WO2016176668A1

WO2016176668A1 - Breathing disorder detection and treatment device and methods

Info

Publication number: WO2016176668A1
Application number: PCT/US2016/030325
Authority: WO
Inventors: Anton Alferness; Brett Cross; Clifton Alferness; Kurt Fischer; Brian FARIS
Original assignee: Somtek, Inc.
Priority date: 2015-04-30
Filing date: 2016-04-30
Publication date: 2016-11-03

Abstract

Disclosed are systems, methods and devices for diagnosing and treating breathing disorders of humans and other mammals

Description

BREATHING DISORDER DETECTION AND TREATMENT DEVICE AND

METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001 ] This application claims the benefit of U.S. Provisional Patent

Application Serial No. 62/154,930 entitled "Breathing Disorder Detection and

Treatment Device and Methods," filed April 30, 2015, the disclosure of which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The invention relates to improved devices, systems and methods for diagnosing and treating breathing and/or breathing-related disorders of humans and other mammals. More specifically, disclosed herein are improved devices and related systems to monitor, diagnose, treat and/or alleviate the symptoms of

Obstructive Sleep Disordered Breathing, other breathing disorders, including sleep apnea, Cheyne-Stokes breathing and Sudden Infant Death Syndrome (SIDS), as well as other non-breathing disorder conditions.

BACKGROUND OF THE INVENTION

[0003] Snoring is a typical nocturnal manifestation of Obstructive Sleep Disordered Breathing (OSDB). OSDB encompasses a wide range of psychological effects, including upper airway resistance syndrome, non-obstructive and obstructive sleep apneas and nocturnal Cheyne-Stokes breathing. While snoring is often characterized by partial occlusion of the upper airway passage during sleep, sleep apnea and Cheyne-Stokes breathing is normally characterized by intermittently complete occlusions and/or temporary cessation of breathing.

[0004] Sleep apnea is an extremely common form of OSDB, and is

characterized by the absence of breathing for a certain period of time, such as 30 to 45 seconds, and may repeatedly occur many times during each hour of sleep.

Doctors estimate that at least 18 million Americans suffer from sleep apnea. One cause for sleep apnea can be an obstruction of the airway when the muscles of the tongue or uvula relax. Obesity and an abnormal amount of fat in the throat area can contribute to this condition. Another possible cause of apnea is a temporary cessation of the message from the brain that tells the diaphragm to breathe. In sleep apnea, with each period of breathlessness, which can be as many as twenty or more in an hour, the carbon dioxide level in the blood can rise and fall to extreme levels, with a corresponding periodic decrease in the blood oxygen levels. These variations, along with the stress and the struggle to draw breath, can place significant increased strain on the heart and other physiological systems. Untreated, sleep apnea can cause a patient to develop high blood pressure and other cardiovascular disease, memory problems, weight gain, impotency, and headaches. However, if the sleep apnea is diagnosed and treated sooner during the degenerative cascade, the effects of such physiological problems might be avoided in some cases, or at least the damage might be reduced.

[0005] Polysomnography is a commonly accepted diagnostic approach to detecting the presence of sleep apnea in an individual. This approach requires the patient to stay overnight in a hospital or sleep clinic for monitoring and observation. A polysomnographic procedure involves tethered connections and monitoring of many parameters while the patient sleeps, typically rendering this procedure quite invasive and uncomfortable for the patient, as well as intensive, site dependent, and costly. In many cases, such an approach is not practical for screening a large number of patients, and thus the majority of patients suffering from OSDB often remain undiagnosed and untreated.

[0006] One approach for treating sleep apnea is for the sufferer to wear a Continuous Positive Airway Pressure (CPAP) device while sleeping. A CPAP device employs a face or nasal mask connected to a small air compressor or fan that desirably forces enough air through the nasal passages to maintain the nasal passages open during the night. While such systems can often alleviate some apnea conditions and allow the wearer a good night's sleep, it is also common for such masks to be uncomfortable for the wearer (including restricting the wearer's movements and/or comfortable sleeping positions) and potentially to disrupt the sleep patterns of the user and/or the user's sleeping partners. Moreover, such systems are also often bulky and difficult to transport, typically require a fixed power supply, and are often relatively expensive. Moreover, the long term use of such devices can make the user prone to nasal congestion and infections. In many cases, such devices are not well-tolerated by patients, and compliance rates are low.

[0007] Another approach to treating breathing disorders of this type is to pace the heart at a faster rate, which can stimulate the sleeper's breathing. However, such a treatment typically requires a surgical procedure to implant a pacemaker or other heartbeat regulating device, a procedure that itself can cause significant

complications for the patient. In most cases, therefore, this approach is not cost effective, reasonable and/or deemed medically necessary for the vast majority of apnea sufferers, especially those with mild to moderate effects from this disease.

[0008] Another approach to treating breathing disorders has been to pace or stimulate the muscles of the tongue or uvula, desirably preventing these muscles from relaxing and maintaining the patency of the open airway. Such an approach can reduce constriction of the airway and allow a sleeper to maintain and/or resume their breathing. However, such approaches also typically require an implantable nerve or muscle stimulator, which can involve a costly surgical procedure with the attendant risks of surgical complications.

[0009] Another prior art approach to treating breathing disorders has been to surgically remove a portion of the posterior tongue or uvula muscles, such that the air pathway remains sufficiently open when the muscles of the tongue and/or throat relax. While such a procedure can potentially maintain the airway sufficiently open to not totally occlude airflow, this procedure carries a significant risk of surgical complications, including the potential for damage to the central nerves of the tongue (which can cause speech impediments and/or the inability to manipulate food in the mouth). Thus, as previously noted in connection with other surgical procedures, such a surgical approach has not provided an acceptable long-term solution.

[0010] In yet another prior art approach to treating breathing disorders, the nerves of a patient's external skin surfaces can be periodically stimulated by a high voltage shock, desirably to induce the sleeper to awaken and resume breathing. Aside from the necessity for relatively high voltages to jolt the patient awake, this approach can also be quite painful and can eventually result in nervous injury after repeated shocks.

[001 1 ] In another prior art approach, US, Patent No. 8,406,884 to Nielsen describes a system for detecting and treating OSDB in which a physiologic indicator of OSDB is detected from sensors in or around the ear canal. Once detected, such a device can be configured to treat OSDB by providing an audible stimulating signal (i.e., sounds produced by a speaker) within or near the ear canal in an attempt to awaken the user and terminate the OSDB event. If after multiple attempts the audible signal has reached a loudest setting, the Nielsen device can ultimately administer an electrical shock to the user's neck or a location behind their ear, or activate an external audible alarm, in a final attempt to awaken the user. However, the various apparatus disclosed in Nielsen are relatively bulky, require significant power, and when disposed in the ear canal can be a sleep disruption in and of itself, which may prove unacceptable to patients for a wide variety of reasons.

BRIEF SUMMARY OF THE INVENTION

[0012] The present invention includes the realization of a need in the art for improved devices, systems and methods for diagnosing and treating breathing disorders of humans and other mammals. More particularly, there is a need for inexpensive and easy-to-use devices and related systems to monitor, diagnose, treat and/or alleviate the symptoms of Obstructive Sleep Disordered Breathing and/or other breathing disorders, including sleep apnea, Cheyne-Stokes breathing and Sudden Infant Death Syndrome (SI DS). In addition, the various devices and systems disclosed herein may be utilized to address a wide variety of hypoxemia conditions, including low blood oxygen conditions induced by physiological conditions, low oxygen conditions (i.e., altitude, diving, suffocation, anesthetics, fires and/or air depletion of oxygen) and/or excessive exercise. In many instances, the various stimuli induced by the present devices and systems may be sufficient to direct the user's attention to the low oxygen condition, allowing the user to address the condition before loss of consciousness and/or judgement deficiencies manifest.

[0013] Among sleep disorders, apnea is usually assumed to be caused primarily by some obstruction of the air passageways to the lungs. For this reason, treatments have long focused on either reducing the obstructive elements by various means or by forcing air into the lungs to overcome the obstruction. Many devices have emerged to alter the air passageways in attempts to create an unobstructed path for breathing. Often, these devices and methods have failed to alleviate the problem or been too obtrusive to sleep themselves and fallen out of favor. Also, such devices fail to treat central sleep apnea that results from neurological dysfunction rather than airway obstruction. Such dysfunction occurs in many sleep apnea patients as well as heart failure patients suffering from Cheyne-Stokes breathing. Sudden Infant Death Syndrome (SIDS) is also now believed to be a result of a neurological dysfunction that resolves as the infant matures. CPAP has been utilized very successfully in many patients to force air into the lungs even with some airway obstruction, but suffers from a high incidence of noncompliance. Thus there is a clear need for a device to treat the central aspects of sleep apnea as well as obstructive apnea in noncompliant patients. This invention treats such disorders by stimulating a neurological response to alleviate, prevent or eliminate an apnea episode.

[0014] In various embodiments, a system can include a monitoring simulating unit ("MS unit"), which may optionally include computing resources for analyzing data, that is desirably powered by mobile and/or stored power (i.e., installed rechargeable battery, fuel cell, solar cell, electro-magnetic power generator, thermal energy harvester, etc.) which can be worn by a user, which is in communication with a separate computing and/or communications unit that desirably utilizes wireless communications protocols to and/or from the MS unit. In various embodiments, the separate computing and/or communications unit can comprise a mobile computing device and/or "smart phone," which desirably incorporates significant computing ability and stored energy resources (i.e., battery power), and in many instances further incorporates an ability for two-way communication with remote locations using relative low power wireless communication techniques and/or Wi-Fi.

[0015] One significant advantage of utilizing a mobile computing device such as a smart phone in conjunction with the components of the present system are that the smart phone's capabilities can greatly enhance the usability and flexibility of the system. Patients are known to experience different types of sleep during various periods of time during their sleep. For example, early in a person's sleep, they may have a light sleep cycle wherein they are easily treated for the onset of an OSDB episode. Later, perhaps during REM sleep, they may require a stronger stimulus or multiple stimuli. The ability to monitor, store and analyze data regarding these differing sleep patterns, as well as the ability to transmit and receive data to/from remote locations where additional data, analysis tools and/or live patient monitoring can be accommodated, can greatly enhance the ability of the apparatus and system components to accommodate such variability and adapt to the sleep patterns of an individual.

