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1. (WO2019027491) RESPIRATION MONITOR SYSTEM WITH SENSORY ALERT
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RESPIRATION MONITOR SYSTEM WITH SENSORY ALERT

FIELD OF INVENTION

[001] This application claims the benefit of U.S. Provisional Application Serial No. 62/538887, filed July 31, 2017. The disclosure of the prior application is incorporated herein in its entirety by reference.

FIELD OF INVENTION

[002] The present general inventive concept generally relates to respiration monitor systems, and more particularly to health and respiration monitor systems having a sensory alert system used to physically, visually, and/or audibly alert a user based on biological signals measured from the user.

[003] The present general inventive concept also relates to respiration monitoring systems and sleep apnea systems with stimulation, and more particularly to sleep apnea and respiration monitoring and stimulating systems and methods designed to deliver stimuli to awaken a user based on biological signals measured from the user, including respiration. The system is designed to deliver stimuli to awaken a user with sleep apnea or other respiratory ailment or to provide an alert to healthy users based on biological signals measured from the user.

Description of the Related Art

[004] Sleep apnea is a sleep disorder which is characterized by brief pauses in breathing during sleep. Many elderly people having various types of health conditions may often pass away during sleep due to these brief pauses in breathing. Respiration typically refers to the amount of one's breathing in and out cycles per minute. Most people breathe in and out about 12 to 20 times per minute. However, when a person is ill with lung or heart disease or other respiratory conditions, their respiration rate should be monitored to determine whether their condition is getting worse to prevent premature deaths.

[005] One solution that has been previously developed includes using a monitor which projects a beam at a sleep surface to detect a motion of a user's body. However, this solution is cumbersome and only monitors motion which is not an accurate measure of proper respiration and fails to provide a method of alerting and waking up the user to prevent a premature death.

[006] In addition, many people around the world are health conscious and strive to obtain

optimal physical health. As a result, these people often monitor their heart rates and/or respiration to make sure they are optimizing their work outs. However, there currently are no solutions which allows a user to define an ideal heart rate range and which can then alert the user when their heart rate is out of this range, without requiring the user to stop working out and checking a display.

[007] Therefore, what is desired is a convenient wearable and effective health status and sleep apnea monitor that can detect and monitor a user's heart rate and low or no respiration condition and then to alarm or trigger an external device to deliver a stimulus to the user or perform a predetermined action defined by the user to awake or alert a user who is asleep or desires to maintain a certain level of respiration or heart rate.

BRIEF SUMMARY OF THE INVENTION

[008] The present general inventive concept generally relates to a health status monitor, and more particularly to a health monitor and sleep apnea monitor system that is designed to communicate to a plurality of sensors and external devices, including heart rate sensors and pacemakers.

[009] The present general inventive concept also generally relates to a health status monitoring system, and more particularly to a health status and alert system that is designed to communicate to a plurality of sensors and external devices, including heart rate and respiration sensors and to deliver a stimulus to the user if the user's heart rate and/or respiration falls outside of a user defined range.

[0010] The present general inventive concept also generally relates to a respiration monitoring system, and more particularly to a sleep apnea and/or respiration monitor system that is designed to communicate to a plurality of sensors and external devices, including pacemakers to deliver a stimulus to the user if the user's respiration falls below a predetermined threshold.

[0011] Additional aspects of the present general inventive concept will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the general inventive concept.

[0012] The foregoing and/or other aspects of the present general inventive concept may be achieved by providing a health status monitor system configured for monitoring and alerting a user based on a determined health condition of the user, the system includes one or more sensors configured to measure biological signals of a user used to determine a health condition of the user, a stimulation device in communication with the user used to generate a stimulation, and a

processor configured by machine-readable instructions to: receive the measured biological signals from the one or more sensors, determine a health status of the user based on the measured biological signals, determine whether the health status of the user is in a first condition when the measured biological signals are within a predetermined range, and in a second condition when the measured biological signals are above or below the predetermined range, send an activate signal to the stimulation device to deliver an alert to the user when the health status is in the second condition, and send a deactivate signal to the stimulation device to deactivate the stimulation device when the health status is in the first condition.

