Systems and methods of generating and modulating compositions for transcutaneous vibratory stimulation

Abstract

Disclosed herein are systems and methods of dynamically generating, modulating, adjusting, delivering, emitting, and programming transcutaneous vibratory stimulation compositions. The systems and methods afford the delivery of more complex compositions capable of achieving a wide range of effects. The systems and methods can use a variety of file types and devices, including devices that are typically used by most American adults, instead of conventional firmware updates and dedicated transcutaneous vibratory stimulation devices.

Description

PATENTAttorney Docket No. APLO-0018-WOSYSTEMS AND METHODS OF GENERATING AND MODULATING COMPOSITIONS FOR TRANSCUTANEOUS VIBRATORY STIMULATIONCLAIM TO PRIORITY

[0001] This application claims the benefit of the following provisional application, which is hereby incorporated by reference in its entirety': U.S. Ser. No. 63 / 703,572, filed Oct. 4, 2024 (APLO-0018-P01).BACKGROUND

[0002] Field:

[0003] This disclosure provides systems and methods of generating transcutaneous vibrations on demand.

[0004] Description of the Related Art:

[0005] The autonomic nervous system (ANS) is a part of the peripheral and central nervous system and comprises the nerves that communicate between the brain stem and the body's internal organs. The ANS comprises the complementary' sympathetic and parasympathetic branches or systems. The sympathetic nervous system is often referred to as a body’s “fight or flight” system, as it prepares the body for intense physical activity to enhance the likelihood of survival when coping with threatening situations. The parasympathetic nervous system - sometimes called the “rest and digest” system — does the opposite, as it causes the body to relax, and it can reduce or inhibit many of the body’s high energy' functions that are required for effectively managing survival situations to favor recovery, digestion, reproduction, etc. when situations are determined to be safe or non-threatening.

[0006] The ANS functions below one’s level of awareness through complex interactions between its two branches to respond quickly and continuously to perturbations that threaten the stability' of the body's internal environment. As such, the sympathetic and parasympathetic systems work together to maintain homeostasis. Activity’ in the ANS may be modulated intentionally by activities such as meditation, deep breathing, and self-touch that improve parasympathetic activity.

[0007] The autonomic nervous system can be manipulated via sensory pathways. For example, in a resonance method periodic sensory stimulation may evoke a physiological response that peaks at certain stimulus frequencies. This includes a resonance mechanism that is characterized by the peaking of the physiological response versus frequency such that the periodic sensory signals evoke an excitation of oscillatory' modes in certain neural circuits. The most common example of this phenomenon is music. Music resonates with each person slightly differently, but nonetheless in a highly similar manner, that has the capacity toPATENTAttorney Docket No. APLO-0018-WO reliably induce significant shifts in awareness, cognition, mood, and a host of other sensations. Fast loud music typically induces a sympathetic physiological and subjective response, while slow gentle quiet music tends to elicit the opposite parasympathetic response. This general rule with respect to intensity and frequency relationships to physiological and subjective responses are similar for tactile and most other stimuli.

[0008] Responses to sympathetic and parasympathetic stimulation are frequently antagonistic. For example, they have opposing or antagonistic effects on heart rate. While stimulation of the sympathetic branch increases heart rate, stimulation of the parasympathetic branch decreases heart rate. In addition, the body's response to activity in one branch depends on the level of activity in the other branch. Sympathetic and parasympathetic activity make up a complex, dynamic system that is continuously adjusting to changing conditions in the body and in the external environment. The ANS strives to optimize activity in each branch and to balance the two branches in real time, depending on both internal and external conditions, thereby maintaining homeostasis.

[0009] In certain diseases and conditions, the balance between sympathetic and parasympathetic system activity is implicated either causally or in attempted remediation.

[0010] Existing systems for deliver} of transcutaneous vibratory stimulation have limitations with respect to response time in adjusting delivery', whether in response to user input or measured feedback. In general, current systems for providing transcutaneous vibratory stimulation operate under firmware that allows delivery of a relatively limited number of simple vibratory compositions that are pre-recorded and known to have a general effect on a wide audience. In order to implement changes in the compositions, computations are performed at a centralized computing location (e.g., the cloud) and new' compositions are delivered to the system for providing to a user in the form of a firmware update.

[0011] It has traditionally been understood in the field of transcutaneous vibratory stimulation that the touch receptor system is only sensitive to variation in three specific parameters of transcutaneous vibratory' stimulation, the pitch (the highness or lowness of the frequency), the duration (the rhythm / time of how long the vibration lasts), and the intensity’ (amplitude of the vibration). To the inventor’s knowledge, there was a belief among experts in transcutaneous vibratory' stimulation that the touch receptor system was unable to detect or respond to variations in transcutaneous vibratory' stimulation that involved the other characteristics beside pitch, duration, and intensity' (including timbre, texture, articulation, and form, among others).PATENTAttorney Docket No. APLO-0018-WO

[0012] Despite the shortcomings of existing systems articulated above, they can be effective for upwards of 85-95% of the population, but a need exists for systems and methods to service the remaining 5-15% of the population.SUMMARY

[0013] This disclosure describes ways for modulating or generating transcutaneous vibratory stimulation that affects a subject’s health or condition by stimulating and refining the function of the sympathetic and / or parasympathetic branches of the ANS, both acutely and progressively over time. The present disclosure relates generally to a method, system, and apparatus for affecting a subject's health or condition by using information, such as sensed information (e.g., mobile and environmental data and biometric or physiological sensing), third party information, user or provider (e.g., therapist, other caregiver) input, or information regarding the sympathetic and / or parasympathetic branch of the autonomic nervous system to modulate and / or apply stimuli to the patient (e.g., as a function of the heart rate) that stimulates the sympathetic and / or parasympathetic branch.

[0014] Throughout this disclosure, methods and systems herein are directed at assisting a subject to reach a target state (e.g., calm, focus, flow, presence of being, asleep, wakeful, relaxed, aroused, euphoric, or a performance state), maintain the target state, and / or prime the user to be able to achieve the target state. Throughout this disclosure, a user’s sensory threshold, which may be determined as described in United States Patent No. 11,260,198 which is incorporated by reference herein in its entirety for all purposes, both lower and upper, may be used as bounds for the transcutaneous vibratory output that is generated. The lower sensory threshold is minimum intensity level at which the user becomes aware of the waves / vibrations. The upper end of the sensory threshold may be an intensity’ level of the stimulation at which the user would have difficulty ignoring the vibrations or find them distracting.

[0015] Throughout this disclosure, physiologically sensed data may include any of heart rate (HR), heart rate variability (HRV), galvanic skin response (GSR), movement, respiration rate, temperature, SpCh, spirometry, EEG, ECG, EMG, CO2, motion, blood pressure, or glucose. As with any of the embodiments herein, any disclosed synthesizers, processors, or transducers may be in communication with one or more sensors, with other systems, devices, or transducers and any processor thereof, or with a remote server.PATENTAttorney Docket No. APLO-0018-WO

[0016] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a complex vibratory composition.

[0017] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality.

[0018] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a determination of ineffectiveness of the transcutaneous vibratory stimulation, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality.

[0019] In some aspects, the disclosure herein relates to a method including: receiving input of at least one of a user condition, an event, or an environmental attribute; and composing, in response to the input, a transcutaneous vibratory stimulation, wherein composing includes selecting an input channel controlling one or more properties of the transcutaneous vibratory stimulation.

[0020] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory7stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dynamically modulating the transcutaneous vibratory7stimulation by changing one or more properties of the vibratory' composition, wherein the dynamically modulating occurs within 1 hour of the sensing the predetermined condition in the subject.

[0021] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dynamically modulating the transcutaneous vibratory' stimulation by' changing one or more properties of the vibratory' composition, wherein the dynamically modulating is implemented without a firmware update to the device.

[0022] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratoryPATENTAttorney Docket No. APLO-0018-WO stimulation having a vibratory composition, wherein the vibrator}' composition is not precomposed.

[0023] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory composition within a modulatory effect window.

[0024] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition that is statistically associated with a desired effect in the subject, wherein the desired effect is statistically associated with an unmodulated decay when the initial underlying vibratory composition continues to be applied to the subject without dynamic modulation; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory composition.

[0025] In some aspects, the disclosure herein relates to a method including: delivering transcutaneous vibratory' stimulation from a device to a subject, the transcutaneous vibratory' stimulation including an initial underlying vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory' composition, wherein the dynamically modulating changes the one or more properties on a time scale of between 50 ms and 100 ms.

[0026] In some aspects, the disclosure herein relates to a method including: composing a transcutaneous vibratory stimulation composition on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein the synthesizer produces a digital composition output; mapping the digital composition output onto an input format for a vibratory delivery device to produce a digital composition input; inputting the digital composition input to the vibratory delivery device, thereby producing the transcutaneous vibratory stimulation composition from the vibratory delivery device.

[0027] In some aspects, the disclosure herein relates to a method including: delivering a transcutaneous vibratory stimulation composition from a vibratory delivery device to a subject; modulating the transcutaneous vibratory stimulation composition by changing one orPATENTAttorney Docket No. APLO-0018-WO more properties of the transcutaneous vibratory stimulation composition, wherein the modulating is one or more of random, pseudo-random, probabilistic, or a combination thereof.

[0028] In some aspects, the disclosure herein relates to a method of modulating a wide- spectrum transcutaneous vibratory stimulation composition for delivery' through a narrower- spectrum delivery system, wherein the wide-spectrum transcutaneous vibratory stimulation composition includes parts across a wide spectrum, wherein the narrower-spectrum delivery system is capable of delivering a narrower spectrum transcutaneous vibratory stimulation that includes parts across a narrower spectrum, the method including: re-assigning the parts across the wide spectrum which fall outside of the narrower spectrum to commensurate portions of the narrower spectrum.

[0029] In some aspects, the disclosure herein relates to a method of modulating a broad transcutaneous vibratory7stimulation composition for delivery7through a narrower-application delivery7system, wherein the narrower-application delivery system has one or more limitations that prevent the narrower-application delivery system from fully delivering the broad transcutaneous vibratory7stimulation composition, the method including: adjusting the broad transcutaneous vibratory7stimulation composition to comply with the one or more limitations.

[0030] In some aspects, the disclosure herein relates to a method of calibrating a transcutaneous vibratory stimulation delivery system, the method including: frequency sweeping the transcutaneous vibratory' stimulation delivery system across a spectrum spanning from 0.0001 Hz to 200 Hz; measuring intensity' from the transcutaneous vibratory' stimulation delivery7system, thereby identify ing active portions and inactive portions, wherein the intensity is above a predetermined threshold within the active portions of the spectrum and below the predetermined threshold within the inactive portions of the spectrum; and re-assigning portions of a transcutaneous vibrational stimulation composition from the inactive portions of the spectrum to the active portions of the spectrum.

[0031] In some aspects, the disclosure herein relates to a method including: composing a transcutaneous vibratory stimulation composition on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein the synthesizer produces a digital composition output; modulating a first input of the one or more of the inputs for modulating parameters by introducing a modulation composition into the first input.PATENTAttorney Docket No. APLO-0018-WO

[0032] In some aspects, the disclosure herein relates to a system for modulating a wide- spectrum transcutaneous vibratory stimulation composition for delivery’ through a narrower- spectrum delivery system, wherein the wide-spectrum transcutaneous vibratory stimulation composition includes parts across a wide spectrum, wherein the narrower-spectrum delivery system is capable of delivering a narrower spectrum transcutaneous vibratory stimulation that includes parts across a narrower spectrum, the system including: a processor in electronic communication with the narrower-spectrum delivery system, the processor programmed to: re-assign the parts across the wide spectrum which fall outside of the narrower spectrum to commensurate portions of the narrower spectrum.

[0033] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations for modulating a wide-spectrum transcutaneous vibratory stimulation composition for delivery7through a narrower-spectrum delivery7system, wherein the wide- spectrum transcutaneous vibratory stimulation composition includes parts across a wide spectrum, wherein the narrower-spectrum delivery7system is capable of delivering a narrower spectrum transcutaneous vibratory stimulation that includes parts across a narrower spectrum, the operations including: re-assigning the parts across the wide spectrum which fall outside of the narrow er spectrum to commensurate portions of the narrower spectrum.

[0034] In some aspects, the disclosure herein relates to a system for modulating a broad transcutaneous vibratory stimulation composition for delivery through a narrower-application delivery system, wherein the narrower-application delivery system has one or more limitations that prevent the narrower-application delivery system from fully delivering the broad transcutaneous vibratory7stimulation composition, the system including: a processor in electronic communication with the narrower-application delivery system, the processor programmed to: adjust the broad transcutaneous vibratory7stimulation composition to comply with the one or more limitations.

[0035] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations for modulating a broad transcutaneous vibratory stimulation composition for delivery7through a narrower-application delivery7system, wherein the narrower- application delivery7system has one or more limitations that prevent the narrower-application delivery7system from fully delivering the broad transcutaneous vibratory stimulation composition, the operations including: adjusting the broad transcutaneous vibratory stimulation composition to comply with the one or more limitations.PATENTAttorney Docket No. APLO-0018-WO

[0036] In some aspects, the disclosure herein relates to a system for calibrating a transcutaneous vibratory stimulation delivery system, the system including: a processor in electronic communication with transcutaneous vibratory stimulation delivery system, the processor programmed to: frequency sweep the transcutaneous vibratory stimulation delivery system across a spectrum spanning from 0.0001 Hz to 200 Hz; measure intensity from the transcutaneous vibratory stimulation delivery system, thereby identifying active portions and inactive portions, wherein the intensity is above a predetermined threshold within the active portions of the spectrum and below the predetermined threshold within the inactive portions of the spectrum; and re-assign portions of a transcutaneous vibrational stimulation composition from the inactive portions of the spectrum to the active portions of the spectrum.

[0037] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations for calibrating a transcutaneous vibratory stimulation delivery system, the operations including: frequency sweeping the transcutaneous vibratory stimulation delivery system across a spectrum spanning from 0.0001 Hz to 200 Hz; measuring intensity from the transcutaneous vibratory stimulation delivery system, thereby identifying active portions and inactive portions, wherein the intensity is above a predetermined threshold within the active portions of the spectrum and below the predetermined threshold within the inactive portions of the spectrum; and re-assigning portions of a transcutaneous vibrational stimulation composition from the inactive portions of the spectrum to the active portions of the spectrum.

[0038] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a device, the processor programmed to: deliver transcutaneous vibratory stimulation from the device to a subject, the transcutaneous vibratory stimulation having a complex vibratory composition.

[0039] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory’ stimulation having a complex vibratory composition.

[0040] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a device, the processor programmed to: deliver transcutaneous vibratory stimulation from the device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a predetermined condition, dynamically modulate the transcutaneous vibratory stimulation by changing one orPATENTAttorney Docket No. APLO-0018-WO more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality.

[0041] In some aspects, the disclosure herein relates to a non- transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality.

[0042] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a device, the processor programmed to: deliver transcutaneous vibratory stimulation from the device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a determination of ineffectiveness of the transcutaneous vibratory stimulation, dynamically modulate the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality.

[0043] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a determination of ineffectiveness of the transcutaneous vibratory stimulation, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality’.

[0044] In some aspects, the disclosure herein relates to a system including: a processor, the processor programmed to: receive input of at least one of a user condition, an event, or an environmental attribute; and compose, in response to the input, a transcutaneous vibratory stimulation, wherein composing includes selecting an input channel controlling one or more properties of the transcutaneous vibratory stimulation.

[0045] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: receiving input of at least one of a user condition, an event, or an environmental attribute: composing, in response to the input, aPATENTAttorney Docket No. APLO-0018-WO transcutaneous vibratory stimulation, wherein composing includes selecting an input channel controlling one or more properties of the transcutaneous vibratory' stimulation.

[0046] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a device, the processor programmed to: deliver transcutaneous vibratory stimulation from the device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dy namically modulate the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the dynamically modulating occurs within 1 hour of the sensing the predetermined condition in the subject.

[0047] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory’ stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the dynamically modulating occurs within 1 hour of the sensing the predetermined condition in the subject.

[0048] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a device, the processor programmed to: deliver transcutaneous vibratory stimulation from the device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dynamically modulate the transcutaneous vibratory' stimulation by changing one or more properties of the vibratory' composition, wherein the dynamically modulating is implemented without a firmware update to the device.

[0049] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dynamically modulating the transcutaneous vibratory' stimulation by changing one or more properties of the vibratory' composition, wherein the dynamically modulating is implemented without a firmware update to the device.

[0050] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a device, the processor programmed to: deliverPATENTAttorney Docket No. APLO-0018-WO transcutaneous vibratory stimulation from the device to a subject, the transcutaneous vibratory stimulation having a vibratory composition, wherein the vibratory’ composition is not pre-composed

[0051] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition, wherein the vibratory composition is not pre-composed.

[0052] In some aspects, the disclosure herein relates to a system including: a processor, the processor programmed to: deliver transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition; in response to a predetermined condition, dynamically modulate the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory composition within a modulatory' effect window.

[0053] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory’ stimulation to a subject, the transcutaneous vibratory’ stimulation including an initial underlying vibratory’ composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory composition within a modulatory effect window.

[0054] In some aspects, the disclosure herein relates to a system including: a processor, the processor programmed to: deliver transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition that is statistically associated with a desired effect in the subject, wherein the desired effect is statistically associated with an unmodulated decay when the initial underlying vibratory composition continues to be applied to the subject without dynamic modulation; in response to a predetermined condition, dynamically modulate the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory’ composition.

[0055] In some aspects, the disclosure herein relates to a non-transitory’ computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition that is statistically associated with a desired effect in the subject, wherein thePATENTAttorney Docket No. APLO-0018-WO desired effect is statistically associated with an unmodulated decay when the initial underlying vibratory composition continues to be applied to the subject without dynamic modulation; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the initial underly ing vibratory composition.

[0056] In some aspects, the disclosure herein relates to a system including: a processor, the processor programmed to: deliver transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition; in response to a predetermined condition, dynamically modulate the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory' composition, wherein the dynamically modulating changes the one or more properties on a time scale of between 50 ms and 100 ms.

[0057] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory stimulation including an initial underlying vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory' stimulation by changing one or more properties of the initial underlying vibratory composition, wherein the dynamically modulating changes the one or more properties on a time scale of between 50 ms and 100 ms.

[0058] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a synthesizer, the processor programmed to: compose a transcutaneous vibratory stimulation composition on the synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein the synthesizer produces a digital composition output; map the digital composition output onto an input format for a vibratory delivery device to produce a digital composition input; input the digital composition input to the vibratory' delivery device, thereby producing the transcutaneous vibratory stimulation composition from the vibratory’ delivery device.

[0059] In some aspects, the disclosure herein relates to a non-transitory' computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: composing a transcutaneous vibratory' stimulation composition on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein thePATENT Attorney Docket No. APLO-0018-WO synthesizer produces a digital composition output; mapping the digital composition output onto an input format for a vibratory delivery device to produce a digital composition input; inputting the digital composition input to the vibratory delivery device, thereby producing the transcutaneous vibratory stimulation composition from the vibratory delivery device.

[0060] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a vibratory’ delivery device, the processor programmed to: deliver a transcutaneous vibratory stimulation composition from the vibratory delivery device to a subject; modulate the transcutaneous vibratory stimulation composition by changing one or more properties of the transcutaneous vibratory' stimulation composition, wherein the modulating is one or more of random, pseudo-random, probabilistic, or a combination thereof.

[0061] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: delivering a transcutaneous vibratory stimulation composition from a vibratory delivery device to a subject; modulating the transcutaneous vibratory stimulation composition by changing one or more properties of the transcutaneous vibratory stimulation composition, wherein the modulating is one or more of random, pseudo-random, probabilistic, or a combination thereof.

[0062] In some aspects, the disclosure herein relates to a system including: a processor in electronic communication with a synthesizer, the processor programmed to: compose a transcutaneous vibratory stimulation composition on the synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory’ stimulation composition, wherein the synthesizer produces a digital composition output; modulate a first input of the one or more of the inputs for modulating parameters by introducing a modulation composition into the first input.

[0063] In some aspects, the disclosure herein relates to a non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations including: composing a transcutaneous vibratory stimulation composition on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein the synthesizer produces a digital composition output; modulating a first input of the one or more of the inputs for modulating parameters by introducing a modulation composition into the first input.PATENTAttorney Docket No. APLO-0018-WO

[0064] All documents mentioned herein are hereby incorporated in their entirety by reference. References to items in the singular should be understood to include items in the plural, and vice versa, unless explicitly stated otherwise or clear from the text. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of conjoined clauses, sentences, words, and the like, unless otherwise stated or clear from the context.BRIEF DESCRIPTION OF THE FIGURES

[0065] The disclosure and the following detailed description of certain embodiments thereof may be understood by reference to the following figures:

[0066] Fig. 1 depicts a system for facilitating neural state transitions.

[0067] Fig. 2A and Fig. 2B depict block diagrams of a stimulation device.

[0068] Fig. 3 depicts various embodiments of devices that provide stimulation.

[0069] Fig. 4 depicts a process for calibration.

[0070] Fig. 5 depicts a process for mitigating negative side effects of a treatment.

[0071] Fig. 6 depicts a process for promoting epigenetic change.

[0072] Fig. 7A depicts an embodiment of a method of assisting a subject to reach or maintain a target state.

[0073] Fig. 7B depicts an embodiment of a method of assisting a subject to reach or maintain a target state.

[0074]

[0075] Fig. 8A depicts an embodiment of a method assisting a subject to reach or maintain a sexually aroused state.

[0076] Fig. 8B depicts an embodiment of a method assisting a subject to reach or maintain a sexually aroused state.

[0077] Fig. 9 depicts an embodiment of a system for determining tissue characteristics.

[0078] Fig. 10 depicts an embodiment of a system for determining adequate body contact.

[0079] Fig. 11 depicts an embodiment of a system for determining adequate body contact.

[0080] Fig. 12 depicts an embodiment of a system for determining body characteristics using signal reflections.

[0081] Fig. 13A depicts an embodiment of a method assisting a subject to reach or maintain a sexually aroused state.PATENTAttorney Docket No. APLO-0018-WO

[0082] Fig. 13B depicts an embodiment of a method assisting a subject to reach or maintain a sexually aroused state.

[0083] Fig. 14A depicts an embodiment of a method of assisting a subject to reach or maintain a sexually aroused state.

[0084] Fig. 14B depicts an embodiment of a method of assisting a subject to reach or maintain a sexually aroused state.

[0085] Fig. 15 A depicts an embodiment of a method of assisting a subject to suppress a sexually aroused state.

[0086] Fig. 15B depicts an embodiment of a method of assisting a subject to suppress a sexually aroused state.

[0087] Fig. 16A depicts an embodiment of a method of assisting a subject to prevent or reduce a sexually aroused state.

[0088] Fig. 16B depicts an embodiment of a method of assisting a subject to prevent or reduce a sexually aroused state.

[0089] Fig. 17A depicts an embodiment of a method of assisting a subject to prevent or reduce a sexually aroused state.

[0090] Fig. 17B depicts an embodiment of a method of assisting a subject to prevent or reduce a sexually aroused state.

[0091] Fig. 18 depicts an embodiment of a method of coordinating with an external device.

[0092] Fig. 19 depicts an embodiment of a method of controlling an external device.

[0093] Fig. 20 depicts a system including a transducer embedded in a sexual aid device.

[0094] Fig. 21 depicts a system of a sexual aid device delivering transcutaneous vibratory' output.

[0095] Fig. 22A depicts an embodiment of a method of an artificial intelligence to leam parameters that best achieve sexual arousal.

[0096] Fig. 22B depicts an embodiment of a method of an artificial intelligence to leam parameters that best achieve sexual arousal.

[0097] Fig. 23 A depicts an embodiment of a method of an artificial intelligence to leam sexual arousal states of a user.

[0098] Fig. 23B depicts an embodiment of a method of an artificial intelligence to leam sexual arousal states of a user.

[0099] Fig. 24 depicts an embodiment of a method of assisting a subject to reach a target state of sexual arousal.PATENTAttorney Docket No. APLO-0018-WO

[0100] Fig. 25 depicts an embodiment of a system for delivering personalized stimulation for an experience.

[0101] Fig. 26 depicts an embodiment of a method of generating stimulation during an expenence.

[0102] Fig. 27 depicts an embodiment of a method of synchronizing a stimulation with an experience.

[0103] Fig. 28 depicts an embodiment of a method of identifying a stimulation for an experience.

[0104] Fig. 29 depicts an embodiment of a method of generating a stimulation configuration for an experience.

[0105] Fig. 30 depicts a modular signal core.

[0106] Fig. 31 depicts a composition generator.

[0107] Fig. 32A depicts a composition parameter with many points.

[0108] Fig. 32B depicts a processed version of the composition parameter shown in Fig. 32A.

[0109] Fig. 33 is a flowchart of an example method for delivering transcutaneous vibratory stimulation from a device to a subject.

[0110] Fig. 34 is a flowchart of an example method.

[0111] Fig. 35 is a flowchart of an example method.

[0112] Fig. 36 is a flowchart of an example method.

[0113] Fig. 37 is a flowchart of an example method.

[0114] Fig. 38 is a flowchart of an example method.

[0115] Fig. 39 is a flowchart of an example method for delivering transcutaneous vibratory stimulation from a device to a subject.

[0116] Fig. 40 is a flowchart of an example method.

[0117] Fig. 41 is a flowchart of an example method.

[0118] Fig. 42 is a flowchart of an example method.

[0119] Fig. 43 is a flowchart of an example method.

[0120] Fig. 44 is a flowchart of an example method.

[0121] Fig. 45 is a flowchart of an example method.

[0122] Fig. 46 is a flowchart of an example method for modulating a wide-spectrum transcutaneous vibratory stimulation composition for delivery through a narrower-spectrum delivery system.PATENT Attorney Docket No. APLO-0018-WO

[0123] Fig. 47 is a flowchart of an example method for modulating a broad transcutaneous vibratory stimulation composition for delivery through a narrower-application delivery system.

[0124] Fig. 48 is a flowchart of an example method for calibrating a transcutaneous vibratory stimulation delivery7system.DETAILED DESCRIPTION

[0125] Methods, systems, and devices disclosed herein may have an effect on a user causing an improvement in HRV, resilience, performance, and recovery. One mechanism by which the effects may occur may be through activity at one or more of the touch receptors and mechanoreceptors in the skin. Other mechanisms that may account for the effectiveness of the methods, systems, and devices disclosed herein may include one or more of changes in vagal tone, changes in parasympathetic nervous system reactivity (e.g.. sync breathing to slow stimuli), potentiation of vagus nerve function, direct nerve stimulation or other routes such as stimulation of underlying muscles, pressure on baroreceptors, activity in the vagal and limbic sy stems, activation of one or more brain networks, activation of C-tactile fibers (e.g., skin receptors) by low-indentation stimuli, release of endocannabinoids in response to tactile stimulation, desensitization or sensitization of chemoreceptors, changes in skin conductance, changes in finger pulse volume, or the like.

[0126] An apparatus with transducers may deliver stimulation and / or treatment to a portion of a subject, such as in response to an input, that is intended to allow the subject to achieve a target state, such as a neural state. Such "stimulation” will be described herein more fully, however, the stimulation shall be briefly referred to here as transcutaneous vibratory stimulation. However, individuals reside in ecosystems with many inputs, devices, and sources of stress such that achieving and maintaining any one state, recovering from states, or being resilient to certain states, such as stress, may be difficult. This apparatuses, methods and systems described herein provide solutions to certain problems, such as how to: mitigate the negative effects of co-treatment with a stimulation protocol, predict a particular neural state onset and treat proactively with particular waveforms, utilize data external to the apparatus to determine a subject's state and / or achievement of a target state post- stimulation / treatment, leam a user's stimulatory preferences and needs to generate a stimulation / therapy plan, determine a user’s sensory threshold, develop protocols to avoid habituation to stimulation or stimulation patterns, taper or ramp up a stimulation protocol,PATENTAttorney Docket No. APLO-0018-WO fine tune the stimulation necessary to achieve a target state based on real-time or longitudinal data, program the device to deliver pattems / sessions of stimulation, facilitate entry into a sleep state, provide visual feedback to a user of a state and / or a treatment protocol to facilitate entry into a state, coordinate stimulation from a plurality of transducers, control external devices based on aspects of the stimulation therapy, provide a meditation / mindfulness application, provide stimulation therapy to a user via any connected hardware, provide stimulation therapy in various products (e.g., seat / fumiture. mobile seat, gaming seat, infant seat or other furniture, cradle / bassinet / crib, bedding, wearable / garment, eyewear, augmented reality eyewear, wearable pet product, gaming / entertainment devices), provide haptic protocols of multiple frequencies, provide treatment using audible frequencies, provide the transducers as a component of another device (e.g., in a clasp / portion of a smartwatch band that is communicatively coupled to a smartwatch or other device), measure and track epigenetic changes as a result of treatment, or the like. Certain solutions described herein are directed to solving the aforementioned problems.