[0016] In at least one preferred embodiment the computer comprises a smart phone with data processing capability and wireless communication capability.

Broadly, various embodiments of the present disclosure generally provide for a locally-operable compact device(s) and associated system components for diagnosing and treating breathing disorders and/or other oxygen deficient conditions, while various additional embodiments (or other device features) could provide for a telemedicine-capable integrated compact device for the remote diagnosis and management of an assortment of disorders and/or other conditions.

[0017] The present application provides new and improved apparatuses and methods to detect and treat OSDB with the least amount of sleep disturbance possible to overcome the above limitations. In at least one embodiment, a monitoring and/or therapy system can include "learning" or "smart" features that can adapt to the particular sleep patterns of the individual patient. A physiological parameter measuring device is disposed within or near an ear canal of a subject to non-invasively sense at least one physiological parameter of the subject, which one physiological parameter can be associated with and/or indicative of the existence of an OSDB event. An analyzing device is operatively coupled to the physiological parameter measuring device to analyze the sensed physiological parameter and detect the onset of OSDB for the subject. Based on the detection and analysis of the physiological parameters detected from the subject, a stimulating device stimulates the subject with a stimulus within or near the ear canal that has been previously successful terminating a similar OSDB during a similar sleep cycle. The type and strength of stimulation delivered to the patient can be selected and/or adapted based of the time of the OSDB event within the patient's particular sleep cycle.

[0018] With reference to another exemplary embodiment, a method is disclosed in which at least one physiological parameter of a sleeping subject is non- invasively sensed via an auditory canal of the subject, the physiological parameter being associated with at least one physiological condition of the subject such as OSDB. The desired physiological parameters may be collected and stored in at least one patient specific database. If desired, the collected data of the sensed

physiological parameter can be analyzed to detect the condition (such as OSDB) of the subject, as well as optionally utilized to determine a "confidence level" or other metric of the sensed physiological parameter. Analysis may include comparing the physiological parameter collected data to patient-specific historical data, the confidence level or other relevant metric, and/or access a second database with other averaged patient data. Once analysis has been performed, feedback may be communicated to the monitoring and/or therapy system, where the monitoring and/or therapy system can administer a diagnosis and/or the intended course of treatment. For example, in response to the detection of the physiological condition of the subject, further sensors and/or testing can be brought "on line (if desired) to improve the confidence level of the diagnosis, and/or the subject can be stimulated so that the physiological condition of the subject is mitigated based on historical data indicating the likelihood of success in terminating this particular episode of OSDB. The likelihood of termination may be estimated from historical data relating to the elapsed time during sleep and success of previous attempts at terminating such OSDB episodes at this time. Thus, with increased use the apparatus can become more effective as the information available increases.

[0019] In at least one additional exemplary embodiment, a system for monitoring and treating obstructive sleep disordered breathing (OSDB) is disclosed, in which an in-the-ear sensing device is disposed within an ear canal of a subject to non-invasively sense at least one physiological parameter of the subject which one physiological parameter is associated with the OSDB, with the in-the-ear device adjusted to comfortably fit the anatomy of the ear canal of the subject. The in-the ear sensing device may comprise a monitoring device, an analyzing device, a feedback device and/or a stimulation device, and/or any combination thereof. A monitoring device can be operatively coupled to the in-the-ear sensing device to communicate with the in-the-ear sensing device. An analyzing device analyzes the sensed physiological parameter and detects an OSDB event. A feedback or stimulation device is disposed in the in-the-ear sensing device, which the feedback device, based on the detected OSDB event, stimulates the subject to mitigate the OSDB event.

[0020] In various embodiments, the disclosed systems, devices and methods for treating OSDB can include monitoring and/or communications features that allow the user to manually communicate with the in-the-ear device, such as to adjust treatment stimulus strength and/or otherwise alter performance of the in-the-ear device. Such communication could include features to directly alter parameters of the device (i.e., using button and/or motion operated features to alter the in-the-ear device, as well as sound and/or motion sensitive actuators) as well as manual, semi- automated, fully automated and/or remotely actuated communications techniques that can utilize an associated connected device such as a mobile phone to modify the in-the-ear device and/or the programming associated therewith. If desired, program alteration could include the employment of pre-recorded programs and/or "learning" modes, as well as direct activation and/or deactivation of features (i.e., alarm modes, "sleep" features, escalating and and/or de-escalating treatment methods).

[0021 ] In another exemplary embodiment, the devices and/or systems described herein could include a temperature sensor or other means of detecting body temperature, which can be included within the in-the-ear device (or located on an externally-mounted device at a location proximate to a tissue surface) to enable the in-the-ear device to stimulate treatment only if the detected temperature is within a specified range that indicates that the device is in a desired location and/or orientation within the ear canal, or adjacent to the ear canal or otherwise properly positioned in a desired fashion. If desired, the absence of a desired temperature level (which may indicate the device has fallen out of the user's ear canal) can be utilized to modify the treatment program, such as to alter an electrical stimulation (i.e., an intended "shock" treatment), mechanical stimulation (i.e., vibration), sound and/or other alarm (i.e., a buzzing, beeping or ringing noise) so as to properly notify the user of the device condition ensure an adequate response to the device stimuli in a variety of device conditions.

[0022] In at least one alternative embodiment, the proper placement and/or positioning of the device within a desired anatomical area (i.e., within the ear canal, for example) could be monitored by the use of a pressure trigger or other device (i.e., a means of detecting placement in the ear a via a pressure trigger, such as a strain gauge or switch), which could be included within the in-the-ear device to enable the in-the-ear device to stimulate treatment only if the device is within the ear canal, or adjacent to the ear canal. In a similar manner, the device could include an accelerometer or other movement-sensitive device which can identify how the patient moves during the sleep episode and/or identifies the current orientation of the device. In such case, the failure to move for a certain amount of time may indicate that the device has fallen from the user's anatomy and/or may indicate the need for an alarm condition indicative of a related health concern.

[0023] In various aspects, a monitoring, assessment and therapy applying system and associated components is disclosed. A physiological parameter measuring device is disposed on and/or adjacent to a patient, optionally within or near an ear canal of the subject, to non-invasively sense at least one physiological parameter of the subject, which one physiological parameter is associated with at least one physiological condition of the subject. An analyzing device is operatively coupled to the physiological parameter measuring device to analyze the sensed physiological parameter and detect the physiological condition of the subject. Based on the detection and analysis of the physiological condition of the subject, a stimulating device stimulates the subject with the physiological parameter measuring device, optionally including one or more stimulating devices within or near the ear canal of the subject, to desirably prevent, alleviate and/or mitigate the physiological condition of the subject.

[0024] In various embodiments, the disclosed devices and/or system components could potentially be incorporated into existing commercial devices, such as a Bluetooth headset for a mobile phone and/or hearing protection earplugs, such that the device could be used as a headset and speaker during the daytime and a medical treatment device during the nighttime. Similarly, various of the disclosed components could be incorporated into existing fitness tracking devices, such as the Fitbit™ line of wireless tracking devices and wearable technology devices

(commercially available from Fitbit, Inc. of San Francisco, CA USA). Various components and/or devices could comprise a wireless transmission element for wirelessly transmitting the obtained data and/or assessment information to a processing or computing device. Alternatively, the apparatus may communicate with a processing or computing device via a wired connection. A non-limiting list of examples of computing devices include mobile telephones, smartphones, laptop computers, tablet computers, desktop computers, servers, mainframes, and dedicated hardware computing devices. These devices can operate using mobile operating systems such as iOS (from APPLE Inc.) and ANDROID (from GOOGLE Inc.), desktop operating systems such as iOSX (from APPLE Inc.) and WINDOWS (from Microsoft Corp.), or any other kind of operating system or platform. The computing device can also be custom-designed and manufactured for use specifically with the components described herein.

[0025] In another embodiment, the in-the-ear devices and/or systems described herein may communicate with a software application resident on a portable electronic device. The software application (APP) may comprise a set of executable instructions that will receive collected physiological sensed data, store physiological sensed data, analyze physiological sensed data, diagnose

physiological sensed data and provide recommended treatment, transmit diagnosis and treatment (e.g., provide feedback or treatment) to the in-the-ear sensing device. Such APP and collected data may be accessed by the physician, staff, patient, and/or significant other to view real-time data and/or historical data in various numerical or graphical representations.

[0026] Still further advantages and benefits of the present application will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0027] The foregoing and other objects, aspects, features, and advantages of embodiments will become more apparent and may be better understood by referring to the following description, taken in conjunction with the accompanying drawings, in which:

[0028] FIG. 1 depicts an exemplary embodiment of an OSDB device and associated system components;

[0029] FIG. 2 depicts a side plan view of the device of FIG. 1 , with a distal tip being compressed by the user;

[0030] FIG. 3 depicts a side plan view of the device of FIG. 1 installed within the user's ear, with a proximal tip being compressed by the user;

[0031 ] FIG. 4 depicts a block diagram of features of one exemplary embodiment of a system and associated components for sensing, analyzing and/or adjusting OSDB;

[0032] FIG. 5 depicts a flow diagram of one exemplary embodiment of a system for adjusting OSDB treatment stimuli;

[0033] FIG. 6 depicts a simplified block diagram of a detecting and stimulation system utilizing wireless communications between the various components;

[0034] FIG. 7 depicts an alternative embodiment of an OSDB detection and treatment device;

[0035] FIG. 8 depicts an alternative embodiment of an in-the-ear device that includes an enclosure which at least partially surrounds the tragus;

[0036] FIG. 9 depicts a cross-sectional view of a tragus and exemplary transmissive pulse oximetry components;

[0037] FIG. 10 depicts another embodiment of a device incorporating a pair of electrical stimulation electrodes;

[0038] FIG. 11 depicts radially indexing a user's ear for device placement in a desired location and orientation; [0039] FIG. 12 depicts another embodiment of a device incorporating a mechanical impulse generator and rod with a contact tip that is in intimate contact with a cough reflex point within the ear canal;

[0040] FIG. 13 depicts another embodiment of a device including a stimulation component for stimulating an antitragus portion of an ear;

[0041 ] FIG. 14 depicts another embodiment of a device including a stimulation component for stimulating a Crux-helix region of an ear;

[0042] FIG. 15 depicts another alternative embodiment of an OSDB detection and treatment device;

[0043] FIG. 16A depicts another alternative embodiment of an OSDB detection and treatment device which includes a mechanical force transmitter.

