SYSTEMS AND METHODS FOR NON-CONTACT MULTIPARAMETER VITAL SIGNS MONITORING, APNEA THERAPY, APNEA DIAGNOSIS, AND SNORE THERAPY

• US 20130030257A1
• Filed: 11/16/2011
• Published: 01/31/2013
• Est. Priority Date: 05/14/2010
• Status: Abandoned Application

• Current Assignee: ResMed Sensor Technologies Limited (ResMed Incorporated)
• Original Assignee: Kai Medical, Inc.
• Inventors: Nakata, Robert, Mostafanezhad, Isar, Miyasato, Scott
• Application Number:
  US13/298,248
• Publication Number:
  US 20130030257A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• 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 5/6822 Neck
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G01S 13/50 Systems of measurement based on relative movement of target
• CPC Class Codes: G01S 13/534 based upon amplitude or phase shift resulting from movement of objects, with reference to the surrounding clutter echo signal, e.g. non coherent MTi, clutter referenced MTi, externally coherent MTi
• CPC Class Codes: G01S 13/825 with exchange of information between interrogator and responder
• CPC Class Codes: G01S 13/87 Combinations of radar systems, e.g. primary radar and secondary radar
• CPC Class Codes: G01S 13/88 : Radar or analogous systems specially adapted for specific applications electromagnetic prospecting or detecting of objects, e.g. near-field detection, G01V3/00
• CPC Class Codes: G01S 7/003 : Transmission of data between radar, sonar or lidar systems and remote stations
• CPC Class Codes: G01S 7/2886 : using I/Q processing
• CPC Class Codes: G01S 7/358 : using I/Q processing

Abstract

Aspects of the of the disclosure relate to a non-contact physiological motion sensor and a monitor device that can incorporate use of the Doppler effect. A continuous wave of electromagnetic radiation can be transmitted toward one or more subjects and the Doppler-shifted received signals can be digitized and/or processed subsequently to extract information related to the cardiopulmonary motion in the one or more subjects. The extracted information can be used, for example, to determine apneic events and/or snoring events and/or to provide apnea or snoring therapy to subjects when used in conjunction with an apnea or snoring therapy device. In addition, methods of use are disclosed for sway cancellation, realization of cessation of breath, integration with multi-parameter patient monitoring systems, providing positive providing patient identification, or any combination thereof.

Claims

1. A system for treating sleep apnea, said system comprising one or more of the following:

a wireless sleep monitor comprising;

one or more antennas, each of the one or more antennas configured to perform one or more of the following;

receive electromagnetic radiation and transmit electromagnetic radiation;

one or more processors configured to extract information related to cardiopulmonary motion by executing at least one of a demodulation module, a non-cardiopulmonary motion detection module, and a rate estimation module;

the one or more processors further configured to detect an apneic event; and

a communications module configured to communicate with a therapeutic device, said therapeutic device configured to perform at least one action related to a sleep apnea state of the subject; and

a therapeutic device comprising a bio-feedback mechanism configured to stimulate an anatomical region of the patient when an apnea event is detected.

2. The system of claim 1, wherein the therapeutic device is configured to stimulate the hypoglossal nerve.

3. The system of claim 1, wherein the therapeutic device is configured to stimulate the hypoglossal nerve noninvasively.

4. The system of claim 1, wherein the wireless sleep monitor includes a vital signs sensor configured to generate information associated with at least one of a beginning, a status, and an ending of an apneic state of the subject.

5. The system of claim 1, wherein the apnea therapy device comprises at least one selected from the group consisting of:

a microphone embedded in the therapeutic device to monitor airflow, a nasal airflow sensor as an auxiliary airflow monitor;

acoustic stethoscopes to detect respiration, a pulse oximeter sensor to detect oxygen saturation and heart rate;

an accelerometer sensor to detect body motion, contact chest and abdomen sensors to detect ventilatory effort paradoxical breathing, respiration rate, a strain gauge sensor, and a PVDF sensor to detect movement in response to stimulation.

6. The system of claim 4, wherein one or more sensors can be coupled with a sensor processing unit configured to process detected apneic events.

7. The system of claim 1, wherein the therapeutic device comprises a vibratory stimulus of progressively increasing pulse width and pulse repetition rate.

8. The system of claim 1, wherein the therapeutic device comprises at least one selected from the group consisting of:

a wrist worn device, pillow, mattress, clothing, and a skin-contact vibrating transducer configured to stimulate the a nerve of the subject.