[0127] Terminology that is relevant to this document includes the following:

[0128] As used in this document, the singular forms “a.” “an;’ and “the” include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. As used in this document, the term “comprising” (or “comprises”) means “including (or includes), but not limited to.” When used in this document, the term “exemplary” is intended to mean “by way of example” and is not intended to indicate that a particular exemplary item is preferred or required.

[0129] In this document, when terms such as “first” and “second” are used to modify a noun, such use is simply intended to distinguish one item from another, and is not intended to require a sequential order unless specifically stated. The term “approximately,” when used in connection with a numeric value, is intended to include values that are close to, but not exactly, the number. For example, in some embodiments, the term “approximately” may include values that are within + / - 10 percent of the value.

[0130] When used in this document, terms such as “top” and “bottom,” “upper” and “lower”, or “front” and “rear,” are not intended to have absolute orientations but are instead intended to describe relative positions of various components with respect to each other. For example, a first component may be an “upper” component and a second component may be a “lower” component when a device of which the components are a part is oriented in a first direction. The relative orientations of the components may be reversed, or the componentsPATENTAttorney Docket No. APLO-0018-WO may be on the same plane, if the orientation of the structure that contains the components is changed. The claims are intended to include all orientations of a device containing such components.

[0131] An '‘electronic device” or a “computing device” refers to a device or system that includes a processor and memory. Each device may have its own processor and / or memory, or the processor and / or memory may be shared with other devices as in a virtual machine or container arrangement. The memory will contain or receive programming instructions that, when executed by the processor, cause the electronic device to perform one or more operations according to the programming instructions. Examples of electronic devices include personal computers, servers, mainframes, virtual machines, containers, gaming systems, televisions, digital home assistants and mobile electronic devices such as smartphones, fitness tracking devices, a mattress, a massage chair, a handheld massager, a baby accessory', a pet collar, and wearable virtual reality' devices. Electronic devices also may include Internet-connected wearables such as smart watches, smart clothing, and smart eyewear. Electronic devices also may be embedded in products that are designed to be used by a human while sleeping, such as a pillow, mattress, mattress topper or bedding (sheets, pillowcase, blanket, etc ). In a client-server arrangement, the client device and the server are electronic devices, in which the server contains instructions and / or data that the client device accesses via one or more communications links in one or more communications networks. In a virtual machine arrangement, a server may be an electronic device, and each virtual machine or container also may be considered an electronic device. In the discussion below, a client device, server device, virtual machine or container may be referred to simply as a “device” for brevity'. Additional elements that may be included in electronic devices will be discussed below in the context of FIGS. 1 and 2.

[0132] The terms “processor” and ‘‘processing device” refer to a hardware component of an electronic device that is configured to execute programming instructions. Except where specifically stated otherw ise, the singular terms “processor” and “processing device” are intended to include both single-processing device embodiments and embodiments in which multiple processing devices together or collectively perform a process.

[0133] The terms “memory,” “memory device,” “data store,” “data storage facility'” and the like each refer to a non-transitory device on which computer-readable data, programming instructions or both are stored. Except where specifically stated otherwise, the terms “memory,” “memory device,” “data store.” “data storage facility” and the like are intended to include single device embodiments, embodiments in which multiple memory devicesPATENTAttorney Docket No. APLO-0018-WO together or collectively store a set of data or instructions, as well as individual sectors within such devices.

[0134] As used herein, the term '‘treat’’, '‘treating” or ‘'stimulating” refers to improving the mood and / or physiology and / or symptoms of a subject, including enhancing a person's positive outlook or suppressing a person's negative outlook. Such may refer to a person's psychological well-being, including but not limited to their emotional, cognitive, and motivational states.

[0135] The term “depression” refers to a morbid sadness, dejection, or melancholy, and includes general physical conditions in which a person exhibits symptoms such as sleep problems, appetite problems, anhedonia or lack of energy, feelings of worthlessness or hopelessness, difficulty concentrating, and suicidal thoughts.

[0136] As used herein, the term ‘‘side effect” refers to undesirable physiological and / or psychological effects of a medical treatment on a subject. Side effects may be reduced by decreasing their severity, by decreasing their frequency, or by decreasing both their severity and frequency. The stimulation of the autonomic nervous system by application of vibrational stimulus (as discussed herein) may reduce side effects from various medical treatments, including, without limitation pharmaceutical agents, drugs, cannabis, psychotherapy, surgical procedures, or the like.

[0137] Throughout this specification, the stimulation described is referred to as transcutaneous vibratory stimulation or transcutaneous vibratory output. One form of such transcutaneous vibratory stimulation or transcutaneous vibratory output may be haptic or tactile stimulation, wherein “haptic” and “tactile” may be used in the alternative. While in other embodiments, the stimulation (transcutaneous or not) may be audible (and thus experienced audibly by the subject). Such audible embodiments are designed to achieve a target state through the subject’s hearing or audiation. All such stimulation may be referred to as “therapy” or “therapeutic output”.

[0138] A “subject” may be referred to as a “user” or a “wearer” of the device. In some instances, there is a “subject”, i.e., the person or organism to whom the vibratory stimulation is applied, and a ‘‘user” who may be separate from the subject. Therefore, the user may be the subject or not depending on the context of the description or the accompanying claims.

[0139] In embodiments throughout this disclosure, and as will be further described herein, a system for treating a subject may include a stimulation device that includes a tactile transducer configured to emit transcutaneous vibratory output to a portion of the subject’s body in communication with a processor. The system may optionally include a sensoryPATENTAttorney Docket No. APLO-0018-WO output device, also in communication with a processor. The processor may be in communication with a memory that has instructions stored thereon that when executed cause the processor to determine a transcutaneous vibratory output and, optionally, a sensory output, wherein the processor causes the tactile transducer to emit a transcutaneous vibratory output determined by the processor. An application in communication with the processor may receive data from the stimulation device and embedded or associated sensors and devices, and may further control the stimulation device and embedded or associated sensors and devices. In embodiments, the processor may optionally cause the sensory output device to output at least one of a visual, an olfactory, or an audible output. The system may also include one or more sensors, such as a physiological sensor or a biometric sensor generating data indicative of a condition of the user, wherein the processor is further configured to determine a transcutaneous vibratory output or a sensory output based on the data indicative of a condition of the user.

[0140] The system may include controllers, processors, network infrastructure, cloud-based storage, input / output devices, servers, client devices (e.g.. laptops, desktops, terminals, mobile devices, and / or dedicated devices), sensors, actuators, data storage or subscriptions, and / or components configured as computer-readable instructions that, when performed by a processor, cause the processor to perform one or more functions. The system may be distributed across a number of devices, including wearable devices, and / or the functions of the system may be performed by one or more devices in cooperation.

[0141] The system may include application programming interfaces that facilitate connection among the components of the system and between the system to entities that are external to the system and facilitate operation, programming, and use of the system by a user. Any component or interface to the system may be controlled by or have control over a controller. In some embodiments, a mobile device being operated by a user may form a portion of the system as described herein.

[0142] Certain considerations for the person of skill in the art, in determining the configuration of components, circuits, controllers, and / or devices to implement the system as described herein include, without limitation: the availability of sensed or collected data; a communication status with one or more sensors; the knowledge of one or more sensory thresholds; the proximity of a suitable transducer to a portion of a user’s body; the availability of a suitable transducer; if instructions are to be provided directly by a user or if the system is to be triggered; if another treatment modality is being used concomitantly (e.g., pharmacological, sensory, or therapeutic), or the like.PATENTAttorney Docket No. APLO-0018-WO

[0143] While specific examples of the system and considerations are described herein for purposes of illustration, any system benefitting from the disclosures herein, and any considerations understood to one of skill in the art having the benefit of the disclosures herein, are specifically contemplated within the scope of the present disclosure.

[0144] In embodiments, waveforms may be generated, modulated, adjusted, delivered, emitted, programmed, coordinated across multiple transducers, and / or compressed as previously described in in United States Patent No. 11,260.198. which is incorporated byreference herein in its entirety for all purposes.

[0145] In other embodiments, waveforms may be generated, modulated, adjusted, delivered, emitted, programmed, coordinated across multiple transducers, and / or compressed as described herein, and may be utilized in various applications, including applications previously described in United States Patent No. 11,260,198, United States Patent Application 20220362095, and PCT International Patent Application WO 2023 / 229598, each of which is incorporated by reference herein in its entirety for all purposes.

[0146] In embodiments herein, dynamic modulation may occur in response to a received signal, such as one from a subject, relating to a sensed parameter, such as from a physiological sensor (e.g., BP, HR, HRV), or such as a received signal measuring something external to the subject such as work output / performance or from the environment (e.g., rhythms sensed in the environment). In some embodiments, the type of modulation may va based on the goals or desired effect of the stimulation. For example, if a user has achieved a flow state based off a composition, the composition may be modulated to maintain the flow state. In another example, if a user has achieved a relaxation state based off a composition, the composition may be modulated to maintain the relaxation state. Various embodiments and examples will be described herein.

[0147] In one embodiment, a wide-spectrum transcutaneous vibratory stimulation composition can be modified for delivery through a narrower-spectrum delivery system. The narrower-spectrum delivery system is capable of delivering a narrower spectrum transcutaneous vibratory stimulation. In some examples, the narrower-spectrum delivery system includes one or more of a smartphone, a fitness tracking device, a wearable virtual reality device, a smart watch, smart eyewear, a mattress, a massage chair, a handheld massager, a baby accessory, a pet collar, or an internet-connected wearable device. The narrower spectrum transcutaneous vibratory stimulation includes parts across a narrower spectrum. The wide-spectrum transcutaneous vibratory stimulation composition includes parts across a wide spectrum. It should be understood that compositions may be encoded inPATENTAttorney Docket No. APLO-0018-WO any format, such as MIDI, AHAP, AHAF, a universal audio output, an excel table, a text format, or the like.

[0148] Modification includes re-assigning the parts across the wide spectrum that fall outside of the narrower spectrum to commensurate portions of the narrower spectrum. This modification may be necessary when the narrower-application delivery system has one or more limitations that prevent the narrower-application delivery system from fully delivering the wide-spectrum vibratory stimulation composition. Limitations include at least one of a scheduling limitation, a power limitation, a high-frequency limitation, a low-frequency limitation, or an amplitude limitation. These limitations are overcome by adjusting the broad transcutaneous vibratory stimulation composition to be commensurate with the narrower- application delivery system.

[0149] In cases where the composition is modified for delivery through a different device, the re-assignment of parts that fall outside of the capability of the new device can be done in a variety of ways. For example, in one case, the re-assignment of parts can be done by substituting a part that falls outside of the capability of the new device with a harmonic of the part. As another example, the re-assignment of parts can be done in a random or pseudorandom fashion using techniques known to those in the programming arts.

[0150] The transcutaneous vibratory' stimulation delivery' system may be calibrated which may be done by frequency sweeping across a spectrum spanning from 0.0001 Hz to 200 Hz. During this sweep, intensity from the transcutaneous vibratory stimulation delivery system is measured and active and inactive portions are identified by the relative intensity to a predetermined threshold. If the measured intensity' is above the predetermined threshold, it is determined to be active. If the measured intensity is below the predetermined threshold, it is determined to be inactive. Inactive portions of the transcutaneous vibrational stimulation composition are reassigned to active portions of the spectrum.

[0151] The inventors unexpectedly discovered challenges when adapting their transcutaneous vibratory stimulation for delivery' through a device that is not specifically- tailored for this purpose (e g., an Apollo device is specifically tailored for this purpose, while a smartphone or smartwatch is not specifically tailored for this purpose). Specifically, the inventors encountered unexpected variations in TVS intensity when using devices that were not tailored specifically for this purpose.

[0152] The intensities of the transcutaneous vibrations generated by the methods disclosed herein were not the same as those generated by prior methods. Specifically, transcutaneous vibratory generated by the methods disclosed herein resulted in certain high frequencyPATENTAttorney Docket No. APLO-0018-WO(>100hz) vibrations and very7low frequency (<40hz) vibrations having low intensity. It was not immediately apparent at the time that these high and low frequencies were barely detectable when delivered by devices not specifically tailored for TVS delivery. In order for the vibrations to feel smooth and equalized, the inventors discovered a correction factor. Generating the correction involved repeated exposure of expert users to each vibration pattern generated by the disclosed methods repeatedly to determine the exact timing of when the intensity varied incorrectly compared to the waveforms generated via the pnor method. After each timepoint of intensity difference was determined, a pattern of intensity could be established and the new vibration generation method could be tuned or otherwise adjusted to ensure that the intensities matched as they were supposed to. Following this adjustment process, which included matching and equalizing, the expert users were once again exposed to the TVS generated by the new method for an extended period (e.g., weeks to months) and were asked to compare the subjective effects of the TVS generated via the disclosed methods to the subjective effects of TVS generated by prior methods. After the extended period of testing and tuning, it was determined that the subjective experience was indistinguishable from the prior vibration generation method and ready for implementation in the product.

[0153] After identify ing the intensity irregularities in a given device, the adjustments can be made at various levels as would be appreciated by a person having ordinary7skill in the art. For example, all compositions could be transmitted through a filter that adjusts intensity at specific frequencies to either increase or decrease intensity according to observed spikes in intensity from devices delivering the stimulation . As another example, the compositions could be adjusted at the composition level, such that the TVS would have irregular intensity if delivered via a device lacking the intensity irregularities (i.e., delivering the non-adjusted compositions through a conventional Apollo device, which would not be done because they are specifically tailored for the new device, such as a smartphone or smartwatch, would produce TVS with intensity irregularities).

[0154] Intensity adjustments can be performed in the process of composition of TVS by ensuring that the stimulation intensity is aligned with the goal output. Intensity adjustments can be performed immediately following composition using filtration software that detects unexpected peaks and valleys and equalizes them (similar to the way that a equalizer works in music mastering). Intensity adjustments can be performed in the firmware on the device delivering the stimulation to ensure a particular delivery7goal of the TVS, such as smoothness or sharpness. Intensity adjustments can be performed by7the end user experiencing the TVSPATENTAttorney Docket No. APLO-0018-WO who can adjust the intensity in real time on a mobile application controlling the device delivering the TVS or directly on the device using controls.

[0155] These transcutaneous vibratory stimuli, which possess a complex vibratory composition, are delivered from a device to a subject. This complex composition cannot be generated additively, via an interference pattern, multiplicatively, or other combinations of fewer than 50 sine waves, fewer than 45 sine waves, fewer than 40 sine waves, fewer than 35 sine waves, fewer than 30 sine waves, fewer than 25 sine waves, fewer than 20 sine waves, fewer than 15 sine waves, fewer than 10 sine waves, or fewer than 5 sine waves. Without wishing to be bound by any particular theory, it is believed that traditional compositions are not complex. A person having ordinary' skill in the mathematical arts will appreciate the minimum number of sine waves necessary to generate a given signal.

[0156] Without wishing to be bound by any particular theory, it is believed that the evolution of transcutaneous vibratory stimulation occurred on a parallel track to the evolution of haptic generators more broadly, and haptic generators tailored specifically for the purpose of transcutaneous vibratory’ stimulation have traditionally been required to generate effective transcutaneous vibratory stimulation. Haptic generators can include subwoofers and bass shakers that are designed to deliver the bass range of music (musical frequencies <60Hz) more effectively and more faithfully with extremely high fidelity7. These specially tailored haptic generators focused on the clean generation of sine waves for the purpose of additive, interference, multiplicative, and otherwise combining into relatively simple vibratory’ compositions having a perceived pitch, a perceived beat, a perceived intensity, an envelope, and a base tone. In parallel and on a separate development track, haptic generators have evolved to be capable of providing a much broader range of haptic signals, thereby broadening the scope of capabilities of vibrational generation. However, these newer haptic generators cannot generate the signals that are generated by the specially tailored haptic generators by simply providing the instructions from the specially tailored haptic generators to the newer haptic generators. Specifically, when the inventors attempted to generate the simple transcutaneous vibratory stimulation produced by the specially tailored haptic generators by combining the process of generating signals from the specially tailored haptic generators with the inputs of the newer haptic generators, the output from the newer haptic generators w as not useful for transcutaneous vibratory' stimulation.

[0157] The complex vibratory composition includes variations in one or more secondary properties, including a variation in timbre (tone color), quality, pitch, duration (rhythm / tone), intensity (volume), texture, tempo, dynamics (macro / micro), articulation, register, spatialPATENTAttorney Docket No. APLO-OQ18-WO location / acoustics, form, silence, or a combination thereof. The complex vibratory composition also includes waveforms lacking smoothness, including one or more square waves, triangle waves, or other non-sine waveforms. Certain features of these non-smooth waveforms may be too sharp for production by previously known methods and systems.

[0158] Without wishing to be bound by any particular theory, it was believed that the touch receptor system in humans was only sensitive to variations in the pitch, duration, and intensity of transcutaneous vibratory stimulation, and that varying the vibrations in a fashion consistent with the other 9 characteristics of sound (i.e., timbre, texture, tempo, dynamics, articulation, register, spatial location / acoustics, form, silence).

[0159] While there is arguably a component of tempo, dynamics, register, and silence that is inherently present when utilizing pitch, duration, and intensity, and while spatial location / acoustics may be less applicable to transcutaneous vibratory stimulation, this is not the case for the timbre, texture, articulation, and form.

[0160] Without wishing to be bound by any particular theory, it is believed that prior to the discoveries in the present disclosure, those skilled in the art of transcutaneous vibratory’ stimulation did not consider timbre to be a characteristic of transcutaneous vibratory stimulation that was capable of being sensed by the touch receptor system. The inventors surprisingly discovered that variations in timbre for transcutaneous vibratory’ stimulation could achieve efficacy in reaching one or more desired states for a user.

[0161] Without wishing to be bound by any particular theory, it is believed that prior to the discoveries in the present disclosure, those skilled in the art of transcutaneous vibratory stimulation did not consider texture to be a characteristic of transcutaneous vibratory’ stimulation that was capable of being sensed by the touch receptor system. The inventors surprisingly discovered that variations in texture for transcutaneous vibratory stimulation could achieve efficacy in reaching one or more desired states for a user.

[0162] Without wishing to be bound by any’ particular theory’, it is believed that prior to the discoveries in the present disclosure, those skilled in the art of transcutaneous vibratory' stimulation did not consider articulation to be a characteristic of transcutaneous vibratory’ stimulation that was capable of being sensed by the touch receptor system. The inventors surprisingly discovered that variations in articulation for transcutaneous vibratory stimulation could achieve efficacy’ in reaching one or more desired states for a user.

[0163] Without wishing to be bound by any particular theory, it is believed that prior to the discoveries in the present disclosure, those skilled in the art of transcutaneous vibratory stimulation did not consider form to be a characteristic of transcutaneous vibratoryPATENTAttorney Docket No. APLO-0018-WO stimulation that was capable of being sensed by the touch receptor system. The inventors surprisingly discovered that variations in form for transcutaneous vibratory stimulation could achieve efficacy in reaching one or more desired states for a user.

[0164] As described elsewhere herein, these properties, many of which are typically associated with sound, can be adjusted dynamically to impact the efficacy of transcutaneous vibratory stimulations. While certain of these properties will be described following in the context of sound, it should be understood that the properties and the descriptions thereof are applicable to the transcutaneous vibratory stimulation compositions disclosed herein, and further, it should be understood that the transcutaneous vibratory stimulation disclosed herein is only detectable by the skin / bone and not the ears.

[0165] Pitch refers to the perceived "highness" or "low ness" of a sound, and it is determined by the frequency of vibration of a sound wave. When an object vibrates rapidly, it produces a high pitch; when it vibrates more slowly, it produces a low pitch. For example, a piccolo plays much higher pitches than a double bass because its sound w aves vibrate at a much faster rate. In music, pitch is central because it forms the building blocks of melody and harmony. Notes on a staff correspond to specific pitches, and when arranged in sequence, they create recognizable tunes. Pitch perception is also influenced by cultural and historical contexts. Western music uses a system of twelve semitones per octave, but other musical traditions, such as Indian or Middle Eastern music, use microtones — pitches that lie betw een the notes on a Western piano. Additionally, pitch can be precise or indefinite: a piano key produces a clear pitch, while a drum produces a sound that may not have an exact note value. The expressive use of pitch, through techniques such as bending, sliding, or vibrato, adds emotion and individuality to music. Without pitch, music would lack the melodic and harmonic structures that give it recognizable shape.

[0166] Duration (rhythm / tone) refers to the length of time a sound lasts, forming the foundation of rhythm in music. Some notes may last only a fraction of a second, w hile others may be sustained for several beats or even longer. When durations are organized into patterns of long and short sounds, along with silences, they create rhythm — the heartbeat of music. Duration interacts with tempo (the speed at which beats occur) and meter (the grouping of beats into regular patterns such as duple or triple time) to produce the sense of musical time. This quality is essential for creating movement and structure. For example, a march relies on regular, evenly spaced durations to drive the music forw ard, while jazz often plays with syncopation — unexpected accents and irregular durations that create a sense of swing. Silence, or rests, is equally important: pauses and gaps in sound allow rhythm to breathe andPATENTAttorney Docket No. APLO-0018-WO give shape to musical phrases. Beyond formal structure, duration also conveys emotion. A short, staccato rhythm may feel playful or urgent, while a long, sustained rhythm can create a sense of calm or tension. In this way, duration allows music to guide listeners through a temporal journey, giving shape and momentum to the sonic experience.

[0167] Intensity7(volume) refers to the loudness or softness of a sound, determined by the amplitude of its vibrations. In musical terms, this quality is expressed through dynamics, which range from pianissimo (very soft) to fortissimo (very loud). Dy namics provide contrast, shape, and emotional depth, helping music feel alive and responsive rather than flat and monotonous. For instance, a soft lullaby soothes with gentle dynamics, while a symphonic climax thunders with overwhelming intensity.

[0168] Musicians manipulate intensity in multiple ways. A single note can grow louder or softer through techniques such as crescendo (gradually louder) or decrescendo (gradually softer). Instruments themselves have different natural intensities; a trumpet easily projects loudly, while a harp is more delicate. Intensity is also relative — it depends on the context. A medium-volume passage may seem loud if it follows a very quiet section, or soft if it follows a powerful climax.

[0169] Psychologically, intensity has a strong impact on how listeners experience music. Loud sounds can create excitement, urgency, or even fear, while soft sounds may convey intimacy, vulnerability, or mystery. Intensity also shapes musical form by highlighting important moments and transitions. Without variations in intensity, music would lack the dramatic rise and fall that gives it emotional power.

[0170] Timbre (tone / color) is the unique quality or “color” of a sound that allows us to distinguish between different instruments, voices, or sound sources, even when they play the same pitch at the same volume. For instance, a trumpet and a cello playing the note A at equal loudness are instantly recognizable as different, because their timbres are distinct. This uniqueness arises from the complex mixture of frequencies, harmonics, and overtones produced by each sound source. In another example, a violin and a flute can play the same musical note at the same dynamic level, yet the listener will perceive them as entirely different in character. This unique sonic fingerprint is known as timbre.

[0171] Timbre is shaped by many factors, including the material of the instrument, the method of sound production, and the environment in which the sound is heard. A clarinet produces a rich, reedy timbre, while a piano offers a percussive yet resonant tone. Even within one instrument, players can alter timbre through articulation, vibrato, and playing techniques. Singers, too, display timbral variation, from the bright clarity of a soprano to thePATENTAttorney Docket No. APLO-0018-WO deep resonance of a bass. From a scientific perspective, timbre arises from the complex interaction of sound wave frequencies, overtones, and harmonics. A musical tone is rarely a pure sine wave; instead, it is composed of a fundamental frequency accompanied by a series of higher partials. The relative strength, balance, and decay of these overtones shape the way we perceive the instrument’s sound. Additional aspects, such as attack, sustain, vibrato, resonance, and even the acoustic environment, also contribute significantly to timbre.

[0172] Musically, timbre is essential for creating texture and atmosphere, and in expression and identity. Composers use it to paint with sound — pairing certain instruments together for contrast or blending. Composers and performers use timbral variation to evoke emotion, create contrast, and enrich the sonic landscape. For listeners, timbre makes music personal and emotionally evocative. It is what gives music its individuality and color, transforming notes into expressive, human experience. Without timbre, music would lack its richness and individuality, reducing all sound to indistinguishable tones. In short, timbre is the quality that makes sound personal, recognizable, and deeply expressive.

[0173] Texture in music refers to the way multiple sounds, voices, or instruments are layered and interact with each other. It is not a quality of a single note, but of how sounds combine. Broadly, there are several types of texture: monophonic (a single melodic line, like a solo voice singing unaccompanied), homophonic (a melody supported by chords, common in most pop songs), polyphonic (multiple independent melodies interweaving, like in a Bach fugue), and heterophonic (a single melody with variations performed simultaneously).

[0174] Texture affects the richness and complexity of music. A sparse texture, with only a single instrument playing, may feel intimate and exposed. A thick texture, with many instruments sounding together, can feel powerful, dense, and overwhelming. Texture also shifts within a piece: a symphony might begin with a solo oboe (thin texture) and expand into the full orchestra (thick texture).

[0175] Composers and performers manipulate texture to create contrast, tension, and release. Texture also guides listeners’ focus — whether their attention is drawn to one clear melody or to many interlocking lines. Beyond structure, texture conveys emotion: simplicity often communicates purity or vulnerability, while complexity may suggest grandeur or chaos. In this sense, texture shapes how we perceive the emotional and narrative flow of music.

[0176] Tempo is the overall speed of the beat, usually measured in beats per minute (BPM). A slow' tempo (e.g., a funeral march) creates calmness or solemnity, while a fast tempo (e.g., dance music) creates excitement and energy. Though closely tied to duration and rhythm, tempo is distinct because it provides the pace of the whole piece.PATENTAttorney Docket No. APLO-0018-WO

[0177] While intensity describes loudness in general, dynamics (macro and / or micro) also capture gradual changes (crescendo, diminuendo) and sudden contrasts (forte-piano, accents). Dynamic shape is crucial for emotional storytelling in music.

[0178] Articulation refers to how individual notes are performed: short and detached (staccato), smooth and connected (legato), accented, slurred, etc. Articulation deeply affects expression, even if pitch, duration, and volume remain constant.

[0179] Register refers to the range in which sounds occur: low. middle, or high. The same instrument in a low register often sounds warm or heavy, while in a high register it may sound bright or piercing.

[0180] With respect to Spatial Location / Acoustics, sounds’ perceived position in space — left / right. near / far, echo / reverb — shapes the listening experience. In performance, hall acoustics, microphone placement, and reverb can dramatically alter perception of music.

[0181] Though not a single note quality, form is the large-scale structure of music: binary, ternary, rondo, sonata, verse-chorus, etc. It provides a roadmap, showing how smaller elements fit into a bigger whole.

[0182] Silence, or the absence of sound, is itself a physical and musical characteristic. Pauses and rests create tension, shape phrasing, and make the return of sound more meaningful.

[0183] Without wishing to be bound by any particular theory, the inventors discovered that improved timbre and quality can be achieved with the systems and methods disclosed herein. As one example, a timbre of the complex vibratory composition can be impacted by a sampling rate, with too low of a sampling rate providing insufficient smoothness for the desired timbre.

[0184] In some cases, the complex vibratory composition can possess and / or be transmitted with a data sampling rate of between 2 kHz and 192 kHz. In some cases, the data sampling rate can be at least 2 kHz, at least 10 kHz, at least 30 kHz, at least 60 kHz, at least 90 kHz, at least 120 kHz, at least 140 kHz, at least 160 kHz, or at least 190 kHz. In some cases, the data sampling rate can be at most 192 kHz. at most 180 kHz, at most 150 kHz, at most 100 kHz, at most 50 kHz, at most 15 kHz, or at most 5 kHz.

