MULTIMODAL, MODULAR, MAGNETICALLY COUPLED TRANSCUTANEOUS AURICULAR STIMULATION SYSTEM INCLUDING APPARATUS AND METHODS FOR THE OPTIMIZATION OF STIMULATION AND THERAPEUTIC INTERVENTIONS

Abstract

An improved modular, multi-modal neurostimulation system, includes signal generating, conditioning, and control electronics, stimulation monitoring electronics, and wearable, magnetically coupled energy emitter modules configured for coupling energy emitters to the ear for transcutaneous energy delivery to cranial nerves neurologically accessible in the auricular nerve field. Three energy modalities are available via electrodes for electrical stimulation; optical emitters for electromagnetic stimulation; vibrational emitters for vibrational stimulation. Energy modalities are selectable singularly or in combination. Stimulation control electronics may be integrated within an ear-worn coupling body or located in an external computerized device. Integrated bodily status and biofeedback sensors work with a programmable algorithm to enable closed loop operation based on monitored biofeedback activity, bodily activity and indicia of autonomic functioning. A method for optimizing stimulation using cardiorespiratory feedback and monitoring of divisional indicia of autonomic nervous system function is discussed. Disclosed is a method for optimizing therapeutic interventions via neurostimulation and a method for self-administered neurostimulation and training users in self-administered neurostimulation. Also disclosed is a stimulation coupling apparatus comprising a contour conforming plastic composition for coupling stimulation energy emitters to the auricle of a human being.

Claims

1. An improved, modular energy stimulation system comprising apparatuses including energy stimulation means for generating and conditioning stimulation energy, controller means for controlling said energy stimulation means, magnetic coupling means for coupling energy emitter means to at least one ear of a human being and applying energy stimulation to at least one cranial auricular nerve accessible in the auricular nerve field of a said human being, wherein: said energy stimulation means includes a stimulator for generating and conditioning energy for stimulation, a power source, power control and recharging electronics, and at least one channel of stimulation energy output; said magnetic coupling means providing magnetic coupling force sufficient to securely and conductively couple at least one said energy emitter means to the said at least one auricle of a said human being; said magnetic coupling means is configured for coupling a said at least one energy emitter means to the auricle of a human being; said at least one energy emitter means is selected from a group that includes emitters of electrical energy, optical emitters of electromagnetic energy, and emitters of vibrational energy; said controller means is configured to control energy stimulation parameters selected from a group that includes stimulation frequency, waveform, pulse rate, pulse width, amplitude, stimulation duration, stimulation periodicity, and the like; said stimulation periodicity is comprised of at least one selected time interval of stimulation delivery over a 24 hour period; said at least one cranial nerve is selected from a group of nerves accessible in the auricular nerve field that includes the auricular branch of the vagus nerve, the auriculotemporal nerve, the lessor occipital nerve, and the great auricular nerve also known as the greater auricular nerve.

2. The system of claim 1, wherein: said at least one magnetic coupling means is comprised having at least one magnet and at least one magnetic composition; said magnetic coupling means is comprised having interchangeability means to enable the removal and replacement of magnetic compositions of different magnetic strengths according to the coupling force preferred a human user; at least one said magnetic coupling means and at least one said energy emitter means are configured as an at least one ear-worn coupling apparatus; said at least one ear-worn coupling apparatus is comprised having a dorsal body worn behind the auricle against the dorsal-dorsolateral crotch of the auricle of a human being; said at least one ear-worn coupling apparatus having a weight between 2.5 and 120 grams.

3. The system of claim 2, wherein: said at least one ear-worn coupling apparatus is be further comprised having at least one ventral coupling module including at least one energy emitter means; said at least one ventral coupling module is worn having contact with the front, ventral-ventrolateral surface of the auricle; said at least one ventral coupling module is further comprised having at least one magnetic composition for coupling the ear between said dorsal body and said at least one ventral coupling module; said at least one ventral coupling module is electronically connected to said dorsal body by at least one adjustable conductor means; said at least one adjustable conductor means having adjustability features belonging to a group of adjustability features including positionability, rotatability, flexibility, bendability and the like; said controller means is configured for the selective 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, signal duty cycle, periodicity of stimulation, total energy delivered and the like.

4. The system of claim 3, wherein: said at least one ventral coupling module is configured for contact with the ventral-ventrolateral surfaces of the auricle; said dorsal body is comprised having at least one magnetic composition; said dorsal body and said at least one ventral coupling module are configured for magnetically coupling said at least one energy emitter to the auricle of a human being; said dorsal body is further comprised having at least one connector port for connecting said at least one adjustable conductor means; said at least one connector port on said dorsal body connects said dorsal body to said at least one ventral coupling module via said adjustable conductor means; said adjustable conductor means is comprised of conductive material selected from a group that includes metal wire, conductive plastic material, conductive elastomers, and the like.

5. the system of claim 4, wherein: said at least one ventral coupling module and said dorsal body, each having at least one electrical energy emitter, comprise an electrical energy emitter circuit; said electrical energy emitter circuit is configured to be coupled to the said ventral-ventrolateral and said dorsal-dorsolateral surfaces of a said person's said auricle; said electrical energy emitter circuit is configured to spatially and anatomically intersect said at least one auricular nerve target; said nerve intersection comprises the positioning of a said at least one energy emitter circuit's energy emitters on opposing ventral-ventrolateral and dorsal-dorsolateral surfaces of the auricle wherein a said at least one target nerve lies in-between.