[0044] FIGS. 16B and 16C depict one embodiment of a multi-axial stimulating component;

[0045] FIGS. 17A and 17B depict another alternative embodiment of a device and/or component for assessing and/or treating OSDB;

[0046] FIGS. 18A through 18C depict another alternative embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders;

[0047] FIG. 19 depicts another alternative embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders;

[0048] FIG. 20 depicts another alternative embodiment of a device and/or component for detecting, assessing and/or treating OSDB and/or other disorders;

[0049] FIG. 21 depicts another alternative embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders;

[0050] FIG. 22 depicts another alternative embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders; and

[0051 ] FIG. 23 depicts various exemplary ear structures that could be stimulated using the various devices, systems and/or techniques disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0052] FIG. 1 depicts one exemplary embodiment of an OSDB device and associated system components, in which the ear-mounted device 10 includes a variety of features, including the desired ability to fit comfortably within an ear 20 of a user, as well be adjusted (when necessary) to the particular anatomical features of the user's ear canal and related anatomy. In this embodiment, the device desirably fits at least partially within the ear canal, with an external portion that is desirably recessed below much of the external ear anatomy and/or earlobe of the user.

During use of the device, prior to installation into the ear canal 30, a fluid filled balloon 40 or similar expandable and/or reboundable material located proximate to a distal section 50 of the device 10 can be manipulated by the user's hand, i.e., by manually squeezing the balloon 40 or a portion thereof between the user's thumb 60 and finger(s) 70, to desirably increase the localized pressure within the balloon 40 and impel a portion of the fluid, gas or other contained material (not shown) to pass by or through an elastic band 80, orifice or other opening/restriction out of the distal portion of the balloon 40 and into a proximally-located fluid reservoir 90 (or other location), such as shown in FIG. 2. Desirably, this activity will reduce one or more outer dimensions of the distal portion of the device, thereby facilitating placement of the device 10 into the ear canal and other ear structures of the user (with the distal portion of the device sliding at least partially within the ear canal 30 of the user). Once the device 10 is placed in a desired positon, the user can optionally compress the reservoir 90 or other location (i.e., at or near a proximal end 100 of the device 10), such as shown in FIG. 3, to increase the local pressure of the fluid within the reservoir 90, which desirably urges the fluid back past the elastic band 80, orifice or other opening and back into the distal balloon 40 (i.e., compressing the fluid in the reservoir with a thumb or finger, thereby forcing the fluid past the elastic band and into the distal portion of the balloon to enlarge the balloon and desirably secure the device 10 within the ear canal). If desired, alternative securement devices and systems could be utilized with the device 10, such as the employment of expandable foam inserts (i.e., similar to self-expanding foam ear plugs, commercially available from the 3M company of Maplewood, Minnesota, USA), flexible materials such as silicone, and/or the employment of externally secured moldable materials such as moldable silicone earplug material (commercially available from Insta-Mold Products, Inc. of Oaks, Pennsylvania, USA).

[0053] In various embodiments, the pressure in the distal balloon portion of the device 10 can be limited and/or regulated by a variety of techniques, including via use of the elastic band 80 and and/or other orifice arrangements (i.e., after placement of the device 10 within the ear and after release of the pressure in the reservoir), with the elastic band or other feature desirably acting as a "preset fluid pressure limiting component" to some extent, such that the retained pressure within the distal balloon portion 40 desirably does not exceed a comfortable pressure on the inner surfaces of the ear canal 30. For example, when the pressure on the reservoir 90 is released, any excess pressure within the balloon 40 within the ear canal will desirably impel fluid to flow back past the elastic band 80 into the reservoir 90. This arrangement will desirably maintain a comfortable pressure within the ear canal, yet allow the distal portion of the balloon to remain secured within the ear canal. If desired, an air path (not shown) or other feature may be provided through the device to allow air pressure within the ear canal to equalize with atmospheric pressure during the sleeping period without dislodging the device from the ear canal.

[0054] FIG. 4 depicts a block diagram of features of one exemplary

embodiment of a system and associated components for sensing, analyzing and/or adjusting OSDB treatment stimulus strength based on historical data, which can include analysis and/or estimation of the likelihood of success of a given stimulus at a particular stimulus strength. The disclosed system can include a microcomputer 1 10 powered by a rechargeable battery 120 with a digital memory 130 for storing various data, which could include data representing stimulation type, strength and time after start, if desired. The system can include various data collecting and/or sensing devices, such as a microphone 140 and a pulse oximeter 150, which desirably collect patient and/or environmental data for analysis by various system components. In addition, the system can include various output components, including a speaker 160, a mechanical stimulator 170 and/or an electrical stimulator 180. To facilitate communications with remote components, a wireless Bluetooth Low-Energy Transceiver (BTLE) 200 can be provided (although various known wired and/or wireless communications components could alternatively be used, if desired). In addition, an optional battery charging component 190 can be provided. Other sensing components, such as orientation and/or motion sensing components (i.e., accelerometers) could be incorporated into the system, if desired.

[0055] Once the device is initially positioned at a desired location, such as secured within a patient's ear, and the system is actuated, the system will desirably remain active and/or semi-active and can operate in a "low-energy consumption" mode, with continuous and/or periodic monitoring of the various data collecting and sensing devices for indications characteristic of an OSDB episode. If desired, such sensing devices could include a sound sensing device such as a microphone and/or a pulse oximetry sensor, with each sensor device coupled to the microcomputer. [0056] In one exemplary embodiment the device may include sufficient "onboard" microprocessor and memory system capabilities to analyze collected data to determine an OSDB event without requiring the use of significant power resources to operate the wireless communications transceiver, while in other embodiments, the device may periodically transmit and/or receive sensed data (i.e., using the BTLE transceiver 200) to a remote computing device (i.e., a "smart phone") with a software application resident on the computing device for analysis of potential OSDB events.

[0057] In at least one embodiment, the device can continuously and/or periodically collect data from a low power consumption sensing component such as a microphone and utilize on-board computing resources to analyze said data to identify the occurrence of a sleep apnea event, and when such occurrence is detected the device can activate one or more higher power consumption

components such as a pulse oximeter sensor and/or the disclosed wireless link to allow for transmission and/or reception of information to and/or from a more powerful computing device (i.e., a smart phone or other computing device). Once the system has stimulated the user and assessed the stimulation outcome (or if the more powerful analysis indicates that the apnea event has not occurred), the device could revert to the lower power consumption mode, such as by deactivating the higher power consumption components and/or wireless link and go back to using the microphone and on-board computing resources to detect the next potential apnea event.

[0058] In various embodiments, the system could include a wide variety of physiological measuring devices, which could include sensors integrated into some of all of an in-the-ear probe, which could be at least partially inserted in an ear or auditory canal of a subject or sleeper, for measuring one or more physiological parameters or signals, such as vibration or motion, respiration, blood pressure, pulse oximetry or a level of blood oxygen (sP02), heart or pulse rate, perfusion, and temperature, from within the ear or auditory canal. Alternatively, various sensor components could be integrated into devices positioned outside of the ear canal, such as behind-the-ear devices, on-the-collar devices, extremity and/or "fitness" bands, smart-watches, and/or any other device suitable for collecting and/or interpreting the measurements and providing a suitable therapy, such as described herein. For example, the physiological parameters may be wirelessly transmitted by a wireless transceiver, for example, continuously, periodically at a predetermined rate, on-demand, and upon occurrence of an event, from the monitoring device to a portable computer and/or smart phone having suitable software and/or applications operating thereon. The smart phone or other portable computing unit may be used to record the entire sleep activity and/or only the number and severity of OSDB events. Diagnostic analysis may be performed as data is received, or the recorded activity may be logged within a clinical or home environment and then physically or electronically returned to a Laboratory or other facility for remote diagnostic analysis. The number of stimulation corrected OSDB events, non-corrected OSDB events, along with event seventies and/or stimulation outcomes may additionally be recorded.

[0059] In various embodiments, sensors for measuring pulse rate and/or blood oxygen can be positioned proximate to ear canal tissue that is perfused with arterial blood supplied by branches of the external as well as the internal carotid arteries, which could serve as a well perfused physiological site even if the body is

experiencing peripheral shutdown due to shock or other conditions. Such sensors could include an energy emitting component, such as an LED, which emits light into the tissue, and an energy detecting component that detects light transmission through the vascular tissue to determine pulse rate and/or blood oxygen levels. In another example, a temperature sensor, such as a thermistor, could be positioned proximate to various tissues, including the vascular tissue. In yet another example, sensors for sensing audio signals such as a microphone could be suitably positioned in relatively quiet regions of the ear canal to mitigate sensing erroneous audio signals. For example, a microphone could be used to sense pulse pressure sounds and/or respiration. As another example, sensor(s) for producing audio signals, such as a speaker, could be positioned in the ear canal to produce audio signals for a variety of purposes, including to attempt inducing the user to alter their sleeping position and/or posture as well as to restore the sleeper's breathing patterns such as described herein.

[0060] Once an OSDB event has been detected by the system during use, the system may determine an amount of elapsed time that the patient has been asleep, with the elapsed time from the onset of sleep possibly determined by a simple timer and/or the elapsed time may be computed using various combinations of sensed data described herein. The system memory (i.e., on-board memory 130, remote memory and/or various combinations thereof, which may include transitory and/or non-transitory storage media) may be interrogated to determine a likelihood of success for each previous stimulation episode that may have occurred during the current sleep period and/or during one or more prior sleep periods, which may include data reflective of the estimated minimum type and strength of stimulation selected to achieve a percentage success in excess of a predetermined goal for the current sleep period and/or anticipated stimuli. For example, a user may wish to achieve an average of 75% success with the first stimulation during each sleep state. To accomplish such a desired stimuli level, the microcomputer may initially choose a first stimulation method (i.e., an audible only stimulation, for example) which, if unsuccessful, could be utilized for a second or subsequent stimuli at the same or an increased level (i.e., an increase in volume for a second or subsequent stimuli). If desired, an unsuccessful audible stimulus (or potentially a combination of audible stimuli of increasing volume) might be followed by a different type of stimulus, such as a mechanical stimulus (i.e., induced by a vibrating motor or other electromechanical device) which might incorporate an increasing stimulation strength with each consecutive mechanical stimulus. At a point where mechanical stimuli might become similarly unsuccessful, the device may resort back to audible stimuli, or might switch to an electrical stimulation, which could increase in stimulation strength in a similar manner until all stimuli were unsuccessful and/or if termination of treatment was accomplished. If desired, various combinations of simulation types could also be utilized, if necessary.