[0185] In some cases, the complex vibratory composition can possess and / or be transmitted with a bit depth between 12-bit and 32-bit. In some cases, the bit depth can be at least 12-bit, at least 24-bit, or at least 30-bit. In some cases, the bit depth can be at most 32-bit, at most 28-bit, at most 22-bit, or at most 18-bit.PATENTAttorney Docket No. APLO-0018-WO

[0186] In some cases, the complex vibratory composition can possess and / or be transmitted with a dynamic range betw een about 96 dB and about 144 dB. In some cases, the dynamic range can be at least 96 dB, at least 110 dB, at least 125 dB, or at least 140 dB. In some cases, the dynamic range can be at most 144 dB, at most 130 dB, at most 115 dB, or at most 100 dB.

[0187] In some cases, the complex vibratory’ composition can possess and / or be transmitted with a frequency range between 0.0001 Hz and 1 kHz. In some cases, the frequency range is at least 0.0001 Hz, at least 0.001 Hz, at least 0.01 Hz, at least 0.1 Hz, at least 1.0 Hz, at least 10 Hz, at least 100 Hz, at least 500 Hz, or at least 900 Hz. In some cases, the frequency range is at most 1kHz, at most 750 Hz. at most 250 Hz, at most 50 Hz, at most 5 Hz, at most 0.5 Hz. at most 0.05 Hz, or at most 0.005 Hz.

[0188] Transcutaneous vibratory' stimulation disclosed herein is designed to be transmitted as a lossless, ultra high fidelity signal designed to be indistinguishable from human touch. Lossless in the context of digital audio refers to audio that preserves all the original information from the recording without compression losses (as opposed to lossy formats like MP3). The key technical parameter here rs the sampling rate — how many times per second the analog audio w aveform is measured (sampled) and converted into digital data. The standard lossless sampling rate for music is 44.1 kHz (44,100 samples per second). This is the rate used for CDs and most lossless digital formats (like FLAC. ALAC, or WAV). Why 44.1 kHz?Because of the Nyquist-Shannon sampling theorem, which states that to capture all frequencies up to a certain maximum without distortion (aliasing), the sampling rate must be at least twice the highest frequency present in the signal. Since human hearing typically ranges up to around 20 kHz, a 44. 1 kHz sampling rate can accurately capture all audible frequencies (20 Hz-20,000 Hz) with room for filter roll-off. While 44. 1 kHz is the most common, other rates are used for professional and high-resolution audio, such as 48 kHz which is the standard for film, TV, and professional recording, or 88.2 kHz, 96 kHz, 176.4 kHz, or 192 kHz, w hich are used in high-resolution audio formats, sometimes marketed as better than CD quality. They don’t extend human hearing but can improve production quality by reducing aliasing and offering more headroom in editing and mixing. The sampling rate is only one factor. Bit depth (1 -bit for CD, 24-bit or 32-bit for high-res) determines the dynamic range and detail of the sound. Together, sampling rate and bit depth define the fidelity of digital music recordings.

[0189] Human hearing has a frequency range of roughly 20 Hz to 20.000 Hz. Lossless sampling at 44. 1 kHz covers this range fully. Human vibrotactile perception (feeling throughPATENTAttorney Docket No. APLO-0018-WO skin / muscle) has a much narrower frequency range, roughly 1 Hz to -1,000 Hz (with strongest sensitivity between 20-300 Hz). This means that to achieve a lossless signal for haptics or bass vibrations, a 44.1 kHz sampling rate is not necessary. A rate of just a few kHz is already well beyond what the body can feel, so higher rates don’t add meaningful fidelity.

[0190] To reproduce haptic signals without distortion, the Nyquist principle is applicable: in some cases, sampling is at least twice the highest frequency desired to be represented. Since tactile systems rarely need to reproduce anything above -1.000 Hz, a sampling rate of 2-20 kHz is effectively lossless for human touch perception.

[0191] In hearing, bit depth matters because humans need enough dynamic range (-96 dB for CDs, 144 dB for 24-bit audio). In haptics, the skin doesn’t sense that many “steps” of vibration strength. A 12-16 bit resolution is already more than enough for precise, nuanced force / vibration intensity. What matters more is amplitude resolution — how smoothly a motor or actuator can ramp vibrations up and down without feeling abrupt or harsh.Bass is the bridge betw een hearing and feeling. Bass frequencies (20-200 Hz) sit in a “dual zone”: we both hear them with our ears and feel them in our bodies. The body can actually feel vibrations lower than 1Hz that are not perceptible by the ears (the TVS disclosed herein go well below 1Hz). That’s why a subw oofer at a concert shakes your chest — it’s not just sound, it's vibrotactile stimulation. For truly lossless bass and haptics, you want to capture both the auditory fidelity (44.1 kHz, 16-24 bit) and the tactile fidelity (-1-5 kHz at the lowest end; 192 kHz at the highest end; with a 12-16 bit at the lowest end and a 32 bit at the highest end) so the ear and body perceive the same smooth, continuous wave. Table 1 outlines characteristics possessed by signals that are heard and signals that are felt, including comparing their pitch, Nyquist requirement, standard lossless rate. Bit depth, perception sensitivity, overlap, other factors, and real-world examples.PATENTAttorney Docket No. APLO-0018-WOTable 1. Comparison of characteristics possessed by signals that are heard and signals that are felt

[0192] Transcutaneous vibratory stimulation having a vibratory7composition can be delivered from a device to a subject. The transcutaneous vibratory stimulation is dynamically modulated in response to a predetermined condition by changing timbre, vibration quality7, pitch, duration (rhythm / tone), intensity7(volume), texture, tempo, dynamics (macro / micro), articulation, register, spatial location / acoustics, form, silence, or a combination thereof. The predetermined condition may be determined via a physiological sensor, environmentalPATENTAttorney Docket No. APLO-0018-WO sensor, contextual data, or manual input. This dynamic modulation may be implemented without a firmware update to the device.

[0193] While traditional transcutaneous vibratory stimulation can be highly effective, there are 5-10% of the general population that are seemingly insensitive to the effects or have a paradoxical response (e.g., getting drowsy during stimulation intended to sustain wakefulness). These individuals are. in a non-medical and non-diagnostic sense, “divergent" in how their mind and body process transcutaneous vibratory stimulation. Without wishing to be bound by any particular theory, it is believed that the conventional methods of delivering simple vibratory compositions are ineffective with a small percentage of the population and there is presently no known explanation for this. Without wishing to be bound by any particular theory it is believed that the use of complex vibrational compositions can provide efficacy to this previously underserved population. If the initial transcutaneous vibratory stimulation is determined to be ineffective, such as determination via at least one of a physiological sensor, an environmental sensor, contextual data, or manual input, a further dynamic modification of a following transcutaneous vibrator)’ stimulation of timbre, vibration quality, or a combination thereof may occur and be delivered from the device to the subject. Dynamic modulation can continue until it is determined that the vibratory stimulation being delivered is effective or is eliciting an intended response. By utilizing dynamic modulation, nearly 100% of users report efficacy. This 100% efficacy has been proven to be achievable when tuning TVS to divergent individuals in a laboratory setting.

[0194] In one embodiment, input of a user condition, an event which may be a contextual event, or an environmental attribute is received, and a transcutaneous vibratory' stimulation may be composed by selecting an input channel controlling one or more properties of the transcutaneous vibratory stimulation. The input of a user condition may be from at least one of a physiological sensor sensing the user condition, an environmental sensor, a third-party- device, or a manual input from a provider or user. The transcutaneous vibratory stimulation may be delivered from the device to the subject. The input channel may be the input channel of a synthesizer. The properties may include one or more of the sharpness of the waveform, a pitch, a frequency, a volume / intensity. a timing, a pattern, or a beat.

[0195] When transcutaneous vibratory stimulation is delivered from a device to a subject in response to sensing a predetermined condition in the subject, the dynamic modulation in response to the sensed predetermined condition may occur within one hour, less than 30 minutes, or less than one minute of sensing the predetermined condition. This dynamic modulation may be implemented without a firmware update to the device.PATENT Attorney Docket No. APLO-0018-WO

[0196] Conventional transcutaneous vibratory stimulation devices have been unable to change the composition of a particular vibe without significant downloading / uploading of files and / or updating firmware of the device. This is because previously disclosed TVS vibrations were hardcoded during the composition phase. This means that code for generating the composed vibrations were stored on the device itself. In prior methods of generating TVS, to make any changes to the TVS (aside from the end user turning the intensity up or down), the file generated from the code had to be updated on a central server, inserted into the firmware, and sent back to the vibratory device before the updated TVS vibration could be delivered to the end user.

[0197] The disclosed methods and systems allow for the TVS vibration composition (including the 12 physical characteristics of sound described above) to be updated and modulated on an application controlling the TVS delivery device (e.g., transcutaneous vibratory7stimulation delivery device, smartphone. Etc.), as well as on the TVS delivery device itself based on a variety of data inputs (e g., EKG, brainwaves, body temperature, movement. HRV, subjective reports, vocal tone / volume of the subject, etc.).

[0198] The transcutaneous vibratory stimulation may be composed when delivery is requested or triggered and not precomposed. Requesting or triggering of the transcutaneous vibratory’ stimulation may be in response to at least one of a physiological sensor sensing the user condition, an environmental sensor, a third-party device, or a manual input from a provider or user. In some circumstances, there may be advantages to precomposition, so there remain many instances where the transcutaneous vibratory stimulation is partially or wholly precomposed prior to delivery. For example, certain compositions or patterns may be known to be helpful with relaxation and / or sleep, and those patterns may be precomposed in whole or in part for use in the methods described herein. Precomposed transcutaneous vibratory- stimulation that are composed by the methods disclosed herein can be dynamically modulated / updated over time based on a variety7of inputs from the user.

[0199] When the transcutaneous vibratory stimulation is dy namically modulated by changing in response to a predetermined condition, the dynamic modulation may occur within a modulatory effect window and may adjust a property of the initial underlying vibratory composition, including any of the properties disclosed herein, and in particular, the properties including timbre, texture, articulation, form, and combinations thereof. As used herein, a “modulatory7effect window ” refers to a range of values for one or more properties, where a lower boundary of the range defines a minimum threshold of dynamic modulation that needs to be exceeded in order to maintain a desired effect from delivering transcutaneousPATENTAttorney Docket No. APLO-0018-WO vibratory stimulation (e.g., a desired state in a subject), and an upper boundary of the range defines a noise threshold of dynamic modulation. For some users, effects may only be possible above a noise threshold, and thus, no modulatory effect windows exists for those users. Dynamic modulation, such as modulation directed to maintain a modulatory effect window, unexpectedly affected the efficaciousness of transcutaneous vibratory stimulation. It should be understood that dynamic modulation, the underlying composition, and the modulatory effect window may be individual-specific or may be applicable to a wider group of users. It was not apparent prior to this disclosure that a modulatory effect window existed for certain users. For some users, effects may only be possible above a noise threshold, and thus, no modulatory effect windows exists for those users. Dynamic modulation, such as modulation directed to maintain a modulatory effect window, unexpectedly affected the efficaciousness of transcutaneous vibratory stimulation.

[0200] One specific example of a modulatory effect window relates to the lengthening of total sleep time, as illustrated in Example 1.

[0201] The predetermined condition may include receiving a sensed signal from the subject where the condition may be detected by one or more sensors, by user input, or by a provider input. Providers may be therapists or other caregivers for the user. The sensors may be environmental sensors, physiological sensors, or contextual sensors. The predetermined condition may be the passing of a predetermined length of time. The predetermined condition relates to the user’s own brainwaves, heart rate, and other physiological signals, calendar events, ambient weather, touch, gesture, voice feedback, community and network activity, information or output from generative and predictive artificial intelligence models, and more sources.

[0202] Dynamic modulation of the underlying vibratory' composition may include adjusting a property of the initial underlying vibratory composition. This property may be at least one of tempo or volume / intensity and may7be at least one related to the overall composition or is relative between different parts of the composition. Compositions may be defined in parts and each part may be modulated, independently or in coordination with modulation of other parts. Adjusting a property may include changing via or changes to at least one of: starting (fading in), stopping (fading out), frequencies, amplitudes, bias (DC offset), playback rate, wave shapes, intensity, pitch, haptic sharpness (for continuous haptics), attack time, decay time, release time, duration, sustained intensity envelope, or unsustained intensity7envelope. The parameter changing may be ramp-controlled (e.g.. slewing and smoothing).PATENTAttorney Docket No. APLO-0018-WO

[0203] Dynamic modulation of the composition may include introducing new parts to the initial underlying vibratory’ composition to produce a composition-plus composition. The new part may be a fixed new part introduced in response to a sensed signal independent of the underlying composition. The new part may also be a de novo composition that takes into consideration the underlying composition and modifies it based on the sensed condition. For example, when a heightened stress level is sensed such as by one or more physiological sensors sensing a state of a user, the vibratory stimulation is dynamically modified to provide five staccato pulses of a predetermined timing. Continuous physiological sensing may be used to determine if additional intervention by dynamic modification is necessary’. Once the heightened stress is no longer sensed, the vibratory stimulation may return to the original program, be terminated, or may be dynamically modified again to mitigate re-entry to the stressed state.

[0204] Dynamic modulation of the composition may include removing one or more parts from the initial underlying vibratory composition to produce a composition-minus composition. Dynamic modulation may also include introducing periods of rest / silence independent of the underlying composition.

[0205] The transcutaneous vibratory stimulation may be continuous, transient, or a combination thereof. A metadata instruction in a file encoding the stimulation may instruct modulation of the transcutaneous vibratory stimulation.

[0206] Transcutaneous vibratory stimulation may be delivered to a subject, the transcutaneous vibratory stimulation comprising an initial underlying vibratory’ composition that is statistically associated yvith a desired effect in the subject, wherein the desired effect is statistically associated with an unmodulated decay yvhen the initial underlying vibratory composition continues to be applied to the subject without dynamic modulation. In this case, the underlying vibratory composition may be defined by a proven effect over time that decays at a given rate. As used herein, “statistically associated” refers to a property, effect, or other that has been shown to be statistically associated with a given source using statistical methods understood by skilled artisans to be within the bounds of reasonable science. The term is not intended to be associated with the truth or falsehood of a given statistical association. Outliers can be examples of statistical associations, even though that particular statistical association has a low likelihood of representing an underlying truth. For the avoidance of doubt, if there are one million studies on a given statistical association, if 1 out of the one million shows one result and the other 999,999 show an exactly opposite result, both results are considered statistically associated by the meaning used herein. Dynamic modulation of thisPATENTAttorney Docket No. APLO-0018-WO transcutaneous vibratory stimulation may reduce the unmodulated decay by between 5% and 95% or between 10% and 80%, including but not limited to, at least 5%, at least 15%, at least 20%, at least 25%, at least 50%, at least 60%, at least 80%, or at least 90%, and at most 95%, at most 75%, at most 50%, at most 25%, at most 10%, or at most 5%. Dynamic modulation may also modify one or more of an intensity of the decay or a time scale of the decay. Continuous monitoring for a predetermined condition may be carried out when the desired effect is statistically associated with a large unmodulated decay.

[0207] Examples of compositions that are statistically associated with a desired effect in the subject are those associated with improved sleep length / quality, as described in Example 1.

[0208] Without wishing to be bound by any particular theory, it is believed that the effect identified in Example 1 is extendable to substantially all of the aspects and embodiments of the present disclosure. Specifically, the effects associated with lengthening usage time are believed to be broadly applicable across a wide range of transcutaneous vibratory stimulation techniques, particularly those disclosed herein. In certain aspects, the methods described herein can. in addition to the method steps they already contain, further include: extending a usage time for a user during a time period before and during sleep. The time period before and during sleep generally encompasses the time period from 2 hours before bedtime until the termination of sleep.

[0209] Iteratively extending can take a variety of forms, as would be appreciated by a person having ordinary skill in the art. In one aspect, iteratively extending involves providing a message to a user suggesting extending a usage time, wherein at least a portion of users will comply with the message and voluntarily extend the usage time. In another aspect, iteratively extending involves automatically extending the usage time. In some cases, iteratively extending extends the usage time to 240 minutes or greater during a time window from 2 hours before bedtime until termination of sleep.

[0210] In one embodiment, transcutaneous vibratory7stimulation is delivered to a subject and dynamic modulation of the underlying vibratory7composition may change one or more properties on a time scale between 50 ms and 100 ms. The properties may include one or more of the sharpness of the waveform, a pitch, a frequency, a volume / intensity, a timing, a pattern, or a beat. Modulating properties on a time scale of 50 ms to 100 ms may result in improved neural entrainment / brain learning, which may be assessed via neural function assessments or user surveys, for example. The dynamic modulation may be 50 ms to 100 ms timing offset. The time scale is at least 50 ms, at least 60 ms, at least 75 ms, or at least 90 ms.PATENTAttorney Docket No. APLO-0018-WO and at most 100 ms, at most 95 ms, at most 80 ms, at most 65 ms, or at most 55 ms. In some embodiments, the system may be forward and backwards looking. Various time scales may be assessed for appropriateness. Modulation may occur for a pre-planned length of time, such as a known time when an effect begins to fade. In certain embodiments, there may be a probabilistic chance of change over a certain time window, a consistent chance of change over time, or a time-varying chance of change over time. For example, there may be an increased probability of change as time progresses, but still some smaller probability of an early change. In some aspects, a planned modulation may be foregone, such as in response to sensing something or based on a probability.

[0211] In a new embodiment, a transcutaneous vibratory stimulation composition is composed on a synthesizer where the synthesizer may include inputs for modulating parameters of the transcutaneous vibratory stimulation composition and the synthesizer produces a digital composition output. The digital composition output may be mapped onto an input format for a vibratory delivery' device to produce a digital composition input which then may be input to the vibratory delivery’ device, thereby producing the transcutaneous vibratory stimulation composition from the vibratory delivery device. The input format may be in an AHAP format or a MIDI format. The parameters which may be modulated include starting (fading in), stopping (fading out), frequencies, amplitudes, bias (DC offset), playback rate, wave shapes, intensity, pitch, haptic sharpness (for continuous haptics), attack time, decay’ time, release time, duration, sustained intensity envelope, or unsustained intensity envelope.

[0212] In some cases, the transcutaneous vibratory’ stimulation composition can be input via a musical instrument, such as a keyboard, a guitar, an electric wind instrument, an electric percussion instrument, or another instrument capable of outputting a digital file corresponding to performed music.

[0213] While the transcutaneous vibratory stimulation composition can be input via a musical instrument, one aspect of the present disclosure relates to the transcutaneous vibratory stimulation composition being a composition that does not produce music. Most individuals are familiar with the consequential vibrations that are generated by music that is either particularly loud or particularly low in the frequency range. In some cases, the transcutaneous vibratory' stimulation composition delivered as described herein are delivered without producing audible music and / or without being the consequence of audibly -generated music.PATENTAttorney Docket No. APLO-0018-WO

[0214] In an embodiment, a transcutaneous vibratory stimulation composition is being delivered to a subject from a delivery device where the modulation of transcutaneous vibratory stimulation composition may be one or more of random, pseudo-random, probabilistic, or a combination thereof.

[0215] In an embodiment, a transcutaneous vibratory stimulation composition is being composed on a synthesizer which includes inputs for the modulating parameters of the transcutaneous vibratory stimulation composition and produces a digital composition output. Modulation of a first input of the one or more inputs for modulating parameters may be done by introducing a modulation composition into the first input. The parameters may include starting (fading in), stopping (fading out), frequencies, amplitudes, bias (DC offset), play back rate, wave shapes, intensity, pitch, haptic sharpness (for continuous haptics), attack time, decay time, release time, duration, sustained intensity envelope, unsustained intensity envelope, timbre (tone color), texture, tempo, dynamics (micro and / or macro), articulation, register, spatial location / acoustics, form, and / or silence.

[0216] The modulation composition can be input in the same or different fashion as the transcutaneous vibratory stimulation composition (e.g.. via an instrument, generated composition, precomposed composition, etc.).

[0217] As described herein, vibratory stimulation may be used to enhance, support, coincide with, or mitigate effects of various experiences such as activities (e.g., a postworkout. a meditation session, gearing up for a nerve-wracking event), or blocks of time (e.g., sleep time, focus time, wake time). Times and activities may be inferred and stimulation may be triggered to play upon the detection of certain contexts and biometric data. Previously, a pre-recorded waveform was initiated and could be played / paused and users could adjust the intensity. The present disclosure is directed to interactions, which are more like a script, with access to all sorts of inputs and triggers. In one example, it can commence a stored composition, but one that is allowed to meander and adjust according to a defined behavior. For example, for synced breathwork, the interaction may be a three-part vibratory7composition with undulations that sync to the detected breathing in and out, and intensify or otherwise alters as the breathing becomes consistent. In another example, a sleep disturbance is detected. The intensify may be set according to how much sustained disturbance has occurred. A stored vibratory7composition may commence, but as the user’s 60 second window average restlessness increases above threshold, the vibratory stimulation may be modulated to play lower (deeper) frequencies and raise the intensity. The stimulation may return to the original intensity and composition as the restlessness decreases. If thePATENTAttorney Docket No. APLO-0018-WO restlessness is below a threshold for 2 minutes, for example, then there may be a transition to another component of the vibratory composition to sustain and support sleep. In another example, during a social event block, at the early onset of detected stress as indicated by HRV, noise levels, a particular motion, a stress-mitigating vibratory stimulation may commence. The core frequencies and path of the stress vibe are as defined by the composition, but the undulations of the vibe are synchronized to the heart rate. The undulations may gently slow down to just below the heart rate to attract the user’s heart down also. As the user’s heart meets the lowered undulation rate and syncs to that, undulations may be further lowered. When grounding is detected, vibratory stimulation may fade out.

[0218] In some examples, when a distinct rhythm is detected, and the tempo and detected context is appropriate, a vibratory stimulation may commence to enhance the predicted mood of the user. In another example, when the user is detected to be seated, a focus vibratory stimulation may commence. If “restless but still seated is detected”, the focus wave generator may commence. Depending on a combination of biometrics and context, Focus type A, B or C may be chosen. Each have a different patterning, frequency, amplitude range, but the incoming biometric data such as temperature, noise, motion and heart rate control what frequency and tempo the patterns and undulations do, within the defined boundaries. Further incoming detections can cause it to switch between ty pe A, B, or C. If there have been no plays for 60 minutes, for example, a vibratory stimulation may commence designed to grab the user’s attention, such as to remind the user to stand up.

[0219] In aspects, the detection of biometric data may cause modification or control of the rhythm, amplitude, frequency, etc. of a waveform. Indeed, biometric data may be one input among many, such as environmental data, ambient sound, music, contextual data, user input, or the like that may be input to an input channel of a waveform generator, such as a synthesizer, wherein the input is used by the synthesizer, alone or in combination with other criteria / factors / data / pre-formed vibratory compositions, to generate or modulate waveforms. Waveforms may be anything from undulating sinusoids to a tap / click, chirp, thump, or prerecorded waveform.

[0220] The waveform patterns can meander and modulate in real-time according to sensor inputs, manual inputs, and according to a mixture of environmental and asynchronous patterns. Such irregularity7in stimulative haptic signaling is a useful method to dynamically engage the autonomic nervous system consistently over time.

[0221] Arbitrary waveform generation may be done using a synthesizer with a modular signal core, such as the one shown in Fig. 30. In one example, a modular signal core designedPATENTAttorney Docket No. APLO-0018-WO for arbitrary' waveform generation (Fig. 30) and a sequencer (such as a MIDI sequencer, orEuclidean sequencer), an example composition generator (Fig. 31). together form a customizable set of stream processes and algorithms to generate signals that optimize for a desired outcome when engaging with the automatic nervous system. In an example, the modular signal core receives controls from the composition generator that can modulate any feature including, but not limited to: starting (fading in), stopping (fading out), frequencies, amplitudes, bias (DC offset), playback rate, wave shapes. The modular signal core has several sources, including but not limited to: a main source, a frequency modulator, and an amplitude modulator. All of these sources can range, from a simple sinusoid or pulse generator, to complex wavetables, to full length wave files whose length is only limited by the storage capacity of the device. The composition control takes in user input along with commands and parameters generated by algorithms over network and local to the device to configure a composition generator. The composition generator can then form simple or complex polyrhythms, sequences and arrangements that continuously change according to inputs as well as levels of chance / probability that are injected into the composer. The composition generator can produce parameter changes and modulations in a variety of ways, and with different bandwidths or rates of change, such as 1) occasional, such as a trigger from a detected event or classification of the user’s state; 2) as a continuous meandering pattern; 3) as an arrangement of sections that form a prescribed therapeutic path; or 4) as a waveform same as the modular signal core. The brain is more likely to leam / entrain to a signal that has small irregularities and unpredictable reward moments. Irregularities of approximately 50- 100ms are stimulatory, whereas very' regular or excessively irregular patterns can cause the brain to disengage. By wiring a haptic signal generator using a Euclidean pattern composer to control a modular synthesizer core, a signal can be generated that meets the criteria for consistent and persistent neural entrainment and engagement, similar to a brain computer interface. The signal can be further modulated by, or indeed generated in response to, a variety of inputs, including but not limited to: the user's own brainwaves, heart rate and other physiological signals, calendar, ambient weather, touch, gesture, voice feedback, community and network activity, generative and predictive Al models. The generator can be triggered to automatically start, stop, or be fully reconfigured according to major shifts in physiological signals, the user’s location and environment, daily wake and sleep schedule. Using analysis algorithms on the device and ongoing analysis of user data in a backend, generative and predictive Al algorithms can be used to create new durational vibrational sessions. The user, caregiver, or other experts and creatives can also create and distribute their own patterns andPATENT Attorney Docket No. APLO-0018-WO composer configurations. Using the midi protocol to parameterize, patch, and compose, a variety of common midi controllers and software tools can be used to create compositions and generative patches, and determine the degree of reactiveness to changes in data.

[0222] In one example, vibratory stimulation may be defined by one or more of: total duration, a variant, an intensity, a maximum intensity, a base frequency (e.g., 40 Hz, 100 Hz, 200 Hz, etc.), an envelope frequency (e.g., 0.1 Hz, 0.2 Hz, 4 Hz, etc.), an initial intensity, a relative intensity, a segment duration, and the like, such as in a text or spreadsheet format, wherein the text can be converted to other formats such as MIDI or AHAP.

[0223] Fig. 30 depicts an example synthesizer with 2 modulating oscillators and 1 main carrier oscillator. It offers robust and generalized control of its parameters, such as tone, timbre, texture, abruptness / staccato, real-time dynamic modulation, vibemarks, and the like. The oscillators can generate signals as simple as a sinusoid or square wave, or as complex as playback from a stored file, or externally provided signal stream. Other parameters not shown in this diagram for visual ease, include phase offset, DC bias. There is an amplitude modulator and a frequency modulator, start / stop controls as well as gain staging. Each of the parameters also offer a ramp control. This slews or smooths changes in parameters. The slew can range from instantaneous to 10 seconds. This is done for a couple of reasons. The main use case of the synthesizer is to produce signals that change slowly and smoothly for therapeutic purposes. With a MIDI controllable synthesizer, vibe authors can use common tools to compose a vibe, potentially in real-time with a MIDI controller such as a keyboard, or by direct drawing on a user interface. With many granular changes, expressing a smoothly changing waveform, the file can become quite large with many points, see Fig. 32A. Tools, such as Python scripts, or other tools including composing software can convert these many monotonically rising or falling change points into a single change with a ramp, by calculating the amount of change, and the time to arrive and applying linear interpolation, see Fig. 32B.

[0224] Further with the MIDI file format, other metadata can be inserted that can assist with the diagnosis and prescription process. Organizational details such as tagging the appropriate use, time of day. and context for each vibe can help link diagnosis to prescription. Instructions on how much to dynamically adjust the modulators or the composition when events are detected can also be inserted into the metadata section of the MIDI file format.