6. The system of claim 5 wherein: said at least one ventral coupling module includes energy emitters selected from a group that includes emitters of electrical energy, optical emitters of electromagnetic energy, and emitters of vibrational energy; said dorsal body includes energy emitters selected from a group that includes emitters of electrical energy, optical emitters of electromagnetic energy, and emitters of vibrational energy; said emitters of electrical energy are configured to emit electrical stimulation current having at least one electrical frequency selected from a range of electrical frequencies between 0.5 Hertz to 250 Hertz; said optical emitters of electromagnetic energy are selected from a group of optical emitters that includes LEDS, OLEDS, VCSELS, optical graphene emitters and the like; said optical emitters of electromagnetic energy emit electromagnetic energy having wavelengths selected from a range of wavelengths between 400 and 1600 nanometers; said optical emitters of electromagnetic energy are configured to emit electromagnetic energy having a power density selected from the range between 0.5 and 25 joules per square centimeter; said emitters of vibrational energy are configured to emit vibrational energy at frequencies of 1 Hertz to 10,000 Hertz.

7. The system of claim 6, further comprising: at least one computerized device selected from a group that include a conventional desktop computer, a notebook computer, a laptop computer, a smartphone, a tablet, a handheld computer and a wearable, user-attached computerized device; a graphical user interface configure to provide selective 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, signal duty cycle, and time intervals of stimulation delivery, stimulation periodicity, total energy delivered and the like; said at least one computer device having hardware configured for electronic communication between said at least one computer device and said stimulator, said hardware configured for said electronic communication selected from a group that includes hardware for wired communication and hardware for wireless communication; said communication hardware and said 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 system according to claim 7, further comprising: at least one biofeedback sensor means configured for sensing biological signals and biological functioning of a said human being; at least one bodily activity sensor means configured for sensing the movement and bodily position of a said human being; said at least one biofeedback sensor means selected from a group that includes sensors configured for photoplethysmography, skin conductance monitoring, electromyographical monitoring, and the like; said photoplethysmography configured to monitor at least one cardio-respiratory parameter belonging to a group that includes heart rate, respiratory rate, heart rate variability, arrhythmia, normal sinus rhythm, oxygen saturation and blood pressure; algorithmic control means configured for controlling the delivery of energy stimulation in accordance with algorithm determinants and data obtained from said biofeedback sensor means and said bodily activity sensing means.

9. The system according to claim 8, wherein: said photoplethysmograph monitoring is configured to detect cardiologic activity of a user, particularly normal sinus rhythm, pathological arrhythmias, and respiratory sinus arrhythmia also known as RSA; said detection of said respiratory sinus arrhythmia is accomplished by monitoring to detect the start and end of periods of said respiratory sinus arrhythmia; said photoplethysmograph monitoring is configured to detect the normal sinus rhythm of the heart beats of a user; said detection of said normal sinus rhythm is accomplished by monitoring to detect the start and end of periods of said normal sinus rhythm; said photoplethysmographic monitoring of said respiratory sinus arrhythmia is used to gate stimulation according to detected said respiratory sinus arrhythmia; said photoplethysmographic monitoring of said normal sinus rhythm is used to gate stimulation according to detected said normal sinus rhythm; said photoplethysmographic monitoring of said cardiologic activity of a user is used to gate stimulation according to detected pathological heart rhythms known as arrhythmias; at least one algorithm is composed for selectively controlling stimulation parameters according to algorithm determinants and monitored bodily-generated, sensor-received data selected from a group of sensors means that includes said photoplethysmography sensor means, said biofeedback sensor means, and said bodily activity sensor means.

10. The system according to claim 9, wherein: said photoplethysmography sensor means is further configured to monitor at least one index of autonomic nervous system activity; said photoplethysmographically monitored at least one index of autonomic nervous system activity includes one or more heart rate variability (HRV) frequency domains selected from a group that includes high frequency, low frequency, very low frequency and ratios thereof, and the like; said movement and bodily position sensor are configured to monitor body position changes and body positions including standing, sitting, reclining, and lying supine, and the like; said movement and bodily position sensors are configured for monitoring the acceleration, motion, and position of the body in whole or in part; said at least one algorithm is composed for selectively controlling one or more stimulation parameters according to algorithm determinants and said at least one monitored index of autonomic nervous system activity, and data from said biofeedback sensor means and movement and bodily position sensors; said neurostimulation system is comprised as an algorithm-operated and algorithm-controlled closed-loop system; said closed loop system is further comprised as a self-contained wearable system having a power source and control electronics integrated within a said at least one dorsal body, or composed within a separate second body having electronic communication with said at least one dorsal body and said at least one ventral coupling module; said one or more stimulation parameters controlled by said at least one algorithm are selected from a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, power amplitude, fluence, waveforms, wavelengths, pulse widths, phase characteristics, stimulation channels, stimulation session periods, signal duty cycle, periodicity of stimulation, total energy delivered and the like.

