# US 12,213,775 B1 · Devices and methods for sleep disorder diagnosis and treatment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,775 B1 - Document ID: US12213775B1 - Status: Granted - Kind: B1 - Application number: 18/510,801 - Filed: 2023-11-16 - Granted: 2025-02-04 - Earliest claimed: 2005-11-04 - Assignees: Cleveland Medical Devices Inc. - Applicants: Cleveland Medical Devices Inc. - Inventors: Hani Kayyali; Robert N. Schmidt; Mohammad Modarres-Zadeh; Brian Kolkoski - Web page: https://patentgrep.com/patent/US12213775B1 ## CPC - A61B 5/085: Measuring impedance of respiratory organs or lung elasticity - A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature} - A61B 5/4815: {Sleep quality} - A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation} - 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} - A61M 16/0051: {with alarm devices} - A61M 2016/0027: {pressure meter} - A61M 2016/0039: {in the inspiratory circuit} - A61M 2202/0208: Oxygen - A61M 2205/3553: remote, e.g. between patient's home and doctor's office - A61M 2205/3561: local, e.g. within room or hospital - A61M 2205/3584: using modem, internet or Bluetooth® - A61M 2205/3592: using telemetric means, e.g. radio or optical transmission - A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation - A61M 2230/10: Electroencephalographic signals - A61M 2230/14: Electro-oculogram [EOG] - A61M 2230/202: partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2) - A61M 2230/205: partial oxygen pressure (P-O2) - A61M 2230/60: Muscle strain, i.e. measured on the user - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## 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 method of sleep diagnosis and treatment. ## Claims ### Claim 1 A positive airway pressure (PAP) sleep disorder treatment system comprising: a non-transitory computer readable medium comprising a first software, the first software adapted to be downloaded to a cell phone and executable by a first processor on the cell phone to display to a subject for viewing on the cell phone a treatment efficacy of the subject using a PAP device, the treatment efficacy based in whole or in part on a data based on one or more measure(s) of the treatment efficacy received by the first software, the cell phone comprising at least one first radio frequency wireless transceiver, the first processor, the first software when downloaded, and a display; the PAP device with an enclosure further comprising: a blower having an air output within the enclosure, an airflow sensor being any type of sensor internal to the enclosure of the PAP device adapted for measuring or deriving the respiratory airflow of a subject while using the PAP device and outputting airflow sensor data, a second processor within the enclosure adapted for receiving the airflow sensor data and for calculating the one or more measures of the treatment efficacy comprising: i) the data of a severity of the sleep disorder symptoms of the subject, ii) the data of usage of the PAP device by the subject, and/or iii) the index based in whole or in part on either i) or ii) or both i) and ii), a mask or a nasal cannula connected to the enclosure, and at least one second radio frequency wireless transceiver within the enclosure, the at least one second radio frequency wireless transceiver adapted for transmitting a PAP data based in whole or part on at least one of the one or more measures of treatment efficacy calculated by the second processor; and a remote internet site, the remote internet site adapted for receiving the PAP data or data based on the at least one of the one or more treatment efficacy measures, related to the subject's treatment and the treatment's efficacy in whole or part, generated by the PAP device and transmitted via the at least one second radio frequency wireless transceiver. ### Claim 2 (depends on 1) The system of claim 1, wherein the remote internet site is adapted to be hosted on a remote communication system with a third processor and a recording medium for reprocessing, storing and/or outputting data received from the first and/or second radio frequency wireless transceiver in whole or part, and to further output the reprocessed and/or the outputted data. ### Claim 3 (depends on 2) The system of claim 2, wherein the at least one second radio frequency wireless transceiver of the PAP device and the first radio frequency wireless transceiver of the cell phone are adapted to communicate using Bluetooth wireless protocol. ### Claim 4 (depends on 2) The system of claim 2, wherein the at least one second radio frequency wireless transceiver is adapted to transmit the data to the remote internet site in whole or in part via cell towers. ### Claim 5 (depends on 4) The system of claim 4, wherein the at least one second radio frequency wireless transceiver of the PAP device and the first radio frequency wireless transceiver of the cell phone are adapted to communicate using Bluetooth wireless protocol. ### Claim 6 (depends on 4) The system of claim 4, the PAP device further comprising at least one second software stored on a memory and executed by the second processor, the at least one second software which is adapted for calculating the data in whole or in part, wherein the PAP device is further adapted to be reprogrammed or to modify the at least one second software from the remote internet site or a second remote internet site. ### Claim 7 (depends on 5) The system of claim 5, the PAP device further comprising at least one second software stored on a memory and executed by the second processor, the at least one second software which is adapted for calculating the data in whole or in part, wherein the PAP device is further adapted to be reprogrammed or to modify the at least one second software from the remote internet site or a second remote internet site. ### Claim 8 (depends on 1) The system of claim 1, wherein the PAP device further comprises at least one electronic component adapted to allow the PAP device to be adjusted remotely based on the data received by the remote internet site. ### Claim 9 (depends on 1) The system of claim 1, wherein the first software is adapted to be reprogrammed or modified remotely. ### Claim 10 (depends on 2) The