Systems, methods, and devices for managing chronic conditions using olfaction

Abstract

This disclosure relates to technologies to aid in chronic condition relief without reliance upon medications. More particularly, this disclosure is directed to methods and systems for using conditioning and a scent profile including an olfactory trigger to help users manage chronic debilitating conditions such as chronic pain.

Description

[0001] SYSTEMS, METHODS, AND DEVICES FOR MANAGING CHRONIC CONDITIONS USING OLFACTION

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] The present application claims priority to U.S. Provisional Application No. 63 / 584,438, filed September 21, 2023, the complete disclosure of which is incorporated herein by reference.

[0004] TECHNICAL FIELD

[0005] This disclosure relates to technologies to aid with relief from chronic conditions without reliance upon medications. More particularly, this disclosure is directed to systems, methods, and devices for using conditioning and a scent profile including an olfactory trigger to help individuals manage chronic debilitating conditions such as chronic pain.

[0006] BACKGROUND

[0007] As many as 67 million Americans live with chronic pain, with as many as 24 million having high-impact chronic paining. The definition of what is “successful” management of chronic pain varies from person to person but is often considered to be as minimal as a 30% to 50% reduction in pain. Because pain is a subjective experience specific to the individual, techniques that once worked to successfully manage chronic pain can become less effective or entirely unsuitable to address present chronic pain issues that have evolved over time.

[0008] Chronic pain is known to have a significant negative impact on a person’s quality of life. As many as 36 million people miss work annually due to chronic pain. Approximately five to eight million people have become reliant on opioids after using them to manage chronic pain. Of the population of Americans that suffer chronic pain, approximately 67% have memory or attention problems that stem from their pain, approximately 50% also suffer from major depressive disorder (compared with approximately 10% of the general population), approximately 53% suffer from insomnia (compared with approximately 4% of the general population), and the divorce rate among those with chronic pain is approximately 75% (compared with approximately 40% of the general population). These effects and outcomes of poor pain management further impact the quality of life of those dealing with chronic pain and other chronic debilitating conditions.

[0009] There are currently no fully effective methods to manage chronic pain for most individuals. Drug therapy (e.g., opioids, antidepressants, antiepileptics) is commonly employed to manage chronic pain. Drug therapies are often nonspecific and frequently used off-label to manage pain. Drugs also have side effects which limit their use in many cases, especially for the elderly, children, and those who are pregnant. Psychotherapy is commonly used to manage chronic pain but can be associated with social stigma, and access to care is an issue for many individuals due to a lack of providers or physical distance. Surgery (e.g., pain pumps, spinal cord stimulators) can be effective to manage chronic pain but is very costly and invasive for the individual. There may also be risk of associated morbidity and mortality depending on the type of surgery.

[0010] There are numerous aromatherapy devices on the market, with at least one device specifically intended to target post-surgical pain. For example, U.S. Pat. No. 10,842,433 describes a device that focuses on achieving “less-than-moderate” pain (defined as level three or less using a zero to ten rating scale) before activating the device. Embodiments of the device disclosed therein are quite large and, accordingly, not suitable for users who are moving or who have pain ratings other than “less-than-moderate” or level three or less on the rating scale. For patients living with chronic pain, it is common for many to always have a baseline level of pain that remains at three or more on a zero to ten pain rating scale, rendering therapy with the device of U.S. Pat. No. 10,842,433 impossible. Furthermore, the device of U.S. Pat. No. 10,842,433 lacks the ability to integrate psychosocial user inputs into its algorithms, thereby rendering the algorithms less user-specific and more generic.

[0011] Based on the International Association for the Study of Pain, the most widely accepted definition of pain is, “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.” By definition, to understand and manage pain, one must factor in the emotional and / or other subjective aspects of pain, which is difficult to achieve. Therefore, conventional devices such as the device disclosed in U.S. Pat. No. 10,842,433 can be considered incomplete as they do not account for aspects of pain that are not purely based on physiology (e.g., a patient may have a pain rating of four out of ten and physiology that indicates a pain state; however, if the person is experiencing a positive emotional state, it would still be an ideal time to habituate a user to a scent profile to work toward lessening overall pain, despite physiological markers to the contrary indicating that habituation is not needed at this time).

[0012] The concept of developing a classical conditioned response was first described in 1927 by Ivan Pavlov and is also known as Pavlovian conditioning. By 1938, B.F. Skinner developed the concept of operant conditioning. Unlike classical conditioning, in which a conditioned stimulus should optimally occur before a conditioned response for an association to form, operant conditioning involves altering behaviors based on consequences, a different mechanism of action from Pavlovian conditioning and an important distinction. However, both models suffer from the problem of extinction, which is the decrease and / or loss of an association or behavior over time due to unpairing of the stimuli and / or the behaviors and consequences. For example, U.S. Pat. No. 11,721,425 describes similar concepts as those described in U.S. Pat. No. 10,842,833, except for using scent to form an association to manage satiation based solely on classical (or Pavlovian) conditioning which is well known in the art. However, the concept of preventing extinction is of utmost importance to maximize potential efficacy of any device attempting to use such concepts for therapeutic use. Neither of the aforementioned concepts consider how to maintain an association once it is formed, which is key for long-term efficacy.

[0013] Thus, there is a present need for an adjunctive tool that individuals with chronic conditions can use to help manage symptoms and ultimately improve quality of life. There is a further need for facilitation of individuals to take an active role in managing their symptoms in order to minimize use of controlled substances such as opioids. Lastly, there is a further need for treatments or management systems, methods, and devices that are applicable to a wide variety of chronic conditions and settings, including those other than “less-than-moderate” chronic pain, and for those individuals who are elderly, pregnant, or children.