9. The system of claim 1, wherein the therapeutic device includes one or more visual indicators configured to activate in response to a received intensity signal.

10. The system of claim 1, wherein the sensor processing unit or wireless sleep monitor is configured to communicate with the therapeutic device via one or more selected from the group of communication protocols consisting of:

wired, Mini HDMI, USB, Bluetooth, Zigbee, Wi-Fi, Ethernet, and Cellular.

11. The system of claim 1, wherein the wireless sleep monitor, sensor processing unit and/or therapeutic device are configured to be capacitively coupled to automatically power on when placed in use.

12. The system of claim 1, wherein the therapeutic device comprises a battery, the battery having an indicator supplying information regarding the condition of the battery.

13. The system of claim 1, wherein the system comprises communications hardware and software.

14. The system of claim 1, wherein at least a portion of the system is operably connected to a computing device configured to receive information from the system.

15. The system of claim 14, wherein the system comprises an embedded processor to process the signals and control communications with the computing device

16. The system of claim 1, wherein the therapeutic device is disposable.

17. The system of claim 1, wherein the system comprises software configured to assess the severity of apnea of the patient.

18. The system of claim 1, wherein the therapeutic device comprises a neck patch constructed from biocompatible materials.

19-48. -48. (canceled)

49. A system for sensing a physiological motion, said system comprising

one or more sources for generating electromagnetic radiation, wherein the frequency of the generated electromagnetic radiation is in the radio frequency range;

one or more communications modules configured to perform at least one of the following;

transmit the generated electromagnetic radiation towards a subject and receive a radiation scattered at least by the subject;

one or more antennas, each of the one or more antennas configured to perform at least one of the following;

transmit electromagnetic radiation and receive electromagnetic radiation;

one or more processors configured to;

extract information related to cardiopulmonary motion by executing at least one of a demodulation algorithm, a non-cardiopulmonary motion detection algorithm, a rate estimation algorithm, a paradoxical breathing algorithm and a direction of arrival algorithm;

analyze the signal to obtain information corresponding to a non-cardiopulmonary motion or other signal interference;

extract a Doppler shifted signal from the scattered radiation; and

transform the Doppler shifted signal to a digitized motion signal, said digitized motion signal comprising one or more frames, wherein the one or more frames comprise time sampled quadrature values of the digitized motion signal;

isolate a signal corresponding to a physiological movement at least a portion part of the subject;

obtain information corresponding to the physiological movement of at least a portion of the subject based on the isolated signal, said information substantially separate from at least one of said non-cardiopulmonary motion and other signal interference; and

estimate one or more of the group consisting of;

non-contact, spot, interval and continuous vital signs parameters and communicate the information to an output system that is configured to perform an output action;

wherein the system is configured to perform at least one of the following;

screen a sleep disorder, diagnose a sleep disorder, and provides therapy for the sleep disorder without awakening a patient from sleep.

50. The system of claim 49, wherein the system is configured to estimate at least one or more of:

respiration rate, heart rate, cessation of breath, and apneic events.

51. A method for treating sleep apnea, the method comprising:

detecting, via a wireless sleep monitor and/or a sensor processing unit an apneic event associated with a subject; and

transmitting information related to the apneic event to a therapeutic device configured to stimulate a nerve region in the subject'"'"'s neck when an apnea event is detected.

52. The method of claim 51, further comprising the steps of:

transmitting information associated with breathing of the subject from the therapeutic device to the wireless sleep monitor and/or sensor processing unit;

detecting, via the wireless sleep monitor and/or sensor processing unit, that the subject has resumed breathing within a normal range of breathing; and

in response to detecting that the subject has resumed breathing, causing a command to be sent to the therapeutic device to stop the stimulation signal.

53. The method of claim 51, further comprising causing the therapeutic device to enter an idle state in response to detecting that the subject has resumed breathing.

54. A method of detecting an apneic event, the method comprising:

monitoring an instantaneous amplitude over time of a respiratory signal by squaring the respiratory signal and filtering the respiratory signal via a moving average filter;

generating a cumulative histogram of the instantaneous amplitude;

setting one or more thresholds for a low breathing amplitude based on the cumulative histogram;

determining one or more apneic timespans based on comparing the instantaneous amplitude to at least one of the one or more thresholds within the time span associated with valid physiological motion; and

reporting timestamps corresponding to at least one apneic event.

