Multimodal Transcutaneous Auricular Stimulation System Including Methods and Apparatus for Self Treatment, Feedback Collection and Remote Therapist Control

Abstract

A modular, multi-modal energy therapy system for electrical and electromagnetic stimulation includes signal generating, conditioning, and control electronics, stimulation monitoring electronics, signal conduits, and wearable energy emitter modules configured for coupling energy emitters to surfaces of the human ear for transcutaneous energy delivery to nerves in the auricular nerve field. Electrical emitter modules configured with electrodes deliver electrical stimulation; electromagnetic emitter modules configured with light emitting diodes deliver electromagnetic stimulation. A computer controls signal generating electronics and provides internet connectivity with a remote server. Application software includes stimulation programming and parameter selection, and databases containing user data, records of stimulation sessions, user responses to symptom assessment instruments, and biofeedback sensor input enable local and remote monitoring of a user's health status by therapists.

Claims

1. An energy stimulation therapy system for delivering, controlling and monitoring energy stimulation applied transcutaneously to the body of at least one user, comprising an electronic stimulator package comprising stimulation signal generating electronics, signal conditioning and control electronics, and stimulator monitoring electronics, and at least one channel of stimulation energy output; a power source with power modulation electronics and battery recharging circuitry; electronic hardware and software for communication with at least one computer device; said stimulator conditioning and control electronics configured to produce the selection and control of at least two stimulation parameters belonging to a group of stimulation parameters that includes power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation frequencies, stimulation session periods, time intermittency and intervals of stimulation delivery and the like, and compilations thereof; at least one energy emitter module comprising a coupling apparatus and at least one energy emitter configured for removably coupling said at least one energy emitter module to the body of a said at least one user, with said coupling structure having between 0.1 and 84 grams of coupling compression force against the skin of a said at last one user.

2. The energy stimulation therapy system according to claim 1 further comprising electronic switches for powering on and powering off said stimulator package, for selecting and enumerating values of said stimulation parameters, for selecting grouped stimulation parameters called protocols for accepting user input and for performing program selection and control operations, and the like; a computerized graphical user interface configured to selectably display the operational status of said stimulator package, selectable programs of stimulation called protocols, power and battery levels, selectable time periods, selectable said stimulation parameters and the like; at least one energy emitter of said at least one energy emitter coupling module is selected from a group of energy emitters that includes emitters of electrical energy, and optical emitters of electromagnetic energy, and acoustic emitters of sound energy; control, conditioning and switching electronics for selecting and controlling a plurality of stimulation energy modalities employing energy variants according to the type of energy emitted by selected said energy emitters.

3. A wearable energy emitter module comprising at least one energy emitter at least one ear-worn loop coupler designed to be worn looping from behind the human ear over the superior crotch of the ear extending forward ventrally and then inferiorly to a position superiorly located above the tragus; said at least one ear-worn loop coupler designed to couple said at least one energy emitter to the external ear tissue of a said at least one user; said at least one ear-worn loop coupler having a weight between 2.5 and 84 grams; said at least one energy emitter selected from a group of energy emitters that includes emitters of electrical energy and emitters of electromagnetic energy; said at least one energy emitter having physical contact with the external ventral and ventrolateral skin surfaces of the auricle and pinna, and particularly the conchal bowl, concha cymba and tragus of the ear of a said at least one user.

4. The wearable energy emitter coupling module according to claim 3 wherein said energy emitter coupling module composed as said wearable said at least one ear-worn loop coupler, further comprising a mounting socket composed on the superior forward end of said at least one ear-worn loop coupler about its terminal position above the tragus; said mounting socket composed as a bearing and coupling structure designed for the removable electromechanical connection of at least one adjustable arm; at least one adjustable arm having adjustability features selected from a group of adjustability features including movability, rotatability, length extension and contraction, torsionability, flexibility, bendability and the like; at least one energy emitter located on said at least one adjustable arm configured to deliver energy to the body of a said at least one user; said mounting socket composed to conduct electricity from said wearable said at least one ear-worn loop coupler to said at least one energy emitter located on said at least one adjustable arm; conductive material comprising the electromechanical connection of the said at least one adjustable arm to said mounting socket selected from a group of conductive materials that includes electrically conductive metal wire, electrically conductive metallic tracing, electrically conductive filaments, metal plating, 3-D printed conductive material, conductive inks, and the like, and combinations thereof; said mounting socket is further composed as a snap-in port for removably connecting said at least one adjustable arm to said at least one ear-worn loop coupler.

5. The wearable energy emitter coupling module according to claim 4 wherein said energy emitter coupling module composed as said wearable said at least one ear-worn loop coupler, further comprises said at least one energy emitter coupled to the ventral surface of the stem of the said at least one ear-worn loop coupler thereby having coupling contact with the skin of the dorsolateral ear crotch and dorsal surfaces of the auricle and pinna comprising said at least one user's external ear; selectable energy emitter coupling modules belonging to a group of energy emitter coupling modules that includes arm-mounted energy emitter coupling modules, clip-mounted energy emitter coupling modules, energy emitter modules mounted on spring-tensioned apparatuses and torsion-adjustable spring apparatuses configured to enable mounting of energy emitters, and an adhesively mounted conductive-gel energy emitter module; said at least one adjustable arm is additionally composed to be length adjustable having said length adjustability in the range from 5 to 85 millimeters; at least one electrical slip-joint rotary connector fastening said at least one adjustable arm to said mounting socket, with at least one electrical slip-joint rotary connector having at least one electrically conductive circumferential slip ring for electronic communication between said ear-worn loop coupler and said at least one adjustable arm; said mounting socket is further composed having, within the interior surface of said mounting socket, at least one electrically conductive ring structure designed to be in physical contact with the said at least one electrically conductive circumferential slip ring located on said least one electrical slip-joint rotary connector.

6. The wearable energy emitter coupling module according to claim 5 wherein said energy emitter coupling module composed as said wearable said at least one ear-worn loop coupler, further comprises said at least one ear-worn loop coupler may be composed with anatomically differentiating structural features corresponding to the left ear of said at least one user; said at least one ear-worn loop coupler may be composed with anatomically differentiating structural features corresponding to the right ear of said at least one user; a plurality of said adjustable arm modules, each having at least one said energy emitter; multiple said adjustable arms simultaneously connected to said mounting socket by incorporating with each said adjustable arm said at least one electrical slip-joint rotary connector, wherein the said electrical slip-joint rotary connectors on said multiple adjustable arms maybe be nested within the electrical slip-joint rotary connectors on other said adjustable arms and within said mounting socket, with each said conductive circumferential slip ring and said socket port ring structure pair comprising at least one said channel of electrical conductance electronically linking said energy emitters on said adjustable arms with said at least one ear-worn loop coupler; said at least two energy emitters located on said at least one ear-worn loop coupler spatially arranged to have contact on the opposing, contralateral ventral and dorsal surfaces of the auricle to produce energy emissions designed to intersect nerve targets located between said ventral, ventrolateral and dorsal, dorsolateral surfaces, with said nerve targets belonging to a group of nerve targets within the auricular nerve field.

7. The energy stimulation therapy system according to claim 2 further comprising at least one computer device selected from a group of computer devices that include a conventional desktop computer, a notebook computer, a laptop computer, a smartphone, a tablet, a handheld computer and a wearable, user-attached computer device; hardware and software for wired and wireless electronic communication between said at least one computer device and said stimulator package; communication hardware and software installed on said at least one computer device to enable internet connectivity and the communicative exchange of data with at least one remote server;

8. The energy stimulation therapy system according to claim 7 further comprising a method of optimizing user control of stimulation parameters wherein a said at least one user selects stimulation parameter settings by at least one communicative action selected from the group of communicative actions that includes audible communication, touch-based communication on a touch-sensitive device, switch-based communication using switches; software residing on said at least one computer device includes at least one algorithm for ramping up said stimulation parameters from a base level in a series of selected increments of said stimulation parameters, particularly stimulation intensity and frequency; software residing on said at least one computer device having at least one algorithm for ramping down said stimulation parameters from a base level in a series of selected decrements of said stimulation parameters, particularly stimulation intensity and frequency; at least one algorithm which executes at least two stimulator control functions belonging to a group of stimulator control functions that includes powering said stimulator package on and off, starting, pausing and stopping a stimulation session, increasing and decreasing stimulation intensity, increasing and decreasing stimulation frequencies, and the like; a microphone circuit in electronic communication with said computer device and said stimulator package enabling a said at least one user to configure optimal stimulation parameters via voice commands; at least one algorithm for processing user verbalized commands, said stimulation parameters and keywords received by said microphone circuit.

9. The energy stimulation therapy system of claim 7 further comprising software installed on a said at least one computer device having at least one database for storing data comprising stimulus queries and statement stems used in psychological, behavioral, emotional, symptomological and experiential tests, surveys, questionnaires, rating scales and the like, designed to query said at least one user regarding user experience matters belonging to a group of user experience matters that includes the nature, type, frequency, duration, and intensity of said emotions, symptoms, experiences and related manifestations and measures of psychological, emotional, and bodily conditions, disorders, and diseases, including the mobility, health and fitness, activities and social life of said at least one user; at least one database for storing data comprising the responses of a said at least one user to said stimulus questions and statement stems; at least one database for storing data comprising communications exchanged between a said at least one user and at least one remote therapist, wherein said communications may include conversations between a said at least one user and a said remote therapist and said stimulation parameters to parameterize and thereby control and modify the operation of a said at least one user's said stimulation package; at least one software algorithm to monitor and track the time, date and duration of a said at least one user's stimulation sessions and the stimulation parameters used, wherein the said at least one software algorithm may be configured to present reminder advisements to the senses of a said at least one user regarding stimulation according to a recommended schedule of stimulation frequency, duration and stimulation parameters, including algorithm-developed schedules; said at least one software algorithm to monitor and track the time, date and duration of a said at least one user's stimulation sessions additionally transmits such data to a said at least one remote server.

10. The energy stimulation therapy system of claim 9 further comprising server software composed to produce an encryption-secured, access-controlled web-based graphical user interface configured to remotely and selectably monitor, display and control said stimulation parameters of a said at least one user's said stimulator package via said internet connectivity of said at least one user's said at least one computer device; at least one database configured to store the data of a said at least one user belonging to a group of data that includes user account data, user medical history data, said stimulation parameters, said user stimulus-response data, said biofeedback sensor data, said user-reported symptoms and the like; at least one software algorithm to monitor and track the time, date and duration of a said at least one user's stimulation sessions and the stimulation parameters used; at least one database configured to store data comprising stimulus questions and statement stems used in psychological, behavioral, emotional and experiential tests, surveys, questionnaires, rating scales and the like; at least one database configured to store data comprising responses of a said at least one user to said stimulus questions and statement stems used in psychological, behavioral, emotional and experiential tests, surveys, questionnaires, rating scales and the like; at least one database configured to store data comprising data received from biological sensors coupled to the body of a said at least one user; at least one database configured to store data comprising said communications exchanged between said at least one user and said at least one remote therapist; at least one software-encoded algorithm to collect, aggregate and analyze said stimulus-responses of a said at least one user to said stimulus questions, said biological sensor data and said personal information of said at least one user collectively called user data; at least one software-encoded algorithm to develop from said user data optimized stimulation parameters, optimized stimulation therapy and robotic stimulation therapy protocols; at least one algorithm providing remote monitoring and analysis of said user data; at least one algorithm providing remote control functions designed for use by at least one remote therapist selected from a group of remote therapists that includes human paraprofessionals, human healthcare professionals and at least one robotic therapist comprising at least one artificial intelligence algorithm programmed in software; at least one algorithm enabling at least one remote therapist to select, apply and transmit said stimulation parameters and protocols to the said at least one computer device of a said at least one user for configuring and controlling the stimulation produced by a said at least one user's said stimulator package.

11. The energy stimulation therapy system of claim 10 further comprising a remote, server-based graphical user interface control panel programmed and configured to comprise server software configured for a said at least one remote therapist to select floor and ceiling threshold values for said biofeedback sensor data, said stimulus-response data, said personal information data and said stimulation parameter data received from said at least one users' computer device, to serve as decision-points; server software comprising said at least one algorithm using said floor and ceiling threshold values as trigger-points for the automatic generation of alarms, notices, and automatic responses sent to a said at least one user's computer device, and to selected other parties and devices; server software configured for the transmission of said stimulation parameters selected by a said at least one remote therapist to the said at least one computer device of a said at least one user.

12. A wearable energy emitter coupling module comprising at least one energy emitter circuit mounted on a clip-like coupler having two opposing, elongated jaw-like surfaces wherein said at least one energy emitter is selected from the group of energy emitters that includes metallic electrodes, optical emitters, graphene emitters, conductive filament, conductive ink and the like; said two opposing elongated jaw-like mounting surfaces may be composed with a positional biasing mechanism selected from a group of positional biasing mechanisms that includes a leaf spring, spring steel, a coil spring, an active hinge, a compressible elastomeric body and the like; said clip-like coupler includes a coupling-locking mechanism selected from a group of coupling-locking mechanisms that includes a static lock, friction-lock, a locking cam, ratchet, friction ridges and the like, maintains a user-set separation distance between said two opposing elongated jaw-like structures; electrically conductive pathways are composed of conductive compositions belonging to a group of conductive compositions that includes screen-printed carbon ink, 3-D printed conductive filaments, metallic tracing, metal wires, and screen printed metal inks and the like.

13. The energy stimulation therapy system according to claim 2 wherein said at least one energy emitter module comprises a wearable electromagnetic energy emitter coupling module having at least one optical emitter in electronic communication with said stimulator package, wherein said wearable optical electromagnetic energy emitter coupling module is configured to be worn proximally to the external surfaces of the human ear comprising the auricular nerve field.

14. The wearable energy emitter coupling module according to claims 3, 4, 5, and 6 wherein said at least one ear-worn loop and energy emitter coupling module may further comprise stimulation generation electronics and stimulation control, modulation and switching electronics having wireless electronic communication with a said at least one user's said computer device; a power source and battery recharge circuits wherein said power source is selected from a group of battery power sources that include alkaline batteries, lithium batteries, capacitor batteries, micro-batteries and the like.

15. The energy emitter coupler modules of claims 2, 3, 4, 5, 6, 12 and 14, wherein said at least one energy emitter may be comprised of an electrode circuit having both negative and positive terminals configured to deliver electrical stimulation to the body of a said at least one user; said at least one wearable energy emitter coupling module includes at least two energy emitter units spatially arranged to have contact on the opposing, contralateral ventral and dorsal surfaces of the auricle to produce energy emissions designed to intersect nerve targets located between said ventral, ventrolateral and dorsal, dorsolateral surfaces, with said nerve targets belonging to a group of nerve targets within the auricular nerve field.

16. The energy emitter coupler modules of claims 2, 3, 4, 5, 6, 13, 14 and 15 wherein said at least one energy emitter may be comprised of an emitter of electromagnetic energy, wherein said at least one emitter of electromagnetic energy is selected from a group of optical emitters that includes LEDS, OLEDS, VCSELS, optical graphene emitters and the like;

17. The energy stimulation therapy system including claims 2, 3, 4, 5, 6, 7, 8, 9, 10 and 15 wherein said energy stimulation comprises electrical energy stimulation delivered to the body of a said at least one user via said at least one electrical energy emitter module coupled to the body of a said at least one user; said electrical stimulation current is comprised having at least one electrical frequency selected from a range of electrical frequencies between 0.5 hertz to 250 hertz; said electrical current is comprised having a waveform selectable from a group of waveforms that includes sinusoidal waveforms, triangular waveforms, square waveforms, and combinations thereof and the like.

18. The energy stimulation therapy of system of claims 2, 3, 4, 5, 6, 7, 9, 10, 11, 13, 14 and 16 wherein said energy stimulation comprises electromagnetic energy stimulation delivered to the body of a said at least one user via said at least one electromagnetic optical energy emitter module coupled to the body of a said at least one user; said at least one emitter of electromagnetic energy is configured for emitting and transcutaneously delivering to the body of a said at least one user electromagnetic energy having wavelengths selected from a range of wavelengths between 400 and 1600 nanometers; said electromagnetic energy is delivered to the body of a said at least one user having a power density selected from the range of fluence between 0.5 and 35 joules per square centimeter.

19. The energy stimulation therapy system according to claims 7, 9, 10, 11, 17 and 18 further comprising at least one biofeedback sensor module removably coupled to the body of said at least one user to enable monitoring of a said at least one user's biological signals and status; communication hardware and software protocols electronically linking said biofeedback sensor module with a said at least one user's said at least one computer device, wherein said communication hardware and software protocols are selected from a group of communication hardware and software protocols that includes Bluetooth, Wi-Fi, Zigby, and the like; said at least one sensor in said biofeedback sensor module belonging to a group of biofeedback sensors that includes a heart rate sensor, a Heart Rate Variability (HRV) sensor, a blood pressure sensor, an oxygen saturation sensor, a breathing sensor, a sensor for detecting peripheral vasodilation and vasoconstriction, sensors for detecting autonomic nervous system activity, sensors for detecting brainwaves and the like; software installed on said at least one computer device including at least one database for storing data received from a said at least one user's said biofeedback sensor module.

20. The energy stimulation system of claims 2, 3, 4, 5, 6, 17 and 18, wherein said stimulator package additionally comprises at least one audio input channel; frequency analysis electronics and an algorithm to determine the fundamental dominant frequency of incoming audio received via said at least one audio input channel selected by a said at least one user from a group of incoming audio that includes voice audio, music audio and audio ambient in a said at least one user's immediate physical environment; frequency modulating and conditioning electronics which modulate at least one stimulation signal according to the said determined dominant frequency of said input audio; at least one audio emitter affixed to the descending dorsal stem of said at least one ear-worn loop coupler wherein said at least one audio emitter is positioned and worn proximal to at least one ear-canal of a said at least one user.

Description

DRAWING FIGURES

[0034] FIG. 1. Smart Stimulation System Block Diagram illustrates a user's human ear to which is applied an exemplar energy stimulation earpiece. Said earpiece connects to a stimulation generator package in communication with a personal computing platform. Said computing platform locally controls modalities of operation with said user and inputs biofeedback signals and serves as a gateway through the internet to a web server to enable various remote functions such as data aggregation, evaluations and operational parametric protocols.

[0035] FIG. 2A Human ear nerve fields subject to beneficial energy stimulation.

[0036] FIG. 2B Human ear ventrolateral stimulation targets,

[0037] FIG. 2C Human ear dorso-crotch stimulation targets.

[0038] FIG. 3A An exemplar adjustable stimulation earpiece to be worn by a user that provides a single ventrolateral stimulation emitter and a plurality of dorsal and a plurality of complimentary located dorsolateral and dorsal crotch electric energy stimulation emitters.

[0039] FIG. 3B An exemplar adjustable stimulation earpiece to be worn by user that provides a plurality of electric energy stimulation emitters and a plurality of complimentary located dorsolateral and dorsal crotch electric energy stimulation emitters.

[0040] FIG. 4A An exemplar adjustable stimulation earpiece to be worn by a user that provides a plurality of ventrolateral stimulation emitter and a plurality of dorsal and a plurality of complimentary located dorsolateral and dorsal crotch optical energy stimulation emitters.

[0041] FIG. 4B An exemplar adjustable stimulation earpiece to be worn by a user that provides a plurality of ventrolateral stimulation emitter and a plurality of dorsal and a plurality of complimentary located dorsolateral and dorsal crotch optical energy stimulation emitters with an audio earbud.

[0042] FIG. 5A An exemplar spring actuated adjustable compression force clip designed to be affixed to a user's ear lobe with a stimulation connection cable affixed at the bottom end of said clip.

[0043] FIG. 5B An exemplar spring actuated adjustable compression force clip designed to be affixed to a user's ear lobe with a stimulation connection cable affixed to a swivel connector at the upper end of said clip.

[0044] FIG. 5C An exemplar press to position ear lobe stimulation clip.

[0045] FIG. 6A An exemplar ear lobe clip version worn on a user's ear with bottom affixed connection cable looped over said ear.

[0046] FIG. 6B An exemplar ear lobe clip version worn on a user's ear with upper affixed connection cable looped over said ear.

[0047] FIG. 6C An exemplar ear lobe clip version worn on a user's ear with bottom connection cable attached to a separate ear loop.

[0048] FIG. 6D An exemplar energy stimulation earbud designed for ventrolateral coupling contact.

[0049] FIG. 6E Illustrates an exemplar energy stimulation earbud in user's ear with contact and cable.

[0050] FIG. 7. Illustrates a configuration of a user wearing a stimulation electronics package supported by a lanyard about the neck with attached cable leading from said lanyard to ear worn stimulation energy emitter coupling module assembly.

[0051] FIG. 8 Remote Function Block Diagram illustrates the signal and information flows from a user's mobile computing platform, through the internet cloud, web server remote function application and health care providers.

[0052] FIG. 9 Stimulator Unit Block Diagram illustrates the major functional components incorporated in a typical stimulation generator electronics package.

REFERENCE NUMERALS IN DRAWINGS

[0053] 80 Human ear, [0054] 81 Trigeminal nerve fiber zone [0055] 82 Vagus nerve fiber zone [0056] 83 Great auricular nerve fiber zone [0057] 84 Lesser occipital nerve fiber zone [0058] 85 Ventrolateral Trigeminal Nerve (v.3) (TNV3) Target D1 [0059] 86 Ventrolateral Auricular Branch Vagus Nerve (ABV) Target D2 [0060] 87 Ventrolateral Lesser Occipital Nerve (LON) Target D3 [0061] 88 Ventrolateral Auricular Branch Vagus Nerve (ABV) Target D4 [0062] 89 Ventrolateral Great Auricular Nerve (GAN) Target D5 [0063] 90 Dorsolateral Trigeminal Nerve Target V1 [0064] 91 Dorsolateral Auricular Branch Vagus Nerve Target V2 [0065] 92 Dorsolateral Lesser Occipital Nerve Target V3 [0066] 93 Dorsolateral Auricular Branch Vagus Nerve Target V4 [0067] 94 Dorsolateral Great Auricular Nerve Target V5 [0068] 100 Energy emitter coupling module assembly [0069] 101 Ear loop structure [0070] 102 Ear loop dorsal lateral emitters [0071] 103 Ear loop crotch emitters [0072] 104 Energy stimulator ventrolateral contact shape 1 [0073] 105 Ear loop arm swivel assembly [0074] 106 Energy stimulator ventrolateral contact shape 2 [0075] 107 Ear loop swivel arm [0076] 108 Ear loop extension arm [0077] 109 Ear stimulator connection cable [0078] 120 Optical energy ear loop [0079] 121 Optical energy dorsal lateral emitter [0080] 122 Optical energy crotch emitter [0081] 130 Optical energy ear loop with audio [0082] 131 Audio swivel hub subassembly [0083] 132 Audio earbud speaker subassembly [0084] 140 Stimulator package assembly [0085] 141 Stimulator lanyard [0086] 150 Ear lobe compression type clip assembly [0087] 151 Ear lobe clip arm 1 [0088] 152 Ear lobe clip arm 2 [0089] 153 Ear lobe clip arm cam slot [0090] 154 Ear lobe clip arm cam slider [0091] 155 Ear lobe clevis position lock and release assembly [0092] 156 Ear lobe arm compression torsion spring [0093] 157 Ear lobe stimulation emitter contact [0094] 158 Ear lobe clip connection cable [0095] 160 Ear lobe press to set position clip assembly [0096] 161 Ear lobe clip cable connector swivel [0097] 162 Ear lobe clip crotch loop [0098] 163 Conductive adhesive ear lobe energy emitter coupler [0099] 164 Ear lobe clip press to set position release [0100] 170 Earbud wedge [0101] 171 Earbud concha loop [0102] 200 Stimulation electronics unit [0103] 300 Personal mobile computing platform

DESCRIPTIONS OF PREFERRED AND SYSTEM EMBODIMENTS

[0104] The present invention comprises a system of hardware components and software integrated to provide energy stimulation to specific nerve targets proximal to a human user's ear. As illustrated by the system block diagram in FIG. 1, said components include a personal mobile computing platform 300, a stimulation unit 200 and a variety of electromagnetic energy stimulation emitter earpieces 100 worn about the ear 80.

[0105] A significant advantage of the present invention is that stimulation of a target nerve field is by means of energy flow through the nerve field rather than conventional electric stimulation techniques in which the electric current flows between two adjacent surface contacting electrodes.

[0106] For clarification, various embodiments for each component and methods for use are categorized and described separately herein.

[0107] User Mobile Personal Computing Platform

[0108] A preferred embodiment for said computing platform 300 consists of a conventional smart phone, tablet or computer, providing an intelligent graphic user interface (GUI) with Internet and local connectivity network interfaces such as WIFI, Bluetooth and USB. Said controller operates under software applications to communicate with a with a cloud based web server for client data tracking, software upgrades and user session protocol stimulation optimization. The controller communicates with said stimulation unit 200 by means of wireless connection such as Bluetooth or a wired serial communication such as USB.

[0109] In a further embodiment, said computing platform incorporates audio output to instruct and prompt the user to invoke proper control commands. Such audio instructions include proper ro attachment of the stimulation emitter and prompts for setting stimulation parameters and protocol selection. Said instructions may be downloaded remotely from health care providers via the internet to the user mobile computing platform.

[0110] In a further embodiment, said computing platform incorporates voice recognition to enable the user to conveniently invoke control commands such as to start, pause or end a stimulation session and to adjust the stimulation intensity level.

[0111] In a further embodiment, said computing platform provides a graphical user interface to enable control output stimulation parameters including waveforms, intensity levels, frequency, as well as selection of pre-programmed protocols.

[0112] In a further embodiment, said computing platform may be used to output selected music to be received by said stimulation unit by means of wireless transmission or by direct wired audio output. Said audio output music is processed by said stimulation unit electronics to modify and coordinate various energy stimulation output waveforms, intensity and frequency parameters. Said stimulation output as modified by music may enhance the efficacy of energy stimulation for said user.

[0113] Stimulation Unit

[0114] A preferred embodiment for said stimulation unit 200 includes electronic circuitry and battery powered, microprocessor controlled, multichannel amplifier system as depicted in FIG. 9. Said stimulation unit communicates with said user computing platform 300 unit by means of wireless connection such as Bluetooth or using a wired serial communication such as USB. Stimulation signals including waveforms, frequency and amplitude are generated by said microprocessor and converted to analog output energy by means of amplifier electronics.

[0115] A further embodiment, wherein the output stimulation energy is electric current, includes electronic circuitry and software to monitor output voltage and current and automatically adjust output to maintain stimulation setpoint levels in order to compensate for impedance variations inherent in maintaining consistent electrical contact between emitter contacts and associated skin tissue targets.

[0116] A further embodiment, wherein the output stimulation energy is electric or electromagnetic (photonic/optical) includes electronic circuitry and software to generate various ro waveforms such as square, pulsed, triangular and sinusoidal. Further, in the case of electrical said output stimulation energy, the intensity level is ramped up in a manner to minimize transient transmission cable inductive spikes inherent with square waves that has been shown to irritate skin tissue with prolonged use.

[0117] Current research results indicates the optimal effect of nerve stimulation occurs in the range from 0.5 to 250 Hertz. Additionally, research also has found electromagnetic energy provides optimal parasympathetic nervous system response in the range of wavelengths from 400 to 1600 nanometers with a fluence power density from 0.5 to 35 joules per square centimeter.

[0118] A further embodiment incorporates electronics and application software to modify said stimulation signals such as waveforms, intensity and frequency modified in accordance with audio input signals such as music received from said computer platform by through wireless means such as Bluetooth or hardwired connection.

[0119] A further embodiment provides electronic circuitry to enable use of a rechargeable battery to provide power to the stimulation unit.

[0120] A further embodiment utilizes the microprocessor to monitor and control power supply and battery charger functions and communicate battery condition data to said computing platform.

[0121] A further embodiment provides wired or wireless connection of an auxiliary remote control device connected to said stimulation unit to enable basic control functions such as start, stop, pause and intensity control. Said control device may also include rudimentary operational displays as convenient to allow operation without the need for realtime connection to said user mobile platform.

[0122] Energy Stimulation Emitters

[0123] Embodiments for said energy stimulation emitters may include electrical or photonic types designed to target specific nerve field targets as indicated in FIG. 2A, FIG. 2B and FIG. 2C and held proximal to a user's ear by means of energy emitter coupler apparatus. FIG. 3A illustrates an electrical energy type with at least one emitter 104 supported by an ear loop 100 assembly fitted over and within the fold of the ear and skull, termed herein as crotch.

[0124] FIG. 3B illustrates an embodiment incorporating an ear loop 101 integrating one or more electrical energy coupling emitters 102 and 103 designed to contact the dorsal side nerve targets 90 through 93 as depicted in FIG. 2C. A rotary slip ring swivel assembly 105 supports one or more swivel arms 107 and mating extension arms 108. Said rotary slip ring provides mechanical coupling and may be designed utilizing a removal pin or post, or by plug-in features made part of said swivel arms. Additionally, said rotary slip ring can include electrical contacts fabricated by means of mechanical components molded or assembled into, or by means of conductive material molded or printed as part of said swivel. Said extension arm supports electrical energy emitters 104 or 106 configured to address specific desired said nerve targets. As indicated, said emitter 104 is shaped to optimally fit and contact the Ventrolateral Auricular Branch Vagus Nerve target 88 as depicted in FIG. 2B. FIG. 3B illustrates an embodiment of said ear loop with said slip ring swivel assembly supporting three said support arms with different shaped energy coupling emitters. Said emitter 106 is shaped to optimally fit and contact the Ventrolateral Trigeminal Nerve (v.3) (TNV3) 85 and the Ventrolateral Auricular Branch Vagus Nerve (ABV) 88.

[0125] In one embodiment, said ear loop connects to said stimulation unit by means of a multiconductor electrical cable 109. In a further embodiment, said ear loop includes stimulation electronics and communicates with said user controller via wireless or by means of said cable. This embodiment may also include said cable 109 to provide electrical power and utilize fiber optic for transmission of stimulation waveforms to said loop integrated stimulation electronics.

[0126] Further embodiments in FIG. 4A illustrates an optical energy stimulation ear loop 120 with an array of optical dorsal lateral energy emitters 121 and an array of optical crotch energy emitters 122. FIG. 4B similarly illustrates said loop and emitter arrays with addition of an electromechanical swivel 131 and audio earbud 132 to operate in coordination with stimulation electronic circuits and software to enable modulation of the intensity, frequency and waveforms of stimulation energy with the fundamental frequency of selected audio signals which may be music, biofeedback audio response or other sounds found therapeutically beneficial.

[0127] Further embodiments in FIG. 5A FIG. 5B, FIG. 5C, FIG. 6A, FIG. 6B and FIG. 6C provide various means for electromechanical connection for an emitter coupling contacts on said user ear lobe. FIG. 5A and FIG. 5B illustrates a spring compression clip type 150 whereby the compression force exerted by a torsional spring 156 squeezing upon the earlobe by the ear lobe stimulation emitter contacts 157 as exerted by ear lobe arm 1 151 and ear lobe arm 2 152 is ro adjustable by means of a manually operated cam slider 154 restrained by a cam slot 153. Said cam and slot include features such as frictional grooves or ratchet teeth in order to maintain user set position. Said torsional compression spring may be a metal spring component or conveniently molded or 3D printed as part of one or combined said arms. FIG. 5C illustrates a further embodiment of a press to set position earbud clip 160 whereby said coupling emitters are conveniently pressed into a set position upon the ear lobe by the user instead of exerting an active spring compression as is typical. The set position is maintained by means of friction or ratchet features integrated into the ear lobe clevis position lock and release assembly 155 which includes a torsional release spring 164 actuated to open said arms when depressed. Said torsional release spring may be a metal spring component or conveniently molded or 3D printed as part of one or combined said arms. The embodiment of FIG. 5B illustrates a cable connector swivel 161 which permits connection cable 158 to be conveniently connected toward the emitter. This feature may be applied to each of the three embodiments shown in FIG. 5A, FIG. 5B and FIG. 5C.