[0013] The one or more sensors may include a heart rate sensor and an oxygen saturation sensor configured to measure oxygen saturation signals of the user that are used to calculate the health status of the user.

[0014] The processor may be further configured by machine-readable instructions to: receive, while the user is resting, heart rate signals from the heart rate sensor coupled to the user, determine a first condition of the user based on the received heart rate signals and user information, and define the predetermined range as the determined first condition of the user.

[0015] The predetermined range may be a user specific ideal aerobic training heart-range calculated based on the received heart rate signals and user information.

[0016] The stimulation device may include a visual display, an electrical pulse generator, an audible sound generator, a vibration generator, a heater device, and a cooling device.

[0017] The stimulation device may generate an audible sound using the audible sound generator when the processor determines that the user's heart rate is below or above the user specific ideal aerobic training heart range.

[0018] The foregoing and/or other aspects of the present general inventive concept may also be achieved by providing a health status and sleep apnea monitor system configured for monitoring and stimulating a user based on a determined health condition of the user, the system includes one or more sensors configured to measure biological signals of a user used to determine a health condition of the user, a stimulation device in communication with the user used to generate a stimulation, and a processor configured by machine-readable instructions to: receive the measured biological signals from the one or more sensors, determine a health status of the user based on the measured biological signals, determine whether the health status of the user is a first condition when the measured biological signals are below a predetermined level, and a second condition

when the measured biological signals are above the predetermined level, send an activate signal to the stimulation device to deliver a stimulation to the user when the health status is in the second condition, and send a deactivate signal to the stimulation device to deactivate the stimulation device when the health status is in the first condition.

[0019] The one or more sensors may include an oxygen saturation sensor configured to measure oxygen saturation signals of the user that is used to determine the health status of the user.

[0020] The processor may be further configured by machine-readable instructions to: receive, while the user is asleep, the oxygen saturation signals from the oxygen saturation sensor of the user, determine a first condition oxygen saturation of the user based on the received signals, and define the predetermined level as the determined first condition oxygen saturation.

[0021] The one or more sensors may include an electrocardiogram configured to measure heart activity signals of the user that is used to determine the health status of the user.

[0022] The processor may be further configured by machine-readable instructions to: receive, while the user is asleep, the heart activity signals of the user, determine a first condition heart activity baseline of the user based on the received heart activity signals, and define the predetermined level as the determined first condition heart activity baseline.

[0023] The stimulation device may include an electrical pulse generator, an audible sound generator, a vibration generator, a heater device, and a cooling device.

BRIEF DESCRIPTION OF THE FIGURES

[0024] These and/or other aspects of the present general inventive concept will become apparent and more readily appreciated from the following description of the various embodiments, taken in conjunction with the accompanying drawings of which:

[0025] FIG. 1 illustrates a schematic view of a health status monitor and stimulation system according to one or more embodiments of the present general inventive concept;

[0026] FIG. 2 illustrates a front perspective view of a health status monitor and stimulation according to one or more embodiments of the present general inventive concept;

[0027] FIG. 3 illustrates a front view of the health status monitor and stimulation system illustrated in FIG. 2;

[0028] FIG. 4 illustrates a back view of the health status monitor and stimulation system illustrated in FIG. 2;

[0029] FIG. 5 illustrates the health status monitor and stimulation system illustrated in FIG. 2 coupled to a user's arm; and

[0030] FIG. 6 illustrates a method for monitoring and stimulating a user based on a determined health condition of the user.

DETAILED DESCRIPTION OF PREFERRED EMB ODEVIENT S

[0031] The present general inventive concept relates to a health status and alert system that is designed and/or configured to communicate to a plurality of sensors and external devices, including heart rate and respiration sensors and to deliver a stimulus to the user if the user's heart rate and/or respiration falls outside of a user defined range.