11. A method of optimizing therapeutic interventions via neurostimulation, the method comprising: the use of a neurostimulation system configured for transcutaneous delivery of stimulation to at least one cranial nerve target in the auricular nerve field of a human being; at least one cranial nerve target is selected from a group of cranial nerves that includes the auricular branch of the vagus nerve, the lesser occipital nerve, the trigeminal nerve and the great auricular nerve also known as the greater auricular nerve; said neurostimulation system is configured to emit energy from at least one energy emitter selected from a group that includes emitters of electrical energy, optical emitters of electromagnetic energy, and emitters of vibrational energy; at least one selectable energy modality is selected from a group that includes electrical stimulation current having at least one electrical frequency selected from a range of electrical frequencies between 0.5 hertz to 250 hertz with a pulse-width in the range from 100 to 500 micro-seconds (S); optically emitted electromagnetic energy having at least one wavelength selected from a range of wavelengths between 400 and 1600 nanometers emitted at a frequency of between 1 and 5,000 Hertz; said optically emitted electromagnetic energy having at least one power density or fluence selected from the range of fluence between 0.5 and 30 joules per square centimeter; vibrational energy having at least one frequency in the range of 1 Hz to 20,000 Hertz with a pulse-width in the range from 100 to 500 micro-seconds (S); said neurostimulation system is configured to produce at least one energy train having controller-modulated stimulation parameters selected from a group that includes energy frequency, energy intensity, energy fluence, stimulation time duration, energy pulse width, energy waveform, and total energy delivered, stimulation periodicity, and the like; neurostimulation controller functions are operable by means selected from a group of controller function operation means that includes a local human operator, a remote human operator, and at least one algorithm; said neurostimulation controller functions include the adjustment of at least one stimulation parameter selected from a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, stimulation periodicity, total energy delivered and the like; said neurostimulation is selectively timed, applied and parameterized in relation to a therapeutic intervention, wherein said relation marker belongs to a group that includes a temporal marker relative to the delivery of said neurostimulation and a said therapeutic intervention; at least one exteroception marker targeted by a said therapeutic intervention; at least one interoception marker targeted by a said therapeutic intervention; at least one biofeedback marker target by a said therapeutic intervention; a hybrid combination of said markers.

12. The method of claim 11, wherein a said temporal relation marker is based on timing of neurostimulation relative to a said therapeutic intervention; said neurostimulation is delivered for a period of time occurring in at least one of the temporal periods selected from a group that includes: a pre-therapy period comprising the temporal period before a said therapeutic intervention; a concurrent-therapy period comprising the temporal period concurrent with a said therapeutic intervention; a post-therapy period comprising the temporal period after a said therapeutic intervention; said pre-therapeutic neurostimulation is delivered in the temporal period from 20 minutes to 0.001 second prior to a said therapeutic intervention to prepare the neurological environment of a human being for a said therapeutic intervention; said concurrent neurostimulation is delivered concurrently, during the time period concurrent with a said therapeutic intervention to enhance the effectiveness of a said therapeutic intervention; said post-therapeutic neurostimulation is delivered in the time period after a said therapeutic intervention to enhance recovery from a said therapeutic intervention or maximize the effect of a said therapeutic intervention.

13. The method of claim 11, wherein said neurostimulation is commenced in relation to a said at least one targeted exteroception marker selected from a group of targeted exteroception markers that includes a time of day, the presence of one or more persons, a situation, an interpersonal interaction, a behavioral event, an environmental event, an activity of daily living a life experience, and the like.

14. The method of claim 11, wherein said neurostimulation is commenced in relation to a said at least one targeted interoception marker selected from a group of targeted interoception markers that includes a mood, a perception of stress, a psychological experience, a bodily experience, a bodily sensation, breathing, awareness of bodily processes, nociception, and the like.

15. The method of claims 11 wherein biofeedback monitoring means are employed to monitor the biological signals of a person for the occurrence of a said at least one biofeedback marker; said neurostimulation is conditional in relation a said at least one targeted biofeedback marker selected from a group of targeted biofeedback markers that includes: at least one galvanic skin response (GSR) or skin conductance marker; at least one electromyography marker indicating muscle tension or muscle activation; at least one skin temperature marker obtained from a finger-applied temperature sensor; at least one cardiologic activity marker such as particularly markers of heart rate, heart rate variability, normal sinus rhythm, respiratory sinus arrhythmia (RSA), and pathological arrhythmias; at least one respiration marker, such as respiratory rate, expiration, inspiration, oxygenation, and the like; at least one neurological marker, such as brainwave frequency, amplitude and dominance; an index of autonomic nervous system activity used as a marker, includes heart rate variability frequency domains, low frequency and very low frequency; said neurostimulation conditionality invokes changes in neurostimulation selected from a group that includes commencement of stimulation, cessation of stimulation, re-parameterization of stimulation and the like.

16. The method of claim 15, wherein said monitored biofeedback activity includes cardio-respiratory activity, neurological activity, skin conductance, electromyography, peripheral skin temperature, brainwave activity and the like; said monitoring of said cardio-respiratory activity is accomplished using photoplethysmography; said photoplethysmography is further configured to monitor at least one index of autonomic nervous system activity; at least one algorithm is used to selectively control stimulation parameters according to algorithmic determinants and said monitored biofeedback activity; said at least at least one algorithm incorporated as a neurostimulation controller means uses said monitored biofeedback to determine and adjust at least one stimulation parameter belonging to a group that includes energy frequency, energy intensity, stimulation time duration, energy pulse width, energy waveform, stimulation duty cycle, stimulation periodicity, total energy delivered and the like.