system of claim 2, wherein the airflow sensor data is processed by the second processor, at least in part using one or more of the signal processing techniques from the group consisting of a standard deviation technique, a recursively fit ARMAX system identification model, a short-time Fourier transform technique, a discrete Fourier transform technique, a fast Fourier transform technique, a time-frequency signal analysis with a variety of different kernels, and a wavelet analysis. ### Claim 11 (depends on 4) The system of claim 4, wherein the airflow sensor data is processed by the second processor, at least in part using one or more of the signal processing techniques from the group consisting of a standard deviation technique, a recursively fit ARMAX system identification model, a short-time Fourier transform technique, a discrete Fourier transform technique, a fast Fourier transform technique, a time-frequency signal analysis with a variety of different kernels, and a wavelet analysis. ### Claim 12 (depends on 2) The system of claim 2, wherein the remote internet site is adapted to retransmit the data to the first radio frequency wireless transceiver on the cell phone, in whole or in part, of i) and ii), or i), ii), and iii) related to the data of the subject's treatment and the treatment's efficacy calculated and transmitted by the PAP device. ### Claim 13 (depends on 4) The system of claim 4, wherein the remote internet site is adapted to retransmit to the first radio frequency wireless transceiver on the cell phone the data, in whole or in part, the the data of the subject's treatment and the treatment's efficacy calculated and transmitted by the PAP device. ### Claim 14 (depends on 2) The system of claim 2, wherein the PAP device further comprises an adaptive controller to adjust the flow of the blower based in part on the data of the severity of the symptoms of the subject calculated by the second processor. ### Claim 15 (depends on 14) The system of claim 14, wherein the PAP device further comprises an adaptive predictive controller to adjust the flow of the blower based in part on the data of the severity of the symptoms of the subject calculated by the second processor. ### Claim 16 (depends on 2) The system of claim 2, wherein the remote communication system is further adapted to output a report and/or the reprocessed and/or outputted data to a printer and/or a second display for review by a clinician to determine the treatment efficacy. ### Claim 17 (depends on 13) The system of claim 13, wherein the remote communication system is further adapted to output a report and/or the reprocessed and/or outputted data to a printer and/or a second display for review by a clinician to determine the treatment efficacy. ### Claim 18 (depends on 2) The system in claim 2, wherein the second processor of the PAP device is configured to distinguish between and calculate the severity of both obstructive apneas and central apneas of the subject during a treatment with the PAP device. ### Claim 19 (depends on 10) The system in claim 10, wherein the second processor of the PAP device is configured to distinguish between and calculate the severity of both obstructive apneas and central apneas of the subject during a treatment with the PAP device. ### Claim 20 A positive airway pressure (PAP) sleep disorder treatment system comprising: a non-transitory computer readable medium comprising a first software, the first software adapted to be downloaded to a cell phone and executable by a first processor on the cell phone to display to a subject for viewing on the cell phone a treatment efficacy of the subject using a PAP device, the treatment efficacy based in whole or in part on a data based on one or more measure(s) of the treatment efficacy received by the first software, the cell phone comprising at least one first radio frequency wireless transceiver, the first processor, the first software when downloaded, and a display; the PAP device with an enclosure further comprising: a blower having an air output within the enclosure, an airflow sensor being any type of sensor internal to the enclosure of the PAP device adapted for measuring or deriving the respiratory airflow of a subject while using the PAP device and outputting airflow sensor data, a second processor within the enclosure adapted for receiving the airflow sensor data and for calculating the one or more measures of the treatment efficacy comprising: i) the data of a severity of the sleep disorder symptoms of the subject, ii) the data of usage of the PAP device by the subject, and/or iii) the index based in whole or in part on either i) or 11) or both 1) and ii), a mask or a nasal cannula connected to the enclosure, and at least one second radio frequency wireless transceiver within the enclosure, the at least one second radio frequency wireless transceiver adapted for transmitting a PAP data based in whole or part on at least one of the one or more measures of treatment efficacy calculated by the second processor; the non-transitory computer readable medium or a second non-transitory computer readable medium comprising a second software adapted to be executable the first processor on the cell phone or a third processor on a portable, wearable patient data acquisition device comprising a pulse oximeter and an accelerometer the portable, wearable patient data acquisition device adapted to wore on the subject's finger to collect additional physiological data from the subject while using the PAP device for combining with the data collected by the PAP device, the second software further adapted to forward the additional physiological data to combine with the data from the PAP device to determine the treatment efficacy of the subject using the PAP device; and a remote internet site, the remote internet site adapted for receiving the PAP data or data based on the at least one of the one or more treatment efficacy measures, related to the subject's treatment and the treatment's efficacy in whole or part, generated by the PAP device and transmitted via the at least one second radio frequency wireless transceiver, and the additional physiological data collected with the portable, wearable patient acquisition device.