[0032] The health status and alert system may be used to physically, visually, and/or audibly alert a user that his or her heart rate, respiration rate, or other biological health measurement has fallen below or outside a predefined ideal range. The type and intensity of the alert or stimulation delivered to the user may also be defined by the user so as to be sufficient to alert the user of his or her heart rate, respiration rate, or other biological health measurement without disrupting the user's workout. For instance, the user may define a user specific ideal aerobic training heart-rate for fat burning using conventionally known methods.

[0033] In an alternative exemplary embodiment, the health status and alert system according to the present general inventive concept may automatically determine and define the user specific ideal aerobic training heart-rate range based on user data received from an external server, such as a web site. The user may enter information including age and resting heart rate. The system may then calculate the user specific ideal aerobic training heart rate range by first determining the users maximum heart rate by subtracting the user's age from 220. Then, the system may calculate the user's heart-rate reserve by subtracting the user's resting heart rate from the user's maximum heart rate. Next, the system would then define the user specific ideal aerobic training heart-rate range as 50 to 75 percent of the user's heart-rate reserve. For example, for a user having an age of 40 and a resting heart rate of 80 beats per minute, the user specific ideal aerobic training heart rate range is between 130 to 155 beats per minute. The sample calculation is as follows:

Age: 40

Resting heart rate: 80 beats per minute

Maximum Heart Rate: (220-40) = 180

Heart Rate Reserve: (180 - 80) = 100 beats per minute

Fat-burning range: 50% to 75% of Heart Rate Reserve = 50-75

Adding resting heart rate to range:(50+80 = 130) to (75+80 =155)

[0034] The health status and alert system may be used to automatically alert and/or deliver a stimulus to the user if the user's heart rate falls the predefined ideal range of 130 to 155 beats per minute visually, physically, and/or audibly while the user is working out. As such, the user is allowed to continue his workout knowing that he is maintaining an ideal heart rate within the ideal range in order to maximize the workout results.

[0035] The present general inventive concept also generally relates to a health status monitor and stimulation system that includes at least one monitor or sensor device that attaches to a user and is designed to measure the user's respiration rate and/or various other biological signals and trigger an alarm or external stimulation device to deliver a stimulus to wake up or alert the user if predetermined threshold levels corresponding to the measured respiration rate or other biological signals are reached.

[0036] The health status monitor and stimulation system may be used to physically and/or audibly alert a user that his or her respiration rate has fallen below a predetermined threshold level. The type and intensity of the alert or stimulation delivered to the user may be defined by the user so as to be sufficient to have the user regain control of the user's respiration. For instance, the user may define the stimulation to be an electrical pulse of 0.5 mv having a duration of 2 seconds to wake up the user when sleeping or alert the user when a predetermined level has been achieved. The health status monitor and stimulation system may also be used to trigger, activate, or jump start external stimulation devices, such as pacemakers, if the user's respiration rate falls below the predetermined threshold level.

[0037] A user's lungs expand and contract during the breathing cycle, drawing air in and out of the lungs. Typically, the volume of air moved in or out of the lungs under normal resting conditions, referred as resting tidal volume, is about 500ml. Normal respirations range between to 20 times per minute. However, people with respiratory ailments may need to count the number of respirations (in and out breathing cycles), since a change in a person's respiration rate may indicate that the person's condition may be getting worse.

[0038] The health status monitor system may also be used to send a signal (via all conventional signal transmission means, including wireless, WIFI, IR, and Bluetooth™) to audibly alert and physically jolt the user if the plurality of sensors detect the user's respiration rate has suspended or has fallen below the predetermined threshold level. The system may physically jolt the user awake by using a wide range of mechanical devices, temperature generating devices (e.g., heat or cold) or electrical pulses. However, the present general inventive concept is not limited thereto.