[0225] With a synthesizer that can generate signals as simple as a sinusoid and as complex as 3-part frequency and amplitude modulated wave files, any signal in the ID real number space or modulator can be generated, quantized to the limits of the digital-to-analog converter, and within the limited bandwidth of a haptic transducer.PATENTAtorney Docket No. APLO-0018-WO

[0226] Composition can be done in real-time, using any off the shelf MIDI controller orMIDI keyboard, drawn by hand, writen in the text format described herein, or generated with a variety of widely available plugins used for sequencing. Furthermore, local sensors, as w ell as context and triggers provided from a backend & mobile device can be wired to parameters of the synthesizer or the composition to allow it to change in subtle or drastic w ays in response. Information stored in the metadata of the MIDI vibe file can act as descriptors for the behavior of the synthesizer when event changes are received. Adjustments to any of the properties disclosed herein, in particular timbre, texture, articulation, and form, can be stored in metadata for a variety of devices such as smartwatches and smartphones, massage chairs, matresses, handheld massagers, sexual vibrators, etc. The metadata guiding the adjustments would be based on the delivery method and to where on the body the vibration is being delivered as different parts of the body have different sensitivity levels that are based on one or more of the density of touch receptors in a given area of the skin and the density of bone in a given area of the body.

[0227] In one non-limiting example, the generative musical arranging tool shown in Fig. 31 is sufficiently generalized to produce the waveforms, as well as significantly more complex waveshapes, and frequency / amplitude modulation. Further, it can receive information processed from a variety of wearable sensors, context such as w eather, time of day, the user’s interaction with mobile apps, questionnaires, expressed desires or ailments. This information can then start, stop, select, adjust or transition the vibe composition.

[0228] Fig. 33 is a flowchart of an example method 5510 for delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a complex vibratory' composition. Fig. 34 is a flow chart of an example method. At step 5610, transcutaneous vibratory stimulation is delivered from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition. At step 5620, in response to a predetermined condition, the transcutaneous vibratory stimulation is dynamically modulated by changing one or more properties of the vibratory' composition, wherein the one or more properties include timbre and / or vibration quality. Fig. 35 is a flowchart of an example method. At step 5710, delivering transcutaneous vibratory stimulation is delivered from a device to a subject, the transcutaneous vibratory' stimulation having a vibratory' composition. At step 5720, in response to a determination of ineffectiveness of the transcutaneous vibratory' stimulation, the transcutaneous vibratory stimulation is dynamically modulated by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality. Fig.PATENTAttorney Docket No. APLO-0018-WO36 is a flowchart of an example method. At step 5810, input is received of at least one of a user condition, an event, or an environmental attribute. At step 5820, in response to the input, a transcutaneous vibratory stimulation is composed, wherein composing includes selecting an input channel controlling one or more properties of the transcutaneous vibratory stimulation. Fig. 37 is a flowchart of an example method. At step 5910, transcutaneous vibratory7stimulation is delivered from a device to a subj ect, the transcutaneous vibratory7stimulation having a vibratory composition. At step 5920. in response to sensing a predetermined condition in the subject, the transcutaneous vibratory stimulation is dynamically modulated by changing one or more properties of the vibratory7composition, wherein the dynamically modulating occurs within 1 hour of the sensing the predetermined condition in the subject. Fig. 38 is a flowchart of an example method. At step 6010, transcutaneous vibratory stimulation is delivered from a device to a subject, the transcutaneous vibratory7stimulation having a vibratory composition. At step 6020, in response to sensing a predetermined condition in the subject, the transcutaneous vibratory7stimulation is dynamically modulated by changing one or more properties of the vibratory composition, wherein the dynamically modulating is implemented without a firmware update to the device. Fig. 39 is a flowchart of an example method 61 10 for delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory7stimulation having a vibratory7composition, wherein the vibratory composition is not pre-composed. Fig. 40 is a flowchart of an example method. At step 6210, transcutaneous vibratory stimulation is delivered to a subject, the transcutaneous vibratory stimulation comprising an initial underlying vibratory composition. At step 6220, in response to a predetermined condition, the transcutaneous vibratory / stimulation is dynamically modulated by changing one or more properties of the initial underlying vibratory composition within a modulatory effect window. Fig. 41 is a flowchart of an example method. At step 6310, ... transcutaneous vibratory stimulation is delivered to a subject, the transcutaneous vibratory7stimulation comprising an initial underlying vibratory7composition that is statistically associated with a desired effect in the subject, wherein the desired effect is statistically associated with an unmodulated decay when the initial underlying vibratory composition continues to be applied to the subject without dynamic modulation. At step 6320, in response to a predetermined condition, the transcutaneous vibratory7stimulation is dynamically modulated by changing one or more properties of the initial underlying vibratory composition. Fig. 42 is a flowchart of an example method. At step 6410, transcutaneous vibratory stimulation is delivered to a subject, the transcutaneous vibratory stimulation comprising an initial underlying vibratory composition. At step 6420, inPATENTAttorney Docket No. APLO-0018-WO response to a predetermined condition, the transcutaneous vibratory stimulation is dynamically modulated by changing one or more properties of the initial underlying vibratory composition, wherein the dynamically modulating changes the one or more properties on a time scale of between 50 ms and 100 ms. Fig. 43 is a flowchart of an example method. At step 6510, a transcutaneous vibratory7stimulation composition is composed on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein the synthesizer produces a digital composition output. At step 6520, the digital composition output is mapped onto an input format for a vibratory’ delivery7device to produce a digital composition input. At step 6530, the digital composition input is input to the vibratory delivery device, thereby producing the transcutaneous vibratory stimulation composition from the vibratory delivery device. Fig. 44 is a flowchart of an example method. At step 6610, a transcutaneous vibratory stimulation composition is delivered from a vibratory delivery' device to a subj ect. At step 6620, the transcutaneous vibratory stimulation composition is modulated by changing one or more properties of the transcutaneous vibratory stimulation composition, wherein the modulating is one or more of random, pseudo-random, probabilistic, or a combination thereof. Fig. 45 is a flowchart of an example method. At step 6710, a transcutaneous vibratory stimulation composition is composed on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory stimulation composition, wherein the synthesizer produces a digital composition output. At step 6720, a first input of the one or more of the inputs for modulating parameters is modulated by introducing a modulation composition into the first input. Fig. 46 is a flowchart of an example method for modulating a wide-spectrum transcutaneous vibratory stimulation composition for delivery through a narrower-spectrum delivery system, wherein the wide-spectrum transcutaneous vibratory’ stimulation composition includes parts across a wide spectrum, wherein the narrower- spectrum delivery system is capable of delivering a narrower spectrum transcutaneous vibratory stimulation that includes parts across a narrower spectrum. At step 6810, the parts are re-assigned across the wide spectrum which fall outside of the narrower spectrum to commensurate portions of the narrower spectrum. Fig. 47 is a flowchart of an example method for modulating a broad transcutaneous vibratory stimulation composition for delivery through a narrower-application delivery' system, wherein the narrower-application delivery' system has one or more limitations that prevent the narrower-application delivery' system from fully delivering the broad transcutaneous vibratory’ stimulation composition. At step 6910, the broad transcutaneous vibratory stimulation composition is adjusted to comply withPATENTAttorney Docket No. APLO-0018-WO the one or more limitations. Fig. 48 is a flowchart of an example method for calibrating a transcutaneous vibratory stimulation delivery system. At step 7010. the transcutaneous vibratory stimulation delivery system is frequency swept across a spectrum spanning from 0.0001 Hz to 200 Hz. At step 7020, intensity is measured from the transcutaneous vibratory stimulation delivery7system, thereby identifying active portions and inactive portions, wherein the intensity is above a predetermined threshold within the active portions of the spectrum and below the predetermined threshold within the inactive portions of the spectrum. At step 7030, portions of a transcutaneous vibrational stimulation composition are reassigned from the inactive portions of the spectrum to the active portions of the spectrum.

[0229] Referring now to Fig. 1, a system including a stimulation device 102 may be programmed to provide acoustic and / or vibrational energy, such as the waveforms described herein, such as tactile, haptic, or transcutaneous vibratory energy, that may be transmitted to a subject 114 wearing the therapeutic device. The stimulation device 102 may be an apparatus with a transducer adapted to deliver a stimulation to a portion of a subject intended to allow the subject to achieve a state. In certain embodiments, the stimulus may comprise oscillations of different frequencies, such as sine wave oscillations, that results in a beat frequency that is output to the subject. In an embodiment, the stimulation device may be configured, via a processor, to generate a transcutaneous vibratory7output to assist a user in achieving a target state. The stimulation device 102 may be controlled directly through a user interface of the stimulation device 102, such as through a controller 212, or may be controlled through an application executing on a mobile device or computing device. In embodiments, remote servers or applications running in the cloud 104 may be used to control, configure, or otherwise communicate with a processor of the stimulation device 102. I / O devices 110 (e g., third-party devices or software) may be used to provide data for processing by the stimulation device 102 and / or associated applications or systems. Likewise, the stimulation device 102 may provide and / or transmit data to I / O devices 1 10. Mathematical analysis of the collected data from all available sources may be performed by a processor of the stimulation device 102 or application / remote server in communication with the stimulation device to, among other things, generate predictions of a state transition. External devices / systems 108. such as a mobile phone or application (e.g., care provider application) may be used to control the stimulation device 102 or may in turn be controlled by the stimulation device 102 or its output. Any of the sy stem components may be in communication with each other via the cloud, directly or by some other relay. The system may include a remote server 112, whereinPATENT Attorney Docket No. APLO-0018-WO the stimulation device 102 may communicate with the remote server 112 to receive data, instructions, programming or firmware updates, and the like.

[0230] Sensors 1 18 may be external to or integrated with the stimulation device 102 and may be used to obtain feedback from the user before, during, or after the stimulation device’s 102 operation, may be configured to collect biometric, physiological, movement, and / or contextual data from the subject 114 or the subject’s environment to be used to determine the state of the subject, provide data useful for altering a vibratory output, establish a baseline state of the subject, predict a user’s future state, establish a sensory threshold, and in any of the other embodiments described herein. Sensor 118 readings may be used by the device and / or associated applications as feedback with which to potentially alter the pattern, frequency, intensity and / or duration of transcutaneous vibratory output (or audible output, as the case may be), as will be further described herein. Physiological sensors may measure ECG, temperature, heart rate, heart rate variability (e.g., which is a proxy for autonomic nervous system tone and emotion regulation capability), respiration rate, blood volume pulse, blood pressure, transcutaneous cortisol, blood glucose, vocal tone / pitch / vocal rate (e.g., such as with a microphone), galvanic skin response, gamma band EEG, pupil size / reactivity, brain activity (whole brain EEG), muscle activity, facial expressions, temperature, sweat amount, sweat components, cerumen components, or the like. Environmental sensors used to further assess user’s state may include calendar activity, social media postings, screen time / phone usage, texting frequency, screen tap pressure, or game play frequency. Digital image frames may be received from an imaging sensor (e.g., camera) that can capture video and / or still images, wherein the camera may be associated with the stimulation device or a separate device. The system also may include a positional sensor 560 and / or motion sensor 570 to detect position, movement, activity or location of the user or stimulation device. The positional sensor 560 and / or motion sensor 570 may be worn by the user or in a device carried by the user. In embodiments, motion sensors 570 may include gyroscopes or accelerometers. For example, the accelerometer can be used to determine if the stimulation device is placed on body. In some embodiments, only when sensors detect that the stimulation device is on a body will certain stimulation protocols / sessions be triggered. In embodiments, positional sensors 560 may include a global positioning system (GPS) sensor device that receives positional data from an external GPS network. Contextual data, which may be used in any of the disclosed embodiments, may derive from content of social media, a navigation application, a calendar application, a movement tracker, location tracker, direction of travel, an amount of usage of the mobile device, keystrokes input into the mobile device.PATENTAttorney Docket No. APLO-0018-WO or a project management application. Data collected by any of the sensor devices described herein that may be used to modify an aspect of the stimulation, discontinue the stimulation, or otherwise be used in a feedback loop. The sensor device may be embedded in a sensing wearable device such as a watch, wristband, bracelet, shirt, medical device (e.g., blood pressure cuff, pulse ox, thermometer, light stimulation, sound stimulation), exercise / activity monitor, or other wearable item. Alternatively, or in addition, a sensor device may be embedded in a separate device that is touching or proximate to the user, such as a pillow, mattress, blanket, or other bedding.

[0231] The stimulation device 102 may be configured to provide acoustic and / or transcutaneous vibratory stimulation to the subject 114 and may be configured to modulate the autonomic nervous system. In various embodiments, the stimulation device 102 may be configured to apply the stimulation to one or more body parts of the subject 114 by being worn or placed in proximity to, without limitation, the human’s wrist, ears, neck, ankles, hips, knees, feet, sternum, chest, back, whole body, or the like. In certain embodiments, the stimulation device 102 is adapted to be disposed in a portion of a subject, such as by implantation, to deliver a stimulation, such as through implantation of the device 102 or when the device 102 is integrated with another implantable, such as an insulin pump, pacemaker, or the like. Thus, the parts of the stimulation device 102 that emit vibrations may be included in the form of a wearable device such as a band that wraps around the appropriate body part (wrist, ankle, head, feet, etc.), a set of headphones or earbuds, a hat or cap, a wristwatch, a shirt, or other wearable devices, or an implantable device. In some embodiments, the stimulation device 102 must be touching the body to be effective, while in other embodiments, the stimulation device 102 is effective without having to actually contact the body.

[0232] In an embodiment, and referring now to Fig. 3, the stimulation device 102 may be embodied in a wearable (which may be Internet-connected), a watch, a smart watch, a smart phone, a computing device, an anklet, a chest strap, a smart clothing / garment (hat / shirt, scarf, earmuffs, hair band), a shoe / shoe sole / shoe insert, headphones / earbuds / earpiece (e.g., audio stimulation through earpiece), a smart eyewear, an eye mask, a seat, an infant seat / cradle / fumiture, a vehicle seat with sensors in dashboard / seat / wheel, a pillow, a bed, a mattress, a mattress topper or bedding (e.g., sheets, pillowcase, blanket, weighted blanket, animal blanket etc.), a yoga mat. a pet product, a dog bed. a pet collar, a ready-made pod, or other clothing or furniture where the sensors and transducers / stimulators can be disposed or embedded. For example, a system to soothe an infant may include a seat with at least onePATENTAttorney Docket No. APLO-0018-WO strategically placed transducer (e.g., cushion, mattress, mattress topper, bedding, pillow; stuffed animal) adapted to emit vibration selected to induce a soothed state. For example, the system may be embodied in bedding, such as a mattress topper or pillow, wherein the system may deliver therapeutic stimulation to facilitate sleep, including taper functionality and / or sleep detection-turn-off functionality. Sensors may also be embedded in the bedding to track entry and / or exit from sleep, provide feedback on the effectiveness of the stimulation (e.g.. respiration changing, cries diminishing), or to provide a signal to commence stimulation (e.g.. microphones detecting a cry). A speaker may be included to play lullabies, heartbeat sounds, white noise, or other soothing output. In another example, a system may include a transducer located in a seat or seat back, such as an immobile seat or one in a transportation setting, wherein the transducer is configured to deliver a transcutaneous vibratory stimulation to an occupant of the seat. A physiological sensor may be used determine a state of alertness of the occupant of the seat and a processor may control the transducer in response. Where the seat is in an automobile, a vehicular sensor may sense a vehicle operation parameter, wherein the processor further utilizes the vehicle operation parameter to control the transducer. For example, if the vehicular sensor indicates that the user is closing their eyes while the car is still in motion, a processor in communication with a transducer in the seat may cause it to turn on and deliver stimulation directed at wakefulness. In yet another example, a pet or animal collar may have an embedded transducer and processor, wherein the processor can be remotely controlled by a separate device or an application executing on a smartphone, mobile device, computer, or the like to deliver stimulation through the transducer, as described herein, to an animal wearing the collar. Sensors, such as physiological sensors, microphones, cameras, or the like, may be integrated with the collar or associated with it to provide feedback, as described herein, to the processor. In any of the embodiments, control of generating and delivering the stimulation may be through the embodiment itself using firmware embedded in an integrated or associated processor or may be through software or an API executing on a computing facility .

[0233] In an example, when the stimulation device 102 is embodied in a smart phone, an application on a smart phone computing device may be used to control it to emit stimulation, either as transcutaneous vibratory output, audible output, or both. The stimulation may be generated by one or more of a vibratory motor or speaker of the smartphone. In embodiments, other content may be delivered by the smart phone or other apps may be used to cause other actions or control other devices during the therapeutic output. In another example, the stimulation device 102 embodied in a ready-made pod may include modularPATENTAttorney Docket No. APLO-0018-WO parts or kits or parts sold to manufacturers of other products such as seats, sleeping PODS, baby seats, pet collars, and the like to be incorporated into designs / products. API's and wireless connectivity could be a component of the ready-made pod sold to manufacturers to provide control options. In an embodiment, the stimulation device 102 may be embodied in augmented reality or virtual reality eyewear or other equipment associated with these embodiments. For example, a transducer may be incorporated to the arms of the eyewear so as to deliver tactile stimulation, and optionally, audible stimulation to the user. Stimulation that is both tactile and audible may be synergistic or complementary. In embodiments, the augmented reality eyewear may be programmed to deliver content in conjunction with the stimulation.

[0234] FIG. 2A and Fig. 2B each illustrate a block diagram of an example stimulation device 102. As shown in FIG. 2A, the stimulation device 102 may include one or more transducers 201, a controller 212, and a processor 202 in a housing 210. The stimulation device 210 may be in communication with (as shown in Fig. 2A), or optionally include (as in Fig. 2B) a communications interface 203, a power source 204, an optional user interface 205, and a memory 206.

[0235] The one or more transducers 201 may be any device that may transmit vibrational and / or acoustic energy' from an energy' source to a subject in the form of stimulus. Examples of transducers may include, without limitation, bone conductors (e.g., such as a bone conductor in smart or augmented reality eyewear), tactile transducers, transcutaneous vibratory transducers, linear resonant actuators, rotational motors, bass shakers, or audio transducers (e.g., speakers). While not shown here, the transducer 201 may receive the desired stimulation signal from a driver that amplifies and filters it so that an appropriate voltage and current signal is applied to the transducer 201.

[0236] The processor 202 may be configured to control one or more functions of the stimulation device 102 such as, without limitation, application of a suitable stimulation to a subject, frequency control of the applied stimulation, processing of feedback received from the sensor device, communication with a user or an external system, or the like. In some embodiments, the processor 202 may be configured to control the stimulation applied (e.g., frequency, time duration, intensity, etc.) based on, without limitation, readings from the stimulation device 102, sensors 118, 208, 570, 560, user input, or any other information, or combinations thereof. The processor 202 may communicate w ith each of the other components of the stimulation device 102, via for example, a communication bus or anyPATENTAttorney Docket No. APLO-0018-WO other suitable mechanism. The processor 202 may be controlled by an application executing on a mobile device, computing device or remote server 112.

[0237] In certain embodiments, the stimulation device 102 may be configured to apply the desired stimulation to a subject as transcutaneous vibration over a discrete period of time. In some embodiments, it may be a continuous application of frequency sound. The length of time during which the stimulation is applied may vary from situation to situation, depending on factors such as the nature and severity of the condition being treated: the size, age, gender, and overall condition (physical and psychological) of the subject, etc. Alternatively, and / or additionally, the duration may be defined based on input received from a sensor, the user, or third-party data. In general, the duration of application may be in the range of 1 minute to two hours, and optionally in the range of 5-15 minutes or 1-5 minutes. Alternatively, a duly cycle by which the stimulation may be delivered may be an oscillating or pulsed manner e.g., by employing repeated sequences of seconds or minutes on and off, resulting in intermittent (for example, sporadic: 30 seconds on-30 seconds of!) or (for example non-sporadic: 30 seconds on-10 seconds off), alternating delivery and cessation of delivery of the therapeutic stimulation. In embodiments, the signal may be a series of discrete pulses with additional vibrations between pulses. The duty cycle may be programmed to result in staccato vibrations.

[0238] In one or more embodiments, a communications interface 203 may be configured to facilitate communication of data into and out of the stimulation device 102. In some embodiments, the communications interface 203 may include, without limitation, a WiFi transceiver, a Bluetooth transceiver, an RFID transceiver, an Ethernet port, a USB port, and / or or any other t pe of wired and / or wireless communication interfaces. The communications interface 203 may be configured to transmit data to and receive data from computing devices, mobile devices, and / or networks that are not included in the stimulation device 102. For example, communications interface may couple the stimulation device 102 to an application running on a user device such as a mobile device.

[0239] In certain embodiments, the user interface 205 may include any type of input and / or output devices that permit a user to input commands into or receive information from the stimulation device 102. The optional user interface 205 may include elements configured to receive commands or input parameters, or to be used to check or change settings. Examples include a tactile input such as a keypad or touch screen, a microphone, dedicated buttons, dials or switches, or other device. In embodiments, the user interface 205 may be adapted to receive gestural input or verbal input.PATENTAttorney Docket No. APLO-0018-WO

[0240] The user interface 205 also may include elements configured to output data such as a display, light emitting diodes (LEDs), transcutaneous vibratory / haptic facilities, or an audio speaker. Output from the stimulation device 102 may be on a display of the device 102 itself, on a mobile device, on a third-party device, to an application such as a care provider application, or the like. In embodiments, the output may be visual feedback provided to the user in conjunction with delivered therapy. The processor may be in communication with a mobile device and a sensor sensing biometric data of the user, as well. During delivery of transcutaneous vibratory output to the user, the sensor may collect biometric data of the user. The processor may use the biometric data to determine whether the user has at least one of achieved or not achieved the target state, and if the user has not achieved the target state, the processor is further programmed to determine the user’s current state relative to the target state. Based on these determinations, the processor then causes the mobile device to (i) generate output indicating whether the user has achieved the target state, and (ii) if the user has not achieved the target state, generate output to guide the user to achieve the target state.

[0241] In another embodiments, the visual feedback of the user’s state may be provided on a display of the stimulation device itself. For example, a processor, either in the stimulation device or separate from it, may be in communication with the transducer and the display of the stimulation device and a sensor. The processor causes the transducer to generate a first transcutaneous vibratory output and then determines based on biometric data from the sensor whether the user has at least one of achieved or not achieved a target state, and if the user has not achieved the target state, the processor is further programmed to determine the user’s current state relative to the target state. The processor may cause the display to display an indication of whether the user has achieved the target state, and if the user has not achieved the target state, display information to guide the user to achieve the target state. In other embodiments, the visual feedback of the user’s state may be provided in an application executing on a smartphone, mobile device, computer, or the like.

[0242] In any of the embodiments, the output may be at least one of visual, audible, or tactile. For example, the visual output may be an image of a pulsing heart roughly mirroring the actual heartbeat of the individual. In embodiments, the pulsing heart may be configured to slow down or speed up in accordance with a sensed heart rate. The output to guide the user may be generated based on the user’s current state relative to the target state. The output to guide the user may communicate a recommended breathing rhythm. If the processor determines that the user has not yet achieved the desired target state, the processor makes a determination that the output needs to be modified and causes the transducer to generatePATENTAttorney Docket No. APLO-0018-WO another transcutaneous vibratory output that may vary in one or more variable parameters relative to the first vibratory output.

[0243] The user interface 205 may permit a user to control the operation of the stimulation device 102, define settings (e.g., frequencies, intensity, time duration, etc.) of the stimulation device, receive information about operations of the stimulation device, troubleshoot problems with the stimulation device, or the like.

[0244] The system's user interface may include inputs that enable a user to activate and / or turn off the transducers, to modify stimulation patterns including modifying the herein described parameters of the output, and / or to indicate that a particular pattern is agreeable or not agreeable. The system may determine a user’s usage pattern, such as patterns most frequently used and typical durations of usage, and save this data to a user profile so that the system can automatically adjust to the user’s preferences. For example, if a particular therapy has a default duration and the user does not typically turn the therapy off before the end of that duration, the system may retain that duration when applying the therapy again. However, if the user typically turns the stimulation off before the default duration ends, the system may adjust the default duration for that user to match the average or mean duration that the user actually applies the therapy, optionally only considering a threshold previous number or times of application when calculating the mean or average. The system may also use other functions that are based on actual usage data to determine the duration. Similarly, a particular therapy may have a default intensity level, the user interface may permit the user to vary the intensity level, and the system may automatically adjust the default to match the user’s mean or average selected intensity level.

[0245] In some embodiments, the pow er source 204 may be configured to provide pow er to the stimulation device 102. The power source 204 may include one or more of a rechargeable battery, a non-rechargeable battery, a solar cell, a chemical reaction power generator, a power input port that connects to an external power line, or any other device configured to provide pow er to the stimulation device 102 and its components.

[0246] The housing 210 may be configured to secure the transducer 201 at the site of application of the stimulation on a subject. For example, if the stimulation will be applied to the wrist of a subject, the housing may be in the form of a wristband. Similarly, if the stimulus will be applied to various points on the back of a subject, the housing may be a mattress, a mattress topper, a sheet or blanket, a wearable shirt, a seat or seat cushion, a body wrap, or other item that contacts the subject’s back. Some components of the device such asPATENTAttorney Docket No. APLO-0018-WO the transducer 201 may be on or outside of the housing, or sonically conductive leads may extend from the housing from the transducer 201.

[0247] In some embodiments, audible frequencies may be delivered by the stimulation device itself, by a connected audio device, or in combination with tactile vibration. An application or other software may be used to control and / or cause to emit the audible frequency and / or vibration frequencies over the stimulation device or a peripheral device.

[0248] FIG. 1 also depicts various components that may be included in the system, either in the stimulation device or in a mobile device or computing device that is in communication with the stimulation device. In some embodiments, an electrical bus may provide for electronic communication among various components and a controller 120 may control such communications. Processor 505 may be configured to perform calculations and logic operations required to execute programming instructions. As used in this document and in the claims, the terms “processor” and “processing device” may refer to a single processor or any number of processors in a set of processors that collectively perform a set of operations, such as a central processing unit (CPU), a graphics processing unit (GPU), a remote server, or a combination of these. Read only memory (ROM), random access memory (RAM), flash memory, hard drives, and other devices capable of storing electronic data constitute examples of memory' devices 525. A memory device may include a single device or a collection of devices across which data and / or instructions are stored. The processor may be embedded in the stimulation device or may be in a separate device.

[0249] An optional display interface 530 may permit information to be displayed on a display device 535 in visual, graphic, or alphanumeric format. An audio interface and audio output (such as a speaker) also may be provided. Communication with external devices may occur using various communication devices 540 such as a wireless antenna, an RFID tag and / or short-range or near-field communication transceiver, each of which may optionally communicatively connect with other components of the device via one or more communication system. The communication device 540 may be configured to be communicatively connected to a communications network, such as the Internet, a local area network or a cellular telephone data network.

[0250] In an embodiment, a user interface 545 may enable receipt of data from input devices 550 such as a keyboard, keypad, a mouse, a joystick, a touchscreen, a touch pad, a remote control, a pointing device, dedicated buttons, dials, switches, and / or microphone.

[0251] In an embodiment, the one or more transducers 201 may be configured to provide acoustic and / or vibrational energy as a wave pattern that may be transmitted to the subject,PATENTAttorney Docket No. APLO-0018-WO the acoustic and / or vibrational energy comprising the stimulation described herein, which is configured to cause a user to achieve a target state or maintain a current state. A phase accumulator, a numerically controlled oscillator, a synthesizer or other waveform generator may be used to generate waveforms. Data storage 580 may include data related to parameters for fundamental vibration generation, data related to treatment protocols including associated therapies and stimulation, data on how to interpret physiological and / or contextual data, data on endpoints used to trigger stimulation, user profile data including known physiological parameters, sensory thresholds, baseline states, performance states, typical locations, or the like, manually collected data from users, epigenetic data using data collected in part from a biological sample collection device 590, and data from monitoring mobile device and application usage, or the like.