[0128] FIG. 6A, FIG. 6B and FIG. 6C illustrates further embodiments of ear lobe clips as worn on said user's ear. FIG. 6A shows a configuration wherein the emitter coupling 150 is attached to an ear lobe crotch loop 162 which connects to stimulator cable 109. FIG. 6B similarly illustrates an ear lobe clip 161 with said swivel connection. FIG. 6C similarly illustrates emitter coupling connection to said crotch loop and said cable by means an adhesive type ear lobe attachment 163 to support either an electrically conductive or photonic/optical emitter contact. FIG. 6D and FIG. 6E illustrate a typical ear wedge 170 and earbud concha loop 171 devices similar to conventional and available audio earbud speakers, the design of which may be employed to conveniently secure said emitters within the concha.

[0129] In a further embodiment, said loop supports the attachment of at least one modular, interchangeable emitter arm assembly 105 supporting a swivel arm 108 and extension arm 108. Each emitter arm thereby supports an interchangeable modular emitter contact. Each modular s arm integrates swiveling electromechanical connections for attachment to said loop and emitter. Said attached arms may be of a specific length, or incorporate a telescoping feature in order to conveniently accommodate and optimize positioning of said emitter(s) for a particular user.

[0130] In a further embodiment, said swivel and arms provide indexing features to indicate user set swivel and extension positions to conveniently aid the user to record and reset said positions for future use. A further embodiment provides the means to lock said set positions.

[0131] The present invention includes a clip type emitter coupling to enable positioning energy emitter contact upon a user's ear lobe in either or both anteriorly or posteriorly. In order to alleviate user discomfort experienced by conventional clips, the present invention provides two different clip design versions as illustrated in FIG. 5A and FIG. 5B. One version incorporates a sliding cam 154 that enables the user to adjust the spring compression pressure squeezing emitter contacts upon the ear lobe. FIG. 5C incorporates a spring that causes the emitter contacts to open away from the ear lobe. The user then presses the jaws to close against the ear lobe with sufficient pressure to firmly yet comfortably hold the clip in position for effective emitter contact.

[0132] Said ear loop, arms and emitter contacts may be manufactured using conventional plastic injection molded plastic technology. The design may also be conveniently utilize new and future 3D printing technology that can incorporate electrically conductive traces and electrode contact pad surfaces in order to minimize manufacturing process steps, manual assembly and number of components. One advantage of 3D printing wearables is the potential for combining with 3D body (dimension) scanners to make individually customized, fit-optimized wearables that are consequently capable of reading biosignals and delivering stimulation at the lowest effective fluence thereby reducing potential nerve and tissue damage.

[0133] Stimulator Unit Wearable Devices

[0134] FIG. 7 depicts a stimulator package assembly 140 to be worn by the user fastened to a lanyard 141. Said stimulator package assembly includes said stimulator unit which may be connected by a cable 109 or wireless to said energy emitter coupling module assembly 100. Further embodiments to enable the user to conveniently wear said stimulator package include strap clip, pocket clips, belt clip, or other typical fastening devices such as adhesive or hook and loop that provide wearing about the neck, limbs or about the body. In addition, said wearable means may also be used to fasten or attach biofeedback sensors.

[0135] Web Based System

[0136] FIG. 8 depicts an integrated system with a user mobile platform to provide communication via the internet cloud with remote health care providers and web server hosting remote function application software. Said user mobile platform provides local and internet wireless communication, graphical user interface and computational capability and serves to monitor and control said stimulation unit, biofeedback devices and audio input and output. Said web server and application software provide a variety of services for user by users and by health care providers, clinicians and robotic therapist. Application functions include sending user device lock and unlock codes (password) for user security; user compliance tracking; review and tracking of user system parameters; setting and monitoring of user symptom alarms; updating user stimulation parameters; sending of symptom tests to users; storage and aggregating user treatment data; analysis of user data; developing optimized therapy protocols; data formatting for clinical research for clinical trials.

[0137] Manufacturing Techniques

[0138] Devices described by the invention including the ear loop and ear lobe clip embodiments as described and illustrated can be manufactured utilizing conventional materials and processes such as single and multiple plastic injection molded parts, overmolded plastic and silicone and electrically conductive silicone metal stamped electrical and mechanical components and assembled using bonding adhesives. Electrical connections and signal routing within said devices can be readily manufactured utilizing direct wiring; for example between said emitter contacts and electrical cable connections. It is further anticipated that said devices can advantageously be designed and fabricated using advanced materials and additive manufacturing (AM/3D printing) processes, especially as technology improves and costs are reduced. Significantly, components can be manufactured in one process step, utilize a variety of materials to provide integrated electrically conductive circuits, selective flexibility/rigidity and colors, and rapid and one of a kind customization.

[0139] A current prototype design of said three arm earloop as described and illustrated in FIG. 3D, for example, enables 3D printing of all mechanical components including the electrical cable connection to cable 109; internal electrically conductive traces and electro-mechanical slip ring contacts at 104 and 105 as well as the telescoping swivel and extension arms 107 and 108; and electrically conductive nerve target said emitter contacts 102, 103, 104 and 106.