[0039] Sleep apnea refers to a sleep disorder which is characterized by brief pauses in breathing during sleep. Many elderly people having various types of health conditions may often pass away (i.e., die) during sleep due to these brief pauses in breathing. Respiration typically refers to the amount of one's breathing in and out cycles per minute. Most people breathe in and out about 12 to 20 times per minute. However, when a person is ill with lung or heart disease or other respiratory condition, their respiration rate should be continuously monitored to determine whether their condition is getting worse to prevent premature deaths. The term apnea hypopnea index (AHI) refers to any form of measuring disrupted sleep caused by an unstable airway, including respiratory disturbance index (RDI), probability of obstructive sleep apnea (OSA), and/or other measurements. However, the present general inventive concept is not limited thereto.

[0040] FIG. 1 illustrates a schematic view of a health status monitor and stimulation system 100 according to one or more embodiments of the present general inventive concept. FIG. 2 illustrates a front perspective view of a health status monitor and stimulation system 100 according to one or more embodiments of the present general inventive concept, FIG 3 illustrates a front view of the health status monitor and stimulation system 100 illustrated in FIG. 2, and FIG. 4 illustrates a back view of the health status monitor and stimulation system 100 illustrated in FIG. 2.

[0041 ] Referring to FIG. 1, in an exemplary embodiment, the health status monitor system 100 is designed and/or configured to monitor a user's 10 biological signals and alarm or deliver a stimulation to the user 10 when the user's biological signals fall outside a predetermined threshold or below a predetermined level, when the user 10 is asleep. The stimulation may be performed by using a plurality of physical, electrical, audible devices, such as a pacemaker or various other types of external stimulation devices to alert and wake up a sleeping user 10. However, the present general inventive concept is not limited thereto,

[0042] Referring now to FIGS. 1 through 4, in the present embodiment, the health status and sleep apnea monitor and stimulation system 100 includes a housing 102 which is used to store one or more sensors 1 10, a stimulation device 120 which is used to physically, audibly, and/or electrically stimulate the user 10, a processor or CPU 130 which is coupled to the one or more sensors 110 and configured to control an operation of the stimulation device 120 based on signals (i .e., data) received from the one or more sensors 110 coupled to the user 10.

[0043] FIG. 5 illustrates the health status monitor and stimulation system 100 illustrated in FIG. 2 coupled to a user's 10 arm. Referring to FIG. 5, in exemplary embodiments, the stimulation device 120 may be configured externally of the housing 120 and may further include a wireless pacemaker 120a or various other wireless stimulation devices 120b. However, the present general inventive concept is not limited thereto. The system 100 may receive data from a plurality of

external devices and sensors, including but not limited to heart rate sensors, blood gas sensors, glucose sensors, and temperature sensors.

[0044] In the present embodiment, the health status monitor and stimulation system 100 may include a power supply 132 to provide power, a display device 134 to display a user interface screen 134a, an electronic storage device 136 to electronically store machine-readable instructions and data received from the one or more sensors 110, a wireless transmitter 138 to wirelessly communicate with a network and/or an external stimulation device 120a or 120b, and an alarm device 140 to create an audible and/or visual alert or alarm when the user's 10 biological signals fail above or below predetermined threshold levels electrically coupled to the processor 130.

[0045] In further alternative embodiments, the health status monitor system 100 includes a housing 102 which may be designed and/or configured to be removably coupled to the user 10 such that the one or more sensors 110 directly or indirectly contacts the user 10 to measure biological signals from the user 10. However, the present general inventive concept is not limited thereto.

[0046] In exemplary embodiments, the one or more sensors 1 10 are configured to measure biological signals from the user 10 including, but not limited to, heart rate, blood pressure, body temperature, glucose level, user movement, oxygen saturation, and respiration. However, the present general inventive concept is not limited thereto. In further embodiments, the one or more sensors 1 10 may include an accelerometer, an electrocardiogram to monitor heart activity, a vi sual motion detector, or other motion detector sensors.

[0047] The one or more sensors 1 10 may be used to measure various biological signals used to determine sleep quality, health condition, sleep efficiency index, delta-sleep efficiency index, sleep onset latency, respiratory arousals, and/or other indices of the user's health condition.