[0252] The stimulation device 102 and / or associated application may be programmed to deliver stimulation whose parameters are selected to cause a user to reach a target state (e.g., arousal, sexual arousal, relaxation, asleep, low er heart rate, lower blood pressure, calm, focus, flow, presence of being, asleep, wakeful, relaxed, aroused, euphoric, etc.), facilitate entry into a target state, treat a condition (e.g.. trauma, anxiety; insomnia; chronic pain; chronic stress; autism; depression, psychosis, headache, migraine, autoimmune disorders; hypertension; disorders relating to hypoarousal such as narcolepsy, fatigue, excessive daytime somnolence, chronic fatigue syndrome, constipation, catatonia, metabolic syndrome, eating disorders, obesity, hypotension, dysautonomia. attention deficit disorder, attention disorders that are characterized by decreased or unbalanced activity of the sympathetic nervous system over time (e.g., wherein treatment causes increased attention to inside the body by increasing parasympathetic tone relative to sympathetic tone, or increased attention to stimuli external to the body by increasing sympathetic tone relative to parasympathetic), motion sickness, vertigo, vasovagal reactions, disorders of metabolism including insulin insensitivity (ty pe 2 diabetes mellitus) and metabolic syndrome, autonomic disorders, autoimmune disorders, or anemia), mitigate a side effect of a treatment, recovery7from a state (e.g., trauma, stroke, heart attack), and the like. Each target state may be defined by certain parameters, such as physiological parameters or biometric parameters. For example, a calm state may be identifiable based on a heart rate below 60 bpm, an HRV above 80, a high frequency of positive words on social media postings and texts, a low' speaking volume, or the like. In another example, an agitated state might be identifiable based on a heart rate over 100 bpm, an HRV below 40. a high-pitched speaking volume, increased use of negative words, and the like.PATENTAttorney Docket No. APLO-0018-WO

[0253] Configuring the stimulation to achieve a target state, maintain a current state, and / or be dynamically adjusted to prevent habituation may comprise adjusting one or more of the available parameters of the synthesizers.

[0254] In embodiments, the system may be programmed to receive user input and user feedback to manually initiate, terminate or adjust stimulation, such as in a user interface of the stimulation device, in a user input device, verbally indicating the state to a microphone input, in an application controlling the stimulation device, such as an application executing on a mobile device (e.g., smartphone, smart watch, smart eyewear, etc ), or the like. For example, a user may input a current state and / or a desired target state. The user’s current state or condition may be indicated by the user (e.g., “I feel stressed”). A stimulation protocol or transcutaneous vibratory output may be selected based on the desired target state, based on the current state indicated by the user, and optionally, based on the current state relative to the desired target state. Based on the input, the transducer of the stimulation device generates a first transcutaneous vibratory output to be applied to a portion of the user’s body to assist the user in achieving the desired target state. Determining if the user has achieved the target goal state may also be done subjectively, such as by receiving an input from the user of goal achievement (e.g., '‘I feel good”), as described herein, or by the user manually discontinuing stimulation. Throughout the stimulation, the user may also input or be prompted to input if they are still feeling that they have not reached the target state, if they are still in the initial state, or if they feel they are in between states. If the user has not achieved the desired target state, a second transcutaneous vibratory output may be generated, such as with the stimulation device, and delivered to the user in achieving the desired target state.

[0255] Determining current state or condition or goal state achievement may also be done using biometric data, using sensed physiological data (e.g., HRV. GSR, heart rate, respiration rate, etc.), using sensor readings in comparison to a target physiological profile, in accordance with usage patterns, based on third party data, based on social media, or the like. In various embodiments, a target state may be indicated, such as in a user interface or using data collected by the sensor device(s) that indicates the need for a target state. In embodiments, a target state may be a particular health index. Health index may be an aggregate of various health-related measures, such as blood pressure, heart rate, HRV, ratio of HR / HRV, or the like.

[0256] In embodiments, data collected by the sensor device(s) may be used as feedback to initiate and / or control the application of the stimulus, or a first transcutaneous vibratory output, to the subject, via the stimulation device 102. Additionally, and / or alternatively, thePATENT Attorney Docket No. APLO-0018-WO data collected by the sensor device may be used to select and personalize the application of stimulation to the subject 114 based on the data collected by the sensor device. For example, the frequency ranges, stimulation patterns, stimulation application times, stimulation application duration, or the like may be personalized to a user. Continuous or periodic monitoring using sensors may be done, optionally along with comparison to parameters for a known / stored state. For example, if a user is attempting to reach a target state of being asleep, sensed parameters associated with that state may be high HRV. low movement, and low audible sound. In this case, one or more of a motion sensor, biometric or physiological sensor, or microphone may be used to monitor the user for possible entry into the state of sleep based on the group, or part of the group, of sensed parameters in comparison to known ranges of the sensed parameters. In another example, if the target state is wakeful and sensors indicate low HRV, stimulation may be initiated to address hypoarousal. In yet another embodiment, sensors indicating high HR and low HRV in the absence of physical activity may trigger a therapeutic stimulation for hyperarousal. The sensor device may use this sensor feedback to continue operation of the device if the user has not reached the target state or an expected state (e.g., Generally, fast, high intensity vibration patterns may increase HR. respirations, blood pressure, and sweat while decreasing HRV. Generally, slow, gentle, low intensity vibration patterns may decrease HR, respirations, blood pressure, and sweat while increasing HRV.), as evidenced by sensors, terminate operation if the user has reached the target state, begin a tapering of stimulation if sensors indicate the user is approaching the target state, generate a second transcutaneous vibratory output, or the like. The second transcutaneous vibratory output may have parameters that are different from those of the first transcutaneous vibratory output.

[0257] In embodiments, a system to alter the mood of a user may include a user input device, a stimulation device which includes a transducer adapted to emit transcutaneous vibratory output, a physiological sensor sensing a physiological parameter of the user, and a processor in electronic communication with the user input device, the transducer, and the physiological sensor. The system may accept input of a desired state of the user, and in response, cause the transducer to generate a first transcutaneous vibratory output to be applied to a portion of the user’s body to assist the user in achieving the desired target state. The physiological parameter of the user may be used to determine whether the user has achieved the desired target state. If the user has not achieved the desired target state, the transducer may generate a second transcutaneous vibratory output to be applied to a portion of the user’s body to assist the user in achieving the desired target state.PATENT Attorney Docket No. APLO-0018-WO

[0258] In an embodiment, stimulation may be terminated once a state has been reached as indicated by passive sensing (e.g., derived from other information sources) or active sensing (e.g., accelerometer indicates no movement, respiration rate indicates sleep, position, sensors indicate a health index / level). In an embodiment, stimulation may be resumed when sensors indicate the state has changed. The system may be programmed to resume stimulation (or stop it from turning off or extend a tapering time) if data from one or more of these sensors exceeds a threshold value, or alternatively, based on an elapsed time. The system may be programmed to initiate a program when a particular sensor reading is received.

[0259] In certain aspects, sensors may determine a current contextual or physiological condition for the user and stimulation may be initiated, terminated, or adjusted based on one or more detected states. For example, if sensors indicate stress (e.g., based on a health index), other data may be used to modulate turning on / off the stimulation. In an example, if an accelerometer indicates that the user is moving at an exercise rate, then the sensor readings are likely not indicating stress but rather reflect exercise. In an embodiment, if sensors indicate slowing down of movement at a particular time, that may be interpreted as getting ready for sleep, and the stimulation device’s sleep routine may commence. In an embodiment, if sensors indicate the user is in a car but is experiencing drowsiness, the stimulation device 102 may be caused to commence deli very of stimulation configured to promote wakefulness.

[0260] In an embodiment, determining if a user has reached a target or goal state as a result of a stimulation may be done via user input, using system data, passive user data or sensing wearables (e.g., smart watch, medical device (e.g., blood pressure cuff, pulse ox, thermometer)), exercise / activity monitor, or other wearable item, or may be done using external and / or third party sources, such as third-party data, third-party devices, SaaS applications, health and fitness informatics applications, health and fitness APIs, hospital data systems, social media posts, communications, and the like. For example, a processor of or associated with a stimulation device may be programmed to receive a user's social media posts and commentaries and assess the language used for tone and emotion. In some embodiments, any combination of user input, internal sensing, or external data or sources may be used to determine if the user has reached goal state. The external and / or third-party sources may provide data on physiological parameters (e.g., blood pressure, HRV, GSR, respiration rate, etc.). In some embodiments, based on determining if the goal state has been reached from external and / or third-party sources, a second stimulation may be generated and delivered / applied to the subject to assist in reaching or maintaining the target state. In somePATENTAttorney Docket No. APLO-0018-WO embodiments, based on determining if the goal state has been reached from external and / or third-party sources, stimulation may be discontinued or extended.

[0261] Configuring the stimulation to achieve a target state or maintain a current state may comprise generating stimulation of more than one segment, such as to obtain a session of stimulation having a series or a concatenation of stimulation patterns to achieve a desired state. In some embodiments, the session may be associated with an event, such as an entertainment event, an athletic event, a stress-inducing event, a psychotherapy session, or the like, and each segment is selected to produce an “overall” experience conducive to the event or session. For example, a session for mitigating anxiety of air travel may have multiple segments, such as a segment that is executed while the subject is waiting to board, then another while on board but awaiting takeoff, one during takeoff, one during flight, and the like. The user may manually indicate when the status of air travel has changed so that a next segment is executed. Data, such as third-party data may be used to indicate when the status of air travel has changed so that a next segment is executed, such as for example, air traffic control and airline status data. Sensors may be used to indicate the status of the air travel in order to move from one segment to another, such as a microphone to hear announcements, a connected camera in smart eyewear, an altimeter to indicate altitude, or the like. In embodiments, data regarding an event to be or currently being experienced by the user may be obtained by a user interface, a contextual, biometric, or physiological sensor, third party data or applications, and the like. Physiological sensors may include respiration, temperature, GSR, SpCh, spirometry, EEG, ECG, EMG, heart rate, HRV, CO2, motion, blood pressure, glucose, or the like. Biometric sensors may capture data regarding fingerprints, visual / facial cues, vocal tone, vocal pitch, the iris, or the like. Contextual sensors may capture data regarding the geospatial environment, location, meteorology and weather, air pollution / quality monitoring, flood monitoring, or the like. In some embodiments, the data regarding the event is a change in the event, such as a change in a traffic pattern, a delay in takeoff, a significant change in the weather, or the like.

[0262] Other examples of events where a session of stimulation may be useful include at athletic events, during public speaking sessions, during a speech or presentation, during a commute, for the treatment of a particular disorder (e.g., PTSD), for a desired feeling or desired outcome for the day, or the like. In the case of a commute, for example, data, such as from a traffic, GPS, or navigation application, may be used to determine speed, location, volume of surrounding traffic, and the like, and these data may be used to create thePATENTAttorney Docket No. APLO-0018-WO therapeutic session parameters and may also be used to move the session from segment to segment, such as one segment when traffic is moving, and another when traffic is at a crawl.

[0263] In embodiments, the segments of the stimulation may each be defined by one or more parameters. In generating each segment, a value for each of the variable parameters may be assigned for each segment. Data regarding an event to be experienced by the user may be communicated to a computer processor that is configured to create therapeutic session parameters. The therapeutic session parameters may be created by assigning a set of contiguous output segments for the event, and based on the event, assigning a parameter to each output segment. A transducer generates the transcutaneous vibratory' output for the therapeutic session based on the therapeutic session parameters, such as upon receiving the therapeutic session parameters from the computer processor. The therapeutic session parameters may be generated through machine learning of past responses to past events and past stimulations useful in reaching a goal state during or in spite of the event.

[0264] In embodiments, the segments may commence immediately after a prior segment has ended, or the stimulation may ramp up or taper down in at least one parametric aspect between segments. In embodiments, one or more of the variable parameters for each segment may be programmed in accordance with a target state, wherein programming may take advantage of a lookup table, may be based on transcutaneous vibratory' output that previously successfully facilitated entry into the target state for the subject, may be done in real time in accordance with sensor feedback, may be done manually, or the like.

[0265] In some embodiments, the therapeutic session may be accompanied by other therapies or associated interventions, such as the delivery of compounds (e.g., pharmaceuticals, psychoactive agents, etc.), playing of music, back massage, release of certain aromas, dimming of lights, or the like.

[0266] In order to effectively provide stimulation, the device 102 and / or associated algorithm(s) may first be calibrated. Calibration may proceed in a number of ways, as will be described. In one aspect, calibration may comprise establishing characteristics of a baseline, non-stressed state and a health index, or signatures of various non-baseline states. For example, through initial use of the stimulation device and continuous recording of various parameters associated with the user, either through embedded or associated sensors, the user may indicate when they are stressed and non-stressed so that the algorithm associates the stored parameters with the identified states for future recall. Based on the health index, a range of frequencies may be delivered in response. For example, one range may be useful for treating depression while another range may be useful for facilitating sleep. In anPATENT Attorney Docket No. APLO-0018-WO embodiment, periodic or continuous monitoring of the baseline state and health index may enable fine-tuning the calibration in order to customize, individually and temporally, the range of frequencies delivered in response.

[0267] Another method of calibration to be able to detect stress-related transitions and unwanted stress may be to actively encourage entry into a particular state (e.g., resting, stressed, fatigued or other user-specified states) by delivering a particular stimulation known to provoke the state then storing the characteristics of the user after delivery of the stimulation and entry into the particular state for future reference. Confirmation of entry into the state may be done by the user or via sensor input. In another embodiment, a user may be encouraged to enter a relaxed state, such as by use of a mindfulness application, a meditation application, and / or stimulation, then delivery of a different stimulation known to provoke a state may be done and the user characteristics learned and associated with the state. For example, the user may be exposed to stimulation known to provoke increases in sympathetic tone and decreases in parasympathetic tone in order to provoke entry into a stressed state where the device 102 can learn the characteristics of that stressed state.

[0268] In one method of passive calibration, the user may be exposed to a range of stimulation patterns and then sensed parameters are used to determine if the user has reached a target state. After repeated attempts, the best calming pattern and the best arousing therapy pattern may be selected. In another method of passive calibration, a first transcutaneous vibratory output is delivered to a user with parameters. The parameters of the first transcutaneous vibratory output may be selected after determining a desired target state of a user, such as selected from a database or selected by prediction. After or during delivery of the first transcutaneous vibratory output, data, such as physiologically sensed data or user input, are used to determine if the user has reached a target state. Modifications may be made to the transcutaneous vibratory output in the course of this passive calibration to generate a second transcutaneous vibratory output. Then, the second transcutaneous vibratory output is delivered to the user with second parameters, and data are again used to determine if the user has reached the target state. Based on the effectiveness of the first and second transcutaneous vibratory outputs, a processor may be used to select one of the first or second transcutaneous vibratory outputs to be used going forward in assisting the user to achieve the target state. In embodiments, the processor may select neither of the first nor second transcutaneous vibratory outputs in favor of continuing to iteratively modify the transcutaneous vibratory- output in order to find a set of transcutaneous vibratory output parameters that are effective in assisting a user in reaching a target state.PATENTAttorney Docket No. APLO-0018-WO

[0269] In an embodiment, a plurality7of transcutaneous vibratory outputs may be selected based on a desired target state to be used in a calibration session. During or after emitting each of the plurality of transcutaneous vibratory outputs in a corresponding session, such as with an electronic transducer in contact with the portion of the user’s body, data may be obtained regarding whether a user has achieved the desired target state in each of the corresponding sessions (e.g.. with a physiological sensor or from user input). Upon determining the effectiveness of each of the plurality of transcutaneous vibratory outputs based on the data, one of the plurality of transcutaneous vibratory outputs may be selected as effective for assisting with entry7to the desired target state for the user. The selected transcutaneous vibratory output may then be communicated to a database, the database comprising other transcutaneous vibratory outputs determined to be effective for the desired target state. The database may be accessed to identify other effective transcutaneous vibratory outputs. One or more other effective transcutaneous vibratory7outputs may be selected from the database to be emitted with the electronic transducer. The plurality7of vibratory outputs may be from one user, but in other embodiments, the database may store the vibratory outputs (and those deemed effective for a plurality' of users) and thus be used to improve the effectiveness for multiple users. Utilizing broad population data, such as aggregated data from other users, may assist with detecting situations or conditions that will lead to deviations in state / mood where applying vibratory output can prevent it from happening in the first place. For example: if traffic is predicted or detected, applying vibration to users who are stuck in traffic can prevent the deviation of heart rate from happening at all. The device may be triggered to start the vibration automatically without the per-user biometric signals and upon the prediction and / or detection. Other cues, such as location, calendar, social media interaction, activities or lack thereof, etc., for a single user, correlated to aggregated user data, may be leveraged to trigger the device.

[0270] In personalized passive calibration, periodic measurements may be taken at different time points of the day for a period of time after the user begins using the device 102. The measurements may be done by one or more sensors, such as physiological sensors, cameras, microphones, or the like, along with data collected from the user’s manual adjustment of device operation. For example, the physiological parameter sensed by the sensors may be movement, heart rate, GSR, temperature, and the like. The assessments over the course of a period of time, such as the first week of use. may be used to determine a user’s baseline state.

[0271] In embodiments, the intensity of calibration may be determined using aggregated data. Data aggregated across a plurality of users, which may be optionally cohort-segmented.PATENTAttorney Docket No. APLO-0018-WO may be used to determine baseline population-level calibrations. Many users may respond in a known way to a certain intensity / frequency / beat, and that certain intensity / frequency / beat may be used as a starting point for programming a stimulation. For example, if it is found that most users respond to a 30% intensity at a given frequency in a given situation, that could be the starting point for calibration that feeds other per-user calibration methods.

[0272] In any of the embodiments described herein, a user's baseline state may be calculated based on readings from one or more sensors, those sensors being described herein. The baseline state may be determined for a user for a period of time in a day, such as a morning baseline versus an evening baseline. In some embodiments, in addition to using sensor readings to establish a baseline state, the user may be prompted to provide information or ratings about their mood, such as into a user interface of a mobile device. Mood information may be used to confirm a sensor-based establishment of baseline or as another data point in the establishment of the baseline state. In yet other embodiments, the baseline state of the user may be additionally based on contextual data received from a mobile device of the user. The contextual data may be indicative of an amount of usage of the mobile device. The contextual data may be keystrokes input into the mobile device. The contextual data may be indicative of a mood of the user (e g., negative, positive, frustration, anger, anxiety7, distracted, etc.). The contextual data may be the content of social media posts, wherein the content is used to indicate a mood of the user (e.g., negative, positive, frustration, anger, anxiety, distracted, etc.). In yet still other embodiments, physiological data, user input, facial recognition data, contextual data, or any combination thereof may be used to establish a baseline state of a user. In this way, one person’s baseline state can be different from another’s baseline state.

[0273] The system may save baseline state data to a user profile that the system may access to set parameters (such as duration and timing, frequency and / or intensity ) when applying stimulation to that user in the future. The system may' continue to collect new data as the user uses the device, and it may supplement the user profile with that data and / or replace the oldest data with new data as it is received.

[0274] Continued measurement with a sensor may be used to determine a deviation from the baseline state. Deviation from the baseline state may indicate that the user is experiencing a stressor. Deviation from the baseline state may be detected by a change in a sensor reading or a change in a group of sensor readings. For example, the deviation may be a one standard deviation shift from the user’s baseline. In response, a downstream action may be triggered,PATENTAttorney Docket No. APLO-0018-WO such as commencement of therapeutic stimulation, selecting a particular transcutaneous vibratory output to deliver, or triggering a request to commence therapeutic stimulation.

[0275] Depending on the magnitude of the deviation from baseline, an appropriate transcutaneous vibratory output given the user’s current state may be selected. For example, if the user is only experiencing a one standard deviation shift from the user’s baseline, the transcutaneous vibratory output selected may commence at a lower intensity in order to reach a target state than if the user was experiencing a greater shift from baseline. In another example, a smaller shift from baseline may require a shorter duration stimulation than if the user is far from baseline. Knowing where the baseline is and how far from baseline the user is currently at, transcutaneous vibratory' outputs can be dynamically selected to assist the user to reach the target state from whatever their current state is. If the user does not reach the target state with the first transcutaneous vibratory output selected based on the personalized passive calibration, a second transcutaneous vibratory' output can be selected and generated for application to the user in an effort to assist them in reaching the target state. Transcutaneous vibratory outputs may also be dynamically selected to avoid habituation.

[0276] Personalized passive calibration may be embodied in a system comprising the stimulation device as described herein, a physiological sensor of the stimulation device periodically measuring data of at least one physiological parameter of the user, and a processor in electronic communication with a mobile device and the stimulation device. Referring to Fig. 4, the processor may be programmed to (i) determine a baseline state of the user based on periodic measurements from the sensor of at least one physiological parameter of the individual 1320; (ii) determine a deviation from the baseline based on the data of at least one physiological parameter of the user from the sensor 1322; (iii) based on the deviation, determine a transcutaneous vibratory output to apply to a portion of the user’s body to achieve a target state 1324; and (iv) communicate the determined transcutaneous vibratory' output to the stimulation device 1328. Based on the communicated determined transcutaneous vibratory output, the transducer of the stimulation device generates the transcutaneous vibratory output to be applied to a portion of the user's body. The processor may be further programmed to determine a baseline state of the user by prompting the user to input data of the user’s mood into the mobile device or by using contextual data or combinations thereof, as described herein. In any of the embodiments described herein , the processor may be further programmed to determine whether the user has achieved the target state (e.g., via sensor or user input), and if the user has not achieved the target state, cause thePATENTAttorney Docket No. APLO-0018-WO transducer to generate a second transcutaneous vibratory' output to be applied to a portion of the user’s body to assist the user in achieving the target state.

[0277] Continued collection of baseline data may be stored to form a longitudinal data set. Iterative, real-time tuning and optimization of the delivered frequency may be based on the longitudinal data. For example, if the user’s baseline changes over time, therapeutic stimulation is accurately triggered only when there is a deviation from the new baseline. Continuing with this example, as a user progresses with use of the device 102 and the baseline alters, perhaps to a calmer baseline state, the therapeutic stimulation protocol used upon a detection of a deviation from baseline may need to be varied in an aspect (e.g., frequency, intensity', and / or duration) in order to affect the user’s state.

[0278] As indicated previously, determining an individual user’s sensory threshold may be done via: a) calibration, as described herein; b) active data collection (via brief survey questions in-app); c) passive data collection (via monitoring mobile device and app usage to determine how far the user backs down stimulation or how much the user increases it); and the like. In embodiments, a sensory threshold may be determined for a user, such as via a calibration test. The sensory threshold may be manually adjusted by the user. The intensity of treatment frequencies may be delivered within one standard deviation from the sensory- thresholds. The low er sensory threshold may be the level at which the vibration is barely noticeable when the user pays attention to it, but it is not distracting and fades into the background when the user attends away. The upper sensory threshold is where the stimulation may be distracting. Establishing a lower sensory threshold may be done by delivering a transcutaneous vibratory output to a portion of a user’s body and gradually reducing an intensity of the transcutaneous vibratory- output until the user indicates that it is barely noticeable, such as by using a user interface of a stimulation device or an application controlling a stimulation device. Establishing an upper sensory threshold may be by delivering a transcutaneous vibratory output to a portion of a user’s body7and gradually increasing an intensity of the transcutaneous vibratory output until the user indicates that it is distracting, such as by using a user interface of a stimulation device or an application controlling a stimulation device. Alternatively, the user may establish the lower and upper sensory- thresholds themselves by manually adjusting an intensity of a stimulation until it is barely detectable on the low er end or distracting on the upper end, wherein the final values of the adjustment are stored as the sensory thresholds.

[0279] Delivery of stimulation may be configured such that it does not exceed a sensory threshold, is at or within one standard deviation from the sensory threshold, or some otherPATENTAttorney Docket No. APLO-0018-WO point relative to the sensory threshold such that it cannot be felt or is not too distracting or uncomfortable. If the parameters of the stimulation are varied to generate a second stimulation, as described in various embodiments herein, the second stimulation may also be configured such that it does not exceed a sensory threshold, is at or within one standard deviation from the sensory threshold, or some other point relative to the sensory threshold such that it cannot be felt or is not too distracting or uncomfortable.

[0280] Delivery of therapeutic stimulation may take advantage of the sensory thresholds, such as for example to deliver stimulation that tapers. The intensity of tapered stimulation may start at an upper end of a sensory threshold and decrease to a barely detectable level over a first period (such as approximately 2 minutes to 15 minutes) at a rate (e.g., approximately 10% per minute). In embodiments, the intensity may remain at the final level for the remaining duration of stimulation (e.g., for another 15-25 minutes).

[0281] After the taper, stimulation may automatically turn off after a period of time (e.g., after the primary frequency has been applied at its lowest level for a period of time. After the taper, stimulation may automatically turn off after the total cycle (from starting value to lowest level) has been applied for a period of a period of time (e.g.. at least 30 minutes). The intensity of the stimulus may remain at or within 1 standard-deviation of the medians of users' sensory threshold to provide the desired results.

[0282] Treating disorders related to a hyperarousal of the autonomic nervous system may include obtaining input of a hyperarousal disorder and a subject’s sensory threshold for transcutaneous vibratory output. The input of the hyperarousal disorder may be obtained with a user interface in communication with a processor. Alternatively, input of the hyperarousal disorder may be obtained through sensed data or third-party data. The user's sensory threshold is determined as described herein. Based on the hyperarousal disorder, the processor may select a stimulation pattern for transcutaneous vibratory output to be emitted by a transducer of a stimulation device. The computer processor may7cause the transducer to generate the transcutaneous vibratory7output in the selected stimulation pattern at a sensory7threshold value at or above the subject’s sensory7threshold for transcutaneous vibratory7output.

[0283] To decrease symptoms of hyperarousal disorders, layered oscillations may start at a higher frequency that corresponds to a current energy7level of the user, and taper down to slower oscillations that correspond to an upper threshold level of energy7associated w ith deep relaxation and / or somnolence (the goal state in this case). For example, a baseline oscillation may start at a starting value (such as 100 Hz) that is established by any suitable means, suchPATENTAttorney Docket No. APLO-0018-WO as by being a default, or based on a user-selectable input, or based on the user’s response to certain questions such as ‘"how do you feel,’7or based on data collected from the user's mobile electronic device and / or a wearable device having sensors such as accelerometers. Different inputs may be associated with different starting values, such as by a lookup table, or by an algorithm that considers combinations of input details.

[0284] In one embodiment, the frequency could decrease from the starting value (e.g.. 200 Hz) at a rate of approximately 5-10 Hz every 10-20 seconds (approximately) until it reaches an upper threshold (such as approximately 40 Hz) level. Some parameters may remain at the upper threshold for a holding period (stabilization phase), such as approximately 60 seconds. The frequency may then decrease at a rate of approximately 1 Hz every 10 seconds (approximately) until it reaches a second threshold (stabilization phase) that is less than the first threshold (such as approximately 30Hz, or approximately 75% of the first threshold). The frequency may remain at the second threshold for the holding period. After that, the frequency may decrease at a rate of approximately 1 Hz every 10 seconds (approximately) until it reaches a third threshold that is lower than the second threshold (such as 20 Hz. or approximately 50% of the upper threshold) and remain at 20 Hz for an effective period (such as approximately 20 minutes). This effective period may be determined in part by the software time limits (minimum: 5 minutes / maximum: 60 minutes) and / or in part by the user.

[0285] By way of example, a frequency starting at approximately 100 Hz may be available as an option with the longest / slowest taper (e.g.. a 60-minute cycle), approximately 40 Hz may be considered to be an average starting point for one parameter (e.g., a 30-minute cycle), and approximately 33 Hz may be considered to be one parameter’s starting point for the shortest / fastest taper (e.g., a 10-minute cycle). Parameters may also taper independently or in tandem. One iteration of this for rapid relaxation could have one parameter starting at 200Hz and tapering to 40Hz over the course of 5 minutes and then stabilizing at 40Hz for another 10 minutes, while another parameter starts at 2Hz and tapers to 0. 1Hz gradually over 15 minutes. In each case, the value of the difference may taper over time so that the primary and secondary oscillations are very close together, such as a difference of approximately 0.0001 Hz. before each frequency reaches zero. Optionally, the second parameter’s tapers may have a longer period than the first’s taper because they may take the user through more arousal states prior to finally arriving at the desired effect, especially if the user was more symptomatic prior to using the device. In general, for each frequency, the greater the speed of the taper (the less time spent in each frequency state), the quicker the user is likely to transition from symptomatic to asymptomatic.PATENTAttorney Docket No. APLO-0018-WO

[0286] The stimulation works by increasing the balance between the sympathetic and parasympathetic components of the autonomic nervous system, which is required for optimal functioning of the human body. One way in which the stimulation device 102 may deliver treatment therapy is by acoustic and / or vibration induced stimulation to increase parasympathetic activity, inhibit sympathetic activity, increase sympathetic activity, and / or inhibit parasympathetic activity, collectively referred to as modulation of the autonomic nervous system. The above frequency ranges are provided for example purposes only and may be adjusted or tuned for a subject based on the subject’s physiological reactions using a feedback loop, as described below. Specifically, the above frequencies may be personalized to a subject based on biometric data collected by the sensor device 118 (e.g., heart rate, heart rate variability, blood pressure, respirations, sweat level, resting pulse rate, brain activity, etc.) and / or based on user feedback.