[0061 ] For example, a stimulus could be given via a speaker positioned within the ear canal, such as a low power speaker which produces audible sounds that are loud enough to be heard by the user of the device, e.g. the sleeper, but which may not be audible outside of the ear canal of the sleeper. If desired, the system could include a series of preprogrammed sounds, tones and/or alarms, as well as the ability to program additional stimuli such as a sound or a person's voice that tells the sleeper to start breathing, or to move, e.g. to turn on the side. As about 50% of sleepers with OSDB only show signs of OSDB when sleeping in a supine position, simply telling the sleepers to turn on the side might be a highly effect for various members of this group. Desirably, the stimulus will be given subconsciously, or only barely waking up the sleeper, if at all, to desirably resume breathing. The stimulus could occur only a few seconds into the sleep apnea phase, thus significantly reducing the sleep apnea time. If the apnea persists, a louder voice or noise (or other stimulus, as described herein) could be applied. In various alternative embodiments, the stimulating device could provide an external stimulus to the sleeper. If the monitoring device determines that after the stimulus is given there has been no breathing for a predetermined period of time, such as 1 minute or more, and the saturation levels continue to decrease, a stimulating signal could

progressively increase the intensity of the signal (including the use of alternative signal types). If, after reaching the maximum stimulation signal strength, the monitoring device still does not detect that the breathing has been resumed, an external alarm could be provided which awakens, for example, a sleeping partner or caregiver.

[0062] For many patients, apnea occurrence may be more common during different sleep stages. Accordingly, the software applications and/or system components may be more active in some stages (where apnea may be more prevalent) and less active during other stages. For example, the software may sample and analyze sensor data more quickly during certain sleep stages than others, with the treatment components more active and/or biased to potentially kick in faster in the detection and determination phase - such that the system identifies and triggers the stimulus to terminate as soon as possible during such periods. In addition, individual sleep patterns and apnea occurrence patterns not based on sleep stage patterns may also influence and bias the system to be more responsive, with faster determination triggering faster and/or more severe stimuli at different times.

[0063] In various embodiments, the microprocessor may be capable of recording the time and strength of each stimulation into memory, which could include future use by the system in estimating a likelihood of success. In other

embodiments, a computing device such as a smart phone, laptop or desktop computer could include a software program or application ("APP") that is linked to the device and that can be utilized to monitor device performance, provide additional memory and computing resources, and/or potentially provide remote access to additional databases and/or service/support providers. Desirably, the system can include a rechargeable battery 120 and battery charging mechanism 190, which provides power to the system.

[0064] In at least one preferred embodiment, a handheld computer will be a smart phone with various software applications as well as wireless data communication capability, but could easily be envisioned to be a custom dedicated device or other similar functioning device known in the art. The computer could comprise a monitor or screen and a virtual or tactile keypad. Alternate embodiments could also comprise a speaker, microphone, camera, mouse, output port, touch-pad or joystick, camera button and sensor/stimulation components control buttons. The device may optionally have other controls mounted directly thereto used for operating the various sensors and/or stimulation components, including input/output controls (which may include voice actuated features) and/or any associated software.

[0065] In various additional embodiments, remote sensors of other devices may be utilized as additional system components, so as to provide additional data for system analysis. For example, a wireless baby monitor or other camera system may be utilized to detect and/or interpret breathing patterns (i.e., using infrared camera data). Similarly, a wireless "shotgun" type microphone or other sound detecting system may be linked to the various systems described herein and utilized to detect infant breathing (i.e., where a wearable microphone may be less than optimal).

[0066] The presently disclosed devices and/or systems have a broad range of functionality due to the multiple component and/or sensor devices and/or computing capabilities that could be incorporated therein. In various embodiments, modular sensor packages could be provided that change the number, type and/or location of sensors on the various components. Various additional features could be provided by such additional components, such components useful for assessing and/or treating other conditions of the ear and/or other patient anatomy. For example, additional components may provide a visual inspection of a patient's inner ear using a light source and camera. The device could provide a more electronically sensed response due to tiny speakers which emit sound waves and sense reflected sound waves from tissue structures. Temperature within the ear or ears could be simultaneously measured and recorded while any of the previously mentioned tests are being performed. The tests could be used to diagnose ailments, with the versatility of the device eliminating the need for multiple instrumentation. Additionally, the simplicity of the device could allow for a user or patient with almost any level of skill, including a child, to be able to properly position and/or potentially operate the device. The ability to take the various measurements and, in essence, thoroughly examine various physiological conditions may eliminate the need for a patient to travel to a specialized sleep center, hospital and/or be in the presence of a doctor. In fact, a medical practitioner might be able to conduct a diagnosis and prescribe treatment from a remote location using various features described herein.

Accordingly, the various features disclosed herein could also be used to measure or monitor standard diagnostics or vitals, including standard diagnostic information and vital signs such as pulse, oximetry, pulse oximetry, C02 blood levels, temperature, cardiac output (arterial pulse), heart rate, glucose monitoring and/or blood pressure.

[0067] In various embodiments, two earpieces or similar devices could be used. If desired, each earpiece could alternatively take a variety of functional shapes, including different shapes for each earpiece and/or the use of multiple modular tips particularized to a patient's ear(s), as well as other similarly functional shapes, but preferably at least one of the devices would comprise at least one tip which is capable of fitting into the exterior of an ear canal. One or both of the earpieces and/or tips may swivel or pivot or be maneuverable, extendable, flexible or moldable so as to reach different areas and/or make a more secure connection. There may be a soft outer material on the in-the-ear portion for comfort during insertion and while sleeping. These may also be more rigid internal material to maintain a desired shape. The device may include a stop or other feature that interfaces with the patient to prevent over insertion into the ear canal. In one embodiment, the stop presses into the outer ear structures and does not compress tissue into ear canal. There may also be a hole or other opening in the device body to allow air within the ear canal to escape during insertion and sensing, or to prevent echoing or other bothersome noises.

[0068] Sensor devices and associated structures for accessing and/or capturing physiological or other information from the distal tip of the in-the-ear device may be configured for flexibility to allow conformance to a desired location (for example, the tortuous shape of an ear canal) and/or incorporate elements that allow the flexible elements to be manipulated. For example, the components within the tip may be steered by a user in a fashion similar to endoscopes, or be automatically guided by a system computer or be remotely steered by a provider or other person. Alternatively, just the tip elements may be steered or manipulated.

[0069] In at least one embodiment, the system can include one or more features that accommodate a signal or other input from an outside source, such as from a sleep partner's smart phone (which may be operating an associated software application or APP), with the signal desirably initiating some stimulus in the user's device and/or the system. For example, where a user is not experiencing a sufficient obstructive breathing event to trigger a simulating impulse, but the user is

intermittently snoring or otherwise annoying their sleep partner, the sleep partner may have the option of triggering a stimulating impulse (using their own smart phone and associated APP) which can be forwarded to the system and ultimately actuate a stimulation impulse from the device to desirably impel the user to turn over or otherwise alter their current breathing. This system could include a variety of features and safeguards to ensure against misuse, if desired, and this arrangement might be a significant improvement over the current practice of attempting to wake the snorer and/or physically turn over the sleep partner.

[0070] FIG. 5 depicts a flow diagram of one exemplary embodiment of a system for sensing and/or adjusting OSDB treatment stimuli using the various devices disclosed herein, with the treatment stimuli selected based on historical data which desirably includes an indication of the likelihood of success at a particular type and intensity of stimuli. In one exemplary scheme, an input from a microphone or other device (i.e., a "breath detector" 200) is analyzed to determine whether a patient's breathing has ceased for greater than a predetermined amount of time 210. If not, then the system indicates that no breath cessation event has occurred 220 (i.e., "apnea not detected") and returns to monitoring of patient breathing. In the event that breathing has ceased for greater than a predetermined amount of time, the system collects a temperature measurement of the patient 230, and then determines whether the collected temperature measurement is within a

predetermined range 240 (which desirably indicates that the ear device remains in the ear canal). If the measured temperature is outside of the range, the system may indicate that no breath cessation event has occurred 220 (i.e., "apnea not detected") and returns to monitoring of patient breathing (and/or the system may actuate an alarm condition that recognizes that the device may be malpositioned and/or have fallen out of the user's ear - which may include attempting to wake the user to refit the device). If the measured temperature is within the range (potentially indicating that the device is properly in position within the ear and is therefore collecting accurate data), the system collects an elapsed time 250 and determines if the stimuli is being detected within a preset time range from the start (and/or whether a sufficient amount of time has passed) before initiating treatment stimuli 260. [0071 ] If the detected breathing event meets the preset time criteria, a stimulus type and/or strength can be selected 270, which desirably will have a likelihood exceeding a preselected success percentage. The stimulus is then delivered 280, and the results of the stimulus monitored to determine the resultant likelihood of success 290. If successful, the stimulus time, type, intensity and/or duration cam be added into the device and/or system memory, which will desirably be accumulated in the total of successful stimuli that have occurred in that sleep time interval and/or during previous sleep intervals. If the stimuli are unsuccessful, the unsuccessful stimuli information can similarly be entered into a database of unsuccessful stimuli. In the case of a failure, the system may repeat the stimuli and/or select a new stimulus, which could include the use of the same stimuli at a higher intensity (and/or the employment of multiple repeating stimuli), or a differing type of stimuli which may have a higher likelihood of success than the stimulus which failed to terminate the event. The stimulus and response evaluation can be repeated as necessary, and desirably the system will collect a database of successful and unsuccessful stimuli strengths and outcomes over time, with the accumulated data used to gauge effectiveness for future OSDB episode treatment.