[0048] Referring to FIG. 1, in the present embodiment, the health status monitor and stimulation system 100 is configured for monitoring and/or stimulating a user 10 based on a determined health condition of a user 10 using signals measured by one or more sensors 110. The system 100 includes one or more sensors 110 which are configured to measure biological signals of the user

10 and are used to determine a health condition of the user 10, a stimulation device 120 in direct or indirect communication with the user 10 used to deliver various types of stimulation to wake up a sleeping user 10, and a processor 130 configured by machine-readable instructions to control the stimulation device 120 based on data received from the one or more sensors 110.

[0049] In the present embodiment, the processor 130 is configured to receive the measured biological signals from the one or more sensors 1 10, determine a health status of the user 10 based on these measured signals, determine whether the health status of the user 10 is a first condition (i.e., normal condition) when the measured biological signals are below a predetermined level, and a second condition (i.e., abnormal condition) when the measured biological signals are above the predetermined level. The processor 130 may further be configured to automatically send an activation signal 122 to the stimulation device 120 to deliver a stimulation to wake up a sleeping user 10 when the user's health status is determined to be in the second condition and send a deactivation signal 124 to the stimulation device 120 to deactivate the stimulation device 120 when the health status of the user 10 is determined to be in the first condition.

[0050] In exemplary embodiments, the one or more sensors 110 may include an oxygen saturation sensor 112 configured to measure oxygen saturation signals of the user 10, an electrocardiogram device 114 configured to measure heart activity signals of the user 10, and/or a respiratory sensor 116 configured to measure lung activity signals of the user 10.

[0051] In further exemplary embodiments, the one or more sensors 110 may also include a pulse oximeter sensor.

[0052] In the present embodiment, the signals (i.e., data) received from the one or more sensors 110 may be used by the processor 130 to determine whether the health status of the user 10 is in the first condition (i.e., normal) or in the second condition (i.e., abnormal).

[0053] In the present embodiment, the processor 130 may be further configured by machine-readable instructions to receive, while the user 10 is asleep, the oxygen saturation signals from the oxygen saturation sensor of the user, to determine a first condition oxygen saturation of the user 10 based on the received signals, and to define the predetermined level as the first condition oxygen saturation.

[0054] In the present embodiment, the processor 130 may be further configured by machine-readable instructions to receive signals (i.e., data) from the one or more sensors 110 in communication with the user 10, perform various health calculations using the received signals (i.e., data), and analyze the results to determine various health related conditions of the user 10. For instance, when the processor 130 receives oxygen saturation signals from the oxygen saturation sensor 112 coupled to the user 110, the processor 130 calculates the user's 10 oxygen saturation level. The processor 130 may have a predetermined baseline oxygen saturation level corresponding to each user 10 stored within the electronic storage device 136. When the processor 130 receives oxygen saturation signals which are then calculated as being less than the predetermined baseline oxygen saturation level of the user 10, while the user 10 is sleeping, the processor 130 sends an activation signal to the stimulation device 120 to awaken the user.

[0055] When the processor 130 receives oxygen saturation signals which are then calculated as being equal to or greater than the predetermined baseline oxygen saturation level of the user 10, while the user 10 is sleeping, the processor 130 sends a de-activation signal to the stimulation device 120 to deactivate the stimulation device 120, if previously activated.

[0056] In exemplary embodiments, the processor 130 is further configured by machine-readable instructions to receive, while the user 10 is asleep, the oxygen saturation signals from the oxygen saturation sensor 112 of the user, determine a first condition oxygen saturation of the user 10 based on the received signals and define the predetermined level as the determined first condition oxygen saturation.

[0057] In the present embodiment, the one or more sensors 110 include an electrocardiogram device 114 configured to measure heart activity signals of the user 10 that is used to determine the health status of the user 10.

[0058] In the present embodiment, the processor 130 is further configured by machine-readable instructions to receive, while the user is asleep, the heart activity signals of the user, determine a first condition heart activity baseline of the user 10 based on the received heart activity signals, and define the predetermined level as the determined first condition heart activity baseline.

[0059] In exemplary embodiments, the one or more sensors 110 include a respiratory sensor 116 configured to measure respiratory activity signals of the user 10 which are used to determine the health status of the user 10.

[0060] In exemplary embodiments, the processor 130 is further configured by machine-readable instructions to receive, while the user 10 is asleep, the respiratory activity signals of the user 10, determine a first condition respiratory activity baseline of the user 10 based on the received respiratory activity signals, and define the predetermined level as the determined first condition respiratory activity baseline.

[0061] In exemplary embodiments, the stimulation device 120 includes an electrical pulse generator, an audible sound generator, a vibration generator, a heater device, and a cooling device. However, the present general inventive concept is not limited thereto.

[0062] In exemplary embodiments, the health status monitor and stimulation system is used to calculate and analyze data received from a plurality of sensors to determine whether the user's respiration rate has suspended or has fallen below a predetermined threshold level. The processor may then send a display signal to a display device to display the calculated results. In an exemplary embodiment, the processor may display a wide range of health conditions of the user, including the user's heart rate 112a, an emergency situation 112b, and that a physical, heat or cold, or electrical stimulation or jolt is required.

[0063] FIG. 6 illustrates a method for monitoring and stimulating a user based on a determined health condition of the user according to an exemplary embodiment of the present general

inventive concept.

[0064] Referring to FIG. 6, the method begins at step 302 wherein the processor 130 receives signals from the one or more sensors 1 10 coupled to the user 10. Next, at step 304, the processor determines and stores a health status of the user 10 based on the biological signals received from the one or more sensors 10. The user's health is normal in a first condition and abnormal in a second condition.

[0065] Next, at step 306, the processor 130 sends an activation signal to the stimulation device 120 if or when the users 10 health is determined to be in a second condition (i .e., abnormal). The stimulation device 120 generates and delivers a stimulation sufficient to awaken the user 10 when sleeping, thereby allowing the user 10 to regain control of respiration.

[0066] The health status monitor according to the present invention can determine based on data received from the plurality of sensors whether to send a signal to an external device, such as a pacemaker in order to jolt the user awake. The system monitors the user's respiration and using a sensor connected to an output signaler to alert the user's body that a low or no respiration condition has been detected. The system may also be able to directly contact the user's physician, family, and/or hospital to send help immediately.

[0067] In alternative embodiments, the respiration monitor system with physical alert may be configured to contact a third-party using a remote receiver. That is, the system according to the present invention may be coupled to an infant user and when the infant's respiration falls below a predetermined threshold, the system would physically, visually, and/or audibly alert another user of this situation.

[0068] The sleep apnea monitor (SAM) according to the present invention may be used with a wide variety of sensors that are attached to a user's skin via any conventional means to measure the user's respiration and/or other biological signals and calculate respiration rate to determine whether to deliver a stimulation to immediately wake up the user. That is, although the figures illustrate that the sleep apnea monitor is embodied as a wrist strap or watch like device, the SAM system according to alternative embodiments may be embodied as various other types of devices, articles of clothing, or accessories, such as rings, earrings, toe rings, hats, socks, belts, or the like. As such, the user may be able to conceal the sleep apnea monitor in everyday articles, so that their health issues may be kept private. However, the present general inventive concept is not limited thereto.

[0069] In alternative exemplary embodiments, the health monitor system and method may be configured for animals to assist in behavior training or the like. For instance, the health monitor system according to the present general inventive concept may be used to monitor a dog's heart

rate to determine when the dog is getting excited and in response, the health monitor system may deliver a stimulus to the dog to train the dog to calm down. However, the present general inventive concept is not limited thereto.

[0070] While the present general inventive concept has been illustrated by description of several example embodiments, and while the illustrative embodiments have been described in detail, it is not the intention of the applicant to restrict or in any way limit the scope of the general inventive concept to such descriptions and illustrations. Instead, the descriptions, drawings, and claims herein are to be regarded as illustrative in nature, and not as restrictive, and additional embodiments will readily appear to those skilled in the art upon reading the above description and drawings. Additional modifications will readily appear to those skilled in the art. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general inventive concept.