[0014] SUMMARY Disclosed herein are systems, methods, and devices for managing chronic conditions that enable a user to manage symptoms to improve their quality of life. This enables individuals to take an active role in managing their symptoms, has the potential to minimize use of controlled substances such as opioids, and is applicable not only to a wide variety of chronic pain conditions, but can also be modified to aid other chronic conditions including, but not limited to, anxiety, depression, post-traumatic stress disorder (PTSD), suicidal ideation, attention- deficit / hyperactivity disorder (ADHD), and angina.

[0015] In particular, the systems, methods, and devices disclosed herein are intended for use by individuals suffering from chronic conditions. In embodiments, the systems, methods, and devices are configured to release a scent in response to user data received from a user or another person (user data can be quantitative physiological data and / or qualitative data received directly from the user or another person). In embodiments, the systems, methods, and devices are further configured to release scent when manually prompted to do so by the user or another person. The user data may be received from a smart device, from the disclosed devices or systems themselves, or from external equipment operated by the user or another person. Received physiological data may include heart rate, respiratory rate, bodily temperature, skin conductance, blood pressure, sleep statistics, photoplethysmography (PPG) data, electrodermal activity (EDA), and other bodily measurements.

[0016] The systems, methods, and devices disclosed herein may include a wearable, controllable scent delivery device, a consumable scent carrier, one or more sensors, such as external biofeedback sensors, configured to measure physiological data of the user, a digital application, software, algorithm, or other suitable digital component for collecting physiological data from the one or more sensors and for determining an association between a particular scent (used interchangeably herein with “olfactory trigger”) and a physical response of the user, and a method to optionally connect the proposed devices with one or more smart and / or external devices. The association may also be formed between a scent profile customized to user preferences, physiological needs, and a physical response of the user (e g., a scent with a particular concentration, duration of scent release, scent type, position of scent delivery device, user age, user demographic, user health status, etc.).

[0017] In embodiments, the systems, methods, and devices disclosed herein can be configured to form and maintain associations between scents and physical responses of the user without the use of user data received from the user. Advantageously, such embodiments allow for chronic condition management without physiological monitoring by relying instead on qualitative data derived from the user’s personal experience in connection with a scent profile (e g., asking the user how they felt after scent dispersal, observing the user’s physical reaction to scent dispersal, etc.). In embodiments, the systems, methods, and devices disclosed herein can be configured to form and maintain associations using mechanisms other than scent (e.g., using sound, touch, taste, or visual indicators to form an association with a desired physical and / or mental response). Such association-forming mechanisms can also be used with scent mechanisms to create a comprehensive sensory perception approach to conditioning a physical and / or mental response from a user. One objective of the systems, methods, and devices disclosed herein is to form a consistent association between a particular scent and the user exhibiting and / or perceiving to be in a neutral to positive mental state, where a positive mental state indicates the user may be less worried about and / or less focused on their chronic condition (e.g., the user can be characterized as “happy,” “relaxed,” “care-free,” “accepting,” etc.). The positive mental state may also additionally or alternatively indicate a physical state that is consistent with physiological markers indicating a more-optimum-than-average physical state (e.g., lower pain level, lower stress level, higher energy level, etc.). For example, higher energy level could be advantageous for someone using the systems, methods, and devices disclosed herein to treat certain conditions such as chronic fatigue syndrome and / or fibromyalgia.

[0018] In embodiments, after an association between scent and the more-optimum-than-average mental and / or physical state has been established, the user can manually trigger the scent release when exhibiting a less-optimum-than-average mental and / or physical state in order to assist with returning to the more-optimum-than-average mental and / or physical state (this operation can be characterized as “rescue therapy” because the user is “rescuing” themselves from the less- optimum-than-average mental and / or physical state). In reference to previous examples, “more- optimum-than-average mental and / or physical state” can be defined as a bodily state of the user that is more desirable because it causes the user to experience, for example, lower pain and stress levels and to be more relaxed and / or happy compared to an average bodily state experienced with the chronic condition. In contrast, “less-optimum-than-average mental and / or physical state” can be defined as a bodily state of the user that is less desirable because it causes the user to experience, for example, higher pain and stress levels and to be less relaxed and / or happy compared to the average bodily state experienced with the chronic condition.

[0019] The systems, methods, and devices disclosed herein generally operate by collecting and storing user data (e.g., physiological data) which can be subsequently interpreted to establish one or more baselines (used interchangeably herein with “baseline response,” “baseline pain,” “baseline threshold,” “known association,” or any combination of the preceding) during a training session. This data can be optionally combined with quantitative or qualitative data inputted by the user or another person (e.g., user confirming they in a m ore-optimum -than- average mental and / or physical state, user inputting a mental and / or physical score (e.g., pain score) into the digital application, user confirming a positive mood, etc.). Using the received user data, when it is determined that the user is in a more-optimum-than-average mental and / or physical state, a scent can be released by a scent delivery device. The specific scent is chosen by the user, based on personal preference, from an assortment of different scents provided upon receipt of the device. Once a scent is selected, that scent is to be used continually with the device for that condition, unless user retraining is desired. Initial associations between a scent and a physical response of the user can be made during training sessions (e.g., meditation at home, with a medical practitioner in conjunction with ongoing therapy, using the digital application, etc.), or manually when the user is aware that they are in a more-optimum-than-average mental and / or physical state.