[0072] The various components and systems described herein contemplate the use of a wide variety of stimulation types, techniques and/or methodologies, as well as various combinations thereof. For example, the use of electrical (i.e., shock) stimulation and mechanical (i.e., vibrational) stimulation may be particularly effective for some individuals, while being less effective for others. In a similar manner, a combination of audio stimulation with vibrational stimulation (i.e., a high pitched audio "whine" reminiscent of a mosquito's vibrating wings in combination with vibratory motions within the ear canal) may be particularly useful in inducing some individuals to move even during the deepest of slumber, while being less effective in others. By monitoring and/or assessing the effectiveness of given stimulation types, amplitudes and/or combinations thereof over a period of time, the present system can effectively "weed out" ineffective stimulation techniques, and thereby focus on the most effective stimulation methodologies for the specific patient and/or patient demographic.

[0073] The various systems also contemplate the use of "training modes" or similar learning based behaviors that have the potential and/or capacity to identify productive behaviors and/or reactions by the user to stimulation, but where the reactions might not be fully defined as "successful" is achieving a desired objective of alleviation and/or obviating an apnea episode. For example, a given stimulation of a user might impel the user to partially turn over during their sleep, but this stimulation might not be fully effective in impelling the user to completely turn over and restart their breathing in a desired manner. However, once the user begins to turn in response to the first stimulus, a second stimulus of the same or different type and/or intensity (for example) might impel the user to complete their turn and potentially restart their breathing to alleviate the episode. Desirably, the system can analyze a user's responses to various stimuli and potentially select combinations of stimuli (which could occur sequentially and/or simultaneously, as well as overlapping in various aspects) to achieve some of all of the objective(s) of alleviation and/or cessation of the apnea episode.

[0074] In various embodiments, a separate but associated sensor component could be utilized to provide basic and/or additional data regarding the patient and/or surrounding environment to assist with detection and/or treatment of OSDB. For example, US Patent Publication No. 20140228657 (Palley) discloses a system for respiration monitoring involving measurement of motion of the abdomen and/or chest wall. This system may include a Bluetooth or other wireless communication from a sensing device 310 to a mobile device 300 for analysis of respiration signals. Such components could be used in conjunction with a stimulation device 320 such as disclosed herein (i.e., an in-the-ear device) or other components to diagnose and/or treat OSDB. FIG. 6 depicts a simplified block diagram of one such exemplary system, which incorporates such a separate respiration sensor with Bluetooth communication to the mobile device which, in turn, communicates via Bluetooth to an in-the-ear device for OSDB treatment. In this embodiment, the analysis of the time during sleep and the selected treatment may be performed by a mobile device, which may utilize localized data and analysis tools and/or remote data and/or analysis tools potentially available via the internet or other communications modality. This arrangement may be particularly useful where the sensor device may require significant additional power to operate (i.e., a pulse oximeter) as compared to the stimulation device. In such a case, a large battery or other power source may be provided proximate to the to the sensor while a smaller battery can be provided to the stimulation device (which may desirably be of much smaller size and/or weight). [0075] FIG. 7 depicts one exemplary embodiment of an OSDB detection and treatment device 410 and associated system components, in which the device incorporates two or more microphones for detecting patient and/or environmental sounds such as breathing and/or snoring. One microphone 420 can be deployed at a distal end of the device 410, while a second microphone 430 can be deployed on a more proximal portion of the device 410, to desirably sense sounds occurring outside of the ear and/or within the ambient environment. An embedded microcomputer 440 within the device 410 and/or a mobile computing device or smart phone (not shown) could then be utilized to analyze the collected sound data from both microphones (i.e., employing a subtraction subroutine to analyze the differences in the sound detected by the two microphones, for example). The resulting information could then be utilized by the system for a variety of purposes, such as to determine whether the sound is reflective of the patient snoring and/or breathing or is rather being created by a sleeping partner or other environmental factors. Similarly, the different sound signals may be indicative of a device that has become dislodged and/or

malpositioned, especially where the detected sound signals may be of equal intensity. By utilizing such information during the assessment and/or treatment phases, the assessment and/or treatment of OSDB may be greatly enhanced and its effectiveness increased. In addition, accidental triggering of the stimulus device, such as by the snoring of a sleep partner and/or other ambient noises, can be greatly reduced, which may be of particular advantage when both the patient and his or her sleep partner are prone to snoring or apnea.

[0076] In various embodiments, a pulse oximeter sensor may be incorporated into one of more components on an OSDB system. Pulse oximetry is widely used in the detection of drops in blood oxygenation, and may have particular utility in combination with various devices and systems disclosed herein for the assessment and treatment of sleep apnea. FIG. 8 depicts one embodiment of an in-the-ear device 450 in an ear 460 that includes an enclosure 470 which at least partially surrounds the tragus 480 of the ear of a patient needing treatment for OSDB.

[0077] Transmissive pulse oximetry, such as shown in cross section in FIG. 9, can be implemented by shining infrared and red light through the tragus 480 from one side and using detecting the light intensity of corresponding wavelength on the other side of the tragus. LED light sources 485 can be used to shine light 490 of specific types and/or wavelengths through the tragus 480, which can be detected by one or more photodetectors 490. A significant drop in the oxygen saturation in the blood flowing in the tragus could be utilized as a hallmark of OSDB, which may then be treated and/or alleviated using the various devices, systems and methods described herein. However, because pulse oximetry of this type typically consumes a significant amount of power, it maybe desirous to only initiate the measurement of oxygen saturation in this manner after apnea is suspected by other means (i.e., such as by the absence of breath sounds detected by a microphone).

[0078] FIG. 10 depicts one exemplary embodiment of a device portion 500 incorporating a pair of electrical stimulation electrodes 510 and 515 positioned on opposing sides of the tragus 480. In this embodiment, the electrodes 510 and 515 include contact surface portions that are desirably in physical contact with the outer surfaces of the tragus on opposing side portions, such that a stimulating current can desirably pass between them through the tragus. Because the tragus 480 is typically a small appendage to the ear, stimulation of it in this manner essentially isolates the remainder of the patient's anatomy (i.e., the rest of the head) from the stimulus, such that unwanted stimulation of other areas is inhibited and/or precluded. If desired, the electrodes can comprise an electro conductive material such as a conductive plastic polymer containing metal ions (i.e., Metal Rubber™ material, commercially available from NanoSonic, Inc., of Pembroke, VA, USA) or other electrically conductive materials, as known in the art.

[0079] The tragus 480 can also be a useful anatomical location for the application of electrical and/or mechanical stimulation adjacent to and/or within the ear canal 550, such as shown in FIG. 1 1 . In this configuration, the tragus 480 or the depression just superior to it can be used to radially index such stimulating means. As shown, the tragus enclosure can be utilized as a reference, such that the stimulus 570 can be placed a specific angle 580 from the tragus enclosure along the axis of the ear canal.

[0080] In various embodiments, an axial indexing technique may also be used to locate a cough reflex point or other desired anatomical location of the user's anatomy, in order to initiate a response called Arnold's reflex, by stimulating the auricular branch of the vagus nerve (which supplies sensory innervation to the skin of the ear canal, tragus and auricle) within the ear canal using either mechanical or electrical stimulation or both (which may optionally include various combinations of other stimulation, such as air pressure or air pulses, sonic pressure and/or sound waves, etc). FIG. 12 depicts a device 600 incorporating a mechanical impulse generator 610 that is in intimate contact with a metallic rod 620, which is at least partially encased in a soft foam material such as urethane foam 630. Desirably, the foam 630 can serve to secure the device 600 within the ear canal, and if desired the foam may substantially dampen the mechanical impulse from stimulating unwanted portions of the ear canal skin surface 640. The rod 620 can be in intimate contact with a metallic polymer, a carbon filled material and/or an otherwise electrically conductive member 650, which is desirably made of a denser material than the soft foam 630. The rod 620 can also be in electrical contact 660 with an electrical pulse stimulating component 670, which can desirably deliver an output pulse sufficient in amplitude to directly stimulate the cough sensitive point 680 or other targeted anatomy on the ear canal. The electrical stimulus can be delivered with reference to another electrically conductive electrode 690. Preferentially, the electrical stimulus delivered to the cough sensitive area 680 would be a negative impulse in polarity with respect to the reference electrode 690 (although positive polarity is similarly contemplated herein), and would desirably be of a short duration such as 10 to 200 microseconds. Because the electrically conductive material in the stimulating member 650 is desirably a denser material than the surrounding soft foam 630, this member 650 also desirably conducts any mechanical impulses from the mechanical impulse generator 610 through the rod 620 to the cough sensitive area 680. Thus either stimulation method can be accomplished using a single structure, and the impulse may be effectively applied with either a mechanical impulse or an electrical impulse, or by various combinations of both (i.e., sequentially, overlapping and/or simultaneously).

[0081 ] Various embodiments described herein could be utilized to stimulate a wide variety of anatomical regions of a patient. In at least one example, stimulation of one or both (i.e., sequential and/or simultaneous dual stimulation) of a patient's ear canal vagal afferent nerve structures could potentially cause a considerably more effective stimulus than that of other stimulated structures. In other embodiments, various other ear structures could be stimulated in a similar manner, depending upon various objectives of the invention, including structures within the ear canal as well as various structures outside of the ear canal such as the helix 1700, the cms of helix 1710, the antihelix 1720, the tragus 1730, portions of the external auditory canal 1740, the antitragus 1750 and/or the lobule 1760 (see FIG. 23). [0082] FIG. 13 depicts one exemplary embodiment of a device including a stimulation component for stimulating an antitragus portion of an ear. The device 700 can include an in-the-ear portion (not shown) with electrodes 710 and 720 for electrically stimulating the antitragus 730 of the ear 740.

[0083] FIG. 14 depicts another alternative embodiment of a device and system for assessing and treating OSDB wherein an in-the-ear device 800 is incudes electrode components 810 and 820 for electrically stimulating a Crux-helix region 830 of an ear 840.

[0084] It should be understood that the various shapes, sizes and structural features of the devices described herein could be formed in a wide variety of shapes and/or configurations, including shapes and/or features that match and/or

substantially conform, to varying degrees, to the underlying anatomy that they contact. For example, the shape of an in-the-ear device could be particularized to match various anatomical features of the ear canal of an intended patient, including features that may be obtained using invasive, less-invasive and/or minimally invasive imaging methods. For example, various embodiments described herein include the design and manufacturing of patient specific and/or patient adapted devices and/or device components having various pre-defined shapes, sizes, widths, spans, thicknesses and/or contours based, at least partially, off of anatomical shape information obtained from one or more pre-operative scans (i.e., x-ray, sonogram, CT scan, MRI, etc.) of the patient's anatomy. In various embodiments, the skin- contacting surface(s) of the device may be atraumatic, such as non-round and/or irregularly curved and/or otherwise shaped, so as to desirably reduce, prevent and/or inhibit rotation of the device and/or preferentially positon the device relative to a desired anatomical location. It should also be understood that, where components and/or features many be modular and/or separately formed, these features could include circular, non-circular and/or irregularly shaped protrusions and mating openings formed therein, to accommodate the assembly of such device prostheses.

[0085] In various embodiments, the devices and/or components thereof can be designed as a one-piece device to be positioned adjacent desired tissue structures, in a manner similar to a standard hearing aid and/or earplug. However, the patient-specific features of these embodiments, such as the curvature, shape, size and/or thickness, can be utilized to ensure the device is properly positioned relative to the desired anatomy. In various embodiments, the devices and/or components thereof can include at least one patient-specific surface that

substantially matches one or more anatomical features of the patient's anatomy.

[0086] In various exemplary embodiments, one or more sensors of the in-the- ear device (and/or associated external components) could sense at least a respiration rate of the sleeper. In one preferred embodiment, where analysis of the sensed respiration rate of the sleeper indicates a potential for a breathing anomaly (which could be evaluated by the device in its likelihood to exceed a given probability threshold), the device could further activate sensing of at least one of a blood oxygen level and/or the pulse rate of the sleeper. In another preferred embodiment, the device could sense at least one of the blood oxygen level or blood pressure of the sleeper. While sensed characteristics such as the blood oxygen level can be highly correlated with the severity of the sleep apnea due to the cyclic depression of blood oxygen as the sleeper experiences repeated cycles of oxygen deprivation, the activation and/or use of such sensing devices can utilize a significant amount of stored energy in the system. However, analyzing the combination of the respiration rate, blood oxygen level and/or pulse rate can substantially enhance diagnostics of the sleep apnea as compared to analyzing a single signal. For example, an analyzing device can analyze the sensed information for sleep apnea, e.g. for absence of breathing. As the sleeper goes into the sleep apnea phase, the respiration typically ceases and oxygen saturation begins to decrease, as does the pulse rate. In one embodiment, the system can use a low power microphone to sense the breathing rate and identify a potential apnea episode, and then activate more power-hungry sensors, wireless communications devices and/or detection devices (as well as higher powered computing resources and/or detection algorithms, if desired). Preferably, the use of multiple sensed conditions can identify an apnea episode with greater accuracy, with the system then applying the stimulus to the sleeper without wasting power on unnecessary stimuli. For example, for some subjects the stimulus is given after the respiration cessation of 10 seconds, while for others, the stimulus is given after the respiration cessation of 5 seconds, and in yet for others after a longer duration such as 30 or 45 seconds. As another example, for some sleepers the stimulus is given if the sleeper's pulse rate drops below a predetermined value. As another example, the respiration threshold varies dynamically with saturated oxygen level or decreases in the pulse rate, e.g. as carbon dioxide builds up in the blood shorter respiration cessations may be tolerated before stimulation is applied.

[0087] FIG. 15 depicts another alternative embodiment of a device for treating OSDB and/or other disorders. In this embodiment, an in-the-ear component 900 (which could comprise a modular component for attachment to some or all of the various devices described herein) could include a low density foam section 910 that is desirably moldable and/or compressible for placement within the ear canal of a user (in a manner similar to compressible foam earplugs), with a higher density portion 920 extending at least partially there through. The higher density section could comprise a higher density foam, plastic metal, less flexible and/or more rigid material, with at least a portion of the higher density section proximate to and/or extending through an outer wall of the of the low density section. If desired, a mechanical force generating device could contact one portion of the higher density section, with mechanical energy transmitted through the higher density section and into contact with surrounding tissue of the ear and/or ear canal. In this embodiment, the component could be aligned using various anatomical features as the reference, such as the Tragus (not shown). In this manner, mechanical energy could be transferred and/or focused to one or more particularly sensitive area(s) on the skin of the ear canal through the higher density pathway within the low density foam plug. In this embodiment, a highly sensitive location that is a distance A within the canal, and an angle Θ from a cephalad direction, can be created as a conduit for mechanical energy transmission (from an external source, for example).

[0088] In various embodiments the devices and systems disclosed herein could include an "alignment mode" or similar feature which facilitates a user's insertion and alignment of the in-the-ear device so as to align the stimulating device with a desired anatomical location. For example, the device may include a "low power stim" or test mode wherein the device intermittently pulses a low power electrical pulse from the stimulation electrode, wherein the user could insert the device into their ear canal and rotation/maneuver the device until the stimulation was felt in the desired area. Similarly, the device could intermittently and/or continuously provide an electrical pulse and/or mechanical pulse or vibration allowing similar placement of the device. Once the device was placed in a desired positon, which might be verified by the user's sensation of the mechanical and/or electrical pulse and/or by the system's assessment that acceptable measurements are being collected, the user could indicate acceptance of device positioning and the system could revert to normal operating modes.

[0089] FIG. 16A depicts an alternative embodiment of an in-the-ear component 1000 (which could comprise a modular component for attachment to the various devices described herein) which includes a mechanical force transmitter 1010 (which could alternatively comprise a vibration generating mechanism or motor, if desired), a terminal end 1020, a flexible outer covering 1030 and one or more core components 1040 (i.e., formed from generally more rigid plastic and/or metallic materials). In this embodiment the transmitter 1010 can comprise an electrically conductive material (if desired) which could further include a proximal wire 1050 as a source of electrical current, with a conductive tip 1060 (i.e., of stainless steel or other conductive material, such as a flexible, conductive plastic) at the terminal end 1020. In use, the transmitter 1020 can be contacted with a shock, force or vibrational motion S, which is desirably transmitted through the component 1000 to the terminal end 1020, which is desirably in contact with a desired anatomical location, such as a cough inducing location within the ear canal (not shown), with the more rigid core components desirably altering the line of action of the force F out of terminal end 1020 to some degree to contact the desired anatomy in a desired manner.

[0090] FIGS. 16B and 16C depict another alternative embodiment of a stimulating component 1080 that could be incorporated into the various devices described herein. In this embodiment, the component 1080 can include a plurality of individual stimulating elements 1080A, 1080B, 1080C, 1080D, 1080E, 1080F, 1080G and 1080H, each element of which could individually be linked to and/or controlled by a mechanical and/or electrical transmitter (not shown). Desirably, this type of component arrangement could be utilized with an in-the-ear component to provide a stimulating impulse or other stimulus to one or more desired locations within the ear canal (some of which might contact various portions of the peripheral ring element), with the device capable of accommodating a plurality of placement locations and/or orientations of the in-the-ear component. In use, the ear device could be inserted, and the user could manually (and/or the system could automatically) identify the elements or elements which provide an optimum contact point to accommodate the stimulus for the desired treatment. In addition, this arrangement could permit the device to continue operation even if the component was inadvertently rotated and/or malpositioned by the user during insertion and/or during sleep. [0091 ] FIGS. 17A and 17B depict another exemplary embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders. The device 1 100, which can mount around one or both ears (and/or earlobes or other supporting structures) of the wearer (see FIG. 17A) can include various

combinations of a variety of components, including a rechargeable battery 1 1 10, battery charging electronics with a docking port 1 120 (i.e., micro USB), a Helmholtz coil for inductive power and/or battery charging 1 130, a Blue Tooth Low Energy (BTLE) transceiver 1 140, a high voltage pulse generator with switches 1 150, a mechanical force inducing coil 1 160 with FE magnetic slug 1 170 and recoil spring 1 180, nonconductive hollow tubing 1 190, a push rod mechanical coupler 1200, a conductive reference electrode 1210 and a stimulating electrode 1220 (which may be formed from a metallic or nonmetallic material). Desirably, the outer shape of the device 1 100 can include a curved proximal section 1230 to provide gentle contact between the electrode 1220 and the ear and/or ear canal at one or more locations sensitive to mechanical and/or electrical impulses.

[0092] If desired, a pair of such devices could be used, with one device positioned at and/or in each ear to increase the system effectiveness, with the two devices in communication with each other and/or with a separate computing device and/or smart phone. Desirably, such a system could select which device to activate to induce a patient reaction, such as when the patient is sleeping on one side of their body and the system activates the lowermost device to induce the patient to turn over, for example. Alternatively, the system could select actuation of one or both devices, as well as various combinations of electrical and/or mechanical stimulation in one or both devices. If desired, the system could identify the charge status of both devices, and utilize the device having the greatest charge level for detection and/or stimulation (optionally maintaining the other device in a low-power mode), or the system could utilize one device for detection and the other device for stimulation, as desired.

[0093] FIGS. 18A through 18C depict another exemplary embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders. The device 1250, which can mount around one or both ears (and/or earlobes or other structures) of the wearer can include various combinations of a variety of components, including: a device body 1260 (i.e., formed from thin PCB or similar materials), a microphone 1270, a battery 1280, foam insulation 1290, electronics 1300 (i.e., control electronics, memory and optional communications devices) and a Helmholtz charging coil 1310 for wireless charging and power. Such an

arrangement can be particularly well suited for manufacturing a relatively low-profile device, especially towards the back or distal tip of the device where it sits under the earlobe in use (not shown).

[0094] FIG. 19 depicts another exemplary embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders. The device 1370 can include a microphone 1380 or other sensing device to detect surface vibrations and/or audio signals indicative of snoring from the wearer. If desired, a pair of microphones or other sensing devices could be utilized (including

combinations of sensing devices of differing types and/or modes of operation, if desired), with one microphone facing inwards towards the user's anatomy and the other microphone facing outward away from the wearer.

[0095] In various embodiments, a system for assessing and/or treating OSDB and/or other breathing disorders could include programmed features for identifying and/or differentiating snoring or other breathing irregularities from normal breathing. For example, snoring is often louder than breathing, so the system may differentiate breathing types based on volume and/or amplitude. Snoring also often creates lower frequencies of noise and/or vibrations than normal breathing, which may be detected by differentiating between sensed frequencies and/or by utilizing a different bandpass detector. When detected from contact with the neck or throat, snoring may be higher in amplitude (i.e., louder) than normal breathing, when measured against ambient (i.e., air) noise.