[0287] In general, the increase in parasympathetic and sympathetic nervous system balance that results from the application of low frequency sound (or vibration) is perceptible and can be monitored in real time, thereby permitting careful monitoring of the result, and modulation, control, or withdrawal of the stimulation as necessary. In certain embodiments, the results may be presented to a subject by, for example, the user interface and / or via an application on a user device. Furthermore, a treatment plan may be designed in which either continuous or pulsed delivery of low frequency sound is carried out over a period of days, weeks, months, or even years, depending on the particular circumstances of the subject being treated.

[0288] Therapeutic stimulation may facilitate entry into a sleep state. Most people experience difficulty falling asleep and / or staying asleep at some point in their lives. Sleeplessness may occur in reaction to stressful events in a person’s life, during travel when normal body rhythms are disrupted, in response to the person engaging in stimulating activities before bedtime, or for other reasons. Many people repeatedly experience sleeplessness over multiple nights during a week, and such a condition may be considered to be acute insomnia. If this pattern continues over multiple months, it may be considered to be chronic insomnia.

[0289] It has been estimated that 25 to 30 percent of humans experience acute insomnia each year. Because of this, many treatments are offered to help treat insomnia. These treatments range from pharmaceutical treatments such as benzodiazepine and nonbenzodiazepine sedatives as well as natural interventions. Many pharmaceutical treatments can cause unwanted side effects, must be monitored for interaction with other drugs, and canPATENTAttorney Docket No. APLO-0018-WO cause sleepiness to continue past the person’s desired sleep time. Non-pharmaceutical treatments, such as bright light therapy and cognitive behavioral therapy, can be timeconsuming and require a significant amount of self-discipline by the person to continue the course of therapy. Accordingly, better ways of treating insomnia and other forms of sleeplessness are desired.

[0290] This disclosure provides a method and system for treating sleeplessness by applying and removing vibratory or sonic stimulation to the human body in a pattern that increases balance between the sympathetic and parasympathetic components of the autonomic nervous system. The stimulation may improve parasympathetic nervous system activity7, thereby balancing activity7in the autonomic nervous system, by activating afferent sensory nerve fibers in the skin and deep tissue that network with the parasympathetic nervous system in the spinal cord and brain, to include the Vagus nerve and its collaterals as a primary component. This improvement in parasympathetic activity7results in a reduction of aberrant or unwanted activity in the sympathetic nervous system activity7.

[0291] Terminology that is relevant to this disclosure includes the term “sleeplessness”. Sleeplessness includes general physical conditions in which a person exhibits an inability to fall asleep and / or to remain asleep for more than a brief period of time (such as only one to three hours). “Insomnia” refers to a condition in which a person experiences sleeplessness multiple nights per week. Chronic insomnia is insomnia that occurs at least three nights per week and lasts at least three months. Insomnia that persists for a lesser period of time may be considered to be acute insomnia.

[0292] To induce deep relaxation and / or somnolence leading to sleep in a subject who is awake, the transcutaneous vibratory output may start at one combination of parameters that corresponds to a current energy level of the user, and taper to a combination of parameters that corresponds to an upper threshold level of energy associated with deep relaxation and / or somnolence.

[0293] In some embodiments, transcutaneous vibratory output may be caused to commence automatically, such as at a certain time or in response to a sensor worn by or in proximity7to the user providing data to a processor indicating that they are in a pre-sleep state. For example, an accelerometer may indicate slowing or no motion indicating a readiness for sleep.

[0294] In some embodiments, the stimulation pattern may be matched to the sleep state. For example, if the accelerometers indicate a slowing in activity but other indicators suggest the user is ready for sleep but not asleep yet, particular relaxing frequencies may begin to bePATENTAttorney Docket No. APLO-0018-WO emitted to ease the eventual transition to sleep. If the sensor indicates that the user has reached the almost asleep state, a second alteration of the stimulation pattern may be triggered and maintained for a selected period of time or until sensors indicate a change in the user’s sleep state that may require another alteration in the stimulation pattern. For example, during sleep, an accelerometer may sense motion during a bad dream and a stimulation pattern may be triggered to encourage re-entry into a sleep state.

[0295] In some embodiments, the user interface of the system may include an input field in which a user can select modes that will increase or decrease the speed by which the frequencies taper from the upper starting point to the lower ending point. For example, a user who wants to fall asleep very quickly may select a mode in which the frequencies taper on the more rapid end of the spectrum, while those who are winding down (de-escalating) more slowly or who are more highly energized before bed may choose to have a frequency taper on the more delayed end of the spectrum. The user may make this selection by a slider or dial, by entering numeric values, or by selecting from one of various modes (in which each mode will have various times and thresholds assigned to it).

[0296] In some embodiments, as the frequency of the vibration tapers down, the intensity of the vibration is also tapered from a more intense value to a less intense value or the opposite. That is to say parameters can be modulated independently of one another. The device may do this by decreasing the current applied to the transducer’s coil as the device also reduces the sonic emissions’ frequencies. The intensity of the oscillations may start at the upper end of a sensory threshold (at which the user would have a harder time ignoring the vibration). The intensity may then decrease to a barely detectable level (at the bottom end of the sensory threshold) over a first period (such as approximately 15 minutes) at a rate (e.g., approximately 10% per minute). The rate may be measured from the level that existed during the previous minute. The intensity may remain at the final level for the remaining duration of stimulation (e.g., for another 15-25 minutes). Shorter time periods may be used if fewer thresholds are used. In other embodiments, the intensity of the stimulus may remain at or within 1 standard-deviation of the medians of users' sensory threshold to provide the desired results.

[0297] The stimulation may automatically turn off after a period of time, such as after the primary frequency has been applied at its lowest level, or after the total cycle (from starting value to lowest level) has been applied for a period (e.g., at least 30 minutes). Other time values may be used to trigger the automatic shut-off. The vibration may remain on for a longer period associated with a desired rest or treatment period (such as 6 hours, 7 hours, or 8PATENT Attorney Docket No. APLO-0018-WO hours), or can continue until the user wakes up and turns the vibration off. Optionally, the system may default to shutting off after an initial cycle (such as 20-30 minutes) unless a sensor device that is in communication with the stimulation device 102 or its controller provides data showing that the user is not yet reached a desired measurable biometric state (such as a target breathing rate, heart rate, pulse, movement, etc.). Such data may include data from a body movement sensor worn by the user indicating that the user is moving or has moved more than a threshold level during a specified period of time just before the end of the sleep cycle (e.g., 1 minute before the end of the sleep cycle, 3 minutes before the end of the sleep cycle, etc.). The body movement sensor may also indicate that the user is no longer moving, which may be an indication that the user has fallen asleep, and the stimulation may be discontinued, tapered down at a faster rate, or switched immediately to a level for sleep maintenance.

[0298] Optionally, the vibrations may be initiated within 1 hour before the user desires to fall asleep. However, the stimulation may begin to induce states of relaxation and somnolence in as little as three minutes. The stimulation may be effective when the primary frequency’s is applied in combination with the modulation frequency for a duration, such as at least 15 minutes. In some embodiments, a sleep mode may apply the stimulation for a predetermined duration (e.g., 30 - 40 minutes). The system may enable the user to select the duration of the program in some embodiments.

[0299] In an example, if a user is out-of-sync with their circadian rhythm (due to disruptions to sleep, travel across time zones, or other conditions), the transcutaneous vibratory stimulation could help them get back in sync by continuing to run a routine that retrains their body to adjust to their circadian rhythm.

[0300] In examples, the tapering rate may be user-customizable and adjustable. The upper threshold frequency may be user-set based on a current activity, a current user-indicated feeling, a desired feeling, a lookup table, or by an algorithm that considers combinations of input details.

[0301] In embodiments, the therapeutic stimulation may increase from a starting value and ramp up to a target value. The target value may be selected to correspond with a therapeutic goal, may be an upper threshold frequency, or the like. Ramping up may be done via a rate over a period of time, wherein the rate itself may be variable or ramped in speed. As many segments of ramping up to incrementally higher values at the same or a different ramping rate may be used in order to reach the highest value. In embodiments, once the target value isPATENTAttorney Docket No. APLO-0018-WO reached, it may be maintained for a second period of time or until it is caused to be terminated or tapered down, such as in response to sensor feedback or via a manual input.

[0302] In an embodiment, the system may be able to predict the onset of a state for a user, such as an emotional state. Various emotional states include anger, fear, annoyance, sadness, anxiety, apathy, frustration, distracted, or the like. Predicting the onset of the state may cause the system to address the user's current state or avoid the predicted state. Addressing or avoiding may involve a stimulation protocol being triggered, such as a stimulation directed at mitigating the onset of the state or treating the state. The user’s predicted state may be determined by electronically sensing at least one of a physiological state of the user or a contextual data of the user. In some embodiments, the predicted state may be determined by electronically sensing the physiological state of the user and collecting the contextual data of the user. The physiological state may be sensed with a sensor of a wearable device. Information from the sensing wearable and / or third-party sources (e.g., social media) may be used to determine the user's condition, and coordinate delivery' of appropriate stimulation therapy.

[0303] In an example, the sensor may determine HRV. In another example, the sensor may be an audio sensor that senses vocal data, such as a yawn, a sigh, a yell, a vocal pitch, a vocal tone, a speaking speed, a vocal volume, an acoustic characteristic, or the like. The contextual data may be sensed or collected from a device separate from the wearable device (e.g., smartphone, fitness monitor, smart watch, smart speaker, smart eyewear, connected vehicle, smart headphones, etc.), a social media platform, an environmental sensor, third party data, or the like. For example, social media posts may be analyzed to derive indicative of a mood of the user (e.g., negative, positive, frustration, anger, anxiety, distracted, etc.). In another example of contextual data, the user’s movement or location data may be sensed or collected, such as from a mobile device of the user. The system may determine if the user’s location is indicative, or predictive, of the mood of the user. Other contextual user data may include calendar entries, project management entries, social media content, screen time, or a current sensed activity (e.g., flying, commuting, in traffic) to modify an aspect of the stimulation, trigger, or discontinue the stimulation. In embodiments, various metrics of user activity may be extrapolated from the contextual user data, optionally in combination with other data, to obtain a signature of data associated with the user for when they feel that life is great (which may be a goal or target state for the user), when they feel poorly, or any state in between. This life signature, which may be a personalized goal state, may be monitored by the system to predict when the user’s overall mood or feeling of well-being is beginning to decline, suchPATENTAttorney Docket No. APLO-0018-WO as when their life signature begins to move away from great and towards poor. Upon detecting a predicted or actual decline, the system may trigger stimulation that may be targeted at mitigating further decline and / or supporting positive feelings. One such example of a detectable pattern contributing to a declining life signature would be when consistently poor sleep is detected via wearable actigraphy.

[0304] A signature for various other personalized goal states may be developed using sensed or collected data as described herein (e.g., physiological, contextual, environmental, etc.), such as a running goal state / signature, a sleep goal state / signature, an at-work goal state / signature, a performance state, a relaxed state, a focused state, or the like. In one method of establishing a personalized goal state, while receiving a first transcutaneous vibratory output to achieve a desired target state, the user may provide feedback on if they have reached the target state. A user interface may be used by the user to select a target state or input the data regarding whether the user has achieved the desired target state. If the user has achieved the desired target state, at least one of contextual or biometric data of the user may be obtained while the user is in the target state. Biometric data may be obtained with an optionally wearable electronic sensor. Obtaining the contextual data may include receiving data from third-party applications. The at least one of contextual or biometric data of the user while the user is in the target state may be stored, such as in a user profile, as a baseline or personalized goal state. The personalized goal states may be stored in a user profile along with any other additional data, such as identifying data associated with the state and stimulation parameters. A particular stimulation pattern and parameters for its delivery may be associated with maintaining or encouraging entry into the personalized goal state. Continuing with the method, the user’s contextual and / or biometric data may be collected again, periodically, or continuously, and used to determine if the user is not in the baseline state. If the user is determined to not be in the baseline state, a transcutaneous vibratory output aimed at assisting the user to achieve the state is generated for application to a portion of the user's body. Either of the first or second transcutaneous vibratory output may be emitted with or through an electronic transducer.

[0305] When a predicted state is identified, delivery of a therapeutic stimulation pattern may be triggered, discontinued, modified, tapered, or ramped up. The system may generate or trigger a transcutaneous vibratory output to be applied to a portion of the user’s body, such as with a wearable device, to assist the user in at least one of addressing or avoiding the predicted state. As described herein, the transcutaneous vibratory output may be generatedPATENTAttorney Docket No. APLO-0018-WO from variable parameters and can be dynamically modified based on, for example, the predicted emotional state, a physiological state, or contextual data.

[0306] Triggering may be sufficiently in advance of the actual onset of the predicted state such that the stimulation results in avoidance of the predicted state. In embodiments, when the estimated state is determined, a notification may be triggered to a user. The notification may include a suggestion that a therapeutic stimulation protocol be commenced, wherein the user may choose to manually commence the protocol. A response to the stimulation (e.g., from sensors in wearable), movement data, and / or a manual / behavioral response to the therapeutic stimulation (e.g., turning off the stimulation, increasing intensity, changing settings) may be used as feedback to the system. The feedback may be used to identify a current physiological state of the user and may be used to dynamically modify the variable parameters

[0307] In certain embodiments, the system may use any now or hereafter known machine learning algorithms to define new stimulation patterns and / or update existing stimulation patterns for a user based on collected biometric data, user’s manual adjustment in response to stimulation applied to the user (either for training the system and / or in real time), or the like. In some embodiments, the system may utilize machine learning with sensor data to predict an estimated state and may cause or trigger an action in response to a new7predicted state. Machine learning may utilize training data from users that includes sensor data, including point, trend, and longitudinal data, associated with known states. An algorithm may use the training data to learn the correlation between the sensor data and the state and be able to predict what the user’s state is or that the state is imminent. For example, sensor data, for training, validation, or use, may include any of the sensor data types described herein, including GSR, Heart Rate, HF-HRV, HRV interval, other HRV parameters (LF, IBI, Total power, LF / HF ratio, RMSSD, etc.), blood pressure, brain waves (EEG), facial recognition, vocal cues, mobile device usage data, facial recognition, and the like. Machine learning may be used to leam a user’s baseline state and predict that the state is changing or has changed, and in embodiments, what the new state is, such as anxious, drowsy, awake, or the like. In embodiments, when the estimated state is predicted, a therapeutic stimulation protocol may be triggered. Triggering may be sufficiently in advance such that the stimulation results in avoidance of the predicted state. In embodiments, when the estimated state is determined, a notification may be triggered to a user of the state. The notification may include a suggestion that a therapeutic stimulation protocol be commenced. A biometric response to the therapeutic stimulation (e.g., from sensors in wearable), movement data, and / or aPATENTAttorney Docket No. APLO-0018-WO manual / behavioral response to the therapeutic stimulation (e.g., turning off the stimulation, increasing intensity, changing settings) may also be used as seeds for machine learning.

[0308] In an embodiment, delivery of stimulation described herein may be paired, coordinated and / or synchronized with one or more other sensory stimuli 122, such as touch, visual stimulation / sight, sound, olfactory' stimulation / smell, taste, electrical, or the like. For example, with a stimulation device, a first transcutaneous vibratory output to be applied to a portion of the user’s body may be generated. In some embodiments, the sensory stimulation 122 may be applied with the stimulation device or may be in a separate device. The stimulation device may include both a transducer and a sensory output device. In embodiments, a condition of the user may be assessed. Based on the condition, one or more aspects of the stimulation and / or paired sensory stimuli may be selected or altered. In an embodiment, the sensory’ stimulation may be based on at least one of the assessed condition of the user or the selected beat output pattern.

[0309] In any of the aforementioned embodiments, the transcutaneous vibratory’ output maybe applied concomitantly with a treatment modality (e.g., psychotherapy, physical therapy, mindfulness activity), wherein the treatment modality is based on the condition of the subject or a target state of the subject. In these embodiments, the transcutaneous vibratory output may act synergistically w ith or augment the treatment modality' to achieve a positive outcome or enhance engagement in the treatment modality. An application for guided mindfulness may include a facility for programming and / or initiating delivery of a stimulation therapy and guiding the user through a series of mindfulness prompts, such as guided auditory sessions, during the delivery'. The application may prompt the user periodically regarding initiating a delivery' of stimulation therapy as part of the guidance. The application user interface may visually depict biometric changes the user experiences during the guidance.

[0310] Medical treatments such as prescription drug therapy are widely used to treat various medical conditions and disorders. Many prescription drugs produce side effects and adverse reactions in subjects, which can lead to considerable discomfort and poor quality of life. While such drugs may attenuate a certain disorder, they may exacerbate other disorders. For example, side effects of various drugs may be sleep disorders, loss of appetite or other eating disorders, depression, stress, hypertension, digestive issues, pain, cognitive impairment, etc. Similarly, other medical treatments (e.g., hospitalization, surgery, inpatient procedures, psychotherapy) may also produce side effects such as stress, depression, sleep disorders, hypertension, etc.PATENTAttorney Docket No. APLO-0018-WO

[0311] At least some of these side effects may be caused due to an imbalance between the sympathetic and parasympathetic branches of the autonomic nervous system (ANS). As such, ways for monitoring the side effects of a medical treatment and mitigating the same by stimulating the sympathetic and / or the parasympathetic branches of the ANS are desired.

[0312] In one or more embodiments, the system 100 may be used to address physiological and / or psychological aspects of a subject’s functioning that may be attributed to a medical treatment (e.g.. drug side effects, effects of psychotherapy, inpatient procedures, etc.). This may include determining what aspect of a subject’s functioning have been affected by the medical treatment being administered by collecting physiological data from a subject using a sensor device, analyzing, and comparing the physiological data to a baseline state of the subject, and applying vibrational energy to the subject at an appropriate frequency, intensity, duration, etc.

[0313] In one or more embodiments and referring to Fig. 5, the baseline state of a subject may correspond to the state of a subject prior to the start of a medical treatment (e.g.. before drug therapy is started, before hospitalization, etc.), and may include physiological data (corresponding to measurable physiological attributes) collected from the subject before start of the medical treatment 1502. Such physiological data may include, for example and without limitation, heart rate, blood metabolite concentrations, respiration rate, blood pressure, or other quantifiable data that may have a correlation with the potential side effects of the medical treatment. For example, some indications of stress include higher resting pulse rate, frequent sharp spikes in heart rate; shallow respirations, decreased movement for a threshold period of time; high blood pressure; high heart rate with low heart rate variability' (in the absence of physical activity ); sudden intense increases in sw eating (in the absence of physical activity), or combinations thereof. Therefore, if the potential side effect of a medical treatment is stress, the baseline state may include physiological data such as resting pulse rate, heart rate, rate of respiration, blood pressure, etc. Medical treatment may commence 1504 and the system may continuously and / or periodically collect physiological data 1508 from the subject upon start of the medical treatment and analyze it to determine if one or more of the above indications for stress are present 1510. If one or more data collected by the sensor device correlate to conditions of stress, vibrational energy at a beat frequency for alleviation of stress may be applied 1512 to the subject.

[0314] Alternatively, and / or additionally, some side effects may be acceptable during a medical treatment and / or the baseline may be different (that is they may be acceptable up to a certain level), and a user or a medical practitioner may define the baseline state accordingly.PATENTAttorney Docket No. APLO-0018-WO

[0315] A subject may be monitored to identify potential side effects or unwanted effects of a medical treatment during the administration of the medical treatment and / or for a predetermined time after completion the medical treatment. The indications of a side effect may be different and / or the baseline may be different during a medical treatment compared to those upon completion of a medical treatment.

[0316] In embodiments, delivery’ of stimulation described herein may be administered with a compound, such as a pharmaceutical compound, a psychoactive compound (e.g.. MDMA), a psychedelic (e.g., psilocybin), an anti-depressant, an anti-anxiety drug, an amphetamine, a medicament, a therapeutic agent, cannabis, or the like. In some embodiments, the stimulation may mitigate the negative side effects of the compounds, such as by attenuating the restlessness or anxiety associated with the compound and / or the therapeutic experience. In this embodiment, the stimulation device or an associated device may interpret changes in a parameter of a user’s state, which may be attributable to the compound, and then apply a stimulation that enhances or augments the benefit of the compound by mitigating its negative side effects and / or synergizing with or augmenting the beneficial or positive effects of the compound. In some embodiments, the administration of the compound and the stimulation may be done in a controlled session, such as a psychotherapy session. Mitigating the side effects of certain drugs, such as the restlessness that often accompanies many psychoactive drugs, may enhance their use in the psychotherapeutic treatment of certain disorders, such as PTSD or depression, and may enable patients to engage more effectively in therapy.

[0317] In practice, a drug or other compound may be administered to a subject in a therapy session, wherein the drug is one of a psychoactive compound (e.g., MDMA, psilocybin), a psychoactive compound, a psychedelic, a therapeutic agent, cannabis, or some other herbal or pharmaceutical compound or therapeutic agent. The subject may be monitored to determine if the effects of the drug are counterproductive to the therapy session (e.g., anxiety, restlessness). Monitoring may be done using sensors to generate biometric data of the subject or may be done by another participant in the therapy session. Sensors may be part of a stimulation device or may be part of another device or environmental. For example, a sensor may be used to determine HRV. which may be associated with anxiety. In another example, the sensor may be an audio sensor that senses vocal data such as a yell, a cry, an increased vocal tone, or the like.

[0318] Once determined that the drug is having a negative side effect, the stimulation device may be triggered to provide tactile stimulation to the subject during the therapy session, wherein the transcutaneous vibratory output and / or any of the underlying variablePATENTAttorney Docket No. APLO-0018-WO parameters are selected 1514 to reduce the undesirable or unwanted effects of the drug, and in some embodiments, may be based on the kind of effects being experienced. In the case where another participant is monitoring the subject for negative side effects, the stimulation device may be manually triggered to choose and / or deliver a transcutaneous vibratory output. In an embodiment, the vibratory parameters may be selected or altered based on the effects of the drug.

[0319] In addition to applying a stimulation to mitigate the negative side effects of certain drugs, a sensory stimulation may also be applied to the subject. The sensory stimulation may be one or more of a visual stimulation, an ol factory stimulation, a taste stimulation, a touch, or a sound, and may be selected based on the effects of the drug. Further, treatment may be coordinated with one or more other devices for treatment or measurement (e.g., blood pressure cuff, pulse ox, aural stim, light stim, music).

[0320] In this embodiment, and in any of the embodiments disclosed herein, the parameters of the applied transcutaneous vibrational energy (e.g., frequency, intensity7, duration, etc.) may be determined based on the physiological data collected by the sensor device 118. Typically, fast and high intensity7vibrations may cause an increase in heart rate, respirations, blood pressure, and sweat while decreasing heart rate variability. On the other hand, slow, gentle, low intensity vibrations may cause a decrease in heart rate, respirations, blood pressure, and sweat while increasing heart rate variability.

[0321] Furthermore, the parameter values and examples in this disclosure are provided for example purposes only and may be adjusted or tuned for a subject based on the subject’s physiological reactions and data using a feedback loop, as described herein. Specifically, the parameters may be personalized to a subject based on phy siological data collected by the sensor device 118 (e.g., heart rate, heart rate variability, blood pressure, respirations, sweat level, resting pulse rate, brain activity, etc.) and / or based on user feedback. Specifically, in various embodiments, data collected by the sensor device 1 18 may be used in a feedback loop to initiate and / or control the application of stimulus to the subject, via the stimulation device 102. Additionally, and / or alternatively, the data collected by the sensor device to select and personalize the application of stimulation to the subject 114 may be based on the data collected by the sensor device 118. For example, the frequency ranges, stimulation patterns, stimulation application times, stimulation application duration, or the like may be personalized to a user.

[0322] Furthermore, the underlying frequencies of the stimulation may be adjusted based on a subject’s response to the application of the vibratory output in a real-time manner. ForPATENTAttorney Docket No. APLO-0018-WO example, if the data collected by the sensor device 118 indicates that an initial stimulation did not alleviate the stress symptoms (e.g., the resting pulse rate did not decrease to a non-stress level), the applied frequencies / vibratory output may be gradually increased / altered until the desired effect is achieved. Alternatively, and / or additionally, if the data collected by the sensor device 118 indicates that the stimulation is reducing stress in a subject (e.g., the resting pulse rate slowly decreasing), the applied frequencies / vibratory output may be gradually tapered to a shutdown level.

[0323] In addition, user feedback may also be used to control the application of the stimulation (e.g., turning off, turning up intensity, changing settings, etc.)

[0324] In certain embodiments, the baseline state of a subject may also correspond to the state of an average person with similar physical attributes as the subject undergoing medical treatment (e.g., same gender, weight, height, BMI, etc.). For example, some indications of stress include, without limitation, a resting pulse of about 60 beats per minute (bpm) for a healthy man and greater than about 70 bpm for a healthy woman; frequent sharp spikes in heart rate; shallow respirations at a rate of greater than about 12 breaths / minute; decreased movement for a threshold period of time; blood pressure greater than 120 / 80 mm of Hg in a healthy male (in the absence of physical activity ); high heart rate with low heart rate variability7(in the absence of physical activity ); sudden intense increases in sweating (in the absence of physical activity); or combinations thereof.

[0325] In embodiments, external or secondary devices and services may be controlled based on current state or goal state achievement, such as determined by a sensor, external data source, or user input. Controlling the operation of third-party devices may be based on the predicted or actual state achieved based on the delivery of stimulation therapy. For example, when a user has reached a state, the stimulation device may be triggered to deliver a stimulation pattern and / or make an environmental adjustment, such as to turn off / on lights, change light color, change room temperature, commence / discontinue aromatherapy, lower / raise window shades, turn on / off music, trigger a secondary' stimulating device in a mattress / pillow, etc.). In another embodiment, when the user reaches a state upon having applied stimulation (e.g.. more alert), a vibrating car massage seat may be triggered. In another embodiment, when a user has reached a state of emergence from a nap, a red light may be illuminated with increased frequency to aid with exiting the nap. In another embodiment, when a user has reached a state, at least one of a content delivery setting or a content filter for applications and communications may be adjusted. The content filter may determine the types of content delivered to the user. The setting may be a do not disturbPATENTAttorney Docket No. APLO-0018-WO setting. In another embodiment, when a user has reached a state, a social media setting may be adjusted, such as a do not disturb setting or a content delivery setting. In another embodiment, when a user has reached a state, they may be prompted to perform a certain a task. In any of the aforementioned examples, controlling operations and services may result from the stimulation device or associated sensor or processor transmitting an instruction or trigger to another device / server or system controller. Alternatively, the other device or server may periodically check the stimulation device, associated sensor / processor, or remote location aggregating data from the same and determine if a triggering event or data point has occurred. In embodiments, the stimulation device may transmit data to a remote server or cloud location that can be accessed by third party devices or controllers to trigger actions.

[0326] In embodiments, the system may control the operation of third-party devices to achieve a state based on the delivery of stimulation therapy. For example, when a calming transcutaneous vibratory output commences, the system may instruct dimming of lights in the vicinity . Conversely, if a waking therapy begins, instructions may be sent to brighten lights and lift window blinds.