[0020] Once initial training is performed and the disclosed systems, methods, and devices have “learned” the relationship between the user’s physiological markers (as represented by user data) and the user’s subjective information such as chronic condition rating levels, “rescue therapy” will be unlocked, thereby enabling the user to “rescue” themselves if they reach a mental and / or physical state from which they feel they need assistance to recover. The systems, methods, and devices are configured to track the number of “rescue therapy” uses and disallow further uses if the user fails to maintain a positive association (i.e., an association indicating a strong correlation) between the scent and the more-optimum-than-average mental and / or physical state determined previously from training sessions. Further use of “rescue therapy” may also be disallowed if the number of uses exceeds a predetermined limit; this may indicate that the association has weakened (e.g., various user changes over time, ability to smell changes based on age, health status, habituation, etc.) and must be reestablished through additional training sessions or through adjustment of the scent and / or scent profile currently in use.

[0021] The systems, methods, and devices disclosed herein employ various principles of operant conditioning to enable management of chronic conditions. Specifically, the conditioning principles can be facilitated using a digital application that guides a user through exercises based on psychological methods known to reduce symptoms of chronic pain (e.g., guided imagery, cognitive behavioral therapy, hypnosis, etc.). While chronic pain is one focus of the disclosed systems, methods, and devices, other applications contemplated herein include the management and / or treatment of anxiety, depression, PTSD, suicidal ideation, ADHD, and other health conditions known to have chronic symptoms. Outside of medical applications, it is contemplated that the systems, methods, and devices disclosed herein could be used in the contexts of augmented and virtual reality (e.g., using scents to enhance entertainment or therapy for a user), animal training, neurological therapy, education, and habit reversal or behavioral modification applications.

[0022] Certain advantages of the systems, methods, and devices disclosed herein include providing a wearable item that a user can take and use anytime and anywhere with the optional ability to connect and / or collaborate with a smart device or other external devices to collect physiological data (alternatively or in addition to data collected by one or more sensors included with the wearable item). The wearable item can be customized so that a user unable to reduce their pain level below a three on a scale of zero to ten can also benefit from the disclosed advantageous techniques. Moreover, the wearable item is not anticipated to have any significant adverse drug reactions, is suitable for use during pregnancy and in children and the elderly, and can also be used in conjunction with conventional medical therapies. The systems, methods, and devices disclosed herein can be delivered to a user in the privacy of their residence and at their convenience, rather than requiring the user to perform the therapy at the location of their medical practitioner. Cost savings due to less frequent medical practitioner visits are also contemplated through use of the disclosed systems, methods, and devices.

[0023] Moreover, the systems, methods, and devices disclosed herein enable individuals suffering with chronic conditions to learn that they can control and alter their physiology by practicing association-forming tasks. Delivery of a specific scent reinforces this behavior and encourages users to continue engaging in behaviors designed to help manage their chronic condition(s). In embodiments, a method of maintaining an association between a scent profile and a physical response includes receiving user data indicating a physical response of a user to a first scent profile, determining, using the user data, an association metric between the physical response of the user and the first scent profile, comparing the association metric to a known threshold association metric specific to the user, and outputting a second scent profile that satisfies the known threshold association metric specific to the user.

[0024] In embodiments, a system includes a wearable device, a scent delivery device communicatively coupled to the wearable device, wherein the scent delivery device includes a scent carrier having a reservoir for storing a scent, the scent delivery device configured to release the scent after receiving instruction to do so, and one or more sensors communicatively coupled to the wearable device, the one or more sensors configured to measure physiological data, wherein the combination of the wearable device, the scent delivery device, and the one or more sensors are configured to perform operations of maintaining an association between a scent profile and a physical response from the user.

[0025] In embodiments, a method of determining an association between a scent delivery profile and a physical response includes receiving, via one or more sensors, first user data indicating a physical response of a user, storing the first user data as a baseline physical response in a storage module, instructing the user to perform an association-forming task (e.g., deep breathing, meditation, exercises, etc.), receiving, via the one or more sensors, second user data indicating a physical response of the user to the association-forming task, dispersing, via a scent delivery device, a first scent profile to be associated with the second user data, receiving, via the one or more sensors, third user data indicating a physical response of the user to the first scent profile, and outputting a second scent profile based on a comparison of the third user data to the prior physical response(s) (e g., to the physical response of the user to the first olfactory trigger and / or to continued training with the association-forming task itself).

[0026] The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

[0029] FIG. 1 is a system for managing chronic conditions through olfaction, according to embodiments of the disclosure.

[0030] FIG. 2 is a method of olfactory conditioning for chronic condition management and relief, according to embodiments of the disclosure.

[0031] FIG. 3 is a flowchart of a method of determining optimal scent parameters to establish and maintain a scent association, according to embodiments of the disclosure.

[0032] FIG. 4 is a flowchart of a method of training a user to form an association with a scent, according to embodiments of the disclosure.

[0033] FIG. 5 is a flowchart of a method of enabling automatic scent dispersal and maintaining a scent association with a user physical response, according to embodiments of the disclosure. FIG. 6 is a flowchart of a method of maintaining an association between a scent profile and a physical response of a user, according to embodiments of the disclosure.

[0034] FIG. 7 is a flowchart of a method of training a user to form an association with a scent profile, according to embodiments of the disclosure.

[0035] While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

[0036] DETAILED DESCRIPTION OF THE DRAWINGS

[0037] Disclosed herein are systems, methods, and devices for managing chronic conditions through olfaction. The disclosed systems, methods, and devices may be used by individuals suffering from various chronic conditions, various persistent mental illnesses, and other conditions and circumstances requiring long- or short-term active and / or passive management by the individual. This disclosure provides accessible, convenient techniques for individuals with chronic conditions to manage their symptoms.