[0096] In various embodiments, snoring or other breathing irregularities may preferably be detected by observing RMS energy levels over a "window" or period of time, which might include windows of between 30 seconds to a minute in duration or longer. In contrast, normal breathing may be detected on a breath by breath (i.e., per breath) basis, with the absence of a detected breath indicating a potential irregularity. Depending upon the detected breathing gap, a period of time may be determined (or may be preset) to indicates an onset of apnea or other breathing difficulty mandating further assessment, further action and/or treatment.

[0097] Because various embodiments described herein can utilize the same and/or similar devices and/or device components for both detection and treatment of breathing difficulties, it may be necessary and/or desirous to "blank," ignore and/or otherwise deactivate/inactivate various features of the devices and/or systems during treatment. For example, audio detection components may be deactivated during the application of a mechanical impulse so as to prevent incorrect detection of mechanical vibration as a breathing episode.

[0098] In various embodiments the devices and systems described herein could collect and analyze data from the patient during waking periods and/or sleep periods, in order to create a model of the patient's breathing and/or sleeping patterns. Similarly, the system may have access to data from other user's waking periods and/or sleep periods, which may be utilized to improve the detection and/or treatment of breathing disorders. If desired, the system may assess the patient's data and/or "breathing profile" against other profiles stored in a third-party database, with potential similarities and/or matches identified and used to improve assessment and/or treatment of the user's condition.

[0099] Still another sleep disorder occurs tragically in some infants called sudden infant death syndrome (SIDS). In the first few months after birth a small percentage of infants succumb to a cessation of breathing. Although the reasons for this are presently unknown, it has been hypothesized that an inner-ear defect (i.e., a vestibular malfunction - which may occur more often in the right ear) in certain infants puts these babies at risk of SIDS, since this defect may blunt, dull or otherwise inhibit the impulse for the baby to automatically rouse and reposition itself when it is having trouble breathing (i.e., in response to higher levels of carbon dioxide and/or lower levels of oxygen in the blood). SIDS may also be a condition of incomplete development of the normal response to the rise in carbon dioxide (C02), if there is a blockage of airflow such as the infant lying on his or her stomach.

Rubens, et al, speculates that an inner ear malfunction may herald an improper neural response to this rise in C02, thereby triggering an apnea episode.

Regardless of the cause, however, the resulting lack of oxygen in the baby's blood causes a buildup of carbon dioxide in the body, and the baby eventually suffocates. If, while monitoring breathing in a SIDS Susceptible infant, a cessation of breathing is identified and a stimulus applied, this stimulation may terminate the apnea episode and save the infant's life.

[0100] FIG. 20 depicts another exemplary embodiment of a device and/or component for detecting, assessing and/or treating OSDB and/or other disorders, which may have particular utility in the assessment and/or treatment of Sudden Infant Death Syndrome (SI DS) or other infant conditions. By utilizing features of the disclosed system (which may be particularized for use with an infant), the potential for SIDS can be reduced and/or eliminated. As shown, a sleeping infant is clothed in a garment 1420 that can include a resistive, inductive, or capacitive breathing monitor 1435 connected to an electronic module 1430 for wireless transmission of breathing signals to a mobile device 1440 (i.e., a parent's or caregiver's smart phone). A garment-based breathing analysis system incorporating many useful sensor features is described in US patent application no. 20130197387, and is commercially available as the Mimo™ infant monitor (commercially available from Rest Devices, Inc., of Boston, Massachusetts, USA). The infant breathing monitoring system module 1430 may also include features capable of monitoring the infant's orientation to determine if the infant is on his or her back or on his or her stomach or to detect other motion using a technology such as an accelerometer within the electronic module. The system might include a variety of motion sensors attached to the infant and/or the infant's clothing, one or more of which might use accelerometers, orientation sensors (i.e., gyroscopic and/or magnetic bearing sensors) or other devices to determine the frequency, amplitude and/or duration of infant movement, wherein a sensed lack of movement in combination with a detected breathing irregularity invoking a stimulation response.

[0101 ] In the embodiment of FIG. 20, the infant 1400 can desirably be outfitted with a modified OSDB device and associated system components such that the system electrically and/or mechanically stimulates a portion of the infant's anatomy when a breathing difficulty is detected (i.e., which may stimulate the ear canal, the ear surface and/or other anatomical regions, if desired). The system may monitor breathing of the infant, which may include the use of ambient sounds monitors as well as the monitoring of breathing sounds and/or vibrations directly from the infant's skin surface (i.e., at the throat or other location). Similarly, the oxygen and/or carbon dioxide saturation levels of the infant's blood could be noninvasively sensed (including the use of sensors and associated devices as described herein), with various combinations of sensed conditions invoking a stimulus from the device. In addition, detected "warning" conditions and/or other messages (including the identification of induced stimulation occurrences) could be immediately sent in an electronic form to the infant's parents, caregivers, physicians and/or hospital records. [0102] During use, a user will place at least one tip of an earpiece into the external ear canal of their ears. In some circumstances, only one earpiece may be used, while in others two earpieces may be preferred. In one embodiment of the presently disclosed method, the earpieces may also include a speaker which plays audio instructions for proper fit of device. In one exemplary embodiment, the user could also utilize auxiliary securement, such as clips on the pinnea (ear lobe) or external ear, in order to properly secure the device in a desired positon. A best position of the device could be confirmed via audio display from the computing device, or if a camera component is incorporated could provide a visual display of the probe(s) contact point(s) within the ear. Once the earpiece(s) is in position, the user may press an activation button on the mobile phone and/or on the earpiece to activate the sensors (or the system may automatically recognize that operation is desirous). One or more buttons or other features (which may include Graphical User Interface controls on the mobile phone) may then be used to adjust a wide variety of sensor settings. Any number of datasets, pictures and/or video icons will appear on the screen of the mobile computing device. The screen may also display other pictures, data and icons representing all data sets from various tests, various time frames and even various users. If desired, the system can send data and/or pictures to a medical practitioner, who can use the information to make a diagnosis and recommend a treatment, which could be transferred back to the system and potentially alter system operation for its current settings. In more sophisticated embodiments of the present device and methods, software within the device or located at a remote data center could make a diagnosis and recommend a treatment.

[0103] FIG. 21 depicts one additional embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders, which has been sized and particularized for use with an infant or child. In this embodiment, the device 1500 can be enclosed in a "nitecap" 1510 or other headgear type-enclosures, or it may be adhered to the infant's skin or other anatomical structures and/or attached to the infant and/or her clothing via various techniques well known in neonatal care. The device can desirably incorporate some or all of the following components: a breathing sensor 1520, a motion sensor 1530, a pulse oximeter 1540, control electronics and a battery 1550 (which may also include wireless communications capabilities) and a stimulator 1560. This garment 1510 on the infant' s head will desirably provide the desired treatment to terminate the apnea episode. If desired, the garment 1510 could include an in-the-ear apnea treatment device 1500, which can also be in wireless communication with the mobile device 1440. Once the mobile device receives data indicating a cessation of breathing for a prescribed amount of time, the mobile device may transmit instructions to the treatment device 1500 to provide a stimulus to the infant. Alternatively, the mobile device 1440 may transmit instructions to the treatment device 1500 to further interrogate the infant' s breathing condition, such as by initiating a measurement of oxygen saturation using a pulse oximetry component (such as described previously) that may be located on the tragus or other portion of the external ear of the infant prior to initiating an apnea terminating stimulus.

[0104] FIG. 22 depicts another alternative embodiment of a device and/or component for assessing and/or treating OSDB and/or other disorders, which includes a component wearable on anatomy adjacent to and/or away from the ear, such as around the head, neck and/or extremity of the user. In this embodiment, a headband 1600 or other wearable feature can incorporate a variety of electronics and/or other components, including one or more microphones 1610, 1620, a motion sensor 1630, a pulse oximeter or other Sp02 sensor 1640, control electronics 1645, a battery 1650 (which may also include wireless communications capabilities) and a stimulator 1660. Various additional sensors and/or other electronics could include optional electrodes, sP02 sensors, hydrogel electrodes and/or other devices 1655 (on one or both sides of the headband, as desired). Desirably, the stimulator component 1660 will include an in-the-ear portion, with a wireless and/or wired modular or other connection 1670 to a port 1680 on the headband 1600 (with such ports located over one or both ears on the headband, if desired), although alternatively the stimulator 1660 could be hard-wired and/or integral to the headband 1600. In another alternative embodiment, the stimulator can be positioned and/or attached within the headband, with the headband desirably over a portion of the ear (not shown) and holding the stimulator at a desired position within the ear.

[0105] The headband 1600 of FIG. 22 could provide significant additional advantages to the disclosed devices and/or systems, including providing a larger area for accommodating electronics and/or energy storage components (as compared to an in-the-ear and/or around-the-ear component), could provide locations for additional sensors (i.e. , accelerometers with differing sensing orientations and/or geometries and/or differentially located/oriented microphones), and/or could accommodate a wider array of anatomies and/or anatomical geometries. In fact, the disclosed systems may be particularly well-suited for infants and/or small children with smaller and/or developing ear geometries, as well as individuals with unusual and/or injured ear anatomy. Various advantages potentially attendant with this design can include (1 ) the potential to position of many electronics components away from and/or remote from the ear, (2) the potential to obviate any need to rely on ear physiology to secure and/or accommodate the device, other than the stimulation component, (3) the device can accommodate a larger battery and/or multiple batteries, (4) the system may be more comfortable for some individuals than a comparable in-the-ear stimulator, (5) the device can utilize a stretchable fabric and/or adjustable band size and/or the use magnetic and/or Velcro (i.e., hook and loop) type fasteners to adjust band size, (6) the device can allow for additional sensing and data collection components, including electrodes at one or both temples, an sP02 sensor on the forehead (in a manner similar to the sP02 forehead stickers in current clinical use) as well as the use of multiple microphones in up to 4 directions for superior snore discrimination of user and/or sleep partner.

[0106] In addition, various additional alternative embodiments of components for use with the various systems described herein could include: (1 ) A device for securement within a pillow and/or pillowcase of the user (i.e., within a pocket in a pillowcase or pillow liner, for example), which could include features to

accommodate the use of a smart phone and/or other mobile computing device. Desirably, the components would include a microphone to help discriminate the user's breath patterns from a sleeping partner's, and the device could include a mechanical and/or electrical stimulator (and/or various combinations thereof) which plugs into the headphone or other port of a smartphone, with the smartphone some and/or all of the sensing, analysis and/or stimulation features described herein, including the use of the onboard battery of the smartphone to power the various components described herein.