17. The method of claim 15 wherein at least one healthcare provider trains a person or group in the self-administer of said method of neurostimulation, said training comprising/including: education regarding the identification and selection of exteroception marker targets relative to neurostimulation; education regarding the identification and selection of interoception marker targets relative to neurostimulation; education regarding the identification and selection of nociception marker targets relative to neurostimulation; instruction in at least one beneficial purpose of using the said neurostimulation method; instruction in decision-making regarding makers and indications for beneficially using said neurostimulation method; training in the use of a said neurostimulation system, including parameterization, the application of a said at least one energy emitter to a said at least one cranial nerve target in the said auricular nerve field; repeated supervised practice in recognizing said exteroception, interoception and nociception markers personally relevant to the subject individual; training in decision-making about parameterizing and timing said neurostimulation relative to any said personally relevant markers of exteroception, interoception and nociception; repeated supervised practice using said neurostimulation wherein said practice includes preparing the skin, applying a said least one energy-emitter, and selecting stimulation parameters or an at least one pre-parameterized stimulation program.

18. The method of claim 17, wherein training in said self-administration of neurostimulation further includes the use biofeedback means to provide marker and determination guidance, further comprises; education about the anatomy and function of the autonomic nervous system; education about the bodily processes and biological signals sensed and monitored by biofeedback means; education regarding the identification and selection of biofeedback marker targets relative to neurostimulation; training in the selection and use of biofeedback monitoring means relative to neurostimulation; supervised practice in setting up biofeedback means, and in reading and interpreting data obtained therefrom; supervised practice in incorporating said data obtained from said biofeedback means into decision-making regarding the said timing and parameterization of said neurostimulation.

19. An improved, anatomically individualized, contour conforming auricular neurostimulation apparatus to apply energy stimulation to at least one of the cranial nerves accessible in the auricular nerve field, the apparatus comprising: at least one conformal coupling means comprising a conformal plastic composition having at least one energy emitter means; said at least one conformal coupling means couples said at least one energy emitter means to the ventral-ventrolateral surfaces of at least one auricle of a human being; said at least one energy emitter means coupled to said at least one auricle of a human being delivers energy stimulation to said at least one of the cranial nerves accessible in the auricular nerve field; said at least one of the cranial nerves accessible in the auricular nerve field is selected from a group that includes the auricular branch of the vagus nerve, the auriculotemporal nerve, the lesser occipital nerve and the great auricular nerve also known as the greater auricular nerve; said at least one energy emitter means is comprised with said at least one conformal plastic composition to correspond anatomically and spatially with auricular anatomical landmarks associated with said at least one of the cranial nerves accessible in the ventral-ventrolateral auricular nerve field; said anatomical landmarks include the cymba conchae, cavum concha, the tragus, the lobule also known as the ear lobe, the fossa triangularis, the superior crus of the antihelix, the inferior crus of the anti-helix, the helix, the scapha and the like; said at least one conformal plastic composition is comprised of a group of plastic materials that includes thermo-settable plastics, photonic-settable plastics and mechanically-settable plastics; said at least one energy emitter means is selected from a group of energy emitters means that includes emitters of electrical energy, optical emitters of electromagnetic energy, and emitters of vibrational energy; said at least one energy emitter means is selected from a group that includes metallic electrodes, conductive metal, optical emitters, haptic emitters, graphene emitters, conductive filaments, conductive ink, conductive plating and the like; electrically conductive pathways on said conforming plastic composition are composed of conductive compositions selected from a group that includes screen-printed carbon ink, 3-D printed conductive filaments, metallic tracing, screen printed conductive metallic inks and the like.

20. The contour conforming auricular neurostimulation apparatus of claim 19, further comprising: a second said conformal coupling means comprising a conformal plastic composition having at least one energy emitter means; said second conformal coupling means couples said at least one energy emitter means to the dorsal-dorsolateral surfaces of at least one auricle of a human being; said at least one energy emitter means is comprised with said at least one conformal plastic composition to anatomically and spatially correspond with auricular anatomical landmarks associated with at least one of the cranial nerves accessible in the dorsal-dorsolateral auricular nerve field; said at least one of the cranial nerves accessible in the auricular nerve field is selected from a group that includes the auricular branch of the vagus nerve, the auriculotemporal nerve, the lesser occipital nerve and the great auricular nerve also known as the greater auricular nerve; said anatomical landmarks include the posterior crus, the eminence of the triangular, also known as the eminence of the fossa triangularis, the eminence of the cymba conchae, the eminence of the cavum conchae, the antihelical fossa, the posterior antihelix, the posterior lobule, and the like; said at least one energy emitter comprised said second conformal coupling means is configured for electronic communication with a neurostimulation device.

Description

BRIEF DESCRIPTIONS OF THE DRAWINGS

[0037] FIG. 1A Stimulation apparatus, basic unit with stimulation cable.

[0038] FIG. 1B Stimulation apparatus, worn on human ear model 140, indicating dorsal component 104 and ventral module 104 inserted to the cymba concha 145 in order to stimulate the vagus nerve through the cavum concha nerve zone 163.

[0039] FIG. 1C Stimulation apparatus, self-contained wireless unit with dorsal side energy emitters.

[0040] FIG. 2A Human ear anatomical features as indicated 141 through 154.

[0041] FIG. 2B Human ear auricular nerve field indicating target nerve field zones.

