Integrated sleep diagnostic and therapeutic system and method

• US 9,730,632 B1
• Filed: 03/29/2011
• Issued: 08/15/2017
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Kayyali, Hani, Kolkowski, Brian M., Bishop, Dan
• Primary Examiner(s): WESTON, TIFFANY C
• Application Number:
  US13/074,901
• Time in Patent Office: 2,331 Days
• Field of Search: 600529-543
• 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 method of treating a sleep-related breathing disorder comprising steps of:

attaching a first sensor for collecting data to a subject sleeping at home or at a facility remote from a sleep analysis lab and receiving positive airway pressure (PAP) or continuous positive airway pressure (CPAP) therapy;

concurrently providing therapy during a first time period to the subject with a PAP or CPAP device while data is being collected from the first sensor;

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 for receiving a first electrical signal from the first sensor;

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

collecting data from a second sensor during the first time period, the second sensor which is integrated into the separate PAP or CPAP device from the PAP or CPAP device and transmitting the data from the second sensor to the data acquisition system, the separate PAP or CPAP device adapted for delivering a flow of pressurized gas to the subject; and

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

2. The method of claim 1, 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.

3. The method of claim 1, 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 to a remote data storage station for review remotely by medical personnel, and the medical personnel provides a command signal transmitted by cellular service 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.

4. The method of claim 1, wherein the steps of the method can be used to adjust or titrate the PAP or CPAP device to better identify and distinguish between obstructive, central and complex sleep apneas during the second time period when data is no longer collected from the first sensor.

5. The method of claim 1, wherein the data acquisition system comprises the first and an additional third sensors having signals, the sensors including a respiratory effort belt sensor, and a pulse oximetry sensor;

and the second sensor of 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 all three 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.

6. The method of claim 1, wherein the separate PAP or CPAP device is automatically titrated or adjusted based on physiological signals that are specific to the subject being treated for improved treatment during the second time period when data is no longer collected from the first sensor.

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

providing a first sensor for collecting data, a portable data acquisition system, and a PAP or CPAP device separate from the data acquisition system to a subject, the data acquisition system comprising a data acquisition box and being capable of receiving an electrical signal from the first sensor and transmitting data based in part on the electrical signal from the first sensor, and the separate PAP or CPAP device having a second integrated sensor with an electrical signal, the PAP or CPAP device capable of receiving a command signal or being manually adjusted and delivering a flow of pressurized gas to the subject;

attaching the first sensor to the subject;

connecting, before or after attaching the first sensor to the subject, the first sensor to the data acquisition box;

concurrently providing therapy during a first time period to the subject with the PAP or CPAP device while data is being collected from the first sensor;

collecting electrical signals from both the first and second sensors for the first time period while the subject attempts to sleep at home or at a facility remote from a sleep analysis lab while the subject uses the PAP or CPAP device;

transmitting data collected during the first time period, based in part on the signal from the second sensor, from the PAP or CPAP device via cellular service;

transmitting data collected also during the first time period, based in part on the signal from the first sensor, from the data acquisition box via cellular service;

receiving the data from both the devices at a remote data storage station; and

delivering a command signal via cellular service to adjust the flow or manually adjusting the flow of the PAP or CPAP device based in part on analysis of the data from both the first and second sensors received at the remote data storage station to improve therapy to the subject utilizing the PAP or CPAP during a second time period after the first time period when data is no longer collected from the first sensor.

8. The method of claim 7, wherein the data acquisition box and the PAP or CPAP device each have a wireless RF connection and can communicate directly with each other through the wireless connection in real-time.

9. The method of claim 7, wherein the data from the first and second sensors is in part transmitted from both devices in real-time.

10. The method of claim 7, wherein the steps of the method can be used to adjust and titrate the PAP or CPAP device to better identify and distinguish between obstructive, central and complex sleep apneas after the time period when data is no longer collected from the first sensor.

11. A The method of claim 7, wherein the separate PAP or CPAP device is automatically titrated or adjusted based on physiological signals from the data acquisition system that are specific to the subject being treated for improved treatment during the second time period when data is no longer collected from the first sensor.

12. The method of claim 7, wherein the data acquisition system comprises an additional third sensor having a signal, the sensors including a respiratory effort belt sensor, and a pulse oximetry sensor;

and the second integrated sensor of 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 all three 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.

13. The method of claim 12, wherein the PAP or CPAP device is adjusted or titrated by utilizing more robust data collection, by relating the data from the first sensor to the second sensor for improved treatment during the second time period when data is no longer collected from the first sensor.

14. The method of claim 12, wherein the data acquisition system comprises an additional fourth sensor for determining body position of the subject.

15. A method of treating sleep-related breathing disorders comprising steps of:

providing a portable data acquisition system, and a PAP or CPAP device separate from the data acquisition system to a subject, the data acquisition system comprising a data acquisition box having a first sensor for collecting data and adapted for receiving an electrical signal from the first sensor and transmitting data based at least in part on the electrical signal from the first sensor, and the PAP or CPAP device having a second integrated sensor and adapted for receiving data from the data acquisition box and delivering a flow of pressurized gas to the subject;

attaching the first sensor to the subject;

connecting, before or after attaching the first sensor to the subject, the first sensor to the data acquisition box;

concurrently providing therapy during a first time period to the subject with the PAP or CPAP device while data is being collected from the first sensor;

collecting electrical signals from the first sensor attached to the subject while the subject attempts to sleep at home or at a facility remote from a sleep analysis lab over the first time period while using the PAP or CPAP device;

collecting electrical signals from the second integrated sensor on the PAP or CPAP device during the same first time period

transmitting data, based in pan on the electrical signal from the first sensor, from the data acquisition box to the PAP or CPAP device for analysis;

analyzing or reviewing at least in part data from both the first and second sensors to calculate a command signal or to determine the manual titration or adjustment of the PAP or CPAP device to improve therapy to the subject utilizing the PAP or CPAP during a second time period after the first time period when data is no longer collected from the first sensor; and

titrating or adjusting the flow of pressurized gas delivered by the PAP or CPAP device to the subject.

16. The method of claim 15, wherein the data acquisition box and the PAP or CPAP device each have a wireless RF connection and can communicate directly with each other through the wireless connection in real time.

17. The method of claim 15, wherein the data from the first and second sensors is in part transmitted by cellular service to the remote data storage station for review remotely by medical personnel, and the medical personnel provide the command signal transmitted by cellular service 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.

18. The method of claim 15, wherein the steps of the method can be used to adjust or titrate the PAP or CPAP device to better identify and distinguish between obstructive, central and complex sleep apneas during the second time period when data is no longer collected from the first sensor.

19. The method of claim 15, wherein the data acquisition system comprises an additional third sensor having a signal, the sensors including a respiratory effort belt sensor, and a pulse oximetry sensor;

and the second integrated sensor of 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 all three sensors to improve therapy to the subject utilizing the PAP or CPAP during the second time period when data is no longer collected from the first and third sensors.

20. The method of claim 15, wherein the PAP or CPAP is adjusted or titrated in real-time.