[0107] It should be understood that various system components described herein might be particularized and adapted for infant wear on an individual basis (i.e., without use of other associated components), including the use of a "stand alone" infant "nitecap" 1410 which surrounds some portion of the infant's head and contains various sensors and/or impulse creating components. Similarly, a "onesie" 1420 or other garment could include and sensing and/or processing device 1430, which could include some or all of the components described herein.

[0108] Various additional features of the disclosed devices and/or system could be used to assess and/or treat a variety of breathing-related conditions, including conditions such as Cheyne-Stokes Breathing, which is characterized by rapid breathing followed by a cessation of breathing for a time. This disorder occurs often in individuals suffering from moderate to severe heart failure (i.e. ,

approximately a 50% prevalence). This condition can result in an oscillating nervous reaction from parasympathetic to sympathetic, a condition that can be dangerous to heart failure patients as it can lead to lethal arrhythmias. In various embodiments, the various devices and/or systems described herein could be useful in detecting and/or terminating the "apnea" phase of Cheyne-Stokes Breathing, as well as potentially blunt the resulting sympathetic response. In various embodiments, the device and/or system components could be similar to those components previously described herein.

[0109] In various embodiments, the disclosed devices and systems will desirably facilitate the collection of all necessary physiological signals needed for monitoring OSDB using a single device or combination of device, which in various embodiments may be obtained from one site within the ear. The described embodiments have the ability to treat OSDB from within the ear using a variety of stimulation therapy techniques and/or combinations, which may include electrical, vibratory and/or audio stimulation therapy signals that become progressive stronger (or otherwise utilized in a variety of combinations) until the sleeper either

subconsciously or consciously is momentarily semi-awakened or otherwise disturbed, desirably causing the sleeper to breath. The stimulation signal(s) will desirably be directed at the sleeper only, allowing others to not be awakened.

Monitoring and delivery of therapy for OSDB can be provided that does not consciously arouse the sleeper or cause discomfort or stress that leads to the person's incompliance and non-acceptance.

[01 10] By obviating the need for forced air induction devices and/or associated apparatus, an apnea prone sleeper's discomfort is greatly reduced because the annoying breathing mask is no longer required while sleeping. The detection and treatment of OSDB can be performed without tethered connections (air hose, physiological measurement cables) between the sleeper and external contraptions, thus enabling sleeper's movement and position changes during the night. Moreover, the current need for an implanted electrical stimulator or surgical procedures to treat the OSDB condition can be reduced and/or eliminated.

[01 1 1 ] The various inventions disclosed herein include the identification of a need for consumer-and/or user-friendly devices that can be employed by untrained or semi-trained individuals to safely and effectively capture, store, transmit, display, download, assess and/or treat a physiological condition. In accordance with various embodiments described herein, the method includes, without limitation, a nonmedical professional (e.g., a consumer or other patient, etc.) utilizing a device that can monitor and perform an assessment of a patient's condition, and initiate treatment for the condition, all without the need for direct human intervention. In various embodiments, the device and/or software APP will have the capability to store and/or transmit relevant information for use in future assessments of the patient's physical condition, and can include storing information about the patient's condition in a storage medium, include storage media accessed remotely (e.g., USB accessible, LAN accessible and/or internet accessible storage devices), as well as localized storage associated with the device (e.g., RAM or flash memory, SD cards, attached smartphone memory, etc.). The device can simultaneously and/or subsequently upload stored data to a general or specialized storage network, or remote access to the electronic storage medium can be provided over a computer or other communication network. If desired, the stored data could be accessed by a competent medical professional or other caregiver, properly assessed, and recommendations regarding the condition and/or treatment could be transmitted back to the system and implemented without intervention by the user and/or patient.

[01 12] In various embodiments, in situations where a user is unable or unwilling to access emergency services directly (e.g., the user is a fireman fighting a fire, a soldier fighting in a battle, a pilot flying an airplane, or a climber climbing a mountain, etc.), the present system and methods described herein can provide critical care data directly to the patient and/or a remote monitoring station, as well as provide emergency response personnel with detailed information about a patient's condition, that may take mere seconds for the device to collect, allowing responders to prioritize their response and/or equip themselves for specialized medical responses. INCORPORATION BY REFERENCE

[01 13] The entire disclosure of each of the publications, patent documents, and other references referred to herein is incorporated herein by reference in its entirety for all purposes to the same extent as if each individual source were individually denoted as being incorporated by reference. More specifically, the entire disclosure of US Patent No. 8,406,884 to Nielsen is incorporated herein by reference in its entirety.

EQUIVALENTS

[01 14] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus intended to include all changes that come within the meaning and range of equivalency of the descriptions provided herein.

[01 15] Many of the aspects and advantages of the present invention may be more clearly understood and appreciated by reference to the accompanying drawings. The accompanying drawings are incorporated herein and form a part of the specification, illustrating embodiments of the present invention and together with the description, disclose the principles of the invention.

[01 16] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the disclosure herein.

Claims

CLAIMS:

1 . A monitoring and therapy system comprising:

a wearable sensor device having a first sensor for non-invasively sensing a first physiological condition of the user, the first physiological condition indicative of a respiration of the user, the wearable sensor including a first portion extending into an ear canal of the user,

an analyzing device in communication with the wearable sensor probe, the analyzing device configured to analyze the first physiological condition of the user to identify an onset of a cessation of respiration and determine an appropriate stimulus to apply to the patient in response to the sensed cessation of respiration, wherein the determination step utilizes information from a stimulus outcome database to determine the appropriate stimulus, and

a stimulating device connected to the first portion that applies the appropriate stimulus to the user, at least a portion of the stimulating device disposed within the ear canal and in direct contact with a skin surface within the ear canal.

2. The monitoring and therapy system of claim 1 , wherein the analyzing device further determines a success rate of the appropriate stimulus after the stimulating device applies the appropriate stimulus to the user and records the success rate into the stimulus outcome database in a non-transitory storage medium of the analyzing device.

3. The monitoring and therapy system of claim 1 , wherein the stimulating device applies an electrical shock to the skin surface within the ear canal.

4. The monitoring and therapy system of claim 1 , wherein the stimulating device applies a mechanical impulse to the skin surface within the ear canal.

5. The monitoring and therapy system of claim 1 , wherein the portion of the stimulating device contacts the skin surface at a location proximate to an auricular branch of a vagus nerve of the user.

6. The monitoring and therapy system of claim 1 , wherein the wearable sensor device includes a second sensor for sensing a second physiological condition of the user, wherein the second sensor is maintained in an inactive state and is activated when the analyzing device identifies the onset of a cessation of respiration.

7. The monitoring and therapy system of claim 6, wherein the first sensor comprises a microphone and the second sensor comprises a pulse oximeter.

8. The monitoring and therapy system of claim 1 , wherein the portion of the stimulating device contacts the skin surface at a tragus of the user.

9. The monitoring and therapy system of claim 1 , wherein the portion of the stimulating device contacts the skin surface at an antitragus of the user.

10. The monitoring and therapy system of claim 1 , wherein the wearable sensor device comprises an adjustable headband.

1 1 . A method for terminating a manifestation of an Obstructive Sleep Disordered Breathing (OSDB) of a sleeping user, comprising the steps of:

employing a first wearable sensor device to detect a breathing pattern of the user,

analyzing a data stream from the first wearable sensor device to identify an interruption in the breathing pattern of the user,

activating a second wearable sensor component in response to the detected interruption in the breathing pattern, the second wearable sensor component capable of detecting a second physiological condition of the user,

analyzing a data stream from the first and second wearable sensors to identify the manifestation of the OSDB,

accessing a stimulus outcome database to determine a desired stimulus to apply to the user in response to the identified manifestation of the OSDB,

applying the stimulus to the user,

assessing a post-stimulus data stream from at least one of the first or second wearable sensors to determine an effectiveness of the stimulus in terminating the manifestation, and

recording the effectiveness of the stimulus in the stimulus outcome database.

12. The method of claim 1 1 , wherein the step of applying the stimulus to the user comprises applying a stimulus directly to a skin surface within an ear canal of the user.

13. The method of claim 12, wherein the skin surface within the ear canal of the user overlies an auricular branch of a vagus nerve of the user.

14. The method of claim 13, wherein the stimulus comprises an electrical shock.

15. The method of claim 13, wherein the stimulus comprises a vibratory motion.

16. The method of claim 1 1 , wherein the first wearable sensor comprises a portion sized and configured to pass within an ear canal of the user.

17. The method of claim 1 1 , wherein the second wearable sensor detects a blood gas saturation level of the user.

18. The method of claim 1 1 , wherein the second wearable sensor detects an ambient temperature level.

19. The method of claim 1 1 , wherein the Obstructive Sleep Disordered Breathing is Cheyne-Stokes breathing.

20. The method of claim 1 1 , wherein the Obstructive Sleep Disordered Breathing is Sudden Infant Death Syndrome (SIDS) of an infant.

21 . The method of claim 1 1 , wherein the Obstructive Sleep Disordered Breathing is central sleep apnea.

22. A method for treating an Obstructive Sleep Disordered Breathing (OSDB) of a sleeping user, comprising the steps of:

employing a lower power demand sensor component to collect a first set of data on a first physiological condition of the user, the first physiological condition reflective of a breathing pattern of the user,

analyzing the first set of data to identify an interruption in the breathing pattern of the user,

activating a higher power demand sensor component in response to the detected interruption in the breathing pattern to collect a second set of data reflective of a second physiological condition of the user, the second physiological condition reflective of at least one gas level in the blood of the user,

analyzing the first and second sets of data to identify a manifestation of the

OSDB,

accessing a stimulus outcome database to determine an appropriate stimulus to apply to the user in response to the identified manifestation of the OSDB,

activating a stimulating component to apply the stimulus to the user, the stimulating component at least partially located within an ear canal of the user,

utilizing at least one of the lower power demand sensor or higher power demand sensor to assess determine an effectiveness of the stimulus, and

recording the effectiveness of the stimulus in the stimulus outcome database.

23. The method of claim 22, wherein the lower power demand sensor comprises a microphone and the higher power demand sensor comprises a pulse oximeter