[0042] FIG. 2C Human ear dorsolateral view indicating nerve targets including as indicated 165 through 169.

[0043] FIG. 3 Stimulator block diagram.

[0044] FIG. 4A Spherical magnet.

[0045] FIG. 4B Cylindrical magnet with diametric polarity.

[0046] FIG. 4C Cylindrical magnet with axial polarity.

[0047] FIG. 4D Block magnet with axial polarity.

[0048] FIG. 4E Block magnet with planar polarity.

[0049] FIG. 5A Block diagram with biofeedback to user interface.

[0050] FIG. 5B Block diagram with biofeedback to stimulator unit.

[0051] FIG. 5C Block diagram with emitter/biofeedback sensors multiplexed to stimulator unit.

[0052] FIG. 6 Biofeedback controlled neurostimulation block diagram.

[0053] FIG. 7 Temporal periods of stimulation and therapeutic intervention.

[0054] FIG. 8 Yerkey-Dodson Law of optimal arousal applied neurostimulation.

REFERENCE NUMERALS IN DRAWINGS

[0055] 100 Ear worn stimulation apparatus [0056] 101 Dorsal body [0057] 102 Ventral module (pod) [0058] 103 Ventral connection cable [0059] 104 Dorsal body crotch energy emitter coupler [0060] 105 Ventral module energy emitter coupler [0061] 106 External stimulator unit to dorsal body cable [0062] 107 Ventral stimulation trigeminal nerve zone energy coupler [0063] 108 Ventral stimulation lesser occipital nerve zone energy coupler [0064] 110 Computer platform [0065] 111 Communications interface [0066] 112 Stimulator unit [0067] 113 Stimulator controller [0068] 114 Stimulator energy monitor [0069] 115 Stimulator signal output [0070] 116 Protocol data table [0071] 117 Communication I/O [0072] 118 Processor program memory [0073] 119 Analog input [0074] 120 Waveform generator [0075] 121 Voltage monitor signal conditioning [0076] 122 Current monitor signal conditioning [0077] 123 Voltage control amplifier [0078] 124 Current control amplifier [0079] 125 Biofeedback sensor signal conditioning [0080] 126 Multiplexer [0081] 127 Ear worn stimulator emitter/biofeedback sensor couplers [0082] 128 Emitter to user skin coupling and tissue resistance [0083] 140 Human ear [0084] 141 Dorsal apex (farside) [0085] 142 Dorsal crotch (farside) [0086] 143 Cura of antihelix [0087] 144 Scapha [0088] 145 Cymba concha [0089] 146 Antihelix Cavum [0090] 147 Helix [0091] 148 Concha [0092] 149 Antitragus [0093] 150 Lobule [0094] 151 Cavum [0095] 152 Tragus [0096] 153 External auditory meatus [0097] 154 Crus of helix [0098] 155 Triangular fossa [0099] 160 Auricular nerve field [0100] 161 Trigeminal (v.3) nerve zone [0101] 162 Lesser occipital nerve zone [0102] 163 Cavum concha [0103] 164 Great auricular nerve zone [0104] 165 Dorsolateral trigeminal nerve target V1 [0105] 166 Dorsolateral auricular branch vagus nerve target V2 [0106] 167 Dorsolateral lesser occipital nerve target V3 [0107] 168 Dorsolateral auricular branch vagus nerve target V4 [0108] 169 Dorsolateral great auricular nerve target V5 [0109] 201 Magnet [0110] 202 Spherical magnet [0111] 203 Cylindrical magnet indicating diametric polarity [0112] 204 Cylindrical magnet indicating axial polarity [0113] 205 Block magnet indicating axial polarity [0114] 206 Block magnet indicating planar polarity [0115] 230 Biofeedback sensor array [0116] 231 Biofeedback photoplethysmography sensor [0117] 232 Biofeedback body/limb position sensor [0118] 233 Biofeedback body motion sensor [0119] 234 Biofeedback response exception circuit [0120] 235 Biofeedback body acceleration [0121] 236 Biofeedback body position and change rate algorithm [0122] 237 Biofeedback limb motion and change rate algorithm [0123] 238 Biofeedback control algorithm supervisor [0124] 239 Biofeedback control algorithm knowledge base [0125] 240 Biofeedback control algorithm determinants [0126] 250 Pre-intervention [0127] 251 Neurostimulation enhanced therapeutic pre-intervention phase 1 relaxation [0128] 252 Neurostimulation enhanced therapeutic pre-intervention phase 2 warm-up [0129] 253 Therapeutic intervention [0130] 254 Neurostimulation enhanced therapeutic intervention phase 3 exercise [0131] 255 Neurostimulation enhanced therapeutic intervention phase 4 rest [0132] 256 Neurostimulation enhanced therapeutic intervention phase 5 training [0133] 257 Post-intervention [0134] 258 Neurostimulation enhanced therapeutic post-intervention phase 6 recover [0135] 259 Neurostimulation enhanced therapeutic post-intervention phase 7 normalize

Apparatus Embodiments

[0136] Disclosed is an invention comprising an auricular neurostimulation system having modular components for selectively targeting one or more nerves and for selecting and applying the type of energy to be used for stimulation. The invention features removable coupling means for accomplishing secure and consistent positional contact of energy emitters and biofeedback sensors applied to skin surfaces overlaying the auricular nerve field of the human ear. Benefits of the invention include comfortable wearability, rapid attachment and removal, easy electrode positioning and superior attachment security.