[0038] The disclosed devices and systems are configured to release a scent in response to physiological and / or subjective data received from the user. The devices and systems are further configured to form a consistent association between a selected scent and the user experiencing a more-optimum-than-average mental and / or physical state. Once the association between scent and more optimum mental and / or physical state is established, the user may manually trigger the scent release while in a less optimum mental and / or physical state as a “rescue therapy” to return the user to a more optimum mental and / or physical state. The disclosed devices and systems may collect and store physiological data such as heart rate, heart rate variability, respiratory rate, sleep stages, PPG data, EDA data, skin conductance, or other similar bodily measurements from the user, in addition to qualitative data received directly from the user or another person. This data may be interpreted to establish user baselines and can be combined with user inputs via a digital application (e.g., the user confirming they are in a more optimum mental and / or physical state or providing a pain score corresponding to their mental and / or physical state). After determining that the user is in a more-optimum-than-average mental and / or physical state, or a superior emotional state, a specific scent may be released. In embodiments, the scent may initially be chosen by the user from an assortment of scents to provide additional customization.

[0039] The associations between a particular scent and a particular or relative mental and / or physical level may be made during specific training sessions (e.g., at home meditation, with a medical practitioner in conjunction with ongoing therapy, using a digital application provided with the device itself, or other suitable training applications). Associations may be made manually when the individual is aware they are in a more-optimum-than-average mental and / or physical state by triggering release of a scent associated with the more optimum mental and / or physical state. In embodiments, once one or more training session(s) is / are performed and the device or system has learned a relationship between the user's physiological markers, subjective markers, and their mental and / or physical rating levels, the device or system may automatically deliver the trained scent when the user data meets certain criteria for that user. Embodiments with automated release of the trained scent may provide for more effortless maintenance of the association between the trained scent and the more desirable physiological state. Once the user has formed a strong association, the device may be “unlocked” for the user to use “rescue therapy” at their discretion.

[0040] In embodiments, the device or system may track “rescue” uses and disallow them if the user does not maintain the positive association between the trained scent and the more-optimum- than-average mental and / or physical state, or other target state, such as through continued training sessions, manual training releases, or through having enough automatic associations. The disclosed systems, methods, and devices may use principles of classical and / or operant conditioning and may be facilitated with a phone application that guides the user through exercises based on psychological methods shown to improve mental and / or physical states which may also reduce pain (e.g., guided imagery, cognitive behavioral therapy, hypnosis, or other suitable methods). The disclosed systems, methods, and devices may also be used to treat other chronic conditions such as anxiety or depression, and may also be used for general wellness purposes (e.g., treating addiction, managing weight, improving sleep, etc.) and / or for nonchronic conditions, lasting less than three months.

[0041] Referring to FIG. 1, a system 100 may include a wearable, controllable scent delivery device 110 (used interchangeably herein with “olfactory delivery device”), a consumable scent carrier 112, one or more biofeedback sensors 114, and an application run through a smart device

[0042] 120, the application comprising a method to connect to a separate smart device which may have features to monitor user physiological parameters such as heart rate, respiratory rate, sleep characteristics, and PPG or EDA data. The system 100 may also include software to collect and analyze received user data (i.e., physiological data and / or qualitative user data) to employ learning algorithms using, for example, signal processing or an artificial intelligence such as machine learning. The signal processing and machine learning models provided herein can be configured to receive multi-modal inputs including, but not limited to, physiological signals, audio and visual signals, user-entered data, geospatial data (e.g., location, movement), and data extracted from a user's digital presence (e.g., social media). The multi-modal inputs can be used by the signal processing and machine learning models to adapt to changes in the user’s life and accordingly perform classification of the inputs.

[0043] System 100 may comprise multiple separate components, such as scent delivery device 110 and smart device 120, as shown by way of example in FIG. 1. Further embodiments are contemplated which include a single component that integrates the functionality of scent delivery device 110 and smart device 120 into a single device. In embodiments, one or more biofeedback sensors 114 may be various independent separate sensors configured to be worn by the user, such as bands, rings, or patches, rather than the one or more biofeedback sensors 114 integrated with smart device 120 as shown by way of example in FIG. 1. Biofeedback sensors 114 may be coupled to the other components of system 100 through one or more wires, or through wireless communication.

[0044] Scent delivery device 110 may comprise various user-friendly and easily transportable configurations. The example of FIG. 1 shows scent delivery device 110 as a band, which may be a wristband, armband, necklace, ankle-band, belt, or other suitable wearable item, depending on size, configuration, and user preference. In embodiments, scent delivery device 110 may be mounted to the nose, such as a nasal strip, or even mounted inside the nose, such as a nasal clip or dilator, or a septal stimulator. In embodiments, scent delivery device 110 may be integrated into a pair of glasses or into a textile such as a scarf, or affixed to an article of clothing. The scent delivery device 110 may be ear mounted, such as an ear clip or an earring, or integrated with a Bluetooth® device such as an earbud or a headset (e.g., scent delivery device 110 may be an earbud or headset in electrical communication with a physiological data monitoring device). Scent delivery device 110 may include one or more integrated sensors 11 1 configured to measure and record physiological data of a user. Generally, one or more integrated sensors 111 are partially embedded within a housing of scent delivery device 110 and may be in electrical communication with a storage module integrated into scent delivery device 110 or a digital storage module located outside of scent delivery device 110. One or more integrated sensors 111 may include any number of biosensors known to one skilled in the art.

[0045] Consumable scent carrier 112 may be integrated with scent delivery device 110 to provide a refillable reservoir of scent fluid, powder, gas, or other material. In embodiments, scent carrier 112 may be a flexible or a rigid reservoir. The reservoir of scent carrier 112 may generally be integrated with scent delivery device 110 for greater ease of use and transportation. In embodiments, scent carrier 112 may be removable. Scent carrier 112 may have a port or other access method for refilling with scent fluid, powder, gas, or other material.