[0327] In an embodiment, another solution described herein is how to cause and track epigenetic changes as a result of employing the methods and devices described herein. There is growing evidence that epigenetic regulation of gene expression is related to trauma exposure, may be involved in the pathophysiology and treatment response in PTSD patients, and modifications in epigenetic regulation and the epigenome may be persistent and potentially inheritable by subsequent generations. Some of this evidence relates to methylation and acetylation patterns of certain genes, which is associated with regulating expression levels of the different portions of these genes, which are ultimately transcribed and translated into proteins. In some embodiments and referring to Fig. 6, applying a therapeutic stimulation to achieve a target state 1604 (e.g., mental presence, flow, optimal performance, relaxation, non-depressed, etc.) in accordance with this disclosure and either for a single time, intermittently, or repeatedly over a period of time, may result in the causation of or the priming for a measurable epigenetic change in the incidence of: a psychological state-, illness-, disorder-, trauma-, or stress-related regulation of certain proteins (e.g., stress hormones, receptors, receptor ligands, growth factors, and the like), a methylation / acetylation / phosphorylation pattern of a gene or histone, or the incidence of regulation of a reward response gene or protein (e.g., neurotransmitter, neurotransmitter receptors, ion channels, and the like), wherein regulation can be any of increasing levels, decreasing levels, silencing, and the like. Epigenetic markers may be measured before 1602PATENT Attorney Docket No. APLO-0018-WO and after 1608 transcutaneous vibratory stimulation in order to assess the epigenetic impact of the stimulation. The causation or the priming for epigenetic changes may be a result of the therapeutic stimulation itself, the achievement of the target state and the associated physical manifestations of the target state (e.g., achievement of a resonant frequency or resonant state, improved balance between the parasympathetic and sympathetic nervous system, increases in HRV, etc.), a mechanosensitive change in a receptor or receptor affinity’, a downstream effect of a mechanosensitive change in a receptor or receptor affinity, or some combination thereof. In the absence of measuring epigenetic changes directly as described herein (e.g., measuring the methylation or acetylation profile of certain genes pre- and post-treatment, measuring the levels of expression of reward response proteins or stress-related proteins, etc.), certain proxy measurements may be useful in extrapolating an epigenetic change. One proxy may be stress indicators in communications, such as social media posts, mobile device usage, texts, calls, or the like, such as the presence, absence, or frequency of positive or negative words used, or vocal tone / pitch / vocal rate related to the life signature. Another proxy may be a faster time to reach a target state after continued use. Another proxy may be a longer dwell in the target state. In embodiments, stimulation therapy targeted at causing an epigenetic change may be co-delivered with a sensory stimulus, physical therapy / massage, and / or a pharmaceutical treatment.

[0328] In some embodiments, the stimulation device can provide, enhance, or supplement sexual arousal. In embodiments, certain conditions of sexual dysfunction may be mitigated by use of the stimulation device 102. In some embodiments, whether it is to mitigate sexual dysfunction or to support a user’s desire to achieve sexual arousal, the stimulation device 102 and / or associated application may be programmed to deliver stimulation whose transcutaneous vibratory parameters are selected to cause a user to reach a target state of sexual arousal. Sexual arousal may be characterized by certain parameters, such as physiological parameters or biometric parameters. For example, a sexually aroused state may be identifiable based on a heart rate over 100 bpm, an HRV below 40, a high-pitched speaking volume, an increase in vaginal lubrication or blood flow (e.g.. as measured by vaginal photoplethysmography), an achievement of orgasm, an erectile state (e.g., as measured by a tactile sensor), discharge of seminal fluid, increased use of sexually suggestive words, and the like. Configuring the stimulation from the device 102 to achieve the target state of sexual arousal or maintain a current state of sexual arousal may comprise adjusting one or more of the variable parameters. Any of the parameters of the stimulation may be modified, either individually or in combination of two or more. Modification may includePATENT Attorney Docket No. APLO-0018-WO increasing or decreasing one or more parameter or timing of stimulation. For example, in assisting a target in reaching a state of sexual arousal, the parameters of the transcutaneous vibratory output used to reach the state may be derived from a lookup table, may be based on transcutaneous vibratory output that previously successfully facilitated entry into sexual arousal for the subject, may be done in real time in accordance with sensor feedback, may be done manually, or the like. The vibratory stimulation described here can be applied anywhere on the body (e.g., ankle) and does not require application to the genital region. For example, the variable parameters may be modified using a user interface of the stimulation device or of an associated device controlling the stimulation device. In embodiments, during application of the transcutaneous vibratory' output, at least one of the variable parameters may be varied to generate a second transcutaneous vibratory output to be applied to a portion of the subject’s body to assist the subject in achieving sexual arousal.

[0329] In embodiments, the stimulation device 102 may be manually triggered by a user or may be triggered by sensor input, either from a single sensor or a plurality' of sensors, indicative of a state of pre-sexual arousal or a situation that would benefit from support to achieve sexual arousal (e.g.. a pattern of anxiety that attenuates or prevents sexual arousal or achievement of orgasm). For example, an increasing heart rate coupled by auditory' cues may be indicative of a situation where sexual arousal could be supported by use of the stimulation device 102. Sensors may be integrated into the stimulation device 102 or may be in the environment or associated with an external device. In the cases where sensors are not integrated, the stimulation device 102 may be in communication with the external devices or environmentally placed sensors in order to receive the signals.

[0330] In some embodiments, stimulation may be accompanied by other therapies or associated interventions, such as the delivery of compounds (e.g.. sildenafil, flibanserin, hormones), playing of music, back massage, release of certain aromas, dimming of lights, manual or vibratory sexual stimulation, or the like. For example, the stimulation device 102 may receive a signal that a device delivering sexual stimulation was activated and the device 102 may be triggered to deliver transcutaneous vibratory output directed at achieving sexual arousal.

[0331] In an embodiment, achievement of sexual arousal through use of the stimulation device 102 and as measured by sensors or user input may trigger control of external devices. For example, upon achieving one or more measures of sexual arousal, an external device, such as a sexual stimulation device, a music system, or lights, may be powered down.PATENT Attorney Docket No. APLO-0018-WO

[0332] In some embodiments, the stimulation device 102 may be triggered to terminate delivery of transcutaneous vibratory output when the user has achieved a sexually aroused state, such as by indication from one or more sensors sensing a parameter of sexual arousal, as described above, or by manual input from a user. In some embodiments, upon achievement of sexual arousal, the parameters of the transcutaneous vibratory7output may be modified to deliver transcutaneous vibratory output targeted at maintaining the state of sexual arousal or targeted at entering another state.

[0333] In some embodiments, the stimulation device 102 may be triggered to terminate delivery7of transcutaneous vibratory7output when the user experiences a terminating event, such as an orgasm or another physiological event such as sleep, or a change of location or motion, as indicated from one or more sensors sensing a parameter of sexual arousal, as described above, or by manual input from a user. In some embodiments, determination of a terminating event such as orgasm could be detected based on a combined signature of, but not limited to, user metrics to include ambient sound, motion, position, heart rate, and respiratory7rate. In some embodiments, upon achievement of sexual arousal, the parameters of the transcutaneous vibratory output may be modified to deliver transcutaneous vibratory output targeted at maintaining the state of sexual arousal or targeted at entering another state.

[0334] In some embodiments, the system may use any now or hereafter known machine learning algorithms to define new stimulation patterns and / or update existing stimulation patterns or timing of delivery of stimulation patterns directed at achieving sexual arousal for a user based on collected biometric data, mobile device data, user’s manual adjustment in response to stimulation applied to the user (either for training the system and / or in real time), or the like. In some embodiments, the system may utilize machine learning with sensor data to predict an estimated sexual arousal state and may cause or trigger an action in response to anew predicted state. Machine learning may utilize training data from users that includes sensor data, including point, trend, and longitudinal data, associated with a known state of sexual arousal or pre-sexual arousal. An algorithm may use the training data to learn the correlation between the sensor data and the state and be able to predict what the user’s state is or that the state is imminent. For example, sensor data, for training, validation, or use, may include any of the sensor data types described herein. Machine learning may be used to learn a user’s baseline state and predict that the state is changing or has changed. In embodiments, when the estimated state is predicted, a stimulation protocol may be triggered. Triggering may be sufficiently in advance such that the stimulation results in avoidance of or achievement of the predicted state, whichever is desired. In embodiments, when the estimatedPATENTAttorney Docket No. APLO-0018-WO state is determined, a notification may be triggered to a user of the state. The notification may include a suggestion that a sexual arousal protocol be commenced. A biometric response to the stimulation (e.g., from sensors in wearable), movement data, and / or a manual / behavioral response to the stimulation (e.g., turning off the stimulation, increasing intensity, changing settings, turning on an external device) may also be used as seeds for machine learning.

[0335] Certain embodiments of systems and methods described herein relate to the specifics of transcutaneous vibratory output. For example, certain systems and methods may relate to determining vibratory output characteristics based on composition of a user (e.g., thickness of skin, fat depth of skin, bone proximity) which may cause attenuation of the stimulus. Drives / motors / synthesizers producing different shapes of signals (e.g., square, trapezoidal, etc.) may be used to compensate for attenuation of the vibratory output associated with different layers of body fat.

[0336] In some cases, individuals may have difficulty' reaching or maintaining a target state or may simply desire the achievement of a target state using the simplicity' of the stimulation device producing transcutaneous vibratory output, which can be applied to a portion of the body. However, body composition, such as skin thickness, tissue depth, fat composition, fat depth, the presence of scar tissue, and the like may affect the delivery of transcutaneous vibratory' output, such as by dampening, distorting, or otherwise attenuating the vibratory output and / or its depth of action in the dermal / fat layers. In embodiments, the methods and systems described herein may be configured to determine a fat composition of a portion of a body of the subject and emit stimulation having parameters that are selected to compensate for the attenuation or distortion of the signal. The stimulation may be generated such that the signal, after attenuation or distortion by the fat composition, is delivered to the target location with the desired frequency, amplitude, shape (sinusoidal, square, trapezoidal, and etc. w aveforms), and the like. In embodiments, the parameters used to generate the transcutaneous vibratory^ output may take into account body composition to improve performance of the vibratory output. For example, for a subject with a high fat percentage, a parameter may be adjusted upward. In another example, for a subject with a thinner epidermis, a parameter may be adjusted downward. It should be understood that any of the variable parameters may be adjusted to account for any aspect of body composition. In one example, a look-up table or other data repository may be consulted by a processor or controller in communication with the motor in order to provide a recommendation for a known adjustment to the parameters to account for the composition data.PATENTAttorney Docket No. APLO-OQ18-WO

[0337] With reference to Fig. 7A, an illustrative and non-limiting example method 1700 of assisting a subject to reach or maintain a target state is depicted. The method may include the operation 1702 of receiving an indication of a desire to be in a target state, the operation 1704 of receiving data of a composition of a portion of a body of the subject; and, the operation 1708 of generating, using a motor, a transcutaneous vibratory output to be applied to the subject via contact with the portion of the body of the subject to assist the subject in achieving or maintaining the target state wherein the vanable parameters are based in part on the composition data. In embodiments, the composition may relate to a thickness of a skin of the subject. In embodiments, the composition may relate to a fat depth or fat percentage of the portion of the subject. The method 1700 may further include an operation of determining the fat depth is greater than a threshold depth and increasing an intensity of the transcutaneous vibratory output.

[0338] With reference to Fig. 7B, in some embodiments, the method 1700 may further include an operation 1710 wherein determining the composition based on a vibration analy sis during application of transcutaneous vibratory output.

[0339] The method 1700 may further include the operation of applying the transcutaneous vibratory output, the operation of sensing characteristics of vibrations of a skin of the subject during application of the transcutaneous vibratory' output; and the operation of configuring / modifying the transcutaneous vibratory output based on the sensed characteristics.

[0340] With reference to Fig. 8 A, an illustrative and non-limiting example method 1900 of assisting a subject to reach or maintain a sexually aroused state is depicted. The method may include the operation 1902 of receiving an indication of a desire to be in a sexually aroused state; the operation 1904 of receiving data of a composition of a portion of a body of the subject; and the operation 1908 of generating, using a motor, a transcutaneous vibratory output to be applied to the subject via contact with the portion of the body of the subject to assist the subject in achieving or maintaining the sexually aroused state, wherein the variable parameters are based in part on the composition data. In embodiments, the composition may relate to a thickness of a skin of the subject. In embodiments, the composition may relate to a fat depth or fat percentage of the portion of the subject. The method 1900 may further include an operation of determining the fat depth is greater than a threshold depth and increasing an intensity of the transcutaneous vibratory output.PATENTAttorney Docket No. APLO-0018-WO

[0341] With reference to Fig. 8B, in some embodiments, the method 1900 may further include an operation 1910 determining the composition based on a vibration analysis during application of transcutaneous vibratory output.

[0342] The method 1900 may further include an operation of applying the transcutaneous vibratory output; an operation of sensing characteristics of vibrations of a skin of the subject during application of the transcutaneous vibratory output; and an operation of configuring / modifying the transcutaneous vibratory output based on the sensed characteristics.

[0343] With reference to Fig. 9, an illustrative and non-limiting example system 2100 to emit a stimulation is depicted. In embodiments, the system may include a wearable stimulation device 2102 having a transducer 2102 adapted to generate a tactile transcutaneous vibratory output. The wearable device may be worn such that the device is in contact with the skin of a user. In some cases, the wearable device may be worn over clothing and secured to a body part with one or more straps, bands, and the like.

[0344] The system 2100 may further include a processor 2112 in electronic communication with the transducer 2104 and one or more physiological sensors 2106, 2108 structured to sense physiological data of the user. The physiological data may include aspects of the fat composition of the user, thickness of the skin, and the like. In some embodiments, one or more physiological sensors 2106, 2108 may be part of the wearable stimulation device and may be located on or inside the wearable stimulation device. In some embodiments, a physiological sensor may include an electrical sensor that measures the electrical resistance, electrical impedance, and / or bioelectric impedance of the body or body part. In some cases, the bioelectric impedance of a body may be used to determine the body fat composition of the user. In some cases, the bioelectric impedance of a body part may be used to determine the body fat composition of a body part of the user.

[0345] In one example, a wearable stimulation device may include a strap that is used to secure the device around a body part (such as the user’s wrist, waist, ankle, and the like). A physiological sensor 2106 may include at least two electrodes. In one example of two electrodes, the electrodes may be spaced to be on opposite sides of the body part, such as on opposite sides of a wrist, ankle, waist, and the like. The bioelectric impedance may be measured using the electrodes to determine the body fat composition in the body part. In some embodiments, the electrodes may be positioned on opposite sides of the transducer and may be spaced to be at least 1 cm apart. In some embodiments, the measurement of body fatPATENTAttorney Docket No. APLO-0018-WO may be a relative measure and may not correspond to actual body fat measurement but may identify changes in body fat at a particular body part.

[0346] In some embodiments, the physiological sensor 2108 may be an external sensor that is not physically connected to the wearable stimulation device. In some cases, data from the physiological sensor may be received from an external device via a wireless or wired data transfer. External sensors may include wearable sensors and sensors in external devices such as scales, exercise equipment, and the like. In some cases, the processor 2112 may be in communication with one or more repositories of data 2110 related to physiological sensors and may receive data from the repository rather than directly from the sensors. For example, the physiological data may be stored on a user’s phone associated with an application, a remote server, and the like.

[0347] In embodiments, the processor 2112 may be configured to receive the physiological data from one or more of the physiological sensors 2106, 2108 and / or sources of physiological data 2110. The processor 2112 may use the output from the sensors and / or the physiological data to determine or estimate the fat composition of the body or a portion of the body of the subject. The fat composition may be determined by predictive functions and / or table look-ups based on previous analysis and correlations of sensor readings and observed fat composition.

[0348] The system 2100 may be configured to cause the transducer 2104 to emit stimulation. In embodiments, the processor 2112 may adjust the characteristics of the emitted transcutaneous vibratory output to compensate for attenuation and / or distortion of the signal due to the fat composition. In some cases, the thickness of the fat under the skin, for example, may affect the amount of attenuation and / or distortion of the transcutaneous vibratory' output. The amount of attenuation, the frequencies at which attention occurs may be a function of the thickness of the fat. In one example, transcutaneous fat may attenuate or filter high-frequency signals as they travel through the fat layer. In some cases, the level of attenuation of the high- frequency signals or the frequencies that are attenuated may depend on the amount or thickness of fat in the body part to which the transcutaneous vibratory’ output is applied.

[0349] In embodiments, the system 2100 may be configured to emit a signal with a shape based on the determined fat composition (such as fat thickness, BMI, percentage, etc.). The signal shape may include the shape of the envelope of the signal, the intensify of one or more frequencies, and the like. In some embodiments, higher fat content may correspond to increased attenuation of high frequencies, and the signal shape may be a signal with a square wave. In some embodiments, lower fat content may correspond to increased attenuation ofPATENTAttorney Docket No. APLO-0018-WO high frequencies, and the signal shape may be a signal with a sinusoidal wave. In embodiments, the system 2100 may alter the transcutaneous vibratory output in response to the physiological sensor. In one example, the intensify of at least some frequencies may be increased as a function of the fat thickness.

[0350] In embodiments, parameters of the transcutaneous vibratory output may be based on or modified according to various types of physiological sensors, which may include at least one of a fat composition sensor, a conductivity sensor, a heart rate monitor, a vaginal photoplethysmograph, a tactile sensor, a pulse sensor, a sensor for galvanic skin response, a pneumatic anal pressure probe, a temperature sensor, a sensor that measures a muscle contraction force, a motion sensor, or a biometric sensor.

[0351] Certain embodiments of systems and methods described herein relate to determining adequate contact of the wearable stimulation device with the body. In some embodiments, an accelerometer may be used to ensure that adequate, or indeed any, contact is had between the stimulation device and the body. In embodiments, effective stimulation may depend on adequate contact of the transducer or motor with a portion of the body. With reference to Fig. 10. an illustrative and non-limiting example system 2200 to detect adequate contact of the wearable device 2202 with the body is depicted. In some cases, the effectiveness of transcutaneous stimulation may depend on adequate contact of the transducer and / or motor with the body of the user (such as contact with the skin). In embodiments, the system 2200 may include a transducer 2204 adapted to generate tactile transcutaneous vibrator output.

[0352] The system may further include a processor 2206 in electronic communication with the transducer 2204 and programmed to cause the transducer to emit stimulation, wherein the stimulation comprises a transcutaneous vibratory' output having parameters. The system 2200 may further include a tension sensor 2208 to determine and / or monitor the tension and / or contact of the transducer 2204 w ith the body of the user. In some embodiments, the tension sensor 2208 may be a strap tension sensor. In embodiments, the system 2200 may be a wearable device that is attached to a body portion of a body using one or more straps. In embodiments, sensors may be attached to the straps to detect and / or monitor the tension of the strap, which may be used to determine if the wearable device has adequate contact with the body for effective transmission of the stimulation. In embodiments, the straps may include one or more microswitches, torsion sensors, and the like to determine the tension of the strap.

[0353] In some embodiments, the tension sensor 2208 may be used to determine when adequate tension, and therefore adequate contact with the body, is achieved. In embodiments.PATENTAttorney Docket No. APLO-0018-WO when the tension is below a threshold, the system 2200 may provide an alert to the user to increase the tension. In some embodiments, tension sensor readings may be used to adjust the parameters of the transcutaneous vibratory output. In some embodiments, the parameters of the transcutaneous vibratory output may be adjusted for inadequate tension and / or contact with the body. In one embodiment, parameters of the transcutaneous vibratory7output may be altered when the strap tension and / or contact with the body is below a threshold value. In some cases, inadequate contact with the body and / or strap tensions may result in a poor or inadequate transfer of high-frequency signals from the wearable device to the body. In some embodiments, the amplitude or intensity7of high-frequency signals may be increased when the contact with the body is determined to be below a threshold value. In embodiments, parameters are selected to maintain or increase a sexually aroused state in response to the detection of changes in tension or contact.

[0354] With reference to Fig. 11, an illustrative and non-limiting example system 2300 to detect adequate contact of the wearable device with the body is depicted. In embodiments, contact with the body may be determined based on the movement of the wearable device 2302 during stimulation. In embodiments, the system 2300 may include a transducer 2304 that is adapted to generate tactile transcutaneous vibratory7output. The system 2300 may further include a processor 2306 in electronic communication with the transducer 2304 and programmed to cause the transducer to emit stimulation. The system 2300 may further include a movement sensor 2308 structured to detect at least one of the movements of the stimulation device during the stimulation and amplitude of the stimulation at a portion of the body of the user. In embodiments, the movement of the wearable device in response to the device providing stimulation may provide an indication of the contact of the device with the body. In embodiments, the movement (vibration, amplitude of vibration, displacement, frequency of vibrations) may be different depending on the contact of the device with the body. Close contact with the body' may increase the effective mass of the wearable device, thereby affecting the movement of the device during stimulation. In embodiments, a device that is not securely attached to a body part or not in close contact with the body may exhibit different movement than a device that is fastened securely or is in close contact with the body.

[0355] In embodiments, a movement sensor 2308 (such as a piezoelectric sensor or an accelerometer) may detect movement such as vibrations of the device during stimulation. The characteristics, such as the amplitude and / or frequency of the movement determined by the movement sensor 2308 may be compared to the parameters of the transcutaneous vibratory7PATENTAttorney Docket No. APLO-0018-WO output generated by the transducer 2304. Based on the similarities and differences of the generated stimulus and the detected movement, the system 2300 may determine the tightness of the strap of the wearable device. For example, a difference in the amplitude of the stimulus and the detected signal may indicate a loose strap.

[0356] In embodiments, the movement sensor 2308 may be configured to determine movement concurrently with the application of the stimulus. In some embodiments, the movement sensor 2308 may be configured to measure the movement after the stimulation from the device. In one example, the movement sensor 2308 may be configured to measure the decay of the movement in the device as a result of the stimulation. In some embodiments, the time associated with the decay may provide an indication as to the tightness of the strap and, therefore, the contact of the device with the body part. As described herein, the parameters of the stimulus may be adjusted based on the determined contact of the device with the body.

[0357] With reference to Fig. 12, an illustrative and non-limiting example system 2400 to detect aspects of stimulus transmission based on reflections of the stimulus signal is depicted. In embodiments, aspects of the location of the device on the body and / or the contact of the device with the body may be determined based on the reflections of the stimulus. In embodiments, the system 2400 may include a transducer 2404 that is adapted to generate tactile transcutaneous vibratory output. The sy stem 2400 may further include a processor 2406 in electronic communication with the transducer 2404 and programmed to cause the transducer to emit stimulation. The system 2400 may further include a sensor 2408, such as a vibration sensor, structured to detect the vibration from a portion of a body of a user. In embodiments, the processor may be structured to determine the efficiency of stimulation based on the detected vibration. In embodiments, the transducer 2404 may be configured to apply a stimulus to the body, and the vibration sensor 2408 may be used to measure the vibrations of the body in response to the stimulation. The response of the body to the stimulation (referred to herein as reflections) may be used to determine aspects of the body and / or contact of the device with the body. In embodiments, after a stimulus is applied, a sensor 2408 may be used to measure the amplitude and decay of the stimulus from the body. Based on the decay of the signal, for example, the efficiency of the signal transmission may be determined. In other embodiments, the composition of the body, such as fat depth, may be determined. In some embodiments, the transducer 2404 may generate an ultrasonic signal and may be used to determine the location of the device 2402 on the body based on the reflected signals. In some embodiments, the reflected signals may indicate the fat depth, bonePATENT Attorney Docket No. APLO-0018-WO proximity, circumference, and the like of the body part and may be used to determine the location of the device. In some embodiments, the sensor 2408 may be disposed in a device adjacent to a device housing the transducer 2404 or in a same device housing the transducer 2404.

[0358] Certain embodiments of systems and methods described herein relate to stimulation (e.g., transcutaneous vibratory stimulation) to augment or achieve sexual arousal. With reference to Fig. 13A, an illustrative and non-limiting example method 2500 of assisting a subject to reach or maintain a sexually aroused state is depicted. In some cases, individuals may have difficulty reaching or maintaining a sexually aroused state or may simply desire the achievement of a sexually aroused state using the simplicity of the stimulation device described herein, which can be applied to a portion of the body, such as a non-genital portion, and may be used discreetly. In some embodiments, the stimulation device is applied to a genital portion of the body. In any of the embodiments described anywhere herein, the stimulation device may be embedded in a wearable item, such as a hat, underwear, necklace, headband, wristband, pants, strap / hamess. or the like, the wearable item adapted to be worn adjacent to or applied to a portion of the body, whether the portion is genital or non-genital. The method may include the operation 2502 of receiving an indication of a desire to be in a sexually aroused state and the operation 2504 of generating, using a motor, a transcutaneous vibratory output to be applied to the subject via contact with a portion of a body of the subject to assist the subject in achieving or maintaining the sexually aroused state, as described herein. In some embodiments, the indication may correspond to a determination that the subject is in a state of pre-sexual arousal. For example, sensors may detect that the individual is experiencing the beginning phases of engorgement or increased vaginal lubrication, which may be interpreted as a state of pre-sexual arousal and may provide an indication of a desire to be further in a state of sexual arousal. The sensors may be in communication with the motor or a controller / processor providing instructions to the motor. In some embodiments, the indication may be an activation of an external device, wherein the external device may be at least one of a speaker, an olfactory device, a genital stimulator, a massager, or a light. The motor may be in communication with the external device, such as through a wired or wireless connection, and receive a signal related to the activation. In some embodiments, the indication may be based on data from at least one of a sensor, a mobile device, an external device, or a wearable device. The sensor may be at least one of a heart rate monitor, a vaginal photoplethysmograph, a tactile sensor, an audio sensor / microphone, an image sensor, a pulse sensor, a sensor for galvanic skin response, a pneumatic anal pressure probe, a temperaturePATENTAttorney Docket No. APLO-0018-WO sensor, a sensor that measures a muscle contraction force, a motion sensor, a biometric sensor, an EMG sensor, a physiological sensor, or an electrical myography sensor. The physiological sensor may sense at least one of a vaginal air pressure, a perspiration, a blood pressure, a blood flow, an engorgement, skin moisture, eye movement, a vocalization, a body temperature, a muscle tension, a respiration, a temperature, GSR, SpO2, spirometry', EEG, ECG, EMG, a heart rate. HRV, CO2, motion, glucose, a blood / hemoglobin oxygen saturation, a muscle electrical activity, or a fluid secretion. In some embodiments, the motor may be structured to be triggered upon receipt of a signal from a sensor, such as through an associated processor or controller. For example, a heart rate monitor may indicate increased activity in the absence of corresponding motion from an accelerometer measuring the user’s motion. In this case, the processor may interpret the sensor data as indicative of sexual arousal and send a signal to the motor to commence transcutaneous vibratory output.

[0359] In embodiments, the variable parameters may further be selected based on an aspect of a second stimulation, wherein the second stimulation includes a vibration pattern from a sexual aid device, such as a vibrator or massager. The second stimulation may be auditory, such as music or other sounds (e.g., singing bowls).

[0360] In embodiments, the step of generating the transcutaneous vibratory output may further include the step of modifying the variable parameters to correspond to the sexually aroused state. For example, the motor may be used to emit transcutaneous vibratory output intended to target any number of states or outcomes, and the transcutaneous vibratory output, while variable, may have certain parameters that better target a state or better enable a user to enter the state. In some embodiments, the transcutaneous vibratory output may be applied to a skin of the portion of the body of the subject. In some embodiments, the portion of the body is a non-genital portion. For example, transcutaneous vibratory output may be applied to a wrist, ankle, neck, arm, leg, or the like. Application may include use of a band, adhesive, or other attachment to create contact with skin. In some embodiments, the portion of the body is a genital portion of the body. In some embodiments, the motor is embedded in a wearable item, such as a hat. underwear, necklace, headband, wristband, pants, strap / hamess, or the like, the wearable item adapted to be worn adjacent to a portion of the body, whether its genital or non-genital.

[0361] In some embodiments, the sexually aroused state may be identifiable based on at least one of data from a sensor, a heart rate, a heart rate variability, a high-pitched speaking volume, an increase in vaginal lubrication or blood flow, an achievement of orgasm, an erectile state, a discharge of seminal fluid, mobile device data, user input, or an increased usePATENTAttorney Docket No. APLO-0018-WO of sexually suggestive words. In some embodiments, the transcutaneous vibratory' output maybe generated by a combination of oscillations that together form an output with a beat pattern or may be modulated, as described herein. For example, a user may program the adjustment, or the adjustment may be pre-programmed, such as to avoid habituation or may be in response to an indication that the user has reached a sexually aroused state or is not yet reaching the sexually aroused state despite continued transcutaneous vibratory output. Other parameters may also be useful in achieving a sexually aroused state. Indeed, the parameters may be customized, as described herein for other desired states (e.g., sleep, wakefulness). In some embodiments, one or more of the variable parameters are modified in subsequent attempts to reach the sexually aroused state in order to avoid habituation to the transcutaneous vibratory output by the subject.

