensor for collecting a video signal.

5. The system of claim 1, wherein the data acquisition system comprises at least three sensors having signals, the sensors for determining at least respiratory effort, pulse oximetry, and airflow of a subject;

and at least one electronic component for receiving the signals and retransmitting the signals or transmitting a signal based at least in part on the signal from the at least one of the at least three sensors.

6. The system in claim 1, wherein the system further comprises a remote monitor adapted to assess the quality of signals received from the data acquisition system to ensure receipt of sufficient and adequate data to perform the titration correctly, and wherein the system is programmed to ignore sensor signals if the signals are assessed as being corrupted or if the signals are assessed as coming from a sensor that has been disconnected.

7. A sleep-related breathing disorder treatment system comprising:

a portable data acquisition system comprising a patient interface box further comprising at least one sensor having an electrical signal, the sensor for determining a physiological characteristic of a subject;

at least one electronic component for receiving the electrical signal from the at least one sensor, generating a processed signal based at least in part on the signal from the at least one sensor, and transmitting the processed signal; and

a component for wireless radio frequency transmission;

a separate PAP or CPAP device for treating the subject'"'"'s sleep-related breathing disorder, the PAP or CPAP device comprising an electrical component for receiving a wirelessly transmitted radio frequency signal and a nasal cannula or mask for delivering a gas for treating the subject'"'"'s sleep related breathing disorder; and

a remote monitoring station comprising a transceiver for receiving the processed signal from the data acquisition system and transmitting a command signal based at least in part on the transmitted processed signal to the PAP or CPAP device

wherein the PAP or CPAP device is titrated or adjusted based on at least in part the transmitted command signal.

8. The system of claim 7, wherein a clinician located at the remote monitoring station conducts the titration, determines a set of final treatment values for titration or adjustment of the PAP or CPAP device, and programs the PAP or CPAP device directly.

9. The system of claim 7, wherein the electrical component in the PAP or CPAP for wireless radio frequency transmission is a radio frequency transceiver.

10. The system of claim 7, wherein the portable data acquisition system further includes at least one additional sensor, the additional sensor for collecting a video signal.

11. The system of claim 7, wherein the portable data acquisition system comprises at least three sensors having signals, the sensors for determining at least respiratory effort, pulse oximetry, and airflow of a subject;

and at least one electronic component for receiving the electrical signal from the at least three sensors, generating a processed signal based at least in part on the signal from at least one of the at least three sensors, and transmitting the processed signal.

12. The system of claim 7, wherein the remote monitoring station is at least five miles from the subject.

13. The system of claim 7, wherein the PAP or CPAP device is titrated or adjusted based on at least in part the transmitted command signal and at least in part on the signal transmitted from the data acquisition system.

14. A sleep-related breathing disorder treatment system comprising:

a portable data acquisition system comprising a patient interface box further comprising at least one sensor, the sensor for determining a physiological characteristic of a subject, the sensor having a sensor signal, and at least one electronic component for receiving the sensor signal and retransmitting the sensor signal or transmitting a derived signal based at least in part on the sensor signal;

a treatment interface device comprising at least one electronic component for receiving the sensor signal retransmitted or derived signal transmitted from the data acquisition system, optionally processing the sensor signal or derived signal from the data acquisition system, and retransmitting the sensor signal or derived signal or transmitting a new signal based at least in part on the sensor signal or derived signal; and

a PAP or CPAP device separate from the portable data acquisition system for treating the subject'"'"'s sleep-related breathing disorder, the PAP or CPAP device comprising at least one sensor for detecting airflow or air pressure, the sensor having a PAP signal corresponding to airflow or air pressure, and an electrical connection for receiving the PAP signal transmitted from the treatment interface device

wherein, during a diagnostic period of time, data from the sensor signal from the sensor for determining the physiological characteristic of the subject is correlated to data from the PAP signal from the sensor for detecting airflow or air pressure to determine a signature from such data indicative of an apneic event; and

the PAP or CPAP device is initially titrated or adjusted based on at least in part the sensor signal or derived signal retransmitted or new signal transmitted from the treatment interface device, and subsequently titrated or adjusted based at least in part on the PAP signal corresponding to airflow or air pressure and the determined signature but not on the sensor signal or derived signal retransmitted or new signal transmitted from the treatment interface device.

15. The system of claim 14, wherein the at least one electronic component of the portable data acquisition system is capable of wirelessly transmitting the processed signal.

16. The system of claim 14, wherein the at least one electronic component of the portable data acquisition system is capable of transmitting the processed signal via USB.

17. The system of claim 14, wherein the portable data acquisition system further includes at least one additional sensor, the additional sensor for collecting a video signal.

18. The system of claim 14, wherein the portable data acquisition system comprises at least three sensors having sensor signals, the sensors for determining at least respiratory effort, pulse oximetry, and airflow of a subject;

and wherein the at least one electronic component is for receiving the electrical signals from the at least three sensors, generating a processed signal based at least in part on the signal from at least one of the at least three sensors, and transmitting the processed signal.

19. The system of claim 14, wherein the PAP or CPAP device is automatically titrated or adjusted.

20. The system of claim 14, wherein the PAP or CPAP titration or adjustment is remotely monitored.