[0046] Like one or more integrated sensors 111, one or more biofeedback sensors 114 may include any number of biosensors configured to measure various physiological parameters, including, but not limited to, heart rate, respiration rate, blood oxygen, body temperature, skin conductance, photoplethysmography (PPG) data, electrodermal activity (EDA), and any other bodily measurements. Data measured by the one or more biofeedback sensors 114, in addition to any data manually received from the user, can be used in conjunction with the signal processing and machine learning models provided herein to determine a user's health state and adapt the behavior of the scent delivery device 110, including the scent profile unique to the user, accordingly. In particular, the measured physiological parameters as disclosed previously by way of example can be used to indicate a user’s current health state which can subsequently be used by system 100 for calibration and refinement of scent delivery device 110 and / or the unique scent profile.

[0047] Smart device 120 may be a custom monitoring device or any known or developed device with sufficient computing power to execute all or portions of the methods, discussed in further detail below. The smart device 120 may be a smartwatch, a smartphone, a tablet or computer application, an integrated ear device or smart glasses, or any other suitable device known to one of ordinary skill in the art.

[0048] Scent delivery device 110 and smart device 120 may generally be in wireless communication with each other, but in embodiments scent delivery device 110 and smart device 120 may be in wired communication or communicate through another device or system. Communication between scent delivery device 110 and smart device 120 may allow smart device 120 to actuate controlled release of the scent in response to determining that the user is in a mental and / or physical state beyond a baseline threshold. Timing of the release of the scent may be controlled, along with the rate of release, the intensity of the scent, and whether a single scent or a combination of scents are released.

[0049] In embodiments, scent delivery device 110 may be configured to output various stimuli in addition to scent, including stimuli that the user perceives as sounds, touches, tastes, or visual indicators. The non-scent stimuli may be used, in addition to scent or without scent, to form an association with a desired physical and / or mental response for the user.

[0050] Referring now to FIG. 2, a method 200 of providing olfactory conditioning for chronic condition relief is depicted. The method 200 includes prompting a user to select a scent from a variety of scent samples and prompting the user to load the selected scent into a scent delivery device. The method 200 includes prompting the user to perform a training session. The training session can include the steps of prompting the user to apply one or more sensors and the scent delivery device to their body, prompting the user to input baseline information (e.g., current mental and / or physical level or state) and / or recording baseline information with the one or more sensors, calibrating and collecting the baseline information using the scent delivery device, and prompting the user to perform an association-forming program of their choice (e.g., relaxation application, hypnosis, in-person therapy). The one or more sensors may be used to determine the user’s physiological status during the association-forming program while also aiding in relaxing the user through, for example, auditory guidance or physical stimulation.

[0051] The method 200 includes releasing the selected scent to the user after determining that the user has reached a desired physiological state and has achieved a more-optimum-than- average mental and / or physical state. The desired physiological state may be determined based on one or more bodily indicators including, but not limited to, heart rate, respiratory rate, bodily temperature, skin conductance, and / or blood pressure. In embodiments, the rate of scent release may be directly proportional to the user’s physiological state (i.e., stronger scent release with increasing indication of achieving a desired physiological state).

[0052] In embodiments, method 200 includes the option for the user or another person, such as a medical practitioner, to manually release the scent if minimum physiological feedback conditions are satisfied. For example, minimum physiological feedback conditions may include external biofeedback and / or a medical practitioner indicating that the user is in an optimal physiological state (i.e., more-optimum-than-average mental and / or physical state), a medical practitioner affirming that the user is in an optimal physiological state. In embodiments, the scent delivery device may be configured to automatically release the scent if minimum physiological conditions are met. Method 200 includes ceasing release of the scent upon the occurrence of at least one of reaching a set period of time, receiving feedback from the one or more sensors that the user is no longer in a desired physiological state, or the user or another person manually terminating the training session.

[0053] In embodiments, when a user performs method 200 one or more times, and also satisfies an association metric, “automatic mode” can be unlocked whereby the scent delivery device can automatically release the scent to the user when it is determined that the user is in a desired physiological state. The “automatic mode” may use user data recorded using a custom device, or a smart device, such as a smartwatch or a smartphone, to determine when the user is exhibiting a desired physiological state based on one or more bodily indicators, and in response have the scent delivery device automatically deliver the scent to the user. In embodiments, a user that has performed method 200 one or more times (can be the same or different number of times as with “automatic mode”) can unlock “rescue therapy” or “rescue mode” which enables the user to manually press a button on the scent delivery device to release a scent. This allows the user to “rescue” themselves when they are experiencing a less-optimum-than-average mental and / or physical state, thereby giving the user additional control over their chronic condition management.

[0054] Referring now to FIG. 3, a method 300 of determining optimal scent parameters to establish and maintain a scent association is depicted. At 302, a user is instructed to apply a wearable device and / or one or more sensors. At 304, baseline information about the user can be received. The baseline information may be taken, in part or in full, from one or more previous training sessions, or taken in part or in full from user data obtained from the wearable device and the one or more sensors during the present session. At 306, the user is presented with a plurality of scents (i.e., olfactory triggers) at a plurality of times, in order to establish user-specific baseline information. Each one of the plurality of scents is characteristically different than the other scents as distinguished by, for example, concentration, dispersal time, dispersal location, and type of scent (i.e., each scent includes a different scent profile). At 308, a scent corresponding to the user-specific baseline information is released to the user for a period of time.