[0137] The present invention couples energy emitter or electrodes to the skin of the human ear without adhesives or spring-actuated clamps, while employing compressive force sufficient to maintain the positions of the energy emitters and sensors relative to target nerves and sensor targets in all bodily orientations and during normal body movement including light exercise. In the present invention, said coupling is achieved by means of the coupling attraction force between a pair of magnets or a magnet and associated coupled ferromagnetic material.

[0138] In addition to providing consistent compressive contact and nerve intersecting positional alignment, the magnetic coupling between the dorsal and ventral sides of the ear provide positional stability of the ear-worn stimulation coupling apparatus.

[0139] In one exemplar embodiment, wherein stimulation of the auricular branch of the vagus nerve (ABVN) is exemplified, a representative stimulation apparatus 100 having a dorsal body 101 is worn over the dorsal-dorsolateral crotch of the ear 142 and a ventral module component 102 inserted as convenient in the cymba conchae concha trench 145 as shown in FIG. 1A. Said stimulation apparatus as shown in FIG. 1A and FIG. 1C consists of a dorsal body 101 and associated ventral module 102 each containing at least one magnet or an associated ferromagnetic material as convenient to affect magnetic attraction by opposing magnetic poles. Said dorsal body and ventral module components each have associated energy emitter contacts 104 and 105. A ventral module connection cable 103 provides mechanical attachment and electrical connectivity between said dorsal body component and said ventral module coupler. Said ventral module coupler and dorsal body components can be conveniently manufactured utilizing 3D or plastic injection molded materials and conventional processes.

[0140] Magnet components configured as shown in FIG. 4A through FIG. 4E are conventionally and readily available in a variety of sizes and magnetic forces. Magnet shapes include: spherical 201; cylindrical with diametric polarity 202; cylindrical with axial polarity 203; block with axial polarity 204; and block with planar polarity 205. Experimental prototypes utilizing magnets with paired contact attractive forces in the order of 2 to 5 pounds provide the necessary compression to effect the desired attributes of consistent and reliable energy stimulation contact, comfort and secure positioning. Additionally, said magnetic components can readily be custom manufactured in specified shapes, polarity and magnetic forces.

[0141] It is well known that characteristic coupling force between magnetic coupling is reduced according to the reciprocal of the distance squared (F=1/(D{circumflex over ()}2). Various magnet configurations may be utilized within the loop and ventral components in order to optimize compression forces upon selected nerve field ear tissue surfaces. Such configurations in various embodiments may include: different shapes, sizes and force characteristics; mechanically altering the distance between magnet components; mechanically altering polar orientation of magnets. Each of these configurations are considered with respect to the design goal to optimize the positions energy coupling emitters and biofeedback sensors as well as the comfort of the user.

[0142] Various design features may be incorporated as convenient in the structural design and manufacture of ventral and loop components to mechanically alter the position, orientation and distance factors. Using experimental prototype devices for the represented vagus nerve stimulation, the inventors have determined that optimized positional contact, ease of use and wearing comfort is achieved by designs that allow the magnet within the dorsal loop component to self-align magnetic force vectors in polar orientation and also to translate with respect to placement of said ventral module coupler. This has been tested and demonstrated in various prototypes incorporating spherical, block and cylindrical type magnets.

[0143] In a basic embodiment, the ear-worn stimulation coupling apparatus 100 includes a dorsal body component 101 and ventral module component 104 mechanically and electrically connected by means of connecting cable 110. Said dorsal body provides the mechanical structure to include at least one dorsal magnet 102 and at least one energy emitter. Said ventral module provides the mechanical structure to include at least one magnet and at least one energy emitter coupler 105.

[0144] Additionally, said dorsal body magnet and ventral module magnet may conveniently incorporate any one of or combination of the spherical, cylindrical and block types as indicated in FIG. 4A through FIG. 4E and be manufactured from various strength magnets or ferro-magnetic material as suitable.

[0145] Additionally, said dorsal body may incorporate at least one coupler(s) 104 and said ventral module components 102 contain at least one said energy emitter coupling as indicated in FIG. 1A and FIG. 1C. Said energy emitter couplings providing electrical stimulation are manufactured from an electrically conductive material. Said electrically conductive materials include conductive ink, graphene, epoxy, plastic or metal surfaces and the like as convenient. Further, said electrically conductive material used for electrical contact with the skin may be plated with a noble, hypo-allergenic material such as gold, silver, palladium and the like. In the case of electric energy stimulation, said dorsal and ventral energy emitter couplers are nominally aligned such that electrical current path intersects the target nerve and/or nerve field to be stimulated.

[0146] Additionally, at least one said electrically conductive coupling contact surface may be a magnet or ferromagnetic material.

[0147] Additionally, at least one said magnet configured as an electrically conductive contact may be positionally adjustable in order to optimize proximity to a target nerve.

[0148] Additionally, said at least one dorsal body coupler(s) 104 and/or said at least one ventral module coupler(s) 107 may comprise photo-optical emitters. In such case the target nerve and/or nerve field to be stimulated lies beneath the contact of said coupler. In contrast to electrical energy stimulation that requires a conduction path between two electrical contacts through ear tissue, photo-optical emitted energy may be deposited in tissue from single point emitter contact, on the dorsal or the ventral side of the ear, as convenient, or on both sides of the ear if further research indicates advantages and/or benefits of multi-point or nerve intersecting photo-stimulation.