55. A system for diagnosing sleep apnea, said system comprising:

a wireless sleep monitor comprising;

one or more antennas, each of the one or more antennas configured to perform one or more of the following;

receive electromagnetic radiation and transmit electromagnetic radiation;

one or more processors configured to extract information related to cardiopulmonary motion by executing at least one of a demodulation module, a non-cardiopulmonary motion detection module, and a rate estimation module;

the one or more processors further configured to detect an apneic event; and

a communications module configured to communicate with a therapeutic device, said therapeutic device configured to perform at least one action related to a sleep apnea state of the subject; and

a sensor processing unit for processing detecting apneic events.

56. The system of claim 55, wherein the wireless sleep monitor comprises a vital signs sensor configured to generate information associated with at least one of a beginning, a status, and an ending of an apneic state of the subject.

57. The system of claim 55, wherein the system comprises at least one sensor selected from the group consisting of:

a nasal airflow sensor as an auxiliary airflow monitor;

a pulse oximeter sensor to detect oxygen saturation and heart rate;

an accelerometer sensor to detect body motion;

one or more of a contact chest and abdomen sensor for detecting one or more of the group selected from ventilatory effort, paradoxical breathing, and respiration rate; and

a strain gauge sensor to detect movement in response to stimulation.

58. The system of claim 57, wherein at least one of the sensors is in communication with a sensor processing unit.

59. The system of claim 55, wherein the system comprises one or more selected from the group consisting of:

a data storage module, a web interface, a display, user interface and controls, a clock, recording hardware and software, communications hardware, and communications software.

60. The system of claim 55, wherein at least one of the wireless sleep monitor and the sensor processing unit is in communication with a computing device.

61. The system of claim 55, wherein at least one of the wireless sleep monitor and the sensor processing unit comprises an embedded processor to process the signals and control the inter-sensor communications to relay data to an external computing device.

62. A system for detecting and treating snoring, the system comprising:

a therapeutic device comprising a bio-feedback mechanism configured to stimulate a nerve in the subject'"'"'s neck when a snoring event is detected.

63. The system of claim 62, wherein the therapeutic device comprises one or more selected from the group consisting of a microphone, acoustic stethoscope, and a transducer configured to utilize a snoring detection algorithm to determine the onset of a snoring event.

64. The system of claim 62, wherein the therapeutic device comprises a vibratory stimulus of increasing pulse width and pulse repetition rate.

65. The system of claim 62, wherein the therapeutic device comprises one or more selected from the group consisting of:

a wrist worn device, pillow, mattress, clothing, and a skin-contact vibrating transducer configured to stimulate a nerve in the subject.

66. The system of claim 62, wherein the therapeutic device comprises one or more of a vibration transducer and electrodes configured to produce electrical signals to produce vibrations to stimulate the subject'"'"'s neck muscles which will increase in sensation until the snoring event is stopped.

67. The system of claim 62, wherein the therapeutic device is configured to be coupled with a separate stand-alone device selected from the group consisting of:

a sensor, smartphone, and a computer tablet.

68. The system of claim 62, wherein the therapeutic device is configured to be capacitively coupled to automatically power on when placed in use.

69. The system of claim 62, wherein the therapeutic device comprises a battery having an indicator of battery condition

70. The system of claim 62, wherein the therapeutic device comprises one or more selected from the group consisting of:

storage of data, a web interface, a display, user interface and controls, a clock, recording hardware and software, and communications hardware and software.

71. The system of claim 62, wherein the therapeutic device comprises an embedded processor to process the signals and control the inter-sensor communications to relay data to the stand alone device.

72. A method of treating apnea, comprising:

detecting an apneic event of a patient via one or more sensors;

sending information regarding the apneic event from the sensor to a sensor processing unit;

sending a command from the sensor processing unit to a therapeutic device operably connected to an anatomical location of the patient, thereby activating the therapeutic device; and

terminating the apneic event via the therapeutic device.

73. The method of claim 72, wherein the therapeutic device comprises a neck patch.

74. The method of claim 72, wherein terminating the apneic event comprises stimulating the hypoglossal nerve of the patient.

75. The method of claim 74, wherein stimulating the hypoglossal nerve is accomplished invasively.

76. The method of claim 74, wherein stimulating the hypoglossal nerve is accomplished non-invasively.

77. The method of claim 72, wherein the sensors are positioned in a location remote to the patient.

78. The method of claim 72, wherein the sensors are directly attached to the patient.