[0055] If the scent is detected by the user at 308, then at 310 the characteristics of the scent (e.g., scent concentration, duration of scent release) can be modified and the scent is retested on the user for a period of time until the user no longer detects the scent. If the scent is not detected by the user at 308, then at 312 the characteristics of the scent can be increased (e g., scent concentration increased to maximum, increasing duration of scent release), and the scent is retested. If the scent is not detected by the user at 312, then at 314 the scent concentration or the duration of scent dispersal can be further increased, and the scent is retested until the user detects the scent. Optionally, if the scent is not detected by the user at 314, the session ends so that the scent characteristics specific to the user can be reevaluated and retested at a subsequent session. Method 300 can be configured to measure and record user physical response and testing duration for each of 310, 312, and 314, as well as the subsequent operations of 318 and 320, for potential use during the present session or a later session.

[0056] At 316, the method 300 can include verifying a user’s scent detection threshold by retesting at a threshold concentration for a prescribed period of time. This may include using “blanks” to simulate an actual scent test to ensure that the user is accurately detecting scent. For example, when the user correctly identifies a specific scent concentration multiple times in succession, the scent concentration is set for use in an actual scent test. At 318, a static habituation threshold can be determined by delivering the scent at the threshold concentration until the scent is no longer detectable by the user (e.g., as reported by the user themselves) or for a maximum set time limit. The static habituation threshold can be defined as the time it takes the user to no longer detect the scent at a particular concentration. For example, certain strong scents are immediately detectable by an individual when they are first encountered. After a certain period of time, the individual typically can no longer detect the scents because they have grown accustomed to them (i.e., they have become “nose-blind” to the scents).

[0057] At 320, a dynamic habituation threshold can be determined by delivering a “burst” of the scent at the threshold concentration, or a set of different scent concentrations, for a plurality of time periods. Delivering bursts of the scent can help prolong the user’s ability to detect the scent thereby helping to prevent the user from becoming “nose-blind” to the scent. The minimum detectible threshold between bursts indicates the fastest rate of dispersal that the scent “bursts” can be delivered to enable continued scent detection by the user. The dynamic habituation threshold can be defined as the “burst” profile specific to the user (i .e., the type of burst, duration of burst, and number of bursts, for example, to prevent the user from becoming “nose-blind”). At 322, the method 300 can include storing user-specific scent settings for subsequent use in automatic mode and training mode to deliver a custom scent experience specific to the user.

[0058] Referring now to FIG. 4, a method 400 of training a user to form an association with a scent is depicted. The method 400 may be effectuated using a system or a device as described previously. At 402, a user is instructed to apply a wearable device and / or one or more biofeedback sensors configured to measure and record physiological data of the user, in addition to qualitative user data. The wearable device and the one or more sensors may be applied at any suitable bodily location to ensure accuracy in the measurement of physiological data. At 404, baseline information describing various characteristics of the user is received. The baseline information may include, for example, user mental and / or physical state such as pain level, user demographic and age, user residential location, user family history, mood of the user, sleep statistics, stress level, diet information, exercise information, and other user-specific characteristics. The baseline information may also include non -user-specific information, such as weather details and the current date and time, to further define the baseline information at the time of training. Baseline information may be received from the one or more biofeedback sensors and / or received via manual input by the user or another person.

[0059] At 406, the wearable device and the one or more sensors calibrate, collect, and store the baseline information for subsequent use during the training session. The baseline information may be stored in any suitable storage medium, including a physical storage device connected to the wearable device and / or the one or more biofeedback sensors, or a digital storage such as a cloud server. In particular, method 400 may include providing a calibration flow chart which contains specific scent calibration details for the user. At 408, the user is instructed to perform an association-forming program (e.g., a relaxation procedure) of their choosing to determine a target desired physiological threshold indicating that the user is relaxed and / or is experiencing a more- optimum-than-average mental and / or physical state. The association-forming program may be a specific meditation method, ongoing therapy with a medical practitioner, or one of several programs included with a digital application, including, but not limited to, sound relaxation, image meditation, and / or controlled breathing exercises.

[0060] At 410, the method 400 determines that the target desired physiological threshold has been met or exceeded based on physiological data collected by the one or more biofeedback sensors and / or user data inputted manually by the user to indicate certain quantitative or qualitative characteristics of the user’s mental and / or physical state. At 412, a scent is released to the user in response to determining that the target desired physiological threshold is met or exceeded (this is known as positive reinforcement for operant conditioning). The scent can be released automatically if processing of the received user data indicates that the user has achieved the desired state. For example, indication that a desired state has been reached may be effectuated using signal processing or machine learning to predict a more optimum mental and / or physical state based on, for example, less stress as reported by the user or another person, lower heart rate, changes in heart rate variability, changes in electrodermal activity (EDA), or other similar changes in bodily measurements.

[0061] In embodiments, method 400 provides the option for manual release of the scent by the user if, for example, the user is with a medical practitioner that is monitoring the one or more biofeedback sensors and delivering the scent. At 414, the method 400 is configured to evaluate physiological progress of the user by monitoring continued physiological data measured by the one or more biofeedback sensors and / or user data received manually from the user. The physiological progress may indicate the desired physiological state of the user in response to releasing the scent at 412.

[0062] At 416, scent release is ceased upon at least one of the user terminating the training session for any reason, reaching a set time indicating that the training session should end, or detecting, for example via signal processing, machine learning, or another suitable system, that the user is experiencing, for example, pain or stress based on a combination of physiological variables and / or input from the user (e.g., heart rate increasing, higher EDA, etc.). Scent release may also be ceased at 416, for example, because the scent reservoir containing the scent material has emptied, because a medical practitioner terminated the training session on behalf of the user, or because the wearable device and the one or more biofeedback sensors have lost electrical communication with each other. At 418, the training session ends and any measured information, including baseline information, user relaxation characteristics, user response to scent release, and length of training session, are collected and stored for subsequent use to aid in user-specific customization.