[0149] Additionally, said at least one dorsal body coupler(s) 104 and/or said at least one ventral module coupler(s) 102 may incorporate electromechanical-vibrational or piezoelectric-acoustic emitters. In such case the target nerve and/or nerve field to be stimulated lies beneath the contact of said coupler. In contrast to electrical energy stimulation that requires a conduction path between two electrical contacts, (ear tissue), only a single point energy emitter is required as convenient on the dorsal or the ventral side of the ear, or on both sides of the ear if further research indicates advantages and/or benefits of multi-point or nerve intersecting vibrational stimulation.

[0150] Additionally, a mix of electrical and/or photo-optic and/or vibrational energy emitters and couplers may be incorporated in combination.

[0151] Additionally, at least two electrical energy stimulation coupler contact poles may be incorporated on either or both of said dorsal body and/or on said ventral module to enable skin surface electrical conduction circuit path.

[0152] Additionally, a said ventral energy coupler of photo-optic type may integrate a photo-emitter and therefore connect to said dorsal body electromechanically by means of an electrical cable to said stimulation generator. Alternatively, said ventral photo-optic emitting energy coupler may connect photo-optically to said stimulation generator by means of a fiber optic cable with said photo-emitter located in said dorsal body.

[0153] Additionally, biofeedback sensors may be included as optical sensors configured for photoplethysmography. Said biofeedback sensors may be incorporated in either said dorsal body worn behind the ear, in a said ventral module worn of the ventral surface of the ear, or in both utilizing a proximity type, single sided photo-emitter pair, or a through-beam type. Said biofeedback may utilize discrete sensor components, or be designed as part of an energy stimulation coupler, for example whereby the photo-optic stimulation emitter also functions as a photoplethysmography emitter.

[0154] Additionally, said photoplethysmography emitter and/or detector may utilize fiber optic signal transfer between the target skin surface and the photo-electronic emitter and detector device.

[0155] Additionally, electrical sensors may be included as to monitor one or more types of electrical activity such as electrical conduction through the tissue between the dorsal and ventral sides of the ear; the electrical conduction across either or both sides of the skin surfaces of the dorsal and/or ventral; and the electric field strength as occurring proximal to the auricular nerve field areas.

[0156] The energy stimulation electronics package embodiments include a configuration wherein the electronics package is directly wired to the dorsal body by means of a cable 106 as shown in FIG. 1A or as an integrated, embedded version as shown in FIG. 1C. The directly wired version includes a multi-conductor cable from connected from an electrical stimulation unit to the dorsal body. In such embodiment, electrical connections are hardwired to selected energy stimulation emitters and/or sensors located in the dorsal body and/or ventral module couplers, as convenient. As such, the stimulation unit may be used as a standalone device to select operational protocols. The integrated, wireless ear-worn version necessarily includes a battery power source, power supply, microcontroller, wireless communication, and low level real-time stimulation generation and waveform synthesis electronics within the dorsal body as shown in FIG. 1C. As such, high level control features are provided by means of a personal wireless enabled computing platform 110 with high level user interface as conveniently provided by a conventional smart phone, tablet or the like.

[0157] Additionally, stimulation protocols settings including stimulation frequency, voltage, current, waveforms, session duration, session scheduling and the like are set by the user by means of a stimulation control unit whereby the generated stimulation signals are directly connected to the ear-worn dorsal body and/or ventral module couplers. In the case of a wireless connection between a personal computing platform and a wireless embedded unit, said stimulation protocol settings are set using said computing platform and transmitted as a data set to be executed under real-time control of an embedded controller.

[0158] Additionally, said control electronics of both the wired and wireless control embodiments incorporate current and voltage feedback to monitor and regulate the stimulation energy applied to the user according to set points as determined by an algorithm, directly input to the stimulation controller by the user, or received by remote download.

[0159] FIG. 3 is a block diagram illustrating an embodiment of a control system including a computer platform 110 used as a preferred means for user operational interface, to process and store control protocols for download to the stimulator unit 112 and to upload, process and store data from biofeedback sensors and to communicate with the internet, and the like. Said computer platform communicates with said stimulator unit by means of a local wireless communication interface 111 such as Bluetooth or the like. Said stimulator unit contains a controller based on processor such as a microcontroller with program memory 118, with memory allocation for protocol data table 116, communication I/O 117, analog input and signal conditioning 119 and waveform generator 120. Said stimulator unit also incorporates electronic circuitry such as voltage and current regulation amplifiers to provide stimulation signal output 115 to provide stimulation signals to the ear worn apparatus 100. Said stimulation unit also features an energy monitor 114 with signal conditioning electronics to input and condition output voltage 121 and current 122 thereby providing closed loop feedback to the controller electronics analog input in order to adjust the signals from the waveform generator. Said signal output feedback monitoring is advantageous in order to compensate for electrical resistance variations 128 realized by the ear worn apparatus 100 emitter couplers making contact with the user's skin.

[0160] FIG. 5A illustrates an embodiment incorporating a stimulator unit 112 connected to an ear worn stimulator apparatus 100. Said stimulator unit 112 communicates with a computer platform 110 receiving input from a standalone, external signal conditioning electronics package 125 inputting biofeedback sensor(s) 230.

