Abstract:
Disclosed are methods and systems for detecting and remedying a potential hypoxic state. A wearable hypoxic state detector includes an SpO 2  sensor configured to measure a user&#39;s oxygen saturation, an oxygen reservoir, an oxygen conduit positioned to deliver oxygen from the oxygen storage reservoir to the user&#39;s inhalation flow path, and a controller. The controller is operably connected between the SpO 2  sensor and the oxygen delivery component, and is configured to automatically induce a flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level is detected by the SpO 2  sensor.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/723,033, filed on Nov. 6, 2012 and entitled “Automated Hypoxia Recovery System,” the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    The present invention relates to systems and methods for life support, and, more specifically, to systems and methods for hypoxia recovery. 
         [0003]    People are sometimes exposed to conditions where reduced availability of oxygen can cause hypoxia, where the body is deprived of sufficient oxygen resulting in decreased physical and mental capacity. Supplemental oxygen systems can prevent and/or correct hypoxia; however these systems can fail or may require human control of the system which can lead to problems due to human error. In addition, human control can become impossible after the onset of hypoxia either due to lack of recognition of the hypoxic state or the physical inability to control an oxygen system due to hypoxia itself. 
         [0004]    The cardiopulmonary system&#39;s overall ability to deliver oxygen to the body can be monitored using a pulse oximeter which typically measures the absorption of red and infrared light through a patient&#39;s tissue to determine oxygen saturation (SpO 2 ) level. The pulse oximeter generally comprises at least one red light source and one infrared light source with a corresponding detector for each. The orientation of the source and detector can either be on opposing sides of the tissue (transmittance) or on the same surface (reflectance). De-oxyhemoglobin (RHb) absorbs more red light than oxyhemoglobin (HbO 2 ) and oxyhemoglobin absorbs more infrared light than de-oxyhemoglobin. Thus using this known relationship the oxygen saturation can be calculated. In addition, the absorption varies as blood vessels expand and contract allowing a pulse oximeter to also measure heart rate. 
         [0005]    Life support systems are used in environments where reduced oxygen may be a concern. These systems may also include emergency backup systems or may be emergency systems themselves when oxygen is not being continuously applied. Typically these systems involve either human control or automatic control using some metric other than SpO 2  level. Thus, there is a continued need for systems and methods of identifying and remedying a hypoxic state and controlling supplemental oxygen using SpO 2  level monitoring. 
       BRIEF SUMMARY 
       [0006]    The present disclosure is directed to methods and apparatus for remedying a hypoxic state and automatically controlling supplemental oxygen using SpO 2  level monitoring. For example, a device that identifies a hypoxic state and regulates supplemental oxygen can include a reflectance or transmittance SpO 2  sensor, a controller, an oxygen reserve, and a method of delivering oxygen to the mouth or nose. This device could be used in civilian and military aviation as a primary or backup oxygen delivery system, or to treat medical conditions in a clinical setting, ambulance, military field trauma care, automated oxygen delivery first aid kit, or home use by someone requiring supplemental oxygen, among many other uses. 
         [0007]    According to one embodiment is a wearable hypoxic state detection device. The device includes: (i) an SpO 2  sensor configured to measure a user&#39;s oxygen saturation; (ii) an oxygen reservoir; (iii) an oxygen conduit positioned to deliver oxygen from the oxygen storage reservoir to the user&#39;s inhalation flow path; and (iv) a controller operably connected between the SpO 2  sensor and the oxygen delivery component, wherein the controller is configured to automatically induce or modify a flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level is detected by the SpO 2  sensor. 
         [0008]    According to an aspect, the SpO 2  sensor is a reflectance or a transmittance sensor. 
         [0009]    According to another aspect, the controller is configured to automatically stop the flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level is detected by the SpO 2  sensor. 
         [0010]    According to an aspect, the wearable hypoxic state detection device further includes a microphone. 
         [0011]    According to an aspect, the wearable hypoxic state detection device further includes a speaker. 
         [0012]    According to another aspect, the device is at least substantially worn on the user&#39;s head. 
         [0013]    According to another aspect, the oxygen conduit is situated within a mask. 