[0063] Optionally, method 400 includes receiving feedback from the user which may be in the form of answers to survey questions. For example, a feedback survey may prompt the user with questions about the strength of association between the scent and their physical response, or general questions about their experience during the training sessions. Answers from the user can subsequently be used to determine when automatic scent mode should be unlocked for the user (i.e., a weak association may indicate that automatic scent mode should not be unlocked or should be unlocked later; a strong association may indicate that automatic scent mode should be unlocked now or unlocked earlier than a user with a weak association). Method 400 also includes evaluating user progress toward a desired physiological state with the aid of feedback from the user and data measured during the training session. Based on user feedback and training session data, method 400 is configured to further customize subsequent training sessions and / or scent delivery characteristics to provide a more optimized and personal experience thereby improving future treatment outcomes for the user.

[0064] Referring now to FIG. 5, a method 500 of enabling automatic scent dispersal and maintaining a scent association with a user physical response is depicted. At 502, information recorded during one or more training sessions with the user is received and stored. At 504, the training session information from 502 is interpreted to determine if one or more required conditions are satisfied. For example, a test scent burst can be released to the user, and user physiology can be monitored to determine if a change in physiology is detected in response to the test scent burst and / or user feedback can be manually entered. The one or more required conditions can be satisfied or unfulfilled based on the change or non-change in user physiology and / or user feedback. If the one or more required conditions from 504 are not met, then the user can be informed at 506 that at least one training session is needed before automatic mode can be unlocked. The at least one training session may be in addition to the one or more training sessions performed previously by this user. If the one or more required conditions from 504 are met, then calibration operations can be performed at 508, and automatic mode can be unlocked for the user. At 510, the user is instructed to apply a wearable device and perform their regular, daily activities, without interruption. In embodiments, the wearable device is configured to monitor physiological parameters while the user performs their regular activities.

[0065] At 512, the wearable device detects that a target threshold determined from a training session has been met or exceeded by the user. At 514, a scent is released automatically by a scent delivery device separate from, or integrated with, the wearable device, in response to receiving physiological input indicating that the user has achieved a desired state. This indication can be determined using signal processing or machine learning models that are configured to alert the scent delivery device and / or wearable device when the user has, for example, less pain, less stress, or lower heart rate or heart rate variability. At 516, method 500 includes continued monitoring of physiological parameters and continued automatic release of scent until at least one of the user terminating the session, reaching a set time based on manual time limits or user habituation limits determined using a calibrated algorithm, the wearable device running out of scent or battery power, or the wearable device detecting a change in physiological patterns of the user suggestive of losing association with the scent. The session ends at 518 with additional optional operations including instructing the user to provide feedback, either open-ended or using survey questions, about the session for use in customizing future sessions. For example, feedback received from the user can be used for recalibration of the session or increasing the time of future sessions before automatic mode is unlocked.

[0066] Referring now to FIG. 6, a method 600 of maintaining in association between a scent profile and a physical response of a user is depicted. At 602, method 600 includes receiving user data indicating a physical response of a user to a first scent profile. User data may comprise quantitative physiological data recorded using sensors and / or qualitative user data received directly from the user or another person. As used in this context, scent profile is defined as including, but not limited to, a scent with a particular concentration, duration of release, and scent type released from a device at a particular position. Scent profile also includes, but is not limited to, age and demographic information of the user and user health status (e.g., user has a cold, user has allergies, user is in a healthy state). In embodiments, method 600 may include maintaining multiple scent profiles corresponding to different health statuses of the user.

[0067] At 604, method 600 includes determining, using the received physiological and / or subjective user data, an association metric between the physical response of the user and the first scent profile. The association metric can be characterized as a quantitative or qualitative measurement of how the user reacts to the olfactory trigger, including bodily reaction and changes in mood and mental and / or physical state. Said another way, the association metric may provide an indication of the strength of a user’s physical response to the released olfactory trigger. Determination of the association metric may be achieved using signal processing or an artificial intelligence model such as machine learning. For example, a signal processing model or machine learning model can be used to interpret the user’s physical response to determine if the first scent profile (or any other scent profile) is optimal for the user, or if the scent profile should be adjusted to account for any changes to user characteristics including, but not limited to, pain threshold / level, scent ability, user age, and user health status.

[0068] At 606, method 600 includes comparing the association metric to a known threshold metric specific to the user. This operation may also be achieved using signal processing or an artificial intelligence model such as machine learning. The known threshold metric can be determined from a training session as described previously, or provided directly from the user as a quantitative or qualitative metric of how the user is expected to respond to the scent profile. At 608, method 600 includes outputting a second scent profile that satisfies the known threshold association metric specific to the user. “Satisfies” in this context means that the second scent profile will result in a user physical response that meets or exceeds the known threshold association metric thereby improving the user’s mental and / or physical state (e.g., reducing the user’s pain state) when the olfactory trigger according to the sent profile is released. In embodiments, the second scent profile may be identical to the first scent profile which indicates that the first, original scent profile is still usable to help manage the user’s chronic condition. In embodiments, the second scent profile may be different from the first scent profile which indicates that the second, subsequent scent profile should replace the first, original scent profile to continue effective management of the user’s chronic condition.

[0069] Referring now to FIG. 7, a method 700 of training a user to form an association with a scent profile is depicted. At 702, method 700 includes receiving, via one or more sensors, first user data indicating a physical response of a user. The one or more sensors may be included with a wearable device configured to release a scent, included with a separate wearable device coupled to the scent-releasing wearable device, or included separate from any wearable device. At 704, method 700 includes storing the first user data as a baseline physical response in a storage module. The storage module may be a physical storage device or a digital storage such as a cloud server. As noted previously, the baseline physical response (i.e., baseline threshold) indicates initial conditions of the user, including resting mental and / or physical state, user mood, and various bodily measurements taken by the one or more sensors or from manual input by the user. At 706, method 700 includes instructing the user to perform an association-forming procedure (e.g., a relaxation procedure) of their choosing. Association-forming procedures are intended to bring the user to a more-optimum-than-average mental and / or physical state compared to what the user typically experiences when dealing with their chronic condition. The association-forming procedure may be meditation, ongoing therapy, or another method of training that causes the user to experience a more-optimum-than-average physical and / or mental state.

[0070] At 708, method 700 includes receiving, via the one or more sensors, second user data indicating a physical response of the user to the association-forming procedure. The second user data corresponds with the user being in a more-optimum-than-average mental and / or physical state because of the association-forming procedure (this is in contrast with the first user data which corresponds with the user’s baseline mental and / or physical state). At 710, method 700 includes dispersing, via an olfactory / scent delivery device, a first scent profile to be associated with the second user data. In other words, the first scent profile is intended to represent the smell of a more-optimum-than-average mental and / or physical state which can be characterized by the second user data recorded during the association-forming procedure. Second user data may correspond to a second set of data received via the one or more sensors, or a set of data received subsequent to the second set of data. Second user data in this context thus refers to the set of data indicating successful pairing between the user and the association-forming procedure which may require several training sessions each concluding with a user dataset captured for each individual session.

[0071] The olfactory / scent delivery device may be a standalone device communicatively coupled with a separate wearable device configured to measure user data or may be integrated together with such a wearable device to create a single component configured to simultaneously disperse scents and measure user data.

[0072] At 712, method 700 includes receiving, via the one or more sensors, third user data indicating a physical response of the user to the first scent profile. The third user data corresponds to any changes in user physical response after dispersal of the first scent profile. The third user data may be identical or similar to the second user data received in response to the association-forming procedure or may be different than the second user data which indicates the user is experiencing either a worsening mental and / or physical state than what was observed during the association-forming procedure or an improving mental and / or physical state. At 714, the method 700 includes outputting a second scent profile based on a comparison of the third user data to a previous physical response of the user to an olfactory trigger (e.g., to the physical response of the user to the first olfactory trigger). The second scent profile may be identical to or different than the first scent profile depending on whether the third physiological meets or exceeds the expected baseline physical and / or mental response. In embodiments, outputting the second scent profile based on the comparison is achieved using signal processing or an artificial intelligence system such as machine learning.

[0073] Optionally, any of the disclosed may include obtaining user feedback during and / or after a session with a user. For example, the user may be prompted to answer whether they notice a scent when it is dispersed, or asked to indicate when they first detect the scent. At the conclusion of a session, the user may be prompted with a general question such as: “Were you able to smell the scent throughout the duration of your session?” or “If applicable, when did you lose detection of the scent?” The user may be prompted to answer questions through a computer interface or other method known to one skilled in the art. The user may also have a button or other device they can use to indicate, if necessary, when scent detection is lost.

[0074] Various embodiments of systems, methods, and devices have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

[0075] Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

[0076] Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

[0077] Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

[0078] For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

Claims

CLAIMS1. A method of maintaining an association between a scent profile and a physical response, comprising: receiving user data indicating a physical response of a user to a first scent profile; determining, using the user data, an association metric between the physical response of the user and the first scent profile; comparing the association metric to a known threshold association metric specific to the user; and outputting a second scent profile that satisfies the known threshold association metric specific to the user.

2. The method of claim 1, wherein user data is received automatically from one or more sensors connected to the user.

3. The method of claim 1, wherein user data is received via manual input by the user or another person.

4. The method of claim 1, wherein the association metric is a quantitative and / or qualitative measurement of how the user reacts to the first scent profile.

5. The method of claim 1, wherein the operation of determining, using the user data, an association metric between the physical response of the user and the first scent profile, is performed using an artificial intelligence model.

6. The method of claim 5, wherein the artificial intelligence model is machine learning.

7. The method of claim 1, wherein the association metric indicates a strength of the physical response of the user to the first scent profile.

8. The method of claim 1, wherein the second scent profile is identical to the first scent profile.

9. The method of claim 1, wherein the second scent profile is different than the first scent profile.

10. A system comprising: a wearable device; a scent delivery device communicatively coupled to the wearable device, wherein the scent delivery device includes a scent carrier having a reservoir for storing a scent, the scent delivery device configured to release the scent after receiving instruction to do so; and one or more sensors communicatively coupled to the wearable device, the one or more sensors configured to measure user data, wherein the combination of the wearable device, the scent delivery device, and the one or more sensors are configured to perform operations comprising: receiving user data indicating a physical response of a user to a first scent profile;determining, using the user data, an association metric between the physical response of the user and the first scent profile; comparing the association metric to a known threshold association metric specific to the user; and outputting a second scent profile that satisfies the known threshold association metric specific to the user.

11. A method of determining an association between a scent delivery profile and a physical response, comprising: receiving, via one or more sensors, first user data indicating a physical response of a user; storing the first user data as a baseline physical response in a storage module; instructing the user to perform an association-forming procedure; receiving, via the one or more sensors, second user data indicating a physical response of the user to the association-forming procedure; dispersing, via a scent delivery device, a first scent profile to be associated with the second user data; receiving, via the one or more sensors, third user data indicating a physical response of the user to the first scent profile; andoutputting a second scent profile based on a comparison of the third user data to a previous physical response of the user to an olfactory trigger.

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