[0362] With reference to Fig. 13B, in some embodiments, the method 2500 may further include an operation 2508 wherein upon achievement of the sexually aroused state, at least one of terminating the transcutaneous vibratory output or modifying the variable parameters to maintain the sexually aroused state or to enter a new state. In some embodiments, the terminating event may be an orgasm, an ejaculation, a change of location, a motion, or an indication of sleep. The terminating event may be identified via at least one of a sensor, a mobile device, a wearable device, or an external device. For example, the terminating event may be discontinued use of a sexual aid device. The sexual aid device may be in communication with the motor producing transcutaneous vibratory output or a processor / controller providing instructions to the motor and its shutdown may signal the motor to also turn off or alter variable parameters.

[0363] The method 2500 may further include an operation wherein upon occurrence of a terminating event, the transcutaneous vibratory output is terminated or modified.

[0364] The method 2500 may further include an operation of obtaining input of a current state of the subject. In some embodiments, the transcutaneous vibratory output is generated based on the input of the current state of the subject. In some embodiments, the step of generating the transcutaneous vibratory output may further include the step of modifying the variable parameters to assist the subject in reaching the sexually aroused state based on input indicating the current state of the subject. The input of the current state may be based on data from a sensor, including any of the sensors described herein. For example, the sensor may be at least one of structured to be worn by the subject, in an external device, in a device comprising the motor, or positioned in an environment of the subject.PATENTAttorney Docket No. APLO-0018-WO

[0365] The method 2500 may further include an operation of applying a sensory stimulation to the subject, as described herein. In embodiments, the sensory’ stimulation may be automatically triggered upon activation of the motor.

[0366] The method 2500 may further include an operation of administering a substance selected from the group consisting of an erectile dysfunction agent, sildenafd, flibanserin, a hormone, MDMA, psilocybin, cannabis, an anti-depressant, an anti-anxiety drug, an antipsychotic, and a psychoactive drug. In an example, the method may be employed in the context of a therapeutic sex therapy or counseling session. In some embodiments, the motor may be further controlled to emit transcutaneous vibratory’ output that both increases a sexually aroused state as well as mitigates any negative effects from the substance / drug / pharmaceutical / medicament.

[0367] The method 2500 may further include an operation of providing an interface for the subject to terminate the transcutaneous vibratory output. For example, the motor may be embodied in a wearable device with one or more buttons, switches, a touch screen, or the like, or may be in communication with a separate device including such user interface elements structured to control the motor.

[0368] With reference to Fig. 14A, an illustrative and non-limiting example method 2900 of assisting a subject to reach or maintain a sexually aroused state is depicted. The method may include the operation 2902 of receiving an indication that a subject is in a sexually aroused state and the operation 2904 of generating, using a motor, a transcutaneous vibratory- output to be applied to the subject via contact with a portion of a body of the subject to assist the subject in maintaining or amplifying the sexually aroused state. The variable parameters may be further selected based on an aspect of a second stimulation, wherein the second stimulation includes a vibration pattern from a sexual aid device or is auditory. In some embodiments, the indication corresponds to a determination that the subject is in a state of pre-sexual arousal. In some embodiments, wherein the indication is an activation of an external device. The external device may be at least one of a speaker, an olfactory- device, a genital stimulator, a massager, or a light. In some embodiments, the indication may be based on data from at least one of a sensor, a mobile device, an external device, or a wearable device. In some embodiments, one or more of the variable parameters are modified in subsequent attempts to reach the sexually aroused state in order to avoid habituation to the transcutaneous vibratory output by the subject. For example, each successive time the motor is used to provide transcutaneous vibratory output, one of more of the variable parameters may be altered such that the combination is still effective to reach the sexually aroused statePATENTAttorney Docket No. APLO-0018-WO but is not the same as prior uses. In some embodiments, the transcutaneous vibratory output may be generated by a combination of oscillations together form an output with a beat pattern, as described herein, and which may be adjusted over a time period, as described herein. In some embodiments, the transcutaneous vibratory output may be at a non-audible frequency. In some embodiments, the transcutaneous vibratory7output may be user selectable between frequencies within an audible range and frequencies outside the audible range.

[0369] With reference to Fig. 14B, in some embodiments, the method 2900 may further include an operation 2908 of wherein upon achievement of the sexually aroused state, at least one of terminating the transcutaneous vibratory output or modifying the variable parameters to maintain the sexually aroused state or to enter a new state.

[0370] The method 2900 may further include an operation of wherein upon occurrence of a terminating event, terminating or modifying the transcutaneous vibratory output. The terminating event may be an orgasm, an ejaculation, a change of location, a motion, or an indication of sleep, and may be identified via at least one of a sensor, a mobile device, a wearable device, or an external device.

[0371] The method 2900 may further include an operation of obtaining input of a current state of the subject. For example, transcutaneous vibratory output may be generated based on the input of the current state of the subject. In some embodiments, the step of generating the transcutaneous vibratory output further comprises the step of modifying the variable parameters to assist the subject in reaching the sexually aroused state based on input indicating the current state of the subject. Input of the current state may be based on data from a sensor. The sensor may be at least one of structured to be worn by the subj ect, in an external device, in a device comprising the motor, positioned in an environment of the subject. In some embodiments, the step of generating the transcutaneous vibratory output further comprises the step of modifying the variable parameters to correspond to the sexually aroused state. In some embodiments, the transcutaneous vibratory7output may be applied to a skin of the portion of the body of the subject, and the portion of the body may be anon- genital portion, as described herein. In some embodiments, the portion of the body may be a genital portion. In some embodiments, the sexually aroused state may7be identifiable based on at least one of data from a sensor, a heart rate, a heart rate variability7, a high-pitched speaking volume, an increase in vaginal lubrication or blood flow, an achievement of orgasm, an erectile state, a discharge of seminal fluid, mobile device data, user input, or an increased use of sexually suggestive words.PATENTAttorney Docket No. APLO-0018-WO

[0372] The method 2900 may further include an operation of applying a sensory stimulation to the subject, as described herein.

[0373] The method 2900 may further include an operation of administering a substance selected from the group consisting of an erectile dysfunction agent, sildenafd, flibanserin, a hormone, MDMA, psilocybin, cannabis, an anti-depressant, an anti-anxiety drug, an antipsychotic, and a psychoactive drug.

[0374] Certain embodiments of systems and methods described herein relate to stimulation (e.g., transcutaneous vibratory stimulation) to suppress sexual arousal, such as by using time and location settings to trigger transcutaneous vibratory stimulation that is designed to prevent or reduce sexual arousal.

[0375] With reference to Fig. 15A, an illustrative and non-limiting example method 3300 of assisting a subject to suppress a sexually aroused state is depicted. In some scenarios, such as in a work environment, in a classroom, or other setting where sexual arousal may be inappropriate or otherwise not desired, a method and device to suppress, prevent, or reduce sexual arousal may be useful. The method 3300 may include the operation 3302 of receiving an indication that a subject is in a sexually aroused state, and the operation 3304 of generating, using a motor, a transcutaneous vibratory output to be applied to the subject via contact with a portion of a body of the subject to assist the subject in suppressing the sexually aroused state, the transcutaneous vibratory output having variable parameters. In embodiments, the indication of sexual arousal may be an activation of an external device, such as a speaker, an olfactory device, a genital stimulator, a massager, or a light. In some embodiments, the indication may be based on data from at least one of a sensor (as described herein), a mobile device, an external device, or a wearable device and may be related to a heart rate, a heart rate variability, a high-pitched speaking volume, an increase in vaginal lubrication or blood flow, an achievement of orgasm, an erectile state, a discharge of seminal fluid, user input to a mobile device, or an increased use of sexually suggestive words. The transcutaneous vibratory output may be applied to a skin of the portion of the body of the subject, such as a non-genital portion, or in some embodiments, a genital portion. In some embodiments, one or more of the variable parameters are modified in subsequent attempts to suppress the sexually aroused state in order to avoid habituation to the transcutaneous vibratory output by the subject. In some embodiments, the transcutaneous vibratory' output may be at a non-audible frequency, such as to ensure discretion. In some embodiments, the transcutaneous vibratory output may be user selectable between frequencies within an audible range and frequencies outside the audible range.PATENTAttorney Docket No. APLO-0018-WO

[0376] With reference to Fig. 15B, in some embodiments, the method 3300 may further include an operation 3308 of obtaining input of a current state of the subject. In some embodiments, the transcutaneous vibratory output may be generated based on the input of the current state of the subject. In some embodiments, the step of generating the transcutaneous vibratory output may further include the step of modifying the variable parameters to assist the subject in suppressing the sexually aroused state based on input indicating the current state of the subject. In some embodiments, the input of the current state may be based on data from a sensor. The sensor may be at least one of structured to be worn by the subj ect, in an external device (e.g., such as a sexual aid device), in a device comprising the motor, or positioned in an environment of the subject.

[0377] The method 3300 may further include an operation of applying a sensory stimulation to the subject. The sensory stimulation may include one or more of visual stimulation, audio stimulation, olfactory stimulation, taste stimulation, photo- / light stimulation, or massage.

[0378] The method 3300 may further include an operation of administering a substance, as described herein.

[0379] With reference to Fig. 16A, an illustrative and non-limiting example method 3600 of assisting a subject to prevent or reduce a sexually aroused state is depicted. The method 3600 may include the operation 3602 of receiving input of a current location of the subject from one or more sensors, the operation 3604 of determining, based on the cunent location, a need to prevent or reduce sexual arousal for the subject, and, in response to the determined need, the operation 3608 of generating, using a motor, a transcutaneous vibratory' output to be applied to the subject via contact with a portion of a body of the subject to assist the subject in preventing or reducing the sexually aroused state. In embodiments, one or more of the variable parameters are modified in subsequent attempts to prevent or reduce the sexually aroused state in order to avoid habituation to the transcutaneous vibratory' output by the subject. In some embodiments, the transcutaneous vibratory output may be at a non-audible frequency. In some embodiments, the transcutaneous vibratory output may be user-selectable between frequencies within an audible range and frequencies outside the audible range.

[0380] With reference to Fig. 16B, in some embodiments, the method 3600 may further include an operation 3610 of obtaining input of a current state of the subject. The transcutaneous vibratory output may be generated based on the input of the current state of the subject. The step of generating the transcutaneous vibratory output may further include the step of modifying the variable parameters to assist the subject in preventing or reducingPATENT Attorney Docket No. APLO-0018-WO the sexually aroused state based on input indicating the current state of the subject. In some embodiments, the input of the cunent state may be based on data from a sensor. The sensor may be at least one of structured to be worn by the subject, in an external device, in a device comprising the motor, or positioned in an environment of the subject.

[0381] The method 3600 may further include an operation of apply ing a sensory stimulation to the subject. The method 3600 may further include an operation of administering a substance selected from the group consisting of an erectile dysfunction agent, sildenafil, flibanserin, a hormone, MDMA, psilocybin, cannabis, an anti-depressant, an antianxiety drug, an anti-psychotic, and a psychoactive drug.

[0382] With reference to Fig. 17A, an illustrative and non-limiting example method 3900 of assisting a subject to prevent or reduce a sexually aroused state is depicted. The method 3900 may include the operation 3902 of receiving input of an event of the subject (e.g., test, work shift, public speaking, viewing a movie, at a party), the operation 3904 of determining, based on a current time coinciding substantially with the event, a need to prevent or reduce sexual arousal for the subject, and. in response to the determined need, the operation 3908 of generating, using a motor, a transcutaneous vibratory output to be applied to the subject via contact with a portion of a body of the subject to assist the subject in preventing or reducing the sexually aroused state. In some embodiments, the transcutaneous vibratory' output is generated according to a schedule. The schedule may be automatically generated according to at least one of a sensor reading and a user input. For example, the motor may be in communication with a calendar application of the user. In some embodiments, the motor may further be in communication with a GPS sensor or other locating technology7to determine a location of a user. When a location of the user coincides with a location of the event, the generating may be triggered even though the time of the event has not occurred (e.g., early arrival at a location). In some embodiments, determining may not be based on a current time coinciding substantially with the event. Instead, the event may simply be recognized as an event and a determination of the need to prevent or reduce sexual arousal may be based on the event. For example, if sensors determine that sacred choral music is being played in the user’s environment, the event may be recognized as a mass or other religious gathering and a determination may be made to reduce or prevent sexual arousal.

[0383] In some embodiments, the transcutaneous vibratory output is applied to a skin of the portion of the body of the subject. The portion of the body may be a non-genital portion or in some embodiments, a genital portion. One or more of the variable parameters may be modified in subsequent attempts to prevent or reduce the sexually aroused state in order toPATENTAttorney Docket No. APLO-0018-WO avoid habituation to the transcutaneous vibratory' output by the subject. In some embodiments, the transcutaneous vibratory output is generated by a combination of oscillations that together form an output with a beat pattern. In some embodiments, the transcutaneous vibratory output is at anon-audible frequency. In some embodiments, the transcutaneous vibratory output may be user selectable between frequencies within an audible range and frequencies outside the audible range.

[0384] With reference to Fig. 17B, in some embodiments, the method 3900 may further include an operation 3910 of obtaining input of a current state of the subject. Transcutaneous vibratory' output may be generated based on the input of the current state of the subject. The step of generating the transcutaneous vibratory' output may further include the step of modifying the variable parameters to assist the subject in preventing or reducing the sexually’ aroused state based on input indicating the current state of the subject. The input of the current state may be based on data from a sensor. The sensor may be at least one of structured to be worn by the subject, in an external device, in a device comprising the motor, or positioned in an environment of the subject.

[0385] The method 3900 may further include an operation of applying a sensory stimulation to the subject. The method 3900 may further include an operation of administering a substance selected from the group consisting of an erectile dysfunction agent, sildenafil, flibanserin, a hormone, MDMA, psilocybin, cannabis, an anti-depressant, an antianxiety drug, an anti-psychotic, and a psychoactive drug.

[0386] In some embodiments, a method may include receiving input of an event of the subject (e.g., listening to music, viewing a movie, at a party ), determining a need to increase or augment sexual arousal for the subject based on the event, and, in response to the determined need, generating a transcutaneous vibratory output to be applied to the subject via contact with a portion of a body of the subject to assist the subject in achieving, maintaining, or augmenting the sexually aroused state. In some embodiments, the motor may further be in communication with a GPS sensor or other locating technology to determine a location of a user. When a location of the user coincides with a location of the event, the generating may be triggered even though the time of the event has not occurred (e.g.. early arrival at a location). In some embodiments, determining may be based on a current time coinciding substantially with an event, such as a scheduled. In other embodiments, the event may simply be recognized as an event and a determination of the need to increase / augment / maintain sexual arousal may be based on the event. For example, if sensors determine that an X-rated film is being viewed in the user’s environment, such as through audio sensors, data from aPATENTAttorney Docket No. APLO-0018-WO mobile device or other viewing system, etc., the event may be recognized as one where increased or augmented sexual arousal is welcome and / or desired.

[0387] Certain embodiments of systems and methods described herein relate to detecting activation of sexual aid / vibrator devices. For example, detecting another device applied to the body may be done by detecting vibrations, such as by using piezoelectric or sound sensors, at the stimulation device providing transcutaneous vibratory output. In another example, transcutaneous vibratory output may be coordinated with the activity of the sexual aid device stimulation (e g., increasing amplitude to compensate for additional vibrations, changing frequency to distinguish transcutaneous vibratory output from another stimulation).

[0388] With reference to Fig. 18, an illustrative and non-limiting example method 4200 of coordinating with an external device is depicted. For example, when a user commences using an external device, such as a sexual aid device, its action may be detected by the stimulation device, either through a signal received in communication with the external device, or sensing the operation of the external device through a sound of its operation or a vibration during its operation. Action of the external device may be an indicator that the user wishes to be in a sexually aroused state. Once the action of the external device has been terminated, or another terminating event has occurred, either of which can be detected by the stimulation device or a sensor in communication with the stimulation device, the stimulation device may pause, terminate, or modify its transcutaneous vibratory output, such as to maintain the sexually aroused state, reduce it. suppress it, or the like. The method 4200 may include the operation 4202 of detecting action of an external device on a subject at a stimulation device in contact with a portion of a body of the subject, the operation 4204 of determining, in response to detecting, a need to amplify, maintain, or reduce a current state of the subject, wherein the current state is identified by one or more sensors, and the operation 4208 of generating, in response to determining, a transcutaneous vibratory output to be applied to the subject via contact with a portion of the body of the subject to assist the subject in amplify ing, maintaining, or reducing the current state. In some embodiments, generating is using a motor of the stimulation device. In some embodiments, the external device is at least one of a vibrator or a sexual aid device. In some embodiments, detecting the action of the external device is by detecting a vibration at the stimulation device, such as via at least one of a piezoelectric detection facility and a sound sensor. In some embodiments, generating comprises pausing or terminating the transcutaneous vibratory output when the vibration is detected. In some embodiments, the one or more sensors are in at least one of the external device, the stimulation device, or a second external device. In some embodiments, generatingPATENTAttorney Docket No. APLO-0018-WO includes varying the intensity' of the transcutaneous vibratory output to compensate for the detected vibration. In some embodiments, generating includes varying one or more parameters to distinguish from the detected vibration.

[0389] In some embodiments, an application can be used to allow control of the stimulation device and / or the external device to a second user. Such control may be limited, such as to certain features of the stimulation device, certain intensities, for a period of time, and the like. Control of the stimulation device and / or external device may be rescinded at the end of a stimulation session, or at any time, such as by the user wearing the stimulation device discontinuing access through the application, through control of the stimulation device (e.g., voice control, buttons, touch screen, etc.), and the like.

[0390] With reference to Fig. 19, an illustrative and non-limiting example method 4300 of controlling an external device is depicted. The method 4300 may include the operation 4302 of generating, using a motor, a transcutaneous vibratory' output to be applied to a subject via contact with a portion of a body of the subject to assist the subject in achieving or maintaining a sexually aroused state, the operation 4304 of receiving input of a current state of the subject from one or more sensors during application of the transcutaneous vibratory output, and the operation 4308 of controlling an external device based on the input. In some embodiments, the input may be one or more measures of sexual arousal or occurrence of a terminating event, such as an orgasm, an ejaculation, a change of location, a motion, or an indication of sleep. For example, when a terminating event is detected, the external device may be powered down or an operational parameter of the external device may be modified. In some embodiments, the one or more sensors may be in the external device or in a stimulation device associated with the motor. The stimulation device and the external device may be in communication, such as wireless (e.g., Bluetooth, WiFi, etc.) or wired communication.

[0391] In some embodiments, upon activation of the stimulation device to deliver transcutaneous vibratory output directed to achieving, increasing, or maintaining sexual arousal, an external device may be automatically triggered to turn on. Conversely, when the transcutaneous vibratory output pauses or stops, the external device may also be paused or stopped automatically. In this example, transcutaneous vibratory output is generated and applied to a subject, and controlling an external device is based on a commencement of the generating and / or the applying.

[0392] With reference to Fig. 20, an illustrative and non-limiting system 4400 is depicted wherein the transducer of the stimulation device is embedded in a sexual aid device to conveniently provide transcutaneous vibratory output from the stimulation device duringPATENTAttorney Docket No. APLO-0018-WO operation of the sexual aid device. In some embodiments, the sexual aid device may be used to provide transcutaneous vibratory output from the transducer in the absence of activation of the vibratory motor of the sexual aid device. The example system 4400 may include a sexual aid device 4402 comprising a vibratory motor 4404, wherein an amplitude, a frequency, and a pattern of the vibratory motor 4404 may be variable; a transducer 4408 of the sexual aid device 4402 may be structured to generate transcutaneous vibratory output, as previously described herein; and a processor 4410 in electronic communication with the transducer 4408 and structured to cause the transducer 4408 to emit stimulation, wherein the parameters are selected to maintain or increase a sexually aroused state. One or more sensors 4412 may be in electronic communication with at least one of the processor 4410 and the transducer 4408. In some embodiments, the sexually aroused state may be identifiable based on data from the one or more sensors 4412.

[0393] With reference to Fig. 21, an illustrative and non-limiting system 4500 is depicted. The example system 4500 may include a sexual aid device 4502 comprising at least one motor 4504, wherein an amplitude, a frequency, and a pattern of the at least one motor 4504 are variable, and a processor 4510 in electronic communication with the at least one motor 4504 and structured to cause the motor 4504 to emit stimulation, wherein the parameters are selected to maintain or increase a sexually aroused state. One or more sensors 4512 may be in electronic communication with at least one of the processor 4510 and the at least one motor 4504. For example, the sexually aroused state may be identifiable based on data from the one or more sensors 4512.

[0394] With reference to Fig. 22A, an illustrative and non-limiting example method 4600 of an artificial intelligence to learn parameters that best achieve sexual arousal is depicted. For example, previous instances of use of the transcutaneous vibratory output may be correlated with success of the output in achieving a sexual arousal state. Success may be determined by input from a user or from sensor data, such as data indicating sexual arousal or a successful terminating event. Those uses where achievement of sexual arousal was had may be used to train a model. Data from the successful uses may include parameters chosen, if parameters were manually changed during use, a body composition of the user, how often the transcutaneous vibratory output has been used, time between uses, and the like. The model may then be used to match parameters for a transcutaneous vibratory output to a user desiring to achieve sexual arousal that accounts for success, the user’s body composition, and the user’s habits of use.PATENTAttorney Docket No. APLO-0018-WO

[0395] The method 4600 may include the operation 4602 of obtaining data for a plurality' of sessions of delivery of transcutaneous vibratory output, wherein the data relates to a success of achieving a sexually aroused state during one or more of the plurality of sessions, the operation 4604 of selecting a training data set from the data to train an artificial intelligence model of a subject's sexual response to the transcutaneous vibratory' output, yvherein the training data set includes parameters of the transcutaneous vibratory’ output, the operation 4608 of training the artificial intelligence model with the training data set to obtain a trained model, the operation 4610 of receiving an indication of a desire of the subject to enter a sexually aroused state and receiving input of a current state of the subject, and the operation 4612 of selecting, via the trained model, parameters of the transcutaneous vibratory' output to provide the subject. The training data set may further include data regarding a state of the subject before delivery of the transcutaneous vibratory output during the session.

[0396] With reference to Fig. 22B, in some embodiments, the method 4600 may further include an operation 4614 of modifying, via the trained model, parameters of the transcutaneous vibratory output to provide the subject. Modifying may be based on input of a current state of the subject. Input of the current state of the subject may be from at least one of a sensor, a mobile device data, external data or a manual input during application of the transcutaneous vibratory' output. In some embodiments, the manual input may include at least one of turning off the transcutaneous vibratory output, increasing intensity of the transcutaneous vibratory output, modifying one or more parameters of the transcutaneous vibratory output, or turning an external device on or off.

[0397] With reference to Fig. 23 A, an illustrative and non-limiting example method 4700 of an artificial intelligence to learn sexual arousal states of a user is depicted. The method 4700 may include the operation 4702 of obtaining data related to a sexual arousal state of a user, wherein the data are from at least one of a sensor, a mobile device, an external device, or a yvearable device, and a u...

Claims

1. PATENTAttorney Docket No. APLO-0018-WOWhat is claimed is:

1. A method comprising: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a complex vibratory7composition.

2. A method comprising: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the one or more properties include timbre and / or vibration quality.

3. A method comprising: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to a determination of ineffectiveness of the transcutaneous vibratory stimulation, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory' composition, wherein the one or more properties include timbre and / or vibration quality7.

4. A method comprising: receiving input of at least one of a user condition, an event, or an environmental attribute; and composing, in response to the input, a transcutaneous vibratory' stimulation, wherein composing includes selecting an input channel controlling one or more properties of the transcutaneous vibratory stimulation.

5. A method comprising: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition; in response to sensing a predetermined condition in the subject, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the dynamically modulating occurs w ithin 1 hour of the sensing the predetermined condition in the subject.

6. A method comprising: delivering transcutaneous vibratory stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition;PATENTAttorney Docket No. APLO-0018-WO in response to sensing a predetermined condition in the subject, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the vibratory composition, wherein the dynamically modulating is implemented without a firmware update to the device.

7. A method comprising: delivering transcutaneous vibratory’ stimulation from a device to a subject, the transcutaneous vibratory stimulation having a vibratory composition, wherein the vibratory composition is not pre-composed.

8. A method comprising: delivering transcutaneous vibratory' stimulation to a subject, the transcutaneous vibratory stimulation comprising an initial underlying vibratory composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory’ stimulation by changing one or more properties of the initial underlying vibratory composition within a modulatory' effect window.

9. A method comprising: delivering transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory^ stimulation comprising an initial underlying vibratory composition that is statistically associated with a desired effect in the subject, wherein the desired effect is statistically associated with an unmodulated decay yvhen the initial underlying vibratory composition continues to be applied to the subject without dynamic modulation; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory’ stimulation by changing one or more properties of the initial underlying vibratory' composition.

10. A method comprising: delivering transcutaneous vibratory stimulation to a subject, the transcutaneous vibratory' stimulation comprising an initial underlying vibratory' composition; in response to a predetermined condition, dynamically modulating the transcutaneous vibratory stimulation by changing one or more properties of the initial underlying vibratory’ composition, wherein the dynamically modulating changes the one or more properties on a time scale of between 50 ms and 100 ms.

11. A method comprising: composing a transcutaneous vibratory stimulation composition on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneousPATENTAttorney Docket No. APLO-0018-WO vibratory stimulation composition, wherein the synthesizer produces a digital composition output; mapping the digital composition output onto an input format for a vibratory delivery device to produce a digital composition input; inputting the digital composition input to the vibratory delivery device, thereby- producing the transcutaneous vibratory stimulation composition from the vibratory delivery device.

12. A method comprising: delivering a transcutaneous vibratory stimulation composition from a vibratory delivery- device to a subject; modulating the transcutaneous vibratory stimulation composition by changing one or more properties of the transcutaneous vibratory stimulation composition, wherein the modulating is one or more of random, pseudo-random, probabilistic, or a combination thereof.

13. A method comprising: composing a transcutaneous vibratory stimulation composition on a synthesizer, wherein the synthesizer includes inputs for modulating parameters of the transcutaneous vibratory- stimulation composition, wherein the synthesizer produces a digital composition output; modulating a first input of the one or more of the inputs for modulating parameters by introducing a modulation composition into the first input.

14. A method of modulating a wide-spectrum transcutaneous vibratory stimulation composition for delivery through a narrower-spectrum delivery system, wherein the wide- spectrum transcutaneous vibratory stimulation composition includes parts across a wide spectrum, wherein the narrower-spectrum delivery system is capable of delivering a narrower spectrum transcutaneous vibratory- stimulation that includes parts across a narrower spectrum, the method comprising: re-assigning the parts across the wide spectrum which fall outside of the narrower spectrum to commensurate portions of the narrower spectrum.

15. A method of modulating a broad transcutaneous vibratory- stimulation composition for delivery through a narrower-application delivery system, wherein the narrower-application delivery- system has one or more limitations that prevent the narrower-application delivery system from fully delivering the broad transcutaneous vibratory stimulation composition, the method comprising:PATENTAttorney Docket No. APLO-OQ18-WO adjusting the broad transcutaneous vibratory stimulation composition to comply with the one or more limitations.

16. A method of calibrating a transcutaneous vibratory stimulation delivery system, the method comprising: frequency sweeping the transcutaneous vibratory' stimulation delivery system across a spectrum spanning from 0.0001 Hz to 200 Hz; measuring intensity' from the transcutaneous vibratory stimulation delivery system, thereby identifying active portions and inactive portions, wherein the intensity is above a predetermined threshold within the active portions of the spectrum and below the predetermined threshold within the inactive portions of the spectrum; and re-assigning portions of a transcutaneous vibrational stimulation composition from the inactive portions of the spectrum to the active portions of the spectrum.

17. A system comprising a processor programmed to execute the method of any one of the preceding claims, the system comprising the device operable coupled to the processor.

18. A non-transitory computer-readable medium having stored thereon instructions that, in response to execution, cause a processor to perform operations, the operations comprising the method of any one of claims 1 to 16.

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