         [0014]    According to another aspect, the controller is operably connected to an oxygen flow valve. 
         [0015]    According to an aspect, the wearable hypoxic state detection device further includes a communications module. 
         [0016]    According to an aspect, the wearable hypoxic state detection device further includes an altimeter operably connected to the controller. 
         [0017]    According to one embodiment is a hypoxic state detection system. The system comprises: (i) an oxygen reservoir; and (i) a wearable hypoxic state detection device comprising: (a) an SpO 2  sensor configured to measure a user&#39;s oxygen saturation; (b) an oxygen conduit positioned to deliver oxygen from the oxygen storage reservoir to the user&#39;s inhalation flow path; and (c) a controller operably connected between the SpO 2  sensor and the oxygen delivery component, wherein the controller is configured to automatically induce or modify a flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level is detected by the SpO 2  sensor. 
         [0018]    According to an aspect, the SpO 2  sensor is a reflectance or a transmittance sensor. 
         [0019]    According to another aspect, the controller is configured to automatically stop the flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level is detected by the SpO 2  sensor. 
         [0020]    According to an aspect, the wearable hypoxic state detection device further includes a microphone. 
         [0021]    According to an aspect, the wearable hypoxic state detection device further includes a speaker. 
         [0022]    According to another aspect, the device is at least substantially worn on the user&#39;s head. 
         [0023]    According to another aspect, the oxygen conduit is situated within a mask. 
         [0024]    According to another aspect, the controller is operably connected to an oxygen flow valve. 
         [0025]    According to an aspect, the wearable hypoxic state detection device further includes an altimeter operably connected to the controller. 
         [0026]    According to one embodiment is a wearable hypoxic state detection device configured to be worn at least substantially on a user&#39;s head. The device includes: (i) an altimeter; (ii) an SpO 2  sensor configured to measure a user&#39;s oxygen saturation; (iii) an oxygen reservoir; (iv) an oxygen conduit positioned to deliver oxygen from the oxygen storage reservoir to the user&#39;s inhalation flow path; and (v) a controller in communication with the altimeter, and operably connected between the SpO 2  sensor and the oxygen delivery component, wherein the controller is configured to automatically induce or modify a flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level or altitude is detected by the SpO 2  sensor, and wherein the controller is further configured to automatically stop the flow of oxygen from the oxygen reservoir through the oxygen conduit when a predetermined oxygen saturation level or altitude is detected by the SpO 2  sensor. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0027]    The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which: 
           [0028]      FIG. 1  illustrates a schematic of a wearable hypoxic detection and recovery device according to an embodiment; 
           [0029]      FIG. 2  illustrates a schematic of a wearable hypoxic detection and recovery device according to an embodiment; and 
           [0030]      FIG. 3  illustrates a flow chart of a method for detecting and remedying a hypoxic state using a wearable hypoxic detection and recovery device according to an embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0031]    Referring now to the drawings, wherein like reference numerals refer to like parts throughout, there is seen in  FIG. 1  an embodiment of an automated hypoxia recovery system  100 . According to this embodiment, the wearable headset device  40  includes at least one reflectance or transmittance SpO 2  sensor  60 . Sensor  60  could be located at one or more of several places. For example, sensor  60  could be located at or near the forehead for measuring SpO 2  levels using reflectance, or near one or both ears to measure SpO 2  levels by transmittance or reflectance. Alternatively, the sensor  60  can be remote from the wearable headset device  40  and transmits SpO 2  level measurements or data to the device via wired or wireless communication. 
         [0032]    Wearable headset device  40  also includes a controller  20 . The controller  20  is operably connected between the SpO 2  sensor  60  and the oxygen delivery components. The controller is programmed and/or configured to receive or request SpO 2  sensor data from SpO 2  sensor  60 , modify or interpret that data, and either maintain the status quo or regulate oxygen delivery. For example, controller  20  can be programmed and/or configured to activate oxygen delivery only upon receipt of certain SpO 2  sensor data below a preprogrammed or predetermined threshold. As another example, controller  20  can be programmed and/or configured to deactivate oxygen delivery when a certain SpO 2  sensor data is then achieved, signaling the end of a need for supplemental oxygen. As another example, controller  20  can be programmed and/or configured to regulate the delivery of a specific oxygen flow rate which is dependent upon the specific SpO 2  level. For example, if the SpO 2  level is determined by SpO 2  sensor  60  to be at or below a certain predetermined threshold, then controller  20  can send a wired or wireless signal to the oxygen delivery components to deliver supplemental oxygen at or above a specific flow rate. Alternatively, controller  20  can send a wired or wireless signal to the oxygen delivery components to deliver air containing a certain percentage of oxygen. 
         [0033]    The controller  20  can be programmed or configured with an adaptive algorithm according to an embodiment. This adaptive algorithm allows for many different users to utilize the wearable device  40 . For example, the adaptive algorithm can include variables such as a baseline SpO 2  measurement, which can vary depending on the individual, temperature, time of day or year, location, and/or the altitude, etc. The variables can also include altitude of the individual. There are also many other possible variables. According to an embodiment, a baseline SpO 2  measurement is obtained prior to movement, takeoff, diving, etc., and can be triggered by, for example, powering on of the vehicle, device, etc., or by movement, or via a user interface. The device can also consider altitude, in which an altimeter or the altitude data is utilized to determine that high altitude conditions exist (or lack of cabin pressure in a pressurized aircraft) for both activation of supplemental oxygen and to provide a warning of loss of cabin pressure. The algorithm can factor the baseline SpO 2  measurement and/or altitude into the decision-making process, and/or into determining a minimum SpO 2  measurement for triggering a warning or for applying supplemental oxygen. 
         [0034]    According to an embodiment, the wearable device  40  employs a multi-step process for remedying a hypoxic state. As an initial step, the device detects a possible or imminent hypoxic state (as indicated by low or decreasing SpO 2  levels), which triggers a warning to the user. The warning can be an audible, visual, and/or tactile warning. For example, the warning can be a light, a sound, an instrument reading, or a vibration, among other things. With the triggering of the warning, the device can set a certain amount of time in which the user can remedy the situation themselves, such as decreasing altitude, activating aircraft oxygen, etc. If that amount of time expires and the SpO 2  levels have not improved—or if the user bypasses the time period and requests immediate supplemental oxygen—the device can be triggered to induce or increase the supply of supplemental oxygen. 
         [0035]    Wearable headset device  40  also includes oxygen delivery components configured and/or adapted to deliver supplemental oxygen to the wearer. According to an embodiment, the oxygen delivery components include an oxygen storage component  12  to store the supplemental oxygen. The oxygen may be, for example, compressed and stored in an oxygen storage component  12 . According to the embodiment depicted in  FIG. 1 , the oxygen storage component  12  is affixed to the wearer. However, according to another embodiment, the oxygen bottle is remote from one or more of the other components of the system  100 . For example, the oxygen storage component  12  may be stored in a container or storage device located within the transportation vehicle or gear worn by the user. As an example, the oxygen storage component  12  may be stored in a bottle located within a remote, and more secure, portion of an airplane with tubing that leads from the bottle to the vicinity of the user. The user can then simply connect the device  40  to the tubing, thereby allowing for the delivery of oxygen from the oxygen storage component  12  to the user when necessary. 
         [0036]    As another embodiment, the user wears or carries the oxygen storage component  12 . For example, the oxygen can be stored in a bottle or container that is directly incorporated into the wearable headset device  40 . As another example, the oxygen can be stored in a bottle or container that is carried in a backpack by the user. 
         [0037]    According to an embodiment, the oxygen delivery components include a device or system to deliver the oxygen from the oxygen storage component  12  to the user&#39;s nose and/or mouth. In  FIG. 1 , the oxygen delivery components include a boom  50  that has an oxygen delivery tube running from the oxygen storage component  12  to the user&#39;s mouth. The boom  50  may also include a microphone or other components. For example, in an aviation setting, the boom  50  can include a microphone for communication purposes. Similarly, headset  40  can include one or more speakers for communication purposes. According to another embodiment, shown in  FIG. 2 , the oxygen delivery components include a mask  80  that has an oxygen delivery tube running from the oxygen storage component  12  to the user&#39;s mouth. 
         [0038]    According to an embodiment, wearable device  40  includes an electronically actuated valve or other mechanism to open, close, or regulate the flow of air from the oxygen storage component  12  to the user&#39;s mouth. The valve is operably connected to controller  20 , which sends a wired or wireless signal to the value to open, close, or regulate the flow of air from the oxygen storage component  12  to the user&#39;s mouth. 
         [0039]    According to an embodiment, wearable device  40  includes a communications module to communicate SpO 2  sensor data or levels, altitude, or other data from the device to a local receiver. The communications module can utilize any form of communications (including, for example, wireless, optical, or wired) and/or protocol (including, for example, WLAN, Wi-Fi, Internet-based communications, Bluetooth, and/or SMS, among others). Accordingly, wearable device  40  may interface or communicate via any connectivity or protocol (including, for example, wired, wireless, electrical and/or optical, as described above, as well as all forms of USB and/or removable memory). 
         [0040]    According to an embodiment, the wearable headset device  40  also includes an altimeter  10  configured and/or adapted to monitor altitude of the device in aviation applications. For example, altimeter  10  is operably connected to the controller  20 , which is programmed and/or configured to receive or request sensor data from altimeter  10 , modify or interpret that data, and either maintain the status quo or regulate oxygen delivery. For example, controller  20  can be programmed and/or configured to activate oxygen delivery only upon receipt of certain altitude data above or below a predetermined threshold. As another example, controller  20  can be programmed and/or configured to deactivate oxygen delivery when a certain altitude is then achieved, signaling the end of a need for supplemental oxygen. As another example, controller  20  can be programmed and/or configured to regulate the delivery of a specific oxygen flow rate which is dependent upon the specific altitude. For example, if the altitude is determined by altimeter  10  to be at or below a certain predetermined threshold, then controller  20  can send a wired or wireless signal to the oxygen delivery components to deliver supplemental oxygen at or above a specific flow rate. Alternatively, controller  20  can send a wired or wireless signal to the oxygen delivery components to deliver air containing a certain percentage of oxygen. 
         [0041]    As shown in  FIG. 2 , the device can also comprise a wearable helmet device  40 . The wearable helmet device  40  includes, for example, a controller  20  operably connected between the SpO 2  sensor  60  and the oxygen delivery components. The controller  20  is programmed and/or configured to receive or request SpO 2  sensor data from SpO 2  sensor  60 , modify or interpret that data, and either maintain the status quo or regulate oxygen delivery. The wearable helmet device  40  also includes, for example, oxygen delivery components configured and/or adapted to deliver supplemental oxygen to the wearer, including an oxygen storage component  12  to store the supplemental oxygen, a mask  80  with an oxygen delivery tube running from the oxygen storage component  12  to the user&#39;s mouth. 
         [0042]    According to an embodiment, the wearable helmet device  40  also includes an altimeter  10  configured and/or adapted to monitor altitude of the device in aviation applications. For example, altimeter  10  is operably connected to the controller  20 , which is programmed and/or configured to receive or request sensor data from altimeter  10 , modify or interpret that data, and either maintain the status quo or regulate oxygen delivery. 
         [0043]    According to an embodiment, a wearable device  40  also includes one or more speakers for communication, and/or to provide an audible hypoxia warning to the user. For example, upon detection of a hypoxic state by SpO 2  sensor  60 , or upon detection of a certain altitude which could lead to a hypoxic state, the controller  20  can be programmed and/or configured to activate a warning signal to the user that supplemental oxygen is necessary. The controller  20  can also be programmed and/or configured to activate a warning signal to the user that supplemental oxygen is being delivered, or that delivery is being ceased. The wearable device  40  may also include manual controls and a user interface such that the user can manually override the actions of controller  20  and wearable device  40 . 
         [0044]    Therefore, according to an embodiment of wearable device  40 , oxygen is automatically directed at the face when hypoxia is detected to return the user from a state of incapacitation, thereby providing the user with the cognitive ability to take follow-on corrective actions. According to an embodiment, the implementation of the emergency oxygen system would involve an alarm to allow the user to override the system. 
         [0045]    Depicted in  FIG. 3  is a method  300  for providing supplemental oxygen upon detection of a hypoxic and/or potentially hypoxic state of a user. In step  310 , the user puts on or activates a wearable device  40 , which is configured according to any of the embodiments described herein, or as otherwise envisioned herein. For example, the user&#39;s wearable device  40  can include, among other things, a controller  20  operably connected between the SpO 2  sensor  60  and an oxygen storage component  12  to store the supplemental oxygen, and a boom  50  or mask  80  with an oxygen delivery tube running from the oxygen storage component  12  to the user&#39;s mouth. The wearable device may also include an altimeter  10  operably connected to controller  20  and configured to monitor altitude of the device in aviation applications. 
         [0046]    In step  320 , the wearable device  40  monitors the user&#39;s SpO 2  levels utilizing the SpO 2  sensor. The SpO 2  sensor can monitor the user&#39;s SpO 2  levels continuously or periodically. According to one embodiment, the SpO 2  sensor can monitor the user&#39;s SpO 2  levels continuously but only send a signal to the controller  20  when a certain threshold has been reached. Alternatively, the SpO 2  sensor can monitor the user&#39;s SpO 2  levels and continuously send that information to controller  20 . 
         [0047]    In step  330 , the wearable device  40  detects that the user&#39;s SpO 2  levels have reached a predetermined minimum. For example, the SpO 2  sensor can monitor the user&#39;s SpO 2  levels and send a wired or wireless signal to controller  20  that a threshold has been reached. In another embodiment, the SpO 2  sensor monitors the user&#39;s SpO 2  levels and continuously or periodically sends that information to controller  20 , which compares the data to a predetermined minimum or range to determine if the received data matches or varies from that predetermined minimum or range. 
         [0048]    In step  340 , the controller  20  sends a wired or wireless signal that causes the flow of supplemental oxygen to begin. For example, controller  20  can send a signal to oxygen storage component  12  to start the flow of oxygen through the oxygen delivery components to the user&#39;s nose and/or mouth. In one embodiment, the controller  20  sends a signal to open a valve if oxygen is needed, or a signal to close the valve if oxygen is no longer needed. The controller  20  can also control the flow rate of the oxygen once it is activated. This automated backup oxygen system therefore provides emergency oxygen when the system detects a hypoxic state. 
         [0049]    Alternatively, the controller  20  can send a wired or wireless signal that causes the flow of an existing oxygen supply to increase or decrease, or adjusts the mixture ratio of delivered gas, or adjusts the oxygen pressure, or makes one or more of a number of other changes in order to remedy the hypoxic state. For example, especially in a hospital, ambulance, or home setting, it may be necessary to adjust the flow, ratio, and/or pressure of oxygen delivered to an individual rather than simply turn the oxygen on or off. 
         [0050]    According to another embodiment, the wearable device  40  can also be programmed and/or configured to provide the user with an audio warning that onset of hypoxia has been detected and that emergency oxygen is about to be delivered unless another corrective action is taken. 
         [0051]    In step  350 , the SpO 2  sensor continues to monitor the user&#39;s SpO 2  levels in order to determine whether the levels return to or exceed the predetermined minimum. If they do, the controller  20  can diminish or stop the flow of supplemental oxygen to the user. Similarly, if the wearable device  40  is monitoring altitude instead of or in addition to SpO 2  levels, the controller  20  can diminish or stop the flow of supplemental oxygen to the user if a certain altitude is reached. Therefore, according to an embodiment, a barometric pressure sensor allows the system to detect changes in altitude as an additional feedback tool for the system to apply the hypoxia detection algorithms. This could be used, for example, in aviation to allow the system to automatically obtain a baseline SpO 2  level for the individual before takeoff thus improving the system&#39;s ability to determine the SpO 2  level that corresponds with onset of hypoxia. 
         [0052]    Although the present invention has been described in connection with a preferred embodiment, it should be understood that modifications, alterations, and additions can be made to the invention without departing from the scope of the invention as defined by the claims.