[0161] FIG. 5B illustrates a stimulator unit 112 illustrating the integration of a controller 113, biofeedback signal conditioning electronics 125, energy monitoring electronics 114 and signal output 115. Biofeedback sensor(s) 230 are distinct and may be incorporated as part of the ear worn apparatus, or be externally worn by the user on various parts of the body.

[0162] FIG. 5C illustrates a an embodiment of a stimulator unit 112 integrating a controller 113, biofeedback signal conditioning electronics 125, energy monitoring electronics 114 and stimulation signal output electronics 115. Multiplexing electronics 126 time phases the switching of stimulation signal, energy monitoring signals and biofeedback signals under the control of said controller. Said multiplexer thereby enables the dual use of ear worn stimulator emitters with biofeedback sensor couplers 127. For example, such said emitter/sensor couplers may be photonic emitters also used for the purpose of photoplethysmography. Additionally, electrical emitters may serve as electrical sensor contacts to detect determined signals based on skin impedance, for example.

[0163] Additionally, said dorsal body incorporates at least one connector port for cable connection to at least one interchangeable ventral coupling module as convenient. Said connector port and associated cable serve to interface at least one and/or a combination of electrical, photonic or acoustic stimulation energy and/or biofeedback type signals between said dorsal body and said ventral module wherein electrical energy utilizes and electrical conductor, photonic energy utilizes optical fiber and acoustic energy utilizes an acoustic waveguide.

[0164] Additionally, said dorsal body and at least one ventral module may be conveniently manufactured utilizing conformable plastic material such as silicone rubber, ABS and the like, with appropriate durometer selected for form, fit and function in order to optimize wearing comfort and proper positioning of said coupling emitters. Said dorsal body and said ventral module components can also be overmolded or applied with secondary materials as well as conformable materials overmolded on stiffening structures as convenient. Said stiffening structures may also utilize materials including plastics, metals and/or compositions designed to stiffen as desired using temperature or photonic actuation.

Method Embodiments

[0165] In a further embodiment of the present invention, methods are employed to utilize the apparatus and data derived from user thereof In one method embodiment as illustrated in FIG. 6, the user with the ear worn stimulation apparatus 100 is monitored by a sensor array 230 providing anatomical biofeedback including photoplethysmography 231, body and/or limb positions 232 and body motion 233. Said anatomical biofeedback has been found by research to validate or invalidate the usefulness of other stimulation efficacy measures such as heart rate variability. As shown in FIG. 6, said sensory information is received and processed by an algorithm supervisory program 238. Said processed information is then received by an exceptions circuit program to examine said information to determine the user's body acceleration 235, changes in body position change 236 and limb motion 237. The results of said exception circuit analysis is then handled by the algorithm supervisor 238 utilizing information data from a knowledge database 239 and algorithm determinants 240 in order to provide any necessary adjustments to the stimulator unit 112 and thereby affect the stimulation process for the user.

[0166] A further methodology embodiment of the present invention include neurostimulation enhanced therapy procedures as illustrated in FIG. 7 which describes a sequence of grouped process phases administered over a period of time and includes a table of neural arousal correlates. A properly designed personal stimulation program would enable a therapist and user to construct, for example, a daily schedule of stimulation sessions to enhance the user's wellbeing. These correlates illustrate, as based on current research, recommended frequency ranges to be applied according to each of the group phases. A pre-intervention group 250 involves phase 1 relaxation 251 and phase 2 warm up 252; a therapeutic intervention group 253 involves phase 3 relaxation 254, phase 4 rest 255 and phase 5 training 256; and a post intervention group 257 involving phase 6 recover 258 and phase 7 normalize 259.

[0167] The first step in practical application requires a therapist to plan and map the key phases of the proposed therapy from each of the said groups. The second step is to compose or select from a pre-composed scale of therapeutically relevant neural arousal correlates as shown in the table in FIG. 7 an indexed continuum of neurostimulation frequencies. In the third step, each phase of the therapeutic intervention neurostimulation parameters are selected to provide the most beneficial neural arousal level per intervention phase. Once composed, said stimulation intervention programs could be then be selected by the user by means of single, easy to use icon button on a personal computing platform, smart phone, or the like.

[0168] While various embodiments of the present invention have been described above, it should be understood that they have been presented by of way of example only, and not of limitation. Likewise, the various diagrams may depict and example configurations for the invention, which is done to aid in understanding features and functionality that can be included in the invention. The invention is not restricted to the illustrated example configurations, but can be implemented using a variety of alternative configurations. Additionally, although the invention is described in terms of various exemplary embodiments and implementations, it should be understood that the various features and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which the are described, but instead can be applied, alone or in some combination, to one or more of the other embodiments of the invention, whether or not such embodiments are described and whether or not such features are presented as being part of a described embodiment. Thus, the breadth and scope for the present invention should not be limited by any of the above described embodiments.

[0169] Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term including should be read as to mean including without limitation or the like; the term example is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; and the adjectives such as conventional, traditional, normal, standard, known and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal or standard technologies that may be available or known now or at any time in the future. Likewise, a group of items linked with the conjunction and, should not be read as requiring that each and every one of those items be present in the groupings, but rather should be read as and/or unless expressly stated otherwise. Furthermore, although items, elements or components of the invention may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitations to the singular is explicitly stated. The presence of broadening words and phrases such as one or more, at least, but not limited to or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent.